linjc16/ctgov huggingface dataset:
The EVICEL® Gastrointestinal Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.

Detailed Description
-----------------
This is a single blind, randomized, multi-center controlled study evaluating the safety and effectiveness of EVICEL® when used as an adjunct to gastrointestinal (GI) surgery.

Official Title
-----------------
A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques

Conditions
-----------------
Gastrointestinal Diseases

Intervention / Treatment
-----------------
* Biological: EVICEL Fibrin Sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing primary elective GI surgery Subjects ≥ 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures Exclusion Criteria: Avastin use within 30 days prior to surgery; Known hypersensitivity to the human blood products or the components of the investigational product; Female subjects who are pregnant or nursing; Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.

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: EVICEL Fibrin Sealant: Randomized<br>EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. | Biological: EVICEL Fibrin Sealant<br>* Intraoperative<br>* Other names: Fibrin sealant;|
| No Intervention: Standard of Care<br>Standard surgical technique for GI anastomosis. | |
| Experimental: Experimental: EVICEL Fibrin Sealant: Non-Randomized<br>EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen | Biological: EVICEL Fibrin Sealant<br>* Intraoperative<br>* Other names: Fibrin sealant;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Gastrointestinal (GI) Leak |  | 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | up to Day 90 | 
| Incidence of GI Leak |  | 90 days | 
| Incidence of Stricture |  | up to Day 90 |
Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

Study Overview
=================
Brief Summary
-----------------
Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid control of moderate to severe chronic plaque type psoriasis.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Pioglitazone
* Drug: Acitretin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic plaque type psoriasis having body surface area involvement of > 20% Patients of either sex Females who have completed their family and are tubectomized or are postmenopausal i.e. no menstrual bleeding over at least 1 year Age range 18-65 years Exclusion Criteria: Females of child bearing potential H/O hypersensitivity to acitretin Impaired hepatic function (serum bilirubin, AST, ALT and alkaline phosphatase >1.5 times the upper limit of normal) Impaired renal function (serum creatinine >1.5mg% in males and >1.4 mg% in females) Hyperlipidemia BMI >30 kg /m2 H/O excessive alcohol use Diabetes mellitus Congestive heart failure Ischemic heart disease

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Acitretin | Drug: Acitretin<br>* Acitretin<br>|
| Experimental: Experimental<br>Pioglitazone | Drug: Pioglitazone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PASI score from baseline in the two groups |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with an improvement of at least 75% in the psoriasis area-and-severity index (PASI) by week 12 |  | 12 weeks |
Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

Study Overview
=================
Brief Summary
-----------------
To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and in patients without visual prediction. The automated lamellar keratectomy represents a alternative in treatment of pain in symptomatic patients with BK.

Detailed Description
-----------------
Only patients with BK symptomatic (with pain) were submitted to automated lamellar keratectomy (ALK). Complete ophthalmological examination including UCVA,BSVA, biomicroscopy, tonometry, esthesiometry, UBM pachymetry, impression cytology and pain questionnaire were performed in preoperative, postoperative of one, seven, 30, 90, 180 days and one year.

Official Title
-----------------
Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.

Conditions
-----------------
Corneal Disease

Intervention / Treatment
-----------------
* Procedure: ALK (automated lamellar keratectomy)
* Drug: Mitomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with bullous keratopathy symptomatic (with pain) Exclusion Criteria: herpetic endotelial disorders

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| Active Comparator: 1<br>Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy). | Drug: Mitomycin<br>* mitomycin 0,02%, 30 seconds after ALK<br>* Other names: automated lamellar keratectomy associated with PTK;|
| Active Comparator: 2<br>automated lamellar keratectomy without mitomycin | Procedure: ALK (automated lamellar keratectomy)<br>* ALK is performed with a microkeratome, to make a free cap.<br>* Other names: automated lamellar keratectomy with PTK;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain questionnaire |  | preoperative and postoperative 1,7,30,90,180 days and one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomicroscopy, esthesiometry, UBM pachymetry, impression cytology |  | preoperative, postoperative 1,7,30,90,180 days and one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract extraction, surgery, corneal disease
Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies

Study Overview
=================
Brief Summary
-----------------
ARQ 092 is being investigated for patients with overgrowth diseases and/or vascular anomalies with genetic alterations of the PI3K/AKT pathway and may be available for patients who are ineligible for an ongoing ARQ 092 clinical trial or have other considerations that prevent access to ARQ 092 through an existing clinical trial.

Official Title
-----------------
Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies With Genetic Alterations of the PI3K/AKT Pathway

Conditions
-----------------
Proteus Syndrome, PIK3CA-Related Overgrowth Spectrum (PROS), Growth Disorders

Intervention / Treatment
-----------------
* Drug: ARQ 092


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe overgrowth diseases and/or vascular anomalies with confirmed somatic genetic alterations of PIK3CA or AKT Are unable to participate in an ongoing ARQ 092 clinical trial Willing and able to provide written, signed informed consent. In the case of a minor, a parent or legal guardian must sign an informed consent form. Medically suitable for treatment with ARQ 092 Not eligible for any other available therapy for the diagnosed overgrowth disease and/or vascular anomaly with confirmed somatic genetic alterations of PIK3CA or AKT Exclusion Criteria: Currently enrolled in an ongoing clinical study of ARQ 092 or other investigational drug Currently being treated with any inhibitor of the PI3K/AKT/mTOR pathway

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARQ 092|Open-label expanded access for ARQ 092 capsules|

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
-----------------
ARQ 092, ArQule, AKT, PIK3CA, Overgrowth, Congenital malformations
Evaluation of the New Variant 501Y.V2 of COVID-19

Study Overview
=================
Brief Summary
-----------------
In January 2021, the incidence of COVID-19-and its mortality started rising for the third time in France. This rise may associate with three emerging variants, namely, V1, V2, and V3, which are the 20I/501Y.V1 (English), 20H/501Y.V2 (South African), and 20J/501Y.V3 (Brazilian) variants, respectively. V1 was recently suggested to increase mortality in people in the United Kingdom who tested positive for COVID-19 on community screening. Very little is known about V2 infection, including its outcomes relative to other strains. In early 2021, V2 spread to the Grand-Est region (northeastern France). Here, the investigators aimed to report mortality data of patients admitted in ICU between February and April 2021 in 3 hospitals in Grand-Est: Metz, Thionville and Nancy.

Official Title
-----------------
Comparison of Mortality in Severe SARS-Cov-2 Infection Caused by the 501Y.V2 Variant and B.1.1.7 Variant

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission in ICU in February, March or April 2021 Patient with a SARS-CoV-2 positive polymerase-chain reaction test Patient with 20I/501Y.V1 (English) or 20H/501Y.V2 (South African) SARS-CoV-2 variants Exclusion Criteria: Opposed to use data

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 |
| --- | --- | --- |
| Mortality 28 days after admission | Vital status 28 days after admission in Intensive Care Unit | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | Percentage of mortality in Intensive Care Unit | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mortality, SARS-CoV-2 variants, Intensive Care Unit, 20I/501Y.V1, 20H/501Y.V2
Assessment of GRASP Medical Device to Improve Arm Coordination After Stroke

Study Overview
=================
Brief Summary
-----------------
Assessment of a custom made grasp device in the rehabilitation of stroke victims.

Official Title
-----------------
Assessment of GRASP II Medical Device to Improve Arm Coordination After Stroke

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Damage to the following areas of the brain, all of which may be involved in coordination of reach to grasp confirmed by CT scan: parietal, cerebellar, internal capsule and basal ganglia, A score of 6 or more on the arm section of the Rivermead Motor Assessment (able to reach and pick up a tennis ball and release on thigh), Time between start of hand opening and start of hand transport > 60 ms (measured with GRASP). Exclusion Criteria: Cognitive dysfunction which prevents understanding of the task, Severe concurrent medical problems that prevent repetitive reaching (including shoulder pain), A diagnosis of Parkinson's disease, or Lack of informed consent.
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 |
| --- | --- | --- |
| Time to grasp | Primary outcome measures are: 1) The time elapsed between the start of grasp (when the finger breaks contact with the thumb) and the start of transport (when the wrist leaves the start position); and 2) The time elapsed between maximum aperture of the hand and peak deceleration of the wrist. Secondary outcome measures are: 1) movement duration, 2) time of maximum aperture expressed as % of movement duration, 3) time of peak deceleration expressed as % of movement duration, 4) amplitude of peak velocity of the wrist, 5) time of peak velocity, 6) time of peak velocity of the wrist expressed as % movement duration, 7) size of maximum aperture, 8) time to close hand from time of maximum aperture, 9) distance to target at time of maximum aperture. | 3 sessions |
Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
Primary objective: To describe and compare the safety and efficacy of treatment with AAT in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (TP-IAT).

Detailed Description
-----------------
The goal of this study is to assess whether infusion of Prolastin-C during peri-transplant period can enhance islet autograft survival and function in chronic pancreatitis patients who have total pancreatectomy and islet autotransplantation. This is a prospective, controlled, double-blind study. The primary endpoint will be area under the curve for the serum C-peptide level during the first 4 hours of an mixed meal tolerance test (MMTT), normalized by the number of islet equivalents (IEQ)/kg at day 365±14 after the transplant.

Official Title
-----------------
Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival

Conditions
-----------------
Chronic Pancreatitis

Intervention / Treatment
-----------------
* Drug: Prolastin-C
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for total pancreatectomy and islet auto-transplantation Age > 18 years Diabetes free before surgery Exclusion Criteria: Patients who are under immunosuppression Patients who have had Puestow or Frey pancreatic surgery Patients who have Immunoglobulin A (IgA) deficiency, known antibodies against IgA, or individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis to Alpha1-proteinase inhibitor products (allergic to AAT)

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prolastin-C<br>Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks. | Drug: Prolastin-C<br>* Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation<br>* Other names: AAT;|
| Placebo Comparator: Placebo<br>Subjects will be given Saline weekly for 4 weeks. | Drug: Placebo<br>* Patients will receive saline on day 0, 7, 14, and 21 days of transplantation<br>* Other names: Saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Islet Graft Function | Islet graft function will be measured by 4 hour mixed meal tolerance test (MMTT) at 365 days post transplantation. Specific measurement is the C-peptide area under the curve (AUC) | 365 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Islet autotransplantation, Alpha1 anti trypsin
Use of Telehealth Technology by Mental Health Care Professionals in Times of COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
A brief online survey to be completed by clinical therapists.

Detailed Description
-----------------
A brief online survey to be completed by clinical therapists. This brief 28 question online survey asks mental health care providers questions about their use of technology.

Official Title
-----------------
Use of Telehealth Technology by Mental Health Care Professionals in Times of COVID-19 Pandemic

Conditions
-----------------
Online Therapy

Intervention / Treatment
-----------------
* Behavioral: online survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Must be 18 years old, and must be a licensed mental healthcare provider actively treating patients within the past year. Exclusion Criteria: • Less than 18 years old, or if you are not a licensed mental healthcare provider actively treating patients within the past year.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: online survey|A brief survey for therapists to fill out|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responses to the survey questions | we are not reporting an overall score on a scale, mostly true false and multiple choice | measured at the time they take the survey, data collection will continue for up to 1 year. |
Study of Association of Anti-inflammatory and Anti-rheumatic

Study Overview
=================
Brief Summary
-----------------
Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.

Detailed Description
-----------------
Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.

Official Title
-----------------
Phase III Study Comparing Association of Anti-inflammatory and Anti-rheumatic

Conditions
-----------------
Osteoarthritis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signs the Informed Consent Form Age between 40 and 85 years osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology Exclusion Criteria: Cardiovascular disease Serious chronic comorbidity Hypersensitivity to any component of the study drugs body mass index> 30 kg / m²

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kit 1 ( ML + CG ) + P<br>One sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet | Drug: Meloxicam and Glucosamine<br>* Experimental<br>* Other names: Association Anti-inflamatory/Anti-rheumatic;|
| Active Comparator: Kit 2 ( ML + P)<br>One tablet of meloxicam and one sachet of placebo once per day for 12 weeks | Drug: Meloxicam<br>* Active Comparator<br>* Other names: Anti-inflamatory/Placebo;|
| Active Comparator: Kit 3 ( P+ GC)<br>One sachet of glucosamine and one tablet placebo once a day for 12 weeks | Drug: Glucosamine<br>* Active Comparator<br>* Other names: Anti-rheumatic/Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment | Decrease in score of algofunctional Lequesne index after 12 weeks from the start of treatment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by frequency of adverse event | Safety as measured by total frequency of adverse event during the 12 weeks of treatment | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, Knee