linjc16/ctgov huggingface dataset:
14 Weeks Exercise Training on Lean Women With and Without PCOS

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to investigate the pathophysiology of PCOS in regards to the metabolic profile including defects in insulin sensitivity in skeletal muscle and adipose tissue, and to investigate the effects of exercise training on these parameters.

Official Title
-----------------
14 Weeks Exercise Training on Lean Women With and Without PCOS

Conditions
-----------------
Polycystic Ovary Syndrome (PCOS)

Intervention / Treatment
-----------------
* Other: 14 weeks exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with PCOS Hyperandrogenism and/or hyperandrogenemia Regular menstruation Age: 20-40 Inactive or low physical activity level Low to moderate fitness status Inclusion Criteria: Women without PCOS Normal levels of plasma androgens Polycystic ovary and/or menstrual dysfunction Age: 20-40 Inactive or low physical activity level Low to moderate fitness status Exclusion Criteria: Women with and without PCOS Pregnancy or breast feeding Smoking Use of birth control pills 3 mo before enrolment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lean PCOS training<br>14 weeks exercise training | Other: 14 weeks exercise training<br> <br> |
| Other: Lean healthy controls<br>14 weeks exercise training | Other: 14 weeks exercise training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to exercise training program as assessed by number of training sessions completed | Superviced training program - no. of training sessions are noted by trainer. Compliance must be higher than 80%. | 14 weeks | 
| No change in Body Weight |  | 14 weeks | 
| Component of metabolic syndrome | Hole body insulin sensitivity measured by HOMA index | 14 weeks | 
| Component of metabolic syndrome | Peripheral insulin sensitivity measured by hyperinsulinemic euglycemic clamp methods. | 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic Ovary Syndrome (PCOS)
Enrichment & Purging of Stem Cells in Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of purging the hematopoietic cell graft on outcomes for non-Hodgkin's Lymphoma.

Detailed Description
-----------------
To study the use of peripheral blood stem cells which have been treated in an effort to remove tumor cells. The researchers hope to learn whether or not this will be more effective in removing the tumor cells as compared to other methods of purging (the removal of cancer cells).

Official Title
-----------------
Enrichment and Purging of Stem Cells in the Treatment of Non-Hodgkin's Lymphoma

Conditions
-----------------
Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Procedure: high dose chemo then auto hematopoietic cell transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- relapsed NHL Exclusion Criteria:- liver dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: high dose chemo then auto hematopoietic cell transplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR positivity in peripheral blood cell collections after cyclophosphamide |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrichment of hematopoietic stem cells |  |  |
A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain.

Detailed Description
-----------------
This is a phase II, multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with chronic pain in the lower extremities due to diabetic peripheral neuropathy (DPN).

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EpiCept™ NP-1 Topical Cream in Patients With Pain From Diabetic Peripheral Neuropathy (DPN)

Conditions
-----------------
Diabetic Peripheral Neuropathy, Neuralgia

Intervention / Treatment
-----------------
* Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream
* Drug: placebo cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with chronic pain due to diabetic peripheral neuropathy (DPN) of at least 6 months duration are eligible if they have an average daily pain score of > 4 during the baseline week. Exclusion Criteria: Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments in this study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo cream<br>vehicle cream | Drug: placebo cream<br>* inactive placebo cream applied two times daily<br>|
| Active Comparator: amitriptyline 4% ketamine 2% cream<br>active topical cream | Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream<br>* topical cream applied daily for 4 weeks<br>* Other names: EpiCept NP-1;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks. | diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks. | baseline and 4 weeks treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DPN, Diabetic, Nerve Pain
Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH).

Official Title
-----------------
Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial

Conditions
-----------------
Subarachnoid Hemorrhage

Intervention / Treatment
-----------------
* Other: Liberal Red Blood Cell Transfusion Strategy
* Other: Restrictive Red Blood Cell Transfusion Strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old at time of presentation First ever episode aneurysmal SAH Confirmed aneurysmal SAH diagnosis: as confirmed by treating Neurosurgeon or Neuro-interventionalist and supported by blood in subarachnoid space (demonstrated on cranial imaging or cerebrospinal fluid positive for xanthochromia) that is the result of a ruptured saccular aneurysm (confirmed by cranial imaging - cranial topography or magnetic resonance imaging angiography or catheter angiogram) Incident hemoglobin ≤100g/L within 14 days following SAH (defined by first day of hospital presentation) Exclusion Criteria: Physician and or family decision to withdraw/withhold critical care at time of enrolment Active bleeding with hemodynamic instability at time of enrolment Patients with contra-indication or known objection to blood transfusions SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic and dissecting aneurysms, and aneurysms associated with arteriovenous malformations.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liberal RBC Transfusion Strategy<br> | Other: Liberal Red Blood Cell Transfusion Strategy<br>* RBC Transfusion strategy with hemoglobin trigger of 100g/L<br>|
| Active Comparator: Restrictive RBC Transfusion Strategy<br> | Other: Restrictive Red Blood Cell Transfusion Strategy<br>* Optional RBC Transfusion with hemoglobin trigger of <=80g/L<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Randomization Rate |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Transfusion
Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform

Study Overview
=================
Brief Summary
-----------------
Foot reflexology treatment provides acute and chronic effects on cardiovascular and hemodynamic functions. However, no information is available to us in regarding the treatment effect of foot reflexology after exercise. This study investigated the acute effect of foot reflexology treatment on heart rate variability after anaerobic-based and aerobic-based intermittent exercises.

Detailed Description
-----------------
The sympathetic activation and sympathy-vagal balance after repeat sprint performance can be immediately modulated by foot reflexology massage. The acute benefits of foot reflexology intervention on cardiac sympathovagal balance can be considered as exercise recovery strategies in sports.

Official Title
-----------------
Effects of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform After Yo Yo Intermittent Recovery Test and Repeated Sprint Test

Conditions
-----------------
Massage, Anaerobic Exercise, Aerobic Exercise

Intervention / Treatment
-----------------
* Other: Foot reflexology massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undertake football/futsal training at least 3 times a week Age between 18 and 30 years old Exclusion Criteria: History of severe neuromuscular injury Current lower extremity injury Current neurological diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foot reflexology massage group<br>The duration of intervention was 30 min (15 min massage duration for each leg) | Other: Foot reflexology massage<br>* Foot reflexology technique of Father Josef was used as massage intervention<br>|
| No Intervention: Control group<br>Rest for 30 min | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | 15 minutes resting electrocardiographic record at baseline and post-intervention phase | immediately following intervention phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial pulse waveform | 15 minutes resting arterial plethysmographic waveform at baseline and post-intervention phase | immediately following intervention phase | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart rate variability, Arterial pulse waveform
Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure

Study Overview
=================
Brief Summary
-----------------
Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Different patients experience different pain intensity. This suggests that there may be genetic variants that make some patients susceptible to analgesic failure. Using blood samples from patients, the investigators are going to analyze the relationship between single nucleotide polymorphisms (SNPs) in genes that are known to be involved in analgesic failure.

Official Title
-----------------
Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure After Single-port Video-Assisted Thoracoscopic Surgery

Conditions
-----------------
Pain, Postoperative, Thoracic Surgery, Video-Assisted, Polymorphism, Single Nucleotide

Intervention / Treatment
-----------------
* Genetic: Genetic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 70 and Age ≥18 Selective operation lung section with video-assisted thoracic surgery (VATS) III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I Patients informed and agreed to join the study Exclusion Criteria: Abnormal function of liver and kidney Allergic- dependence history of alcohol, opioids and Local anesthetics No noncompliance Mental disease history，language communication disorder，cicatricial diathesis Underweight or overweight（BMI<18 or >30) Patients not suitable for clinical subjects for other reasons Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24hours before the operation. History of previous abnormal anaesthesia Women during pregnancy or lactation

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 |
| --- | --- |
| Postoperative Analgesic Failure<br> | Genetic: Genetic analysis<br>* Collect 2ml intravenous blood from patients after anaesthesia.<br>|
| Postoperative Analgesic Success<br> | Genetic: Genetic analysis<br>* Collect 2ml intravenous blood from patients after anaesthesia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesic failure | Once patient experience at least one of the following situations: Bad patients sleep quality Require extra analgesic drug Low satisfaction with pain control Bolus times > 1 per hour | 8 a.m. at the first day after surgery. |
Once Daily Given Alfuzosin in the Treatment of BPH

Study Overview
=================
Brief Summary
-----------------
Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the course of everyday practice

Official Title
-----------------
Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Alfuzosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present Exclusion Criteria: Necessity of surgical intervention immediately or within 12 months because of BPH The patient has earlier /within 6 months/ obtained treatment because of BPH The patient did not improve on earlier alpha-1 blocker treatment Known hypersensitivity to alfuzosin Orthostatic hypotension in the history Concomitant application with another alpha-1 blocker Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/ Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/ Intestinal obstruction /because of the castor oil content of the drug/ Tumorous disease Severe, life threatening state The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH) |  | 6 months |
Study Comparing the PET Scan and MRI in Identifying Breast Malignancies in Women With Breast Abnormalities

Study Overview
=================
Brief Summary
-----------------
This is a study looking at advanced imaging such as PET/CT and MRI to see if they can provide a more accurate assessment of the patient with dense breasts or difficult to interpret mammograms. In addition, the ability to determine whether one or the other is more accurate or whether both together would be appropriate in this clinical situation, may be able to be measured. The MRI studies are very sensitive for detection of breast histopathology but less specific in differentiating between small low grade malignancies are more benign pathologies. Multifocal pathology can be challenging in determining site(s) for biopsy. PET scanning is specific in the measurement of metabolic glucose activity of various histopathologies and is accurate in differentiating aggressive from benign pathology in multifocal breast disease. A further drawback of PET is the lack of ability to observe lesions less than 3-4mm in diameter. In select cases the combination of MR and PET/CT is able to come to a more conclusive diagnosis - specifically with bilateral or multifocal breast disease.

Official Title
-----------------
Comparative Study of the Diagnostic Accuracy of Scintimammography (Fluorine 18-FDG PET Scintigraphic Imaging) and Magnetic Resonance Imaging in Identifying Malignant Breast Lesions, In Subjects With Breast Abnormalities

Conditions
-----------------
Breast Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman who have breast volumes allowing utilization of MRI breast coil Patients who are considered, by radiologist reading the mammograms, to have non interpretable or difficult to interpret x-ray studies. These patients may or may not have palpable breast lumps and may and may not have suspicious areas on their x-ray mammograms. Exclusion Criteria: Women of child bearing potential not practicing a medically accepted method of birth control Women who are pregnant or breast-feeding

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

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

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

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
-----------------
Radiology, MRI, Positron emission tomography, Breast Abnormalities, Dense Breast Tissue
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.

Official Title
-----------------
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Conditions
-----------------
Involutional Osteoporosis

Intervention / Treatment
-----------------
* Drug: ONO-5920


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis. Other inclusion criteria as specified in the study protocol. Exclusion Criteria: Patients having secondary osteoporosis or another condition that presents low bone mass. Patients having findings that affect measurement of lumbar spinal bone mineral density by DXA Patients that have been administered bisphosphonate derivatives. Other exclusion criteria as specified in the study protocol.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ONO-5920|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean bone mineral density of the lumbar spine (L2-4 BMD) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-5920, osteoporosis, bisphosphonate