linjc16/ctgov huggingface dataset:
Fluid Restriction After Stapled Hemorrhoidopexy

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid restriction is commonly recommended to minimize complications. However, the need for postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy with/without partial external hemorrhoidectomy could reduce urinary retention and postoperative pain. PATIENTS AND METHODS: In this prospective, double-blinded, randomized controlled trial, we enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was administered to the fluid restriction group after the operation, and 1000 mL/12 h was given to the non-fluid-restriction group. We focused on the need for fluid restriction after stapled hemorrhoidopexy.

Official Title
-----------------
Do We Need Fluid Restriction After Stapled Hemorrhoidopexy? A Pilot, Double-Blinded, Randomized Controlled Trial

Conditions
-----------------
Fluid Restriction

Intervention / Treatment
-----------------
* Drug: 1000 mL 0.9% sterile saline
* Drug: 250 mL 0.9% sterile saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gr. III-IV hemorrhoids paitents Exclusion Criteria: Age<20 or >80 Allergy to NSAID or opoids Impaired renal function Pregnant or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluid restriction<br>Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously. | Drug: 1000 mL 0.9% sterile saline<br>* Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.<br>|
| Placebo Comparator: Non-fluid restriction<br>Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously | Drug: 250 mL 0.9% sterile saline<br>* Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first urination | the time to first urination after surgery | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stapled hemorrhoidopexy, Fluid restriction, Urinary retention
Linox Smart S DX PME/Master Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.

Official Title
-----------------
PME/Master Study of the Linoxsmart S DX ICD Leads

Conditions
-----------------
ICD Indication

Intervention / Treatment
-----------------
* Device: Linox smart S DX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with standard ICD indication Be available for follow-up visits on a regular basis at an approved investigational center Exclusion Criteria: Patients with standard ICD contra-indication Patients with permanent atrial fibrillation Have a life expectancy of less than six months Are expecting to receive cardiac surgery within 6 months after enrollment Age < 18 years Not enrolled in another cardiac clinical investigation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Linox smart S DX lead<br> | Device: Linox smart S DX<br>* ICD lead<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of atrial adequate sensing |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linox smart S DX related complication-free rate |  | 6 months |
Girls First - India (2013-2015)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the social, emotional, physical, and educational effects of Girls First, a combined resilience and adolescent health program, vs. its components and a control group, among adolescents in India.

Official Title
-----------------
Girls First - India Evaluation (2013-2015)

Conditions
-----------------
Emotional Wellbeing, Social Wellbeing, Physical Wellbeing

Intervention / Treatment
-----------------
* Behavioral: Peer support groups


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled at schools or present at sites selected for study Must complete consent/assent process Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RC (Girls First Resilience Curriculum)<br>The Girls First Resilience Curriculum is delivered in peer support groups of 12-15 students per group over 23 weekly 1-hour sessions. The curriculum draws from fields such as positive psychology, emotional competence/intelligence, and restorative practices, and aims to improve students' psychosocial assets and wellbeing. | Behavioral: Peer support groups<br> <br> |
| Experimental: HC (Girls First Health Curriculum)<br>The Girls First Health Curriculum is delivered in peer support groups of 12-15 students per group over 21 weekly 1-hour sessions. The curriculum covers topics such as nutrition, sexual and reproductive health, clean water, hygiene, and common diseases, and aims to improve students' physical health and wellbeing. | Behavioral: Peer support groups<br> <br> |
| Experimental: RC+HC (Girls First)<br>Girls First is a combination of the Girls First Resilience Curriculum (RC) and the Girls First Health Curriculum (HC). | Behavioral: Peer support groups<br> <br> |
| No Intervention: SC (School-as-usual control)<br>Participants receive no intervention and attend school as they usually would. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial assets and wellbeing | Measured by self-report scales | Change from baseline, measured at program completion (average of 6 months) | 
| Physical health and wellbeing | Measured by self-report questions | Change from baseline, measured at program completion (average of 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Educational wellbeing | Measured by self-report questions | Change from baseline, measured at program completion (average of 6 months) |
Specific Methylation Profiles in HNSCC

Study Overview
=================
Brief Summary
-----------------
In the study, N-20190047, the investigators aim to define specific methylation patterns in a group of patients with head and neck squamous cell carcinomas. With this study the investigators aim to validate these findings in a larger cohort.

Official Title
-----------------
Validation of Specific Methylation Profiles Ind Head and Neck Cancer - A Cohort Study

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Cancer group: Inclusion Criteria: Written informed consent Verified head and neck squamous cell carcinoma Exclusion Criteria: Other active cancer Uncontrolled comorbidity Unable to give informed consent Control group: Inclusion Criteria: Written informed consent Normal ENT-examination Exclusion Criteria: Other active cancer Uncontrolled comorbidity Unable to give informed consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer group<br>Patients with verified head and neck squamous cell carcinomas | Diagnostic Test: Blood sample<br>* A separate blood sample will be taken for methylation-analyses<br>|
| Control group<br>Matched control group without active or earlier cancer and a normal ENT examination. | Diagnostic Test: Blood sample<br>* A separate blood sample will be taken for methylation-analyses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | How accurate can the methylation profiles diagnose the head and neck squamous cell carcinoma | At diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and neck cancer, Squamous Cell carcinoma, Methylation, DNA
Frozen-thawed Embryo Transfers and Hormone Substitution on Thrombotic Risk Markers

Study Overview
=================
Brief Summary
-----------------
The study focus on the impact of estrogen/progesterone substitution during artificial cycle frozen embryo transfer (AC-FET) in women undertaking assisted reproductive technology treatment (ART).

Detailed Description
-----------------
The aim is to investigate whether the coagulation is activated in women undergoing estrogen/progesterone substitution during artificial cycle frozen embryo transfer (AC-FET) in assisted reproductive technology treatment (ART). An activation of the coagulation might induce an increased thromboembolic risk in these women. Thus, the present study may lead to improvement of the current treatment protocol for women receiving AC-FET and ultimately prevent thromboembolic complications for woman in fertility treatment.

Official Title
-----------------
Impact of Frozen-thawed Embryo Transfers and Hormone Substitution on Thrombotic Risk Markers

Conditions
-----------------
Frozen Embryo Transfer

Intervention / Treatment
-----------------
* Diagnostic Test: Primary and secondary hemostasis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women receiving FET with or without estrogen/progesterone substitution Exclusion Criteria: Known bleeding disorder Indication for thromboprophylaxis during ART treatment Treatment with anti-platelet medication including non-steroid-anti-inflammatory drugs (NSAIDs) within the last week Donor recipients

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FET<br>Estrogen/progesterone substituted and natural cycles | Diagnostic Test: Primary and secondary hemostasis<br>* Focus on platelet aggregation, primary and secondary hemostasis parameters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coagulation | Primary and secondary hemostasis parameters | 1 year |
Evaluation of Salivary Flow and Buffer Capacity Associated to Aged People's Oral Health

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the relation of the salivary flow and the buffer capacity of the saliva with medicine, buccal discomfort and auto-related illnesses in aged people.

Detailed Description
-----------------
Study clinical of prevalence. 68 aged, average 70.4 years, SD ± 7.27 represented institution's residents of long permanence. Questionnaire was applied, organizing the data for Software SPSS version 15. The test qui-square of Pearson was used, level of significance 5% and reliable interval 95%. 80% presented pH normal. The salivary Flow: 32.3% very low, 41.2% reduced and 25.5% normal. 30.9% mentioned dry mouth, 22.1% tasting's problems, 17.6% dysphagia and 14.7% burning mouth. Main systemic illnesses: 48.5% declared cardiovascular problems, 17.6% diabetes and 16.2% osteoporosis. 76.5% used medicine. There was a significance statistic between medicine taking and dry mouth (p=0.013), buffer capacity and burning mouth (p=0.019), salivary flow and medicine taking (p=0.048). The low salivary flow and the buffer capacity of the saliva influence in the aged people's health condition, as the drugs influence the results.

Official Title
-----------------
Evaluation of Salivary Flow and Buffer Capacity Associated to Aged People's Oral Health

Conditions
-----------------
Oral Health, Diagnosis, Oral, Public Health

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged people with 60 years old or more, ills or not, able to realize tests people who want to participate of research Exclusion Criteria: people less 60 years old

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Saliva, Oral health, Aged
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment

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

Intervention / Treatment
-----------------
* Drug: Quetiapine
* Drug: Amitriptyline
* Drug: Bupropion
* Drug: Citalopram
* Drug: Duloxetine
* Drug: Escitalopram
* Drug: Fluoxetine
* Drug: Paroxetine
* Drug: Sertraline
* Drug: Venlafaxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 to 65 years A documented diagnosis of major depressive disorder Exclusion Criteria: Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment

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

| Intervention/Treatment |
| --- |
|Drug: Quetiapine|nan|
|Drug: Amitriptyline|nan|
|Drug: Bupropion|nan|
|Drug: Citalopram|nan|
|Drug: Duloxetine|nan|
|Drug: Escitalopram|nan|
|Drug: Fluoxetine|nan|
|Drug: Paroxetine|nan|
|Drug: Sertraline|nan|
|Drug: Venlafaxine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of quetiapine fumarate sustained release |  |  | 
| (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder, MDD
NSAID vs. Narcotics

Study Overview
=================
Brief Summary
-----------------
This will be a single-center, prospective observational study. The study will compare post-operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other cohort will receive only Percocet. Both pain management options are considered to be standard of care. The primary objective of the study is to compare patients' reported pain and narcotic use following meniscectomy, and determine if NSAIDs can provide adequate pain relief.

Official Title
-----------------
Multimodal Analgesia With NSAID vs. Narcotics Alone for Post-operative Meniscectomy: A Prospective Observational Study

Conditions
-----------------
Multimodal Analgesia, Nonsteroidal Anti-inflammatory Drugs

Intervention / Treatment
-----------------
* Drug: Ibuprofen 600 mg
* Drug: standard oxycodone/acetaminophen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be at least 18 years of age ASA class I-II Patients scheduled for meniscectomy Exclusion Criteria: Contraindication to ibuprofen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder) Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.) Younger than 18 years of age or older than 65 Any patient considered a vulnerable subject Patients on pain medication prior to surgery

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with pain following knee arthroscopic meniscectomy<br> | Drug: Ibuprofen 600 mg<br>* Ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN<br>Drug: standard oxycodone/acetaminophen<br> <br> * Other names: Percocet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) score | Scale consisting of a drawn line from 0 to 100 - you will be asked to mark where you believe your pain is (100 being worse pain). | 4 Hours | 
| Pain Verbal Rating Scale | Verbal rating scale, consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe). | 4 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesic efficacy, knee arthroplasty, Opioid consumption, Pain Medicine, Narcotics, Multimodal Analgesia
Emotional and Cognitive Self-regulation, an EEG Study

Study Overview
=================
Brief Summary
-----------------
The main goal of the proposed project is to assess treatment-induced changes of electrophysiological and psychophysiological correlates of the capacity to regulate emotion, executive functions, and clinical measures in individuals with complex posttraumatic stress disorder and dissociative disorders in a naturalistic inpatient setting.

Official Title
-----------------
Effectiveness of Therapeutic Treatment: Hot and Cold Self-regulation in Posttraumatic Stress Disorder and Dissociative Disorder

Conditions
-----------------
Complex Posttraumatic Stress Disorder (cPTSD), Dissociative Disorder Not Otherwise Specified (DDNOS), Dissociative Identity Disorder (DID)

Intervention / Treatment
-----------------
* Other: therapeutic treatment (inpatient and outpatient setting)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -ability to undergo EEG measurement/psychophysiological measurement Exclusion Criteria: regular substance use acute suicidality comorbid psychosis

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient group<br>Inpatient setting (cPTSD, DDNOS, DIS): Trauma-adapted psychotherapy (individual and group setting), body-related, cognitive stabilization groups, pharmacotherapy, and other non-verbal treatment modalities (e.g. music, art, and occupational therapy) | Other: therapeutic treatment (inpatient and outpatient setting)<br> <br> |
| No Intervention: healthy control group<br>passive control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event-related potential (ERP) |  | up to 6 months | 
| power in specific frequency bands |  | up to 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  | up to 6 months | 
| electrodermal activity |  | up to 6 months | 
| executive function | working memory, Schuhfried test battery | up to 6 months | 
| measurement of psychological symptoms | questionnaire, Brief Symptom Inventory (BSI) | up to 6 month | 
| assessment of emotion regulation and dysregulation | questionnaire, Difficulties in Emotion Regulation Scale (DERS) | up to 6 month |