linjc16/ctgov huggingface dataset:
Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
Multicenter, Double-blind, Double-dummy, Randomized Parallel Group Study to Evaluate the Safety and Efficacy of SH D 00659 E for 6 Treatment Cycles in Female Patients With Acne Papulopustulosa in Comparison to SH D 00659 G and Placebo.

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Valette
* Drug: Diane
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with mild to moderate facial papulopustular acne Exclusion Criteria: Contraindication against use of hormonal contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Valette<br>* 1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles<br>|
| Active Comparator: Arm 2<br> | Drug: Diane<br>* 1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* 2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lesions |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ISGA |  | 6 months | 
| Parameters of safety and tolerability |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne papulopustulosa
SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
A 6-week, Multicenter, Double-blind, Double-dummy, Randomized Comparison of the Efficacy & Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

Conditions
-----------------
Schizophrenic Disorder

Intervention / Treatment
-----------------
* Drug: Seroquel Sustained Release (SR)
* Drug: Seroquel Immediate Release (IR)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate. Exclusion Criteria: Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and dependence, or medical conditions such as specific kidney, heart or thyroid problems, and patients with a known lack of response to drugs for schizophrenia will not be considered for this study.

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

| Intervention/Treatment |
| --- |
|Drug: Seroquel Sustained Release (SR)|nan|
|Drug: Seroquel Immediate Release (IR)|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome variable will be the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 
| To demonstrate a higher PANSS response rate |  |  | 
| To demonstrate superior Clinical Global Impressions (CGI) response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenic disorder
PSA Glycomics Assay for Early Detection of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.

Official Title
-----------------
Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer

Conditions
-----------------
PSA, Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: PSA Glycomics Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with elevated PSA (>3 ng/mL) Signed informed consent Exclusion Criteria: Patients that have a cystitis (bladder infection) Patients under chemotherapy Patients using 5-alpha reductase inhibitors History or presence of cancers, or non-prostate urological disorders.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PSA Glycomics Assay|PSA Glycomics Assay will be performed on urine and blood samples|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA Glycomics Assay | The relative abundance of glycoforms of PSA in plasma and urine from the subjects will be measured. These will be related to the stage of PCa and compared to non-prostate cancer patients. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, PSA, Glycomics Assay
Nipple Stimulation for Labor Induction

Study Overview
=================
Brief Summary
-----------------
This study will examine the use of nipple stimulation for cervical ripening in women who present to the labor and delivery ward after their water has broken but have a contraindication to prostaglandins.

Official Title
-----------------
Nipple Stimulation for Labor Induction: Efficiency, Safety and Satisfaction Measures

Conditions
-----------------
Delivery Delayed

Intervention / Treatment
-----------------
* Other: nipple stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Week 37 + 0 and on PROM (premature rupture of membranes) Multiparity (birth sixth or higher) or TOLAC (trial of labor after Caesarean section) Not in active labor - without regular contractions fetal monitor, cervical dilation < 4 cm and effacement < 80%. Exclusion Criteria: Water break > 24 hours at the time of admission to the delivery room Active vaginal bleeding with suspected placental abruption Maternal fever Multifetal pregnancy Women with contraindication for vaginal birth Preeclampsia IUGR (intrauterine growth restriction) Macrosomia Non-reassuring fetal heart tracing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: nipple stimulation<br> | Other: nipple stimulation<br> <br> |
| No Intervention: no intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression to active labor as measured by the Bishop score |  | 6 hours |
Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tracking for Head & Neck Cancer

Study Overview
=================
Brief Summary
-----------------
To determine if a new optical system that can track a patient's movement during treatment can be used to measure motion and allow for motion adjustments in order to decrease the amount of healthy tissue that receives radiation without limiting our ability to cure cancers using radiation.

Official Title
-----------------
Comparison of Intrafraction Motion in Patients With Head and Neck Cancer Using Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tracking

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Procedure: Radiotherapy
* Procedure: Align RT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with HNC undergoing radiation therapy at Stanford University Age >= 18 years old Radiation course >= 4 weeks duration Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Factors such as claustrophobia inhibiting use of thermoplastic mask immobilization device. Patients who are pregnant or nursing, which preclude them from undergoing active radiation treatment.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiation therapy arm<br> | Procedure: Radiotherapy<br>* Standard of care<br>* Other names: radiation oncology;Procedure: Align RT<br>* Standard of care<br>* Other names: Image-Guided Radiation Therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We are measuring how much a patient moves during treatment. |  | This information will be available immediately have the patient is treated. |
Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety of the combination of CHOP plus daclizumab in patients with ATLL previously untreated with anthracycline based chemotherapy.

Official Title
-----------------
HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)

Conditions
-----------------
HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)

Intervention / Treatment
-----------------
* Drug: CHOP-daclizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed ATLL requiring treatment Frank acute leukaemia or lymphoma subtypes Chronic and smouldering cases should be considered if they are symptomatic and require therapy, or there is evidence of disease progression No previous treatment with anthracycline based cytotoxic chemotherapy a. Patients may have received interferon and /or zidovudine and/or non-anthracycline based therapy Age 18-75 years Written informed consent Exclusion Criteria: HIV 1 or 2 positivity Pregnancy or breast-feeding Concomitant chemo-radiotherapy Prior hepatic or renal insufficiency with a bilirubin or transaminases greater than 5 times the normal range or a creatinine greater than 150μmol/l (not related to hypercalcaemia) following rehydration Other concomitant neoplasms not related to HTLV-I Cardiac or respiratory insufficiency with an ECOG score of greater than 3 Any serious active uncontrolled infection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHOP-daclizumab<br> | Drug: CHOP-daclizumab<br> <br> * Other names: CHOP-Zenapax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is to investigate whether a moderate weight loss (i.e. a weight reduction of at least 5%) could improve the response rate to a suboptimal dose of cyclosporine in patients with severe psoriasis.

Official Title
-----------------
Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial

Conditions
-----------------
Chronic Plaque Psoriasis, Obesity

Intervention / Treatment
-----------------
* Other: low calorie diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age,active but clinically stable plaque psoriasis involving at least 10 percent of the body surface area and a psoriasis area and severity index (PASI) score ≥10 and a body mass index ≥30. Exclusion Criteria: Other type of psoriasis (guttate, erythrodermic and pustular psoriasis) Uncontrolled hypertension Severe congestive heart failure Renal and liver impairment Active or chronic infections, including HIV, HBV and HCV infections, latent tuberculosis Previous or active malignancies Pregnancy and lactations Previous treatment with cyclosporine Phototherapy or any systemic or topical therapy for psoriasis within the previous 4 weeks before enrolment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: first group<br>patients who adhered to a low-calorie diet associated to sub-optimal cyclosporine dose (2.5 mg/Kg/day)for 24 weeks | Other: low calorie diet<br>* Low calorie diet was designed to achieve a loss of 5-10% of initial weight. All enrolled patients received a balanced diet scheme, based on a caloric intake reduction related to BMI and sex (range 1200-1500 Kcal/day for women, 1300-1600 Kcal/day for men). Calorie intake consisted approximately of 60% carbohydrates, 25% fat, 15% protein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary end point PASI 75 response |  | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary end point was % of body weight reduction |  | week 24 |
Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease

Study Overview
=================
Brief Summary
-----------------
Graves' disease (MIM 27500) is the leading cause of hyperthyroidism worldwide. The prevalence of Graves' disease is quite high (2.7% in women), and there is solid evidence of genetic predisposition. Despite its clinical and scientific significance, Graves' disease is still mysterious in terms of its susceptibility genes or pathophysiological mechanisms. The immune repertoire, being the sum of T and B lymphocytes in a body at any given time, is both a snapshot and a historical record of a person's immune function. Thanks to the power of next-generation sequencing (NGS), massively parallel sequencing of the B cell and T cell receptors suddenly becomes plausible, and opens a door for many creative approaches to study immune related diseases. The ultimate goal of this project is to use both the NGS deep sequencing and immune repertoire experiment to perform Graves' disease sub-group genetic fine mapping, and to identify Graves' disease-specific T cell and B cell receptors. Furthermore, using the immune repertoire approach, investigators want to study the critical epitopes of thyroid auto-antigens, and to delineate the pathophysiological steps in various disease stages and in various sub-groups. Investigators expect to solve the immune repertoire of Graves' disease of different sub-group presentations and at various disease activity stages.

Official Title
-----------------
Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease

Conditions
-----------------
Graves Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with Graves disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| B lymphocyte and T lymphocyte receptor profiles of Graves' disease patients | B lymphocyte and T lymphocyte receptor profiles mean the sequence of the receptors and also the quantity of the lymphocytes with those specific receptor sequences. | Three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immune repertoire, Graves' disease
GTA-Glyceryltriacetate for Canavan Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether oral supplementation of glyceryl triacetate improves the clinical prognosis of Canavan Disease.

Detailed Description
-----------------
Canavan Disease is caused by a deficiency in the enzyme named Aspartoacylase (ASPA). This disease is a devastating, progressive disease with no available treatment. As a result of the ASPA deficiency, there are high levels of N-acetylaspartate (NAA) and low levels of L-aspartate and acetate. We hypothesize that one of the functions of ASPA is to provide sufficient levels of acetate for CNS myelinization. For this reason, we offer to supplement acetate levels by the oral administration of glyceryl triacetate (GTA). Such treatment must be offered to patients before the age of 18 months, prior to the termination of CNS myelinization. Two patients, aged less than 15 months, will receive daily doses of oral GTA The daily dose will be increased incrementally until the maintenance dose is reached. This will be done under close monitoring of the patients, including periodic blood gas sampling. GTA has not been shown to cause any known toxicity, according to the Cosmetic Ingredient Review Expert Panel (Fiume, 2003).

Official Title
-----------------
Phase 1 Treatment With GTA in Two Infant With Canavan Disease

Conditions
-----------------
Infantile Canavan Disease, Deficiency Disease, Aspartoacylase

Intervention / Treatment
-----------------
* Drug: GTA: Glyceryltriacetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age below 15 months Biochemically diagnosed with Canavan Disease Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 15 Months

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: GTA: Glyceryltriacetate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All primary outcome will be evaluated 4 months following the initiation of treatment: |  |  | 
| Neurological Status |  |  | 
| Brain Imaging: MRI & MRS |  |  | 
| NAA Levels in Urine |  |  | 
| Ophthalmologic Examination |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Canavan Disease, Aspartoacylase Deficiency, NAA, Acetate, Glyceryltriacetate