linjc16/ctgov huggingface dataset:
Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population

Study Overview
=================
Brief Summary
-----------------
Crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses). The treatment of perforating Crohn's disease is not codified.

Detailed Description
-----------------
The old dogmas leading to surgery after failure of medical treatment have recently been overturned, particularly since the advent of anti-TNFs. Biotherapies now have a central place, including for complicated forms. Previous studies have already looked at the usefulness of anti-TNFs in stenosing forms, or concerning ano-perineal lesions, but what about digestive fistulas. Indeed, data are scarce, especially in paediatrics.

Official Title
-----------------
Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: Infliximab
* Procedure: Stomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minor patients (aged 3 to 18). Diagnosed with Crohn's disease. fistulizing crohn's disease Exclusion Criteria: - perianal crohn disease

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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: Infliximab|Drug|
|Procedure: Stomy|Surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No fistula | Complete remission = clinical remission and biological remission and iconographic remission: clinical remission (asymptomatic at 12 months from inclusion). biological remission (normalization of biological parameters 12 months after inclusion). iconographic remission (no active lesion, and in particular no visualized fistula) | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fistula, abscess, pediatrics, medical treatment, surgery, drug
Pulsed Radiofrequency Treatment Of the Gasserian Ganglion for tRigeminal nEuralgia: a retroSpective Study

Study Overview
=================
Brief Summary
-----------------
With the Pulsed Radiofrequency treatment (PRF) Of the Gasserian ganglion for tRigeminal nEuralgia: a retroSpective Study (PROGRESS) the objective is to document the outcome of PRF (Pulsed Radiofrequency treatment) for patients with TN (Trigeminal Neuralgia), unresponsive to conservative treatment.

Detailed Description
-----------------
Primary objective: To determine the proportion of patients in which PRF (pulsed radiofrequency) of the Gasserian ganglion for trigeminal neuralgia (TN) provides acute pain relief of at least 50% on the GPE (Global perceived effect) score (six weeks after treatment) Secondary objectives: - To determine the duration during which PRF of the Gasserian ganglion for trigeminal neuralgia provides a reduction of at least 50% on the GPE (Grade Point Equivalent) score.

Official Title
-----------------
Pulsed Radiofrequency Treatment Of the Gasserian Ganglion for tRigeminal nEuralgia: a retroSpective Study

Conditions
-----------------
Trigeminal Neuralgia (TN)

Intervention / Treatment
-----------------
* Procedure: PRF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with trigeminal neuralgia who underwent their first PRF of the Gasserian ganglion between 01/09/2013 and 31/08/2021 Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| TN<br>Patients with trigeminal neuralgia | Procedure: PRF<br>* Pulsed Radiofrequency Current of the Gasserian Ganglion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GPE <50% | To determine the proportion of patients in which PRF (pulsed radiofrequency) of the Gasserian ganglion for trigeminal neuralgia (TN) provides acute pain relief of at least 50% on the GPE (Global perceived effect) score (six weeks after treatment) | Six weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of GPE <50% | To determine the duration during which PRF of the Gasserian ganglion for trigeminal neuralgia provides a reduction of at least 50% on the GPE (Grade Point Equivalent) score. This will be assessed six weeks post procedure and will be followed-up until definitive or possible relapse of neuralgia, assessed up to 48 months. | From six weeks post procedure until definitive or possible relapse of neuralgia, assessed up to 48 months. |
Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects

Official Title
-----------------
A Phase 1, Double-blind, Single-dose, Randomized, Placebo and Active-Controlled, Four-Way Crossover Study Evaluating the Effects of Bemnifosbuvir on Cardiac Repolarization in Healthy Adult Subjects

Conditions
-----------------
Healthy Volunteer Study

Intervention / Treatment
-----------------
* Drug: Bemnifosbuvir (BEM)
* Drug: Placebo
* Drug: Moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug Females must have a negative pregnancy test at Screening and prior to dosing Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2 Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: Pregnant or breastfeeding Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19 Abuse of alcohol or drugs Use of other investigational drugs within 28 days of dosing Other clinically significant medical conditions or laboratory abnormalities

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bemnifosbuvir (BEM) therapeutic dose<br>oral tablets | Drug: Bemnifosbuvir (BEM)<br>* A single dose of BEM will be administered.<br>* Other names: AT-527;|
| Experimental: Bemnifosbuvir (BEM) supratherapeutic dose<br>oral tablets | Drug: Bemnifosbuvir (BEM)<br>* A single dose of BEM will be administered.<br>* Other names: AT-527;|
| Placebo Comparator: Placebo<br>oral tablets | Drug: Placebo<br>* A single dose of matching placebo will be administered.<br>|
| Active Comparator: Moxifloxacin<br>oral tablet | Drug: Moxifloxacin<br>* A single dose of Moxifloxacin will be administered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc). | C-QTc analysis | 24 hours prior to dosing thru 48 hours post dose |
Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
To evaluate the validity of lung ultrasound compared to CT chest and chest radiograph for diagnosis of ARDS and prediction of successful weaning from mechanical ventilation in those patients compared to traditional methods.

Detailed Description
-----------------
57 patients will be diagnosed as ARDS by CT chest and clinical criteria, then will be compared between the findings by lung ultrasound and chest radiograph to detect the sensitivity of both imaging to CT chest as gold standard in diagnosis of ARDS patients

Official Title
-----------------
Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome and Prediction of Successful Weaning From Mechanical Ventilation in Those Patients

Conditions
-----------------
of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients or legal guardian's consent .All patients with suspicious criteria of acute respiratory distress syndrome .Hemodynamically stable in the absence or minimal of vasopressors. Exclusion Criteria: Pregnant women. patients with traumatic lung injury or pneumothorax. surgical dressings over the right lower rib cage which would preclude ultrasound examination. presence of ascites. presence of lung collapse, fibrosis, or pleural effusion. -presence of any mass or mechanical factor in the chest or the abdomen interfering with the diaphragmatic mobility.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| diagnostic data checklist | Data of CT chest ,lung ultrasound and chest radiography in diagnosis of ARDS . | immediately after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | compared the success of both methods in terms of reintubation or not for those patients | within 24 hours after weaning | 
| lung ultrasound as a predictor for weaning | evaluate the scoring of lung aeration | immediately before weaning | 
| diaphragmatic ultrasound as a predictor for weaning | diaphragmatic thickness and excursion | immediately before weaning | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung ultrasound, acute respiratory distress syndrome
Alveolar Ridge Augmentation Following Tooth Extraction Using Bovine Xenograft With Platelet Rich Fibrin Membrane

Study Overview
=================
Brief Summary
-----------------
fourteen patients requiring extraction of one posterior tooth with lost buccal bone (>50%) confirmed preoperatively by Cone-beam computed tomography (CBCT) scans. Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets. (CBCT) scans, performed before tooth extraction and after 6 months, were used to assess vertical and horizontal bone changes.

Official Title
-----------------
Alveolar Ridge Augmentation Following Tooth Extraction Using Bovine Xenograft With Platelet Rich Fibrin Membrane

Conditions
-----------------
Bone Regeneration

Intervention / Treatment
-----------------
* Procedure: a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients required implant treatment after tooth extraction Age group ranged from 20-60 years old. Patients could undergo the treatment under local anesthesia. Loss of buccal bone (>50%) confirmed by preoperative cone beam computed tomography (CBCT). Presence of other socket walls; mesial, distal and lingual walls. Tooth needed to be extracted in upper or lower posterior regions Exclusion Criteria: Uncontrolled diabetic diseases. Uncontrolled hypertension, or hepatic and renal disorders. Any systemic diseases associated with bone metabolism.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket<br> | Procedure: a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket<br>* Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in alveolar bone width and height in mm using CBCT scans. | Cone Beam Computed Tomography were taken for each patients before tooth extraction and after 6 months, which were used to assess alveolar ridge changes in width and length in mm. | 6 months |
Prospective Multi-Center Trial for FemBloc Permanent Birth Control

Study Overview
=================
Brief Summary
-----------------
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Official Title
-----------------
FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: FemBloc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, 21 - 50 years of age desiring permanent birth control. Sexually active with male partner. Regular menstrual cycle for last 3 months or on hormonal contraceptives. Exclusion Criteria: Uncertainty about the desire to end fertility. Known or suspected pregnancy. Prior tubal surgery, including sterilization attempt. Presence, suspicion, or previous history of gynecologic malignancy. Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test. Abnormal uterine bleeding requiring evaluation or treatment.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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: FemBloc<br>Investigational device and procedure | Device: FemBloc<br>* Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year. | one (1) year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliance Rate | Number of subjects who were told to rely on FemBloc. | ninety (90) days post treatment | 
| Long term Pregnancy Rate | Number of subjects who were told to rely on FemBloc for birth control that became pregnant after one (1) year through 2-, 3-, 4-, and 5-years. | Five (5) years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Permanent Birth Control, Permanent Contraception, Permanent Sterilization
Multimodal Brain Monitoring as a Prognostic Tool for Intracerebral Hemorrhage

Study Overview
=================
Brief Summary
-----------------
To verify if there is an association between advanced multimodal brain monitoring parameters in the first 48h and fist 7 days of admission with intrahospital and six-months functional outcome, even when controlled to other factors that may influence the outcome. Secondary Goals: To describe multimodal neuromonitoring parameters variation in the first seven days of ICH and identify any trends.

Official Title
-----------------
Multimodal Brain Monitoring as a Prognostic Tool for Intracerebral Hemorrhage - A Prospective Observational Cohort Study.

Conditions
-----------------
Intracerebral Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spontaneous Intracerebral Hemorrhage ICU admission in the first 24hours Need for intraparenchymal Neuromonitoring Over 18 years old Exclusion Criteria: Tumour, Trauma or known Vascular Lesion Pregnancy

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between multimodal brain monitoring parameters and outcome. | Association between advanced multimodal brain monitoring parameters of the first 48h of admission and six months functional outcome (Glasgow Outcome Score Extended) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICH Neuromonitoring Pattern. | Describe multimodal neuromonitoring parameters variation in the first seven days of ICH and identify trends. | 7 days | 
| ICH Neuromonitoring and Short Term Outcome | Association between advanced multimodal brain monitoring parameters and 28 days functional outcome (Glasgow Outcome Score Extended) | 28 days |
Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?

Study Overview
=================
Brief Summary
-----------------
To identify the current mortality rate for initial ALIF procedures. Establish/prove mortality rates for this operation have dropped in the past decade.

Detailed Description
-----------------
Establish the mortality rate for re-do ALIF procedures [i.e., is it different than that of initial ALIF procedures and - if so - postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk. This study is not designed to prove the latter hypothesis.] This is a single sample study where medical records will be searched by CPT codes for ALIF codes (e.g. 22558, 22585, 22845, etc.) by trained researcher(s) at participating Methodist facilities going back 5-10 years to see if 1500-3500 cases can be identified within that time period.

Official Title
-----------------
Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?

Conditions
-----------------
Lumbar Spondylolisthesis, Lumbar Spine Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 17 years of age, patients having had ALIF procedures as defined by CPT codes at participating Methodist facilities during 2010-2020 targeted. Exclusion Criteria: Pediatric patients (as defined by age <18 years old), pregnant women and incarcerated individuals. We do not anticipate any of these in an elective spine surgery group of patients. If they have emergency spine surgery it is normally not an ALIF.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Establish/prove mortality rates | Establish mortality rates of patients for this operation have dropped in the past decade. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the mortality rate for re-do ALIF procedures [ | Establish the patient's mortality rate, postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk. | 5 years |
Neostigmine Versus Sugammadex on Renal Functions

Study Overview
=================
Brief Summary
-----------------
The study will assess the acute effects of sugammadex or neostigmine on renal function as determined with more specific and sensitive tests in laparoscopic cholecystectomy

Official Title
-----------------
Evaluation of The Effects of Neostigmine Versus Sugammadex on Renal Functions in Laparoscopic Cholecystecomy A Randomized Controlled Study

Conditions
-----------------
Sugammadex, Neostigmine

Intervention / Treatment
-----------------
* Drug: Neostigmine
* Drug: Sugammadex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal renal function (serum Cr 0.4- 1.4 g/dL) American Society of Anesthesiologists (ASA) Class I-II Exclusion Criteria: Incapacity to consent. Pre-existing impaired kidney functions. Severe neuromuscular disease, as: myasthenia gravis & muscular dystrophy. Intra-operative bleeding Lengthy operations that exceed 2 hours. Hemodynamic changes more than 20% of the base line

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neostigmine Group<br> | Drug: Neostigmine<br>* a combination of 0.04 mg/kg neostigmine with 0.01 mg/kg atropine intravenously at the reappearance of a second twitch of TOF after the last dose of rocuronium<br>|
| Active Comparator: Sugammadex Group<br> | Drug: Sugammadex<br>* 2-4 mg/kg sugammadex intravenously upon the reappearance of a post-tetanic count 1-2 or a second twitch of TOF after the last dose of rocuronium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neutrophil gelatinase associated lipocalin (NGAL) values | normal overall unisex value 47-55 ng/ml | baseline ( 2 days preoperative) and 12 hours after surgery |