linjc16/ctgov huggingface dataset:
Investigation of Muscle Activity Pattern of Gluteus Medius and Tensor Fascia Lata in Patients With PFPS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the muscle activity of gluteus medius and tensor fascia lata in health control group and patients with PFPS during submaximal isometric muscle contraction.The research question :Is there any difference of muscle activity of gluteus medius and tensor fascia lata between health control group and patients with PFPS during submaximal isometric muscle contraction ？Null hypothesis:There is no difference of muscle activity of gluteus medius and tensor fascia lata between health control group and patients with PFPS during submaximal isometric muscle contraction.

Detailed Description
-----------------
Basic data - Name, age, sex, BW, BH, pain VAS scale（VAS-activity）, affected side, dominate leg, symptom duration, activity level Measurement Flexibility of iliotibial band：Ober test EMG data collection during 8s submaximal muscle contraction Muscle strength measurement of hip abductors

Conditions
-----------------
Patellofemoral Pain Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-50 years old Insidious onset of symptoms Pain exist at least 3 month, VAS activity>4 Two of the following activities induce pain at anterior or retropatellar site prolonged sitting, stair-climbing, squatting, running, kneeling, and hopping/jumping Diagnosed by an orthopedic surgeon Exclusion Criteria: History of lower extremity fracture or operation Neurological disease involved Observed knee deformity Other well-defined musculoskeletal problems in lower extremity

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patellofemoral pain syndrome, electromyography, gluteus medius, tensor fascia lata
Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee.

Official Title
-----------------
A Multi Center, Randomized, Double Blind, Saline Controlled Study of a Single Injection of Durolane® Versus a Single Injection of Phosphate Buffered Saline (PBS) to Treat Pain Associated With Osteoarthritis of the Knee

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Durolane
* Device: PBS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) ≤ 35 kg/m2 Symptomatic osteoarthritis (OA) of the knee K L severity grade 1 or 2 If bilateral OA, contralateral knee K L severity grade 0 or 1 Exclusion Criteria: Has clinically apparent tense effusion of the index knee Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months Has any painful orthopedic disorders of the back or hip Has a joint disorder other than osteoarthritis in the index knee

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Durolane<br>Single intraarticular injection of Durolane | Device: Durolane<br>* 4.5 mL<br>|
| Placebo Comparator: PBS<br>Single intraarticular injection of PBS | Device: PBS<br>* 4.5 mL<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change in WOMAC VAS Pain Score From Week 6 to Week 30 | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain. | Up to 30 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Double-blind, Randomized, Intraarticular injection, Hyaluronic acid, Placebo, Knee osteoarthritis
Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety of lofexidine in the treatment of opiate withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to alleviate opiate withdrawal signs and symptoms.

Official Title
-----------------
Safety Evaluation of Lofexidine for Treatment of Opioid Withdrawal

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Lofexidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lofexidine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo® on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary hyperlipidemia or mixed dyslipidemia

Conditions
-----------------
Hyperlipidemia, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: NK-104-CR
* Drug: Placebo
* Drug: Livalo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with primary hyperlipidemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent; Fasting plasma LDL-C ≥160 mg/dL and ≤250 mg/dL and TG values of ≤300 mg/dL Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 6 weeks before randomization and throughout study participation Exclusion Criteria: Homozygous familial hypercholesterolemia; Any conditions which may cause secondary dyslipidemia. Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c >8%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NK-104-CR<br>Controlled release NK-104 | Drug: NK-104-CR<br>* NK-104-CR 8 mg daily for 52 weeks<br>|
| Placebo Comparator: Placebo<br>Livalo Placebo | Drug: Placebo<br>* Placebo daily for 12 weeks<br>|
| Active Comparator: Livalo® Immediate Release IR<br>Immediate Release Livalo® | Drug: Livalo<br>* Livalo® IR daily from week 12 to week 52<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in LDL-C from baseline |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change from baseline in fasting serum total cholesterol (TC ) |  | 12 Weeks |
Study Evaluating Single Ascending Doses of MR1817

Study Overview
=================
Brief Summary
-----------------
This is a first-in-human study of MR1817. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after administration of ascending single oral doses to healthy adult subjects.

Official Title
-----------------
A Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Doses of Orally Administered MR1817 in Healthy Adult Subjects

Conditions
-----------------
Adult

Intervention / Treatment
-----------------
* Drug: MR1817
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 1- Men or women of non-childbearing potential (WONCBP) aged 18 to 55 years inclusive at screening. 2- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg. 3- Healthy as determined by the investigator on the basis of screening evaluations. Exclusion criteria: 1- Presence or history of any disorder that may prevent the successful completion of the study. 2- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 3- History of drug abuse within 1 year before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MR1817<br> <br> |
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MR1817 plasma and urine concentration. |  | 6 weeks |
Fatigue and Cancer Treatment(FACT)- an Exercise Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized controlled trial is to determine the effects of a nurse-directed, home-based walking exercise program to mitigate fatigue and maintain physical functioning during adjuvant therapy for cancer. The sample will be randomized into exercise (EX) or usual care (UC) groups. The independent study variable is participation in a walking exercise program. Outcomes include: fatigue, sleep disturbance, emotional distress, physical functioning and quality of life. The effects of the walking exercise program will be evaluated using self-report questionnaires administered pre- and post-treatment, patient diaries, and symptoms assessments at defined intervals during adjuvant therapy

Official Title
-----------------
Mitigating Cancer Treatment-Related Fatigue by Exercise

Conditions
-----------------
Cancer, Fatigue

Intervention / Treatment
-----------------
* Behavioral: home based self paced walking program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of cancer (Stage 1,2,or 3), 21 years of age or older, Free of cognitive or physical deficits that would preclude entry into study, not currently exercising 120 min/wk or more Exclusion Criteria: Concurrent major health problems or disabilities that would limit participation in an exercise program. Stage 4 cancer (metastisis)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: home based self paced walking program|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatigue, Cancer treatment
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC

Study Overview
=================
Brief Summary
-----------------
A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

Official Title
-----------------
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: Herceptin (trastuzumab)
* Drug: SB3 (proposed trastuzumab biosimilar)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who received the study treatment of SB3-G31-BC. Subjects who provide informed consent. Exclusion Criteria: Subjects unwilling to follow the study requirements are not eligible for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Herceptin (trastuzumab)<br>Intravenous administration | Drug: Herceptin (trastuzumab)<br>* Intravenous administration<br>* Other names: Herceptin;|
| SB3 (proposed trastuzumab biosimilar)<br>Intravenous administration | Drug: SB3 (proposed trastuzumab biosimilar)<br>* Intravenous administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of congestive heart failure and LVEF decrease | Incidence of symptomatic congestive heart failure (CHF) NYHA class II, III, and IV and asymptomatic significant LVEF decrease | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HER2, Trastuzumab, Biosimilar, Cancer, Breast, Positive
Prevalence of Renal Artery Stenosis in Patients Referred for Cardiac Catheterization

Study Overview
=================
Brief Summary
-----------------
All patients referred for coronary angiography will simultaneously be evaluated for renal artery stenosis and then stenosis more than 50% will be analyzed according to clinical conditions, risk factors and lab data.

Detailed Description
-----------------
Renal Artery Stenosis (RAS) is a common finding in patients with generalized atherosclerosis. It is the cause of 15-20% of end stage renal disease in elderly patients. The prevalence of asymptomatic RAS in general population is unknown but it estimated to be 18% in 7th decade and more than 50% in the 8th. It is critical to find and manage the RAS before it's symptoms appear. The Gold standard for diagnosis of atherosclerotic arterial stenosis is angiography. In this study we will evaluate the prevalence, severity, location and related factors to renal artery stenosis in patients whom referred for coronary angiography in period of July-September in one of the most referral heart center in Iran, The Tehran heart center which is doing more than 50 coronary angiography daily.

Official Title
-----------------
Prevalence of Renal Artery Stenosis in Patients Refered for Cardiac Catheterization to Heart Center Hospital in July-September 2008

Conditions
-----------------
Renal Artery Stenosis

Intervention / Treatment
-----------------
* Procedure: angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18 years Exclusion Criteria: contraindication to contrast use not signing consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>patients with renal artery stenosis | Procedure: angiography<br>* all patients undergoing coronary angiography with VISIPAQUE and if they had coronary stenosis then renal artery angiography will be done. the dose of contrast will be chosen according to renal function and clinical conditions which will be varied from 75 to 300 ml.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Renal Artery Stenosis (RAS) |  | 2 months | 
| The Number of Patients With Renal Artery Stenosis | the prevalence of renal artery stenosis in patients with coronary artery disease | 3months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RAS(renal Artery Stenosis), Atherosclerosis, angiography
Influence of Heavy Metals Exposure on in Vitro Fertilization (IVF) Outcome

Study Overview
=================
Brief Summary
-----------------
Exposure to heavy metals may interfere with basic cellular functions, including DNA synthesis. The aim of the study is to correlate heavy metals concentration in body fluids of reproductive importance and IVF outcome.

Detailed Description
-----------------
Concentration of heavy metals will be measured in blood, urine, semen fluid and follicular fluid of IVF patients. Study group: poor prognosis patients: repeated IVF failure, implantation failure, poor ovarian response, low sperm quality (according to WHO criteria) Control group: Good prognosis patients. Normal sperm count. Heavy metals concentrations will be measured using atomic absorption spectrometer, and will be correlated with IVF outcomes: number of mature oocytes obtained, fertilizations, embryos quality, and reproductive outcome post embryo transfer.

Conditions
-----------------
Fertilization in Vitro

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age of female patients: <=39 Age of male patients: 18-50 Exclusion Criteria: Smoking Alcohol/drug abuse Long-term/chronic medications Severe health/mental problems Dental or other transplants Fragile X mutations Fertility preservation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate (take-home baby) | IVF cycle resulting in pregnancy that ends in a live birth. | 9 months from embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Gestational sac(s) seen by ultrasound 1 month after embryo transfer. | 1 month from embryo transfer |
Effectiveness and Safety of Yiqitongluo Granule for Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of the prospective study is to evaluate the effectiveness and safety of Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over China.

Official Title
-----------------
Phase IV Clinical Trial of Yiqitongluo Granule in the Treatment of Stroke With Qi-deficiency and Blood-stasis Syndrome

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Drug: Yiqitongluo granule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild and moderate ischemic stroke patient with 4-25 NIHSS score stable patients within 1 week to 3 months sign informed consent before study Exclusion Criteria: CT shows cerebral hemorrhage disease: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, and subarachnoid hemorrhage severe disturbance of consciousness dysphagia TIA hemorrhagic diathesis patient with malignant tumor whose expected lifetime is less than 3 months allergic constitution gestation period, lactation period, woman with the possibility or plan of pregnancy those who participated in other clinical trials within 3 months or taking part in other clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yiqitongluo group<br>Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks. | Drug: Yiqitongluo granule<br>* administered after dissolved<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Yiqitongluo for stroke measured by laboratory index |  | change from baseline laboratory index at 28(±7) days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Yiqitongluo for stroke with mRS | mRS: modified Rankin Scale | 90(±7) days | 
| Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine |  | 28(±7) days | 
| Effect of Yiqitongluo for stroke with NIHSS | NIHSS: the NIH stroke scale | 28(±7) days | 
| Effect of Yiqitongluo for stroke with BI | BI: Barthel Index | 28(±7) days | 
| Effect of Yiqitongluo for stroke with EQ-5D | The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. | 28(±7) days |