linjc16/ctgov huggingface dataset:
The Effect of Valproate on Benzodiazepine Withdrawal Severity

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether valproate is effective in the treatment of benzodiazepine withdrawal symptoms in subjects receiving maintenance treatment for opiate dependence.

Detailed Description
-----------------
In Finland, 90% of subjects with opioid dependence are dependent on benzodiazepines too. Concurrent use of opioids and benzodiazepines has increasingly caused deaths. Benzodiazepine withdrawal treatment usually comprises gradual drug discontinuation. In one study, valproate was shown to improve benzodiazepine discontinuation success in chronic benzodiazepine users. In the present study, the effectiveness of gradual benzodiazepine discontinuation combined with valproate treatment and carried out in an inpatient setting is compared with gradual discontinuation without pharmacological augmentation.

Official Title
-----------------
The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients

Conditions
-----------------
Substance Withdrawal Syndrome

Intervention / Treatment
-----------------
* Drug: valproate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of benzodiazepine dependence (DSM IV-R) Induction of buprenorphine or methadon maintenance treatment, or need of benzodiazepine withdrawal treatment during ongoing buprenorphine/methadon maintenance Exclusion Criteria: Pregnancy History of convulsions Unstable somatic diseases

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>Gradual benzodiazepine discontinuation and valproate treatment | Drug: valproate<br>* Valproate 20 mg/kg per day for 2 weeks, reduction during week 3. Conversion of benzodiazepines to an equivalent dose of diazepam (maximum 80 mg per day). Dosage reduced 10 mg daily until 40 mg per day. Reduction then continued 5 mg daily.<br>* Other names: Deprakine depot;|
| No Intervention: A<br>Gradual benzodiazepine discontinuation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| benzodiazepine withdrawal severity |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| benzodiazepine use |  | 4 weeks after treatment | 
| attrition from treatment |  | 3 weeks |
Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
We want to study the effect of the combination of metoprolol (a beta-blocker) with formoterol (a beta-agonist) on long function in patients with Chronic Obstructive Pulmonary Disease (COPD). There are more and more clues that a beta-blocker, when well chosen and in the right dosage, won't harm the long function in patients with COPD. Since a beta-blocker can be a valuable addition to treating patients with heart problems we would like to see if this category of medication can be available for COPD patients in the future.

Official Title
-----------------
Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: Metoprolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male/female aged between 40-70 inclusive COPD defined by GOLD criteria FEV1 greater or equal to 60% of predicted without medication baseline FEV1 greater or equal than 1.2L 10 or more pack years no hard contraindications for use of beta blockers being able to perform technically acceptable pulmonary function tests signed informed consent systolic blood pressure equal to 130 or greater Exclusion Criteria: instable COPD during the month before visit 1 usage of corticosteroids during the month before visit 1 significant pulmonary diseases other than COPD a history of cancer within the last 5 years (basal cell carcinoma or cutaneous squamous cell carcinoma allowed) a recent history of myocardial infarction use of an investigational drug within one month or six half lives (which ever is greater) of visit 1 contra-indications for the use of ipratropium-bromide

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in airway reactivity after treatment with metoprolol compared to placebo. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of formoterol on airway reactivity comparing metoprolol with placebo. |  |  | 
| Borg-scores during provocation test |  |  | 
| Peak-flow measurements |  |  | 
| CCQ-scores |  |  | 
| Exacerbation rate and rescue medication use |  |  |
Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients

Study Overview
=================
Brief Summary
-----------------
Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. Examine the ability of thymopentin to stimulate the immune system and alter the clinical findings of patients infected with HIV who do not yet have AIDS.

Official Title
-----------------
Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients

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

Intervention / Treatment
-----------------
* Drug: Thymopentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Aerosolized pentamidine. Patients must have the following: - Seropositive for HIV-1 (ELISA assay) confirmed by Western blot. HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patients' peripheral blood monocytes (PBMC) on two separate occasions. Voluntarily sign consent. Patients with HIV wasting syndrome are included. Prior Medication: Allowed: Aerosolized pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: AIDS as defined by the CDC (except for those with HIV wasting syndrome). Significant hepatic disease. Thrombocytopenia. Hypersensitivity to thymopentin. Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products. Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry. Patients with the following are excluded: AIDS as defined by the CDC (except for those with HIV wasting syndrome). Significant hepatic disease. Thrombocytopenia. Hypersensitivity to thymopentin. Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products. Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry. Prior Medication: Excluded within 30 days of study entry: Immunomodulatory or experimental therapy. Excluded within 90 days of study entry: Zidovudine (AZT). Intravenous drug abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thymopentin|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
-----------------
Semen, Thymopentin, Leukocytes, Mononuclear, HIV Seropositivity, AIDS-Related Complex
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a reliable method for detection of rectal cancer patients with aggressive tumor at risk of metastatic disease and death by functional MRI.

Official Title
-----------------
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

Conditions
-----------------
Rectal Diseases, Rectal Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms

Intervention / Treatment
-----------------
* Procedure: new functional magnetic resonance imaging (MRI) protocols


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is willing and able to give full written consent according to the protocol approved by the Regional Ethics Committee. The patient has confirmed rectal cancer diagnosis and is scheduled to radical surgery alone or preoperative CRT followed by surgery. The patient is ≥ 18 years. The patient has no prior rectal cancer treatment. The patient has adequate renal function: creatinine clearance ≥ 60 ml/minute. The patient has signed the written informed consent according to the protocol approved by the Regional Ethics Committee. Exclusion Criteria: The patient has contraindication to MRI or MRI contrast agent according to clinical practice. The patient wants to withdraw for any reason 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rectal cancer<br> | Procedure: new functional magnetic resonance imaging (MRI) protocols<br>* diffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of metastatic disease 5 years after rectal cancer treatment |  | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histomorphological response to preoperative chemoradiotherapy |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging, Magnetic Resonance Imaging, Functional
Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate, in a prospective cohort, the link between preoperative contractile reserve of oesophagus evaluated by high resolution manometry (HRM) and the occurrence of post operative dysphagia after anti-reflux surgery.

Official Title
-----------------
Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Procedure: Multiple rapid swallows test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with an indication validated at a fundoplication directed by a visceral surgeon from Vienne county Patient sent for the realization of a preoperative HRM, Patient giving consent to participate in the study. Exclusion Criteria: Patient unable to sign a consent or protected (minors, pregnant women, patient under guardianship), History of oesophageal surgery or radiotherapy, History of systemic pathology with oesophageal involvement, Contraindication to an oesophageal manometry : altered general status and vigilance , important swallowing disorders

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 |
| --- | --- |
| Other: Multiple rapid swallows test<br>Multiple rapid swallows test consists in giving to patient 4 to 6 sips of 2 mL of water, with an interval less than 4 seconds between the different sips. | Procedure: Multiple rapid swallows test<br>* Multiple rapid swallows test consists in giving to patient 4 to 6 sips of 2 mL of water, with an interval less than 4 seconds between the different sips.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of dysphagia | clinically evaluated by the surgeon | 3 months |
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling.

Official Title
-----------------
Pilot Study of the Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling: an Open Trial

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: quetiapine fumarate or valproate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, men and women aged ³18 to £65 years with diagnosis of DSM-IV criteria for bipolar I or II disorder, most recent episode manic, hypomanic, mixed or depressive with Rapid Cycling. Exclusion Criteria: Substance or alcohol dependence, female patients who are pregnant, lactating or at risk of pregnancy, diagnosis of schizophrenia or borderline personality disorder or antisocial personality disorder, history of seizure disorder, acute suicidal or external aggressive behaviour, legal incapacity or indication for treatment against the will of the patient by law.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: quetiapine fumarate or valproate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinically relevant recurrences of depression or mania. Recurrence is defined by a change in LCM-C/P to moderate or severe or by 2 or more steps. End of an episode is defined as reduction to mild or baseline or by 2 or more steps. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline on the (recalculated) HAM-D, YMRS, MADRS, total score. Absolute change from baseline on the CGI-BP severity score per dimension (mania, depression, overall bipolar illness). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder I or II with Rapid Cycling
Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD

Study Overview
=================
Brief Summary
-----------------
Non-inferiority efficacy of telithromycin versus azithromycin

Official Title
-----------------
A Multicenter, Multinational, Randomized, DB Controlled Study of the Efficacy & Safety of Oral Telithromycin 800 mg Once QD for 5 Days vs Azithromycin in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD.

Conditions
-----------------
Bronchitis, Chronic

Intervention / Treatment
-----------------
* Drug: Telithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult outpatients, either sex, aged 45 years or older. Patients with a documented history of chronic bronchitis with a basal FEV1 <70% and >35% made in the previous 12 months and who had had at least one or more AEBC in the previous year and with FEV1/FVC <70% (lung function tests made in the previous 12 months). Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis presumably due to bacterial infection based on all of the following signs and symptoms of AECB: increased sputum purulence, and at least 1 of the 2 following signs and symptoms (increased dyspnea, increased sputum volume). Patients with negative chest radiography (posterior/anterior and lateral views) to rule out a pneumonia within 48 hours before initiation of study medication or at the latest 24 hours after initiation of study medication (it was necessary to not include patients with pneumonia associated with AECB). Patients with sputum specimens collected at inclusion for gram stain and bacteriological culture. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Telithromycin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Principal efficacy criterion: clinical outcome - Main secondary efficacy criteria: - Bacteriological response at TOC visit; - Time to relapse up to 6 months after inclusion. |  | At TOC visit (Day 17-Day 21). |
Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.

Official Title
-----------------
To Assess the Safety of a Sunscreen Product,BAY 987519, Bayer Sponsored, CC Products

Conditions
-----------------
Sunscreen Agents

Intervention / Treatment
-----------------
* Drug: BAY 987519, SPF 50, Y51-002
* Drug: BAY 987519, SPF 50, P04-147


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects, aged 18 to 65 years No actinic keratosis, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions Must not have visible erythema, blistering or peeling that would indicate recent sunburn Must not have asthma. Must not be undergoing therapy with system or topical corticosteroids, anti-inflammatories or antihistamine agents Must not be taking any medication in which exposure to the sun is contraindicated Must be willing to obey all rules of the test facility

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

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safety of a Sunscreen product<br>Sunscreen product safety evaluation under supervised out-door conditions on sport users. | Drug: BAY 987519, SPF 50, Y51-002<br>* Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.<br>Drug: BAY 987519, SPF 50, P04-147<br>* Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Erythema as graded on a 5 point scale. |  | approximately 24 hours | 
| Evaluation of AEs, including eye stinging | Reported as product related or likely product related by the investigator or trained designee | approximately 24 hours |