linjc16/ctgov huggingface dataset:
Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion.

Study Overview
=================
Brief Summary
-----------------
A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and quality of life.

Official Title
-----------------
Systematic Provision of Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion. A Randomized, Prospective Trial.

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: Immediate intrauterine contraception


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duration of pregnancy < 12 weeks. Age ≥18 years Exclusion Criteria: Contraindication for spiral insertion: uterine anomaly, infection, copper allergy (Cu-IUD).

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

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate intrauterine contraception<br>IUD (either Cu-IUD or LNG-IUS) inserted immediately after abortion. | Device: Immediate intrauterine contraception<br>* A Cu-IUD or LNG-IUS is inserted after abortion.<br>|
| No Intervention: Control group<br>Post-abortal contraception is prescribed by the hospital but on the responsibility of the patient. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of repeat abortions | Number of subsequent abortions during five years follow-up time. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraception, Abortion, First trimester, Intrauterine device
Intestinal Fatty Acid Binding Protein in Very Low Birth Weight Infants With Meconium Obstruction

Study Overview
=================
Brief Summary
-----------------
Urinary intestinal fatty acid binding protein (i-FABP), a marker of intestinal mucosal cell damage, has recently been proposed as a clinically useful measure in the early detection of necrotizing enterocolitis (NEC). However, there are no data on urinary i-FABP in meconium obstruction of prematurity (MOP). This study aimed to evaluate urinary i-FABP in MOP patient as a marker for early detection.

Official Title
-----------------
The Clinical Utility of Urine Intestinal Fatty Acid Binding Protein in the Management of Very Low Birth Weight Infants With Meconium Obstruction

Conditions
-----------------
Meconium Obstruction of Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants weighing <1,250g Exclusion Criteria: major congenital anomalies perinatal asphyxia (cord pH <7.0)

Ages Eligible for Study
-----------------
Maximum Age: 36 Weeks

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of i-FABP level between the meconium obstruction group and the normal feeding advance group |  | within 48 hours after birth |
Abdominoplasty Under Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing abdominoplasty under general anesthesia

Detailed Description
-----------------
200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II, were enrolled in this feasible study. All patients were subjected to abdominoplasty operation under spinal anesthesia or general anesthesia. Any intraoperative complications like hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and the need for analgesia to be administered.

Official Title
-----------------
A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.

Conditions
-----------------
Spinal Anesthesia Suitability for Abdominoplasty

Intervention / Treatment
-----------------
* Drug: Propofol 10 Mg/mL Intravenous Emulsion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients between 18-55 years ASA I and II Exclusion Criteria: BMI more than 35 years Contraindications for regional anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal anesthesia<br>Patients undergoing abdominoplasty under spinal anesthesia may need to drug administration like propofol or ketamine or change anesthesia to general anesthesia. | Drug: Propofol 10 Mg/mL Intravenous Emulsion<br>* when spinal anesthesia is not satisfactory intervention drugs are used<br>* Other names: ketamine;|
| No Intervention: General anesthesia<br>General anesthesia for abdominoplasty | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain sensation: Visual analogue scale | Visual analogue scale for Pain assessment from 1 with least pain to 10 with maximum pain felt | pain assessment during the operation and every 4 hours for 12 hours | 
| Patients satisfaction: Satisfaction score changes | Satisfaction score with maximum score is fully satisfied and least is completely disagree | Intraoperative assessment every 30 minutes till end of surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominoplasty, spinal anesthesia, general anesthesia, postoperative pain
Effects of Dihydropyridine Calcium Channel Inhibitors on Respiratory Gas Exchanges in the Intensive Care Unit: a Pharmacovigilance Study in VigiBase® and a Comparison With Urapidil

Study Overview
=================
Brief Summary
-----------------
Due to their effects on hypoxic pulmonary vasoconstriction (HPV), dihydropyridine calcium channel inhibitors (CCI) could lead to hypoxia in patients with a pulmonary shunt. To the present time only preclinical studies and case reports focused on this potential adverse drug reaction. We aimed to assess the reporting association between CCI and hypoxia using the World Health Organization pharmacovigilance database (VigiBase®).

Official Title
-----------------
Effects of Dihydropyridine Calcium Channel Inhibitors on Respiratory Gas Exchanges in the Intensive Care Unit: a Pharmacovigilance Study in VigiBase® and a Comparison With Urapidil

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Drug: dihydropyridine calcium channel inhibitors use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: present in the database Exclusion Criteria: chronology not compatible with the drug imputability
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hypoxia<br> | Drug: dihydropyridine calcium channel inhibitors use<br>* administration of dihydropyridine calcium channel inhibitors<br>|
| Patients without hypoxia<br> | Drug: dihydropyridine calcium channel inhibitors use<br>* administration of dihydropyridine calcium channel inhibitors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| association between dihydropyridine CCI or urapidil and hypoxia |  | from the 01/01/1963 to the 14/08/2022 |
Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Oocytes Recipients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy of embryo transfer procedure guided by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as the advantages and disadvantages of the new technique.

Official Title
-----------------
Evaluation of Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Recipients of Oocytes. A Single-centre, Randomized Clinical Trial.

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

Intervention / Treatment
-----------------
* Procedure: ultrasound-guided embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oocyte recipients. Uterus without previously detected anomalies. Patients able to understand the study requirements who want to participate during all its duration and that have signed the informed consent. Exclusion Criteria: Turner syndrome, Black race (significantly lower implantational rates)

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

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

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 |
| --- | --- |
| Other: abdominal ultrasound<br>traditional technique | Procedure: ultrasound-guided embryo transfer<br>* Embryo transfer in oocyte recipients<br>|
| Other: transvaginal ultrasound<br>new technique | Procedure: ultrasound-guided embryo transfer<br>* Embryo transfer in oocyte recipients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Evidence of gestational sac by transvaginal ultrasound | 40 days after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Female infertility with indication of oocyte reception
Utilizing Free DNA in Embryo Culture for PGT

Study Overview
=================
Brief Summary
-----------------
In the way for developing and optimizing protocol to be used as non- invasive methodology used as routine testing for PGS. This protocol is to be adapted to replace the using of life embryo cells for genetic testing and aneuploidy study as well as for any type of genetic testing including single gene disorder or HLA typing or study.

Detailed Description
-----------------
Compare 100 embryos studied using NGS for chromosomal aneuploidies, and compare the results came from free media DNA with this results.

Official Title
-----------------
Utilizing Free DNA in Embryo Culture Media for Preimplantation Genetic Screening

Conditions
-----------------
Chromosome Abnormalities, Genetic Diseases, Inborn, Mutation

Intervention / Treatment
-----------------
* Procedure: NGS reading for Media Free DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all abnormal/aneuploidy embryos rejected for embryo transfer. Exclusion Criteria: all embryos had unsuccessful diagnosis with blastomere biopsy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- |
| NGS reading for Media Free DNA<br>Ability to read the DNA product available in embryo culture media using NGS to have valuable diagnostic image for genetic composition of embryo before implantation. | Procedure: NGS reading for Media Free DNA<br>* NGS reading for Media Free DNA instead of blstomer biopsy<br>|
| NGS reading for blastomer DNA<br>DNA extracted from Blastomere used for aneuploidy screening. | Procedure: NGS reading for Media Free DNA<br>* NGS reading for Media Free DNA instead of blstomer biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA isolation | reading amplified DNA using NGS | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NGS evaluation | Free DNA isolation and amplification using WGA | 2 years | 
| Comparison with cell reading using NGS | compare the obtained result with the results provided collected for the same embryo using its blastomer for PGS | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PGS, PGD, free embryo DNA, NGS, PGT, PGT-a, PGT-m, PGT-HLA
The Effects of Dexmedetomidine on Postoperative Renal Function in Valvular Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of study is to compare the incidence of acute kidney injury in patients receiving perioperative dexmedetomidine or placebo undergoing valvular heart surgery.

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: dexmedetomidine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients over the age of 20 scheduled for valvular heart surgery Exclusion Criteria: Left ventricular-ejection fraction < 30% Preexisting congestive heart failure Severe coronary artery disease Hemodynamically unstable arrhythmia Cardiogenic shock during perioperative period Ventricular assist device Severe renal dysfunction (eGFR < 15ml/min per 1.73m2)

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine group<br> | Drug: dexmedetomidine<br>* 0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery<br>|
| Placebo Comparator: Saline group<br> | Drug: Saline<br>* 0.4 mcg/kg/h, IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of postoperative renal function in patients with or without dexmedetomidine undergoing valvular heart surgery: | BUN/Creatinine, cystatin C, eGFR, urine output Incidence of acute kidney injury (based on the AKIN criteria) | 24 hours after surgery. |
Continuity of Care and Use of Urgent Healthcare in Multimorbid Patients

Study Overview
=================
Brief Summary
-----------------
Chronic disease management is a public health problem that faces monitoring difficulties related to complex care pathways. This study will analyze the use of unscheduled or urgent care according to the continuity of care in multimorbid patients

Detailed Description
-----------------
The prevalence of chronic diseases in the population is increasing significantly. It represents a new challenge for doctors and health authorities. However, patients often have at least two chronic diseases. These are referred to as multimorbid patients, whose continuity of care has not been well studied to date. This observational study evaluates the association between the continuity of care in multimorbid patients seen in general practice and their use of urgent healthcare, their quality of life and their burden of treatment.

Official Title
-----------------
Continuity of Care and Use of Urgent Healthcare in Multimorbid Patients

Conditions
-----------------
Multimorbidity, Continuity of Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years of age, seen in consultation in the office by an investigating doctor, with a follow-up for more than 12 months in the office, presenting at least two chronic disease , having given their written consent to participate in the study Exclusion Criteria: seen at home unable to respond (cognitive problems or language barrier)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| multmorbid patients<br>patients with 2 chronic diseases (medical conditions requiring management for more than 6 months) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuity of care | Bice-Boxerman index, measuring continuity of care (from 0 to 1, 1 = good continuity of care) | over the past 1year | 
| care pathway | the number of health care consultations with any physician (primary care, emergency department, hospitalisation), collected from the French national health insurance database | over the past 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global quality of life | EuroQol Health Questionnaire in 5 questions measuring quality of life by the EuroQol Group. (from 0 to 100, 100= good quality of life) | over the past 1 year | 
| burden of traitement | Treatment Burden Questionnaire developped by VT Tran (from 0 to 130, 130 = treatments are a huge problem for the patient) | over the past 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuity of care, primary care, multimorbidity, quality of life
A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
This study will examine duloxetine compared with placebo and an active comparator in the treatment of generalized anxiety disorder.

Official Title
-----------------
A Comparison of Duloxetine Hydrochloride, Venlafaxine Extended Release, and Placebo in the Treatment of Generalized Anxiety Disorder.

Conditions
-----------------
Anxiety Disorders

Intervention / Treatment
-----------------
* Drug: Duloxetine
* Drug: venlafaxine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female outpatients at least 18 years of age, presenting with generalized anxiety disorder (GAD) based on the disease diagnostic criteria. Must suffer from GAD and not from an adjustment disorder or anxiety disorder not otherwise specified. The symptoms of GAD should not be situational in nature. Exclusion Criteria: Any current and primary DSM-IV Axis I diagnosis other than GAD, including: Patients diagnosed with major depressive disorder within the past 6 months; or Patients diagnosed with panic disorder, or post-traumatic stress disorder within the past year; or Patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders during their lifetimes. The presence of an Axis II disorder or history of antisocial behavior, which, in the judgement of the investigator, would interfere with compliance with the study protocol.

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine|nan|
|Drug: venlafaxine|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess whether duloxetine hydrochloride 60 to 120 mg once daily is superior to placebo in the treatment of GAD during a 10-week, double-blind acute therapy phase, defined as statistically greater reduction in anxiety symptoms as measured by the HAMA. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported anxiety symptomatology;Quality of Life;Clinical Global Improvement;HAMA factor scores |  |  |