linjc16/ctgov huggingface dataset:
Delayed Cord Clamping in Premature Infants

Study Overview
=================
Brief Summary
-----------------
Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. In this study the investigators look at using a plastic covering and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to clamp the umbilical cord.

Detailed Description
-----------------
Enrolled premature infants will be compared to age matched historical controls that did not receive delayed cord clamping but were placed under a warmer immediately after birth. Outcomes to be analyzed include initial body temperature, hematocrit at birth and 24 hours of age, number of red blood cell transfusions during hospital stay, umbilical cord gas, first blood gas following delivery, blood pressure data in the first 24 hours, fluid bolus and inotrope requirement in the first 24 hours, incidence of intraventricular hemorrhage and late-onset sepsis, peak bilirubin level, length of phototherapy, and Apgar scores.

Official Title
-----------------
Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants

Conditions
-----------------
Hypothermia, Anemia

Intervention / Treatment
-----------------
* Other: Delayed cord clamping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premature infants at 24-28 completed weeks gestation at the time of delivery informed consent obtained from parents prior to delivery Exclusion Criteria: multiple gestation (twins, triplets, etc) prolonged fetal bradycardia placental abruption or previa maternal illness major congenital anomalies maternal fever in labor fetal illness (e.g. isoimmune hemolysis)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delayed cord clamping<br> | Other: Delayed cord clamping<br>* Infants will be covered with plastic and placed on a chemical warmer at delivery and then clamping of the umbilical cord will be delayed for 30-60 seconds.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial body temperature |  | At birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit at birth and 24 hours of age |  | first day of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
delayed cord clamping, premature infants, hypothermia, anemia, intraventricular hemorrhage, Anemia in premature infants
Validation of Methods to Estimate Body Fat

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate various methods for estimating body composition in human subjects. Each subject is evaluated by several methods that are then compared to a criterion value. We hypothesize that the prediction method will yield the same result as the criterion value. The risks to subjects are minimal and all techniques are routinely performed.

Official Title
-----------------
Validation of Methods to Estimate Body Fat

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male and female (pre-menopausal) volunteers Exclusion Criteria: post-menopausal and pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding

Study Overview
=================
Brief Summary
-----------------
To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.

Official Title
-----------------
One-visit Multi-site Pre-exposure Intradermal Rabies Vaccination: Dose Finding in Healthy Adults.

Conditions
-----------------
Rabies Pre-exposure Prophylaxis

Intervention / Treatment
-----------------
* Biological: rabies vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Good health according to the investigator Willingness and ability to adhere to the study regimen Able to give informed consent Exclusion Criteria: Known or suspected previous vaccination against rabies Known or suspected allergy against any of the vaccine components History of unusual or severe reactions to any previous vaccination Immunocompromized state due to illness or medication Administration of plasma or blood products three months prior to inclusion in the study (hydroxy)chloroquine or mefloquine use History of any neurological disorder including epilepsy or febrile seizures Pregnancy or breastfeeding Any current infectious disease other than seasonal cold Bleeding disorders or use of anticoagulants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - ID<br>Intradermal administration. 20% dose in a single visit. | Biological: rabies vaccine<br>* Compare ID administration to IM administration. 1 visit schedule.<br>|
| Experimental: B - ID<br>Intradermal administration. 40% dose in a single visit. | Biological: rabies vaccine<br>* Compare ID administration to IM administration. 1 visit schedule.<br>|
| Experimental: C - ID<br>Intradermal administration. 60% dose in a single visit. | Biological: rabies vaccine<br>* Compare ID administration to IM administration. 1 visit schedule.<br>|
| Active Comparator: D - IM<br>1x IM | Biological: rabies vaccine<br>* Compare ID administration to IM administration. 1 visit schedule.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory response in vaccinated subjects 1 year after primary vaccination (defined as seroprotection rate for all subjects within 7 days post-booster in a simulated post-exposure scenario) |  | 1 year |
Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges

Study Overview
=================
Brief Summary
-----------------
Surgical sponges can be accidentally left inside patient's bodies. We are working on special tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray.

Detailed Description
-----------------
Surgical sponges can be accidentally left inside patient's bodies. We are working on special tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray. We wish to take x-rays of healthy people's abdomens with microfabricated tags lying on them. The x-rays will help us improve our system for detecting sponges left inside people's bodies.

Official Title
-----------------
Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges

Conditions
-----------------
Injury Due to Foreign Object Accidentally Left in Body During Surgical Operation

Intervention / Treatment
-----------------
* Radiation: Abdominal radiographs with microfabricated tags


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women Ages 18 or older - Exclusion Criteria: Under 18 years of age Pregnant female or if female has not had a negative pregnancy test prior to the research scans. -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal radiographs with microfabricated tags<br> | Radiation: Abdominal radiographs with microfabricated tags<br>* Subjects will have 2 x-rays of their lower thorax/ abdomen taken. For each x-ray, a microfabricated tag or no tag will be placed in a different position. The x-rays will take approximately 15 minutes to complete.<br>* Other names: Abdominal CT (computerized tomography);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the CAD (computer aided detection) system | X-rays of the microfabricated tag will be taken. These x-rays will be reviewed and the individual tags identified manually and a control file created. The images will then be processed by the CAD (computer aided detection)system and the output will be compared to the control file. | 3 years |
The Factors Affecting Intentions of Medical Staff to Use Personal Health Record in Northern Hospitals of Taiwan

Study Overview
=================
Brief Summary
-----------------
Application of health information technology be able to solve a lot of problems of medical management, and effective actions to achieve the purpose of medical care. The Personal Health Record (PHR), so that patients can have, access and update their health records and share health information to a new healthcare provider can avoid the duplication of a clinic procedures, reduce medical costs and time, and can make an appointment online, tracking vaccinations, check drug allergy, master with health-related information such as exercise, diet condition, and have no time constraints to the hospital clinic. In the future, PHR is expected to reduce medical errors, reduce costs, effective use of medical resources. Purpose of this study is to understand the impact to the staff's attitude and intention when they use the PHR, and to explore the medical records of personal health awareness and intention to use the relevant factors, the research result will be a reference to government authority or medical institutions in order to promote personal health record system in Taiwan. In this study, there will include the medical staff of three hospitals in Taipei, the Technology Acceptance Model (TAM model) based structured questionnaire will be used, questionnaire had tested by validity and reliability. The electronic questionnaires will be used, and apply the software SPSS and Amos17.0 descriptive and inferential statistical analysis.

Official Title
-----------------
The Factors Affecting Intentions of Medical Staff to Use Personal Health Record in Northern Hospitals of Taiwan

Conditions
-----------------
Healthy Subjects, Health Care Providers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health care provider Volunteer Subject Be able to understand the content of questionnaire Exclusion Criteria: - None
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 |
| --- | --- |
| Health Care Providers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
In Vitro Human Embryo Culture System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the development of human embryos grown in a conventional culture dish to those grown in a new embryo culture device known as the SMART System.

Detailed Description
-----------------
This study is a multi-center, randomized, performance study.

Official Title
-----------------
In Vitro Human Embryo Culture System

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: SMART System
* Device: Culture dish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - All recruited subjects must meet all of the following inclusion criteria to be enrolled in the study: Female 21 to 35 years of age inclusive First or second IVF cycle Not pregnant No physical abnormalities that would adversely affect oocyte retrieval Male factor is acceptable ICSI is acceptable 10 zygotes or more Exclusion Criteria- Potential subjects are excluded from the study if any of the following conditions exist: The sperm were retrieved using TESE or MESA The embryos were created with either donor oocytes or donor sperm. Medical condition precluding a safe pregnancy Medical condition disqualifying the subject from safely participating in the study in the judgment of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental arm<br>Embryos cultured in SMART System | Device: SMART System<br>* microfluidic embryo culture system<br>* Other names: System for Microfluidically-Assisted Reproductive Technology;|
| Active Comparator: Control<br>Embryos cultured in microdrops in dishes | Device: Culture dish<br>* Standard IVF culture dish<br>* Other names: dish;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of development of human embryos |  | Day 3 (t=72 hrs) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, embryo development
Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension

Conditions
-----------------
Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost/timolol fixed combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes Patient requires IOP-lowering drug in both eyes Exclusion Criteria: Uncontrolled medical condition Contraindication to beta-adrenoceptor antagonist therapy

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bimatoprost/timolol fixed combination|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP |  |  |
A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117 ophthalmic solution (one drop once daily for 7 days) in healthy male adults.

Official Title
-----------------
A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -

Conditions
-----------------
Healthy Male Adults

Intervention / Treatment
-----------------
* Drug: DE-117


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male adult volunteers Exclusion Criteria: Subjects with any history of severe diseases that preclude participation in this study for safety reasons Subjects with any diseases that preclude participation in this study for safety reasons

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DE-117 ophthalmic solution<br> | Drug: DE-117<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under concentration-time curve (AUC) |  | 7 days | 
| Maximum plasma concentration (Cmax) |  | 7 days | 
| Time to maximum plasma concentration (Tmax) |  | 7 days | 
| Elimination half-life (T1/2) |  | 7 days |
The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).

Detailed Description
-----------------
Research subjects participation is about 6 months. Subjects will give themselves daily injections of teriparatide after instruction on technique.

Official Title
-----------------
The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL

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

Intervention / Treatment
-----------------
* Drug: teriparatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide Exclusion Criteria: Patients with diabetes mellitus current smokers patients with a history of organ transplantation Patients currently of previously on glucocorticoid therapy within the past year Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater) Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis History of radiation therapy Patients pregnant or nursing History of bone metastasis or skeletal malignancies History of hypercalcemia

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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: 1<br>Teriparatide | Drug: teriparatide<br>* Teriparatide<br>* Other names: Forteo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels |  | baseline, 3, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP levels |  | Baseline and at 6 months of therapy |
Effectiveness Study of Hydrotherapy Against Pain and Other Symptoms in Diabetes-induced LEAD

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether the hydrotherapy are effective in against pain and other symptoms in diabetes-induced LEAD.

Official Title
-----------------
Hydrotherapy for the Treatment of Symptomatic Lower Extremity Arterial Disease in Diabetes Type 2 Patients:A Randomized Controlled Trial

Conditions
-----------------
Diabetes, Lower Extremity Arterial Disease

Intervention / Treatment
-----------------
* Other: hydrotherapy
* Other: hydrotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Type 2 diabetes mellitus diagnosis of lower extremity arterial disease Exclusion Criteria: Severe heart disease can't hydrotherapy

Ages Eligible for Study
-----------------
Minimum Age: 48 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 |
| --- | --- |
| Active Comparator: hydrotherapy<br> | Other: hydrotherapy<br>* 30-minutes/per day,for 4weeks<br>Other: hydrotherapy<br>* 30-minutes/per day;4weeks<br>* Other names: hot spring;|
| Other: hot spring<br>30-minutes/per day;4weeks | Other: hydrotherapy<br>* 30-minutes/per day,for 4weeks<br>Other: hydrotherapy<br>* 30-minutes/per day;4weeks<br>* Other names: hot spring;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the intensity of numbness and cold feeling at 4 weeks. Change from the improvement of the pain index at 4 weeks. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from ankle-brachial index at 4 weeks |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hydrotherapy, randomized controlled trial, lower extremity arterial disease, diabetes