linjc16/ctgov huggingface dataset:
GnRH for Luteal Support in IVF/ICSI/FET Cycles

Study Overview
=================
Brief Summary
-----------------
During IVF cycles an embryo is generally placed into the uterine cavity between 3 and 5 days after fertilization. For a successful pregnancy to take place, that embryo must then implant in the properly primed and staged endometrium, which subsequently must continue to develop to accommodate the growing and maturing embryo and then fetus. This process is normally regulated by hormonal interactions between the fetal, endometrial and luteal tissue. It has been found that after IVF additional support for the endometrium with progesterone improves implantation and subsequent live birth rates in IVF cycle . Recent data has shown that additional supplementation with a single administration of a GnRH agonist around the time the time of embryo transfer may further enhance these rates .

Detailed Description
-----------------
see above

Official Title
-----------------
GnRH for Luteal Support in IVF/ICSI/FET Cycles

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: GnRH
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women undergoing IVF/ICSI or frozen embryo transfers (FET) that less than 40 years old. Exclusion Criteria: day 3 transfers

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH agonist<br> | Drug: GnRH<br>* single shot of GnRH agonist<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth per transfer |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rates |  | 4 weeks | 
| clinical pregnancy |  | 4 weeks | 
| rates of OHSS |  | 4 weeks |
Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia

Study Overview
=================
Brief Summary
-----------------
Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Assess the Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia

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

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males 45 to 64 years of age Lower urinary tract symptoms > 6 months International Prostate Symptom Score > 12 Exclusion Criteria: Prostate Specific Antigen > 3 ng/ml Residual urine volume > 150 m History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months Nitrate use Other exclusion criteria apply acc. to Summary of Product Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 64 Years

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

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: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 10 mg Vardenafil bid<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score and maximal urinary flow |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score, storing and voiding subscore |  | 8 weeks | 
| IIEF-EF domains score |  | 8 weeks | 
| Safety and tolerability |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign Prostate Hyperplasia, Vardenafil, Genital Disease, Male: Signs and symptoms of Benign Prostate Hyperplasia
Safety and Efficacy Study of Salvage Chemotherapy (R-ESHAP) to Treat Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. Various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. Improvement in efficacy by adding relatively new agent, rituximab, to chemotherapy is now widely accepted in non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP therapy.

Official Title
-----------------
Phase 2 Study of Rituximab and ESHAP (Etoposide, Methylprednisolone, Cytarabine, and Cisplatin) in Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

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

Intervention / Treatment
-----------------
* Drug: Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of aggressive non-Hodgkin's lymphoma Refractory to the first line chemotherapy or relapsed Expression of CD20 on lymphoma cells Measurable lesions on imaging studies Exclusion Criteria: Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration Circulating lymphoma cells equal to or more than 25,000/microliter Hepatic dysfunction Renal insufficiency Cardiac dysfunction or arrhythmia Sever infection (bacterial, viral) CNS involvement Other malignancies Pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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 |
| --- |
|Drug: Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response |  |  | 
| Safety |  |  | 
| Overall survival |  |  | 
| Progression free survival |  |  | 
| Effectiveness of peripheral blood stem cell collection |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aggressive non-Hodgkin's lymphoma, salvage chemotherapy, rituximab
Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR

Study Overview
=================
Brief Summary
-----------------
Primary objective: To compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group. Secondary objectives: To compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group based on measurements of timed up and go (TUG, as primary outcome), range of motion, pain and quality of life.

Official Title
-----------------
Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR

Conditions
-----------------
Osteoarthritis, Total Knee Replacement

Intervention / Treatment
-----------------
* Other: Hydrotherapy
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates for first total knee replacement surgery. Age over 18. Diagnosed with Osteoarthritis. Consent to participate in the trial. Exclusion Criteria: - Rheumatic diseases. Neurological diseases involving lower limbs. Prior knee surgery in operated knee. Secreting surgical wound. Skin diseases. Incontinence. Incapable of signing informed consent. Patients living outside Jerusalem

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 |
| --- | --- |
| Active Comparator: Physiotherapy<br> | Other: Physiotherapy<br> <br> |
| Experimental: Hydrotherapy<br> | Other: Hydrotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed up and go test |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford knee score |  | 6 weeks | 
| Visual analogue pain score |  | 6 weeks | 
| Range of knee motion |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Total knee replacement
Does a Multi-ingredient Pre-workout Supplement Enhance Cycling Time Trial Performance?

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to test the effect of ingesting a multi-ingredient pre- exercise supplement containing caffeine, creatine, beta-alanine and L-Citrulline compared to a placebo, on endurance exercise performance.

Official Title
-----------------
Does a Multi-ingredient Pre-workout Supplement Enhance Cycling Time Trial

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Dietary Supplement: Ladder Supplement
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion criteria: Any diagnosed metabolic health condition Pregnant Non-habitual caffeine intake Smoker No endurance training Diagnosed Cardiovascular disease Recent history of musculoskeletal injury Anti-depressant and anti-anxiety medication Inclusion criteria Age 18-40 Healthy Highly trained endurance athletes (V̇O2max: males >55 and females >50 mL⋅kg bm-1⋅min-1) Both males and females are allowed to participate. If females are on the oral contraceptive pill they are to be tested on consecutive weeks. If they are not on the oral contraceptive pill, then female subjects are to be tested every 4 weeks, at the same point of their menstrual cycle.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ladder Supplement<br>Ladder Supplement | Dietary Supplement: Ladder Supplement<br>* Caffeine 200mg L-Theanine 200mg L-Citrulline 6g Creatine 5g Beta-Alanine 1.6g Phosphatidylserine 100mg<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Performance | Work done during 15 min time trial (TT) | 15 Minitues | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alertness | Visual analog scale | 1 Hour | 
| Motivation | Visual analog scale | 1 Hour | 
| Rate of perceived exertion | Visual analog scale | 1 Hour | 
| Gas analysis | Analysis of expired gas | 1 Hour |
International Ledless Pacemaker Registry

Study Overview
=================
Brief Summary
-----------------
The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers. The aim of this multi-center study is to assess the clinical outcomes of patients implanted with Micra LLPM in real life, in different clinical scenarios.

Detailed Description
-----------------
The study includes consecutive patients implanted with a pacemaker leadless device (Micra Transcatheter Pacing System; Medtronic, Inc., Minneapolis, MN, USA). Baselines characteristics, procedural and clinical outcomes will be collected and analyzed.

Official Title
-----------------
International Ledless Pacemaker Registry (i-LEAPER)

Conditions
-----------------
Block Complete Heart, Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Leadless Pacemaker (Micra)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients implanted with the MIcra leadless pacing system At least 1 month of follow up At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Leadless Pacemaker (Micra)|Micra leadless pacemaker is implanted in the right ventricle via femoral vein. The Micra introducer/dilator assembled system is inserted over a stiff guidewire in the right atrium. After the removal of the guidewire and the dilator, the delivery system is advanced into the introducer and the Micra is placed under fluoroscopy guidance, preferably in the septal region of the right ventricle.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | overall mortality | through study completion, an average of 2 years | 
| Implant complication rates | Dislodgments, Cardiac perforation, vascular complications (access site). | during and immediately after the intervention | 
| Electrical performance of the pacing system | Pacing thresholds | Through study completion, an average of 2 years | 
| Electrical performance of the pacing system | R wave sensing | Through study completion, an average of 2 years | 
| Electrical performance of the pacing system | pacing impedances values | Through study completion, an average of 2 years | 
| Upgrading with a different pacing system | Need of an additional transvenous pacing system | Through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leadless pacing
The Effect of Sedation on Eye Movements

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether sedation affects saccadic eye movements.

Official Title
-----------------
The Effect of Sedation on Eye Movements

Conditions
-----------------
Saccadic Eye Movements

Intervention / Treatment
-----------------
* Drug: propofol
* Drug: dexmedetomidine
* Drug: Midazolam
* Drug: saline placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, human volunteers, age 19-65. American Society of Anesthesiology (ASA) class I-II for inclusion criteria Exclusion Criteria: Pregnancy Respiratory disease (severe asthma, emphysema) Cardiac disease (coronary artery disease, congestive heart failure) Symptomatic reflux disease Advanced rheumatic disease involving cervical spine Propofol or egg allergy Neurological disease (stroke, intracranial processes) Severe anemia

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol<br>active drug | Drug: propofol<br>* sedative<br>|
| Active Comparator: dexmedetomidine<br>sedative | Drug: dexmedetomidine<br>* Sedative<br>|
| Active Comparator: midazolam<br>Sedative | Drug: Midazolam<br>* sedative<br>|
| Placebo Comparator: placebo<br>placebo control | Drug: saline placebo<br>* saline placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Eye Movement Measures | Change in Eye Movements Parameters | baseline to Sedation State (approx. 1 hr) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedation, Eye Movements
Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection

Study Overview
=================
Brief Summary
-----------------
This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. Sentinel lymph node dissection may have fewer side effects than removing all lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors confirm the safety of the procedure.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To prospectively observe patients who receive radiation +/- chemotherapy immediately after lymph node dissection to confirm the safety of this procedure. OUTLINE: Patients receive standard therapy including sentinel lymph node dissection. Patients are then observed to collect information about treatment and outcomes every 2 months for 2 years.

Official Title
-----------------
GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study

Conditions
-----------------
Stage I Vulvar Cancer, Stage II Vulvar Cancer, Stage III Vulvar Cancer, Vulvar Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Other: Clinical Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have squamous cell carcinoma with a depth invasion > 1 mm Patients must have T1 or T2 tumors (International Federation of Gynecology and Obstetrics[FIGO] staging), < 4 cm, not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes Localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible Preoperative imaging do not show enlarged (< 1.5 cm) suspicious nodes Patients must sign informed consent Exclusion Criteria: Inoperable tumors with diameter > 4 cm Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (> 1.5 cm) suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases Patients with multifocal tumors Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial

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 |
| --- | --- |
| Observation (observe patients undergoing SLN dissection)<br>Patients receive standard therapy including sentinel lymph node dissection. Patients are then observed to collect information about treatment and outcomes every 2 months for 2 years. | Other: Clinical Observation<br>* Undergo observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of sentinel lymph node dissection |  | Up to 2 years |
Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness

Study Overview
=================
Brief Summary
-----------------
Certain lung disease medications can influence diagnostic tests and research investigations. This study will investigate how long ipratropium bromide must be withheld before a methacholine challenge test can be conducted. This information will be useful for validating current guidelines.

Official Title
-----------------
Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: ipratropium bromide
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma; stable and controlled FEV1 greater than or equal to 65% predicted Exclusion Criteria: Concomitant lung disease other than asthma

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: ipratropium bromide<br>* 2 puffs (40 micrograms) 2 puffs (0micrograms)<br>* Other names: Atrovent HFA Inhalation Aerosol;|
| Placebo Comparator: 2<br> | Drug: placebo<br>* Matched placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| methacholine PC20 |  | 6hours and 12 hours post inhalation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methacholine bronchoprovocation, Antimuscarinic