linjc16/ctgov huggingface dataset:
Induction of Labor in Oligohydramnios

Study Overview
=================
Brief Summary
-----------------
When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term. The study will be a prospective randomised trial.

Official Title
-----------------
Induction of Labor in Oligohydramnios - A Comparison Between Two Modes of Cervical Ripening for Patients With Oligohydramnios at Term

Conditions
-----------------
Cervical Ripening

Intervention / Treatment
-----------------
* Device: double balloon catheter
* Drug: prostaglandins E2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy normal pregnancy, well dated, at term un ripened cervix Exclusion Criteria: previous cesarean section multiple pregnancy intra uterine growth restricted fetus

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: double balloon catheter<br>Cervical ripening by double balloon catheter | Device: double balloon catheter<br>* cervical ripening using double balloon catheter<br>|
| Placebo Comparator: prostaglandins E2<br>cervical ripening using prostaglandins E2 | Drug: prostaglandins E2<br>* prostaglandins E2 - Intravaginal Propess for 24 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor. |  | during induction of labor, delivery and early post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients satisfaction |  | induction of labor, delivery and early postpartum |
Ixabepilone Administered as an Enteric Coated Formulation.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.

Official Title
-----------------
An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Ixabepilone
* Drug: Ixabepilone
* Drug: Ixabepilone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG status of 0-2. Exclusion Criteria: Unable to swallow pills. Current or recent GI disease or GI surgery. Brain mets. Severe nerve damage. ANC <1,500/mm3 Platelets <125K. Bilirubin >=1.5 times the IULN. ALT/AST >=1.5 times the IULN. Creatine >1.5 times the IULN. Prior treatment with Ixabepilone. Strong use of CYPP450 drugs.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Ixabepilone<br>* Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of IV oral and oral dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.<br>* Other names: Ixempra;|
| Active Comparator: A2<br> | Drug: Ixabepilone<br>* Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of oral IV and oral dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.<br>* Other names: Ixempra;|
| Active Comparator: A3<br> | Drug: Ixabepilone<br>* Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of oral oral and IV dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.<br>* Other names: Ixempra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body. |  |  |
A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors

Study Overview
=================
Brief Summary
-----------------
This research is being done to study the effects (good and bad) of taking CellCept based on blood concentrations versus taking a fixed dose of CellCept without measuring the blood concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the immune system) which will be taken as part of this kidney transplant study. Cyclosporine or tacrolimus and corticosteroids are the two other drugs which will be taken.

Detailed Description
-----------------
This study is an open label study, which means the participant will know which drugs they are on. Participants will be put in one of three groups within 24 hours of the participant's transplant. The participant will be asked to return throughout the 24 months for physical exams, blood and urine tests.

Official Title
-----------------
An Open Label, Prospective, Randomized, Controlled, Multicenter Study Assessing Fixed Dose vs. Concentration Controlled CellCept Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors

Conditions
-----------------
Kidney Transplantation, Delayed Graft Function

Intervention / Treatment
-----------------
* Drug: CellCept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be between 18 and 70 years of age and should be receiving their first or second kidney transplant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- |
|Drug: CellCept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up |  | during the first 12 months following randomization | 
| Assessment of renal function |  | 12 months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients experiencing biopsy proven acute rejections |  |  | 
| The total number of biopsy proven, acute rejection episodes, per patient |  |  | 
| The proportion of patients treated for acute rejection |  |  | 
| The time to the first proven acute rejection |  |  | 
| The time to the treatment failure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Transplant
Cell-free DNA Methylation Markers for Cancer Screening

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.

Official Title
-----------------
Cell-free DNA Methylation Markers for Cancer Screening

Conditions
-----------------
Cancer Screening

Intervention / Treatment
-----------------
* Diagnostic Test: methylation markers screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is average risk for development of cancer Subject able and willing to undergo screening test within 90 days of enrollment Subject is 40 to 74 years of age inclusive Subject is able to comprehend, sign, and date the written informed consent document to participate in the study Exclusion Criteria: Subject has any condition which, in the opinion of the investigator should preclude participation in the study Subject has a history of cancer Participation in any interventional clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.

Ages Eligible for Study
-----------------
Minimum Age: 40 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

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal screening group<br>patients receive the routine screening examination | Diagnostic Test: methylation markers screening<br>* Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis<br>|
| Experimental: methylation markers screening group<br>patients receive the methylation markers screening | Diagnostic Test: methylation markers screening<br>* Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity (true positive rate) | The proportion of persons with disease who have a positive test (positive test results among persons with disease) | 2 year | 
| Specificity (true negative rate) | The proportion of persons without disease who have a negative test (negative test results among persons without disease) | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cell-free DNA, methylation, markers, cancer, screening
Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry.

Study Overview
=================
Brief Summary
-----------------
During emergency anesthesia (rapid sequence induction) , a firm pressure is applied to the cricoid cartilage of the patient in order to prevent passive regurgitation of gastric content into the pharynx. This maneuver is called cricoid pressure. Cricoid pressure is often performed incorrectly, due to difficulties to locate the cricoid cartilage in many patients. Despite this, the effectiveness of an incorrectly applied cricoid pressure has not been investigated. In this study we have used high-resolution manometry (HRM) to evaluate pressures in the upper esophagus during correctly applied cricoid pressure (against the cricoid cartilage) compared to incorrectly applied cricoid pressure (against the thyroid cartilage and against the trachea) during a rapid sequence induction.

Official Title
-----------------
Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry

Conditions
-----------------
Cricoid Pressure

Intervention / Treatment
-----------------
* Procedure: Cricoid Pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery and Anesthesia with intubation, ASA physical status I-II (American Society of Anesthesiologist classification system = system for assessing the fitness of cases before surgery) Body Mass Index > 18,5 and < 30 Informed, signed and dated consent Exclusion Criteria: Suspected difficult airway, Pharyngoesophageal dysfunction, Body Mass Index < 18,5 or > 30,

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Correctly and incorrectly applied cricoid pressure<br> | Procedure: Cricoid Pressure<br>* Correct Cricoid pressure applied against the cricoid cartilage, Incorrect Cricoid pressure applied against the thyroid cartilage and trachea<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in pressure (mmHg), detected by high resolution solid state manometry, between correctly vs incorrectly applied cricoid pressure |  | 15 sec. during ongoing cricoid pressure application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cricoid pressure, Rapid Sequence Induction
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI for the acute treatment of moderate to severe migraine headache.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Efficacy, Safety and Tolerability Study of Dronabinol MDI in the Acute Treatment of Migraine Headache

Conditions
-----------------
Migraine With Aura, Migraine Without Aura

Intervention / Treatment
-----------------
* Drug: Dronabinol MDI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects 18 to 65 years, inclusive, with clinically diagnosed migraine with or without aura based on International Headache Society criteria Exclusion Criteria: Subjects who experience migraine with prolonged aura; familiar hemiplegic migraine; migrainous infarction or basilar migraine; and those with greater than eight migraine attacks per month and/or greater than 14 migraine days per month.

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

| Intervention/Treatment |
| --- |
|Drug: Dronabinol MDI|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
-----------------
efficacy & safety, migraine headache, placebo-controlled, migraine headache with or without aura
Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether transdermal fentanyl patch

Detailed Description
-----------------
Total knee arthroplasty (TKA) has severe postoperative pain that prevents mobilization of patient. The best standard analgesia regimen is patient-control analgesia (PCA) which requires a PCA pump that is expensive. Transdermal fentanyl patch (TFP)(50 mcg/hr) can release fentanyl into blood circulation at rate 50 mcg/hr for three days. It has slow onset of about 12-14 hours, so it's used to treat chronic pain, not popular for a cure of pain. If the investigators apply TFP at appropriate times, i.e. 12-14 hours before surgery, it may be used to treat acute postoperative pain. If it can give good analgesia for TKA, it can replace PCA. The benefit is that it is much cheaper and more convenient.

Official Title
-----------------
Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: transdermal fentanyl patch
* Drug: placebo patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were scheduled for TKA gave informed consent for inclusion Exclusion Criteria: ASA class 3-4 Known allergy to any of the drugs to be used, eg. TFPs ,MO History of substance or alcohol abuse, and tolerance or dependence on opioids Can not use PCA Contraindication for spinal anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>group 1 = transdermal fentanyl patch | Drug: transdermal fentanyl patch<br>* TFP = transdermal fentanyl patch (50 microgram/hour)<br>* Other names: Duragesic;|
| Placebo Comparator: group 2<br>placebo patch | Drug: placebo patch<br>* group 2 = placebo patch<br>* Other names: Duragesic;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intravenous morphine consumption |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative, pain score, morphine consumption
Accuracy of Non-contact Thermometry

Study Overview
=================
Brief Summary
-----------------
Subjects will be admitted to hospital the evening prior, or the morning of surgery, whereupon they will undergo standard admission processes, including pre-operative assessment by the anaesthetist assigned to that list (One of the two study authors). The anaesthetist will then explain the study again, reiterating the potential risks and benefits of the study to the patient themselves, and to the population as a whole. Consent will be sought at this point. Patients will be transferred to theatre, anaesthetised and operated on as per normal practice. Inclusive of this, in accordance with NICE guidelines, patients will have a nasal or oesophageal Doppler probe inserted to accurately measure core temperature. At this point, patients enrolled in the study will have temperature measurements taken every minute from the oesophageal probe and non-contact thermometers. If the patients requested it previously, they will be informed of the results of the study at a later date. Statistics will then be carried out on the data to compare accuracy of the two novel methods to the oesophageal probe.

Official Title
-----------------
A Study to Determine the Accuracy of a Non-contact Thermometer in the Perioperative Setting

Conditions
-----------------
Hypothermia

Intervention / Treatment
-----------------
* Device: Geratherm non Contact thermometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will be patients undergoing elective gynaecological, vascular or urological surgery at the Royal Sussex County Hospital, and as such will be seen at a pre-operative assessment clinic as part of their normal work up for theatre. Exclusion Criteria: - Lacking mental capacity Not speaking English Malignancy in medical history Undergoing open abdominal surgery

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Geratherm non Contact thermometer|Temperature taken from subject using non-contact device as per manufacturers instructions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core body temperature measurement will be taken from 30 patients to compare non-contact infra-red thermometer to oesophageal temperature probes | Bland Altman analysis to compare the readings of 2 methods of temperature measurement | 12 months |