linjc16/ctgov huggingface dataset:
Remote Video Consultation for Quality of Life Assessment in Patients Hospitalised After COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
Around 90.000 patients have been hospitalised due to COVID-19 infection in France between March 1st and June 15th; 19% of those requiring intensive care. Approximately 80% of these patients have been discharged home by September 30th. Nonetheless, COVID-19 infection along with intensive care consequences are very likely to impede those patients quality of life and functional capacities. This study aims to describe the quality of life outcomes and functional capacities of COVID-19 survivors, at least 6 months after primary care hospital discharge.

Official Title
-----------------
Remote Evaluation of Quality of Life and Functional Capacities in Patients Hospitalised for COVID-19: a Prospective Observational Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient COVID-19 hospitalisation at Le Havre hospital between March 1st and May 11th Non-opposition during first phone contact Exclusion Criteria: Guardianship Juvenile patients Pregnancy Inability to communicate Cognitive disorders Deceased patient

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | Measured with the Short-Form health survey (SF-36) scale (score ranging form 0 (worst score) to 100 (best score) per item) | 10 to 12 months after hospital discharge during remote video consultation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | One-minute Sit-to-stand test | 10 to 12 months after hospital discharge during remote video consultation | 
| Independency | KATZ score (ranging 0 (fully dependent) to 6 (fully independent)) | 10 to 12 months after hospital discharge during remote video consultation |
Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.

Detailed Description
-----------------
Patients allergic to the specific pollen are divided into two groups randomly. One group is being administered Lectranal and the other group is being administered placebo during the period of 6 weeks in season of the pollen. Methods used for evaluation are: SARS questionnaire(seasonal allergic rhinitis symptoms), Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) skin Prick test, specific IgE and IgG, eosinophilia in nasal secretion. Methods used for follow up safety include side effects report, physical examination and vital signs.

Official Title
-----------------
Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Dietary Supplement: Lectranal
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of seasonal allergic rhinitis symptoms to pollen positive skin prick test to pollen negative history of seasonal allergic asthma male or female older than 18 female participants must use appropriate contraception able to comply to study procedures Exclusion Criteria: pregnancy alcohol or drug abuse subject receiving antihistamines , immunotherapy or on hyposensibilisation

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br> | Dietary Supplement: placebo<br>* Dosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks<br>|
| Active Comparator: 1<br> | Dietary Supplement: Lectranal<br>* Dosage form: capsule 1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in SARS (seasonal allergic rhinitis symptoms) |  | 6 weeks | 
| changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) |  | 6 weeks | 
| changes in specific IgE |  | 6 weeks | 
| changes in specific IgG |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prick test change |  | 6 weeks | 
| change in eosinophilia in nasal secretion |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seasonal allergic rhinitis, lectranal, allergy
Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Whether high-dose omega-3 fatty acids supplement would be an effective treatment in patients with major depressive disorder during pregnancy and breast-feeding.

Official Title
-----------------
Omega-3 Polyunsaturated Fatty Acids in Women With Major Depressive Disorders During Pregnancy

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

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants were pregnant women, aged 18 to 40 years, with major depressive disorder onset between their 16th week (second trimester) and 32nd week (third trimester) of gestation at the Department of Obstetrics. Exclusion Criteria: Subjects were excluded with a DSM-IV diagnosis of bipolar disorders, psychotic disorders, substance abuse or dependence for at least 3 months, or any Axis-II diagnosis of borderline or antisocial personality disorder.

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>omega-3 fatty acid with 2.2 g of eicosapentanoic acid (EPA) and 1.2 g of docosahexanoic acid (DHA) | Dietary Supplement: Omega-3 fatty acids<br> <br> |
| Placebo Comparator: 2<br>Placebo (olive oil ethyl esters) | Dietary Supplement: Omega-3 fatty acids<br> <br> |

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
-----------------
Omega-3 Fatty Acids, Major Depressive Disorder, Pregnancy, Women during pregnancy and after childbirth are more vulnerable to psychiatric disorders, Pharmacotherapy for depression during pregnancy is a clinical dilemma., Omega-3 polyunsaturated fatty acids (PUFAs) might be a promising alternative of treatment for pregnant women with depression.
Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers

Study Overview
=================
Brief Summary
-----------------
Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.

Official Title
-----------------
Assessment of Efficacy and Safety for a New Wound Dressing URGO 310 3166 in the Local Treatment of Venous or Mixed Leg Ulcers: A European, Randomised Clinical Trial

Conditions
-----------------
Leg Ulcers

Intervention / Treatment
-----------------
* Device: Urgo 3103166
* Device: Aquacel Extra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old who has provided his/her written informed consent, Patient who can be monitored by the same investigation team throughout the whole duration of the study, Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing, Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3, Ulcer area > or equal to 5cm2, Ulcer duration > or equal to 6 months, Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue, Moderately or heavily exudative ulcers. Exclusion Criteria: Clinical infection on the wound bed.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Urgo 3103166<br>Soft-adherent hydro-desloughing dressing | Device: Urgo 3103166<br>* URGO 310 3166 dressing should be changed as often as required (let to the Investigator's convenience). The dressing change frequency is based on the exudate level and the clinical progress of the wound (up to 7 days).<br>|
| Active Comparator: Device Aquacel Extra<br>Hydrofibre dressing | Device: Aquacel Extra<br>* Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative regression of wound surface area |  | week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of debrided wounds |  | at each clinical evaluation up to 20 weeks | 
| Occurrence of adverse events as assessed by the investigator according to a classification MedDRA |  | between inclusion and week 20 | 
| Patient's Quality of Life |  | at inclusion visit and at week 20 or at the end of study treatment |
Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds

Study Overview
=================
Brief Summary
-----------------
This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin sheet bilayer or single layer products for complex soft tissue reconstruction of lower extremity diabetic wounds compared to other treatments. Participating sites will collect information for all patients who received Integra, free flap, local tissue flap, or negative pressure therapy over a 5 year period. The patient must be a minimum of 1 year from index procedure, with index procedure being defined as the application of Integra, free flap, local tissue flap, or negative pressure. Any follow-up occurring during the year is eligible for inclusion.

Official Title
-----------------
A Retrospective, Multi-Center Study Evaluating the Outcomes for Integra® Skin Sheet Bilayer or Single Layer Products Used in Complex Lower Extremity Soft Tissue Reconstruction

Conditions
-----------------
Complex Lower Extremity Soft Tissue Reconstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic (I or II) male or female, age greater than 18 years Lower extremity wounds that required operative application of Integra, free flap, local tissue flap, or negative pressure wound therapy. Complex wounds are defined as wounds that involve exposed deep tissue (e.g. bone, tendon, fascia, ligament) The patient must be a minimum of 1 year from the index procedure, any follow-up occurring during the year is eligible for inclusion. Exclusion Criteria: Age less than 18 years

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 |
| --- | --- |
| Integra<br> | |
| Integra + NPWT (short-inpatient use only)<br> | |
| Integra + NPWT (long-all other durations)<br> | |
| Integra + STSG<br> | |
| Integra + Dermoinductive Agent<br> | |
| Free Flap<br> | |
| Local Tissue Flap<br> | |
| NPWT<br> | |
| NPWT then Integra (on same admission)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound recurrence rates after Integra application (and final split-thickness skin graft or dermoinductive agent application) as compared with free flap, local tissue flap, and negative pressure wound therapy. | A dermoinductive agent is a product that is said to promote rapid wound healing. | 5 year period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy. |  | 5 year period |
Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that chemoradiation based on 2 drugs will improve local control and long-term survival in patients with locally advanced pancreatic cancer. That is why gemcitabine and irinotecan are combined in an induction phase of 2 months and then this IrinoGem combination is given for 3 more cycles, in reduced doses,concurently with irradiation.

Official Title
-----------------
Phase II Study of Irinotecan and Gemcitabine (IrinoGem) Combined With 3-D Conformal Radiation Therapy for Locally Advanced Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: irinotecan, gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: locally advanced pancreatic cancer performance status 0-2 normal blood count and chemistry no previous chemotherapy or radiotherapy Exclusion Criteria: serious concurrent systemic disease

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irinotecan, gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to treatment failure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate, survival, toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carcinoma, pancreas, chemotherapy, radiotherapy
Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to describe characteristics and trends for thrombin generation (TG) and thromboelastography (TEG) at 4 time points during the menstrual cycle.

Detailed Description
-----------------
We propose that TG and TEG will be more sensitive than traditional coagulation assays to detect physiologic variation in hemostasis, fibrinolysis, and platelet activation throughout the menstrual cycle. We expect that TG and TEG will better discriminate patients with vWD than traditional coagulation studies during the menstrual cycle. In this study we plan to measure TG and TEG in healthy women and women with von Willebrand's disorder during four phases of the menstrual cycle. We will compare specific measurements of endogenous thrombin generation potential from the TG and fibrinolysis and platelet activation from the TEG with standard measures of coagulation, fibrinolysis, and platelet activation markers during the menstrual cycle.

Official Title
-----------------
Changes in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

Conditions
-----------------
Von Willebrand Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females of reproductive age with regular menstrual cycles and a diagnosis of von Willebrand disease according to the International Society of Thrombosis and Hemostasis diagnostic criteria. Exclusion Criteria: Females who are pregnant, or have a history of endocrinopathy or hormone imbalance History of hysterectomy or bilateral oophorectomy History of ovarian or uterine cancer Use of intrauterine device Use of antifibrinolytic therapy, hemostatic agents, or anti-platelet agents.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endogenous Thrombin Potential | Comparison of 4 values collected during 4 phases of through the menstrual cycle | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
von Willebrand Disease, Healthy Women and Women with von Willebrand Disease
P3: Pacemaker Patient Profiling Study

Study Overview
=================
Brief Summary
-----------------
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.

Official Title
-----------------
Pacemaker Patient Profiling (P3) Study

Conditions
-----------------
Bradycardia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient meets Class I / Class II indications for pacing Patient implanted with one of the following market-approved single or dual chamber Medtronic devices: EnRhythm™, EnPulse®, Kappa® 700, Kappa® 900, Vitatron Clarity™, Vitatron Selection® AFm, Vitatron C-Series, Vitatron T-Series, or the AT500™ DDDR Pacing System Exclusion Criteria: Patient is enrolled in a device or cardiovascular drug study that affects treatment and/or study device programming Patient whose life expectancy is less than two years

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 |
| --- | --- | --- |
| Number of Participants With Dual Chamber Devices | Pacemaker device choice characterized by the number of patients with dual chamber devices | at original implant | 
| Days Hospitalized | Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year | implant to one year | 
| Multiple In-clinic Visits | Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation | implant to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemaker, Bradycardia
PhysioGlove Versus Clinic Electrocardiogram Comparison

Study Overview
=================
Brief Summary
-----------------
Comparison of the quality of the outpatient clinic electrocardiogram performed on patients sent to a cardiology consultation with a standard cable and the PhysioGlove-ES electrocardiograms performed in the cardiology clinic.

Detailed Description
-----------------
The correct performance of a 12 lead electrocardiogram depends on the correct placement of the electrocardiogram electrodes in internationally agreed upon anatomic locations on the patient's limbs and chest. This process requires specific training and diligence on the part of the electrocardiogram performer. The literature points towards a progressive quality degradation of the electrocardiogram performance probably due to the delegation of it's performance to lesser trained individuals. This study is attempting to ascertain the quality of the electrocardiogram recordings performed in non-specialized out patient clinics. For this purpose we will compare outpatient electrocardiograms of patients referred to a cardiological consultation with electrocardiogram's acquired using a conventional electrocardiogram cable as well as the PhysioGlove-ES by the well training cardiology clinic personnel.

Official Title
-----------------
Reliability of Outpatient Electrocardiogram Recordings in Patients Refered for a Cardiology Consultation

Conditions
-----------------
Patients With Normal ECG, Patients With Pathological ECG

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consenting male and female patients age 18-95 - Exclusion Criteria: All patients using shirt-sizes under small mand over extra-large all patients with severe chest malformations or open wounds or contagious skin infections involving the chest and/or arms -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Comparison of the technical and diagnostic quality of outpatient clinic electrocardiogram with the on-site (cardiology consultation clinic) performed electrocardiograms | The cardiology clinic electrocardiogram will be compared to the out-patient electrocardiogram brought by the patient to the cardiology consultant | Each patient will be tested once while visiting the cardiology consultation clinic. No further patient follow-up is planed. Data collection and evaluation is estimated at 6-9 months from study initiation |