linjc16/ctgov huggingface dataset:
Early Diabetes Intervention Program

Study Overview
=================
Brief Summary
-----------------
This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.

Detailed Description
-----------------
A double blind, randomized, placebo-controlled clinical trial of acarbose in subjects with type 2 diabetes (an FDA-approved indication). Subjects were identified who had diabetes by glucose tolerance test criteria but non-diabetic fasting glucose concentrations. Treatment interventions were assessed for their ability to delay worsening of fasting glucose control.

Official Title
-----------------
Early Diabetes Intervention Program

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

Intervention / Treatment
-----------------
* Drug: Acarbose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting plasma glucose <140 mg/dL 75 g OGTT 2hr glucose >120 mg/dL BMI > 25 OR history of gestational diabetes mellitus OR family history of type 2 diabetes Age at least 25 years Exclusion Criteria: Cancer within 5 years Chronic infectious disease (HIV, Hepatitis) CVD event within 6 months Uncontrolled hypertension or requiring beta blockers or thiazide diuretics for control elevated AST or ALT Serum creatinine >1.4 mg/dL (men) or >1.3 mg/dL (women) TG >600 mg/dL Known glucosidase intolerance Inability to comply with protocol requirements.

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acarbose<br>acarbose 100 mg once daily | Drug: Acarbose<br>* acarbose 100 mg PO once daily<br>* Other names: Precose;|
| Placebo Comparator: Placebo<br>Matched placebo was administered for acarbose 100 mg once daily | Drug: Placebo<br>* acarbose placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of fasting glucose >140 mg/dL | Fasting plasma glucose was measured quarterly for up to 5 years. Two consecutive measures above 140 mg/dL defined progression. | From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes acarbose alphaglucosidase prevention
Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients

Study Overview
=================
Brief Summary
-----------------
Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)

Detailed Description
-----------------
Recruitment is indicated in patients with chronic pain management with or without controlled substance therapy. This is a diagnostic accuracy study performed in an interventional pain management referral center in the United States.

Official Title
-----------------
Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Urine Drug Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: • Chronic pain management with or without controlled substance therapy. Exclusion criteria: None

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

| Intervention/Treatment |
| --- |
|Other: Urine Drug Testing|LC/MS/MS Laboratory Evaluation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Controlled substances, Opioids, Benzodiazepines, Illicit drugs, Immunoassay drug testing, Point of care (POC) testing, Liquid Chromatography Tandem Mass Spectometry
Behavioral Treatment of Weight Gain in CF

Study Overview
=================
Brief Summary
-----------------
The current study examines the efficacy of two treatments to help children with cystic fibrosis (CF) meet their dietary calorie requirements of 120% to 150% of the recommended daily allowance of energy and the effect of these treatments on weight gain and maintenance. One treatment provides children with CF and their parents nutrition education about the best foods for meeting their dietary needs. The second treatment gives children with CF and their families similar nutritional information plus behavioral parenting methods for motivating children to eat the recommended foods. Children with CF and their families are seen weekly for 7 treatment sessions across 9 weeks for the active phase of treatment. Families are then followed for 2 years after treatment in order to better understand how long the treatments are effective and to determine the health benefits of better nutrition status and weight gain.

Official Title
-----------------
Behavioral Treatment of Weight Gain in CF

Conditions
-----------------
Cystic Fibrosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight percentile for age or height below 40th for age and sex Pancreatic insufficiency Exclusion Criteria: Developmental delays Pseudomonas cepacia Supplemental enteral or parenteral nutrition

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavioral Treatment|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
-----------------
Nutrition, Behavior Therapy, Cystic Fibrosis
Safety and Efficacy Study of the NeuGuide Device

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the safety, efficacy, peri and postoperative complications, and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of pelvic organ prolapse (POP). Prolapse staging for all subjects in this study will be performed according to the POP-Q staging system. Ultrasound examinations for all subjects in this study are subjected to the surgeon need and will be performed if required by qualified personnel

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Device: NeuGuide device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ages 18-80 years old POP-Q stage III prolapse or higher Scheduled to undergo a POP Surgery and has agreed to undergo it using the NeuGuideTM device Patient is willing to return for follow-up evaluation and fill questionnaires as indicated on study protocol No exclusion criteria fulfilled Exclusion Criteria: Diagnosis of reproductive tract anomalies Prior pelvic radiation therapy or any malignancy Inability to complete written questionnaires. Women with significant Pelvic Inflammatory Disease (PID) history Women with known allergy to Nickel or Nitinol

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NeuGuide device|The NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage of pelvic floor prolapse as defined by POP-Q score |  | 6 months | 
| Complications (SAE, AE) |  | Up to 6 months |
Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy

Study Overview
=================
Brief Summary
-----------------
To compare the prognosis and adverse reactions of unresectable hepatocellular carcinoma receiving stereotactic radiotherapy combined with hepatic arterial chemoembolization and conversion hepatectomy

Official Title
-----------------
Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy

Conditions
-----------------
Hepatocellular Carcinoma Non-resectable, Conversion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unresectable HCC patients were diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology Patients who received SBRT plus TACE have tumor regression, and surgical experts assess that R0 resection could be achieved CP-A or B classification; Eastern Cooperative Oncology Group (ECOG) score 0-1; Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L; ICG R15≤10%; Normal effective liver volume >30%; patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative. Exclusion Criteria: -the patients receive other treatments (such as targeted treatment, immune checkpoint inhibitors,etc) after CK-SBRT plus TACE.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CK-SBRT with TACE group<br> | |
| Conversion hepatectomy after CK-SBRT plus TACE<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time |  | From date of randomization until the date of death from any cause, assessed up to 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival time |  | From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 24 months. | 
| Radiation-induced liver injury rates |  | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. | 
| Adverse reaction |  | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CyberKnife, unresectable hepatocelluar carcinoma, TACE, hepatectomy, prognosis
Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood

Study Overview
=================
Brief Summary
-----------------
Sleep deprivation was found to affect many organs including the immune system and predisposing for various health consequences including diabetes hypertension infections and increase in neoplastic diseases. Subjects will be evaluated for immune parameters in peripheral blood test following a regular nigh sleep and compared with a test performed following a night shift in which they slept less than 3 hours. Each participant will serve as its own control.

Detailed Description
-----------------
Overall Study Design and Plan Subjects will be bled on the day of the experiment between 8and 9 AM. Blood tubes will be tested for T cell markers, serum cytokines levels, and other immune parameters by western blots. The first tube will be tested on the day of experiment. The second tube will kept in the lab and will be tested 24 hours later. The third tube will be kept in the pocket of the subject and be tested 24 hours later. The fourth tube will be kept in the pocket of another subject and will be tested 24 hours later. The subject will be tested again following 24 hours. Each subject will be tested twice following a regular 6-8 hours of sleep, and following an on call duty in which he slept less than 3 hours.

Official Title
-----------------
Effect of Sleep Deprivation on Expression of T Cell Markers in Peripheral Blood of Medical Residents

Conditions
-----------------
Sleep Deprivation

Intervention / Treatment
-----------------
* Other: Blood withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female ages 18-40 signed confirmed consent no evidence of chronic disease or chronic medications Exclusion Criteria: Any type of acute infection or other acute illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| surface markers on T cells as assessed by FACS<br> | Other: Blood withdrawal<br>* Blood withdrawal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surface markers of T cell as assessed by FACS |  | 6 months | 
| serum cytokine levels |  | 6 months | 
| immune parameters to be assessed by western including STAT proteins |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T cell markers
Comparison of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil and a Nitinol Guide Wire

Study Overview
=================
Brief Summary
-----------------
In ERCP practice, most often a combined use of guidewires is necessary to attain a therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a stricture to a nitinol wire for improved stability with the use of therapeutic devices. A new guide-wire (G240) combines these characteristics with a stable shaft and a hydrophilic tip. The investigators test the hypothesis that the use of this new guidewire would decrease number of guidewires used within one ERCP session.

Detailed Description
-----------------
This is a randomized, monocentric study.

Official Title
-----------------
Comparison of the Use of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil Guide Wire With a Nitinol Wire in Patients With Stenosis of the Bile Ducts in ERCP

Conditions
-----------------
Other Specified Diseases of Biliary Tract

Intervention / Treatment
-----------------
* Device: Guidewire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data) Exclusion Criteria: Operatively alternated anatomy of the patient. Intervention of the pancreatic duct.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Classic guidewires<br>Conventional guidewires used in combination as preferred by the investigating ERCP specialist | Device: Guidewire<br>* Use of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others)<br>* Other names: G-240 2527S/A, G-240 2545S/A, G-240 3527S/A, G-240 545S/A;|
| Active Comparator: New guidewire (G240)<br>Primary use of the new guidewire (G240) | Device: Guidewire<br>* Use of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others)<br>* Other names: G-240 2527S/A, G-240 2545S/A, G-240 3527S/A, G-240 545S/A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of guidewires per ERCP session |  | Within the same ERCP session (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment aim | Comparison of number of patients in whom the treatment aim could be achieved in both study groups | day 1 | 
| Time of ERCP session | Comparison of time needed for the ERCP session in both study groups. | day 1 |
Mental Health Care Provision for Adults With Intellectual Disability and a Mental Disorder

Study Overview
=================
Brief Summary
-----------------
Quality of mental health services provision for adults with intellectual disability and comorbid mental disorder is considered inadequate and therefore in need of further improvement. However, empirical findings on this topic are rather scarce. The MEMENTA-study therefore aims to compare mild and moderate intellectual disabled adults with a comorbid mental disorder to mild and moderate intellectual disabled adults who do not have a comorbid mental disorder with respect to clinical parameters. The MEMENTA-study is an observational, epidemiological, cross-sectional study. A representative sample of the target population is realised by the assessment of approximately n=600 intellectual disabled adults working at specialized facilities (sheltered workshops). A cluster sampling with probability proportional to institution and size (n of overall employed persons) will be followed by a simple random sampling of persons of these clustered facilities. A number of parameters such as severity of mental health impairment, needs for care, quality of life (QoL), caregiver burden, health services utilization, and costs for care will be assessed by using a set of well-established standardised instruments. Quality of mental health care will be assessed and examined by open questions to intellectual disabled adults with a comorbid mental disorder as well as informal caregivers and staff of caring institutions.

Official Title
-----------------
Mental Health Care Provision for Adults With Mental Retardation and a Psychiatric Diagnosis

Conditions
-----------------
Mental Disorder, Intellectual Disability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild or moderate intellectual disability adults aged between 18-65 years

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intellectual disabled adults without a mental disorder<br> | |
| Intellectual disabled adults with a mental disorder<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health status |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intellectual disability, mental disorder, dual diagnosis, provision, needs assessment, quality of life
Efficacy of Radial Keratotomy in the Optical Rehabilitation of Mild to Moderate Keratoconus Cases

Study Overview
=================
Brief Summary
-----------------
Keratoconus is a progressive ectatic disorder that steepens the cornea resulting in a conical shape. Radial Keratotomy can provide an optical rehabilitation by its flattening effect. It can also halt the progression of disease owing to fibrotic activation in perpendicular corneal incisions.

Official Title
-----------------
Efficacy of Radial Keratotomy in the Optical Rehabilitation of Mild to Moderate Keratoconus Cases

Conditions
-----------------
Radial Keratotomy in Keratoconus Cases

Intervention / Treatment
-----------------
* Procedure: radial keratotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: keratoconus with a central corneal thickness (CCT) over 400µm, poor corrected visual acuity (≤0.4 at Snellen visual acuity charts), contact lens intolerance Exclusion Criteria: apical scarring, ocular or systemic problem other than keratoconus

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 |
| --- | --- |
| mild to moderate keratoconus cases<br>keratoconus with a central corneal thickness (CCT) over 400µm, poor corrected visual acuity (≤0.4 at Snellen visual acuity charts), contact lens intolerance, no apical scarring, no ocular or systemic problem other than keratoconus | Procedure: radial keratotomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| outcome measures: uncorrected and best spectacle corrected visual acuity, keratometer readings | Preoperative and postoperative uncorrected visual acuity, best spectacle corrected visual acuity, and keratometer readings will be reviewed retrospectively. As reviewed follow up time range is 12 to 52 months, time frame is assessed as  12 to 52 months | after surgery - 12 to 52 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radial keratotomy; keratoconus; optical rehabilitation