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Kunming Shi, China

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  • Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

    Phase

    3

    Span

    102 weeks

    Sponsor

    Beijing InnoCare Pharma Tech Co., Ltd.

    Hefei, Anhui

    Recruiting

  • To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A

    Phase

    3

    Span

    296 weeks

    Sponsor

    Gritgen Therapeutics Co., Ltd.

    Hefei, Anhui

    Recruiting

  • TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

    Phase

    3

    Span

    119 weeks

    Sponsor

    Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

    Hefei, Anhui

    Recruiting

  • Effect of Combined Aerobic and Resistance Exercise on Semen Quality Among Chinese College Students

    Investigators will conduct a randomized controlled trial to examine whether moderate-intensity combined aerobic and resistance exercise can improve semen quality. A total of 60 participants will be recruited from one university. Inclusion criteria were college students aged 18 to 24 who signed informed consent form, good health with no eating disorders, mental health disorders, chronic diseases, serious systemic illnesses, genitourinary diseases or infections, and were assessed as having "low" physical activity on the self-reported International Physical Activity Questionnaire (IPAQ), with sperm progressive motility of less than 32%, at least two evaluations at three-month intervals. Exclusion criteria include smoking, alcohol dependence, and use of drugs that affect sperm production function such as hormones and antibiotics within the past 3 months, and history of reproductive system surgery (e.g., cryptorchidism, postoperative varicocele). After stratification by BMI, participants were assigned 1:1 to the intervention and control groups. The intervention group will receive 12 weeks of moderate-intensity combined aerobic and resistance exercise training for 90 minutes three times per week on non-consecutive days. Aerobic exercise is carried out in the form of running and skipping rope, and resistance exercise involves different muscle groups in the upper and lower limbs of the body. All training sessions will be conducted daily at the same time (17:00-18:30) under the guidance of a professional physical education teacher and two trained postgraduate medical students. Before the start of the exercise intervention, participants in the intervention group will be tested to determine the maximum heart rate and the repetitions maximum (RM) of resistance training. Training sessions begin with a 15-minute warm-up period that includes jogging and dynamic muscle stretching. This is followed by 25 minutes of running/jumping rope on the playground. Each intervention participant will wear a heart rate armband (Polar OH1, Finland) for real-time heart rate detection to maintain achievement of a predetermined target heart rate and training intensity. Target heart rate of moderate-intensity = maximum heart rate x 64%~76%. Then, after 10 minutes of rest adjustment and preparation, a 25-minute resistance training session will be performed, including all major muscle groups. Exercises for upper body muscles such as push-ups, pull-ups, and bench press; Lower body exercises included leg press, squats, and supine leg raises; and exercises for core muscle groups such as planks, sit-ups, and hip bridge. Resistance training will start at 50% of 1RM and increases intensity by 10% after every three sessions, with two sets of repetitions and 60-90 seconds of rest between sets. By the third week, it will reach 70% of 1RM, and repeat 3 sets at 70% of 1RM starting at week 4. After the end of week 6, re-evaluate the RM every 3 weeks and repeat 3 sets at 70% of the new 1RM (i.e., starting from Week 7 and Week 10), maintaining a 60-90 second rest between each sets. During resistance training the heart rate is likewise detected to be in the target heart rate. The Borg rating of perceived exercise (RPE) is combined with target heart rate for monitoring exercise intensity during exercise implementation. RPE will be applied at the end of warm-up, aerobic exercise, and resistance exercise to assess the subjective perception of participants during exercise. RPE scores of 12-13 indicate moderate intensity. After resistance training, investigators will perform a 15-minute relaxation session that includes slow walking and static muscle stretching. The control group did not receive exercise intervention and maintained their original physical activity habits. All participants were required to maintain normal dietary habits during the study period. The primary outcome of this study is to compare the change of sperm progressive motility between intervention and control groups from pre- to post-intervention at 12 weeks.

    Phase

    N/A

    Span

    25 weeks

    Sponsor

    Anhui Medical University

    Hefei, Anhui

    Recruiting

  • Clinical Studies for the Treatment of Advanced Solid Tumors

    Phase

    1/2

    Span

    78 weeks

    Sponsor

    Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

    Hefei, Anhui

    Recruiting

  • Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty

    The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application. The main questions it aims to answer are: Does the Orthopedic Joint Surgery Navigation System improve the accuracy of prosthetic component placement in knee replacement surgery? Is the Orthopedic Joint Surgery Navigation System superior to traditional total knee replacement What medical problems do participants encounter when taking medication ABC? Researchers will compare the Orthopedic Joint Surgery Navigation System with traditional total knee replacement surgery (using a "four-in-one" osteotomy guide) to see if the Orthopedic Joint Surgery Navigation System is superior to traditional total knee replacement in terms of prosthesis three-dimensional position, force alignment, patient satisfaction, functional scores, complications, etc. Participants will: End-stage knee osteoarthritis patients receive total knee replacement with the Orthopedic Joint Surgery Navigation System or traditional total knee replacement surgery Visit the clinic for examination and testing every 3 months Record their imaging data, satisfaction, functional scores, complications, etc.

    Phase

    N/A

    Span

    196 weeks

    Sponsor

    The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui

    Recruiting

  • A Phase II Study on Recombinant Botulinum Toxin Type a (YY001) for Injection in the Treatment of Upper Limb Spasticity in Adults

    Phase

    2

    Span

    35 weeks

    Sponsor

    Chongqing Claruvis Pharmaceutical Co., Ltd.

    Hefei, Anhui

    Recruiting

  • Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia

    Screening period: D-14~D0 (D1 recorded on the day of chemotherapy drug infusion) Subjects who planned to receive induction chemotherapy for the first time signed informed consent for this study, completed screening period examination, checked the inclusion criteria before drug infusion, and successfully screened subjects received CINV(chemotherapy-induced nausea and vomiting) prophylaxis regimen including Dolasetron mesylate injection. Treatment observation period: D1~D5 (beginning of study drug administration - 120 h after chemotherapy drug infusion) Subjects who met all inclusion criteria and did not meet any exclusion criteria were required to complete pre-chemotherapy CINV prophylaxis 30±10 min before induction chemotherapy drug infusion, as described in the administration protocol. The time of starting infusion of chemotherapy drugs (referring to other chemotherapy drugs except hormone drugs in the chemotherapy regimen) was recorded as 0 h, and the subsequent days were calculated as 24 hours. Within 120 h after the start of chemotherapy infusion, if the subject had at least one episode of vomiting, retching, or nausea and complained of antiemetic therapy, the investigator evaluated the subject and gave remedial antiemetic therapy, which was determined by the investigator. Within 120 h after the infusion of chemotherapy drugs, the subject or guardian will fill in the occurrence of vomiting/retching and nausea daily through the subject's diary. If there were any omissions in the subjects' diaries, the researchers would remind the subjects to fill in the contents through phone calls and wechat. Follow-up period: D6~D7 (or until this discharge, whichever occurs first) Adverse events were collected from D6 to D7 after chemotherapy drug infusion began (or until this discharge, whichever occurred first), and the relevant data were recorded in the study medical records and EDC(Electronic Data Capture) system.

    Phase

    N/A

    Span

    58 weeks

    Sponsor

    Anhui Provincial Children's Hospital

    Hefei, Anhui

    Recruiting

  • Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis

    [18F]AlF-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [18F]F-DCFPyL PET/CT.

    Phase

    1

    Span

    54 weeks

    Sponsor

    Anhui Provincial Hospital

    Hefei, Anhui

    Recruiting

    Healthy Volunteers

  • Long-term Impact of Inhaled Tobramycin for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE II)

    Individuals with bronchiectasis are particularly susceptible to infections from Pseudomonas aeruginosa (PA), which can become chronic and lead to increased mortality and disease severity. To address this critical issue, we have designed a multi-center, 2×2 factorial randomized, double-blind, placebo-controlled trial known as the ERASE study. This trial aims to evaluate the efficacy and safety of Tobramycin Inhalation Solution in the eradication of Pseudomonas aeruginosa in bronchiectasis patients with newly or firstly isolated PA. Building upon the findings of the ERASE study, the ERASE II study seeks to investigate whether successful eradication of PA influences the long-term prognosis of patients after the completion of the randomized controlled trial. To achieve this, we plan to extend the observation period to a total of 36 months, comprising the initial 9 months of the ERASE study, followed by an additional 27 months of comprehensive follow-up. This extended observation period will enable us to assess the long-term impact of eradication therapy on various clinical outcomes, including patients' quality of life, lung function, frequency of pulmonary exacerbations, frequency of hospitalization, and overall economic treatment costs. Additionally, we will evaluate the timing of any potential reinfections/relapse with Pseudomonas aeruginosa, thereby providing valuable insights into the long-term benefits of eradication strategies in patients with bronchiectasis.

    Phase

    N/A

    Span

    168 weeks

    Sponsor

    Shanghai Pulmonary Hospital, Shanghai, China

    Hefei, Anhui

    Recruiting

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