linjc16/ctgov huggingface dataset:
A Retrospective Study of Cardiovascular Events Related to the Use of Glucose Lowering Drug Treatment in Primary Care

Study Overview
=================
Brief Summary
-----------------
To describe the type II diabetes population in primary care with special reference to treatment, other diseases and mortality during the last decade. To test the hypothesis that the type or combination of per oral glucose lowering drugs have different effects on the risk of cardiovascular disease and diabetic complications.

Official Title
-----------------
A Retrospective Epidemiological Study to Investigate Outcome and Mortality With Glucose Lowering Drug Treatment in Primary Care

Conditions
-----------------
Diabetes Type II

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type II diabetes, according to medical records, diagnosis, prescription or lab assessments Exclusion Criteria: Patients followed by physician for less than 6 months after diagnosis of Diabetes type II
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Diabetes type II patients, according to medical records, prescriptions or lab results, followed for >6 months after diagnosis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite end-point consisting of Cardiovascular Disease, elective coronary revascularisation and mortality |  | The endpoints will be extracted from the medical records on one occassion, covering a period of one decade. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinopathy, renal failure, hypoglycaemic episodes, other diabetic complications |  | The endpoints will be extracted from the medical records on one occasion, covering a period of one decade. | 
| Time from: Metformin (MET) to Insulin (INS) versus Metformin (MET) -> Metformin (MET)+Sulfonylurea (SU) ->Insulin (INS) |  | The endpoints will be extracted from the medical records on one occasion, covering a period of one decade. | 
| Number of consultations in primary care. Number of hospitalisations |  | The endpoints will be extracted from the medical records on one occasion, covering a period of one decade. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidemiological, Diabetes, Glucose Lowering Drug Treatment in Primary care, CVD
Immunogenetic Factors of Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
To assess the association of immunogenetic factors with onset of coronary heart disease and the interrelationship of these factors with standard coronary heart disease risk factors.

Detailed Description
-----------------
BACKGROUND: Although the familial clustering of coronary heart disease has been well documented, it is unclear as to whether the familial clustering can be explained by shared environmental factors by members of a family or by clustering of risk factors having a genetic component such as blood pressure, familial hyperlipidemia and/or diabetes. Studies indicate that a family history of coronary disease may be an independent risk factor. Major histocompatibility complex genetic markers to identify individuals at risk within a family may be useful. In 1985 when the study began, there was a paucity of data dealing with the interrelationship of family history, genetic markers, immunological markers, and traditional risk factors. DESIGN NARRATIVE: In this case-control study, the study population consisted of incident cases who presented to the Georgia Heart Clinic in La Grange, Georgia with coronary heart disease. The majority of the subjects were from three counties in mideastern Alabama and from counties in midwestern Georgia. All subjects had undergone diagnostic coronary angiography. A determination was made in patients and controls of the association of major histocompatibility complex genetic markers HLA-A, -B, -C, -DR, C4 and BF, C3, the restriction fragment length polymorphisms (RFLP's) flanking the apolipoprotein AI and insulin genes, presence of autoantibodies, and family history of coronary disease, diabetes, or hypothyroidism. The frequency of these variables was compared with the standard coronary risk factors of family history, hypertension, lipid abnormalities, lifestyle, Type A behavior, obesity and with diseases such as diabetes and hypothyroidism. An analysis was made of the strength of these variables for predicting those individuals at risk and whether there were variables which predict severity of disease based on 1, 2, or 3 vessel involvement. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypertension, Obesity, Diabetes Mellitus, Hypothyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Factors Associated With Pain During Unsedated Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Colonoscopy is the gold standard in the diagnosis and treatment colorectal disease, but due to the uncomfortable or even painful procedure, a part of people unwilling to undergoing the examination and giving analgesic agents were recommended in several guidelines. However, use of analgesic agents have their own drawbacks, and nearly 70% patients felt no pain or only mild discomfort with the unsedated colonoscopy, routine administration of sedative or analgesic agents to all patients was considered as unnecessary. However, unsedated colonoscopy was thought to be an option for some but not for all, therefore a method to identify which patients at high risk for painful colonoscopy in preoperational stage is necessary.

Official Title
-----------------
A Novel Intubation Discomfort Score Identifies Patients Feeling Painful During Unsedated Colonoscopy

Conditions
-----------------
Colonoscopy, Unsedated, Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-80 years underwent unsedated colonoscopy Exclusion Criteria: no bowel preparation or colon cleansing by enema only no need to reach cecum prior finding of severe colon stenosis or obstructing tumor history of colectomy unstable hemodynamics pregnant unable to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| training<br>The training cohort was used to determine the influencing factors of the pain during the colonoscopy and establish the intubation discomfort score (IDS) | |
| validation<br>The validation cohort was used to verify the IDS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factor associated with painful colonoscopy rate | Abdominal pain during the examination was evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain)[14], and moderate or severe pain during the procedure was defined as a painful colonoscopy | 2 hours |
Anastomotic Leakage After Anterior Resection of Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Anastomotic leakage (AL) is one of the most-feared postoperative complications after anterior resection of rectal cancer. This complication compromises both short term and long term outcome of patients. The incidence of AL after anterior resection was approximately 6-11%. Although several risk factors for AL such as male sex, smoking, tumor location, longer operative time, intraoperative blood loss had been reported in previous studies, the incidence of AL did not meet a significant decrease. So far there is no multi-site observational study on incidence and risk factors of AL after anterior resection in China, therefore this study aims to work on this issue and provide evidence for clinical practice.

Official Title
-----------------
The Incidence and Risk Factors of Anastomotic Leakage After Anterior Resection of Rectal Cancer: a Multi-site Observational Study

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adenocarcinoma of the rectum by biopsy single lesion anterior resection was performed anastomosis using circular stapler Exclusion Criteria: history of colorectal cancer surgery emergency surgery because of bowel obstruction, bleeding or perforation colo-anal anastomosis subtotal colectomy total colectomy abdominal perineal resection Hartmann procedure pull out anastomosis
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 |
| --- | --- | --- |
| Anastomotic leakage | Anastomotic leakage is defined as a defect of the intestinal wall integrity at the colorectal anastomotic site leading to a communication between the intra- and extraluminal compartments. | 14 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anastomotic leakage, Anterior resection, Risk factors, Incidence, Rectal Cancer
Statins and ARBs on Rheumatoid Activity

Study Overview
=================
Brief Summary
-----------------
Investigational and comparative study between the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients

Detailed Description
-----------------
The study aims at ivestigating and comparing the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients

Official Title
-----------------
Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Angiotensin receptor blockers
* Drug: Statins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis. Exclusion Criteria: Pregnant or lactating Hepatic or renal impairment.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No intervention | |
| Active Comparator: Angiotensin receptor blockers<br>ARB ( Angiotensin receptor blockers) + Traditional therpy. | Drug: Angiotensin receptor blockers<br>* Candesartan<br>* Other names: Cansartan;|
| Active Comparator: Statins<br>Statin + Traditional therapy. | Drug: Statins<br>* Atorvastatin<br>* Other names: Ator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease activity score | DAS28-ESR | 6 months |
Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations. The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.

Official Title
-----------------
An Open-label, Noncomparative, Multi-center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms. Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies. Patient must give informed consent. Exclusion Criteria: Patients with an expected survival of less than 2 weeks. Patients who have been designated as Do Not Resuscitate. Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents. Pregnant women or nursing mothers.

Ages Eligible for Study
-----------------
Minimum Age: 8 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: Tigecycline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| micro response at subject level |  |  | 
| micro response at pathogen level |  |  | 
| clinical response at pathogen level |  |  | 
| development of decreased susceptibility |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bacterial Infections
Evaluation of the Results of Simultaneous Pancreatic and Hepatic Resections for Metastatic Neuroendocrine Tumors.

Study Overview
=================
Brief Summary
-----------------
The indications for synchronous liver resection for metastatic neuroendocrine tumors of pancreatic origin remain debated and poorly described in the literature. The reported mortality of this type of simultaneous resection remains very high, especially when a cephalic duodenopancreatectomy is associated with a hepatic resection (up to 40%). The benefit in terms of survival remains to be evaluated. The ReSiPaTNE study proposes to create a retrospective cohort of simultaneous pancreatic and hepatic resections for metastatic neuroendocrine tumors in order to evaluate the short and long term results of this type of resection. The evaluation of the results of this type of resection may be useful for the selection of patients for treatment.

Official Title
-----------------
Evaluation of the Results of Simultaneous Pancreatic and Hepatic Resections for Metastatic Neuroendocrine Tumors

Conditions
-----------------
Tumor of Pancreas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subjects (≥18 years old) Subject having had a first pancreatic resection for NET with resections of synchronous metastases Subject having had a first pancreatic resection for NET followed by a delayed resection of synchronous metastases Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research Exclusion criteria: Subject who expressed their opposition to participating in the study Pregnant women Subject under safeguard of justice Subjects under guardianship or curatorship

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 |
| --- | --- | --- |
| Postoperative morbidity and mortality of simultaneous pancreatic and hepatic resectio |  | Morbidity and mortality at 90 postoperative days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumor of Pancreas, Metastatic neuroendocrine tumors, Hepatic resection, Pancreatic resection
Does Pupil Size Matters in Refractive Surgery?

Study Overview
=================
Brief Summary
-----------------
To determine the influence of pupil size in refractive surgery. If any influence exist.

Conditions
-----------------
Myopia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - above 18 years suffers from myopia Exclusion Criteria: - suffer from keratoconus younger than 18 years old had previous eye surgery.

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
-----------------
refractive surgery, pupil, Pupil size
Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes mellitus (T2DM) results from early phase insulin secretory defect and insulin resistance. Studies have shown that most of the populations in which insulin resistance is considered to be the primary pathogenetic cause of diabetes, have a higher degree of obesity than those of primary insulin defect. Meanwhile, defective early insulin secretion plays a predominant role in the non-obese subtype of T2DM which includes majority of Japanese patients. Sitagliptin is a dipeptidyl peptidase-4 (DPP-IV) inhibitor as indicated for the treatment of T2DM. Sitagliptin increases plasma concentrations of active glucagon-like peptide-1 (GLP-1) and active glucose-dependent insulinotropic peptide (GIP) two- to three-fold in patients with T2DM. The effect of sitagliptin on GLP-1 results in lower fasting and postprandial glucose concentrations through increases in glucose dependent insulin release and suppression of inappropriate glucagon secretion. Namely, several mechanistic studies using standardized meal showed that sitagliptin improved glucose control with decreased glucagon levels and increased insulin concentration in obese or overweight T2DM patients with BMI > 25 kg/m2. However, how sitagliptin affects islet function, including glucagon secretion in non-obese patients with low insulin secretion are not known. Therefore, the investigators will examine the effect of sitagliptin on glycemic control and the mechanism involved using a standardized test meal in non-obese Japanese patients with T2DM whose BMI levels are < 25 kg/m2.

Official Title
-----------------
The Effect of Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, on Glycemic Control and Inappropriate Glucagon Secretion in Non-obese Japanese Patients With Type 2 Diabetes.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients non-obese patients Exclusion Criteria: patients treated with insulin therapy patients aged less than 20 years and more than 90 years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sitagliptin<br> | Drug: Sitagliptin<br>* 50 mg once per day<br>* Other names: Other name is known;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon secretion |  | One month |
Effect of Intravenous Magnesium During Robot Assisted Prostatectomy

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the effect of intravenous magnesium on blood pressure after Trendelenburg position during robot assisted prostatectomy. The secondary purpose of this study is to investigate the effect of intravenous magnesium on pain after robot assisted prostatectomy.

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: Magnesium Sulfate
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Robot assisted prostatectomy Exclusion Criteria: Allergy to magnesium Chronic pain Chronic opioid use Chronic NSAID use Renal dysfunction Liver dysfunction Cardiac arrythmia Seizure

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium group<br>Intravenous administration of Magnesium Sulfate | Drug: Magnesium Sulfate<br>* adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h<br>|
| Placebo Comparator: Control group<br>Intravenous administration of normal saline | Drug: Normal saline<br>* the same bolus and infusion volumes of normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood pressure |  | Up to 2 hours after Trendelenburg position | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | pain assessment using visual analog scale | Up to 24 hours after surgery end |