linjc16/ctgov huggingface dataset:
Prospective, Randomized, Double Blind Study Comparing IV vs PO Acetaminophen in Patients Undergoing Lumbar Discectomy

Study Overview
=================
Brief Summary
-----------------
Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores when given preoperatively. This study investigates if there is a difference between the intravenous and the oral forms when given preoperatively to patients undergoing lumbar microdiscectomy. We hypothesize that the intravenous formulation does not improve pain scores or decrease opioid consumption during the first postoperative day compared to the oral formulation.

Official Title
-----------------
Prospective, Randomized, Double-blind, Placebo-Controlled Study to Compare the Effects of Intravenous Versus Oral Acetaminophen on Postoperative Clinical Outcomes After Ambulatory Lumbar Discectomy

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

Intervention / Treatment
-----------------
* Drug: oral acetaminophen
* Drug: intravenous acetaminophen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single level lumbar micro disk surgery Ages 18-65 Exclusion Criteria morbid obesity prior back surgery opioid tolerance pregnancy

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral acetaminophen<br>Patients in this arm of the study will receive oral acetaminophen and an IV placebo | Drug: oral acetaminophen<br>* 1000 milligrams given orally before surgery<br>* Other names: Tylenol;|
| Active Comparator: intravenous acetaminophen<br>Patients in this arm of the study will receive IV acetaminophen and an oral placebo | Drug: intravenous acetaminophen<br>* 1000 milligrams of intravenous acetaminophen given before surgery<br>* Other names: Ofirmev;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores | Pain scores are measured using a visual analog scale with patient at rest and also with movement of the lower extremities at four separate times following surgery. | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of intraoperative and postoperative opioids administered. | All doses of opioids given on the day of surgery will be recorded. | Day of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acetaminophen intravenous oral pain scores opioids
Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases

Study Overview
=================
Brief Summary
-----------------
Non-small cell lung cancer patients may have brain metastases at diagnosis. Patients with brain metastasis may contribute as poor prognosis factors. This trial aims to explore the efficacy and the safety of immune checkpoint inhibitors in non small cell lung cancer patients with initial brain metastasis.

Official Title
-----------------
Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases：A Retrospective Study

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: immune therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Diagnosed with advanced non-small cell lung cancer 2.Patients with brain metastasis 3. Treated with ICIs Exclusion Criteria: 1.Patients with a clear driver mutation that can be targeted for first-line treatment

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy alone or chemotherapy combined with anti-angiogenesis<br>patients with Chemotherapy | |
| immuntherapy<br>patients treated with immune checkpoint inhibitor monotherapy or combination therapy. | Drug: immune therapy<br>* The patient receives immunotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | disease remission rate | November 2017- October 2021 | 
| PFS | progression free survival | November 2017- October 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | November 2017- October 2021 |
Comparison of Gray-scale Inverted Rib Series With Conventional Ones in Rib Fracture Detection by Emergency Physicians and Medical Students

Study Overview
=================
Brief Summary
-----------------
There were many studies which examined the availability of inverted gray-scale chest X-ray for increasing the detection of lung nodules. In emergency medicine, rib fracture is an important part for patient's disposition, so investigators designed this study to evaluate the availability of inverted gray-scale chest X-ray for the detection of rib fracture.

Conditions
-----------------
Rib Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency resident who want to participate Exclusion Criteria: Emergency resident who does not want to participate
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 |
| --- | --- | --- |
| Sensitivity of detection for rib fracture | Sensitivity of detection for rib fracture in 139 fracture of 55 patients | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy for rib fracture |  | up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rib fracture, Inverted grayscale
Study Comparing Bioavailability of Oral Formulations of Vabicaserin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.

Official Title
-----------------
A Randomized, Open-Label, Single-Dose, 4-Period Crossover, Comparative Bioavailability Study of 3 Sustained- Release Formulations and an Immediate- Release Formulation of Vabicaserin (SCA-136) in Healthy Subjects

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: vabicaserin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men aged 18-50 years. Exclusion Criteria: Any significant disease state. History of drug or alcohol abuse within 1 year. Abnormal liver function tests.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the bioavailability of four oral formulations of vabicaserin. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtain additional safety and tolerability data for vabicaserin in healthy male subjects. |  |  |
Outpatient Birth: Pilot Study

Study Overview
=================
Brief Summary
-----------------
The diminution of the average length stay (ALS) in French maternity is a clear evolution, the objective of the draft law on social security is to reduce the ALS to equal other OECD countries. The over-medicalization of maternal health raises the question of relevant and iatrogeny of Professional practices. Furthermore, pregnant woman, future parents expressed their wish for an individual support and more physiological respectful. A more-effective Professional coordination is expected where the midwife is a major player.

Detailed Description
-----------------
The aim of the study is to identify and evaluate an outpatient birth path during the first 24 hours after the birth.

Official Title
-----------------
Outpatient Birth: Pilot Study to Assess the Feasibility of Maternity Out the Same Date or the Next Day of the Birth

Conditions
-----------------
Outpatient Birth

Intervention / Treatment
-----------------
* Other: Outpatient birth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With no multiple pregnancy, of less than 20 weeks of gestation With a BMI between 17,5 and 35 kg/m² is able to understand research's informations affiliated member of the social security system Have given an informed consent Exclusion Criteria: With psychological vulnerability, social vulnerability, addictions and high dependency With an unbalanced chronic pathology or susceptible to contraindicated a physiologic birth With history of caesarean, foeto-maternal incompatibility, gestational hypertension, pre-eclampsia, HELLP syndrome or retro-placental hematoma, sphincter tear With history of birth with perinatal asphyxia and sequelae or an unexplained perinatal death With history of puerperal psychosis Under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient birth<br>Maternity out the same date or the next day of the birth | Other: Outpatient birth<br>* Maternity out the same date or the next day of the birth and home-based follow up with a liberal midwife<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Output rate | Output rate within 24 hours of birth | Day 1 |
Evaluation of Autonomic Function in Individuals With Cornelia de Lange Syndrome (CdLS)

Study Overview
=================
Brief Summary
-----------------
Based on survey data, individuals with Cornelia de Lange Syndrome (CdLS) often experience symptoms of autonomic dysfunction however there are no reported studies in which these patients have had objective testing of the autonomic nervous system. This is a pilot study in which patients with CdLS will undergo the standard clinical testing for autonomic dysfunction with a autonomic reflex screen and thermoregulatory sweat test.

Official Title
-----------------
Evaluation of Autonomic Function in Individuals With Cornelia de Lange Syndrome (CdLS), a Pilot Study.

Conditions
-----------------
Cornelia de Lange Syndrome

Intervention / Treatment
-----------------
* Other: Autonomic Dysfunction Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients (aged 8-17 years of age) with Cornelia de Lange syndrome. Consent obtained from responsible guardian. Exclusion Criteria: Patients less than age 8 or 18 and older Female patients known to be pregnant Individuals not thought to be able to tolerate the testing. Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- |
| Clinical Testing for Autonomic Dysfunction<br>COMPASS-31 Survey completion. Autonomic Reflex Screen. Thermoregulatory Swear Test. | Other: Autonomic Dysfunction Testing<br>* The participants with CdLS will complete the COMPASS-31 survey and will complete standard clinical testing for autonomic dysfunction including an autonomic reflex screen (tilt table and quantitative sudomotor axon reflex testing) and thermoregulatory sweat test (TST).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who tolerated 70 degree head up tilt table test | Patients tolerating at least 5 minutes of tilt table | 1 year | 
| Number of patients who show evidence of dysautonomia | Dysautonomia measured by excessive heart rate (>40 bpm) on a tilt table test or reduced sweating on a thermoregulatory sweat test. | 1 year | 
| Number of patients who tolerated thermoregulatory sweat test | Patients tolerating at least 15 minutes of thermoregulatory sweat test | 1 year |
Photopill Treatment in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in chemotherapy/radiotherapy oral mucositis. Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule treatment in mice showed a significant beneficial effect on the endoscopic severity of DSS-induced colitis in mice. Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill treatment in healthy volunteers.

Official Title
-----------------
The Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Healthy Volunteers, a Phase 1 Trial

Conditions
-----------------
Ulcerated Mucosa of Colon

Intervention / Treatment
-----------------
* Device: Photopill treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are generally healthy. Signed informed consent. Exclusion Criteria: Subjects with any known GI related symptoms complaints or GI diseases. Subjects with cancer or other life threatening diseases or conditions. Subjects with cardiovascular or pulmonary diseases. Pregnant women. Subjects who underwent any colon surgery. Morbid Obesity (BMI > 40). Drug abuse or alcoholism. Bed-ridden patient. Any rectal therapy. Participation in current clinical study or clinical study within 30 days prior to the study.

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

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

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

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: Photopill treatment<br>Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times | Device: Photopill treatment<br>* 2 courses of 5 Photopill treatments within 14 days. In each treatment, 3cm of rectal tissue will be exposed, 2 minutes per cm, to low level light therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability |  | During Study period: day 0-14 |
Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis

Study Overview
=================
Brief Summary
-----------------
The recording or bowels is easy and cheap. The investigators wonder if these sounds are modified in babies with high risk of necrotizing enterocolitis. In this study, the investigators suggest to record and do a spectral analysis of 30 seconds of bowel sounds in preterm babies of less than 32WA before and after enteral nutrition, every day until the end of hospitalization. A spectral analysis will be made for each record to determine frequencies of the signal. The investigators will try to determine physiological frequencies and look for modifications in pathological situations.

Official Title
-----------------
Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis

Conditions
-----------------
Bowel Sounds, Spectral Analysis, Necrotizing Enterocolitis, Preterm Babies

Intervention / Treatment
-----------------
* Other: Recording of the bowel sounds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm babies of less than 32WA Exclusion Criteria: preterm babies of more than 32WA, digestive congenital malformation

Ages Eligible for Study
-----------------
Maximum Age: 32 Weeks

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

| Intervention/Treatment |
| --- |
|Other: Recording of the bowel sounds|Recording of the bowel sounds before and after enteral feeding three times a week with an electronical stethoscope|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of spectral analysis of bowel sounds (frequency in Hz) before and after enteral nutrition | establishing spectral analysis of bowel sounds | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bowel sounds, spectral analysis, Necrotizing Enterocolitis, preterm babies
Study of the Impact of Virtual Patient Designs on the Reasoning Pattern and Therapeutic Decision Making

Study Overview
=================
Brief Summary
-----------------
There is a lack of evidence of the impact of the information provided in the introduction screen on the students diagnostic and therapeutic decisions. The reasoning pattern may also be altered if positive findings are provided to the student without an active request for it. The results will be of importance when virtual patients are used for assessing students.

Detailed Description
-----------------
The problem-solving approach is found in virtual patient designs concerned with teaching clinical reasoning and diagnosis. Generally the student has to collect a range of information, usually from menus of possible history questions, physical examination, and lab tests, and make diagnostic and therapeutic decisions based on their findings. The information is not cued - the student have to decide what is relevant. An introduction screen is shown to the student when the virtual patient is initiated. Case author have used it differently - some entered a complete chief complaint and part of anamnesis findings while other have not disclosed anything about the patient. There is a lack of evidence of the impact of the information provided in the introduction screen on the students diagnostic and therapeutic decisions. The reasoning pattern may also be altered if positive findings are provided to the student without an active request for it. The results will be of importance when virtual patients are used for assessing students.

Official Title
-----------------
Study of the Impact of How the Virtual Patient's Anamnesis is Designed on the Reasoning Pattern and Therapeutic Decision Making

Conditions
-----------------
Decision Making, Computer-Assisted

Intervention / Treatment
-----------------
* Procedure: Virtual patient is NOT introduced


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the students enrolled in the comprehensive dentistry course at the time of the study (2007)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Virtual patient is NOT introduced|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic decision making |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical history reasoning (required/unnecessary) |  | 1 hour | 
| Time allocation to the different phases in solving a VP |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual patient, therapeutic decision making
Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, 2-Sequence Crossover Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions

Conditions
-----------------
Dry Mouth

Intervention / Treatment
-----------------
* Drug: Pilocarpine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Pilocarpine or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |