linjc16/ctgov huggingface dataset:
Multi-country, Multi-center Cohort Study of Anti-Mullerian Hormone Profile in Asia Pacific Infertile Patients

Study Overview
=================
Brief Summary
-----------------
This study is to detect the infertile couple (women) Anti-Mullerian Hormone (AMH) profile in major subgroups such as Poly Cystic Ovarian Syndrome (PCOS), Endometriosis, etc via age intervals and ethnic difference.

Detailed Description
-----------------
To consecutively enroll infertile couple (women) who are undergoing their first controlled ovarian stimulation cycles. To mainly compare the inter-ethnic difference in age-specific AMH profile in unexplained infertility, male factor infertility, PCOS, Endometriosis etc. subgroups. To detect the influence of past or present smoking on age-specific AMH levels To study the influence of body mass index (BMI) on age specific AMH levels

Official Title
-----------------
Multi-country, Multi-center Cohort Study of Anti-Mullerian Hormone Profile in Asia Pacific Infertile Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as infertile couple Naive patients who plan to enter their first ovarian stimulation cycles Women among 20-43 years old Exclusion Criteria: Systematic disease that impact AMH (eg. systemic lupus erythematosus (SLE), Crohn's disease etc.) Chemotherapy history Alcohol abuse Currently taking oral contraceptive pills

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 43 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 |
| --- | --- | --- |
| Anti-mullerian hormone level in general population | Inter-ethnic difference in age-specific AMH level | within 3 months before controlled ovarian stimulation cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-mullerian hormone level in PCOS patients | AMH level in PCOS patients vs non-PCOS patients in age-specific intervals | within 3 months before controlled ovarian stimulation cycles | 
| Anti-mullerian hormone level in endometriosis patients | AMH level in endometriosis patients vs non-endometriosis patients in age-specific intervals | within 3 months before controlled ovarian stimulation cycles |
Satisfaction and Recovery After Trigger Finger Release

Study Overview
=================
Brief Summary
-----------------
Trigger finger release is one of the most common procedures in hand surgery. However, little is known about the patient perceived outcome directly after surgery and the timespan to recovery of normal hand function.This study focuses on patient reported outcome scores within the first six weeks after surgery.

Detailed Description
-----------------
Patients scheduled for release of trigger finger are assessed regarding the following outcome measures: VAS score for pain VAS score for finger movement VAS score for fréquence of triggering HAKIR questionnaire (validated instrument for hand function in the Swedish national hand registry) Quick-DASH questionnaire. After surgery, the patients records the following outcomes: Each day: 1,2,3 and records of pain medication details Each week: 4,5 for 6 weeks

Official Title
-----------------
Satisfaction and Recovery After Trigger Finger Release- a Prospective Cohort Study With Weekly PROMs

Conditions
-----------------
Trigger Finger Disorder

Intervention / Treatment
-----------------
* Procedure: trigger finger release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trigger phenomenon and/or Tenderness volarly to MCP joint of affected finger/thumb Patient scheduled for trigger finger release Signed informed consent Exclusion Criteria: Concomitant hand injuries/ conditions Multiple fingers/thumbs to be treated Unable to read/understand instructions in Swedish

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: trigger finger release|The A1 pulley and tendon sheath is divided in local anaestethic through a small incision in the palm|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-assessed hand function | change in total score of hand-specific questionnaire (HAKIR) week by week. Best score 100, worst 0 | every week for 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (assessed by patient) | change in Visual Analouge Scale-score day by day (0= worst, 10=best) | 6 weeks | 
| Movement of finger (self-assessed by patient) | change in Visual Analouge Scale-score day by day (0= worst, 10=best) | 6 weeks | 
| Frequency of trigger phenomenon (self-assessed by patient) | change in Visual Analouge Scale-score day by day (0= worst, 10=best) | 6 weeks |
Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg Tablets, administered as a 1 x 800 mg tablet, under fed conditions.

Official Title
-----------------
A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Ibuprofen Tablet Formulations in Normal, Healthy Men and Women Following Standard Meal

Conditions
-----------------
Bioequivalency

Intervention / Treatment
-----------------
* Drug: Ibuprofen Tablets, 800 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men or women, 18 years of age or older body mass index between 19 and 30 willing to participate and sign a copy of the informed consent form Exclusion Criteria: history of allergy or hypersensitivity to ibuprofen recent history of drug or alcohol addiction or abuse pregnant or lactating women use of tobacco products during the past 3 months evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant receipt of any drugs as part of a research study within 30 days prior to study dosing

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Product<br> | Drug: Ibuprofen Tablets, 800 mg<br> <br> |
| Active Comparator: Reference Product<br> | Drug: Ibuprofen Tablets, 800 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioequivalency, ibuprofen
Studies on the Expression and Functions of RLIP76 in Blood Samples of Healthy Human Subjects

Study Overview
=================
Brief Summary
-----------------
RLIP76 (Ral binding protein1) is a 76 kDa splice variant protein encoded by the human gene (RALBP1, 18p11.22). It is a multifunctional modular protein found ubiquitously from Drosophila to humans, in cells ranging from red blood cells to endothelial cells of the brain. Its expression more predominant in breast, heart, liver and less so in colon and brain parenchyma.

Detailed Description
-----------------
RLIP76 is shown to be over expressed in a variety of cancer cells. However, no study has yet been done on its expression on normal cells. The studies proposed in this project will study the expression of RLIP76 in blood cells of healthy human subjects in the population of North Texas region.

Official Title
-----------------
Studies on the Expression and Functions of RLIP76 in Blood Samples of Healthy Human Subjects

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as defined by lack of serious health conditions or diseases Exclusion Criteria: Children, pregnant women, prisoners, persons with any medical condition that precludes phlebotomy and persons unwilling or unable to provide consent will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Expression of RLIP76 in red blood cells and white blood cells of 100 healthy human subjects. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the RLIP76 mediated transport of glutathione conjugates and chemotherapeutic drugs. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RLIP76, Cancer, apoptosis
Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This study involves the use of an experimental product, TG4010. The purpose of the study is to determine if TG4010 can stimulate the body's immune system to help it fight the cancer.

Detailed Description
-----------------
The experimental product, TG4010, is a modified vaccinia virus (already used in humans) into which two (2) genes have been placed. One gene is for a protein (MUC1) found in cancer cells. The second gene is for human interleukin 2 (IL2) which the body's immune system makes to help it fight cancer. The TG4010 is given as an injection under the skin (subcutaneous) once a week for six weeks followed by a schedule of every three weeks or every three weeks for the first twelve (12) weeks. If the therapy is working, it can be continued for up to 9 months until no further improvement or until the patient gets worse for as long as it is tolerated.

Official Title
-----------------
Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Biological: MVA-MUC1-IL2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rising PSA after surgery or radiation for prostate cancer Exclusion Criteria: Metastasis or local disease Prior hormone treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MVA-MUC1-IL2|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenocarcinoma of the prostate
A Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a modified protocol of constraint-induced movement therapy (CIT) is effective in rehabilitation treatment of arm paresis in children with cerebral palsy. In these children one main problem the non-use of the affected arm. Many studies showed that the non-use phenomenon can by reversed by the CIT, a rehabilitation program consisting of 15 days of restraining the unaffected arm plus a daily intensive (6 hours/day) physiotherapy training of the paretic arm. The present study aims at evaluating if a shortened CIT protocol (restraining device plus only 2 weekly hours of physiotherapy) is effective in improving use and function of children paretic arm

Official Title
-----------------
Phase1 Effectiveness of a Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy: a Cross-Over Study

Conditions
-----------------
Hemiparesis, Cerebral Palsy

Intervention / Treatment
-----------------
* Behavioral: Modified Constraint-induced movement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of mild-moderate arm paresis (after cerebral palsy) enabling to reach and grasp a pellet age between 1-10 years active participation during proposed activities parents consent for participation - Exclusion Criteria: presence of severe behaviour disturbances presence of severe mental retardation (QI<60)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Modified Constraint-induced movement therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm Use Test |  | Four months for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm Function Test |  | Four months for each patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Children, Cerebral Palsy, Arm, Paresis
Acute Comfort of Lubricant Eye Drops FID 112903

Study Overview
=================
Brief Summary
-----------------
To evaluate the acute comfort and blurring profile between two artificial tears in dry eye patients.

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

Intervention / Treatment
-----------------
* Other: Lubricant Eye Drops FID 112903
* Other: Optive Lubricant Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of dry eye Must not have worn contact lenses for 1 week preceding enrollment Exclusion Criteria: Age related

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubricant Eye Drops FID 112903<br>Lubricant Eye Drops FID 112903 1 drop each eye one time | Other: Lubricant Eye Drops FID 112903<br>* Lubricant Eye Drops FID 112903 1 drop each eye 1 time<br>|
| Active Comparator: Optive Lubricant Eye Drops<br>Optive Lubricant Eye Drops 1 drop each eye 1 time | Other: Optive Lubricant Eye Drops<br>* Optive Lubricant Eye Drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop Comfort Upon Instillation | Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable. | Three minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, Artificial tear
The Effect of GCSF in the Treatment of ALS Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.

Official Title
-----------------
The Effect of Granulocyte Colony Stimulating Factor (GCSF) in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Patients Referred to Tehran Imam Khomeini and Shariati Hospital Centers in 2013

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: Granulocyte Colony Stimulating Factor
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 85 definite or probable ALS according to revised El Escorial criteria maximum 2 years from initiation of symptoms to study entry mild to moderate disability according to revised ALS functional rating scale (ALSFRS-r) Exclusion Criteria: familial ALS pregnancy or lactation myeloproliferative or hematologic disorders active immunological disease liver or renal or heart disease HIV positive significant cognitive disorder hypersensitivity to GCSF

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Granulocyte Colony Stimulating Factor<br>Granulocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously | Drug: Granulocyte Colony Stimulating Factor<br> <br> |
| Placebo Comparator: Placebo<br>normal saline 0.01 ml/kg/day for 5 days subcutaneously | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's function | based on revised ALS Functional Rating scale (ALSFRS-r) | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mobilizing bone marrow stem cells | based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting | 1 year | 
| amplitude of compound muscle action potential in ulnar and peroneal nerve | based on compound muscle action potential (CMAP) measured in nerve conduction study | 1 year | 
| quality of life | based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40) | 1 year | 
| muscle power | based on Muscle Manual Test (MMT) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyotrophic Lateral Sclerosis, Granulocyte Colony Stimulating Factor
Comparing Pleth Variability Index (PVI) Measurements at Different Sensing Locations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the suitability of the ear and forehead as a better site for measure of fluid responsiveness.

Detailed Description
-----------------
The aim of this study is to compare Pleth Variability Index (PVI) measurements at different sensor locations in respect to signal quality, sensor fit to site location and fluid responsiveness. PVI will be measured at 3 different sensor sites: the fingers, ear lobes and forehead. The ability to predict fluid responsiveness will be analyzed using cardiac output as the reference value.

Official Title
-----------------
Comparing PVI Measurements at Different Sensing Locations

Conditions
-----------------
Fluid Imbalance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Undergo any type of surgeries under general anesthesia in UCI Medical Center Mechanically ventilated during surgery Arterial line placement is preferred but not required Agree to sign the consent and HIPAA forms Exclusion Criteria: Less than 18 years of age Pregnant women Refused to sign the consent and HIPAA forms Receive vasoactive medication prior to surgery Has these conditions: hypotension, hypothyroidism, moderate or poorly controlled hypertension, chronic poorly-controlled diabetes, heart failure patients, and patients with active airway flow obstruction, left ventricular dysfunction, intra-cardiac shunts, right ventricular dysfunction, atrial fibrillation, arrhythmias patients with surgeries at or around site of sensor placement Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PVI measurement of fluid responsiveness | The primary outcome is to test the ability of PVI recorded at the finger and at the ear to predict fluid responsiveness. | Intra-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Goal-directed fluid therapy