linjc16/ctgov huggingface dataset:
Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland

Study Overview
=================
Brief Summary
-----------------
200 participants at Eye Hospital of Wenzhou Medical University during September, 2020 to November, 2020 will be enrolled in this study. The meibomian gland related therapy are pulsed light therapy and meibomian gland hot compress massage.

Official Title
-----------------
Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland

Conditions
-----------------
Xerophthalmia

Intervention / Treatment
-----------------
* Device: Intense pulsed light therapy
* Other: Hot compress massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated patients with xerophthalmia Exclusion Criteria: No history of ocular surgery and trauma Any eye diseases except xerophthalmia No treated for xerophthalmia before Successful completion of follow-ups

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intense pulsed light therapy group<br> | Device: Intense pulsed light therapy<br>* Patients with xerophthalmia were treated with intense pulsed light of meibomian gland.<br>|
| Experimental: Hot compress massage group<br> | Other: Hot compress massage<br>* Patients with xerophthalmia were treated with hot compress massage of meibomian gland.<br>|
| Experimental: Intense pulsed light therapy and hot compress massage group<br> | Device: Intense pulsed light therapy<br>* Patients with xerophthalmia were treated with intense pulsed light of meibomian gland.<br>Other: Hot compress massage<br>* Patients with xerophthalmia were treated with hot compress massage of meibomian gland.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of meibomian glands after the treatment. | Length in millimeters. | up to 2 months | 
| The area of meibomian glands after the treatment. | Area in millimeters^2. | up to 2 months | 
| The percentage of meibomian glands after the treatment. | Percentage of meibomian glands in %(area of meibomian glands (mm^2) and area of palpebral conjunctiva (mm^2) will be combined to report percentage of meibomian glands in %) are used to assess this outcome measure. | up to 2 months |
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg ER Tablets under fasting conditions.

Official Title
-----------------
Comparative Bioavailability Study of Eplerenone 50 mg Tablets (Sandoz Inc., USA) and Inspra 50 mg Tablets (GD Searle LLC, USA) in Healthy Male and/or Female Volunteers Under Fasting Conditions.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA
* Drug: Inspra 50 mg Tablets GD Searle LLC, USA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Eplerenone 50mg Tablets | Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA<br> <br> |
| Active Comparator: 2<br>INSPRA 50mg Tablets | Drug: Inspra 50 mg Tablets GD Searle LLC, USA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA guidelines |  | 10 days |
A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt

Study Overview
=================
Brief Summary
-----------------
The primary goal of this investigation is to describe perioperative thrombin generation in neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the coagulation changes that precipitate postoperative shunt occlusion.

Detailed Description
-----------------
To accomplish our goal, the investigators will measure preoperative levels of one major procoagulant (prothrombin) and one major anticoagulant (Antithrombin). The investigators will also measure preoperative and postoperative thrombelastograms (TEG) and preoperative and postoperative thrombin generation curves (TGC).

Official Title
-----------------
A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt

Conditions
-----------------
Aortic Coarctation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full-term neonates (37-42 weeks gestational age) Apgar score of 7 or more at 5 minutes after delivery Surgical placement of BT shunt or repair of an aortic coarctation Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent Exclusion Criteria: Preterm neonates (less than 37 weeks gestation) Apgar score of less than 7 at 5 minutes after birth Emergent procedure Surgical procedure other than placement of BT shunt or repair of aortic coarctation Neonates with a known coagulation defect or coagulopathy Mother with a known coagulation defect or coagulopathy Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent

Ages Eligible for Study
-----------------
Maximum Age: 30 Days

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 |
| --- | --- | --- |
| Thrombin generation - peak amount | The thrombin generating capacity of plasma is measured using a fluorogenic substrate. Coagulation is initiated by contact activation and thrombin generation is monitored by a microplate fluorometer set that displays the progression of the fluorescence reaction. The peak amount of thrombin generated is expressed by absorbancy (nM). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombin Generation Curve validation in neonates | The peak amount of thrombin generated as determined by the thrombin generation curve will be compared to the peak amount of thrombin generated as determined by the thromboelastogram. Both measure thrombin generation by absorbancy (nM). | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neonatal surgery, Blalock-Taussig shunt
CHOICES: Understanding Clinical Trials as a Treatment Option

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine whether having a telephone discussion with a nurse educator about making treatment decisions and participating in a clinical trial increases trial participation. The investigators hypothesize that the participants in the intervention group will be more likely to take part in a clinical trial than those in the usual care group.

Official Title
-----------------
Increasing Participation in Cancer Clinical Trials

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Tailored Telephone Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are potentially eligible for one of the designated clinical trials on the basis of automated data from pathology reports and other databases Exclusion Criteria: Patients who meet specific exclusion criteria for designated clinical trials

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Telephone Counseling<br> | Behavioral: Tailored Telephone Counseling<br>* The intervention is comprised of a letter introducing patients to the idea of participating in a clinical trial as a possible treatment option, followed by a telephone call by a nurse educator who describes the clinical trials process and answers any questions patients may have. The nurse educators will use a tailored counseling protocol that will enable them to conduct an assessment of patients' understanding about and interest in clinical trials and tailor messages according to patient health literacy and language. The protocol will consist of both proactive and reactive counseling. The nurse educator will have a general list of topics to cover but will tailor the discussion and information provided to individual patients' questions and desire for particular types of information.<br>|
| No Intervention: Standard Trial Recruitment Procedures<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials |  | Up to three months after the index oncology visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who leave the identification and recruitment process at each step. |  | Up to three months after the index oncology visit |
The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health

Study Overview
=================
Brief Summary
-----------------
The aim of this analysis was to compare the effects of oscillating-rotating (O-R), side-to-side (sonic), and manual toothbrushes on plaque and gingival health after multiple uses.

Official Title
-----------------
The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health: A Meta-Analysis

Conditions
-----------------
Gingivitis, Plaque

Intervention / Treatment
-----------------
* Device: Oscillating-rotating electric toothbrush
* Device: Side-to-side electric toothbrush
* Device: Manual toothbrush


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects were excluded from this study for the following reasons; pregnancy, rampant caries, severe periodontitis, at discretionary of the Principal Investigator.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oscillating-rotating electric toothbrush<br>Twice daily brushing | Device: Oscillating-rotating electric toothbrush<br>* Oscillating-rotating electric toothbrush used twice daily<br>|
| Side-to-side electric toothbrush<br>Twice daily brushing | Device: Side-to-side electric toothbrush<br>* Side-to-side electric toothbrush used twice daily<br>|
| Manual toothbrush<br>Twice daily brushing | Device: Manual toothbrush<br>* Manual toothbrush used twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Bleeding Sites | Change from baseline as measured on number of bleeding sites ( via gingival bleeding index, Loe Silness index, Papillary bleeding index or Mazza gingival index). | Up to 12 weeks | 
| Dental Plaque Scores | Change from baseline as measured by mean plaque score reduction from baseline (via Turesky's Modification of Quigley-Hein index, or Rustogi Modified Navy Plaque Index). | Up to 12 weeks |
Long-term Safety and Tolerability of AFFITOPE AD02

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002

Official Title
-----------------
Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD02 Applied During AFFiRiS 002

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent signed and dated by patient and caregiver Patients having participated in AFF002 and having received at least 1 vaccination with AFFITOPE AD02 Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits Exclusion Criteria: Patients having received no vaccination with AFFITOPE AD02 History of questionable compliance to visit schedule, patients not expected to finish the clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 2<br>AFFITOPE AD02 with adjuvant | |
| 1<br>AFFITOPE AD02 without adjuvant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term tolerability |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and immunological efficacy (evaluated in an explorative manner only) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer, Morbus Alzheimer, Vaccine, Alzheimer Vaccine, A-beta immunotherapy
Long-term Effects of Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of LABS-2 is to use standardized techniques and measures to assess the longer-term safety and efficacy of bariatric surgery by: comparing post-surgical outcomes to pre-operative status examining risks and benefits of surgery. LABS-2 will determine the associations between clinical/demographic patient characteristics, components of the surgical procedure, and peri-operative and post-operative care with post-operative risks and changes in patient status. Funds are not available to pay for the surgery for patients, only to address research questions.

Detailed Description
-----------------
The primary goal of LABS-2 is to evaluate the efficacy and safety of bariatric surgery over a longer term than LABS-1, i.e., more than 30 days. Using a sample of the LABS-1 cohort, approximately 2,400 patients, will be recruited over 3 years. LABS-2 will include clinical assessments and detailed interviews and questionnaires pre-operatively and at several post-operative time points (30 days, 6 months, 12 months following surgery, and annually thereafter) to assess risks of surgery, and changes in clinical, metabolic, and psychosocial characteristics in patients, and health care utilization following bariatric surgery. Detailed data about the surgical procedure and peri- and post-operative care will also be collected to determine if components of the surgical procedure, and peri-operative and post-operative care as well as clinical/demographic patient characteristics are associated with post-operative risks and changes in patient status. Patients enrolled in LABS-2 will provide blood specimens pre-operatively and post-operatively to address LABS-2 hypotheses and additional samples will be stored at the NIDDK tissue repository for serologic, pathologic and genomic testing of other hypotheses.

Official Title
-----------------
Longitudinal Assessment of Bariatric Surgery (LABS-2)

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon Previous enrollment in LABS-1 Selected by algorithm to be included in LABS-2 Exclusion Criteria: Informed consent not obtained Prior bariatric surgery Unlikely to comply with follow-up protocol Unable to communicate with local study staff

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)

Study Overview
=================
Brief Summary
-----------------
The metabolic syndrome is a highly prevalent disorder, which causes atherosclerotic cardiovascular disease and is closely associated with insulin resistance. The alteration of the secretion of adipocytokines from accumulated visceral adipose tissue in the obese induces insulin resistance. The purpose of this study is to identify gene polymorphisms that confer susceptibility to the metabolic syndrome and to make up a new health guidance program based on genetic risk assessment. About 25% of male employees over 45 years old in a certain company are diagnosed with the metabolic syndrome in medical examination. We, the researchers at Nagoya University, will analyze gene polymorphism and various biomarkers of over 3500 company employees.

Official Title
-----------------
Assessment of Genetic Risk of Metabolic Syndrome in Company Employee and Making New Health Guidance Program (NGK Study)

Conditions
-----------------
Healthy, Metabolic Syndrome X, Hyperlipidemia, Hypertension, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects who work for a certain company

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin resistance, adipocytokine, Metabolic syndrome, Diabetes
Construction and Application of Early Lung Rehabilitation Training Programs

Study Overview
=================
Brief Summary
-----------------
This study is intended to construct early lung rehabilitation training programs for adult patients after double lung transplantation, including safety assessment, exercise training, respiratory function training, psychological support and health education, with a view to helping double lung transplant patients achieve lung rehabilitation at an early date, improve patients' motor endurance and respiratory function, and improve the quality of near- and long-term survival.

Detailed Description
-----------------
The first stage constructs the lung rehabilitation program, and the second stage implements the non-contemporaneous study control trial.

Official Title
-----------------
Construction and Application of Early Lung Rehabilitation Training Programs for Adult Patients After Double Lung Transplantation

Conditions
-----------------
Pulmonary Transplantation

Intervention / Treatment
-----------------
* Behavioral: Early Lung Rehabilitation Training
* Behavioral: Routine treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years consent to early lung rehabilitation informed consent to this study. Exclusion Criteria: Unstable condition, not allowed to receive pulmonary rehabilitation treatment A person with a mental disorder who cannot cooperate.

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: routine treatment<br>Review the collection of patient-related clinical data, collation of clinical data and outcome indicators | Behavioral: Routine treatment<br>* Provide rehabilitation training as usual, without standard program<br>|
| Experimental: Experimental group<br>The intervention was implemented in accordance with the Early Lung Rehabilitation Training Programme for Adult Double Lung Transplant Patients | Behavioral: Early Lung Rehabilitation Training<br>* It is implemented in accordance with the Early Lung Rehabilitation Training Program for Adult Double Lung Transplant Patients. Establish multidisciplinary collaboration teams, including competent doctors, nurses, rehabilitation physicians, and psychologists.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation time | The time for mechanical ventilation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary transplantation, pulmonory rehabilitation