linjc16/ctgov huggingface dataset:
Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration. The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.

Official Title
-----------------
Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: ChAgly CD3
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with Type 1 diabetes mellitus included in the phase II therapeutic trial with a humanized non-mitogenic CD3 monoclonal antibody (ChAgly CD3) at time of clinical diagnosis and who agree and are likely to comply with the investigator's instructions Exclusion Criteria: Any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient Use of illicit drugs or over consumption of alcohol (> 3 beers/day) Being legally incapacitated, having significant emotional problems at the time of the study

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: B<br> | Drug: Placebo<br>* 6 days<br>|
| Active Comparator: A<br>ChAgly CD3 | Drug: ChAgly CD3<br>* 6 days treatment 8mg/d intravenous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients |  | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, type 1, ChAgly CD3
Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery

Study Overview
=================
Brief Summary
-----------------
Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. The investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. This is a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure.

Detailed Description
-----------------
Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. The investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. After having studied the available literature on this particular topic the investigators have decided to prepare a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure focusing on radiological and clinical signs of unilateral pulmonary edema.

Official Title
-----------------
Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery: a Retrospective Single Center Observation

Conditions
-----------------
Pulmonary Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years of age Exclusion Criteria: urgent surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Unilateral right sided pulmonary edema or congestion after surgery | retrospective analysis using the electronic and the paper-based patient specific database | Postoperatively within the first 12h after admission to intensive care unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minimal-invasive surgery, mitral valve
An Eight-Week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and escitalopram 10 mg once daily in outpatients with major depressive disorder.

Official Title
-----------------
An Eight-Week, Multicenter, Double-Blind, Placebo- and Escitalopram-Controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Major Depressive Disorder

Conditions
-----------------
Depressive Disorder

Intervention / Treatment
-----------------
* Drug: SSR149415


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of major depressive disorder, as defined by DSM-IV criteria and confirmed by the semi-structured MINI, recurrent episode. Exclusion Criteria: Total score of less than 24 on the MADRS. HAM-D total score less than 18. Duration of the current depressive episode less than 1 month or greater than 2 years. Patients with a history or presence of bipolar disorders or psychotic disorders. Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence. Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, MAOIs within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week except as allowed in the protocol. The investigator will evaluate whether there are other reasons why a patient may not participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: SSR149415|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint is the change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main secondary endpoints are the changes from baseline to Day 56 in the HAM-D depressed mood item, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Clinical Global Impression (CGI) Severity of Illness scores. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, antidepressive agents, controlled clinical trial
Dreaming During Anaesthesia and Anaesthetic Depth

Study Overview
=================
Brief Summary
-----------------
Patients commonly report that they have been dreaming when they awaken from general anaesthesia. Our hypothesis is that patients who report dreaming are less deeply anaesthetised during anaesthesia than patients who do not report dreaming. Depth of anaesthesia will be determined using a processed electroencephalographic monitor (called the BIS monitor).

Detailed Description
-----------------
In this study, we will record the depth of anaesthesia during surgery with the BIS monitor and then interview patients immediately upon emergence to determine whether they recall dreaming or not. The depth of anaesthesia of dreamers and non-dreamers will be assessed.

Official Title
-----------------
Dreaming During Anaesthesia and Anaesthetic Depth

Conditions
-----------------
Anaesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-50 years American Society of Anesthesiologists physical status 1-3 Non-cardiac surgery under relaxant general anaesthesia Tracheal extubation planned at end of surgery Exclusion Criteria: Inadequate English language skills (due to language barrier, cognitive deficit or intellectual disability) Major drug abuse or psychiatric condition Expected to be unable to co-operate or be available for followup

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dreaming, anaesthesia, electroencephalography, bispectral index, awareness
24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance

Study Overview
=================
Brief Summary
-----------------
Over 24 hrs serum and plasma samples were collected every 3 hrs. With this a day histamine profile was created. 15 healthy persons with 20 patients with a high level of IgE in serum and 20 patients with afflictions but no high IgE level were compared. Measurment of histamine in plasma, urine and stool were realized. In addition to that Diaminoxidase, TNF alpha and IgE Antibodies were measured.

Official Title
-----------------
24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance: Correlations Between Subjective Affliction and Measured Histamine Parameter

Conditions
-----------------
IBS, Allergy

Intervention / Treatment
-----------------
* Other: blood profile


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects appropriate invalid persons Exclusion Criteria: pregnant and weaning persons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>healthy subjects | Other: blood profile<br> <br> |
| IgE positive<br>patients with high IgE level in serum | Other: blood profile<br> <br> |
| IBS patients<br>patients with afflictions, but no high IgE level and suspicion on histamine intolerance | Other: blood profile<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histamine |  | 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diaminoxidase |  | 24 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
histamine profile, IgE Antibodies
Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19)

Study Overview
=================
Brief Summary
-----------------
Breath analysis is the evaluation of exhaled air of humans. It aims to get information about the clinical status of a human being by monitoring its volatile organic compounds (VOCs) in exhaled air. In this feasibility study it is intended to find specific biomarker(s) in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).

Official Title
-----------------
Study to Identify Differences of Exhaled Breath Components Using Ion Mobility Spectrometry (IMS) in Patients Tested Positive or Negative on SARS-CoV-2

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Device: Ion Mobility Spectrometry (IMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SARS-CoV-2-Polymerase chain reaction (PCR) test result is available Signs or symptoms of any respiratory system infection or Signs or symptoms indicating SARS-CoV-2 infection or Radiological findings suggesting viral lung infection Breath test (Study intervention) must be performed within a 2 day time period after latest SARS-CoV-2 PCR Exclusion Criteria: History of SARS-CoV-2 outside the current respiratory episode (known from medical history) Participation in another clinical study prior to breath analysis which could influence the result of the breath analysis

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 |
| --- |
|Device: Ion Mobility Spectrometry (IMS)|Two breathing gas samples will be taken from each study participant using ion mobility spectrometry with an ultrasound-based spirometer. The total sampling time is 1 minute (at least 5-7 breath takes) following an analysis time of 5-12 minutes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 related volatile organic compounds (VOC) |  | 1 hour after breath gas sampling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 and diagnostic findings |  | Within 3 days |
Ibuprofen 5% Topical Gel CIPT

Study Overview
=================
Brief Summary
-----------------
This study will determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause irritation after repeated topical application to the healthy skin of human subjects under controlled conditions.

Official Title
-----------------
Cumulative Irritancy Patch Test (Cipt) of Ibuprofen 5% Topical Gel in Human Volunteers

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Ibuprofen 5% topical gel
* Drug: Topical gel vehicle
* Drug: Sodium lauryl sulfate 0.2%
* Drug: Sodium chloride solution 0.9% (saline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects (to be confirmed by medical history) 18 years of age or older, female subjects of childbearing potential and males who are using an acceptable form of birth control, subjects who are free of any systemic or dermatologic disorder Exclusion Criteria: Have skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, unwilling or unable to stop use of sunscreens, creams, or similar products on the back during the study

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen 5% topical gel<br> | Drug: Ibuprofen 5% topical gel<br>* 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions<br>|
| Experimental: Topical gel vehicle<br> | Drug: Topical gel vehicle<br>* 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions<br>|
| Active Comparator: Sodium lauryl sulfate 0.2%<br> | Drug: Sodium lauryl sulfate 0.2%<br>* 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions<br>|
| Sham Comparator: Sodium chloride solution 0.9% (saline)<br> | Drug: Sodium chloride solution 0.9% (saline)<br>* 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of local skin irritation at patch sites |  | Daily for 21 days, Days 2 through 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Days 1 through 22, + 28 days after last product administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cumulative irritancy patch test (CIPT)
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

Study Overview
=================
Brief Summary
-----------------
This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.

Official Title
-----------------
Lansoprazole in Preterm Infants With Gastroesophageal Reflux

Conditions
-----------------
Premature Infants, Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: Lansoprazole
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infant symptoms suspecting gastroesophageal reflux Exclusion Criteria: unstable general conditions due infection or acute illness congenital anomaly in upper gastrointestinal tract including esophagus drug history of H2, proton pump inhibitor, blocker during last 1 week medication of warfarin, carbamazepine, phenytoin, rifampin inappropriate clinical conditions judged by researchers

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PL<br>Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days | Drug: Lansoprazole<br> <br> * Other names: lanston LFDT;Drug: Placebo<br> <br> |
| Experimental: LP<br>Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days | Drug: Lansoprazole<br> <br> * Other names: lanston LFDT;Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acid reflux time (%) | measured by 24hr pH impedance monitor | day 0, day 7, day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acid reflux frequency | measured by 24hr pH impedance monitor | day 0, day 7, day 14 | 
| Composite score | measured by 24hr pH impedance monitor | day 0, day 7, day 14 | 
| Acid reflux fraction | measured by 24hr pH impedance monitor | day 0, day 7, day 14 | 
| acid bolus reflux time/%, | measured by 24hr pH impedance monitor | day 0, day 7, day 14 | 
| nonacid bolus reflux time/% | measured by 24hr pH impedance monitor | day 0, day 7, day 14 | 
| bolus reflux time/% | measured by 24hr pH impedance monitor | day 0, day 7, day 14 | 
| I-GERQ GERD score | I-GERQ GERD score chart (Infant Gastroesophageal Reflux Questionnaire Gastroesophageal Reflux Disease) | day 0, day 7, day 14 |
rTMS-induced Cumulative Pattern of sBDNF in Chronic Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study aims at investigating the neuroplastic potential and the possible factors affecting rehabilitation in chronic schizophrenia patients on stable medication, by investigating the cumulative pattern of serum BDNF representing the neuroplasticity in the brain, through quantitative stimulus such as rTMS.

Detailed Description
-----------------
Subjects who have been enrolled for this study will take baseline evaluation for sociodemographic data and serum level of BDNF, plasma Prolaction, and magnesium, etc. And then, weekday regular stimulation through rTMS will be applied on DLPFC of brain. After the completion of stimulation for 2 weeks, the change or response of serum BDNF will be analyzed and compared.

Official Title
-----------------
Short-Term Response of Serum Brain-Derived Neurotrophic Factor to Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Schizophrenia

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

Intervention / Treatment
-----------------
* Device: CR Technology, TAMAS for repetitive TMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: duration of illness over 10 years on stable medication, antipsychotics no change on medication within at least 2 weeks Diagnosis of Schizophrenia according to DSM-IV-TR Exclusion Criteria: left or both-handedness anticonvulsant use lorazepam equivalent over 3 mg

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: repetitive TMS<br>repetitive TMS is a quantified stimulation method of specifie area of brain, for which CR Technology, TAMAS for repetitive TMS was used. | Device: CR Technology, TAMAS for repetitive TMS<br>* repetitive TMS, lef DLPFC, 20Hz, 100% of MEP, 2weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline of serum BDNF concentration |  | baseline-1 week-2 week-4 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rTMS-induced cumulative pattern of sBDNF