linjc16/ctgov huggingface dataset:
Glucose Metabolism After Partial Pancreatectomy

Study Overview
=================
Brief Summary
-----------------
This is a single center observational study to assess alteration of glucose metabolism after pancreatectomy.

Detailed Description
-----------------
Biochemical markers of glucose metabolism including oral glucose tolerance tests, fasting blood glucose, insulin, glucagon and HbA1c were performed on patients receiving pancreatectomy (pancreaticoduodenectomy and distal pancreatectomy). Tests were done preoperatively, postoperatively at 3 months, and at 1 year. The primary endpoints were the incidence and risk factors of new-onset and worsened DM after each type of pancreatectomy.

Official Title
-----------------
Alteration of Glucose Metabolism After Partial Pancreatectomy Assessed With Biochemical Markers :A Single Center Prospective Observational Study

Conditions
-----------------
Diabete Mellitus, Pancreatectomy; Hyperglycemia

Intervention / Treatment
-----------------
* Diagnostic Test: oral glucose tolerance test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: partial pancreatectomy Exclusion Criteria: total pancreatectomy incomplete testing follow-up loss death within 1 year
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD<br>pancreaticoduodenectomy | Diagnostic Test: oral glucose tolerance test<br> <br> |
| DP<br>distal pancreatectomy | Diagnostic Test: oral glucose tolerance test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence & risk factors of new-onset DM | incidence & risk factors of new onset DM after pancreatectomy | at 1 year | 
| incidence & risk factors of worsened DM | incidence & risk factors of worsened DM after pancreatectomy | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characteristics of new-onset and worsened DM | changes of glucose metabolism during study period | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatectomy, Diabetes Mellitus, pancreaticoduodenectomy
Fall Prevention Study Among Seniors in Bomlo

Study Overview
=================
Brief Summary
-----------------
Recruiting seniors age 65-85 at risk of falling in Bomlo municipality. Clinical tests performed by physiotherapist. If risk of falling is confirmed, participants will be randomized to either intervention group with fall-preventing exercize program or to a control group. Follow-up over 5 years.

Detailed Description
-----------------
Participants randomized to either exercise group or control group. Tests for balance and strength performed by physiotherapist at inclusion, and after three and six months and one year for both groups. Further follow-up and further inclusion of participants had to be terminated due to the pandemic in Mach 2020, when group activities were no longer allowed.

Official Title
-----------------
Early Identification and Intervention in Risk of Falling Among Seniors i Bomlo Municipality

Conditions
-----------------
Fall

Intervention / Treatment
-----------------
* Behavioral: Physical exercize


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65-85, home-dwellers in Bomlo municipality, capable of following up group-exercize, informed consent. Exclusion Criteria: Serious illness, in need of walking-aid indoors, moderate to severe cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercize group<br>10 weeks of physical exercise. Testing of strength and balance. | Behavioral: Physical exercize<br>* 10 weeks group exercize followed by community-based voluntary exercize<br>|
| No Intervention: Control group<br>Testing of strength and balance. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fall-related injuries | identified in electronic patient record in primary care | First year |
Pharmacogenetics of Cannabinoid Response

Study Overview
=================
Brief Summary
-----------------
This study attempts to examine genetic influences on the effects of tetrahydrocannabinol (Δ9-THC), the active ingredient of marijuana, cannabis, ganja, or pot.

Official Title
-----------------
Pharmacogenetics of Cannabinoid Response

Conditions
-----------------
COMT Gene Polymorphism

Intervention / Treatment
-----------------
* Drug: delta 9 tetrahydrocannabinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 and 55 years (extremes included) on the day of the first dosing. Exclusion Criteria: Cannabis naïve individuals.

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Very low dose (0.005 mg/kg = 0.35 mg in a 70kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1/10th of a marijuana cigarette, or joint. Low dose (0.025 mg/kg = 1.75 mg in a 70kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1/2 of a marijuana cigarette, or joint. Medium dose (0.05 mg/kg = 3.5 mg in a 70 kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1 marijuana cigarette, or joint. | Drug: delta 9 tetrahydrocannabinol<br>* 0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes<br>* Other names: cannabis;|
| Placebo Comparator: 2<br>small amount of ethanol, (quarter teaspoon), with no THC | Drug: delta 9 tetrahydrocannabinol<br>* 0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes<br>* Other names: cannabis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Measures |  | Baseline, +15, +25, +60, +300 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
THC, COMT gene polymorphism, schizophrenia, cannabis use
Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity

Study Overview
=================
Brief Summary
-----------------
A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 < 70% of expected value or < 1.5L who undergo resections of the lung.

Official Title
-----------------
Prospective Randomized Controlled Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With FEV1 < 70% of Expected Value or < 1.5L

Conditions
-----------------
Respiration Disorders

Intervention / Treatment
-----------------
* Procedure: Fast track lung surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resection of the lung FEV1 <70% of expected value or below 1.5L 18-80y given written informed consent Exclusion Criteria: contraindication for epidural anesthesia prio ipsilateral thoracotomy chemotherapy <6 weeks prior to study enter existing pneumonia (fever, elevated WCC, elevated CRP)

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: 1<br>conventional perioperative management for lung surgery | Procedure: Fast track lung surgery<br>* fast track lung surgery: carbohydrate drink preoperatively, PCEA, early removal of chest tube conventional: no carbohydrate drink preoperatively, ICB+PCA, removal of chest tube depending upon chest x-ray<br>|
| Experimental: 2<br>fast track management for lung surgery | Procedure: Fast track lung surgery<br>* fast track lung surgery: carbohydrate drink preoperatively, PCEA, early removal of chest tube conventional: no carbohydrate drink preoperatively, ICB+PCA, removal of chest tube depending upon chest x-ray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of ICU treatment |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung resection, reduced pulmonary function
Integration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the cervical muscular force control , taking into account the proprioceptive signals, in patients with and without cervical dystonia.

Conditions
-----------------
Cervical Dystonia

Intervention / Treatment
-----------------
* Device: Electromyogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients presenting focal or segmental cervical dystonia diagnosed by a neurologist expert in the diseases with abnormal movements having signed a consent for study participation No Inclusion Criteria: Neurological affection other than cervical dystonia (typical or atypical parkinsonism, other ...) Severe pain, trauma or disease of the cervical spine known or suspected other than cervical dystonia requiring treatment in the last 6 months Ongoing neuroleptic treatment Pregnancy or breastfeeding Lack of insurance coverage For patients, are added the following no inclusion criteria are added: Trembling cervical dystonia Injection of botulinum toxin in the past three 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients with cervical dystonia<br>Computerized assessment of the cervical muscular force and with electromyogram in patients with cervical dystonia | Device: Electromyogram<br> <br> |
| Other: patients without cervical dystonia<br>Computerized assessment of the cervical muscular force and with electromyogram in patients without cervical dystonia | Device: Electromyogram<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring (in Newton) of the muscular force exerted by extending movements of the cervical spine in static and dynamic condition |  | two hours |
Autoimmune Hepatitis Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the role special antibodies play in possibly identifying Autoimmune Hepatitis through the following: Identify the response of specific T cells to antibodies and Monitor the response of the cells that regulate the immune system

Detailed Description
-----------------
The object of this protocol is to characterize and monitor auto antigen-specific T cell responses in blood and liver biopsies of patients with anti-SLA/LP or anti-LKM-positive autoimmune hepatitis. The results will provide insight into the pathogenesis of autoimmune hepatitis and the monitoring of auto antigen-specific T cell reactivity in correlation to disease exacerbation and therapy.

Official Title
-----------------
Evaluation of the Cellular Immune Response in Patients With Anti-SLA/LP- or Anti-LKM-Positive Autoimmune Hepatitis

Conditions
-----------------
Hepatitis, Autoimmune

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects,All ethnic groups, Over 18 years of age, anti-SLA/LP or anti-LKM-positive autoimmune hepatitis Exclusion Criteria: Subjects with a hematocrit of <25

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?
-----------------
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
-----------------
AIH, Autoimmune Hepatitis
Phase II Study of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop new treatments that will hopefully result in the relief of symptoms and prolongation of life. For this reason, your doctors have offered you treatment with a new experimental drug called PS 341.

Official Title
-----------------
Phase II Study to Evaluate the Efficacy and Safety of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: PS-341 (Velcade-drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have confirmed NSCLC (squamous, adeno- and large cell anaplastic carcinoma)stage III B or Stage IV. No prior chemotherapy regimen Patients must have adequate organ and marrow function Exclusion Criteria: Untreated symptomatic brain metastasis Patients with known HIV positivity

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PS-341 (Velcade-drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  |
Chewing Gum Facilitates an Earlier Return to Bowel Function in Pediatric Scoliosis Patients: A Prospective Randomized Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of chewing gum on reducing post-operative ileus and reducing post-operative gastrointestinal symptoms in pediatric patients undergoing surgical correction of scoliosis. This study would provide minimal risk to its study population, and has the opportunity to provide a benefit to patients undergoing scoliosis surgery. If shown to be effective, this could lead to changes and improvement of the post-operative course for pediatric scoliosis patients.

Official Title
-----------------
The Use of Chewing Gum Reduces Post-operative Ileus and Gastrointestinal Complications in Pediatric Scoliosis Patients.

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Other: Chewing gum
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Otherwise meets criteria for surgical correction of scoliosis Mental capacity to understand the purpose of the study Idiopathic scoliosis or neuromuscular scoliosis with mild cerebral involvement Posterior surgery approach only Exclusion Criteria: Unable to safely chew gum due to oropharyngeal issues or airway issues History of GI surgery (G-tube, fundoplication, ostomy etc...) Anterior approach

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>No gum | Other: Control<br>* No intervention will be assessed for this group.<br>|
| Active Comparator: Chewing Gum<br>Bubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day | Other: Chewing gum<br>* Subjective assessment - subjective assessment of abdominal pain and nausea.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return of normal bowel function. | Patients are interviewed daily as inpatient and then several days after surgery to determine the time (reported in hours post-operative) first flatus and first bowel movement was experienced. | 72-96 hours |
Database and Biobank of Patients With Hypersensitivity Pneumonitis

Study Overview
=================
Brief Summary
-----------------
Sub-study of the main Pulmonary Fibrosis Biomarker (PFBIO) cohort (NCT02755441), recruiting patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP). Patients are included for the collection of blood samples and regular clinical data. The database and biobank will be available for studies of HP, and can be directly compared to the main PFBIO cohort, which has recruited patients with Idiopathic pulmonary Fibrosis (IPF) since 2016. Biomarkers will be assessed as diagnostic and prognostic. Further subtyping of HP, based on blood markers (including precipitins) will also be possible with the PFBIO-HP project.

Official Title
-----------------
Pulmonary Fibrosis Biobank - Hypersensitivity Pneumonitis

Conditions
-----------------
Hypersensitivity Pneumonitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of HP at an MDT conference according to the current international guidelines Age of 18 years or older The patients must be capable of giving informed consent Exclusion Criteria: - Unable to sign informed consent

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP)<br>The overall inclusion criteria of patients in the HP cohort are: Diagnosis of HP at an MDT conference according to the current international guidelines Age of 18 years or older The patients must be capable of giving informed consent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of HP | MDT-Diagnosis of HP | 0 days | 
| Exposure to inciting antigen (patient reported) | Known exposure, as reported by the patient | 0 days | 
| Exposure to inciting antigen (measurable) | Measurable exposure, as tested by precipitins | 0 days | 
| Progression free survival | Survival without progression | 3 years | 
| Overall survival | Survival after diagnosis | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaires | SGRQ | 3 years | 
| Pulmonary function test | FVC | 3 years | 
| Pulmonary function test | DLCO | 3 years | 
| Imaging | HRCT scans | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarker, prognosis, diagnosis, phenotyping, genotyping