linjc16/ctgov huggingface dataset:
Group CBT for Depression and AOD Disorders

Study Overview
=================
Brief Summary
-----------------
The investigators will adapt and test an existing treatment (group CBT for depression) for use in outpatient substance use treatment settings as delivered by trained substance use counselors. The investigators expect that treatment will lead to improved depression and substance use outcomes.

Detailed Description
-----------------
Aim 1. To adapt an existing group therapy (CBT for depression), creating a manualized treatment and accompanying implementation measures and tools for use with clients with persistent depressive symptoms and AOD disorders and to obtain preliminary assessments of the treatment from patient and provider perspectives. Aim 2. To conduct a pilot test of the revised treatment in which we (a) demonstrate that when the therapy is implemented with fidelity, clinically significant reductions in depressive symptoms and AOD use occur; (b) estimate the likely effect size; and (c) investigate the underlying mechanisms of change, including both cognitive-behavioral and group processes and their relationship to depression and AOD treatment outcomes.

Official Title
-----------------
Group Cognitive Behavioral Therapy for Depression and Alcohol and Other Drug Disorders

Conditions
-----------------
Depression, Substance Use

Intervention / Treatment
-----------------
* Behavioral: Group CBT for Depression and AOD Disorders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in outpatient substance abuse program BDI II score >13 Probable alcohol or substance use problem Exclusion Criteria: Cognitive impairment (Short Blessed > 10) Probably bipolar or schizophrenic disorder

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Clients are invited to attend 18 group CBT sessions | Behavioral: Group CBT for Depression and AOD Disorders<br>* 18 sessions of 2-hour group CBT<br>|
| No Intervention: 2<br>Clients receive usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reductions in depressive symptoms as measured by the BDI II |  | Post treatment | 
| Reductions in AOD use |  | Post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Substance Use, Group Cognitive Behavioral Therapy
Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the investigators study is to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding.

Detailed Description
-----------------
The investigators are performing a nationwide population based cohort study to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding. The results of the investigators study should give us information about patients who are at high risk of rebleeindg and enable us to manage these patients appropriately.

Official Title
-----------------
Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study

Conditions
-----------------
Peptic Ulcer Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with peptic ulcer bleeding by endoscopy Patients who consent to be enrolled in the study Exclusion Criteria: Patients who refuse to be enrolled in the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Peptic ulcer bleeding patients<br>Endoscopy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding rate of peptic ulcer bleeding | The rebleeding rate of patients diagnosed with peptic ulcer ble4eding | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rates of peptic ulcer bleeding | The 30 day mortality rate of patients diagnosed with peptic ulcer bleeding | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peptic ulcer bleeding, rebleeding, mortality, nationwide
Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV.

Official Title
-----------------
Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

Conditions
-----------------
Symtomatic Macular Polypoidal Choroidal Vasculopathy

Intervention / Treatment
-----------------
* Biological: Intravitreous aflibercept injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female >/= 18 years Confirmed diagnosis of symptomatic macular PCV in the study eye defined by: - Active macular polypoidal lesions shown by ICGA and - Presence of serosanguinous maculopathy BCVA letter score between 78-24 using ETDRS visual acuity chart measured at 4 meters Exclusion Criteria: Previous treatment with systemic anti-VEGF drugs within 6 months prior to Baseline (e.g., sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®]) Study eye: Active ocular inflammation or infection (ocular or periocular) Uncontrolled intraocular hypertension or glaucoma (IOP> 30 mmPIg) despite treatment with anti-glaucoma medication Predominantly-scarred PCV lesions Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period Prior treatment with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy Prior treatment with any anti-VEGF compound or any investigational treatment Treatment with intravitreal or subtenon corticosteroid injection or device implantation within 90 days

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aflibercept<br> | Biological: Intravitreous aflibercept injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity (BCVA) |  | 2 years |
Calcium Ionophore Solution Can Increase Fertilization Rate in Patients During Intracytoplasmic Sperm Injection(ICSI) Who Have Poor Ovarian Reserve?

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate calcium ionophore solution on fertilization rate of patients during intracytoplasmic sperm injection who have poor ovarian reserve

Detailed Description
-----------------
During ICSI cycle , female patients who have poor ovarian reserve have low oocyte numbers. So by calcium ionophore solution which we know that it can increase fertilization rate in males who have azospermia or globozoospermia. we planned to check if this solution can increase fertilization rate also in poor ovarian reserve patients?

Official Title
-----------------
Effect of Calcium Ionophore Solution on Fertilization Rate During ICSI Cycles of Poor Ovarian Reserve Patients

Conditions
-----------------
Fertilization Failure

Intervention / Treatment
-----------------
* Other: calcium ionophore solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile couples who have no male factor infertility infertile females who are poor ovarian reserve Exclusion Criteria: infertile couples who have male factor infertility infertile female who have endometriosis

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 39 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>the patients who have no intervention with calcium ionophore during ICSI cycle | |
| Experimental: calcium ionophore<br>the patients whose oocytes are incubated with calcium ionophore solution during ICSI cycle | Other: calcium ionophore solution<br>* After microinjection of sperm into the oocyte, oocytes are incubated for 15 minutes in a 30 microlitre droplet of calcium ionomycin solution<br>* Other names: ionomycin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calcium ionophore solution effect on fertilization rate | Before Intracytoplasmic sperm injection adding calcium ionophore solution to the medium can increase fertilization rate of oocytes or not? | 18 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium ionophore solution increase on going pregnancy rate | İf the calcium ionophore can increase fertilization rate , pregnancy rate up to 20 weeks, can increase or not? | up to 21 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
calcium ionophore, fertilization rate, poor ovarian reserve
Health-related QoL Following TAVI TAo, TAVI TF and AVR

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate short- and long-term changes in QoL in patients undergoing TAVI and to assess differences in patient QoL when using the TAVI TAo approach compared with the transfemoral approach (TAVI TF) and surgical aortic valve replacement (SAVR).

Official Title
-----------------
Health-related Quality of Life Following Transcatheter Aortic Valve Implantation Using Transaortic, Transfemoral Approaches and Surgical Aortic Valve Replacement - a Single-center Study

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aortic valve stenosis Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVI TAo<br> | Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement<br>* Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.<br>|
| TAVI TF<br> | Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement<br>* Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.<br>|
| AVR<br> | Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement<br>* Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life: EQ-5D-3L questionnaire | EQ-5D-3L questionnaire | 1 month and 1 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAVI, quality of life, SAVR
Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether timely feedback to providers on patient experiences with delayed chemotherapy induced nausea and vomiting (CINV) lead to differences in patient outcomes for subsequent cycles.

Official Title
-----------------
Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis

Conditions
-----------------
Chemotherapy Induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Behavioral: Disease Management Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Highly or moderately emetogenic chemotherapy planned for at least 2 cycles Exclusion Criteria: Concurrent other anti-cancer therapy (e.g. radiation, hormone, etc.); vomiting during the 24 hours prior to first chemotherapy cycle; having a disease/condition or taking medication that may cause emesis

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Disease Management Assessment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CINV at the delayed phase during cycle 2 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment for CINV |  |  |
Chronic Pain Self-Management With Integrative Yoga Therapy (IYT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate efficacy of chronic pain self-management program in community settings to adopt Integrative Yoga Therapy (IYT).

Official Title
-----------------
Evaluating Community-Based Pain Self-Care Using Integrative Yoga Therapy (IYT): Quasi Experimental Study

Conditions
-----------------
Chronic Pain, Chronic Nonmalignant Pain

Intervention / Treatment
-----------------
* Other: Integrative Yoga Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years old. having a chronic pain of more than 3 months of duration, no matter the aetiology. Capable of understanding and giving written informed consent. Significant levels of distress and disability related to the pain at the beginning of treatment Exclusion Criteria: Intelectual disability or cognitive impairment Planning to move out of area Serious mental illness Drugs or substance abuse in the last 6 months Post surgery or scheduled for surgery Cancer related pain

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Yoga Therapy<br>Self managed Yoga based practices were included in one to one sessions for 6-sessions. | Other: Integrative Yoga Therapy<br>* Integrative Yoga Therapy included personalised yoga therapy sessions including their standard care, yoga movements, relaxation, meditation, breathing practices and yoga counselling sessions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Analogical Visual Scale from 0 to 10 scores where 0 describes no pain and 10 worst pain. | From baseline to 6-week post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and Depression | Hospital Anxiety and Depression Scale (HADS). 14 item, 7 each of anxiety and depression. Each item score between 0-3. | From baseline to 6-week post intervention | 
| Satisfaction with the treatment | Satisfaction with the treatment (CRES-4) 4 questions. | From Baseline to 6-week post intervention | 
| General Quality of Life | Nottingham Health Profile score between 0 to 100 where 0 is best and 100 is worst | From baseline to 6-week post intervention |
Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery. Aim of the study is the validation and comparison of the innovative medical device with the current standard method.

Official Title
-----------------
Virtual Implant Planning System - A Method to Support Image-guided Surgical Interventions

Conditions
-----------------
Fracture of Distal End of Radius

Intervention / Treatment
-----------------
* Procedure: Treatment with investigational method (virtual implant positioning system)
* Procedure: Treatment with surgical standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diastal fracture of the radius Patients with the mentioned fracture and indication for surgical treatment according to national guidelines Age >/= 18 years of age Patients willing to participate and after having given their informed consent in written form Exclusion Criteria: Participation in other interventional clinical trials Pregnant or lactating women

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 |
| --- | --- |
| Other: A<br>Treatment with investigational method (virtual implant positioning system) | Procedure: Treatment with investigational method (virtual implant positioning system)<br> <br> |
| Other: B<br>Treatment with surgical standard of care | Procedure: Treatment with surgical standard of care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of screw replacements in both treatments arms | The number of screw replacements in both treatment arms will be assessed to evaluate the investigational method in comparison to the standard of care (arm B) | Participants will be followed for the duration of the hospital stay, an expected average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the investigational method to the standard of care regarding radiation time. |  | Participants will be followed for the duration of the hospital stay, an expected average of 3 days | 
| Number of adverse events and serious adverse events during the clinical investigarion. |  | Participants will be followed for the duration of the hospital stay, an expected average of 3 days |
Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction

Study Overview
=================
Brief Summary
-----------------
The investigators want to compare blood microbiota profile between patients with documented coronary lesions and patients free of coronary disease.

Official Title
-----------------
Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction

Conditions
-----------------
Coronary Disease, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases : patients who have had a myocardial infarction within one month to one year before the inclusion Controls : patients without history of myocardial infarction, free of coronary disease in the view of one of the following tests performed within one year before the inclusion : Effort test Echocardiographic stress test Myocardial perfusion scintigraphy Coronarography with >= 2 major cardiovascular risk factors: Treated hypertension, Treated dyslipidemia Current smoking Diabetes mellitus Exclusion Criteria: Infectious disease within one week before the inclusion Immunocompromised patients Antibiotic treatment within one month before the inclusion Chronic viral infection Chronic inflammatory intestinal bowel disease Renal failure (estimated glomerular filtration rate< 50 ml/min//1.73 m2) Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 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 |
| --- | --- |
| case<br>patients with a myocardial infarction within one month to one year before the inclusion | |
| control<br>patients without history of myocardial infarction, free of coronary disease in the view of one of the following test performed within one year before the inclusion : Effort test Echocardiographic stress test Myocardial perfusion scintigraphy Coronarography with >= 2 major cardiovascular risk factors : Treated hypertension Treated dyslipidemia Current smoking Diabetes mellitus | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood bacterial 16s rDNA bacterial gene concentration | compare blood bacterial 16s rDNA bacterial gene concentration | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood microbiota profile | compare blood microbiota profile as assessed at all taxonomic levels of interest (genus, family, order, class, phylum) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood microbiota, coronary disease, myocardial infarction