linjc16/ctgov huggingface dataset:
Fast Titration Of Quetiapine Versus Currently Approved Titration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of a more rapid dose titration in acute schizophrenic patients compared to the conventional titration.

Official Title
-----------------
Fast Titration Of Quetiapine Versus Currently Approved Titration: A Randomised, Multicentre, Parallel Group Open Trial In Schizophrenia And Schizoaffective Disorder

Conditions
-----------------
Psychotic Disorders

Intervention / Treatment
-----------------
* Drug: Quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. Should stay in hospital for at least 7 days. Exclusion Criteria: Patients treated with Risperdal consta or Clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with moderate and severe adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daily level of somnolence and orthostatic dizziness as rated on AE intensity scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Schizoaffective disorder
IMMUNONUTRITION IN FAST-TRACK SURGERY

Study Overview
=================
Brief Summary
-----------------
Compare the results in terms of morbidity, mortality and hospitalization among patients with input from immunonutrients and patients with enteral nutrition intake of high calorie and high protein undergoing colorectal surgery within a multimodal rehabilitation program.

Official Title
-----------------
NUTRITIONAL EFFECTS AND INFLUENCE IN THE MORBIDITY AND MORTALITY OF DIET IMMUNOMODULATORY IN FAST-TRACK SURGERY

Conditions
-----------------
IMMUNONUTRITION

Intervention / Treatment
-----------------
* Dietary Supplement: IMMUNONUTRITION
* Dietary Supplement: STANDART NUTRITION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing colorectal surgery. Signing informed consent. Exclusion Criteria: Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis) Patients with contraindications for electrical stimulation. Psychiatric Disorders HIV Pregnant or breastfeeding intestinal obstruction uncontrolled infection ASA IV No acceptance or failure to follow protocol multimodal rehabilitation.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CONTROL<br>STANDARD NUTRITION | Dietary Supplement: STANDART NUTRITION<br>* STANDART NUTRITION PERIOPERATIVE<br>|
| Experimental: IMMUNONUTRITION<br>INMUNONUTRITION | Dietary Supplement: IMMUNONUTRITION<br>* IMMUNONUTRITION SUPLEMENTS PERIOPERATIVE<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complications |  | UP TO 30 DAYS POST-OPERATIVE |
Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy (NARROW CRT)

Study Overview
=================
Brief Summary
-----------------
Current recommendations require a QRS duration of ≥120ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure of ischemic origin, current indications for defibrillator implantation and QRS <120ms may benefit from CRT in the presence of marked mechanical dyssynchrony.

Official Title
-----------------
Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy

Conditions
-----------------
Heart Failure, Systolic

Intervention / Treatment
-----------------
* Procedure: cardiac resynchronization therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NHYA class II-III heart failure ischemic cardiomyopathy ejection fraction of 35% or less QRS interval of 120ms or less evidence of mechanical dyssynchrony as measured on echocardiography Exclusion Criteria: conventional indication for cardiac pacing persistent atrial fibrillation life expectancy lower than 1 year

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRT<br>The CRT group undergoes implantation of a CRT defibrillator | Procedure: cardiac resynchronization therapy<br>* Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads<br>|
| No Intervention: no-CRT<br>The no-CRT group receives a dual-chamber defibrillator | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart failure clinical composite score | Patients are classified according to a score, which assigns subjects to one of three response groups - improved, worsened, or unchanged. Patients are judged to be worsened if they died or were hospitalized because of worsening heart failure (at any time during the 12 months), or demonstrated worsening in NYHA functional class at their 12-month visit. Patients are judged to be improved if they had not worsened and had demonstrated improvement in NYHA functional class at 12 months. Patients who are not worsened or improved are classified as unchanged. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to the first heart failure hospitalization or death | Kaplan-Meier analysis is used to analyze time to death or first heart failure hospitalization | up to 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRT, heart failure, narrow QRS, dyssynchrony
Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

Study Overview
=================
Brief Summary
-----------------
The researchers are trying to develop an allergy skin test to help predict allergic responses to medications commonly given to patients during surgery.

Detailed Description
-----------------
This study will be a prospective study to accurately determine the negative predictive value of skin testing with NMBAs. It is hypothesized that the concentrations that should be used for NMBAs are actually much lower than previously recommended and that the higher incidence of identifiable NMBA induced allergic reactions during anesthesia in the past may be due to irritation of the skin rather than a true allergic reaction (false positives).

Official Title
-----------------
The Negative Predictive Value and Non-irritant Skin Testing Concentrations of Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Diagnostic Test: Skin Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults > or = to 18 y/o undergoing surgery Exclusion Criteria: Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Study team is developing a new diagnostic skin testing procedure for patients who receive NMBAs during surgery in order to determine Negative Predictive Values and Non-Irritant Concentrations. | Diagnostic Test: Skin Testing<br>* Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Irritant Concentrations to common NMBAs | Determine the NIC to common NMBAs | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs | Determine Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs | 1 Year | 
| Max Concentration used when skin testing to NMBAs | Close gap on the variability of the maximal concentration used when skin testing NMBAs. | 1 Year |
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the investigators designed this prospective study. The investigators will enroll 100 children with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs, multivitamins and lipid-lowering agents. Follow-up is every second week for the first 4 weeks, then monthly. After initiation of tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.

Detailed Description
-----------------
Subsequently , monthly measurements were made until stable levels of tacrolimus were achieved. Urine was analyzed for proteinuria at each visit. Serum creatinine, glucose, albumin and alanine aminotransferase were measured and complete blood counts were obtained at each visit during the study.

Official Title
-----------------
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

Conditions
-----------------
Nephrotic Syndrome

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Frequent relapse nephrotic syndrome steroid resistance nephrotic syndrome Exclusion Criteria: secondary nephrotic syndrome estimated glomerular filtration rate < 60 mL/min/1.73m2 with active hepatitis

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- |
| Experimental: Tacrolimus<br>Tacrobell | Drug: Tacrolimus<br>* dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year<br>* Other names: Trcrobell;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission Rate | Complete remission at 12 months Per KDIGO clinical practice guideline for glomerulonephritis (2012): Complete remission (CR), urine protein creatinine ratio below 200mg/g (20mg/mmol) or 1+ of protein on urine dipstick for 3 consecutative days | 12-month treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Remission | Mean duration of remission | 12-month treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Nephrotic syndrome
This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus

Study Overview
=================
Brief Summary
-----------------
This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.

Official Title
-----------------
A 2-year Extension to a 1-year Multicenter, Randomized, Open Label, Parallel Group Study of the Safety, Tolerability and Efficacy of Two Doses (1.5 and 3 mg/Day) of Everolimus With Steroids and Optimized Administration of Cyclosporine in de Novo Renal Transplant Recipients.

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Everolimus (RAD001)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are receiving study medication at Month 12 of the one-year study (CRAD001A2306) and sign a new Informed Consent to extend the treatment and observation period beyond Month 12. Females patients must agree to continue using an approved method of birth control throughout the study and for 3 months following the last dose of study medication. Another Informed Consent was required for the extension amendment. This Informed Consent allowed for separate consent to the amendment study itself, and the retrospective collection of biopsies and/or the yearly protocol biopsies Inclusion and exclusion criteria were not changed, except that patients who completed the core study in follow-up became eligible to participate in the amended extension. Exclusion Criteria: Patients who are receiving study medication and do not sign a new Informed Consent to extend the treatment and observation period beyond Month 12 RAD001A2306)

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Everolimus (RAD001)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To assess the incidence of graft loss, death, biopsy-proven acute rejection, antibody-treated acute rejection, biopsy-proven chronic allograft nephropathy, retransplantation or dialysis up to 36 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify the incidence of biopsy-proven acute rejection episodes, graft loss, death or lost to follow-up at 6, 12, 24 and 36 months in both groups. To assess the incidence of graft loss, death, biopsy-proven acute rejection, |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal transplantation, everolimus, Immunosuppressants
Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Controls

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare functional beta-cell mass using the hyperglycaemic clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney recipients and normal controls as well as with the partially previously reported data in beta-cell recipients.

Official Title
-----------------
Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Non-Diabetic Kidney Recipients, Insulin Independent Recipients of Beta-cell Grafts and Healthy Controls.

Conditions
-----------------
Kidney Transplantation, Pancreas Transplantation

Intervention / Treatment
-----------------
* Other: hyperglycemic clamp test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: kidney pancreas recipients kidney recipients healthy volunteers beta-cell recipients immunosuppression with MMF-Tacrolimus 1-4 years after transplantation Exclusion Criteria: high doses of steroids insulin dependent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>kidney-pancreas recipients | Other: hyperglycemic clamp test<br>* hyperglycemic clamp test<br>|
| Active Comparator: 2<br>kidney recipients | Other: hyperglycemic clamp test<br>* hyperglycemic clamp test<br>|
| Active Comparator: 3<br>healthy controls | Other: hyperglycemic clamp test<br>* hyperglycemic clamp test<br>|
| Active Comparator: 4<br>beta-cell recipients | Other: hyperglycemic clamp test<br>* hyperglycemic clamp test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin secretion during clamp test |  | time 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucose clamp, beta-cell
Phase 1 Food Effect Study for Alicaforsen Tablets

Study Overview
=================
Brief Summary
-----------------
Phase 1 study to compare the effect of food on alicaforsen tablet.

Detailed Description
-----------------
A study on healthy male vounteers in a phase 1 unit. Alicaforsen tablets are gievn in a fed and fasted state

Official Title
-----------------
A Two-Period, Randomised, Crossover Study Designed to Evaluate the In Vivo Performance of a Modified Release Formulation of Alicaforsen in Healthy Male Subjects in the Fed and Fasted State

Conditions
-----------------
IBD

Intervention / Treatment
-----------------
* Drug: Alicaforsen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteer Exclusion Criteria: Drugs of abuse Alcohol abuse

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

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alicaforsen tablets<br>Regimen A - Alicaforsen tablets with food | Drug: Alicaforsen<br>* Alicaforsen tablet<br>|
| Experimental: alicaforsen tablets<br>Regimen B - Alicaforsen tablets without food | Drug: Alicaforsen<br>* Alicaforsen tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Area under the curve recovery of alicaforsen in plasma | 24 hours |
Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods

Study Overview
=================
Brief Summary
-----------------
Self evaluating tools based on smartphone devices are public available on the market for each person. The tools are used to estimate the existing refractive error for each eye of a patient. Hereafter, e.g. ordering glasses via internet could be the next step for this persons. The daily routine within an eye hospital shows, that estimation of the refractive error is a difficult and time consuming procedure. The study compares the results of the measured refractive error using a smartphone based tool with the results of conventional measurement methods.

Official Title
-----------------
Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods

Conditions
-----------------
Refractive Errors, Self-Examination

Intervention / Treatment
-----------------
* Diagnostic Test: Smartphone
* Diagnostic Test: Autorefractor
* Diagnostic Test: Individual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: existing refractive error using glasses or contac lenses Exclusion Criteria: opacities (visus limitating) of cornea, lens or vitreous known ocular pathologies except refractive error epilepsia irregular corneal topography

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Main group<br>Main study group including all individuals that underwent the study procedures | Diagnostic Test: Smartphone<br>* Smartphone based measurement of refractive error and visual acuity testing using these measurements.<br>Diagnostic Test: Autorefractor<br>* Autorefractor based measurement of refractive error and visual acuity testing using these measurements.<br>Diagnostic Test: Individual<br>* Individual, human measurement of refractive error and visual acuity testing using these measurements.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive Error | Comparison of refractive error measurements between methods | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Visual acuity of persons using based on different methods. | 6 month | 
| Personal evaluation of measuring accuracy (Questionnaire) | Would persons be willing to order glasses by using only self-test-results? | 6 month | 
| Time consumption | Comparison of needed time to reach self-test refraction error results and conservative-test results. | 6 month |