linjc16/ctgov huggingface dataset:
Observation of Treatment Patterns With Lucentis in Approved Indications

Study Overview
=================
Brief Summary
-----------------
A multicentre, open-label, non-interventional study to observe treatment patterns in patients with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to chorioidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a 24 months observational period under real life conditions.

Official Title
-----------------
Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications

Conditions
-----------------
Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Presence of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) or visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM) Patients for whom a therapy with Lucentis® is medically indicated. Written patients informed consent. Exclusion criteria: As described in the SmPC. Preceding intravitreal treatment of the study eye with anti-VEGF drugs in the last three months before enrollment Preceding intravitreal treatment of the study eye with steroids

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 |
| --- | --- |
| Cohort with routine OCT monitoring<br> | |
| Cohort without routine OCT monitoring<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Visual Acuity (VA) to Month 12 | Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution. | Baseline, Month 12 | 
| Change from Baseline in Visual Acuity (VA) to Month 24 | Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution. | Baseline, Month 24 |
Detection of Immunotoxic Gluten Peptides in Feces

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces.

Detailed Description
-----------------
Certain immunotoxic peptides from gluten are resistant to gastrointestinal digestion and can interact with celiac patient factors to trigger immunological response. Gluten-free diet (GFD) is the only effective treatment for celiac disease (CD) and its compliance should be monitored to avoid accumulative damage. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available. This study assesses the capacity to determine the gluten ingestion, and to monitor the GFD compliance in celiac patients by detection of gluten and gliadin 33-mer equivalent peptidic epitopes in human feces.

Official Title
-----------------
Phase 0 Monitoring of Gluten-free Diet Compliance in Celiac Patients by Assessment of Gliadin 33-mer Equivalent Epitopes in Feces

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Other: Detection of gluten in feces


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Celiac patient 1-12 years old Written informed consent Exclusion Criteria: Known inflammatory bowel diseases Participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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 |
| --- | --- |
| Celiac patients<br> | Other: Detection of gluten in feces<br>* Detection of Gluten in Feces<br>* Other names: Celiac patients;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring of gluten-free diet compliance in celiac patients | Usual gluten diet for celiac (home diet not modified for this trial) | April-July 2011 (3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
celiac disease, gluten-free diet, gluten peptides, feces
Effects of Resistin on Neutrophil Function

Study Overview
=================
Brief Summary
-----------------
To assess the effect of resistin on neutrophil migration and intracellular bacterial killing

Official Title
-----------------
Effects of Resistin on Neutrophil Function

Conditions
-----------------
Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age ≥ 18 gender: male or female Exclusion Criteria Adults who are unable to provide informed consent themselves History of chronic kidney disease as defined by estimated glomerular filtration rate (GFR) <60 ml/min prior to cardiogenic shock Patients with hematologic malignancies Pregnant women Patient/surrogate is not fluent in English Long-term immunosuppressive therapy Prisoner Patients on pre-existing continuous reno-renal therapy (CRRT) or intermittent hemodialysis (IHD

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intracellular bacterial killing, assessed by number of colonies of bacterial growth following neutrophil exposure to bacteria and resistin |  | 6 months |
Incidence of Perioperative Hypothermia in Adults

Study Overview
=================
Brief Summary
-----------------
Perioperative hypothermia is associated with many complications, including surgical site infections, delayed wound healing, coagulopathy, prolonged hospital and intensive care unit length of stay. Perioperative close monitoring of the body temperature is important, and this is recommended by many clinical practice guidelines. In this study the investigators aimed to detect the incidence of perioperative hypothermia in adult patients in the operating room, and to detect the possible associated risk factors.

Official Title
-----------------
Incidence of Perioperative Hypothermia and Associated Risk Factors in Adults

Conditions
-----------------
Hypothermia; Anesthesia, Hypothermia Following Anesthesia

Intervention / Treatment
-----------------
* Diagnostic Test: Measurement of body temperature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any elective operation ASA I-III physical status Exclusion Criteria: Emergency operations ASA IV-V physical status Open heart surgeries

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Measurement of body temperature|The patients' body temperature will be measured pre-, intra- and post-operatively via an infrared thermometer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature | Body temperature of the patients will be measured via infrared termometer. | Perioperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypothermia, perioperative, intraoperative, postoperative
Blind Assessment of the Concordance Between the Administered Treatment and the Recommendations of a Medical Algorithm Decision Support Software in Systolic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The PREMEDIC is a prospective, observational study. Patients hospitalized for Systolic Heart Failure will be enrolled and health data will be collected at hospital admission and during hospital stay. No data will be collected before detailed information is given to the patient and a non-opposition is obtained. The aim of this observational and prospective study is to evaluate the concordance actual patient management during the in hospital treatment of heart failure and the therapeutic proposals from a medical algorithmic decision support software.

Detailed Description
-----------------
Main Objective: The aim of this observational and prospective study is to evaluate retrospectively the concordance between the actual systolic heart failure patient management during the inhospital treatment of heart failure (as recorded from the usual healthcare data collected) and the therapeutic proposals from a medical algorithmic decision support software. Secondary Objectives: To study the evolution of biological, hepatic and cardiopulmonary ultrasound usual markers in hospitalization, in connection with the duration of hospitalization and drug administered.

Official Title
-----------------
Blind Assessment of the Concordance Between the Administered Treatment and the Recommendations of a Medical Algorithm Decision Support Software in Systolic Heart Failure

Conditions
-----------------
Hearth Failure, Systolic

Intervention / Treatment
-----------------
* Other: Patients with systolic heart failure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or over Patients hospitalized for decompensated systolic heart failure Patients informed Exclusion Criteria: Patients unwillingness 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Patients with systolic heart failure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective evaluation of the concordance between the drug therapy actually used and the therapeutic algorithm's proposals |  | an average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization (number of days) |  | an average of 7 days | 
| Weight evolution (Kilograms) |  | an average of 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systolic Heart Failure, medical algorithm decision support system
Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to setup a collection of maternal plasma and serum from patients with preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on extra-corporal removal of sFlt-1

Detailed Description
-----------------
A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP) : Between 20WG and 23WG+6D : 20 patients with PE and 30 patients with NP Between 24WG and 27WG+6D : 20 patients with PE and 30 patients with NP Between 28WG and 31WG+6D : 20 patients with PE and 30 patients with NP Between 32WG and 35WG+6D : 20 patients with PE and 30 patients with NP Between 36WG and 40WG+6D : 20 patients with PE and 30 patients with NP

Official Title
-----------------
New Therapeutic Strategy Against Preeclampsia: Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1

Conditions
-----------------
Preeclampsia

Intervention / Treatment
-----------------
* Biological: A collection of maternal plasma and serum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 18 to 50 years old Singleton pregnancies between 20 and 41 weeks of gestation Preeclampsia Normal pregnancy Exclusion Criteria: Age<18 Infectious disease: HIV, HBV or HCV Multiple pregnancies Opposition of the patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| preeclampsia<br>pregnancy with preeclampsia | Biological: A collection of maternal plasma and serum<br>* A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)<br>|
| control<br>pregnancy without preeclampsia | Biological: A collection of maternal plasma and serum<br>* A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio sFlt-1/PlGF | measurement of of sFlT-1 and PlGF | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetics of these ratios sFlt-1/PlGF during pregnancy | measurement of of sFlT-1 and PlGF at many times | until 5 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sflt-1, Preeclampsia, apheresis
Safety/Proof of Concept Study of Oral QLT091001 in Subjects With Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin:Retinol Acyltransferase (LRAT) Mutations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: to evaluate the safety of oral QLT091001 to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP due to RPE65 or LRAT mutations to evaluate duration of visual function improvement (if observed)

Official Title
-----------------
Phase 1b Study to Evaluate QLT091001 in Subjects With Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Inherited Deficiencies of Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin:Retinol Acyltransferase (LRAT)

Conditions
-----------------
LCA (Leber Congenital Amaurosis), RP (Retinitis Pigmentosa)

Intervention / Treatment
-----------------
* Drug: QLT091001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with LCA or RP (with a mutation in either RPE65 or LRAT) Subjects with LCA must be 5-65 years of age Subjects with RP must be 18-65 years of age Subjects who have a best-corrected visual acuity of 3 letters or better (20/800 Snellen equivalent) or viable photoreceptors on OCT/FAF. Exclusion Criteria: Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of Day 0. Subjects with any clinically important abnormal physical finding at Screening. Subjects who have taken any prescription or investigational oral retinoid medication (e.g., Accutane,® Soriatane®) within 6 months of Day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure. Subjects with a history of diabetes or chronic hyperlipidemia, hepatitis, pancreatitis, or cirrhosis. Subjects who have taken any supplements containing ≥10,000 IU vitamin A within 60 days of screening

Ages Eligible for Study
-----------------
Minimum Age: 5 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: QLT091001|oral QLT091001 administered once daily for 7 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Field |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs, clinical laboratory tests, electrocardiogram (ECG), and adverse events |  | 12 months |
Cognitive-behavioural Treatment of Chronic Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of the study: to compare two cognitive-behavioral treatments

Detailed Description
-----------------
128 patients suffering from chronic back pain were randomly assigned to either Wait List Control, Cognitive Behavioral Treatment or Cognitive Behavioral Treatment and Biofeedback. Measures were conducted 6 months before treatment (Wait List Control) immediately before and after treatment and at 6-months follow-up. 25 weekly 1-hr sessions of individualized outpatient cognitive behavioral treatment of chronic back pain Treatment elements: Cognitive treatment: identification, evaluation and correction of dysfunctional beliefs about themselves and pain by cognitive restructuring, problem-solving training and coping skills training Behavioural treatment: increasing activity levels (sports, social activities, work), reducing medication intake and unnecessary health care utilization Relaxation training: progressive muscle relaxation, biofeedback.

Official Title
-----------------
Study to Compare a Cognitive-behavioral Treatment With a Cognitive-behavioral Treatment With Biofeedback Elements to Patients With Chronic (Low) Back Pain

Conditions
-----------------
Back Pain

Intervention / Treatment
-----------------
* Behavioral: cognitive-behavioral treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Back pain since 6 months Exclusion Criteria: Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>cognitive-behavioral treatment | Behavioral: cognitive-behavioral treatment<br> <br> |
| Active Comparator: 2<br>cognitive-behavioral treatment with biofeedback elements | Behavioral: cognitive-behavioral treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity |  | start of treatment, end of treatment, 6-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain disability |  | start of treatment, end of treatment, 6-months follow-up | 
| depression |  | start of treatment, end of treatment, 6-months folow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive-behavioral therapy, back pain, low back pain, biofeedback, randomized controlled study, EMG biofeedback
A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma; To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.

Official Title
-----------------
Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG) Adequate bone marrow reserve Adequate hepatic and renal function Ability to swallow capsules 3 weeks or more from prior chemotherapy and have recovered from prior toxicities Exclusion Criteria: Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism Patients with other active/uncontrolled clinically significant illnesses Pregnant or nursing female patients

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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma. |  |  | 
| PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration. |  |  |