linjc16/ctgov huggingface dataset:
Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence

Official Title
-----------------
A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Versus Placebo as Adjunct Therapy With Mood Stabilizers (Lithium or Divalproex) for the Treatment of Alcohol Dependence in Patients With Bipolar I Disorder

Conditions
-----------------
Bipolar I Disorder, Alcohol Dependence

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate
* Drug: lithium
* Drug: divalproex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for Bipolar I Disorder with Alcohol dependence Outpatient Status Recent history of heavy drinking Exclusion Criteria: Unstable medical illness Recent antipsychotic use Poorly controlled Diabetes Mellitus or Diabetes related illness

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine fumarate|nan|
|Drug: lithium|nan|
|Drug: divalproex|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale |  |  | 
| Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar I Disorder, Alcohol Dependency
Spinal Cord Stimulation Research Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.

Official Title
-----------------
Neuro Ambulatory Data Recorder (ADR) Spinal Cord Stimulation (SCS) Study

Conditions
-----------------
Chronic Low Back and Leg Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Candidate for SCS device trial Subject is ambulatory Diagnosed with low back pain or low back pain plus leg pain for at least 6 months Undergoing treatment for low back pain or low back pain plus leg pain Does not have or has not had a previous SCS implant Willing and able to complete protocol requirements Willing and able to sign the study-specific Informed Consent form Male or non-pregnant female Exclusion Criteria: Have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study Cancer or any other malignant disease Present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder A pain-related surgery in the previous 12 weeks of enrollment, the intent to undergo surgery during the period of the study Non-English speaking or an inability to complete questionnaires accurately

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 |
| --- | --- | --- |
| Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds) |  | 4, 12, 24 weeks post implant | 
| Change from Baseline in Posture Parameters (minutes per 24 hours) |  | 4, 12, 24 weeks post implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
activity, spinal cord stimulation, pain
Observational Study of Meloxicam in Any Labeled Indication

Study Overview
=================
Brief Summary
-----------------
Evaluation on the amelioration of symptom intensity of the indication and to evaluate drug tolerability.

Official Title
-----------------
Programa de Experiencia Therapéutica Personalizada (Personalized Therapeutic Experience Program)

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: Meloxicam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients according to the physicians medical criteria on the labeled indications for Meloxicam Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Meloxicam<br> | Drug: Meloxicam<br>* tablets or injectable solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in assessment of intensity of pain on a 4-point verbal rating scale |  | up to 1 year | 
| Assessment of tolerability on a 4-point scale |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 1 year |
Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract. PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy.

Detailed Description
-----------------
OBJECTIVES: Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host disease refractory to standard therapy or with a contraindication to systemic steroids. Minimize the serious side effects associated with systemic steroid use in these patients. OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then receive a second course for 31 days if symptoms of graft-versus-host disease persist. Patients may receive up to 4 treatments (1 or 2 courses each) per year. PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.

Official Title
-----------------
Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease

Conditions
-----------------
Graft Versus Host Disease

Intervention / Treatment
-----------------
* Drug: beclomethasone dipropionate


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Clinically or pathologically confirmed graft-versus-host disease of the gastrointestinal tract Failed standard therapy with or has a contraindication to systemic immunosuppressive agents No clinically significant intestinal infection (confirmed by stool culture) No persistent vomiting of all oral intake Not a candidate for approved beclomethasone dipropionate Enteron Pharmaceuticals protocol PATIENT CHARACTERISTICS: Age 4 to 70 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Able to swallow medication PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy See Disease Characteristics Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: beclomethasone dipropionate|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
-----------------
graft versus host disease
Mycophenolate Mofetil in Membranous Nephropathy

Study Overview
=================
Brief Summary
-----------------
Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects. In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.

Official Title
-----------------
Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study

Conditions
-----------------
Glomerulonephritis, Membranous

Intervention / Treatment
-----------------
* Drug: mycophenolate mofetil orally 1000 mg twice a day (BID)
* Drug: prednisone 0,5 mg/kg orally on alternate days
* Drug: intravenous (i.v.) methylprednisolone 1000 mg, total 9


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Membranous nephropathy Serum creatinine (Screat)> 1,5 mg/dl or ECC < 70 ml/min or increase Screat > 50% Proteinuria > 2 g/day Exclusion Criteria: Systemic diseases Pregnancy wish Active infection Liver dysfunction Abnormal hematology lab Unstable angina Nonsteroidal anti-inflammatory agents (NSAIDs)

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mycophenolate mofetil orally 1000 mg twice a day (BID)|nan|
|Drug: prednisone 0,5 mg/kg orally on alternate days|nan|
|Drug: intravenous (i.v.) methylprednisolone 1000 mg, total 9|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function (serum creatinine) |  |  | 
| proteinuria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects |  |  | 
| relapse rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
membranous nephropathy, mycophenolate mofetil, cyclophosphamide, prednisone
Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP)

Study Overview
=================
Brief Summary
-----------------
Patients with primary sclerosing cholangitis (PSC) are affected by an inflammatory condition of the bile ducts. Unfortunately, patients with PSC have a 10 to 15 percent lifetime risk of developing gallbladder and bile duct cancers. Gallbladder and bile duct cancers have a five-year survival of only 5 to 10 percent. Surgery to provide a cure must remove all cancer confined to one area. In order to increase survival rates there is a need to identify cancer and pre-cancer early. This has been difficult to do. Patients who have lab tests, positive imaging tests or obstructions will usually have a test called ERCP (Endoscopic Retrograde Cholangiopancreatogram) to take biopsies and enlarge bile ducts or opening bile ducts with stents. Patients usually have cells in the bile ducts removed and analyzed, but there are not studies to show how sensitive this may be to determine if the cells are cancer or pre-cancerous. A new scope with a system using light filters called Narrow Band Imaging (NBI) may help detect cancer and pre-cancer more often and at an earlier stage.

Official Title
-----------------
Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing ERCP.

Conditions
-----------------
Primary Sclerosing Cholangitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PSC presenting for ERCP where tissue sampling is indicated Adults age 18 to 75 years old Able to give informed written consent Either male or female Exclusion Criteria: PSC with acute cholangitis Patients with acute or chronic, debilitating cardiopulmonary disease who are unable to safely undergo prolonged conscious sedation Patients with a prior history of liver transplant Prisoners Unable or unwilling to give informed consents

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholangioscopy with NBI will enhance the ability to identify sites of potential dysplasia or malignancy in patients with PSC and will be more sensitive in identifying dysplasia than ERCP with biliary brushing and fluoroscopy-guided forceps biopsy. |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary sclerosing cholangitis
Urinary Incontinence and Practice of Physical Exercises

Study Overview
=================
Brief Summary
-----------------
Introduction: Urinary incontinence is often seen as a problem that affects multipara and old-aged women, however, there is evidence that during high impact physical activity, mainly, or those ones which promote a sudden increase of intra-abdominal pressure, this symptom is common, even among young women, physically active, and without known risk factors. Objective: Evaluate the prevalence of urinary incontinence in nulliparous and nulligest women who regularly practice physical activities. Method: 108 women, nulliparous and nulligest, average age 23.9 years old (from 18 to 30 years old) who exercise regularly. They were divided into 3 groups according to the regular practice of exercise forms, they are (G1) weight training, (G2) aerobic exercises, included jump, step and dancing classes, and (G3) swimming (crawl mode). All participants were questioned about the perception of leakage of urine during the practice of exercises. The established exclusion criterion included: surgeries of urinary tract, urinary infections, gestations, child-birth, advanced aged, obesity, sedentariness and practice of only one form of physical activity.

Detailed Description
-----------------
The assessment was carried out in academies of the city of Franca. All participants were questioned about the perception of loss of urine during the practice of exercises.

Official Title
-----------------
Urinary Incontinence and Practice of Physical Exercises Among Nulliparous and Nulligest Women

Conditions
-----------------
Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: practice of exercises Exclusion Criteria: surgeries of urinary tract urinary infections gestations child-birth advanced aged obesity sedentary and practice of only one form of physical activity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>practice of weight training exercises | |
| Group II<br>aerobic exercises as part of lessons jump, step and dance classes | |
| Group III<br>swimming (crawl mode) | |

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
-----------------
urinary incontinence, physical exercise
Functional Neuroimaging in Depression

Study Overview
=================
Brief Summary
-----------------
Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks

Official Title
-----------------
Functional Neuroimaging in Depression: Longitudinal Study of PET Metabolism in Correlation With Changes in Attentional Bias, Autobiographical Memory, Future Fluency and Facial Recognition in Depressed Patients Treated With Escitalopram.

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Drug: Oral administration of escitalopram during 8 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Depression, Depressive episode, following DSM-IV criteria MADRS-score > 25 Age: 18-65 yrs Medication-free or anti-depressant wash-out 7 days (for fluoxetine: 6 weeks) Lorazepam 1mg or zolpidem 10mg are allowed Exclusion Criteria: Suicidality Bipolar disorder, following DSM-IV criteria Psychotic symptoms Substance abuse Personality disorder, following DSM-IV criteria Cognitive dysfunction due to trauma capitis or dementia Diabetes mellitus Women without contraceptive protection, with pregnancy or breast feeding Pharmacological treatment or ingestion of substance that can influence cerebral perfusion less than a month before inclusion IQ below 80 Conditions not compatible with SPC

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral administration of escitalopram during 8 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain metabolism |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functions |  |  | 
| Efficacy scales (mood, anxiety, anger and hopelessness) |  |  |
The Serum Lipid Profiles in ITP: a Retrospective Study

Study Overview
=================
Brief Summary
-----------------
The project was retrospectively undertaking by Qilu Hospital of Shandong University in China. In order to investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.

Detailed Description
-----------------
Background: Immune thrombocytopenia (ITP) is an autoimmune hemorrhagic disease characterized by increased platelet destruction and impaired thrombopoiesis. Platelet indices changes depending on the morphology and volume of platelets. Serum lipids have been found to affect platelet formation and activity in certain diseases, thus induce the corresponding variation of platelet indices. Objectives: To investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP. Methods: The clinical data from 457 ITP patients were retrospectively collected and analyzed, including platelet indices, serum lipids, hemorrhage and therapeutic regimen.

Official Title
-----------------
The Serum Lipid Profiles in Immune Thrombocytopenia: a Retrospective Study

Conditions
-----------------
Immune Thrombocytopenia

Intervention / Treatment
-----------------
* Other: ITP patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia. Exclusion Criteria: (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ITP patients|ITP patients were enrolled in this study based on Chinese consensus of ITP.12 Patients were excluded as (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet count at 1 month after initial therapy | Platelet count was tested at 1 month after initial therapy | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immune thrombocytopenia