linjc16/ctgov huggingface dataset:
Talk Therapy After Stroke

Study Overview
=================
Brief Summary
-----------------
Strokes are the first cause of acquired physical disability among adults. Some studies proved that depression is often an unrecognized complication from stroke, associated with a vital prognosis, functional and cognitive pejorative diagnosis. It led us to pose the hypothesis of the existence of a particular psychological state after stroke particularly favorable to a psychotherapeutic alliance. So, this longitudinal monocentric study aims to estimate the feasibility of a talk therapy and its impact on the anxio-depressive symptomatology after stroke.

Official Title
-----------------
Talk Therapy After Stroke. PS-POST AVC

Conditions
-----------------
Adams-Stokes Syndrome

Intervention / Treatment
-----------------
* Behavioral: talk therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ischemic or aemoragic stroke minor 1 week, confirmed by cerebral imaging Exclusion Criteria: severe aphasia (NIHSS criteria 9: sup or egal: 2) Chronic psychiatric preexistant desease.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Talk therapy<br>A cohort of 25 patients | Behavioral: talk therapy<br>* Psychotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptability | Participation rate in the study | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of anxiety and depression | Montgomery and Asberg Depression Rating Scale(depressive patients) and wide COVI (anxious patients) | at 3 and 6 months | 
| Evaluation of quality of life | MM20-QOL scale | at 3 and 6 months | 
| Evaluation of functional recovery | Barthel index and Rankin score NIHSS score | at 3 and 6 months | 
| Assessment of apathy | apathy index | at 3 and 6 months | 
| Categorization of patients | according to their pattern of coping with specific scales and RWCQ (Revised Ways of Coping Questionnaire - stroke modified version) QSSP (Questionnaire de soutien social perçu) | 6 months |
ELAZOP Switching Study in Korea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from prior pharmacotherapy in patients with open-angled glaucoma.

Conditions
-----------------
Open Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: Elazop (Azarga)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older. Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes. Must be on a stable regimen of Intraocular Pressure (IOP) lowering medication (i.e., either a single therapeutic agent or two separate ocular hypotensive agents) for at least one month prior to the Screening Visit. Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in the study that is deemed clinically significant in the opinion of the Principal Investigator. Intraocular conventional surgery or laser surgery in either eye less than three months prior to the Screening visit. History of ocular herpes simplex. Pregnant or lactating. Participation in any other investigational study within 30 days of Screening visit. Other protocol-defined exclusion criteria may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elazop (Azarga)<br>Elazop Treatment arm | Drug: Elazop (Azarga)<br>* Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) change from baseline at final visit. |  | 12 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open angle glaucoma, OAG, Elazop, Azarga, Brinzolamide/Timolol combination
A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.

Official Title
-----------------
A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: ITCA 650
* Drug: glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c between 7.5% - 10.5% on metformin monotherapy BMI between 25 & 45 kg/m2 Exclusion Criteria: On thiazolidinedione, sulfonylurea, DPP-4, alpha glucosidase inhibitor, meglitinides or insulin within last 3 months history of pancreatitis

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITCA 650 60 mcg/day<br> | Drug: ITCA 650<br>* ITCA 650 is exenatide in DUROS<br>|
| Active Comparator: glimepiride<br> | Drug: glimepiride<br>* glimepiride will be up-titrated to 8 mg/day over first 13 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | 52-week Treatment Period followed by 52-week Extension Period | 52 weeks |
Therapeutic Drug Monitoring of Anxiolytics in Children

Study Overview
=================
Brief Summary
-----------------
In this study, the therapeutic drug monitoring of anxiolytics is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then the investigators analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of anxiolytics in Chinese children.

Official Title
-----------------
Therapeutic Drug Monitoring of Anxiolytics in Children

Conditions
-----------------
Anxiolytics

Intervention / Treatment
-----------------
* Drug: Midazolam/diazepam/propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anxiolytics was used for therapeutic purposes; Age:≤18 years; Patients with therapeutic concentration monitoring of anxiolytics. Exclusion Criteria: Patients without therapeutic concentration monitoring of anxiolytics; The blood concentrations of the patient was not approved by the quality control center Use foods or products that inhibit or induce CYP 3A activity.

Ages Eligible for Study
-----------------
Minimum Age: 29 Days
Maximum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anxiolytics<br>Pediatric patients treated with sedation using anxiolytics | Drug: Midazolam/diazepam/propofol<br>* Therapeutic drug monitoring of anxiolytics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma drug concentration | To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM). | Through study completion, an average of 14 days |
Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility

Study Overview
=================
Brief Summary
-----------------
Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse

Official Title
-----------------
Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility: Randomized Controlled Trial

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Clomiphene Citrate 50mg
* Drug: Cabergoline Oral Tablet
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unexplained infertility, Primary or secondary. Absence of galactorrhoea. Normal serum prolactin. Normal hysterosalpingography. Normal spermogram. Exclusion Criteria: Women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen. Known hypersensitivity for cabergoline or clomiphene citrate. Other factors of infertility as tubal factor, uterine factor or male factor.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: study group<br>will receive a dose of Clomiphene citrate 50 mg tablet , 1 tab twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) first three months then Clomiphene citrate 50 mg tablet , 2 tabs twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) | Drug: Clomiphene Citrate 50mg<br>* oral tablets<br>Drug: Cabergoline Oral Tablet<br>* oral tablets<br>|
| Active Comparator: control group<br>will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration | Drug: Clomiphene Citrate 50mg<br>* oral tablets<br>Drug: Placebo Oral Tablet<br>* oral tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of mature follicles | the follicles reach the size of 18 mm | 14 days |
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.

Detailed Description
-----------------
A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients

Official Title
-----------------
A 52-week, Multi-center, Open Label, Single Arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Drug: Hepabulin IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBsAg Positive candidate for HBV-related liver transplant Primary, single organ recipients written informed consent Exclusion Criteria: acute renal failure, Serum creatinin >1.5*ULN severe cardiac disease or other significant disease HAV, HCV or HIV positive Immunoglobulin A deficiency. History of hypersensitivity to Human Immunoglobulin. History of cancer within 5 years. (without HCC) History of alcohol or/and drug abuse. History organ transplantation. Within 30 days, participation in another clinical trial and use of an investigational product. Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepabulin IV<br> | Drug: Hepabulin IV<br>* I.V.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV(HBsAg) recurrence |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence |  | 52 weeks | 
| Survival |  | 52 weeks | 
| viral Marker of HBV |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Transplantation, HBV Recurrence, HBsAg Positive, HBV
Preoperative Mindfulness: Minimally Invasive Hysterectomy

Study Overview
=================
Brief Summary
-----------------
This is a randomized control trial investigating the effects of a preoperative mindfulness intervention on postoperative pain, quality of recovery and stress scores in women undergoing minimally invasive hysterectomy. The mindfulness intervention will be delivered via the application Headspace™. The primary outcome will be pain scores measured on postoperative day one. Secondary outcomes will include quality of recovery scores and perceived stress scores measured on postoperative days 1 and 7, amount of opioid consumed, and dose response between number of sessions and/or numbers of minutes of meditation performed on pain and quality of recovery scores. The study team hypothesizes that mindfulness practiced in the form of meditation delivered via an internet application will lead to reduced pain scores on postoperative day 1.

Official Title
-----------------
Preoperative Mindfulness In Patients Undergoing Minimally Invasive Hysterectomy: A Randomized Controlled Trial

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Behavioral: Mindfulness training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergo minimally invasive hysterectomy Fluency in English Access to a device capable of running the Headspace application (smart phone or computer) Exclusion Criteria: Minors Inability to access Headspace app Inability to complete surveys in English

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

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness training<br>Completion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery | Behavioral: Mindfulness training<br>* Guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Postoperative day 1 pain score using Numeric Pain Rating Scale | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOR-15 score | Quality of Recovery Score | 7 days | 
| PSS-10 score | Perceived Stress Scale | 7 days | 
| Opioid consumption | Number of opioid tablets used postoperatively | 7 days |
Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks

Study Overview
=================
Brief Summary
-----------------
In Paris, France, home hospice care for terminally ill patients is organized by four palliative care networks. These networks are responsible for information sharing and coordination of all health care professionals working with the patient. Two different systems are in place to ensure continuity of care outside working hours, in such a setting. In the first system, palliative care specialists from the network are reachable over the phone 24/7 by the patient or its caregivers, whenever needed. In the second system, medical information about the patient, regularly updated by the network's medical team, is available to professionals via a secure website, so that in case the patient requires an urgent medical home visit outside working hours, the visiting physician has access to accurate information. The study's goal is to compare patient's and caregiver's satisfaction between these two systems of continuity of care. For that purpose, patients will be taken care of as usual by every palliative care network. In every instance where the patient or caregivers have reached out for medical help through the network's continuity of care system, the patient or caregiver will be called 5 days later by the investigation team to go through a satisfaction questionnaire (Likert scales)

Official Title
-----------------
Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks

Conditions
-----------------
Terminal Illness, Neurodegenerative Diseases, Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a disease with fatal prognosis and requires palliative care Patient lives in Paris, France Patient benefits from home hospice care through one of the four official Paris palliative care networks Exclusion Criteria: Pregnant women Breastfeeding womed Altered cognitive function with a Mini Mental Status below 20 Patient not able to communicate or not speaking French Patient legally not capable of giving informed consent

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 |
| --- | --- | --- |
| Satisfaction about the response given by the network's continuity of care system | Patient's (or caregiver's) satisfaction about the response given by the network's continuity of care system, after the patient or caregiver activated this system at night time or during week-ends or bank holliday, as measured on a 4-level Likert scale (verbal questionnaire by phone call) | between the first and tenth day after the patient or caregiver activated the network's continuity of care system |
Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether prostacyclin analogues' cathodal iontophoresis induce a cutaneous vasodilation in healthy volunteers's forearm, without local side effects.

Official Title
-----------------
Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: treprostinil
* Drug: iloprost
* Drug: NaCl 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers age above 18 Exclusion Criteria: any chronic disease any drug intake

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treprostinil<br>Treprostinil iontophoresis (250, 25 and 2.5 microM) | Drug: treprostinil<br>* Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min<br>|
| Experimental: Iloprost<br>Iloprost iontophoresis (200, 20 and 2 microM) | Drug: iloprost<br>* Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min<br>|
| Placebo Comparator: NaCl 0.9%<br> | Drug: NaCl 0.9%<br>* Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of forearm cutaneous vasodilatation assessed using laser Doppler imaging |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tolerance assessed clinically |  | Day 0 and after 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers, iontophoresis