linjc16/ctgov huggingface dataset:
Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigational study is to determine if a study medication is safe and effective in reducing the symptoms associated with endometriosis; if the study medication reduces the need for pain medication for endometriosis symptoms; and if the study medication improves a participant's ability to carry out daily activities. Qualified participants will receive no cost treatment, which may include study-related examinations, diagnostic procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified participants will also receive study medication at no cost. As a participant, the study volunteer may also experience the satisfaction of knowing she is helping the advancement of women's health care.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Effect of ERB-041 in the Reduction of Symptoms Associated With Endometriosis in Reproductive-Age Women

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: ERB-041


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical diagnosis of endometriosis within 5 years Not pregnant and not lactating Willing to use non-hormonal contraception, history of regular menstrual cycles Exclusion Criteria: Hysterectomy, surgical treatment for endometriosis within 3 months Certain medications for the treatment of endometriosis Previous history of a malignancy Abnormalities on physical or gyn exams and abnormal lab tests

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ERB-041|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effects and to compare the safety profile of an investigational |  |  | 
| medication on the relief of endometriosis-related symptoms. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and subject assessment of symptoms related to endometriosis and the |  |  | 
| use of analgesia to relieve symptoms. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis
Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo

Study Overview
=================
Brief Summary
-----------------
To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo

Detailed Description
-----------------
Approximately 5-20 per 100,000 persons are afflicted with SSHL annually, and nearly 20-60% of SSHL patients complain of simultaneous vertigo.The aim of this study was to evaluate the prevalence of vestibulocochlear lesions in sudden sensorneural hearing loss(SSHL) with vertigo, as well as the role of vestibular rehabilitation in the prognosis of SSHL with vertigo.

Official Title
-----------------
Vestibular Function and Vestibular Rehabilitation in Sudden Sensorneural Hearing Loss With Vertigo

Conditions
-----------------
Vestibular Disorder

Intervention / Treatment
-----------------
* Behavioral: Vestibular rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A rapid onset sensorineural hearing loss of more than 30 dB for at least three contiguous audiometric frequencies within a period of 3 days, according to standard AAO - HNS; Within 10 days from onset; Without other virus infectious disease within three months. Exclusion Criteria: BPPV; Meniere's disease and vestibular migraine. With certain Known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, Hunt syndrome, etc

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non-training group<br> | Behavioral: Vestibular rehabilitation<br>* Vestibular Rehabilitation Exercises<br>|
| Experimental: training group<br> | Behavioral: Vestibular rehabilitation<br>* Vestibular Rehabilitation Exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 1(before treatment) | Vestibular function status in SSHL with vertigo at stage 1(before treatment) | before treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 weeks after treatment) | Vestibular function status in SSHL with vertigo at stage 2(2 weeks after treatment) | 2 weeks after treatment | 
| Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 months after treatment) | Vestibular function status in SSHL with vertigo at stage 2(2 months after treatment) | 2 months after treatment |
Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin inducing agent for sickle cell anemia patients.

Detailed Description
-----------------
: High level of fetal haemoglobin (Hb F) decreases sickle cell anaemia (SCA) severity and leads to improved survival. Butyrate proved to increase HbF production in vivo and in vitro studies. Nonetheless, its short half-life limited its utilization in clinical practice. Gum Arabic (GA) is edible, dried, gummy exudate from Acacia Senegal tree. GA fermentation by colonic bacteria increases serum butyrate concentrations. The investigators hypothesized regular intake of GA will increase serum butyrate level. The latter will induce fetal hemoglobin production and ameliorate patients' symptoms. 47 patients hemoglobin SS aged 5-42 years, on regular follow up in Military hospital were recruited from April 2014 to January 2015 Patients received dose of G A 30g/day for 12 weeks. Hb F, complete blood count and Erythropoietin level were measured. The main outcome of interest was the level of HbF after 12 weeks.

Official Title
-----------------
Potential Role of Gum Arabic as Fetal Hemoglobin Agent in Sudanese Sickle Cell Anemia Patients

Conditions
-----------------
Sickle Cell Anemia

Intervention / Treatment
-----------------
* Dietary Supplement: Gum Arabic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 5 year old less t5han 50 diagnosed with homozygous sickle cell anemia by Hb electrophoresis Exclusion Criteria: 1. patients received blood transfusion within the last three months or admitted to the hospital within 2 weeks because of Sickle cell anemia -related events or crisis.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrevention arm<br>Patients received Gum Arabic as intervention | Dietary Supplement: Gum Arabic<br>* oral ingestion of 30 gram every day for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study will be the level of fetal hemoglobin after three months | fetal hemoglobin will be measured each month for three months | 12 weeks |
Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance - Impact on Outcome

Study Overview
=================
Brief Summary
-----------------
In acute myocardial infarction cardiovascular magnetic resonance imaging can retrospectively detect the myocardium at risk and the irreversible injury. This allows for quantifying the extent of salvaged myocardium after reperfusion as a potential strong end point for clinical trials and outcome. The aim of the present study is to determine the prognostic significance and determinants of myocardial salvage assessed by CMR in reperfused ST-elevation myocardial infarction (STEMI).

Official Title
-----------------
Prognostic Significance and Determinants of Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance in Acute Reperfused Myocardial Infarction

Conditions
-----------------
ST-Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Other: magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ST-elevation myocardial infarction < 12 hours primary percutaneous coronary intervention Exclusion Criteria: previous myocardial infarction prior fibrinolysis contraindications to CMR at study entry (such as implanted pacemakers, defibrillators, claustrophobia or metallic intracranial implants)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Acute myocardial infarction patients<br>Patients undergoing primary percutaneous coronary intervention in ST-elevation myocardial infarction plus magnetic resonance imaging | Other: magnetic resonance imaging<br>* magnetic resonance imaging is used for prognosis assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial salvage, cardiovascular magnetic resonance, magnetic resonance imaging, myocardial infarction, prognosis
Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.

Official Title
-----------------
A Randomized, Double-blind, Multicentre, Phase II Controlled Trial Assessing ZACTIMATM (Vandetanib) Against Placebo in Prolonging the Off-treatment Interval in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: vandetanib
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of prostate cancer Prostate specific antigen (PSA) greater than or equal to 5 ng/mL Recent completion of first hormone treatment [intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue] Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1) Exclusion Criteria: Bone or soft tissue metastases Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vandetanib<br>300 mg orally, once daily for up to 18 months | Drug: vandetanib<br>* 300 mg orally, once daily for up to 18 months<br>* Other names: Zactima;|
| Placebo Comparator: Placebo<br>orally, once daily for up to 18 months | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) |  | 78 weeks during off-treatment phase of ADT | 
| Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL) |  | From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL | 
| Serum Testosterone Levels |  | Change from baseline at each visit post-randomization until until week 78 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, hormone treatment
Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with cancer hospitalized for an acute medical illness have an increased risk of venous thromboembolic events. Although international guidelines suggest the use of thromboprophylaxis in these patients, the recommendations are based on studies which included a percentage of patients with cancer without primarily focusing on this high risk group. Since patients with cancer present an increased risk of bleeding complications it is critical to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies suggest a limited use of thromboprophylaxis in these patients. The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in medical cancer patients hospitalized for an acute medical disease. Design: observational, prospective study Primary end-point: incidence of major and clinically relevant non major bleeding during hospitalization Secondary endpoints: frequency of use, doses and contraindications for pharmacological thromboprophylaxis; venous thromboembolic events up to three months after discharge

Official Title
-----------------
Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

Conditions
-----------------
Hemorrhage, Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with cancer hospitalized for an acute medical illness Exclusion Criteria: current use of oral or parenteral anticoagulant treatment no informed consent to participate

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 |
| --- | --- | --- |
| Major bleeding and clinically relevant non major bleeding |  | Participants will be followed for the duration of hospital stay, an expected average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism |  | Participants will be followed up to 3 months after discharge, an expected average of 13 weeks | 
| Minor bleeding |  | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
Interrater Reliability of Subjective Pupillary Assessments

Study Overview
=================
Brief Summary
-----------------
Prospective, observational, non-randomized study of interrater reliability of pupillary assessments, comparing two clinical assessments to the Pupillometer.

Conditions
-----------------
Interrater Reliability Among Pupillary Assessments

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are eligible for this study if they have been diagnosed with some form of brain trauma (e.g., stroke, traumatic brain injury, aneurysm) Exclusion Criteria: Prisoners Under 18 years of age

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 |
| --- | --- | --- |
| 1. Explore the Interrater Reliability of Pupillary Assessments When Conducted in the Natural Setting by a Diverse Group of Practitioners | Two human assessors conducted and recorded the results of a clinical pupillary assessment on one patient within 5 minutes of one another. The researcher then conducted and recorded pupillary information on the same patient (within the same 5 minute window) using the NeurOptics Pupillometer. | 9 months of pupillary assessments |
Program for Cardiovascular Prevention and Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Develop and evaluate a model of organization and management in the management of patients with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control and treatment effectiveness.

Official Title
-----------------
Management Models for Cardiovascular Risk Reduction in Primary for Brazil: Developing a Program for Cardiovascular Prevention and Randomized Clinical Trial

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Support for the Family Health Team


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of hypertension (> 140/90 mmHg) Age > 40 years Sitting: USF da Restinga e Extremo Sul - USF Chapéu do Sol and USF Paulo Viaro Exclusion Criteria: Institutionalized individuals Patients with mental illness or disabling chronic illnesses Users of health services belonging to the supplementary health Individuals with life expectancy less than 1 year

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| No Intervention: Educational program<br>Educational Program with Professional Physical Education, Pharmacist and Nutritionist | |
| Experimental: Educational program and individual care<br>Educational program and individual care with professional Physical Education; Pharmacist and Nutritionist | Behavioral: Support for the Family Health Team<br>* Participation in physical educator, dietitian and pharmacist in primary health care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | Change from baseline in Systolic Blood Pressure at 6 months |
A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
=================
Brief Summary
-----------------
Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study will be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment with corticosteroids.

Official Title
-----------------
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Biology, and Clinical Effects of Interferon Gamma-1b Administered Subcutaneously to Patients With IPF Followed by an Open-Label Extension

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: Interferon-gamma 1b


Participation Criteria
=================
Eligibility Criteria
-----------------
Male or Female 20-79 years old

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon-gamma 1b|200 mcg, SQ, 3x per week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in percent predicted FVC, resting arterial blood gas assessment of alveolar-arterial oxygen gradient, percent predicted DLCO, dyspnea scale, baseline dyspnea index/transition dyspnea index |  | 23 weeks |