linjc16/ctgov huggingface dataset:
One Year Drug Treatment in First-Episode Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.

Detailed Description
-----------------
The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).

Official Title
-----------------
One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Haloperidol, Risperidone (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20) Age between 18 and 55 Informed consent Exclusion Criteria: Residence outside of the catchment area Legal reasons Insufficient knowledge of the German language Substance abuse or addiction Pregnancy Serious physical illness Organic brain disease Contraindication to neuroleptic treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Maintenance antipsychotic treatment with risperidone | Drug: Haloperidol, Risperidone (drug)<br>* targeted dose of 2-4 mg/day over 1 year<br>|
| Active Comparator: 2<br>Maintenance antipsychotic treatment with haloperidol in low-dose | Drug: Haloperidol, Risperidone (drug)<br>* targeted dose of 2-4 mg/day over 1 year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| course in psychopathology |  | 1 year | 
| social and cognitive functioning |  | 1 year | 
| side-effects |  | 1 year | 
| drop-out |  | 1 year | 
| quality of life |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, first episode, long-term treatment, typical vs. atypical neuroleptics
Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

Study Overview
=================
Brief Summary
-----------------
This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.

Official Title
-----------------
A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan

Conditions
-----------------
Healthy Adults

Intervention / Treatment
-----------------
* Drug: SC Methylnaltrexone (MNTX)
* Drug: IV Methylnaltrexone (MNTX)
* Drug: Oral Paroxetine
* Drug: SC Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males between the ages of 18 and 55 Non-Smokers Body weight range form 154-220 lbs No history of clinically significant metabolic disorders. Exclusion Criteria: Any history of low CYP450 2D6 activity History of alcohol abuse or recreational drugs History of any clinically significant disease or condition affecting a major organ system Donation or loss of blood, 60 days proceeding to screening visit.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Arm 1<br> | Drug: SC Methylnaltrexone (MNTX)<br> <br> |
| Experimental: Arm 2<br> | Drug: IV Methylnaltrexone (MNTX)<br> <br> |
| Active Comparator: Arm 3<br> | Drug: Oral Paroxetine<br> <br> |
| Placebo Comparator: Arm 4<br> | Drug: SC Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of MNTX | The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of Paroxetine | The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity. | 4 months |
Institut Paoli Calmettes Breast Cancer Database

Study Overview
=================
Brief Summary
-----------------
Database of Institut Paoli-Calmettes patients diagnosed with breast cancer

Official Title
-----------------
Institut Paoli Calmettes Breast Cancer Database

Conditions
-----------------
Breast Cancer Diagnosis

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a diagnosis of breast cancer Exclusion 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with breast cancer diagnosis<br> | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients with breast cancer | Overall survival of all patients who come in the center | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patients characteristics | Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies | 10 years |
Characterization of Local Vascular Effects of LNMMA

Study Overview
=================
Brief Summary
-----------------
Characterization of an unexpected venodilative effect of higher L-NMMA-doses in dorsal human hand veins.

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

Intervention / Treatment
-----------------
* Drug: L-NMMA(drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: any relevant disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: L-NMMA(drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Perception of Needs of Patients With Chronic Intestinal Failure and Their Practitioners: a Qualitative Study

Study Overview
=================
Brief Summary
-----------------
The SBS NEEDS Study is a qualitative transversal study aiming to describe and understand the needs and knowledge of patients with Chronic Intestinal Failure as well as the representations of their practitioners Chronic Intestinal Failure (CIF) is the long-lasting reduction of gut function, below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation is required to maintain health and/or growth. CIF is the rarest organ failure. Home parenteral nutrition (HPN) is the primary treatment for CIF. Semi-structured interviews will be conducted with patients in two nutrition unit and specialized in the small bowel diseases in two French region. 20 situations will be included. After analysing the data of the individual interviews, focus groups will be conducted with health professionals from an accredited home parenteral nutrition department.

Official Title
-----------------
Qualitative Assessment of the Needs and Knowledge of Patients With Chronic Intestinal Failure of Their Disease as Well as Those of Their Practitioners

Conditions
-----------------
Chronic Intestinal Failure, Small Intestine Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18 and over With Chronic Intestinal Failure (CIF) : reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status medical follow-up in one of the two nutrition departments of the study Informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study. Exclusion Criteria: Persons with proven and significant cognitive impairment preventing the completion of semi-structured interviews Person who does not speak French easily Generally, any person unlikely to cooperate in the study Adults under guardianship

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 |
| --- | --- | --- |
| 20 semi-structured interviews | Qualitative data analysis - Theorical saturation | 12 months |
Balance, Pulmonary Function, and Low Back Pain in Pregnant and Non-pregnant Women

Study Overview
=================
Brief Summary
-----------------
The aims of this study were to investigate balance and pulmonary functions in pregnant and non-pregnant women and to determine their relationship with LBP.

Official Title
-----------------
Assistant Professor, Physioterapist, PhD

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Other: Physical characteristic assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women (in the second and third trimester), non-pregnant women, aged between 18 and 40 years, volunteering to participate in the study Exclusion Criteria: Having a high-risk pregnancy, preeclampsia, multiple pregnancies, gestational diabetes mellitus, hypertension, any physical disability, prior history of surgery related to spine or abdominal, spinal deformity, serious neurological, rheumatologic, cardiopulmonary or psychiatric diseases, malignancy, fracture history, or those having any exercise program or sportive activity in the last 3 months for pregnant women Having any physical disability, spinal or abdominal surgery, spinal deformity, serious neurological, rheumatologic, cardiopulmonary or psychiatric diseases, malignancy, or fracture history, or those having any exercise program or sportive activity in the last 3 months for non-pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant group<br>Balance with the one leg balance test with the eyes open and closed, pulmonary functions with a spirometer, and LBP with the Visual Analogue Scale (VAS) were assessed. | Other: Physical characteristic assessment<br>* Physical characteristics related to balance, pulmonary function and low back pain were evaluated<br>|
| Non-pregnant group<br>Balance with the one leg balance test with the eyes open and closed, pulmonary functions with a spirometer, and LBP with the Visual Analogue Scale (VAS) were assessed. | Other: Physical characteristic assessment<br>* Physical characteristics related to balance, pulmonary function and low back pain were evaluated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance | Balance with the one leg balance test was assessed | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function | Pulmonary function with a spirometer was assessed | through study completion, an average of 6 months | 
| Low back pain | Low back pain with the Visual Analogue Scale was assessed | through study completion, an average of 6 months |
A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)

Official Title
-----------------
A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol pMDI
* Drug: Budesonide pMDI
* Drug: Formoterol Turbuhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical diagnosis of COPD with symptoms for more than 2 years Smoking history of 10 or more pack years A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit. Exclusion Criteria: A history of asthma Patients taking oral steroids. Any significant disease or disorder that may jeopardize the safety of the patient

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide/formoterol pMDI|nan|
|Drug: Budesonide pMDI|nan|
|Drug: Formoterol Turbuhaler|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries |  |  | 
| Health care utilization |  |  | 
| Pharmacokinetics (subgroup) |  |  | 
| Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry. |  |  | 
| - all variables assessed over the 6 months treatment period |  |  |
SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.

Official Title
-----------------
A Multicenter, Randomized, Double-blind Recommended Dose-finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III Study)

Conditions
-----------------
Lumbar Vertebra Hernia

Intervention / Treatment
-----------------
* Drug: SI-6603
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root Patients assessed as positive in the SLR test Patients with sciatica in either lower leg Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block Exclusion Criteria: Patients who have 2 or more lumbar disc herniations as assessed by MRI Patients with extrusion-type or sequestration-type herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI Patients who have received nerve block within 3 weeks before screening Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Drug: SI-6603<br>* SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.<br>|
| Experimental: II<br> | Drug: SI-6603<br>* SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.<br>|
| Experimental: III<br> | Drug: SI-6603<br>* SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.<br>|
| Placebo Comparator: IV<br> | Drug: Placebo<br>* Placebo is administrated into the nucleus pulposus of an intervertebral disc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in leg pain from baseline. |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The leg pain |  | At each assessment time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemonucleolysis, Lumbar Vertebrae, Hernia
Endoscopic Detection of Dysplasia in Crohn 's Disease Patient

Study Overview
=================
Brief Summary
-----------------
Patients with Crohn's disease (CD) have an increased risk of small bowel adenocarcinoma (SBA). Long duration of CD is the main risk factor. SB dysplasia has been associated with SBA in 20% of cases, always described in diseased sites. The progression to neoplasia and natural history remains unknown but progression of inflammation to dysplasia and then to adenocarcinoma is suspected. As for surveillance recommendations for colorectal carcinoma in long standing inflammatory colonic disease, endoscopic screening of SB could be proposed in CD patients with risk factors of SBA. No study can be found in literature. The investigators propose a multicenter exploratory open study on prospective cohort of CD patients with high risk of dysplasia or cancer. The goal is evaluate the rate of dysplasia and adenocarcinoma detected by enteroscopy with biopsies in a high risk CD population

Official Title
-----------------
Endoscopic Detection of Small Bowel Dysplasia and Cancer in Patients With Jejuna or Ileal Crohn Disease : Prospective Study in a Cohort of High Risk Patients

Conditions
-----------------
Crohn Disease Located in Jejunum or Ileum

Intervention / Treatment
-----------------
* Procedure: enteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 18-years-old Crohn disease on jejunum and/or ileum since at least 10 years Radiography done during last year Exclusion Criteria: Dysplasia previously detected Pregnancy

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: Single group open label<br>Prospective Cohort | Procedure: enteroscopy<br>* endoscopic enteroscopy to do biopsies on jejunum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of dysplasia and adenocarcinoma | dysplasia will be described as high or low level Samples will be analysed by 2 different team of anapathologists | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of endoscopic detection | the success will be measured by reaching at least one pathologic area during the endoscopic procedure | 1-3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn disease, dysplasia, adenocarcinoma, endoscopy, jejunum, ileum