linjc16/ctgov huggingface dataset:
Epidemiological Study of Post-operative Chronic Pediatric Pain.

Study Overview
=================
Brief Summary
-----------------
This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.

Detailed Description
-----------------
Chronic pain, defined as continuous or intermittent pain for 3 months or more, postoperative because in the territory of the surgical procedure and does not exist before the operation, is common in adults. Its prevalence varies according to the surgeries between 10 and 50% of the operated adults. The factors potentially responsible for their occurrence are gradually being highlighted in the recent literature, which has made it possible to develop an appropriate analgesic management strategy. In pediatric surgery, acute pain has long been known and treated as early as possible using multimodal analgesic techniques. On the other hand, there are very few studies evaluating postoperative chronic pain 3 months after infant surgery, as was the case a few years ago in adults. This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.

Official Title
-----------------
Epidemiological Study of Post-operative Chronic Pediatric Pain.

Conditions
-----------------
Chronic Pain, Postoperative Pain

Intervention / Treatment
-----------------
* Other: Pain questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children between the ages of 6 and 18, who are scheduled for surgery or video-surgery, scheduled or urgent, in the pediatric surgery department of the Bordeaux University Hospital. All patients who consented to participate in the research. Exclusion Criteria: All children operated on outpatient surgery. Children and parents with difficulties in understanding the questionnaires. Refusal of the child or one of the parents. Change of home planned during the post-operative follow-up period (3 months).

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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 |
| --- | --- |
| Single arm<br>The evaluation at 3 months of the postoperative pain will be carried out without the information collected in preoperative and immediate postoperative. | Other: Pain questionnaire<br>* Pain questionnaire, 3 months after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic postoperative pain | Visual analogic scale from 0 to 100: (between 0 and 30: low pain, between 30 and 60: moderate pain, between 60 and 100: severe pain) | 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics
Outcome of Surgery for Idiopathic Macular Holes

Study Overview
=================
Brief Summary
-----------------
Retrospective medical chart review of patients undergoing surgical repair of idiopathic macular hole

Conditions
-----------------
Idiopathic Macular Hole

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffering from primary idiopathic macular hole and treated by retinal repair surgery Exclusion Criteria: Presence of other retinal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Primary closure of macular hole after repair surgery |  | within six months after surgery |
Eltrombopag in Chronic ITP

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.

Official Title
-----------------
Efficacy of Eltrombopag in Chronic Immune Thrombocytopenia in Pediatrics

Conditions
-----------------
Immune Thrombocytopenia

Intervention / Treatment
-----------------
* Drug: Eltrombopag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with chronic ITP aged 1 to 17 years. Platelet count is less than 30×109 per liter. Patients neither have had spontaneous resolution of the thrombocytopenia nor responded to corticosteroids and/or IV immunoglobulin. Exclusion Criteria: Patients with clinical and/or laboratory evidence of hepatotoxicity/liver decompensation (Hepatotoxicity due to eltrombopag is defined as increased serum alanine aminotransferase ≥3 times the upper limit of normal (ULN), aspartate aminotransferase ≥3 ULN, alkaline phosphatase >1.5 ULN, total bilirubin >1.5 ULN) Patients with history of thrombotic/thromboembolic events.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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

| Intervention/Treatment |
| --- |
|Drug: Eltrombopag|Thrombopietic agent approved for its efficacy in chronic immune thrombocytopenia in pediatric patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the platelet count response to eltrombopag in pediatric chronic ITP |  | 6 months |
Sleep Disturbances as a Risk Factor in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine if either short night time sleep or poor night time sleep could be a risk factor for increasing the rate at which kidney function deteriorates in persons with mild to moderate kidney disease.

Official Title
-----------------
Sleep Disturbance as a Non-Traditional Risk Factor in CKD

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Other: Controls Short sleep
* Other: CKD- sleep extension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to Moderate CKD Healthy controls age and gender matched to CKD subjects Regular bedtimes of at least 6h/night, sedentary lifestyle Exclusion Criteria: Diabetes Current or previous dialysis for more than 1 month Uncontrolled hypertension Heart failure Liver disease HIV Hemoglobin < 10.5 g/dl Treatment with EProcrit, Epogen, or Aranesp Bone or organ transplant, Use of immunosuppressive drugs within past 6 months Current oral contraceptive use Current pregnancy Chemotherapy for malignancy within past 2 years

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline<br>CKD subjects and healthy, matched controls will have measures of cardiovascular function (BP, HR) measure of hormonal fluid balance (renin/aldosterone) measure and measures of glucose metabolism (response to glucose load and over 24 hr profile) with 3 days of habitual sleep time | |
| Experimental: CKD- Sleep extension<br>Measures as in baseline but with bed time increased by 2 hours | Other: CKD- sleep extension<br>* Sleep will be increased by 2 hours each night for 3 nights<br>* Other names: Sleep intervention;|
| Experimental: Controls short sleep<br>Measures as in baseline but with sleep disruption | Other: Controls Short sleep<br>* Healthy control subject's bedtime will be decreased by 2 hours/night with acoustic sleep disruption<br>* Other names: Sleep intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of chronobiological profiles of renin/aldosterone, sympatho-vagal balance and CV function in CKD subjects to controls at baseline and after extended sleep in CKD subjects and after decreased time and quality of sleep in control subjects. |  | Immediately after intervention. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Poor sleep, CKD, Kidney Failure
Prevalence of Coronary Artery Disease in the Siblings of Premature Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study is to investigate the prevalence of coronary artery disease using computed tomography with family history of premature coronary heart disease

Official Title
-----------------
Assessment of Occult CAD: Premature CAD Sibling Study (PreCASS)

Conditions
-----------------
Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: within 1 year the siblings of premature coronary heart disease (male<55years old, female<65yeasrs old: Framingham Heart Study) patients admitted relevant hospital Exclusion Criteria: Documented coronary heart disease experienced adverse events with relevant treatment contraindicated with beta-blockers Any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| evaluation of prevalence to coronary artery disease using CT |  | within 2 weeks from CT scanning | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Heart Disease, computed tomography, prevalence of coronary artery disease
Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.

Official Title
-----------------
A 24-week, Multi-center, Open-label Evaluation of Compliance and Tolerability of the Once-daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease.

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Rivastigmine transdermal patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria; MMSE score of ≥10 and ≤ 26; Exclusion Criteria: Bradycardia (beats per minute less than 50) Body weight less than 40 kg; Hypersensitivity to cholinesterase inhibitors. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 50 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: 1<br> | Drug: Rivastigmine transdermal patch<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks. |  | At week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination (MMSE), Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), Global Deterioration Scale (GDS), caregiver burden (Zarit Burden Interview). |  | At baseline, wk 12 and wk 24 | 
| Patient compliance (drug accounting) |  | During 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, rivastigmine, patch
Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

Study Overview
=================
Brief Summary
-----------------
This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.

Official Title
-----------------
A Phase II Monocentric Study of Oxaliplatin in Combination With Gemcitabine in Patients With Advanced/Metastatic Transitional Cell Carcinoma of the Urothelial Tract

Conditions
-----------------
Carcinoma, Transitional Cell

Intervention / Treatment
-----------------
* Drug: gemcitabine, oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transitional cell carcinoma Histologically-proven Locally advanced unresectable or metastatic With at least one measurable target Informed consent signed Exclusion Criteria: Previous chemotherapy Previous radiotherapy Performance status >=2 Peripheral neuropathy >=1

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine, oxaliplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 
| disease free survival |  |  | 
| toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carcinoma of the urothelial tract
Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF).

Official Title
-----------------
A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombinant Factor VIIa (NovoSeven®) and Standard Haemostatic Replacement Therapy in Patients With Dengue Haemorrhagic Fever

Conditions
-----------------
Acquired Bleeding Disorder, Dengue Haemorrhagic Fever

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the clinical diagnosis of Dengue Haemorrhagic Fever (DHF) Patients with a clinical diagnosis of DHF Grades II and III8, requiring standard replacement therapy Exclusion Criteria: Patients with a clinical diagnosis of DHF Grade IV Known or suspected allergy to trial product or related products Known hypersensitivity to mouse, hamster or bovine protein Prior treatment with activated recombinant human factor VII

Ages Eligible for Study
-----------------
Maximum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rFVIIa<br> | Drug: activated recombinant human factor VII<br>* 100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects requiring standard haemostatic replacement therapy during 2 hours after first trial product administration |  |  | 
| Proportion of subjects with effective haemostatic efficacy at 2 hours after first trial product administration |  |  | 
| Coagulation related variables |  |  | 
| Adverse events |  |  |
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

Study Overview
=================
Brief Summary
-----------------
The purpose of this Open Label Safety Study is to provide access to and evaluate the safety and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who have failed at least two PI-containing regimens, and have limited treatment options.

Official Title
-----------------
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Tipranavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Triple anti-retroviral class experienced patients with at least 2 previous PI-based regimens who had failed or are intolerant to currently approved HIV-1 treatments. Age equal or more than 18 years Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter Patient voluntarily provides written informed consent to participate, in compliance with local law. Exclusion Criteria: Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir Required use of restricted medications. Female patients of childbearing potential who have a positive pregnancy test at baseline or are breast feeding. Any medical condition which in the opinion of the investigator would interfere with the patients' ability to participate in or adhere to the requirements of this protocol. Use of other investigational drugs, within 30 days prior to TPV boosted with ritonavir initiation and for the duration of study participation Hepatic impairment evidenced by the following baseline laboratory findings: AST or ALT more than 5X ULN or total bilirubin more than 3.5X ULN AST or ALT more 2.5X ULN and total bilirubin more 2X ULN

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tipranavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.

Official Title
-----------------
Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates

Conditions
-----------------
Respiratory Distress Syndrome, Newborn, Continuous Positive Airway Pressure, Low Birth Weight Infants

Intervention / Treatment
-----------------
* Device: RAM Cannula
* Device: Binasal Prong CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low Birth Weight Infant Currently on continuous positive aireway pressure of 5-7 cm water pressure Receiving continuous positive airway pressure support for > 24 hrs prior to enrollment Fraction of inspired oxygen requirement of 23-50% Exclusion Criteria: Fraction of inspired oxygen > 50% Congenital defects of head, pulmonary or cardiovascular systems Chromosomal abnormalities/genetic syndromes Invasive Surgical Procedure within 24 hrs prior to enrollment Enrollment in separate clinical trial that has ongoing data collection
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAM Cannula CPAP<br>CPAP provided by RAM Cannula | Device: RAM Cannula<br> <br> |
| Active Comparator: Binasal Prong CPAP<br>CPAP provided by binasal prong | Device: Binasal Prong CPAP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation | Pulse oximetry | 3 hrs | 
| Ventilation | transcutaneous carbon dioxide monitor | 3 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal pressure measurements | Esophageal Pressure Catheter | 3 hrs | 
| Apnea | 3-channel pneumogram | 3 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal Cannula