linjc16/ctgov huggingface dataset:
Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy

Study Overview
=================
Brief Summary
-----------------
Childbirth is one of the most painful events that a woman is likely to experience, and thus is a major concern for most parturient. Severe pain releases stress mediators and may thus compromise fetus well-being if placental perfusion is decreased. Epidural analgesia is the golden standard for the management of severe labor pain. However, it could not always be used both due the parturient related factors and the organizational reasons.However, the knowledge on safety and efficacy of oxycodone involving mother, fetus and newborn is limited. Aim of the study is firstly, to evaluate the efficacy and safety of oxycodone in labor pain healthy parturients. Secondly, to measure parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth.

Official Title
-----------------
The Efficacy and Safety of Intravenous Oxycodone and Plasma Oxycodone Concentrations in Labour Pain

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Drug: Oxycodone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Labouring healthy women Early labour Age 18-45 years Exclusion Criteria: Sleep apnea or other central deficit affecting breathing Pulmonary insufficiency Liver of kidney insufficiency Use of mono amine oxidase medication Thyroid, pituitary insufficiency Paralytic ileus Other contraindication specified by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- |
| Other: Oxycodone, labour pain<br> | Drug: Oxycodone<br>* Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy and safety of oxycodone in labor pain |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxycodone, Labour pain, Pregnancy, Pregnant women
Absorption and Distribution of Glucosamine and Chondroitin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the way the dietary supplements glucosamine and chondroitin are absorbed and distributed throughout the body.

Detailed Description
-----------------
Osteoarthritis is the most common musculoskeletal disease in the world. While predisposing conditions have been identified, the actual cause of osteoarthritis remains unknown. Traditional treatments, most often anti-inflammatory drugs and pain relievers, produce variable results and may cause significant toxicity. The use of complementary and alternative therapies in the treatment of osteoarthritis has become more common, and particular interest has focused on glucosamine and chondroitin treatments. This study will examine the pharmacokinetics of glucosamine and chondroitin. This study consists of two phases. In Phase I, participants will have two study visits, during which multiple blood samples will be taken to determine levels of glucosamine and chondroitin found naturally in the body. During Phase II, participants will be randomly assigned to receive glucosamine, chondroitin, or a combination of the two for 3 months. Blood samples will be taken at each of the three Phase II study visits to examine the pharmacokinetics of glucosamaine and chondroitin.

Official Title
-----------------
A Pharmacokinetic Study of Glucosamine and Chondroitin

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Glucosamine
* Drug: Chondroitin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to walk Exclusion Criteria: Allergy to glucosamine, chondroitin, or shellfish Liver or kidney disease Diabetes mellitus Concurrent use of other complementary or alternative therapies

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- |
|Drug: Glucosamine|nan|
|Drug: Chondroitin|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complementary Therapies
Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome

Detailed Description
-----------------
Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome: Does this add to current treatment?

Official Title
-----------------
A Comparative Study to Assess Safety and Effectiveness of Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome

Conditions
-----------------
IBS - Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: pentoxyifylline
* Drug: Mebeverine
* Drug: ethosuximide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Age ≥ 18 years, Man and Women, Negative pregnancy test and effective contraception, IBS defined by the Rome criteria IV During the previous seven days the inclusion visit, average numeric rating scale (NRS) pain ≥ 4. IBS Treatment stable for 1 month Exclusion Criteria: • Breastfeeding Diabetic patients Significant liver function abnormalities (transaminases> 3N, cholestasis) and moderate renal disease (MDRD <60 ml / min) Addiction to alcohol and / or drugs, Antiepileptic drugs taken (epilepsy or chronic pain) Chronic pain of greater intensity than that related to IBS, Known Allergyto succinimides (ethosuximide, methsuximide, phensuximide) and pentoxifylline. History or current severe depression (hospitalization, long-term antidepressant treatment) Psychotic disorders,

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mebeverine<br>Mebeverine 3 times daily for 3 months | Drug: Mebeverine<br>* Mebeverine 3 times for 3 months<br>|
| Experimental: Ethosuximide<br>Ethosuxemide 3 times daily for 3 months | Drug: ethosuximide<br>* ethosuximide 3 times for 3 months<br>|
| Experimental: Pentoxyifylline<br>pentoxyifylline 2 times daily for 3 months | Drug: pentoxyifylline<br>* Pentoxyifylline two times daily for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS | the number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS | 6 months |
Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)

Study Overview
=================
Brief Summary
-----------------
The investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation

Detailed Description
-----------------
Pulmonary vein isolation has emerged as an effective therapy for paroxysmal atrial fibrillation. However, atrial fibrillation recurs in up to 50% of patients, generally because of recovery of pulmonary vein conduction. Adenosine given during the initial procedure may reveal dormant pulmonary vein conduction, thereby identifying the need for additional ablation, leading to improved outcomes.

Official Title
-----------------
Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)

Conditions
-----------------
Atrial Fibrillation, Persistent Common Pulmonary Vein

Intervention / Treatment
-----------------
* Drug: Adenosine arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed atrial fibrillation recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use written informed consent Exclusion Criteria: intracardiac thrombus pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: adenosine arm<br>single arm study | Drug: Adenosine arm<br>* After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.<br>* Other names: APPLE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion | After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection. | 5 minutes after IV adenosine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation Recurrence | At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform electrocardiographically documented by electrogram (At 1,3,6,12 months post ablation) and Holter monitoring (At 12 months post ablation) | between 0 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Vein Isolation, Adenosin effect, Atrial fibrillation ablation
Identification of a New Metabolite of Furosemide in Humans

Study Overview
=================
Brief Summary
-----------------
Recent in-vitro and in-vivo studies performed by one of the investigators (ESO, ICMPE, UPEC, France) have recently allowed to synthetize a new and easy-to-synthesized chemical compound of the furosemide (pyridinium furosemide) during furosemide degradation by electro-Fenton or bioconversion. The biological properties of pyridinium furosemide are currently under investigation. Furosemide is a diuretics currently used in the treatment of patients with heart failure. The goal of the investigators is to assay pyridinium furosemide in urine of patients treated by furosemide to demonstrate that pyridinium is or not a metabolite of furosemide in humans. This study will contribute to assess the fate of pharmaceutical residues of furosemide in the environment.

Official Title
-----------------
Identification of a New Metabolite of Furosemide in Humans

Conditions
-----------------
Treatment by Furosemide

Intervention / Treatment
-----------------
* Other: Not intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Written informed consent Affiliation to social security Known heart failure Treatment by furosemide Exclusion Criteria: None

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 |
| --- |
|Other: Not intervention|None. there is no modification in the treatment of patients. A urine collection is carry out in patients during the day of their enrolment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assay of furosemide and pyridinium furosemide in urine of heart failure patients treated by furosemide | Assay of furosemide and pyridinium furosemide in urine of heart failure patients treated by furosemide | 1 day |
Arterial Stiffness, Wave Reflections and Renal Failure

Study Overview
=================
Brief Summary
-----------------
Cardiovascular risk is high in patients with renal failure. Cross-sectional studies have indicated a relationship between arterial stiffness and renal function. However, there are no prospective longitudinal studies in the literature. In dialysis patients, arterial stiffness as well as wave reflections, predict mortality. However, there are no data on patients with mild-to-moderate renal impairment available. Therefore, we designed a study to test the hypothesis that: a) measures of arterial stiffness and wave reflections predict the progression of renal impairment in patients with mild-to-moderate renal failure; and b) measures of arterial stiffness and wave reflections predict cardiovascular events in patients with mild-to-moderate renal failure

Official Title
-----------------
Observational Study on the Prognostic Significance (Renal and Cardiovascular) of Arterial Stiffness and Arterial Wave Reflections in Patients With Mild to Moderate Renal Impairment

Conditions
-----------------
Chronic Renal Failure, Arterial Stiffness, Arterial Wave Reflections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic renal failure patients (KDOQI III, IV) undergoing regular control visits at our nephrology department > 19 years written informed consent Exclusion Criteria: atrial fibrillation valvular heart disease severely impaired systolic function no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| renal endpoint | doubling serum creatinine, need for dialysis, renal transplantation |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic renal failure, arterial stiffness, arterial wave reflections
Reduction of Topical Anesthetic Onset Time Using Ultrasound

Study Overview
=================
Brief Summary
-----------------
Children ages 3-7 who are undergoing blood drawing receive either standard care, topical medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure is evaluated.

Official Title
-----------------
Reduction of Topical Anesthetic Onset Time Using Ultrasound: A Randomized Controlled Trial Prior to Venipuncture in Young Children

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Device: SonoPrep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 3-7, requiring venipuncture Exclusion Criteria: Emergent procedure Allergy to lidocaine or sodium lauryl sulfate

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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

| Intervention/Treatment |
| --- |
|Device: SonoPrep|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain associated with venipuncture |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  |  | 
| skin effects |  |  | 
| tolerability |  |  |
Fatty Acid Antiarrhythmia Trial (FAAT)

Study Overview
=================
Brief Summary
-----------------
To determine if the dietary N-3 class of polyunsaturated fatty acids (PUFAs) provided in the diet largely from marine fish oils would prevent fatal ventricular tachycardia (VT) or ventricular fibrillation (VF).

Detailed Description
-----------------
BACKGROUND: Sudden death is a common manifestation of ischemic heart disease and therefore of great public health concern. Unfortunately several promising antiarrhythmic drugs proved not to be effective in preventing sudden deaths. This project would test whether a relatively inexpensive and presumably innocuous therapy, fish oil supplements, can prevent life-threatening arrhythmias. There is ample basic evidence that n-3 fatty acids contained in fish oil supplements may suppress arrhythmias, and a clinical trial seems warranted. DESIGN NARRATIVE: Prospective, randomized, placebo-controlled, double-blind. Patients were randomized to 4 grams per day of a PUFA fish oil supplement versus an olive oil placebo. The number of therapeutic discharges were recorded from the ICDs and then confirmed from the recorded electrocardiogram strips with the kinds of arrhythmias which had induced the ICD response. The primary end point, time to first ICD event for ventricular tachycardia or fibrillation (VT or VF) confirmed by stored electrograms or death from any cause, was analyzed by intention to treat. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Arrhythmia, Heart Diseases, Tachycardia, Ventricular, Ventricular Fibrillation

Intervention / Treatment
-----------------
* Behavioral: dietary polyunsaturated fatty acid


Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: dietary polyunsaturated fatty acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine effectiveness of parents' manipulation in newborn with talipes calcaneovalgus over observation group.

Detailed Description
-----------------
Talipes calcaneovalgus is one of the common foot deformity in newborn. Most of patients can be cure without specific treatment. Manipulation was easy method that parents can preform by their own and may be beneficial in speeding resolution of deformity.

Official Title
-----------------
Natural History and Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneovalgus,a Randomized Controlled Trial

Conditions
-----------------
Talipes Calcaneovalgus

Intervention / Treatment
-----------------
* Procedure: manipulation
* Procedure: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all newborn with talipes calcaneovalgus Exclusion Criteria: patient associated with congenital musculoskeletal anomaly patient with other serious medical condition

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: manipulation<br>home program for parents manipulation | Procedure: manipulation<br>* home programme<br>|
| Placebo Comparator: observe<br>observation | Procedure: No intervention<br>* observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of success treatment with in six month |  | six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration from start treatment until cure |  | six month | 

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