linjc16/ctgov huggingface dataset:
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot study evaluating the recruitment strategies for sites and patients, data collection instruments, follow-up procedures, administrative processes, and the proposed management strategy for the future large scale national trial.

Official Title
-----------------
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Alendronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Females 65+ 2.3+ years of alendronate (Fosamax/Binosto) use 3. Valid social security number Exclusion Criteria: History of any other metabolic bone condition, such as Paget Disease of Bone Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer. Has significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 3 years)? HIV positive Involved in a conflicting (investigational drug) clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuation Arm<br>Alendronate continuation arm | Drug: Alendronate<br> <br> |
| Active Comparator: Discontinuation Arm<br>Alendronate discontinuation arm | Drug: Alendronate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Study Sites--Length of Contracting Procedures | Mean time Between Clinical Site Recruitment and Contract Execution | Length of time Between Clinical Site Recruitment and Contract Execution | 
| All Study Sites--Length of Time to Site IRB Approval | Mean time to gain site IRB approval | Length of time to site IRB approval | 
| All Study Sites-Length of Time to 1st Participant Enrolled | Mean time from study initiation to 1st participant enrolled. | Length of time t for sites to recruit/enroll 1st participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Fracture Rate | Patient reported fracture rate at 6 months following enrollment via survey. | Baseline to 6 months following enrollment | 
| Atypical Femoral Fracture | Patient reported fracture rate at 6 months after enrollment via follow-up survey | Baseline to 6 months following enrollment | 
| Osteonecrosis of the Jaw | Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey . | Baseline to 6 months following enrollment |
Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation in Parkinson's Disease.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate issues relating to comfort and tolerance to surface neuro muscular electrical stimulation in a parkinson disease population.

Detailed Description
-----------------
The comfort and tolerance of Parkinson Disease (PD) patients to surface neuro muscular electrical stimulation (NMES) will be investigated. Six muscle sites will be tested sensory, motor and pain thresholds recorded. Furthermore pain tolerance will be recorded as the level at which the stimulus is unbearable.

Official Title
-----------------
An Evaluation of Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation (NMES), When Applied to Parkinson's Disease Patients for Both Sensory and Motor Activation.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Device: NMES Device comfort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of idiopathic PD (UK, PD Brain Bank Criteria) A Hoehn and Yahr stage of 2 - 4 Exhibiting Freezing of Gait or another gait abnormalityin the ON or OFF state. An ability to mobilise independently for the purpose of research when in the 'off' state An ability to walk unaided for 10 meters. Exclusion Criteria: A serious cognitive impairment (MMSE<24) Pregnant or currently involved in another clinical trial. Uncontrolled heart problems Pacemakers On opioid or neuropathic pain medication

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMES Device comfort<br>NMES Device comfort, establishing Sensory, Motor and Pain thresholds. Max Pain tolerance is also established. | Device: NMES Device comfort<br>* NMES device, establishing Sensory, Motor and Pain thresholds and Pain tolerance.<br>* Other names: Device name: Duo-Stim;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort in response to neuromuscular electrical stimulation in Parkinson's disease. | Participants will be tested over a range of stimulation intensities at different muscle sites. Primary outcome measure will be patient comfort and tolerance to neuromuscular electrical stimulation. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Freezing of Gait, Neuromuscular Electrical Stimulation, Comfort, Pain tolerance, Pain, Sensory threshold, Motor threshold, Pain threshold
CellAdhesionMolecule EndometriosisRatio - CAMERA

Study Overview
=================
Brief Summary
-----------------
Background: Endometriosis, which is characterized by the growth of endometrial stroma and glands outside of the uterine cavity, is estimated to occur in 6-10% of women of reproductive age. Clinical presentation of endometriosis can vary widely, often significantly reducing quality of life, and the mean interval between the onset of symptoms and obtaining a definitive diagnosis is approximately 10 years. Currently, laparoscopy is the gold standard for diagnosing endometriosis; however, this procedure is invasive, carries surgery-related risks, and contributes to diagnostic delay. Therefore, the field has an urgent need for an efficient, sensitive, non-invasive tool for diagnosing endometriosis. Recently, it was shown that sVCAM-1/sICAM-1 ratio is a promising serum biomarker, which may lead to the development of a new, efficient, sensitive, non-invasive tool for diagnosing endometriosis, thereby potentially avoiding surgical interventions. Primary aim: To determine whether the serum sVCAM-1/sICAM-1 ratio can be used todiagnose endometriosis. Study design: Prospective multicenter validation study

Official Title
-----------------
The Soluble VCAM-1 / Soluble ICAM-1 Ratio as a Non-invasive Biomarker for Diagnosing Endometriosis - a Prospective Multicenter Validation Study

Conditions
-----------------
Endometriosis (Diagnosis), Identification of Biomarkers in Serum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unfulfilled desire for children chronic pelvic pain suspicion of endometriosis cysts myomas Exclusion Criteria: acute infections malign diseases drug abuse pregnancy infectious diseases

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br>participants undergoing a diagnostic laparoscopy and have a histologically confirmed Endometriosis | |
| controls<br>participants undergoing a diagnostic laparoscopy where no evidence of Endometriosis could be found | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sICAM and sVCAM in serum | levels of these two soluble adhesion factors in serum of patients and controls | up to 1 week |
Study of Ischemic Colitis Compared to Other Diagnoses in Patients With Lower Gastrointestinal Bleeding

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the demographic,laboratory,endoscopic, and outcomes of ischemic colitis patient presented with severe lower gastrointestinal bleeding compared to other diagnoses.

Detailed Description
-----------------
Secondary purpose of this study is to assess the risk factors for predicting diverticulosis versus ischemic colitis.

Official Title
-----------------
Ischemic Colitis Is a Common Cause of Severe Hematochezia and Patient Outcomes Are Worse Than With Other Colonic Diagnoses

Conditions
-----------------
Colitis, Ischemic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bright red blood clots or burgundy colored stool documented by a health care worker clinical or laboratory evidence of significant blood loss, manifested by any one of the following: (a) more than three bloody bowel movements in eight hours (b) a decrease of two grams of hemoglobin (Hgb) from baseline, or (c) transfusion of more than three units of red blood cell (URBC). Exclusion Criteria: age less than 18 year history of inflammatory bowel disease hypotension or shock refractory to resuscitation severe coagulopathy refractory to resuscitation (platelet count < 30,000; prothrombin time [PT]- more than 2 times normal; partial thromboplastin time [PTT]- more than 2 times normal) acquired immune deficiency syndrome or neutropenia the inability to provide informed consent documentation of anal disorders as a cause of bleeding such as internal hemorrhoids, anal fissures, polyps or cancer of the anal canal, and fistulae

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 |
| --- | --- |
| Ischemic colitis<br>Ischemic colitis, Diverticulosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical course and outcomes of the ischemic colitis group compared to other colonic diagnoses group |  | 12 year period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors and prediction of ischemic colitis versus diverticulosis as the cause of severe hematochezia |  | 12 year period |
Fall Risk Prediction and Reduction in Community Ambulators 65 Years of Age or Older

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the diagnostic efficacy of the Tinetti Assessment, Timed up and Go test (TUG) and Gait Speed on predicting fall risk in adults 65 years of age or greater who are community ambulators.

Official Title
-----------------
Fall Risk Prediction and Reduction in Community Ambulators 65 Years of Age or Older

Conditions
-----------------
Accidental Falls, Elderly, Ambulatory

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults 65 years or older who are community ambulators. Exclusion Criteria: known neurological disorder;limitation secondary to recent orthopedic condition; currently resides at skilled nursing facility

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Recommend assistive device | |
| Group 2<br>Consultation for PT assessment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effects of Medical and Surgical Weight Loss on Metabolism

Study Overview
=================
Brief Summary
-----------------
This study will follow ,morbidly obese subjects as they undertake weight loss before and after laparoscopic gastric banding, examining markers of glucose and lipid metabolism, adipokines and measures of body fat.

Official Title
-----------------
The Role of Adipocyte-derived Inflammatory Cytokines in the Pathogenesis of Diabetes, Dyslipidaemia, Atherosclerosis and Gastro-oesophageal Reflux Disease: the Effects of Medical and Surgical Weight Loss

Conditions
-----------------
Type 2 Diabetes, Obesity

Intervention / Treatment
-----------------
* Procedure: laparoscopic gastric banding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: morbidly obese subjects with type 2 diabetes or metabolic syndrome age <70 Exclusion Criteria: contra-indications to bariatric surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| 1<br> | Procedure: laparoscopic gastric banding<br>* standard surgical procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 6 months |
Assessment of Myocardial Injury in Simultaneous Pancreas and Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
Diabetic cardiomyopathy( DCM) is a major complication of diabetes and is a common cardiovascular complication independent of coronary artery disease and hypertension．Trial to assess of myocardial injury in recipients of simultaneous pancreas and kidney transplantation by nuclear magnetic T２ mapping technology.

Detailed Description
-----------------
Evaluate the changes of myocardial injury before and after SPK by cardiac magnetic resonance imaging (CMR), Evaluate the value of SPK in the repair of myocardial injury by comparing with the single renal transplant in recipients with diabetic nephropathy.

Official Title
-----------------
Assessment of Myocardial Injury in Recipients of Simultaneous Pancreas and Kidney Transplantation

Conditions
-----------------
Simultaneous Pancreas-kidney Transplantation, Diabetic Cardiomyopathy

Intervention / Treatment
-----------------
* Radiation: cardiac magnetic resonance(CMR) T2 mapping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with type 2 diabetes were treated with SPK; 2.No definite history of cardiovascular diseases (such as congenital heart disease, coronary heart disease, cardiomyopathy or valvular heart disease, etc.); 3. Preoperative hemodialysis 4. No history of heart failure Exclusion Criteria: Contraindications in cardiac magnetic resonance imaging；2.poorly controlled hypertension；3.CMR examination revealed marked hypertrophy of the left ventricular myocardium

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| SPKT<br>patients with end-stage diabetic nephropathy got simultaneous pancreas-kidney transplantation | Radiation: cardiac magnetic resonance(CMR) T2 mapping<br>* T2 value before transplant，3 month and 6month after transplant<br>|
| RT<br>patients with end-stage diabetic nephropathy got single kidney transplantation | Radiation: cardiac magnetic resonance(CMR) T2 mapping<br>* T2 value before transplant，3 month and 6month after transplant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of myocardial injury | Assessment of myocardial injury between two groups | 1year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SPK ,DCM,CMR
Testing the Efficacy and Safety of the WEI Nasal Jet

Study Overview
=================
Brief Summary
-----------------
Testing the efficacy and safety of the WEI Nasal Jet.

Detailed Description
-----------------
This is only initial thought and suggestions from the inventor Dr. Huafeng Wei. Principal investigator from each medical center interested in testing this new device should design their own clinical trials based on patient population and their own ideas for clinical trials. Just remind you that patient safety is number one and try all efforts to minimize patient risks during your clinical study.

Official Title
-----------------
Efficacy and Safety of the WEI Nasal Jet

Conditions
-----------------
Complication of Surgical Procedure

Intervention / Treatment
-----------------
* Device: Experimental group and control groupl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study. Exclusion Criteria: Patients with coagulopathy and tendency of nose bleeding. Patients with any diagnosed cardiac diseases (e.g. cardiac failure, angina, MI, cardiac arrhythmia. etc.) Patients with any diagnosed pulmonary disease (e.g. asthma, COPD, pulmonary embolism, pulmonary edema etc.) Pregnant patients Patients with liver failure Patients with kidney failure

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 58 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| wei group and control group<br>wei group(n=25) and control group(n=24) | Device: Experimental group and control groupl<br>* JET<br>* Other names: Control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lowest SaO2 in Wei JET group | Compare with Control group,there was no significant difference in lowest SaO2 in Wei JET group. | 2 second | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wei JET
Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to assess the impact of the factors ´bed rest´ and ´hypocaloric nutrition´ on endothelium-dependent vasoreactivity in healthy volunteers.

Detailed Description
-----------------
In a randomized, four-phase cross-over study the effect of simulated microgravity (13 days of bed rest), energetic restriction (-25%, fat reduced), and their combination on endothelium-dependent and -independent vasodilation will be compared with ambulatory control conditions. Using venous occlusion plethysmography cumulative intraarterial dose-response curves to endothelium-dependent (acetylcholine) and -independent (sodium nitroprusside) vasodilators will be constructed in 10 healthy male volunteers before and on day 13 of each of the four intervention periods.

Official Title
-----------------
Influence of Bed-Rest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: bed rest, hypocaloric nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:´ Healthy, male volunteers, age: 18-40 Able and willing to give written informed consent Exclusion Criteria: Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, smoking, hyperhomocysteinaemia) Regular medication and/or treatment with drugs within the last 4-6 weeks (exclusion has to be decided in each case) Acute or chronic illness Participation in clinical trial/blood donation within 2 month before the study Nicotine during 1 year before the study; drug and/or alcohol abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: bed rest, hypocaloric nutrition|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug-induced changes of forearm blood flow |  |  |