linjc16/ctgov huggingface dataset:
Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
There is a high prevalence of vitamin D deficiency in the critically ill patient population, with approximately 60% of patients found to be vitamin D deficient, (25(OH)D concentrations <20 ng/mL) and an additional 30% of patients being vitamin D insufficient, (25(OH)D = 20-30 ng/mL).Approximately 80% of sepsis/septic shock patients experience respiratory failure and require mechanical ventilation. Furthermore, several studies document that vitamin D deficiency could be associated with poor outcomes in critically ill patient.

Official Title
-----------------
Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation; A Randomized Controlled Trial

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: Vitamin D3 tablets
* Drug: Vitamin D tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with sepsis and required mechanical ventilation (MV) within 24 hours from ICU admission. Expected to require mechanical ventilation for at least 72 hours after study entry. Exclusion Criteria: Age <18 years. inability to obtain informed consent from the patient and/or legally authorized representative. BMI> 40. Pregnant or breastfeeding. Chronic kidney diseases Pancreatitis. Hepatic insufficiency Cases with coagulopathy Moribund and not expected to survive 96 hours. Ongoing shock History of therapy with high dose vitamin D3 within previous 6 months. History of disorders associated with hypercalcemia Cancer as the cause of sepsis. Subjects undergoing chemotherapy. Immune compromised patients. Pneumonia developed < 48 hours following intubation. Patients with history of aspiration before intubation. known allergy to vitamin D.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1(Treatment group)<br> | Drug: Vitamin D3 tablets<br>* Vitamin D3 tablets 50,000 IU units<br>|
| Active Comparator: Group 2(Control group)<br> | Drug: Vitamin D tablets<br>* Vitamin D tablets 5000 units as daily requirements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7. | Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7. | 7 days |
Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.

Official Title
-----------------
Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any trial-related activities Type 2 diabetes HbA1c between 7-9% Insulin naive Inadequate control with oral antidiabetics therapy as judged by investigator Exclusion Criteria: Patients with type 1 diabetes Hypersensitivity to Levemir® or to any of the excipients Pregnancy, or desire of pregnancy within next 6 months HbA1c greater than or equal to 9% Known or suspected allergy to the trial product or to any of the excipients Subjects who are unlikely to comply with protocol

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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation<br>* Other names: Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia. |  | During study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 12 weeks (3 months) AND after 24 weeks (6 months) | 
| FBG (Fasting Blood Glucose) |  | Monthly average for each month, and average of the past quarter | 
| Weight |  | after 12 weeks (3 months) AND after 24 weeks (6 months) |
Innovative Ultrasound Technology in Neuromuscular Disease

Study Overview
=================
Brief Summary
-----------------
This study is utilizing ultrasound measurement to measure neuromuscular disease status in adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that ultrasound can be utilized as a tool to determine if a disease is responding to therapy or progressing.

Conditions
-----------------
Muscular Dystrophy, Amyotrophic Lateral Sclerosis, Radiculopathy, Myopathy, Polyneuropathy and Mononeuropathies, Trauma Injury, Orthopedic Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of a well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy. Exclusion Criteria: Multiple generalized neuromuscular conditions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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 |
| --- | --- |
| Neuromuscular Disease Patients<br>Amyotrophic lateral sclerosis patients, myopathy patients, muscular dystrophy patients, myasthenia gravis patients, radiculopathy patients, mononeuropathy patients | |
| Healthy volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative ultrasound data, including quantified grayscale data and backscattered acoustic data | Ultrasound data will be collected on multiple muscles in each person. The images will then be quantified using either 1. A grayscale technique in which the images themselves are analyzed via standard image software (e.g., Adobe Photoshop) as to level of echo intensity in a pre-specific region of interest or 2. the raw quantified backscatter data is captured by the transducer, expressed as a unit of power, in the same pre-specified area of interest | 1 year |
A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.

Detailed Description
-----------------
The study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study comparing 2 doses of inhaled R343 bid to placebo over 8 weeks in patients with mild to moderate allergic asthma. Patients who meet specific inclusion and exclusion criteria after an initial screening evaluation and a single-blind, run-in period will be randomized to receive either R343 or placebo.

Official Title
-----------------
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Doses of Inhaled R940343 in Patients With Mild to Moderate Allergic Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: R940343 1mg
* Drug: R940343 2mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical history of asthma Ability to perform spirometry Exclusion Criteria: Chronic obstructive pulmonary disease or bronchiectasis Upper or lower respiratory infection

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: R940343 2mg, 2 puffs bid<br>R343 2mg, 2 puffs bid | Drug: R940343 2mg<br>* R343 2mg, 2 puffs bid<br>* Other names: R343;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 puff bid or 2 puffs bid<br>|
| Active Comparator: R940343 1mg, 1 puff bid<br>R343 1mg, 1 puff bid | Drug: R940343 1mg<br>* R343 1mg, 1 puff bid<br>* Other names: R343;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 | Change from baseline in pre-BD FEV1 (% predicted) at Week 8. | Baseline and Week 8 |
Treatment for Acute Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
This clinical trial aims to treat a damaged spinal cord by injecting your own bone marrow stromal cells (autologous bone marrow stromal cells) into cerebrospinal fluid through the lumbar puncture, and assess the safety and efficacy of the procedure.

Official Title
-----------------
Clinical Study of Treatment for Acute Spinal Cord Injury Using Cultured Bone Marrow Stromal Cells

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Procedure: Transplantation of bone marrow stromal cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinal cord injury is confirmed with MRI Methylprednisolone therapy according to this study can be started within 8 hours after the injury Bone marrow stromal cells (BMSCs) incubation can be started within 72 hours after the injury Age between 15 and 60 With the informed consent of obtaining bone marrow and injecting incubated BMSCs. Exclusion Criteria: Complete disruption of spinal cord Central spinal cord injury Spinal canal stenosis before the injury Brain or spinal cord disease before the injury Positive serologic test in at least one of the following; HBs antigen, HCV antibody, HIV antibody, or HTLV-1 antibody Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transplantation of bone marrow stromal cell|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor function |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensation |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord Injury, Central nervous system, Regeneration, Bone marrow stromal cells, Transplantation
Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12 months post-op.

Official Title
-----------------
Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair

Conditions
-----------------
Umbilical Hernia, Ventral Hernia

Intervention / Treatment
-----------------
* Procedure: transvaginal NOTES ventral hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Umbilical or incisional hernia greater than 2 cm in size Female, age 18-75 Mentally competent to give informed consent Scheduled to undergo a transvaginal NOTES ventral hernia repair Exclusion: Pregnant women Patients with defects measuring greater than 10 cm in size Patients with complex hernias requiring fascial mobilization for closure Morbidly obese patients (BMI >45)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| transvaginal NOTES<br> | Procedure: transvaginal NOTES ventral hernia repair<br>* ventral hernia repair via the transvaginal approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection). |  | 1 Year | 
| To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection). |  | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
umbilical hernia, ventral hernia
Molecular Markers of Prognosis in Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To correlate the molecular profile of a series of defined CRCs with prognosis and toxicity.

Official Title
-----------------
Molecular Markers of Prognosis in Colorectal Cancer Patients

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients participating in the RMHNHST study of infusional versus bolus 5FU (Saini et al. 2003).

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 |
| --- | --- | --- |
CLE for Differential Diagnosis of IBD

Study Overview
=================
Brief Summary
-----------------
Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Device: Endomicroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: equal or above 18 years of age ability to provide written informed consent well-established diagnosis of CD or UC Exclusion Criteria: history of IBD reclassification in the last 3 years Boston Bowel Preparation Scale score's < 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon) inability to provide written informed consent severe uncontrolled coagulopathy impaired renal function pregnancy or breast feeding active gastrointestinal bleeding known allergy to fluorescein residence in institutions

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 |
| --- | --- |
| Ulcerative colitis<br> | Device: Endomicroscopy<br> <br> |
| Crohn's disease<br> | Device: Endomicroscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with IBD |  | 4 years |
Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD

Study Overview
=================
Brief Summary
-----------------
Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection usually is difficult, associated with high risk of complications and sometimes is not feasible. Surgical resection is also associated with a risk of complications and often refused by the patients. With the developement of the gFTRD-System gastric SET can now be resected endoscopically. The advantage of this technique is the complete resection and a full-thickness resections specimen for are definite histology.

Official Title
-----------------
Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD

Conditions
-----------------
Feasibility, Complications

Intervention / Treatment
-----------------
* Device: EFTR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Gastric SET up to 15 mm (measurement: endoscopic ultrasound) Exclusion Criteria: Age < 18 years Gastric SET > 15 mm and/or large extramural part Criteria of Lipoma (endoscopic ultrasound) Positive lymph nodes (endoscopic ultrasound) Stenosis (Esophagus) Diverticulum (Esophagus) Pregnancy or Nursing period

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

| Intervention/Treatment |
| --- |
|Device: EFTR|EFTR with the FTRD developed for gastric resection (gFTRD).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Successful enbloc- and macroscopically complete resection | 1 minute (immediate) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0-Resection | Histologically confirmed complete resection | three days | 
| Histologically confirmed full thickness resection | Histologically confirmed full thickness resection | three days | 
| Procedure-associated complications | Procedure-associated complications such as bleeding or perforation | three months | 
| Necessity of surgical treatment | Necessity of surgical treatment | three months | 
| Residual or recurrent adenoma/carcinoma at endoscopic follow up | Residual or recurrent adenoma/carcinoma at endoscopic follow up | three months |
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).

Official Title
-----------------
Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Insulin naive diabetes Current treatment with OHA, secondary failure Body mass index (BMI) below 40 kg/m2 HbA1c over 8.5% Willing and able to start with insulin therapy and to perform self-blood glucose monitoring Exclusion Criteria: History of drug or alcohol abuse Receipt of the investigational drug within the last month prior to this trial Known or suspected allergy to trial products or related products Severe uncontrolled hypertension Any disease or condition, which the Investigator feels, would interfere with the trial

Ages Eligible for Study
-----------------
Minimum Age: 35 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: biphasic insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose profiles |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| Incidence of adverse events |  |  |