linjc16/ctgov huggingface dataset:
Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions.

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Lithium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to lithium, or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Fourteen day washout |
Fish, Polyunsaturated Fatty Acids Intake and Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of type 2 diabetes (T2D) is heavily debated but evidence from large populations in China is scant. We aim to use data from the China Health and Nutrition Survey (CHNS) to assess the long-term association between fish, PUFA intake and T2D risk.

Detailed Description
-----------------
The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of T2D is heavily debated but evidence from large populations in China is still lacking. We aim to utilize data from China Health and Nutrition Survey (CHNS, 1997-2011). We will calculate cumulative means of fish and PUFA intake based on 3-day food records in each wave. Sex-specific Cox regression models will be used to estimate relative risk of T2D. Results from this work will provide epidemiological evidence for improving recommendations on fish and PUFA intake for Chinese in dietary guidelines.

Official Title
-----------------
Fish, Polyunsaturated Fatty Acids Intake and Type 2 Diabetes in CHNS

Conditions
-----------------
Type2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged ≥20 with complete data on diet and follow-up time Exclusion Criteria: Missing information for Type 2 diabetes Type 2 diabetes Cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Type 2 diabetes | Incidence of type 2 diabetes, on basis of self-reported physician diagnosis, fasting plasma glucose ≥ 7.0 mmol/l or HbA1c ≥ 6.5% | From entry into the study (baseline: 1997-2009) until 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fish and polyunsaturated fatty acids intake | Cumulative averages of fish and PUFA intake based on 3-day 24-hr recall in each wave | From entry into the study (baseline: 1997-2009) until 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fish, Polyunsaturated fatty acids, CHNS
A Study That Will Look at the Impact of Immunosuppression on Antibody Production in Kidney Transplant Recipients.

Study Overview
=================
Brief Summary
-----------------
This study is being done to collect blood and bone marrow samples for biologic studies of antibody producing cells. Donor specific antibodies can cause damage to the kidneys after they are transplanted. The study will look at the impact of immunosuppression on antibody production by antibody producing cells.

Detailed Description
-----------------
Bone marrow and blood samples from both non-sensitized kidney transplant recipients and sensitized kidney transplant recipients will be collected. The samples will be used to compare the effect immunosuppression has on the antibody producing cells from both of these kinds of transplant recipients. Bone marrow will be collected from sensitized kidney transplant recipients before desensitization therapy prior to transplantation and at the time of kidney transplant surgery. Non-sensitized patients will have bone marrow collected only at the time of kidney transplant surgery. Blood will be collected at the same time point that the marrow is collected in both kinds of patients.

Official Title
-----------------
The Effects of Thymoglobulin on Antibody Screening Cells.

Conditions
-----------------
Kidney Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Participants must be between the ages of 18 and 70 years of age and undergoing a kidney transplant.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Primary Molars Restoration Using CAD/CAM Crowns.

Study Overview
=================
Brief Summary
-----------------
study aims to compare hybrid ceramic CAD/CAM and prefabricated zirconia crowns restoring primary molars through In-vivo evaluation of the clinical outcomes in terms of; treatment failure, amount of tooth wear in the opposing tooth and gingival health

Official Title
-----------------
CAD/CAM Crowns Versus Prefabricated Zirconia Crowns for Restoration of Primary Molars: A Prospective Study.

Conditions
-----------------
Restoration of Primary Molars With CAD/CAM Crowns

Intervention / Treatment
-----------------
* Other: CAD/CAM crowns


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range of the patients from 4 to 7 years old. Have no history of spontaneous pain or swelling. Patients willing to return for follow-up examinations and evaluation. Medically free patients or with controlled systemic disease ASA I or II. No active periodontal diseases. Patients with posterior pulpotomized tooth/teeth indicated for crown restoration (e.g. 2-3mm of teeth above cement-enamel junction). Exclusion Criteria: Age range of the patients from 4 to 7 years old. Have no history of spontaneous pain or swelling. Patients willing to return for follow-up examinations and evaluation. Medically free patients or with controlled systemic disease ASA I or II. No active periodontal diseases. Patients with posterior pulpotomized tooth/teeth indicated for crown restoration (e.g. 2-3mm of teeth above cement-enamel junction).

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zirconia crowns<br> | Other: CAD/CAM crowns<br>* CAD/CAM crowns<br>|
| Active Comparator: CAD/CAM crowns<br> | Other: CAD/CAM crowns<br>* CAD/CAM crowns<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical success | United States Public Health Service (USPHS) index | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crowns, Zirconium, Computer-Aided Design
Bilevel Versus Servoventilation in Complex Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.

Detailed Description
-----------------
Patients with primary obstructive sleep apnea, who develop complex sleep apnea after CPAP treatment of 4-6 weeks duration were randomized to either receive Bilevel of Servoventilation treatment. Parameters of sleep as well as apnea-hypopnea indices are to be compared.

Official Title
-----------------
Bilevel Versus Servoventilation in Complex Sleep Apnea

Conditions
-----------------
Complex Sleep Apnea, CPAP Induced Central Sleep Apnea

Intervention / Treatment
-----------------
* Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)
* Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment Exclusion Criteria: primary central sleep apnea non-compliance to CPAP therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bilevel<br>Bilevel therapy | Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)<br>* nighttime positive airway therapy for 6 weeks<br>|
| Active Comparator: Servoventilation<br>servoventilation therapy | Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)<br>* nighttime positive airway therapy for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea-hypopnea index | apneas and hypopneas under therapy | at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy | parameters of sleep quality | at 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep apnea, central sleep apnea, bilevel, servoventilation, CPAP
Comparison of Patients Undergoing Radial or Femoral Arterial Access for Percutaneous Catheterization-Nursing Aspects

Study Overview
=================
Brief Summary
-----------------
Transradial access is a recently developed alternative for diagnostic andf interventional cardiac catheterization. We sought to compare the differences between patients that have undergone PTCA transradial and transfemoral access from the nursing point of view: Anxiety levels Pain at access point, pain in general and level of pain during mobility Differences in feelings of embarrassement Differences in satisfaction

Conditions
-----------------
Femoral Artery Access, Radial Artery Access

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled for PTCA without any exclusion criteria Exclusion Criteria: Dementia Psychiatric patients Unconscious Minors Patients who had PTCA in past Patients who were initially scheduled for different access

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>Femoral access | |
| 2<br>Radial access | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Risk Factors for Recurrent Intussusception Successful Reduction in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
To determine risk factors associated with recurrent intussusception among pediatric patients who have undergone successful reduction at a tertiary care hospital.

Detailed Description
-----------------
This is the prospective observational study. In this study, 78 patients,age <16 years with diagnosis of intussusception between June 2019 and April 2020 who had successful reduction with either hydrostatic reduction and/or operative reduction in Teaching Hospital were enrolled in the study. They were followed up to a period of 1 month for recurrence of intussusception. The recurrent cases were thus identified and various variables were compared between recurrent and non-recurrent cases by univariable and multivariable analysis. This prospective observational study was approved by the ethics committees of Institutional review board of Tribhuvan University, Institute of Medicine. A standard structured questionnaire was filled by interviewing the patient (if possible) and family members/relatives after taking informed written consent. The questionnaire documented the patient's age, sex, weight, duration of symptoms, presenting symptoms: abdominal pain, excessive cry, vomiting, lethargy, blood in stool, fever, palpable mass, constipation, diarrhoea ,location of mass, enlarged lymph nodes(LNs), blood counts and methods of reduction. Age of 2 years, weight of 12 kg and duration of symptoms of 48 hours was used to classify patients into two groups

Official Title
-----------------
Risk Factors for Recurrent Intussusception After Successful Reduction in Pediatric Patients in a Tertiary Care Hospital of Nepal: A Prospective-Study

Conditions
-----------------
Intussusception

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We included the patients who were diagnosed with intussusception from the age of 0 year to 16 years who received nonoperative and operative reduction as an initial treatment. Exclusion Criteria: Pediatric patients with spontaneous reduction of hydro-reduction and who required resection and anastomosis as a part of operative procedure were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 16 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 |
| --- | --- | --- |
| Risk factor for recurrent intussusception | Significant risk factor for recurrent intussusception after successful reduction | June 2019-April 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydrostatic reduction, Recurrence, Pediatrics
Quality of Life and Cardiometabolic Risk Factors in Patients After Debanding

Study Overview
=================
Brief Summary
-----------------
Follow up of debanding patients

Detailed Description
-----------------
Follow up of debanding patients regarding cardiometabolic risk factors

Official Title
-----------------
Quality of Life and Cardiometabolic Risk Factors in Patients After Debanding

Conditions
-----------------
Bariatric Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Previous debanding after lap. gastric bypass Exclusion criteria: Further bariatric procedures

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 |
| --- | --- | --- |
| Quality of Life |  | 2 to 5 years after debanding |
Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data. The examinations performed are those usually done in the follow-up of epiretinal membrane surgery, apart from microperimetry which is an examination of the central visual field. Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months and 6 months after the surgery. The consultation includes an assessment of visual acuity, a fundus examination an SD-OCT of the retina. The present protocol will require no additional visits. The microperimetry will be done in addition to the usual follow-up examinations after ERM surgery.

Official Title
-----------------
Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

Conditions
-----------------
Epiretinal Membrane Surgery

Intervention / Treatment
-----------------
* Other: Microperimetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons who have provided consent, Patients about to undergo idiopathic epiretinal membrane surgery, Patients undergoing first-line macular surgery Exclusion Criteria: Persons not covered by national health insurance Preexisting disease of macula/epiretinal membrane (ARMD, chorioretinal scarring) Preoperative amblyopic eye Insufficiently transparent media making it impossible to do the examinations

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 |
| --- | --- |
| Other: Patients about to undergo epiretinal membrane surgery<br> | Other: Microperimetry<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale |  | Up to 6 months after the operation. | 
| Anomalies observed in the outer layers of retina |  | Up to 6 months after the operation | 
| Evaluation of retinal sensitivity by microperimetry |  | Up to 6 months after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal surface autofluorescence |  | Up to 6 months after the operation |
Brain Changes in Stimulant Dependent Subjects - 8

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the neurophysiologic indicators of cocaine or methamphetamine use and withdrawal, to examine the relationship between subjects' reports of depression, craving, and stimulant use, and neurophysiologic measures, and to identify neurophysiologic measures which can be used to identify new treatments for stimulant dependence.

Detailed Description
-----------------
By Incorporating QEEG into clinical trails, the plan is to develop physiologic markers of treatment efficacy, and to aid in the identification of effective treatments.

Official Title
-----------------
Brain Changes in Stimulant Dependent Subjects

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: counseling|nan|

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
-----------------
stimulant dependence