linjc16/ctgov huggingface dataset:
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.

Official Title
-----------------
A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: ELX/TEZ/IVA
* Drug: IVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Completed study drug treatment in parent study or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study Key Exclusion Criteria: History of study drug intolerance in the parent study Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 6 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: ELX/TEZ/IVA<br>Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening. | Drug: ELX/TEZ/IVA<br>* Fixed-dose combination (FDC) tablets for oral administration.<br>* Other names: elexacaftor/tezacaftor/ivacaftor;Drug: IVA<br>* Tablets for oral administration.<br>* Other names: ivacaftor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Week 100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1) |  | From Baseline up to Week 96 | 
| Absolute Change in Sweat Chloride (SwCl) |  | From Baseline up to Week 96 | 
| Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain (RD) Score |  | From Baseline up to Week 96 | 
| Absolute Change in Body Mass Index (BMI) |  | From Baseline up to Week 96 | 
| Absolute Change in Weight |  | From Baseline up to Week 96 | 
| Number of Pulmonary Exacerbations (PEx) |  | From Baseline up to Week 96 |
Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté

Study Overview
=================
Brief Summary
-----------------
This study aims to assess different methods for early adiposity rebound determination at the age of 4/5 years old according to current medical screening criteria in schools, and to assess their prognostic value for obesity amongst 11 years old pre-adolescents according to the known risk factors.

Official Title
-----------------
Rebond d'adiposité précoce Chez l'Enfant de 4 Ans et Risque de Surpoids Chez l'Enfant de 11 Ans : troisième Temps d'Une Cohorte Franc-comtoise.

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and girls born between 1st July 2003 and 30th June 2004 Attending school in Haute-Saône Enrolled in the 2008 cohort survey Exclusion Criteria: Children whose parents refused to take part in this cohort study.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 11 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 |
| --- | --- |
| Questionnaire<br>Questionnaires distributed to the families 15 days before child's medical consultation | Other: Questionnaire<br>* Questionnaires distributed to the families 15 days before child's medical consultation + anthropometric measures and data collected from the personal interview with school nurse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index of 11 years old pre-adolescents | Composite outcome based on height and weight | month 22 |
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs

Study Overview
=================
Brief Summary
-----------------
Advanced airway interventions are common high risk, high stakes events for children in intensive care units (ICU) and emergency departments (ED), with risk for life and health threatening consequences.

Detailed Description
-----------------
This study will evaluate local pediatric intensive care unit (PICU), cardiac intensive care unit (CICU) and neonatal intensive care unit (NICU) as well as EDs and delivery room (DR) practice, and benchmark against other PICUs, CICUs, NICUs, DRs and EDs as a part of Multi-Center Airway Safety collaborative network (NEAR4KIDS). The goal of the study is to utilize collected benchmarked data to improve local practice. In order to develop this quality improvement (QI) intervention and collaboration, it is necessary to collect baseline data to describe current practice and to continuously evaluate the effectiveness of any QI intervention.

Official Title
-----------------
Observation of Multi-center Quality Improvement Project: Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs

Conditions
-----------------
Failed or Difficult Intubation, Sequela, Intubation; Difficult, Intubation Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary advanced airway events (on patients of all ages) in the PICU, CICU, NICU, DR and ED including: Tracheal Intubation, Laryngeal mask placement, Emergency tracheostomy and/or cricothyrotomy Failed extubation attempts or unplanned extubations that require re-intubation will be considered a new primary intubation. Exclusion Criteria: Primary advanced airway events (tracheal intubations, laryngeal mask placement, emergency tracheostomy and/or cricothyrotomy) in the Operating Suites.
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 |
| --- | --- | --- |
| Change in number of tracheal intubation associated events (TIAEs) | The number of TIAEs during primary tracheal intubation will be compared to any TIAEs documented during subsequent intubation attempts. | participants will be followed for the duration of their hospital stay, an expected average of 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intubation, Advanced airway intervention, Intensive care unit
Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

Study Overview
=================
Brief Summary
-----------------
Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Detailed Description
-----------------
Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Official Title
-----------------
A Prospective, Randomized, Controlled, Parallel Groups Evaluation of Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

Conditions
-----------------
Open-angle Glaucoma

Intervention / Treatment
-----------------
* Device: iStent
* Other: SLT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL) Primary open-angle glaucoma (including pseudoexfoliative) Exclusion Criteria: Aphakic or pseudophakic with anterior chamber IOLs (AC-IOLs) (study eye) Prior stent implantations (study eye)

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 |
| --- | --- |
| Active Comparator: iStent<br>implantation of two iStent devices | Device: iStent<br>* Implantation of two iStent devices<br>|
| Active Comparator: SLT<br>Laser treatment | Other: SLT<br>* Laser treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit. |  | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open angle glaucoma, Pseudoexfoliative glaucoma
A Study in Subjects With Retinal Detachment

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to access the tolerability of INS37217 Intravitreal Injection when administered intravitreally in subjects with macula-on or macula-off rhegmatogenous retinal detachment (RRD).

Official Title
-----------------
A Double-Masked, Randomized, Dose-Ranging Study of a Single Intravitreal (IVT) Injection of INS37217 Intravitreal Injection in Subjects With Retinal Detachment

Conditions
-----------------
Retinal Detachment

Intervention / Treatment
-----------------
* Drug: denufosol tetrasodium (INS37217) Intravitreal Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have macula-on or macula-off rhegmatogenous retinal detachment are eligible for pneumatic retinopexy, with identifiable retinal breaks are phakic or pseudo-phakic Exclusion Criteria: have detachments not of a rhegmatogenous nature currently have blood in the vitreous, corneal opacity, or other conditions which limit the view of peripheral retina have evidence of intraocular inflammation (uveitis) have a history of current condition of uncontrollable, elevated IOP or open-angle glaucoma have breaks not conducive to a single procedure of pneumatic retinopexy treatment have proliferative vitreoretinopathy of type C or D have previously had a vitrectomy or require one have previously had a scleral buckle procedure

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: denufosol tetrasodium (INS37217) Intravitreal Injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacological activity |  |  |
Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy

Study Overview
=================
Brief Summary
-----------------
The cerebral oxygen saturation is assessed by means of near-infrared spectometry in parturients undergoing cesarean delivery under spinal anesthesia. The investigators hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.

Conditions
-----------------
Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery

Intervention / Treatment
-----------------
* Other: Spinal Anesthesia with cerebral oxygen saturation monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term healthy parturients Exclusion Criteria: Body Mass Index > 35 preeclampsia neurological,cardiovascular, respiratory disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Spinal Anesthesia with cerebral oxygen saturation monitoring<br>The cerebral oxygen saturation of the right and left frontal lobe as well as the thigh oxygen saturation are monitored during spinal anesthesia by means of the near-infrared spectroscopy. Hemodynamic variables were recorded at the same time points. | Other: Spinal Anesthesia with cerebral oxygen saturation monitoring<br> <br> * Other names: INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral oxygen saturation of the right frontal lobe | Cerebral oxygen saturation is important as it may affect patient's outcome | Change from the performing of spinal anesthesia untill 1 minute after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral oxygen saturation of the left frontal lobe | Cerebral oxygen saturation is important for patient's outcome | 5, 10, 50 min after spinal,1 minute after delivery | 
| Thigh oxygen saturation | Thigh oxygen saturation may reflect blood redistribution due to spinal block | 5, 10, 50 min after spinal, 1 minute after delivery | 
| Arterial Oxygenation | Changes in arterial oxygenation may reflect blood redistribution due to spinal block | 5, 10, 50 min after spinal, 1 minute after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral oximetry, cesarean delivery
Bicarbonate Given During Dystocic Labor

Study Overview
=================
Brief Summary
-----------------
Dystocic deliveries and the use of bicarbonate

Detailed Description
-----------------
A randomized controlled trial of 200 primiparous women in active labour.If cervical dilation crossed the action line in the partogram or if labour progress was arrested for two hours or more the delivery was considered to be dystocic, and Oxytocin was suggested for stimulation. Inclusion criteria were: primiparity, singleton pregnancy, with an arrested labour progress with a need for oxytocin. Gestational age was between 37-42 weeks, and no maternal /fetal chronic and/or pregnancy-related conditions. Excluded were multiparous women, deliveries with non-cephalic presentation, multiples, deliveries with fetal chronic and/or pregnancy-related conditions, IUFD (Intra Uterine Fetal Death) or premature < 37 weeks of gestation. A randomization into two groups was performed. One group was treated with two bags of Samarin® (=Samarin® group, 5g bicarbonate) one hour before stimulation with oxytocin started. The other group (=nonSamarin® group) received no bicarbonate and started oxytocin immediately, according to local clinical guidelines. Maternal and fetal data was collected from medical files after delivery and analysed according to group.

Official Title
-----------------
Bicarbonate, a New Treatment of Labour Dystocia

Conditions
-----------------
Arrested Labor

Intervention / Treatment
-----------------
* Dietary Supplement: Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primiparity, singleton pregnancy with an arrested labour progress according to the partogram with a need for oxytocin Gestational age was between 37-42 weeks and no maternal /fetal chronic and/or pregnancy-related conditions. Exclusion Criteria: multiparous women deliveries with non-cephalic presentation multiples deliveries with fetal chronic and/or pregnancy-related conditions IUFD (Intra Uterine Fetal Death) or premature < 37 weeks of gestation
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no treatment<br>Dystocic women where no bicarbonate was given | |
| Experimental: Treatment<br>Dystocic women where bicarbonate was ingested | Dietary Supplement: Treatment<br>* Bicarbonate was ingested<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of spontaneous vaginal delivery |  | during labor | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor dystocia
Effectiveness of Dry Needling in Shortened Triceps Surae Muscle

Study Overview
=================
Brief Summary
-----------------
To date, there are not studies about the effectiveness of dry needling versus ischemic compression in the triceps surae trigger points. A randomized clinical trial is carried out. A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic compression (n = 15). Outcome measurements such as dorsal flexion range of motion, plantar pressures, temperature, superficial muscle activity and trigger points pressure pain threshold are measured immediately before and after treatment.

Official Title
-----------------
Effectiveness of Deep Dry Needling in Subjects With Shortened Triceps Surae Originated by Myofascial Pain Syndrome

Conditions
-----------------
Trigger Point Pain, Myofascial, Myofascial Pain Syndrome

Intervention / Treatment
-----------------
* Other: Dry needling
* Other: Ischemic compression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myofascial pain syndrome in the triceps surae muscle, limitation of ankle dorsal flexion range of motion. Exclusion Criteria: Neurologic disorders, pharmacologic treatment (within the previous 3 months), cognitive impairment, prosthesis in the lower limb, systemic or infectious diseases, autoimmune diseases, fibromyalgia, hypothyroidism, anticoagulants or antiplatelet agents, and fear of needles.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry needling<br> | Other: Dry needling<br>* Trigger point deep dry needling<br>|
| Experimental: Ischemic compression<br> | Other: Ischemic compression<br>* Trigger point ischemic compression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion | Ankle dorsal flexion by means of the goniometer | Change from Baseline Range of motion at 25 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plantar pressures | Plantar pressures platform | Change from Baseline Plantar pressures at 25 minutes | 
| Temperature | Thermal imaging | Change from Baseline Temperature at 25 minutes | 
| Superficial muscle activity | Electromyography | Change from Baseline Superficial muscle activity at 25 minutes | 
| Pressure pain threshold | Algometer | Change from Baseline Pressure pain threshold at 25 minutes |
Single Incision Laparoscopic Varicocelectomy

Study Overview
=================
Brief Summary
-----------------
Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of varicocele in our department since the nineties. However, the relatively several trocar wounds represent a big challenge against its acceptance by many of our patients who prefer the open approach with one or at least two wounds. Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven to be feasible and effective, with high patient satisfaction rates regarding improved cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10, 11) SILS for varicocelectomy has been reported to be safe and effective alternative to conventional laparoscopic varicocelectomy in a few studies.

Official Title
-----------------
Single Incision Transumbilical Laparoscopic Varicocelectomy: Comparison With the Conventional Laparoscopic Approach.

Conditions
-----------------
Varicocele

Intervention / Treatment
-----------------
* Procedure: single incision laparoscopic varicocelectomy
* Procedure: conventional transperitoneal laparoscopic varicocelectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with palpable varicoceles Exclusion Criteria: unfit for anesthesia or laparoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SIL-V<br>single incision laparoscopic varicocelectomy | Procedure: single incision laparoscopic varicocelectomy<br>* bilateral and unilateral varicocelectomy was performed through a single transumbilical flexible SILS port.<br>|
| Active Comparator: CTL-V<br>conventional transperitoneal laparoscopic varicocelectomy | Procedure: conventional transperitoneal laparoscopic varicocelectomy<br>* bilateral and unilateral varicocelectomy was performed through a conventional 3-ports transperitoneal varicoceletomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with improvement in semen parameters and resolution of testicular pain |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients developing postoperative complications |  | 2 years |