linjc16/ctgov huggingface dataset:
To Study the Impact of CPAP on Gait Parameters in OSA Patients

Study Overview
=================
Brief Summary
-----------------
To study the impact of CPAP therapy on gait in patients with obstructive sleep apnea syndrome.

Detailed Description
-----------------
To study the impact of CPAP therapy on gait velocity and temproral gait in patients with obstructive sleep apnea syndrome using the SMTEC system. Patients will be assessed before and 8 weeks after CPAP therapy.

Official Title
-----------------
Impact of the CPAP on Gait in OSA Patients

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: CPAP therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OSA patients newly diagnosed Exclusion Criteria: acute medical illness in the past months neurological and psychiatric diseases orthopaedic, rheumatologic or any sensory conditions affecting normal walking
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| On CPAP therapy<br>OSA patients assessed before and after 8 weeks of CPAP therapy | Device: CPAP therapy<br>* 8 weeks of CPAP therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait parameters: gait velocity [m/s] |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gait, Dual task
Sepsis Institutional Registry in Hospital Italiano de Buenos Aires

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create an institutional registry of sepsis through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

Detailed Description
-----------------
The main goal is to describe the occurrence of sepsis and the characteristics of clinical presentation, evolution and predisposing factors within the population of the Hospital Italiano de Buenos Aires.

Official Title
-----------------
Sepsis Institutional Registry in Hospital Italiano de Buenos Aires

Conditions
-----------------
Death, Severe Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 17 years Two or more sirs criteria Active infection Exclusion Criteria: Refusal to register or to the informed consent process Ambulatory patients

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 |
| --- | --- | --- |
| clinical features, mortality |  | Clinical characteristics are evaluated during the acute event and in-hospital mortality and annual monitoring |
Changes in Cardiac Output During Delayed Umbilical Cord Clamping

Study Overview
=================
Brief Summary
-----------------
Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the newborn to receive his/her own blood from the placenta (placental transfusion) which helps their transition in the first hours of life. The purpose of the study is to learn about the amount of blood flow to and from the baby's heart during normal newborn transition

Official Title
-----------------
Changes in Cardiac Output During Delayed Umbilical Cord Clamping

Conditions
-----------------
Cardiac Output, Low

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy full term infants Delivered by vaginal birth Estimated gestational age of 37+0to 41+6 weeks corrected gestational age Exclusion Criteria: Multiples Known fetal anomalies (including cardiac defects). Instrumentation during delivery (forceps or vacuum) Non-reducible nuchal cord during delivery. Any maternal or neonatal indication requiring immediate cord clamping.

Ages Eligible for Study
-----------------
Maximum Age: 1 Minute

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 |
| --- | --- | --- |
| Cardiac Output |  | 5 minutes of Life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Volume |  | 5 Minutes of Life | 
| Bilirubin level |  | until discharge | 
| Hemoglobin level |  | until discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delayed Cord Clamping
Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

Study Overview
=================
Brief Summary
-----------------
More than ninety percent of adults in Taiwan are suspected to carry periodontal disease, which causes bad breath, swollen and bleeding gums, plaque and even tooth loss. Half of the patients, however, are ignorance these clinical syndromes because of no obvious pain. In this study, the investigators selected six periodontal disease-associated bacteria strains, including Porphyromonas gingivalis (Pg), Fusobacterium nucleatum (Fn), Actinobacillus actinomycetemcomitans (Aa), Tannerella forsythia (Tf), Treponema denticola (Td) and Prevotella intermedia (Pi) as diagnostic markers. Using real-time PCR and MALDI Biotyper, the investigators will establish the database of oral microorganisms in Taiwanese people, providing periodontal disease clinical markers of high-risk groups and the basis for personal medicine of therapy in the future.

Official Title
-----------------
Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

Conditions
-----------------
Periodontal Diseases, Peri-Implantitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≧25 3≦periodontal screening and recording≦4 16 natural teeths and 6 front teeth at lesat GI≧1.25 PI≧2 Exclusion Criteria: People who have oral lesion, dental braces, denture, mouthwash allergy, or serious systemic disease People who have ever eaten antibiotics and Anti-inflammatory drugs over the last 6 months People who have ever eaten Immunosuppressive drugs, antiepileptic drugs, antihypertensive drugs, or anticoagulant Pregnant women or the woman who eat birth control pills

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| Periodontal patient<br> | |
| Healthy person<br> | |
| Peri-implantitis patient<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of PSR score, GI, PI, and oral bacteria strains between periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash | To compare the value of PSR score (0-4 point), GI (0-4 point), and PI (0-5 point) with periodontal disease patients older than 60 years of age, periodontal disease patients younger than 60 years of age and healthy people after receiving periodontal therapy and using mouthwash. Oral bacteria strains are also compared with these groups. | 9 month |
Effect of Evogliptin on Bone Metabolism in Human

Study Overview
=================
Brief Summary
-----------------
This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.

Official Title
-----------------
Pharmacodynamics Study to Investigate the Effect of Evogliptin on Bone Metabolism in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Evogliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal healthy women (at least 5 years) BMI 18 30 kg/m2 Exclusion Criteria: Presence or history of hypersensitivity or allergic reactions to any drug Clinically relevant abnormal medical history or present disease Presence or history of drug abuse Participation in other clinical trial within 2 months before dose. Bood donation during 2 months or apheresis during 1 month before the study. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before dose. Use of any drug which can affect bone metabolism such as sex hormones or their receptor related medicine, calcitonin or parathyroid hormone related medicine, systemic corticosteroid, bisphosphate, or etc. Smoking of more than 10 cigarettes/days within 3 months before first dose. Use of alcohol over 21 units/weeks Subject judged not eligible for study participation by investigator.
Sexes Eligible for Study
-----------------
Female

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: Evogliptin 10 mg<br>Single oral administration of 2 tablets of evogliptin 5 mg with water 250 mL | Drug: Evogliptin<br>* 10 mg<br>* Other names: Suganon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline |  | Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2 |
A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.

Official Title
-----------------
A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women between 45 and 79 years of age Must be osteopenic/osteoporotic Exclusion Criteria: Any women of child-bearing potential Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 79 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zoledronic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect on markers of bone turnover by comparing the percent change from baseline in serum C-telopeptide (CTx) and urine NTx in post-menopausal women |  |  | 
| To assess the frequency, intensity, and bothersomeness of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist |  |  | 
| To assess patient preferences for annual i.v. therapy compared to weekly oral therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, osteopenia, post-menopausal, zoledronic acid
Elmex Gel Efficacy in Preventing White Spot Lesions

Study Overview
=================
Brief Summary
-----------------
the objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride concentration of 1.25% compared with placebo by determining prevention of white spot lesions in patients wearing fixed orthodontic appliances.

Detailed Description
-----------------
314 healthy subjects undergoing orthodontic treatment will be examined. follow up will take place from bonding the appliance till debonding, at least 12 months and no more than 30 months. tooth brushing with product (test product or control) once per week during the entire study. 4 times a year additional tray application of test product or control. subjects wiil clean their teeth with the toothpaste they usually use during the entire study. toothbrush and a sandglass will be provided every 6 weeks

Official Title
-----------------
Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Drug: elmex gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treatment plan: minimum of 10 teeth to be bonded labially at least 10 years old written declaration of informed consent Exclusion Criteria: known allergy to components of test products handicapped patients who have difficulties brushing their teeth pathological desquamation changes known pregnancy, breast feeding eating disorders disease that effect dental hard tissue participation in another clinical trial either currently or within the lase 30 days

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: elmex gel|elmex gel once a week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time and frequency of visually detected WSL (white spot lesions) |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mineral loss according to QLF readings |  | 3 month | 
| Frequency and chronoloy of WSL |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
qlf, amine fluoride, white spot lesions
A Study to Compare Insulin Pump With Conventional Treatment in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type 2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents. Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does not only have efficacy in glucose control but also restore beta cell failure. The investigators plan to compare the efficacy/safety and beta cell function between insulin pump treatment and the intensification of conventional treatment in patients with uncontrolled type 2 diabetes.

Official Title
-----------------
A Study to Compare the Efficacy and Safety of Insulin Pump Treatment in Patients With Uncontrolled Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Device: insulin pump
* Drug: conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes age: 18   85 yrs HbA1c: > 7.5% no change of anti-diabetic medication within 3 months Exclusion Criteria: systemic corticosteroid administered within previous 6 months pregnancy severe liver or renal disease, heart failure History of cancer within 5 years Thyroid disease Anti-obesity drugs or slimming products within previous 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin pump<br>insulin pump | Device: insulin pump<br>* stop any antihyperglycemic medication and convert to insulin pump<br>|
| Active Comparator: conventional treatment<br>intensification of conventional treatment | Drug: conventional treatment<br>* intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of HbA1c |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of body weight |  | 24 weeks | 
| frequency of hypoglycemia | severe hypoglycemia : glucose <40 mg/dl mild hypoglycemia : glucose 40 - 70 mg/dl | 24 weeks | 
| change of beta cell function | insulin secretion-sensitivity index-2 = insulinogenic index x Matsuda index | 24 weeks | 
| Percent of patients who reach target goal of HbA1c (<7.0%) |  | 24 weeks |
Air Tamponade in Macular Holes < 400 μm

Study Overview
=================
Brief Summary
-----------------
Macular hole is a hole formation which takes place in the center of the retina. Such a hole needs surgical steps in order to close. Closure of the macular hole will lead to a substantially improvement of vision in most cases. Following macular hole surgery a tamponade of intraocular gas is normally injected in order to keep the macula dry for the postoperative period. Postoperative face down position for a week was earlier standard. Several authors report of good closure rates with both air tamponade or lack of face down positioning. In this study standard pars plana vitrectomy with peeling of the internal limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down positioning will not be used. Only macular holes less than 400 μm will be included.

Official Title
-----------------
Air Tamponade in Macular Holes < 400 μm

Conditions
-----------------
Macular Holes

Intervention / Treatment
-----------------
* Procedure: Postoperative air tamponade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary macular hole less than 400 μm in diameter Duration of symptoms less than 36 months Informed consent Exclusion Criteria: Previous vitreomacular surgery Myopia more than 6 diopters Ocular trauma Disease affecting visual function
Sexes Eligible for Study
-----------------
All

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postoperative air tamponade<br>Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention. | Procedure: Postoperative air tamponade<br>* Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure rate of macular hole |  | 1 month after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular hole, Vitreoretinal surgery, Macular surgery, Air tamponade
Insulin Resistance in Patients With Major Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the relationship between insulin and glucose action and neuropsychological functioning (memory, attention, general thinking abilities) in persons with depression.

Official Title
-----------------
Insulin Resistance in Patients With Major Depression

Conditions
-----------------
Depression, Bipolar Disorder, Mood Disorders, Insulin Resistance, Depressive Disorder, Major, Depressive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1)Willingness to sign the Human Subject Protection Consent Form prior to enrollment into the study. 2)Men and women ages 20 to 65 years of age. 3)Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD) or depressive episode of bipolar disorder (Bipolar I, II or NOS), based on a Structured Clinical Interview for DSM-IV Axis I disorders (SCID) and confirmed by a psychiatrist. 4) Depression severity as defined by score of <17 on the 21-item Hamilton Rating Scale for Depression and no psychiatric admission within 6 months from study entry and no suicide attempt within the last 12 months. 5)Adequate visual and auditory acuity to allow neuropsychological testing. 6)Stable regime of psychiatric medications for 1 month prior to insulin test. Exclusion Criteria:1)Diagnosis of possible or probable cognitive impairment. 2)For women only: pregnancy, breastfeeding. 3)Personal history of Type I or Type II diabetes. 4) Unstable cardiovascular disease or other major medical condition, or history of myocardial infarction within the previous year. 5)Significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressures > 100). 6) Current drug or alcohol abuse. 7)History of neurological disorder, e.g. multiple sclerosis, stroke etc. 8)Use of any drug that may significantly affect psychometric testing, or the insulin testing

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify insulin-mediated glucose uptake as assessed by the SSPG concentration in patients with depression and compare the values to those previously obtained in a healthy age-matched control population |  | Within 3 hours of initial infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the association between insulin resistance and cognitive performance and clinical course of depression in patients with depression |  | 1 wk |