linjc16/ctgov huggingface dataset:
Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly

Study Overview
=================
Brief Summary
-----------------
This study was designed to determine whether elderly residents of long term care facilitated who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal spray improved these subjects' vitamin B12 status.

Detailed Description
-----------------
Subjects had serum creatinine <1.8 mg/dL, no diagnosis of severe megaloblastic or pernicious anemia, and had not been taking vitamin B12 supplements. At baseline, serum vitamin B12 and methylmalonic acid (MMA) concentrations of 34 subjects from the PPI group were compared with those of the non-PPI group. The PPI group (n=13) was treated with cyanocobalamin nasal spray for eight weeks, and post-treatment vitamin B12 and MMA concentrations were compared with baseline concentrations.

Official Title
-----------------
Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly

Conditions
-----------------
Vitamin B12 Deficiency

Intervention / Treatment
-----------------
* Other: blood collection
* Drug: treatment (cyanocobalamin nasal spray)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 60-89 years PPI use for >12 months (PPI group) no PPI use for 30 days prior to arm 1 long term care resident Exclusion Criteria: pernicious anemia severe megaloblastic anemia free-living serum creatinine > 1.8 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 89 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Comparison of serum vitamin and B12 concentrations of PPI and non-PPI groups | Other: blood collection<br>* blood collection<br>* Other names: baseline;|
| Experimental: 2<br>Comparison of baseline and end of treatment serum vitamin B12 and MMA concentrations. | Drug: treatment (cyanocobalamin nasal spray)<br>* cyanocobalamin nasal spray -- 500 mcg q week for eight weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum vitamin B12 |  | baseline and after 8 weeks of treatment | 
| serum methylmalonic acid (MMA) |  | at baseline and after eight weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin B12 deficiency, cyanocobalamin deficiency, proton pump inhibitors, omeprazole
Predictive Value of Whole Blood Coagulation Parameters for Post-discharge Venous Thromboembolism After Cancer Resection

Study Overview
=================
Brief Summary
-----------------
This study plans to learn more about the role of 2 blood tests in predicting who might develop a blood clot in their arm or leg after major surgery. The investigators know that patients who have cancer and major surgery have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous because the clot can move into your lungs.

Detailed Description
-----------------
Venous Thromboembolism (VTE) after cancer surgery hospitalization is the most common cause of death at 30 days after cancer surgery, and is a significant source of patient morbidity and health care cost. Pharmacoprophylaxis has proven efficacy in preventing post-discharge VTE in surgical cancer patients, but perceived risks and costs pose barriers to widespread adoption by clinicians. Risk stratification of this patient population is necessary to allow appropriate prescription of prophylaxis to the highest risk patients. Can the investigators develop a risk stratification model that includes a readily available laboratory test, the thromboelastogram with or without platelet mapping?

Official Title
-----------------
Predictive Value of Whole Blood Coagulation Parameters for Post-discharge Venous Thromboembolism After Cancer Resection.

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Other: blood tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects who are having primary, open resection surgery of gastrointestinal or bladder cancer Exclusion Criteria: currently receiving anticoagulation therapy pregnant

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: diagnostic blood tests<br>We are using 2 standard approved blood tests that may be useful in predicting who may develop a venous thromboembolism after cancer surgery. | Other: blood tests<br>* thromboelastogram platelet mapping<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism free survival after surgery for gastrointestinal or urologic cancer |  | 3 months post-discharge from hospital |
Modified Step by Step Mitrofanoff Continent Cystostomy : Functional Results of a Teachable Procedure

Study Overview
=================
Brief Summary
-----------------
The creation of an abdominal continental cystostomy orifice is an irreplaceable surgical technique that allows for the simple self-sounding of the bladder in patients with severe disabilities or malformations, and to obtain urinary continence. This operation, the principle of which was described by Paul Mitrofanoff in 1980, has benefited from countless descriptions, difficult realization and questionable design, so it is insufficiently proposed. Faced with this learning difficulty at the beginning of the year, we decided to define a step-by-step technique, in seven well-differentiated steps. This approach has simplified the teaching and dissemination of this technique. To validate its quality, it is necessary to evaluate the expected results of a continental cystostomy, by answering two simple questions: -is the cystostomy opening really continent? Is the cystostomy tube easy to catheterize?

Detailed Description
-----------------
This research consists in highlighting that the Mitrofanoff surgery technique used by the CHUGA surgeons during a cystostomy is easier to perform while having the necessary same results as the other methods. To do this, we must validate the quality of this method and therefore we will evaluate the results expected from a continuous cystostomy via a questionnaire. After a first telephone contact by Dr BOILLOT for a presentation of the study, patient will therefore be contacted by telephone by the Clinical Research Associate of the service. During this interview patient will be asked to answer a questionnaire consisting of five questions.

Official Title
-----------------
Modified Step by Step Mitrofanoff Continent Cystostomy : Functional Results of a Teachable Procedure

Conditions
-----------------
Mitrofanoff Continent Cystostomy, Cystostomy; Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult who has undergone a Mitrofanoff cystostomy by Dr. BOILLOT Exclusion Criteria: Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturient women, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure) Patients operated on by other surgeons

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 |
| --- | --- | --- |
| To evaluate, in a series of identically operated patients, the expected results of a continuous cystostomy: -is the cystostomy hole really continental? -is the cystostomy tube easy to catheterize | Average of the Scores obtained on the questionnaires carried out | 1 month |
Non-interventional (NI) Study to Observe Efficacy and Usage of Quetiapine in Acute Episodes of Schizophrenia and as Maintenance Therapy Following Standard Clinical Practice in Croatia

Study Overview
=================
Brief Summary
-----------------
Observational, non-comparative, epidemiological study to collect and analyse real life data on schizophrenic patients receiving quetiapine according to the standard medical practice in Croatia. The main objectives are to assess after 6 months of quetiapine therapy severity of illness and global improvement in patients using Clinical Global Impression (CGI) scale.

Official Title
-----------------
Non-interventional Study to Observe Efficacy and Usage of Quetiapine in Acute Episodes of Schizophrenia and as Maintenance Therapy Following Standard Clinical Practice in Croatia

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of schizophrenia Patients who are already treated with quetiapine for at least 12 weeks (outpatients or hospitalised patients) Patients capable of signing ICF Exclusion Criteria: Patients with hypersensitivity to active substance or any of the excipients of this product Patients with contraindication for quetiapine therapy according to the approved SmPC

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess severity of illness and global improvement in patients after 6 months of quetiapine therapy using Clinical Global Impression (CGI) scale |  | CGI - 2 measures (after 3 and after 6 months of quetiapine therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure therapeutic response in schizophrenic patients using BPRS scale |  | BPRS - 2 measures (after 3 and after 6 months of quetiapine therapy) | 
| To evaluate compliance with the prescribed antipsychotic treatment |  | CGI - 2 measures (after 3 and after 6 months of quetiapine therapy) | 
| To evaluate prescribing practices for quetiapine in the treatment of schizophrenia in Croatia |  | 3 measures (at the time of quetiapine therapy introduction, after 3 and 6 m of quetiapine therapy) | 
| To evaluate type and frequency of concomitant therapy |  | At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in concomitant therapy | 
| To evaluate average number of hospitalisations |  | At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in numbers of hospitalisations | 
| To evaluate frequency of mental illnesses in patient's family |  | at visit 1 (day 0) |
Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 in subjects with type 2 diabetes.

Official Title
-----------------
An Open-labelled, Randomised, Parallel Group, Multicentre, Safety and Efficacy Study of NN-X14Mix50 (BIAsp50) in a Twice Daily Regimen in Type 2 Diabetic Subjects

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 50
* Drug: biphasic human insulin 50


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes Subjects with insulin treated for at least 24 weeks HbA1c maximum 11.0% Body mass index (BMI) below 30.0 kg/m^2 Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes Exclusion Criteria: Recurrent severe hypoglycaemia Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year Impaired hepatic function Impaired renal function Cardiac diseases Uncontrolled hypertension Subjects with history of severe allergic or severe hypersensitive reactions Total daily insulin dose at least 100 IU Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: BIAsp<br> | Drug: biphasic insulin aspart 50<br>* Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected immediately before breakfast and dinner<br>|
| Experimental: BHI<br> | Drug: biphasic human insulin 50<br>* Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated haemoglobin A1c (HbA1c) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse event(s) |  |  | 
| Blood glucose |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| Change from baseline in insulin antibodies |  |  | 
| Insulin doses |  |  |
The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.

Study Overview
=================
Brief Summary
-----------------
Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.

Detailed Description
-----------------
All patients who present with clinically significant bile leakage after liver resection at postoperative day two or longer are offered the opportunity to become randomized to either continuous external drainage or the addition of transpapillary stent.

Official Title
-----------------
The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.

Conditions
-----------------
Bile Leakage

Intervention / Treatment
-----------------
* Device: Transpapillary plastic stent (7-10 Fr)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver resection including at least two liver segments. Exclusion Criteria: Hepatobiliary digestive anastomosis.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Continued external drainage<br>Continued external drainage alone. | |
| Active Comparator: Continued external drainage + transpapillary stent<br>External drainage + transpapillary plastic stent (7-10 Fr). | Device: Transpapillary plastic stent (7-10 Fr)<br>* Duodenoscopy plus transpapillary bile cannulation plus stent insertion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days of bile leakage from the abdominal cavity |  | From intervention until day discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General complications rates. Postoperative hospital stay |  | From intervention until day of discharge from hospital |
Machado-Joseph Disease in Israel

Study Overview
=================
Brief Summary
-----------------
Machado-Joseph disease (MJD) or spinocerebellar ataxia type 3 (SCA-3) is the most common dominant ataxia. The genetic cause of this late-onset degenerative disorder is the expansion of a (CAG)n tract located in the exonic region of the ATXN3 gene. In 1994 the first case of MJD among the Yemenite Jewish subpopulation living in Israel was published. The puropse of this study is to describe the clinical phenotype and genotype of the Yemenite Jewish subpopulation with MJD living in Israel

Official Title
-----------------
Machado-Joseph Disease in Israel: Clinical Phenotype and Genotype of a Jew Yemenite Subpopulation

Conditions
-----------------
Spinocerebellar Ataxia 3

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinocerebellar Ataxia 3 Yemenite Jews patients Exclusion Criteria: All others

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 |
| --- | --- |
| Spinocerebellar Ataxia 3 Yemenite Jews patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical phenotype of SCA3 Yemenite Jews patients |  | 3 years |
Prevalence and Profiles of Sports Injury in Taiwanese Adolescent Baseball Players

Study Overview
=================
Brief Summary
-----------------
To investigate prevalence and profile of sports injury in Taiwanese adolescent baseball players in a longitudinal study.

Official Title
-----------------
Prevalence and Profiles of Sports Injury in Taiwanese Adolescent Baseball Players

Conditions
-----------------
Sports Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Taiwanese adolescent baseball players Exclusion Criteria: Who are not willing to join this study

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 19 Years

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

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
-----------------
baseball, injury
The Impact of Chloroprocaine 3% for Ambulatory Foot Surgery on Perioperative Process Costs

Study Overview
=================
Brief Summary
-----------------
Background and Objectives Short acting regional anesthetics have already been successfully employed for peripheral nerve blocks in an ambulatory surgery setting. However, the impact on direct and indirect perioperative costs comparing two different short-acting local anesthetics has not been performed, yet. Methods In an observational study including 50 patients per group, patient undergoing popliteal block with chloroprocaine 3% or mepivacaine 1.5% for ambulatory minor foot surgery were compared. The primary outcome was the saving of both direct and indirect perioperative costs. Secondary outcomes were block success, onset time and block duration, patient satisfaction and unplanned outpatient visits or readmissions after discharge.

Official Title
-----------------
Can the Choice of the Local Anesthetic Have an Impact on Ambulatory Surgery Perioperative Costs? Chloroprocaine for Popliteal Block in Outpatient Foot Surgery

Conditions
-----------------
Impact of Anesthetic Choice on Costs

Intervention / Treatment
-----------------
* Drug: Chloroprocaine
* Drug: Mepivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III scheduled for elective, unilateral, ambulant minor foot surgery (percutaneous hallux valgus correction, osteotomies, tenotomies, mallet and hammer toes correction, screws and/or plaques removal) Exclusion Criteria: known allergy to drugs used in the study; coagulopathies, known neuropathy; pregnancy; chronic pain; drug or alcohol abuse; psychiatric disease or lack of competence affecting compliance and evidence of ongoing sepsis or local skin / subcutaneous tissues infections in the popliteal fossa.

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 |
| --- | --- |
| Chloroprocaine<br>Patient undergoing popliteal block with chloroprocaine | Drug: Chloroprocaine<br> <br> |
| Mepivacaine<br>Patient undergoing popliteal block with mepivacaine | Drug: Mepivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost minimization analysis |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
local anesthesia, regional anesthetic
Prevalence of Carbohydrate Intolerance in Lean and Obese Children

Study Overview
=================
Brief Summary
-----------------
The prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is more than just a cosmetic problem, having substantial metabolic consequences. Insulin resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen in obese children. In this study the prevalence of impaired glucose (carbohydrate) tolerance in lean children with a family history of diabetes and obese children with acanthosis nigricans with or without a family history of diabetes mellitus will be studied.

Conditions
-----------------
Obesity, Glucose Intolerance, Diabetes, Acanthosis Nigricans

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obesity: BM +/- 95% for age general good health

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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 |
| --- | --- | --- |