linjc16/ctgov huggingface dataset:
Chlamidia Antibodies Test for Tubal Factor Screening

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the usefulness of a Chlamydia Antibody Test for screening of tubal factor in patients who undergo artificial insemination.

Official Title
-----------------
Chlamidia Antibodies Test for Tubal Factor Screening

Conditions
-----------------
Sterility

Intervention / Treatment
-----------------
* Other: CAT test
* Other: Histerosalpingography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 38 years FSH < 12. Treatment intrauterine insemination Exclusion Criteria: Insulin dependent diabetes Thyroid disease Severe male factor Policystic ovarian syndrome Previous abdominal or uterine surgery Prevous abdominal or genital infections Uterine myomas Hidrosalpinx Uterine congenital abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Arm A performs a CAT test to study tubal factor causes | Other: CAT test<br>* A CAT test is performed in order to diagnose tubal factor causes<br>|
| Experimental: Arm B<br>In Arm B a histerosalpingography is performed. | Other: Histerosalpingography<br>* A Histerosalpingography is performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy outcome using the two different treatments. | Pregnancy rate, cumulative pregnancy rate and ectopic pregnancy rate in order to evaluate de usefulness of the CAT test as a predictor of tubal pathology. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chlamidia Antibody test, Hysterosalpyngography, Tubal disease
Modafinil for the Treatment of Cocaine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.

Detailed Description
-----------------
This is a double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.

Official Title
-----------------
Modafinil for the Treatment of Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Modafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must have DSM-IV diagnosis of cocaine dependence as determined by SCID. Must be seeking treatment for cocaine dependence. Must be able to understand and provide written informed consent. Exclusion Criteria: Please contact the study site for more information.

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine abstinence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Brain Cell Injury in Patients With A First Episode of Psychosis

Study Overview
=================
Brief Summary
-----------------
Patients experiencing a first episode of psychosis may have brain cell damage due to a chemical process called oxidation. This study will compare patients with psychosis to healthy volunteers to determine if there are differences in their blood that reflect oxidative brain cell damage.

Detailed Description
-----------------
Preliminary research indicated that impaired antioxidant defense and increased lipid peroxidation is associated with brain changes during the onset of psychosis. Oxidative cell injury may contribute to poor outcomes in some patients. This study will define the extent and nature of oxidative cell injury that is associated with psychopathology at the onset of psychosis. Participants in this study will be patients at the D. D. Eisenhower Army Medical Center who are experiencing a psychotic episode for the first time. Patients will be compared with 40 healthy volunteers (control group) matched with patients for age, gender, education, ethnic background, and occupational status. Patients and volunteers will have blood tests to determine the level of oxidative cell injury. Tests will be performed at onset of psychosis, and after 6 and 12 weeks of neuroleptic drug treatment. Medical histories and MRI scans will be used to examine the relationship of the laboratory tests to the clinical presentation.

Official Title
-----------------
Oxidative Cell Injury: First Episode Psychotic Patients

Conditions
-----------------
Psychoses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must meet clinical diagnostic criteria for psychosis Healthy (control) volunteers must not have any family history of mental illness

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 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
-----------------
Complementary Therapies
A Randomized Trial of L-735,524, An Inhibitor of the HIV Protease Enzyme, and Interleukin-2 in Persons Infected With HIV (NOTE: Only For Patients Who Previously Completed NIAID 93 CC-113)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study L-735,524, which is an inhibitor of the HIV protease enzyme. It will be used with interleukin-2 in patients infected with HIV.

Official Title
-----------------
A Randomized Trial of L-735,524, An Inhibitor of the HIV Protease Enzyme, and Interleukin-2 in Persons Infected With HIV (NOTE: Only For Patients Who Previously Completed NIAID 93 CC-113)

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate


Participation Criteria
=================

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Genetic Diagnosis and Human Growth Hormone Treatment in Small for Gestational Age Children With Short Stature

Study Overview
=================
Brief Summary
-----------------
This study is a multi-center, retrospective and non-interventional research. In this study, a total of 150 short children who were small for gestational age and had been treated with recombinant human growth hormone (rhGH) are selected for genetic testing. The aims of this study are to analyze the genetic etiology of SGA children with short stature, and to compare the efficacy and safety of rhGH treatment in subjects with different etiologies.

Official Title
-----------------
Genetic Diagnosis and the Response to Recombinant Human Growth Hormone Treatment in Small for Gestational Age Children With Short Stature

Conditions
-----------------
Small for Gestational Age Infant, Silver-Russell Syndrome, Genetic Diseases, Inborn

Intervention / Treatment
-----------------
* Genetic: Blood collection for genetic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single birth, clinical diagnosis of SGA; rhGH treatment beginned before puberty (Tanner stage I), regardless of gender; Before starting rhGH treatment, height was lower than -2 SDS compared with normal children of the same age and sex; All the subjects and their guardians signed the informed consent and the informed consent for genetic testing. Exclusion Criteria: No efficacy and safety data were recorded after treatment with rhGH; A history of blood transfusion within 3 months before the collection of the genetic blood samples, or a history of bone marrow transplantation between rhGH treatment and the enrollment in this study; Other conditions that the investigator considered unsuitable for inclusion in this study.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 20 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 |
| --- | --- |
| short stature children born small for gestational age<br>This group was defined as a group of children whose birth weight and/or birth length equal or less than -2 SD for sex and gestational age, and who had failed to catch up in growth, remaining short after 2 years old. | Genetic: Blood collection for genetic analysis<br>* Genetic tests in this study are sequential testing, including MS-MLPA, whole exome sequencing, whole genome sequencing, as well as RNA-seq.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic testing | To detect the disease-causing genes of SGA children with short stature | At baseline |
Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
Sympathetic activation is a hallmark of end-stage renal disease and adversely affects cardiovascular prognosis. Hypertension is present in the vast majority of these patients and plays a key role in the progressive deterioration of renal function and in the exceedingly high rate of cardiovascular events. Selective catheter-based renal denervation has been shown to be safe and effective in attaining improved and sustained blood pressure control in patients with resistant hypertension and normal renal function. The investigators hypothesize that catheter-based renal denervation is a safe and effective intervention to achieve sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular outcomes.

Official Title
-----------------
Renal Denervation to Improve Outcomes in Patients With End-stage Renal

Conditions
-----------------
End-stage Renal Disease, Hypertension

Intervention / Treatment
-----------------
* Procedure: Renal Denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: end stage renal disease hypertension (BP≥140/90mmHg) Exclusion Criteria: Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist. Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Renal denervation using a catheter-based Radio-frequency approach | Procedure: Renal Denervation<br>* Renal Denervation<br>* Other names: Symplicity Renal Denervation Catheter;|
| No Intervention: Usual Care<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure change | Difference in the reduction of systolic office blood pressure between the renal denervation and control group at 6 months after the procedure | 6 months |
A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.

Official Title
-----------------
A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Drug: Dalcetrapib (RO4607381)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-75 years of age; CHD, including patients with other CHD risk factors; treated appropriately for dyslipidemia; clinically stable. Exclusion Criteria: previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine; recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident; severe anemia; uncontrolled hypertension; poorly controlled diabetes.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dalcetrapib (RO4607381)<br> | Drug: Dalcetrapib (RO4607381)<br>* 600mg po daily for 24 months<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* po daily for 24 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Mean Wall Thickness |  | 24 months | 
| Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance |  | 6 months | 
| Change From Baseline in Vessel MR Determined Plaque Anatomy |  | Up to 24 months | 
| Blood Lipids,Lipoproteins |  | Throughout study | 
| Biomarkers |  | Up to 24 months | 
| CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure |  | Throughout study |
Mass Balance Study of [14C] TAS-205 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-205 following oral single doses.

Official Title
-----------------
A Phase 1 Open-label Study Evaluating the Pharmacokinetics and Mass Balance of [14C] TAS-205 in Healthy Volunteers

Conditions
-----------------
Healthy Male Subjects

Intervention / Treatment
-----------------
* Drug: TAS-205, [14C]TAS-205


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Healthy adult male who provided written informed consent to participate in the study Aged 20 years or older and younger than 40 years at the time of informed consent Capable of oral intake. Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0 Key Exclusion Criteria Had current or previous hypersensitivity or allergy to drugs Had current or previous drug abuse (including use of illicit drugs) or alcoholism Had any concurrent disease (including symptoms and signs; however, diseases that do not affect valuations in the study such as asymptomatic pollinosis and wart are excluded) Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration Had blood pressure, pulse rate, and body temperature meeting any of the following at screening: Systolic blood pressure: <90 mmHg or ≥140 mmHg, Diastolic blood pressure: <40 mmHg or ≥90 mmHg, Pulse rate: <40 beats per minute (bpm) or ≥100 bp, Body temperature: 35.0°C or ≥37.1°C

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

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

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: TAS-205, [14C]TAS-205<br> | Drug: TAS-205, [14C]TAS-205<br>* single oral administration under fasted conditions on day 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205 |  | Day 1 to Day 8 | 
| Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate into urine and feces. |  | Day 1 to Day 8 | 
| Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces). |  | Day 1 to Day 8 | 
| Plasma, urinary, and fecal metabolite profiles of TAS-205 , and structural estimation. |  | Day 1 to Day 8 |
Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
Glaucoma is a leading cause of blindness worldwide. Non-adherence to glaucoma medication, which may result in loss of vision, is known to be prevalent. Available information regarding adherence to prescribed medical therapy suggests that some apparent treatment failures may actually be due to non-adherence. The investigators' specific aim is to conduct a study that will examine the effect of a glaucoma educator intervention on adherence to topical glaucoma therapy. The investigators' hypothesis is that patient education and counseling delivered by a trained glaucoma educator, through both planned visits and telephone contacts, will increase adherence to topical glaucoma therapy.

Official Title
-----------------
Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Behavioral: standard of care
* Other: education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary or secondary open angle glaucoma. Currently on monotherapy drop treatment for glaucoma. Age > 18 years. Patient has presented for care at the Rocky Mountain Lions Eye Institute Glaucoma Center. Exclusion Criteria: Inability to independently administer eye drops due to physical disability as reported by the patient. Cognitive impairment that would interfere with the ability to self-administer medications as evidenced by a TICS score < 16. Patients who demonstrate > 80% adherence to glaucoma treatment during the 30 day run-in period. It is anticipated that the patient will require glaucoma surgery within the next six months.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>education | Other: education<br>* meet with trained glaucoma educator 6 times over life of study<br>|
| Placebo Comparator: 2<br>standard of care | Behavioral: standard of care<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary outcome is adherence. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences between patients randomized to standard of care and education intervention. |  | 6 months | 
| differences between dropouts and non-dropouts. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, patient educator