linjc16/ctgov huggingface dataset:
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.

Detailed Description
-----------------
Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery

Official Title
-----------------
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy

Conditions
-----------------
Vitreous Hemorrhage Secondary to PDR

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Drug: bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy Exclusion Criteria: follow-up period of less than 3 months not first vitrectomy abnormal blood coagulation uncontrolled hypertension

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1 - no bevacizumab<br>Patients will not receive bevacizumab before nor during vitrectomy | |
| Experimental: 2- bevacizumab before vitrectomy<br>Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy | Drug: Bevacizumab<br>* 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy<br>|
| Experimental: 3- bevacizumab after vitrectomy<br>Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy | Drug: bevacizumab<br>* 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent vitreous hemorrhage incidence after vitrectomy |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual outcome |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab, vitreous hemorrhage, diabetes mellitus
Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea.

Detailed Description
-----------------
Oxygen therapy reduces the number of central apneas among patients with congestive heart failure but it is unknown whether quality of life and heart function also improve. We aim to test whether the quality of life, exercise capacity and heart function are improved with nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or nocturnal air from placebo concentrator.

Official Title
-----------------
Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration. A Randomized Double-Blind Placebo Controlled Cross-Over Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: nocturnal oxygen treatment from oxygen concentrators


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable heart failure with left ventricular dysfunction Cheyne-Stokes respiration with central AHI>15 and obstructive AHI<5 Exclusion Criteria: Heart infarction within 3 months. Dementia Chronic obstructive pulmonary disease and daytime hypoxemia.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: nocturnal oxygen treatment from oxygen concentrators|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity |  |  | 
| Quality of life (SF-36, Minnesota, Living with heart failure questionnaire) |  |  | 
| Brain natriuretic peptide (BNP) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiography |  |  | 
| Radionuclide determination of ejection fraction |  |  | 
| Mortality and hospitalization for cardiovascular causes (combined and individually) |  |  | 
| Hospitality anxiety and depression scale |  |  | 
| Epworth sleepiness scale |  |  | 
| Karolinska sleepiness scale |  |  | 
| Routine lab (haemoglobins, thyroid status, creatinin) |  |  | 
| Urinary catecholamines |  |  | 
| Urinary cortisol |  |  | 
| Polysomnography |  |  | 
| Arrhythmias from 24 hour Holter-ECG registration |  |  | 
| Heart rate variability |  |  |
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

Study Overview
=================
Brief Summary
-----------------
The purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH

Detailed Description
-----------------
Patients affected by Hereditary hemochromatosis need a completeinitial staging of disease, a correct clinical management, a good chance of treatment and long-term follow-up. Clinical manifestations at presentation and during follow-up may consistently vary according to diagnostic criteria, treatment options and follow-up durability, up to the interruption. So, 25 caucasian patients, 16 males and 6 females of age >18 yrs. have been consecutively diagnosed and randomly included into two arms of treatment, phlebotomy vs. eritrocytoapheresis, evaluating, at baseline and 6-12-18-24-36 months, the clinical status concerning liver, kidney, pancreas, heart, endocrine iron overload and function and final outcome related to therapeutic strategy, including the cost/effectiveness analysis

Official Title
-----------------
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

Conditions
-----------------
Hereditary Hemochromatosis

Intervention / Treatment
-----------------
* Procedure: Eritrocytoapheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patiens newly diagnosed having Hereditary Hemochromatosis Exclusion Criteria: Age < 18 yrs. Not obese (BMI <30) Not consuming alchol beverages, Not affected by systemic diseases and known hepatic viruses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Intervention/Treatment |
| --- |
|Procedure: Eritrocytoapheresis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To prospectively determine the best choice of tretment in HH |  |  | 
| To evaluate the global outcome according to treatment choice |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the outcome of specific clinical features according to treatment choice |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical Management, Phlebotomy, Eritrocytoapheresis
Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

Study Overview
=================
Brief Summary
-----------------
The Renin-Angiotensin-Aldosterone-system is important in the development of cardiovascular organ damage caused by arterial hypertension. This study aims at evaluating the importance of aldosterone with regard to hypertension induced damage to the heart. In order to do this the investigators will perform a comparative cross-sectional study in hypertensives and normotensives. In addition as interventional part the hypertensives will be treated with a mineralocorticoid-receptor blocker (spironolactone).

Official Title
-----------------
Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

Conditions
-----------------
Primary Hypertension

Intervention / Treatment
-----------------
* Drug: spironolactone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis hypertension (BP higher than 139/89) Exclusion Criteria: Antihypertensive pretreatment Contraindications against spironolactone Being unable to understand or comply with study procedures

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>spironolactone | Drug: spironolactone<br>* 25mg per oral once daily<br>|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular mass |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary hypertension, aldosterone, left ventricular hypertrophy
Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Study Overview
=================
Brief Summary
-----------------
This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.

Detailed Description
-----------------
Revance is conducting this Phase 2 clinical study to establish the safety of two (2) sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of moderate to severe LCLs at rest.

Official Title
-----------------
A Phase 2, Open-Label, Repeat Dose, Multi-Center Study to Evaluate the Safety of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Conditions
-----------------
Crow's Feet, Facial Wrinkles, Lateral Canthal Lines

Intervention / Treatment
-----------------
* Drug: RT001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent including authorization to release health information Female or male, 18 to 65 years of age and in good general health Willing and able to follow study instructions and likely to complete all study requirements Moderate to severe lateral canthal lines (crow's feet wrinkles) Exclusion Criteria: Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis Muscle weakness or paralysis, particularly in the area receiving study treatment Active disease or irritation at the treatment areas including the eye and the skin Pregnant, nursing, or planning a pregnancy during the study; or is a woman of child bearing potential (WOCBP) but is not willing to use an effective method of birth control Previous participation in a RT001 clinical study Previous treatment with botulinum toxin (any serotype)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: RT001<br>RT001 (Botulinum Toxin Type A) Topical Gel | Drug: RT001<br>* RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of treatment-emergent adverse events based on safety assessments. |  | 4 weeks and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Facial Wrinkles, Lateral Canthal Lines, Crow's Feet
Compatibility of Qnox Values With Hemodynamic Changes in Tracheal Intubation Procedures

Study Overview
=================
Brief Summary
-----------------
The study aimed to analyze the compatibility of Qnox values with hemodynamic changes as a predictor of pain response in tracheal intubation procedures

Detailed Description
-----------------
Fifty-four patients were given informed consent before enrolling the study. Non-invasive blood pressure monitor, electrocardiogram, pulse oxymetry, and Conox probe were set on the subjects in the operation room. Baseline hemodynamic is noted. General anesthesia induction was done by fentanyl 2.5 mcg/kg and propofol 2 mg/kg. Endotracheal tube intubation was facilitated with rocuronium 0.8 mg/kg as muscle relaxant. qNox values right before intubation and after intubation is noted, as well as hemodynamic changes in one minute after intubation

Official Title
-----------------
Compatibility of Qnox Values With Hemodynamic Changes as a Predictor of Pain Response in Tracheal Intubation Procedures

Conditions
-----------------
Qnox Values as a Predictor of Pain Response

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient undergoes general anesthesia with tracheal intubation fasting as required for surgery physical ASA status I - II signing informed consent Exclusion Criteria: patient with difficult airway management patient with history of central nervous system abnormalities patient with history of hypersensitivity to drugs for general anesthesia

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qnox Values | Observe the Qnox Values with Hemodynamic Changes to predict pain response | 1 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
qNox Values, Hemodynamic changes, Predictor of pain
Turkish Life Balance Inventory

Study Overview
=================
Brief Summary
-----------------
The Turkish Version of Life Balance Inventory: Validity, Reliability and Cultural Adaptation.

Detailed Description
-----------------
The Life Balance Inventory (Kathleen Matuska; 2012) is a measure for life balance. This study was planned for the purpose of carrying out Turkish Version of the Life Balance Inventory.

Official Title
-----------------
Turkish Version of Life Balance Inventory: Validity, Reliability and Cultural Adaptation

Conditions
-----------------
Version, Adaptation, Reliability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19-25 years old student at the Faculty of Health Sciences - Exclusion Criteria: not between age 19-25

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 25 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 |
| --- | --- | --- |
| Turkish Life Balance Inventory is Valid and Reliable |  | six months |
First-time Fathers' Experiences of Childbirth in Lorraine

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to evaluate first time father's experience during childbirth in three different maternity hospitals in Lorraine. Secondary aims of this study is to identify domains that need improvement in order to enhance fathers's experience during childbirth.

Official Title
-----------------
First-time Fathers' Experiences of Childbirth in Lorraine.

Conditions
-----------------
Fathers, First Birth

Intervention / Treatment
-----------------
* Other: First time father questionnaire self-administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First time father after a physiological pregnancy and delivery of a healthy newborn of more than 37 gestational weeks. Exclusion Criteria: -

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type I maternity<br>Fathers who experienced a first childbirth in a type I maternity in Lorraine. | Other: First time father questionnaire self-administration<br>* The first-time father questionnaire will be self-administrated to subjects 1 month post-birth.<br>|
| Type II maternity<br>Fathers who experienced a first childbirth in a type II maternity in Lorraine. | Other: First time father questionnaire self-administration<br>* The first-time father questionnaire will be self-administrated to subjects 1 month post-birth.<br>|
| Type III maternity<br>Fathers who experienced a first childbirth in a type III maternity in Lorraine. | Other: First time father questionnaire self-administration<br>* The first-time father questionnaire will be self-administrated to subjects 1 month post-birth.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First-time father questionnaire score | Minimum value of the scale = 1, maximum value = 4, higher score represent a bad experience for the father. | 1 month after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fathers, Childbirth
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysterosalpingography diagnostic practice.

Official Title
-----------------
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled Clinical Trial

Conditions
-----------------
Gynecological Pathology

Intervention / Treatment
-----------------
* Drug: Lidocaine-Prilocaine cream
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients that must perform a hysterosalpingography acceptance to participate in the study signed informed consent Exclusion Criteria: hypersensitivity or allergy to anesthetics refusal of the patient patients under age 18 years old and pregnant unbearable pain that involves other analgesic measures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine-Prilocaine cream<br> | Drug: Lidocaine-Prilocaine cream<br>* Implementation of 3 cm of lidocaine-prilocaine in the endocervical canal, 10 minutes before the intervention with a syringe without needle 5ml. Application, with a swab of the anesthetic cream ectocervix level.<br>* Other names: EMLA;|
| Placebo Comparator: Placebo<br>purified water, ethylene glycol stearate, palm, palm stearate, polyethylene glycol, liquid paraffin, benzoic acid | Drug: placebo<br>* 3 cm of gel application for the transmission of ultrasound into the endocervical canal 10 minutes before surgery, with a 5 ml syringe without needle. Application, with a swab in gel ectocervix.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain reduction in the performance of hysterosalpingography | decrease in pain inmediately after the completion of hysterosalpingography and one month after completion of the diagnostic test by an analogue pain scale. | after hysterosalpingography and a month later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sense of discomfort experience during the procedure | willingness to repeat the diagnostic technique | a month after hysterosalpingography | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysterosalpingography, prilocaine, local anaesthetic, pain relief, gynecological pathology