linjc16/ctgov huggingface dataset:
The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players

Study Overview
=================
Brief Summary
-----------------
According to available data the injury rate in male veteran soccer is high. Interventions to prevent injuries are requested. The 11+ warm-up program was developed by FIFA-experts and consists of several exercises with an overall-length of about 20 min. This study shall investigate the influence of 11+ on injury incidence and Functional Movement Screen (FMS)-Score in male veteran soccer players. Additionally it is to be examined if there is a relationship between FMS-Score and injury incidence. For this purpose the 11+-program is accomplished under supervised conditions over one regular season in a randomized-controlled study design. Injuries are documented via questionnaires in accordance with the FIFA-consensus-statement. FMS-Score is evaluated before and after the interventional period.

Conditions
-----------------
Injury

Intervention / Treatment
-----------------
* Behavioral: FIFA 11+
* Behavioral: no FIFA 11+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male veteran soccer players aged 32 and older, who are member of a club veteran team; training and matches on a regular basis Exclusion Criteria: major time-loss injury, chronic inflammatory joint disease

Ages Eligible for Study
-----------------
Minimum Age: 32 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: warm-up with 11+<br>The FIFA 11+ is a complete warm up program aiming on reduce common soccer injuries | Behavioral: FIFA 11+<br> <br> |
| Placebo Comparator: control<br>the control group follows its regular training routine | Behavioral: no FIFA 11+<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| injury incidence | injury incidence (injuries per 1000h of soccer) | August 2011 - June 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
injury incidence, male veteran soccer, 11+, Functional Movement Screen, FMS, warm-up
SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether supplementation with SierraSil can improve anaerobic power and reduce muscle fatigue in a group of well-trained athletes. A secondary purpose is to examine the effect of SierraSil on the severity of delayed onset muscle soreness.

Detailed Description
-----------------
This is a double blind, crossover, pilot study that will examine the effect of SierraSil supplementation on the determinants of human performance. Anaerobic capacity, muscle fatigue, the severity of delayed onset muscle soreness (DOMS) and markers of inflammation will be measured before and after 3 weeks of supplementation with SierraSil or placebo. There will be a 3 week washout period prior to the crossover to ensure SierraSil supplementation has no residual effect.

Official Title
-----------------
SierraSil as an Ergogenic Aid to Performance in Athletes

Conditions
-----------------
Muscle Power, Muscle Fatigue

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no contraindications to strenuous exercise Exclusion Criteria: muscle or joint injury taking any form of anti-inflammatory or pain medication females due to the variability that might be introduced due to the phases of the menstrual cycle

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 35 Years

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

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: SierraSil<br>SierraSil will be given in a dosage of 3 to 5, 667 mg capsules, according to body weight, daily for 3 weeks. | Dietary Supplement: SierraSil<br>* SierraSil is a natural, mineral supplement currently used to improve joint health and function.<br>|
| Placebo Comparator: Placebo<br>This is a sugar pill and will be given in a dosage of 3 to 5 capsules daily for 3 weeks. | Dietary Supplement: Placebo<br>* Sugar pill manufactured to mimic SierraSil 667 mg capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in total anaerobic capacity |  | change from baseline at 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SierraSil, muscle power, muscle fatigue
Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. However, patients with low response to those agents are reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet therapy for individual patients based on platelet function assay may improve long-term outcomes especially in patients with high risk of thrombosis. In this prospective randomized study, patients in control group all receive standard dual antiplatelet therapy, and patients in optimized group receive different antiplatelet therapy according to risk stratification.

Official Title
-----------------
Pilot Study of Personal Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes

Conditions
-----------------
Ischemic Heart Disease, Acute Coronary Syndromes

Intervention / Treatment
-----------------
* Drug: cilostazol in addition to aspirin and clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-ST-segment elevated acute coronary syndromes patients undergoing selective or emergent PCI Exclusion Criteria: administration of clopidogrel or ticlopidine within 2 weeks ST-segment elevated myocardial infarction contraindications of antiplatelet therapy history of intracranial bleeding known bleeding disorders severe liver or kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: optimal antiplatelet<br>cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance | Drug: cilostazol in addition to aspirin and clopidogrel<br> <br> |
| Active Comparator: standard antiplatelet<br>aspirin and clopidogrel for all patients | Drug: cilostazol in addition to aspirin and clopidogrel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebral events at 1 year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhage events at 1 year |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemic heart disease, acute coronary syndromes, percutaneous transluminal coronary angioplasty, platelet function, aspirin, clopidogrel, cilostazol
Study of Use of Synera for Pain During Local Skin Infiltration With Lidocaine Before Epidural Placement

Study Overview
=================
Brief Summary
-----------------
Local infiltration with lidocaine prior to epidural placement for cesarean section, although brief, can be painful. This pain can lead to increased anxiety and distress, adversely affecting patient's overall experience. This study proposes to examine the application of Synera pain patch prior to lidocaine infiltration to reduce this pain and anxiety. The primary objective of this study is to determine the effect of the Synera on maternal experience during epidural placement. The efficacy of Synera pain patch in reducing subject pain during skin infiltration with lidocaine prior to epidural placement in subjects presenting for scheduled cesarean section will be assessed.

Official Title
-----------------
Randomized Study of the Use of Synera for Pain Relief During Local Lidocaine Needle Skin Infiltration for Epidural Placement in Subjects Undergoing Elective Cesarean Section.

Conditions
-----------------
Pain, Anxiety

Intervention / Treatment
-----------------
* Drug: Synera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old; Undergoing pre-scheduled cesarean section; Expected singleton birth; BMI <=35kg.m-2; Exclusion Criteria: Undergoing emergency cesarean section; Complications during pregnancy; History of hypersensitivity to study medication(lidocaine or tetracaine) or para-aminobenzoic acid; Allergies to bird proteins, feathers, or egg products; or any other skin allergies; dermatitis an open wound at the patch site or a history of difficult epidural placement;

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?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Synera<br>Synera Pain Patch | Drug: Synera<br>* Synera Pain Patch<br>|
| No Intervention: No patch control<br>No intervention group | |
| Sham Comparator: Control<br>Sham | Drug: Synera<br>* Synera Pain Patch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating of pain intensity upon lidocaine infiltration |  | 30 minutes (following patch placement , upon lidocaine infiltration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject anxiety |  | 1 hour (Upon admission to surgical holding area and after epidural placement) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subject
NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye

Study Overview
=================
Brief Summary
-----------------
Study is to assess the safety and efficacy of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions QD compared to vehicle for the treatment of the signs and symptoms of dry eye after a 3 month treatment period.

Official Title
-----------------
A Phase II, Multi-Center, Double-Masked, Randomized Study of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions Compared to Vehicle for the Treatment of the Signs and Symptoms of Dry Eye

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: NOVA22007 ''Cyclosporine''
* Drug: NOVA22007 ''Cyclosporine''
* Drug: vehicle/placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female 18 years and older Diagnosis of dry eye in both eyes Exclusion Criteria: Contraindications to the use of the study medications Known allergy or sensitivity to the study medications or their components Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test Have participated in an investigational drug or device study within 30 days of Visit 1

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cyclosporine 0.05% | Drug: NOVA22007 ''Cyclosporine''<br>* Cyclosporine 0.05% Ophthalmic Cationic Emulsions<br>|
| Experimental: 2<br>Cyclosporine 0.1% | Drug: NOVA22007 ''Cyclosporine''<br>* Cyclosporine 0.1% Ophthalmic Cationic Emulsions<br>|
| Placebo Comparator: 3<br>vehicle/placebo | Drug: vehicle/placebo<br>* vehicle/placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions |  | Approximately 13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye, Cyclosporine
Relationship Between Succinate Dehydrogenase Mutations and High-Altitude Illness

Study Overview
=================
Brief Summary
-----------------
This study is is the first step of a full study named CHEMOGENE because it explores the genetic determinant of an alteration of the chemoreflex. This reflex determines hyperventilation when the pressure of oxygen falls in the blood. This happens when subjects travel to high-altitude where oxygen levels diminish in the atmosphere. Subjects with such an altered chemoreflex are intolerant to altitude and develop pulmonary or cerebral edema associated with a severe headache. In this study we compare subjects tolerant to high altitude (8000 meters)to subjects intolerant to altitude. The chemoreflex is measured i.e. the hyperventilation associated with hypoxia and all subjects are scanned for the genes implicated in the mitochondrial respiratory chain. The idea is that subjects with an impaired oxygen sensing will exhibit an altered chemoreflex and will be intolerant to high-altitude.

Detailed Description
-----------------
Subjects are selected at an outpatient clinic specialised in the diagnosis of tolerance to altitude, where the chemoreflex is analyzed during a bicycle exercise performed with a oxygen deprived air simulating a 8000 meters altitude. All subjects will go later to high altitude for trekking usually. The patients are those subjects with an altered chemoreflex who exhibited cerebral edema or pulmonary edema during the trekking. The controls are the subjects with a normal chemoreflex who did not exhibit any trouble during their journey. Fourty subjects of each group are included. A blood sample is withdrawn and studied for succinate dehydrogenase genes in a blind fashion. After completing the inclusion the allelic mutations will be compared in the two groups.

Official Title
-----------------
Relationship Between Succinate Dehydrogenase Mutations and High-Altitude Illness Associated With Chemoreflex Failure

Conditions
-----------------
Altitude Intolerance, High-Altitude Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chemoreflex sensitivity measured (normal or pathologic) Journey to high-altitude (well tolerated or with a severe disease such as pulmonary edema or cerebral edema) Exclusion Criteria: Asthma, Arterial hypertension, Drug treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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
-----------------
Altitude, Anoxemia, Mitochondria, Reflex, Genetic research
Sun Protection Factor Assay (SPF Assay 18676)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment- Darkening Dose.

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY 987516)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: Arm 1<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY 987516)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation-SR15-78_Y73-167).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial

Study Overview
=================
Brief Summary
-----------------
This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.

Official Title
-----------------
Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis

Conditions
-----------------
Menopause, Postmenopausal Vaginal Atrophy

Intervention / Treatment
-----------------
* Drug: estradiol, 25 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy Postmenopausal Hysterectomized or non-hysterectomized Moderate or severe vaginal dryness and soreness Successful completion of the study VAG/PD/009/USA Exclusion Criteria: Known, suspected, or past history of breast cancer Known, suspected, or past history of hormone-dependent tumor Genital bleeding of unknown etiology Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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: estradiol, 25 mcg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of vaginal symptoms |  | over 12 months of treatment | 
| Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal health, vaginal cytology and urethral cytology |  |  |