linjc16/ctgov huggingface dataset:
A Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)

Study Overview
=================
Brief Summary
-----------------
A medical device study to assess the clinical accuracy and equivalence to reference devices of the SVSS to satisfy the requirements of the recognised applicable international standards.

Detailed Description
-----------------
The SVSS is designed to measure and display 5 vital signs: pulse rate, blood oxygen saturation (Sp02), blood pressure, body temperature and respiration rate. These results will be compared for accuracy with the results obtained using standard vital sign measurement equipment on the same subject.

Official Title
-----------------
An Open Label, Clinical Performance Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Device: SVSS and reference devices
* Device: SVSS and reference devices
* Device: SVSS and reference devices
* Device: SVSS and reference devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, male or female, 18 yrs or older, willing and able to participate and sign the informed consent form. Exclusion Criteria: None.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SVSS and reference devices<br>Vital signs will be measured on the same subject with the reference devices and with the SVSS. The subject will have blood pressure, pulse, blood oxygen, body temperature and respiration rate measured using standard equipment. The same subject will then use the investigational device which measures all vital signs at the same time, by placing the index finger on a sensor. | Device: SVSS and reference devices<br>* Blood pressure will be measured with standard mercury manometer<br>Device: SVSS and reference devices<br>* Body temperature taken with infrared thermometer<br>Device: SVSS and reference devices<br>* Pulse rate and Sp02 measured with a reference pulse oximter. The pulse oximeter is just clipped to the end of the finger.<br>Device: SVSS and reference devices<br>* Measurement of respiration rate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome is satisfactory evidence of substantial equivalence of each of the five vital signs with the reference devices within the ranges specified by the standards. | Accuracy of investigational device compared to the reference devices. | DAY 1 |
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw

Study Overview
=================
Brief Summary
-----------------
Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time.

Official Title
-----------------
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw

Conditions
-----------------
Blood Loss, Healthy

Intervention / Treatment
-----------------
* Device: CM-1500


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Male, 18-65 years of age Subject is suitable for a blood draw of a pint of blood Weighs at least 110 pounds Exclusion Criteria: Subject has a heart condition that may interfere with the Zynex CM-1500 Subject has unstable or untreated heart disease Subject has been diagnosed with chronic fatigue syndrome Subject is taking coumadin (warfarin), heparin, or other prescription blood thinners for at least 7 days prior to blood draw Subject donated blood within 8 weeks prior to blood draw Subject has high or low blood pressure on the day of blood draw Subject hemoglobin < 12.5 g/dL

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Draw<br> | Device: CM-1500<br>* Blood Volume Monitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detect change in blood volume during blood draw |  | 15-30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detect insidious bleeding |  | 15-30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood, loss, healthy, volume, To evaluate the ability of the Zynex BVM to non-invasively detect blood loss in healthy subjects during a blood draw.
Intravenous Tranexamic Acid Versus IV Carbetocin in Abdominal Myomectomy

Study Overview
=================
Brief Summary
-----------------
the aim of the present study is to compare safety and efficacy of intravenous tranexamic acid versus IV carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial

Official Title
-----------------
Comparative Safety and Efficacy of Intravenous Tranexamic Acid Versus IV Carbetocin in Reducing Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial

Conditions
-----------------
Myomectomy

Intervention / Treatment
-----------------
* Drug: intravenous tranexamic acid
* Drug: intravenous carbetocin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with symptomatic fibroids candidate for abdominal myomectomy with staging of myoma from (3 to 6) according to FIGO staging Exclusion Criteria: women with Myoma FIGO staging (1,2,7 and 8) candidate for laparoscopic or hysteroscopic myomectomy, women with allergy or contraindications to carbetocin or tranexamic acid
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous tranexamic acid<br>The tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision | Drug: intravenous tranexamic acid<br>* The tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision<br>|
| Active Comparator: intravenous carbetocin<br>The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision | Drug: intravenous carbetocin<br>* The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision<br>|
| Placebo Comparator: placebo<br>the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision | Drug: placebo<br>* the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss | the intraoperative blood loss in ml will be estimated during the procedure | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for blood transfusion | need for intraoperative or postoperative blood transfusion | 24 hours |
TyVECO: Surveillance Protocol

Study Overview
=================
Brief Summary
-----------------
In Kisantu Health Zone, approximate population 200,000, fever surveillance will be implemented in 8 health centers and 1 tertiary hospital. Individuals presenting to one of these study facilities with acute fever or history of fever or individuals presenting with suspicion of intestinal perforation irrespective of fever status, will be considered for enrollment. Following consent, blood samples (between 2.5 ml for children and 22 ml for adults) will be collected from eligible subjects and demographic and clinical information will be recorded in study forms at the time of enrollment at study health centers and hospitals. Peritoneal fluid and ileal tissue samples will be collected from surgical patients where possible. Biological specimens will be used for various testing, including microbiological culture of blood, tissue and peritoneal fluid for confirmation of bacterial growth, malaria diagnostics (microscopy and rapid testing), and storage of tissue samples for pathological investigation, and biobanking. Hospitalized patients will be followed-up to track clinical outcomes for the duration of hospitalization.

Official Title
-----------------
An Open-label Effectiveness Study of a Typhoid Conjugate Vaccine in Kisantu, Democratic Republic of Congo (TyVECO) - Step 3: Surveillance Protocol

Conditions
-----------------
Typhoid Fever, Intestinal Perforation

Intervention / Treatment
-----------------
* Biological: Typbar-TCV, Bharat Biotech


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At health center: Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation At Hospital: Suspicion of intestinal perforation/peritonitis due to typhoid fever requiring surgery for patients living in and outside the catchment area (even in the absence of laboratory confirmation) OR Patients living in the catchment area of the hospital with invasive salmonellosis confirmed through blood-culture surveillance embedded in routine patient cares Exclusion Criteria: Individuals who do not provide informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Typbar-TCV, Bharat Biotech|Typhoid conjugate vaccine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Typhoid fever | Blood culture confirmed infection with Salmonella typhi | Three years from the time of vaccination |
Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the short-term and long-term efficacy of massage therapy alone compared to massage therapy plus compression bandaging in the treatment of breast cancer treatment-related swelling of the arms and legs.

Detailed Description
-----------------
Massage therapy (in the form of manual lymph drainage [MLD]) and compression bandaging (CB) are integral components of combined physical therapy (CPT), the recommended treatment for peripheral lymphedema (LE). According to the World Health Organization, LE afflicts hundreds of millions worldwide and probably millions in the United States. Effects of various forms of massage on lymph circulation have been postulated for more than a century, but the efficacy of MLD alone without CB has not been demonstrated. New data suggest that MLD alone reduces established LE volume as effectively as CB in combination with CPT and minimizes LE development. Patients will be randomly assigned to either treatment with MLD alone or a combination of MLD and CB. Patients will be treated in 10 one-hour sessions over 2 weeks. They will also undergo lymphangioscintigraphy (a nuclear medicine test) to depict the function of their lymphatic system. Patients will continue self treatment at home and will be followed for 6 months.

Official Title
-----------------
Massage Therapy for Breast Cancer-Related Lymphedema

Conditions
-----------------
Lymphedema

Intervention / Treatment
-----------------
* Procedure: Manual lymph drainage
* Procedure: Combined physiotherapy
* Procedure: Compression bandaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lymphedema (5% to 20% increase in volume) after breast cancer treatment Exclusion Criteria: Physically unable to perform massage or bandaging during home program
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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Manual lymph drainage|nan|
|Procedure: Combined physiotherapy|nan|
|Procedure: Compression bandaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume change |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Manual lymph drainage, Combined physiotherapy
Exposure of Children With Asthma to Household Environmental Tobacco Smoke

Study Overview
=================
Brief Summary
-----------------
To examine whether or not primary school-aged children with asthma from low-income households have lower household environmental tobacco smoke (ETS) exposure than matched control children.

Detailed Description
-----------------
BACKGROUND: Children with asthma are particularly vulnerable to environmental tobacco smoke (ETS). However, despite this special vulnerability to ETS, children with asthma are at least as likely to live in smoking households, as are healthy children. Controversy exists, however, about whether or not the smoking members of households with children with asthma use specific strategies to reduce the harmful effects of their smoking on their children more than the smoking members of households of healthy children. DESIGN NARRATIVE: The case-control study examines whether or not primary school-aged children with asthma from low-income households have lower household ETS exposure than matched control children. Household ETS exposure will be measured by both objective monitoring, specifically passive nicotine dosimeters and child cotinine assays (the primary hypothesis), and maternal-report (the secondary hypothesis). Ninety children with physician diagnosed asthma and smoking mothers will be matched by age, gender, race/ethnicity, and other relevant variables to 90 healthy children. All children will be recruited from Metro Denver clinics providing services to low-income, underserved populations. The sample will contain equal numbers of African Americans, Hispanics, and Whites. Recruitment will target low-income populations due to their increased prevalence of, and associated morbidity from both asthma and tobacco smoking. Specific household smoking behaviors, as reported by mothers, will be examined for association with household nicotine and child cotinine levels. Finally, a set of carefully chosen measures will be examined in tertiary, exploratory analyses to help understand, clarify, and contextualize the observed results. 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
-----------------
Asthma, Lung Diseases

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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- | --- |
Effect of Loaded Functional Training on Hemiplegic Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
weakness of lower limb is common in cp children

Official Title
-----------------
Influence of Loaded Functional Strength Training From a Plantigrade Foot Position Using Shoe Holder on Hip and Knee Extensors Strength and Function Walking Capacity in Children With Spastic Hemiplegic Cerebral Palsy

Conditions
-----------------
Hemiplegic Cerebral Palsy

Intervention / Treatment
-----------------
* Other: expermintal
* Other: CONTROL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 10-12 level I,II according to GMFCM Able to follow and understand instructions Exclusion Criteria: visual and respiratory disorder

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study groip<br>received the designed physical therapy program as the control group. In addition, they received progressive resistive functional strength training in the plantigrade foot position. | Other: expermintal<br>* progressive resistive functional strength training in the plantigrade foot position plus designed physical therapy program<br>|
| Other: control group<br>received a designed physical therapy program | Other: CONTROL<br>* Designed physical therapy program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength dynamometry | The gold standard for evaluating isometric muscle strength is the portable dynamometer | pre and post three month of intervention high score indicate improvement |
Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate a novel thermosensitive topical gel formulation for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.

Official Title
-----------------
Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Conditions
-----------------
Colitis, Ulcerative

Intervention / Treatment
-----------------
* Drug: Thermosensitive gel rectal formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntarily sign written informed consent. Male or non-pregnant and non-lactating females at least 8 years of age. Confirmed diagnosis of active, mild to moderate ulcerative proctitis or proctosigmoiditis extending no further than 40cm from the anal verge. Typically, baseline Mayo Disease Activity Index (MMDAI) score between 5 and 10 (indicating mild to moderate disease). Exclusion Criteria: Known infection with Clostridium difficile (C. difficile) and/or other enteric pathogens 5-aminosalicylic acid (5-ASA) intolerance Current or recent (3 weeks) oral or rectal steroids History of thiopurine or Anti-tumor necrosis factor (Anti-TNF) alpha treatment for colitis Abnormal creatinine Previous small bowel or colonic resection, Anal sphincter incompetence, Current smokers. History or current diagnosis of Crohn's disease or indeterminate colitis. History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease. Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease. Hemoglobin levels < 7.5 g/dL. History of sclerosing cholangitis, cirrhosis, or hepatic impairment Pregnant or at risk of pregnancy. Some medications to treat UC are prohibited during participation in the study, including laxatives and anti-diarrhea medications; oral 5-ASA agents and daily fiber supplements are allowed.

Ages Eligible for Study
-----------------
Minimum Age: 8 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: Thermosensitive gel formulation<br>Thermosensitive gel rectal formulation. | Drug: Thermosensitive gel rectal formulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI) | Using Modified Mayo Score | Between 4-6 weeks post-administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enema, Ulcerative Colitis