linjc16/ctgov huggingface dataset:
Study in Healthy Adult Female Subjects

Study Overview
=================
Brief Summary
-----------------
An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] D-0502 Following Single Oral Dose Administration

Official Title
-----------------
An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C]-D-0502 Following Single Oral Dose Administration

Conditions
-----------------
Mass Balance Recovery

Intervention / Treatment
-----------------
* Drug: [14C]-D-0502


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult female volunteers not of child-bearing potential between the ages of 18 and 65. Other inclusion criteria will be reviewed by the Principal Investigator. Exclusion Criteria: History or presence of any condition or prior surgery that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG, or laboratory tests Other exclusion criteria will be reviewed by the Principal Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Dose<br>All study subjects will receive a a single oral dose of radiolabeled microtracer of D-0502 following an overnight fast | Drug: [14C]-D-0502<br>* Drug: [14C]-D-0502 and D-0502<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiolabel recovery | To assess the mass balance (i.e., cumulative excretion in urine and feces) of D 0502 and the percentages of radiolabel recovered in urine and feces following administration of a single oral dose of D-0502/5 microcuries (µCi) [14C] D-0502 in healthy, adult female subjects | 14 days |
Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis

Study Overview
=================
Brief Summary
-----------------
In this retrospective study the investigators will enroll newborns that were born between 01.01.2010 and 31.12.2012 in Hillel Yaffe Medical Center with the prenatal diagnosis of Pyelectasis according to prenatal sonographic screening test. These babies underwent renal sonography at the age of 2-5 days according to the protocol and were invited to an additional renal sonographic screening test at the age of 1 month. The investigators will compare the results of the 2 examinations and the investigators will try to reach conclusions whether there is correspondence between the severity of the pyelectasis in the first and second sonographic tests and the outcome of these newborn babies

Official Title
-----------------
Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis

Conditions
-----------------
Pyelectasis of Newborns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All newborns that were born at Hillel Yaffe Medical Center with prenatal diagnosis of Hydronephrosis between 01.01.2010-31.12.2012 Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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 |
| --- | --- | --- |
| severity of hydronephrosis by sonographic measures |  | 2 years |
A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza, following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life, with booster dose in the second year of life. Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo (hepatitis A vaccine).

Official Title
-----------------
Assess, in Young Children, the Efficacy in Preventing Acute Otitis Media (AOM) of GSK Biologicals Undecavalent Pneumococcal-protein D Conjugate Vaccine, When Administered as a Three Dose Primary Vaccination Course During the First Year of Life With a Booster Dose in the Second Year of Life.

Conditions
-----------------
Hepatitis A

Intervention / Treatment
-----------------
* Biological: undecavalent pneumococcal-protein D conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between 6 weeks and 5 months (42-152 days) of age at the time of first vaccination. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 27 Months

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: undecavalent pneumococcal-protein D conjugate vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by vaccine-type pneumococcus in fully vaccinated children less than 2 years of age. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by NTHI in fully vaccinated children less than 2 years of age. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylaxis pneumococcal vaccine
A Comparison of the I-gel and the Self-pressurised Air-Q Intubating Laryngeal Airway in Children

Study Overview
=================
Brief Summary
-----------------
Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The air-Q is a new single-use device that may optimise the airway seal while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q SP.

Conditions
-----------------
General Anesthesia, Supraglottic Airway Devices

Intervention / Treatment
-----------------
* Device: Insertion of I-gel
* Device: Insertion of air-Q


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children (1-108 month of age and 7-30kg) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway Exclusion Criteria: Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 108 Months

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-gel group<br> | Device: Insertion of I-gel<br>* After induction of general anesthesia, I-gel will be inserted according to randomly allocated group.<br>|
| Active Comparator: Air-Q group<br> | Device: Insertion of air-Q<br>* After induction of general anesthesia, air-Q was inserted according to randomly allocated group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway leak pressure |  | within 5 min after insertion of each device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion time (insertion parameter) | insertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography. | During and 1 min after insertion of each device | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
supraglottic airway devices, the i-gel, the self-pressurised air-Q intubating laryngeal airway,, children
Risk Indicators in Patients With Ventricular Fibrillation During Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Sudden cardiac death is in most cases triggered by ischemia-related ventricular tachyarrhythmias and accounts for 50% of deaths from cardiovascular disease in developed countries. Chronic elevation of indicators of coagulation activation has been found in patients with coronary heart disease , but a role of coagulation activation and proinflammatory state as a potential risk factor for ventricular fibrillation (VF) during acute myocardial infarction has not been investigated.

Detailed Description
-----------------
Sudden cardiac death (SCD) is in most cases triggered by ischemia-related ventricular arrhythmias and is responsible for 50% of the mortality from cardiovascular disease in developed countries (1). Chronic elevation of indicators of coagulation activation and inflammation has been found in patients with coronary heart disease and may contribute to vasculatory disorders probably contributing to the development of arrhythmogenesis. However, the role of coagulation activation as a potential risk factor for ventricular fibrillation during acute myocardial infarction has not been investigated yet.

Official Title
-----------------
Indicators of Coagulation Activation and Inflammation Contributing to Ventricular Fibrillation Complicating Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction, Sudden Cardiac Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ST-elevation myocardial infarction ventricular fibrillation during acute MI Exclusion Criteria: NSTEMI coagulation disorders, e.g.intake of coumadin

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute myocardial infarction, ventricular fibrillation, coagulation, inflammation
A Study of Viracept in AIDS Patients With Cytomegalovirus Retinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are already being treated for cytomegalovirus (CMV) retinitis.

Official Title
-----------------
A Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Cytomegalovirus (CMV) Retinitis in AIDS Patients Who Are Receiving Standard Induction and Maintenance Therapy for This Infection

Conditions
-----------------
Cytomegalovirus Retinitis, HIV Infections

Intervention / Treatment
-----------------
* Drug: Nelfinavir mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection. Newly diagnosed or first progression of CMV retinitis. Exclusion Criteria Prior Medication: Excluded: Prior therapy (or less than 2 weeks) with protease inhibitor other than saquinavir.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nelfinavir mesylate|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
-----------------
AIDS-Related Opportunistic Infections, Placebos, Antiviral Agents, Cytomegalovirus Retinitis, Treatment Outcome, Nelfinavir
Dextromethorphan for Treatment of Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan compared to Placebo for the Treatment of Postoperative Pain

Detailed Description
-----------------
There is extensive preclinical evidence that dextromethorphan has an analgesic effect in patients with pain of traumatic origin. The primary objective is to of this study is to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing total knee arthroplasty (TKA). This is a single-institution, multi-dose, randomized, placebo-controlled, trial to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing TKA. Male and/or female patients will be randomized to either dextromethorphan treatment group (n = 80) or placebo group (n= 80). Patients will receive 60 mg oral dextromethorphan (or matching placebo) preoperatively, as well as 30 mg 8- and 16-hours postoperatively.

Official Title
-----------------
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan Compared to Placebo for the Treatment of Postoperative Pain

Conditions
-----------------
Post-operative Pain

Intervention / Treatment
-----------------
* Drug: Dextromethorphan Hydrobromide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Patients Age ≥18 planning to undergo total knee arthroplasty ASA classes I - III Main Exclusion Criteria: BMI ≥ 35 History opioid abuse History of intractable vomiting after previous surgery

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 |
| --- | --- |
| Experimental: Dextromethorphan<br> | Drug: Dextromethorphan Hydrobromide<br>* PO<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* PO<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-op opioid use |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective pain | numeric rating scale (NRS) or visual analog scale (VAS) | preoperatively and 6, 12, 24, and 48 hours postoperatively | 
| Postoperative opioid consumption |  | at 48 hours |
Rivaroxaban - Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
We investigated in-vitro the management of intraprocedural anticoagulation in patients requiring immediate percutaneous coronary intervention(PCI) while using regular direct oral anticoagulants(DOACs). Twenty-five patients taking 20mg of rivaroxaban once daily comprised the study group, while five healthy volunteers included the control group. In study group, a beginning(24-hours after the last rivaroxaban dose) examination was performed. Then, the effects of basal and four different anticoagulant doses(50IU/kg unfractionated heparin(UFH), 100IU/kg UFH, 0.5mg/kg enoxaparin, and 1mg/kg enoxaparin) on coagulation parameters were investigated at the 4th and 12th hours following rivaroxaban intake. Anticoagulant activity was assessed mainly by anti-factor Xa(anti-Xa) levels.

Official Title
-----------------
In-Vitro Evaluation of Anticoagulant Therapy Management When Urgent Percutaneous Coronary Intervention is Required in Rivaroxaban-Treated Patients

Conditions
-----------------
Coronary Artery Disease, Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: In vitro heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients using the direct oral factor Xa inhibitor rivaroxaban Atrial fibrillation Exclusion Criteria: malignancy, coagulopathy, heart valve disease, active infection, chronic systemic or inflammatory disease, recent ACS or elective PCI, uncontrolled hypertension and diabetes, cerebrovascular accident, thyroid disorder, left ventricular systolic dysfunction (ejection fraction <50%), glomerular filtration rate <50 mL/min/1.73 m2, underweight and overweight (<60 kg and >100 kg), age >75 years, hyperbilirubinemia and hypertriglyceridemia (>350 mg/dl).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>five healthy adults | Drug: In vitro heparin<br>* In vitro heparin and in vitro LMWH<br>|
| Study group<br>Twenty-five patients using the direct oral factor Xa inhibitor rivaroxaban | Drug: In vitro heparin<br>* In vitro heparin and in vitro LMWH<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticoagulation level | anti-factor Xa | 4 - 12 hours |
Sleep and Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The primary goal of the study is to determine whether insufficient sleep is associated with poor glycemic control in type 1 diabetic children. Secondary goals aim to determine whether salivary amylase could be an easily accessible and non-invasive biomarker of sleep loss and somnolence, and whether insufficient sleep is linked to body composition. Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals, in 82 type 1 diabetic children.

Official Title
-----------------
Sleep and Glycemic Control in Type 1 Diabetic Children

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: Sleep and glucose assessments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Female and male type 1 diabetic children and adolescents who are followed at the Woman, Mother and Child's Hospital (Hôpital Femme Mère Enfant : HFME) of Bron, France. Exclusion Criteria: Refusal of consent of the parents or the child or the adolescent Pregnancy Concomitant pathology that severly impacts sleep Implanted electrical stimulation device Diagnosis of type 1 diabetes <1 year

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep and glucose assessement.<br> | Other: Sleep and glucose assessments<br>* Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between HbA1c and sleep characteristics |  | Month 3, Month 6 and Month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose levels | 3 daily pre- and post- meal glucose levels over a 3-day period | Month 3, Month 6 and Month 9 | 
| Daily salivary amylase variation (Enzyme Activity) | Assessment of salivary amylase levels | Month 3, Month 6 and Month 9 | 
| Body composition (BMI fat and lean mass percentage) | Assessment of body composition | Month 3, Month 6 and Month 9 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, glycemic control, type 1 diabetes, amylase, body composition, lean, overweight, obese