linjc16/ctgov huggingface dataset:
The Monica Fetal Heart Monitor

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.

Detailed Description
-----------------
If a patient is admitted to the antepartum service and is between 24 - 28 weeks gestation, the investigators will approach the patient and inform her about the study. If the patient agrees to the study then the baby's heart tracings and contraction pattern will start to be monitored using the traditional device. If the patient would be receiving continuous fetal heart rate monitoring, then after at least 2 hours of monitoring with the traditional device, the traditional device would be replaced with the Monica device for 2 hours. After the Monica device is used for 2 hours, then the traditional device would be used once again. The entire length of the patient's participation in the study should be nor more than 6 hours. The data collection sheet shows all data elements to be collected from the medical record. In addition it is standard of care that the monitoring strips become part of the medical records and these will also be reviewed as per the data collection sheet. Time it should take to review a patients medical record will be about 1 hour. Total time of patient's involvement will be 7 hours.

Official Title
-----------------
The Monica External Fetal Heart Rate Monitor Compared to the Standard Fetal Heart Rate Monitor

Conditions
-----------------
Fetal Heart Tracing

Intervention / Treatment
-----------------
* Other: Fetal Heart Rate Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant patients between 24 and 28 weeks admitted to the antepartum service Exclusion Criteria: Patients with a non viable pregnancy Patients with multiple gestation Clinically Unstable patients Non English speaking patients

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Fetal Heart Rate Monitor|Standard of care, not part of research|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device | This study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device. | How long can hetal heart tracings be capture continuously |
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients >/= 65 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.

Official Title
-----------------
Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures

Conditions
-----------------
Odontoid Fractures Type II

Intervention / Treatment
-----------------
* Procedure: surgical versus conservative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All new type II odontoid fractures including < those in which the fracture line crosses into the body of C2 < as long as it doesn't enter the superior articular process of C2 Age 65+ Stable and unstable fractures < 3 months postinjury No previous treatment for an odontoid fracture Exclusion Criteria: Pathologic fractures unrelated to osteoporosis Severe dementia or other severe mental health problem if there is no consentable surrogate available Participating in other trials or unlikely to attend follow-ups

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgical versus conservative treatment|Surgical treatment of fractures versus conservative stabilization|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life using the Neck disability Index |  | 12 months | 
| Quality of life using the SF-36 |  | 12 months | 
| Proportion of bony fusion between the two treatments |  | 6 months | 
| Proportion rate of non-union between the two treatments |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications |  | 12 months | 
| Cervical range of motion |  | 12 months | 
| Identify the risk factors for a poor outcome independent of treatment intervention |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Odontoid, Type II fractures, Elderly patients, Surgical vs. conservative treatment
HealtheTech Lifestyle Program

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the efficacy of resting metabolic rate (RMR) using BodyGem and BalanceLog in helping overweight and obese individuals manage their weight.

Detailed Description
-----------------
The study plans are to develop and test the efficacy of a practical, structured, and time-limited behavioral intervention (HealtheLifestyle Program) as a supplement to standard HealtheTech products. Approximately 130 participants will be recruited and randomized to either the HealtheTech Program (focusing on calorie and exercise goals using the BalanceLog for tracking), the HealtheLifestyle Program (using step counters, monthly email letters and calls providing information on activity, nutrition, and weight loss), or a delayed treatment program (after 3 months undergo the intervention above).

Official Title
-----------------
HealtheLifestyle Behavioral Intervention Clinical Trial

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

Intervention / Treatment
-----------------
* Behavioral: HealtheLifestyle Program
* Behavioral: step counters with monthly feedback on logs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult men and women, 18-60 years - Exclusion Criteria: not currently participating in a structured diet or exercise program -

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: HealtheLifestyle Program|nan|
|Behavioral: step counters with monthly feedback on logs|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HealtheLifestyle participants will have greater weight loss |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HealtheLifestyle Program will increase efficacy of products |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight control, compliance, physical activity, nutrition, Health Behavior, Patient Compliance
Value of FLT-PET Before and During Radiotherapy in Head and Neck Tumors

Study Overview
=================
Brief Summary
-----------------
Tumor cell proliferation and repopulation contribute to resistance to radiotherapy in head and neck cancer. Up to now, this characteristic is mostly assessed using biopsies acquired during inspection under general anaesthesia before treatment. 18F-FLT-PET (positron emission tomography) is a non-invasive imaging method showing areas of active proliferation. The aim of this study is to assess the value of the functional information gained by 18F-FLT-PET for radiotherapy planning and early tumor response assessment. Prior to radiotherapy, a planning CT-scan and a 18F-FLT-PET scan are acquired. After approximately two weeks of radiotherapy a further PET scan is obtained.

Official Title
-----------------
Value of FLT-PET Before and During Radiotherapy in Head and Neck Tumors

Conditions
-----------------
Head and Neck Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage II - IV squamous cell carcinoma of the head-and-neck region, treated with radiotherapy or radiochemotherapy with curative intent. 18 years or older Informed consent Exclusion Criteria: Patients who have undergone surgery as primary tumor therapy. Patients treated with palliative intent. Pregnancy

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 |
| --- | --- | --- |
| Correlation of 18F-FLT-PET-signal changes before and during therapy with treatment outcome (clinical response and local tumor control) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the value of the functional information gained by 18F-FLT-PET regarding the definition of the planning target volume (PTV) for radiotherapy. |  | 2 months | 
| Measurement of 18F-FLT-PET-signal changes during radiotherapy or radiochemotherapy. |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cell proliferation, PET, radiotherapy
Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor

Study Overview
=================
Brief Summary
-----------------
Ticagrelor treatment is associated with increased rates of dyspnea, where previous studies have implied a possible role of adenosine. The purpose of this study is to determine if the caffeine-antagonist is effective in reducing dyspnea related to ticagrelor.

Official Title
-----------------
Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor - A Double-blinded, Placebo-controlled, Randomized, Multicenter, Development Phase II Study

Conditions
-----------------
Dyspnea

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Recent acute coronary syndrome with ongoing ticagrelor treatment Stabilized clinical condition with no plans of additional revascularization Dyspnea with onset after start of ticagrelor treatment Willingness to abstain from caffeine intake (e.g. coffee, tea, cola-type beverages; other foods, nutritional supplements or medications containing caffeine) for the duration of the study Provision of signed informed consent form Exclusion Criteria: Chronic obstructive pulmonary disease, asthma or other known pulmonary disease requiring daily medical therapy Obstructive sleep apnea syndrome requiring therapy Ongoing signs and symptoms of heart failure*, or evidence of moderately to severely reduced left ventricular (LV) function Renal failure, glomerular filtration rate (GFR) <30 or on dialysis Pregnancy or lactation Known allergy to ticagrelor, or caffeine, or known intolerance of caffeine Ongoing treatment with any of the following: quinolone antibiotics, fluvoxamine, phenylpropanolamine, carbamazepine, clozapine, lithium, non-steroidal anti-inflammatory drugs (NSAIDs); or any drug containing theophylline or caffeine. Any condition that seriously increases the risk of non-compliance or loss of follow-up

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caffeine<br>Caffeine capsules. 200 mg twice daily orally for 7-10 days. | Drug: Caffeine<br> <br> |
| Placebo Comparator: Placebo<br>Matching placebo capsules twice daily orally for 7-10 days. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale area under the curve (VAS-AUC) for dyspnea |  | 7-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High on-treatment platelet reactivity by VerifyNow |  | 7-10 days | 
| Change in dyspnea by 7-point Likert scale |  | 7-10 days |
Chagas Disease as an Undiagnosed Type of Cardiomyopathy in the United States

Study Overview
=================
Brief Summary
-----------------
A detailed review was made of data pertinent to the occurrence of chronic Chagas disease in the United States.

Detailed Description
-----------------
BACKGROUND: In Latin America, 16 to 18 million individuals are thought to have Chagas' disease and 90 million are considered to be at risk of infection. In the United States, the occurrence of Chagas' disease is virtually limited to individuals who have resided in Latin America where they acquired the infection, and then migrated to this country. DESIGN NARRATIVE: Data on the prevalence of positive serologic reactions for Trypanosoma cruzi (a protozoan causing Chagas cardiomyopathy) serve for calculating that a total of up to 74,000 Latin Americans residing in the United States have the chronic form of chagasic cardiomyopathy. The vast majority of these individuals are either undiagnosed, or misdiagnosed as having idiopathic dilated cardiomyopathy or coronary artery disease. Vector transmission of T. cruzi infection is very unlikely to occur in the United States because of variations in biological behavior of local species of insect vectors and because of changes in human living conditions. Transfusion of blood from infected but asymptomatic individuals is considered the most important mechanism of transmission of this disorder in the United States. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Heart Diseases, Myocardial Diseases, Chagas Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Sildenafil and Uteroplacental Perfusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction.

Detailed Description
-----------------
Fetal growth retardation affects up to 8% of all pregnancies and has massive short term (increased fetal morbidity and mortality) and long-term (increased incidence of cardiovascular disorders in adulthood) health implications. Doppler waveform analysis of these pregnancies suggests compromised uteroplacental circulation and placental hypoperfusion. Our aim is to assess if sildenafil citrate could improve vasodilatation in FGR pregnancies. Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental perfusion in FGR. Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, such as sildenafil citrate, may improve uterine blood flow .

Official Title
-----------------
Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil

Conditions
-----------------
Fetal Growth Retardation

Intervention / Treatment
-----------------
* Drug: sildenafil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FGR pregnancies in 24-37 weeks of GA Exclusion Criteria: vasodilator agents usage history of cardiovascular morbidity specially of right heart side drug or alcohol abusers systolic BP more than 210 mm Hg or diastolic BP more than 120 mm Hg
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sildenafil<br> | Drug: sildenafil<br>* 50 mg TDS orally until birth<br>* Other names: viagra;|
| Placebo Comparator: Placebo control<br> | Drug: placebo<br>* 50mg tid<br>* Other names: placebo tid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uteroplacental Perfusion |  | 2 hours after sildenafil ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal growth |  | after 6 months | 
| umbilical artery blood gass assessment |  | immediately after birth | 
| effect on fetal well being | when BP score is<8 we repeat it after sildenafil ingestion | 2 hours after sildenafil | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sildenafil, FGR
Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant

Study Overview
=================
Brief Summary
-----------------
The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease.

Detailed Description
-----------------
The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease (GVHD) by determining the qualitative and quantitative changes in T regulatory cells throughout the transplant process. Their understanding of this can lead to new treatment strategies and improved clinical therapeutic implications.

Official Title
-----------------
Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant (HSCT)

Conditions
-----------------
Hematopoietic Stem Cell Transplantation, Graft vs Host Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions Exclusion Criteria: Patients < 18 or > 70 years old undergoing either autologous transplant or allogeneic transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T-Lymphocyte Subsets
Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance

Study Overview
=================
Brief Summary
-----------------
This prospective randomized cross over study aims to compare nCPAP with mandibular advancement device for the treatment of sleep apnea syndrome.The effectiveness of nCPAP and oral appliance on apnea-hypopnea index, daytime sleepiness and quality of life will be compared in 60 patients.

Official Title
-----------------
Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance: a Multicentre Prospective Randomized Crossover Trial

Conditions
-----------------
Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Device: nCPAP vs oral appliance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 70 years old BMI < 35 kg/m2 Apnea-hypopnea index between 10 and 60 events/h Complaint of snoring and sleepiness Dental status adequate for treatment with oral appliance informed consent Exclusion Criteria: psychiatric disease professional driver other cause of sleepiness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: nCPAP vs oral appliance|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Measurment of GFR by Nasal Sensors

Study Overview
=================
Brief Summary
-----------------
to measure kidney function by measuring blood creatinine and to compare it to the measurment of GFR by Nanotechnology

Conditions
-----------------
Measure GFR by Nasal Sensor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults between 18-70 yrs Exclusion Criteria: subject under 18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |