linjc16/ctgov huggingface dataset:
Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)

Study Overview
=================
Brief Summary
-----------------
Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control.

Official Title
-----------------
Surgical Treatment of Type 2 Diabetes Mellitus in Patients With BMI <35 kg/m2 (Italian Title: La Terapia Chirurgica Del Diabete Mellito di Tipo 2 Nel Paziente Con BMI Inferiore a 35 kg/m2)

Conditions
-----------------
Type 2 Diabetes Mellitus, Bariatric Surgery, Biliopancreatic Diversion, Gastric Bypass

Intervention / Treatment
-----------------
* Procedure: biliopancreatic diversion, gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Duration of diabetes ≥ 3 years Poor glycemic control (i.e., HbA1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (GCP) Exclusion Criteria: Specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass Pregnancy Medical conditions requiring acute hospitalisation Severe diabetes complications or associated medical conditions [such as blindness, end-stage renal failure (i.e. serum creatinine >2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (NYHA class III and IV)] Recent (within preceding 12 months) myocardial infarction, stroke or TIA Unstable angina pectoris Psychological conditions which may hamper patient's cooperation Geographic inaccessibility Any condition which, in the judgment of the Investigator, may make risky the participation in the study or bias the results

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery<br>patients will be submitted to biliopancreatic diversion or gastric bypass | Procedure: biliopancreatic diversion, gastric bypass<br>* biliopancreatic diversion consists of a distal gastrectomy with a long Roux-en-Y reconstruction, where the enteroenterostomy is placed 50 cm proximal to the ileocecal valve gastric bypass consists of creating a small proximal gastric pouch by division of the upper stomach, with reconstruction of the GI continuity by means of a Roux-en-Y loop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes control, define by FSG and HbA1c |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes control defined by FSG and HbA1c |  | 5 years |
Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether chiropractic manipulation or medical therapy is effective in the treatment of chronic neck pain.

Detailed Description
-----------------
Neck pain is a common complaint, approximately 10% of the population have neck pain. Many modalities are used to treat neck pain, but no therapy has been found to be clearly superior. We conducted a randomized controlled study of chiropractic manipulation versus medical therapy for chronic neck pain. Subjects (n=70) with neck pain for more than 3 months but with no evidence of radiculopathy or myelopathy were randomized. Both groups were instructed to do neck exercises and use heat daily. The chiropractic group received 12 standardized manipulations over 6 weeks. Nurses saw the medical group on the same visit schedule and received acetaminophen 1,000 milligrams four times a day as needed. Blinded observer performed all measurements. The primary outcome measure was the Neck Disability Index (NDI). Secondary measures were pain via a visual analogue scale, global via Medical Outcome Study Short Form and range of motion via Cybex electronic inclinometer.

Official Title
-----------------
Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Procedure: Chiropractic manipulation
* Drug: acetaminophen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neck pain for more than 3 months Exclusion Criteria: Cervical radiculopathy or myelopathy Contraindications to cervical manipulation: metastatic cancer, coagulation disorder, cervical spine abnormalities, neuromuscular disease Medical contraindications: uncontrolled hypertension, active coronary artery disease, history of cerebral vascular disease, alcohol or drug dependency, acetaminophen allergy Active litigation involving neck pain Medical or Chiropractic treatment within the past 3 months

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Chiropractic manipulation|nan|
|Drug: acetaminophen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index scale 0-30, clinically significant difference is a change greater than or equal to 5 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neck Pain, Chiropractic manipulation, Randomized controlled trial
Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of both. The aim of this study is to determine whether there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE ablation in combination or not with linear lesions in patients with persistent AF.

Official Title
-----------------
Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation, Recurrence

Intervention / Treatment
-----------------
* Procedure: PVI+CFAE+DCC
* Procedure: PVI, CFAE, anterior and roof line, DCC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic persistent AF After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia Exclusion Criteria: Left atrial thrombus

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CFAE ablation<br>Intervention: Complex fractionated atrial electrograms (CFAE) Ablation | Procedure: PVI+CFAE+DCC<br>* pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists<br>|
| Active Comparator: CFAE + Lines<br>CFAE Ablation followed by linear lesions (anterior and Roof line) | Procedure: PVI, CFAE, anterior and roof line, DCC<br>* PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial arrhythmia | Documented freedom from atrial arrhythmia (AF or AT) recurrence | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural and safety data | Duration of procedure, ablation time, fluoroscopy time and complications | 12 months | 
| Number and result of reablation procedure | Number of redo procedures, results and type of recurrent arrhythmia | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CFAE, Atrial fibrillation, Recurrence, linear ablation
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones

Study Overview
=================
Brief Summary
-----------------
Ghrelin, an acylated peptide consisting of 28 amino acids, is the endogenous ligand of the growth hormone secretagogue receptor (GHS-R). It is synthesized predominantly in the stomach but has been also identified in a variety of other organs. Alike, a wide range of central and peripheral endocrine and non-endocrine actions has been described, e. g. being a releasing factor of growth hormone, prolactin and ACTH, a modulator of cell proliferation and apoptosis, a regulator of sleep-wake regulation, and a orexigenic hormone. Aims of this study are: A) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in healthy subjects of both genders (age groups: 20-30, 35-45, 60-70 years). B) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the HPA axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in patients with major depression (age range: 20-65 years).

Official Title
-----------------
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones

Conditions
-----------------
Healthy, Major Depression

Intervention / Treatment
-----------------
* Drug: ghrelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy females and males Male and female patients with major depression Exclusion Criteria: Life time or family history of psychiatric or neurological disorders Sleep disturbances Shift work Any current disease Any medication Long distance flight within 3 months prior to study entry Smoking Any medication during the week prior to study entry Any current disease other than major depression

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ghrelin|acylated ghrelin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep, conventionally and quantitatively analyzed |  | study duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis |  | study duration |
Chronic Pain After Lung Transplantation, an Incidence Study

Study Overview
=================
Brief Summary
-----------------
This is an investigation on the frequency of chronic pain amongst recipients after lung transplantation. Factors relating to the development of chronic pain are investigated.

Official Title
-----------------
Chronic Pain After Lung Transplantation, an Incidence Study

Conditions
-----------------
Lung Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand and give consent Can read Residing in Denmark Exclusion Criteria: Unable to understand the written information in Danish Abuse (Medicine, Drugs, Alcohol) Severe psychiatric Illness Conflicting neurological disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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
-----------------
Lung Transplantation, Chronic pain, Thoracotomy
Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study is to assess the safety and tolerability of a five-day titration schedule (using twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg daily. The study duration is two months.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Twice Daily Titration Study of the Safety and Tolerability of Bifeprunox in Subjects With Schizophrenia

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: Bifeprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have current diagnosis of Schizophrenia or Schizoaffective disorder Body weight of 100-250 lbs Male or females 18-55 years of age Exclusion Criteria: Subjects who are acutely psychotic Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia, at significant risk of suicide

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

| Intervention/Treatment |
| --- |
|Drug: Bifeprunox|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
-----------------
Titration Study, Schizophrenia, BID dosing, Pharmacokinetic
Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED

Study Overview
=================
Brief Summary
-----------------
Descriptive study of patients with suspected COVID-19 upon ED arrival of European hospitals between March 09 and April 08 2020. Justification:

Detailed Description
-----------------
Descriptive study of patients with suspected COVID-19 upon ED arrival of European hospitals between March 09 and April 08 2020. Justification: Over the past 3 months, the world has faced a novel infection disease outbreak, due to a novel coronavirus, the severe acute respiratory syndrome coronavirus (SARS-CoV2), with a massive impact on healthcare resource. In Europe, numbers of confirmed cases continue to rise. Europe is currently one of the regions with the highest number of Covid-19 cases and deaths due to this emergent diseases. Most COVID-19 infected patients present with mild to moderate acute respiratory symptoms, including cough, fever, dyspnea and pneumonia. About 20% will present with severe or critical manifestations of the disease, including pneumonia, respiratory failure and acute respiratory distress syndrome (ARDS). Anticipating the needs for hospitalization in ward and/or intensive care is crucial. Emergency departments are at the front line for triaging patients with suspected Covid-19 and referring them to the appropriate level of care. In Europe, the number of ED patients with suspected Covid-19 is variable; rate of hospitalization from ED reaches 40% for this population. Risk stratification and management decisions of patients presenting to the ED with suspected COVID-19 is a challenge for emergency physicians.

Official Title
-----------------
Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>= 18 years old) attending the ED with a clinical suspicion of COVID-19 based on the presence of the following criteria Fever >= 38 °C respiratory symptoms (dyspnea, cough, expectorations) any other symptoms suggestive of COVID-19 including digestive signs (diarrhea, anosmia…) Exclusion Criteria: No insurance patients less than 18 years

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 |
| --- | --- | --- |
| Mortality | Mortality during hospital management | through study completion, an average of 30 days |
Do Patients Who Have Had Surgery for Achalasia Suffer From Reflux

Study Overview
=================
Brief Summary
-----------------
Patients who have had laparoscopic surgery for the treatment of achalasia will be asked to have pH studies done in order to determine is these patients suffer from reflux after surgery.

Detailed Description
-----------------
The purpose of this study is to determine if patients who have laparoscopic Heller myotomies for the treatment of achalasia suffer from reflux after the surgery. Patients at our institution who have had surgery for achalasia will be asked to have pH studies done to determine whether or not these patients have reflux.

Official Title
-----------------
Gastroesophageal Reflux in Patients With Achalasia

Conditions
-----------------
Reflux

Intervention / Treatment
-----------------
* Other: pH study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have had laparoscopic Heller myotomies for the treatment of achalasia Exclusion Criteria: Patients under the age of 18 will not be included Patients who are receiving anti-reflux therapy will not be included

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I<br>All patients in the study will have pH studies done in order to determine the degree of reflux after laparoscopic Heller myotomies. | Other: pH study<br>* All patients will have 48 hour pH study<br>* Other names: Bravo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to determine the degree of post-operative reflux in patients who have had laparoscopic Heller myotomies for the treatment of achalasia. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic Heller myotomy, achalasia, reflux
A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)

Study Overview
=================
Brief Summary
-----------------
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)

Conditions
-----------------
Primary Sclerosing Cholangitis, Cholangitis, Cholangitis, Sclerosing, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases, Adolescent

Intervention / Treatment
-----------------
* Drug: HTD1801
* Drug: Ursodeoxycholic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight ≥ 35 kg Previous cholangiographic evidence of PSC by magnetic resonance cholangiopancreatography (MRCP) or direct cholangiography or liver biopsy findings Serum GGT ≥ 2 × upper limit of normal (ULN) On a stable UDCA treatment regimen for ≥ 8 weeks Exclusion Criteria: Secondary sclerosing cholangitis Percutaneous or endoscopically-placed biliary drain or stent History of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1 year Ascending cholangitis requiring intravenous antibiotic therapy within 60 days prior to Screening Concomitant overlap syndrome with primary biliary cholangitis (PBC) Significant hepatic decompensation Alternative causes of chronic liver disease Hospitalization for colitis within 30 days prior to Screening Serum creatinine > 1.2 x ULN Hemoglobin < 10 g/dL Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HTD1801 500 mg BID (twice daily), or 1000 mg/day<br>HTD1801 tablets in double-blind capsules, 250 mg | Drug: HTD1801<br>* HTD1801 capsules, 250mg<br>|
| Active Comparator: Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day<br>UDCA tablets in double-blind capsules, 250 mg | Drug: Ursodeoxycholic Acid<br>* UDCA capsules, 125mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in gamma-glutamyl transferase (GGT) |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients whose GGT normalizes to <50 units/liter |  | 18 weeks | 
| change in aspartate aminotransferase (AST) |  | 18 weeks | 
| change in alanine aminotransferase (ALT) |  | 18 weeks | 
| change in alkaline phosphatase (ALP) |  | 18 weeks | 
| change in total bilirubin |  | 18 weeks | 
| change in C-reactive protein (CRP) |  | 18 weeks | 
| incidence of adverse events |  | 18 weeks |