linjc16/ctgov huggingface dataset:
Data Collection of Heart Rate and Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is data collection for building and validating the algorithms for analytics of vital signs using wearable earphones (MindMics device).

Detailed Description
-----------------
MindMics is developing technology to enhance an individual's quality of life by continuously monitoring the heart rate, stress thereby allowing people to make better decisions regarding their health. MindMics has a working prototype of the ear buds which will perform all the conventional tasks earbuds do (listen to music, etc.), but, in addition, will measure your vital signs. The earbuds capture the sounds made by the various cardiac structures pulsing and moving blood.

Official Title
-----------------
Data Collection of Heart Rate and Blood Pressure

Conditions
-----------------
Healthy People

Intervention / Treatment
-----------------
* Device: Earbud


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-90 No gender restrictions Cognitive ability to consent Exclusion Criteria: Patients with pacemakers Patients with irregular heart rhythms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Earbud|In ear headphone with embedded infrasonic hemodynography technology|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RR Interval from ECG signal | Time in milliseconds between successive ECG R peaks | 20 minutes | 
| Inter-beat Interval from earbud signal | Time in milliseconds between successive peaks in earbud signal | 20 minutes | 
| Systolic and diastolic blood pressure from blood pressure cuff | Value of blood pressure in mmHg reported by a blood pressure cuff | 20 minutes |
Exercise and Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that a three-month aerobic exercise training program will positively affect the lipid profile, insulin sensitivity , cytokine profile, the cardiovascular parameters and muscle strength in SLE patients.

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Behavioral: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 7 and 40 years SLEDAI ≤ 4 Exclusion Criteria: Cardiovascular dysfunction Rhythm and conduction disorders Musculoskeletal disturbances Kidney and pulmonary involvements Peripheral neuropathy Use of tobacco Treatment with lipid-lowering or hypoglycemic drugs Fibromyalgia Use of chronotropic or antihypertensive drugs Physically active subjects

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>3-month exercise training program | Behavioral: Exercise training<br>* Aerobic exercise training, two times a week<br>|
| No Intervention: Control<br>Control group | |
| Experimental: Healthy control<br> | Behavioral: Exercise training<br>* Aerobic exercise training, two times a week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl) |  | 3 months | 
| Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp |  | 3 months | 
| Cytokine response - Plasma levels of TNF-α (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular parameters | Aerobic capacity, chronotropic function | 3 months | 
| Muscle Strength | Upper and Lower-body muscle strength will be assessed by a 1-RM (repetition maximum) protocol | 3 months |
The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators are randomizing patients to receive chewing gum (Extra Sugar Free, Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. The investigators then have them fill out a survey in house and 1 week after their surgery that record time to first flatus, hunger, toleration of clear liquids and food and some information about pain, satisfaction, and quality of life. The investigators contact them via phone and email a maximum of three times in order to collect this information. 30 days postoperatively the investigators also contact them and perform a chart review for any postoperative complications.

Official Title
-----------------
The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.

Conditions
-----------------
Postoperative Ileus

Intervention / Treatment
-----------------
* Other: Chewing gum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Undergoing benign gynecologic surgery via an exploratory laparotomy Capable of giving consent Exclusion Criteria: Oromaxillary or mental disturbances that would make chewing gum dangerous with regards to mastication or aspiration Intubated or unconscious when leaving the OR Bowel resection performed at the time of surgery Active bowel disease (IBD, appendicitis, etc) Gynecologic malignancy

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

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard postoperative care<br> | |
| Experimental: Chewing gum arm<br>Sugar free (extra, spearment) chewing gum given to the patient to chew during waking hours every four hours for 15 minutes | Other: Chewing gum<br>* Sugar Free (Extra spearment) gum given to chew every 4 hours during waking hours for 15 minutes.<br>* Other names: Extra spearment sugar free gum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to flatus |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative ileus | Nausea, vomiting, abdominal distention two episodes of 100cc of emesis | 30 days | 
| time to discharge |  | 30 days | 
| time to toleration of diet |  | 30 days | 
| patient satisfaction |  | 30 days |
Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.

Official Title
-----------------
A Phase III Observer-Blind, Randomized, Controlled, Single-Coordinating Center Pediatric Study in China Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Using a Local Dosing Regimen in Infants

Conditions
-----------------
Haemophilus Influenzae Type b (Hib) Infection

Intervention / Treatment
-----------------
* Biological: Haemophilus influenzae type b (Hib) vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants 6-12 months of age. Exclusion Criteria: Prior Hib vaccine administration. History of serious reaction(s) following vaccination. Any vaccination within 14 days of study vaccination. Known or suspected immune impairment. For additional entry criteria please refer to the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Months

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Biological: Haemophilus influenzae type b (Hib) vaccine<br>* Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines - a monovalent glycoprotein-conjugated (diptheria toxin - CRM197) vaccine and a tetanus toxoid-conjugated vaccine.<br>|
| Active Comparator: Arm 2<br> | Biological: Haemophilus influenzae type b (Hib) vaccine<br>* Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines - a monovalent glycoprotein-conjugated (diptheria toxin - CRM197) vaccine and a tetanus toxoid-conjugated vaccine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-PRP antibody levels at day 31 post last vaccination |  | 30 days after last vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited local and systemic reactions, AEs, and SAEs |  | 30 days post last vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemophilus influenzae type b (Hib), Vaccine, Booster
Short-term Air Pollution Exposure and In-hospital Outcomes in Patients With Acute Myocardial Infraction

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether or not short-term expose to air pollution is associated with in-hospital outcomes, such as mortality and morbidity.

Official Title
-----------------
Short-term Air Pollution Exposure and In-hospital Outcomes in Patients With Acute Myocardial Infraction

Conditions
-----------------
Air Pollution, Acute Myocardial Infarction, Percutaneous Coronary Intervention

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 12 hours after the onset of myocardial infarction symptoms Documented acute ST (S- and T-wave)-segment elevation myocardial infarction Received emergent percutaneous coronary intervention Exclusion Criteria: Age under 18-year old

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with acute ST (S- and T-wave)-segment elevation myocardial infarction who received emergent percutaneous coronary intervention in Huai'an first people's hospital | |
| 2<br>patients with acute ST(S- and T-wave)-segment elevation myocardial infarction who received emergent percutaneous coronary intervention in Nanjing Drum Tower hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) |  | in the phase of hospital stay, up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | in the phase of hospital stay, up to 30 days | 
| ST (S- and T-wave) segment decreasing |  | within an hour after primary percutaneous coronary intervention | 
| left ventricular function | left ventricular ejection fraction in % and left ventricular end-diastolic diameter in mm, both are evaluated by echocardiography to assess the left ventricular function | in the phase of hospital stay, up to 30 days |
Oral Glucose Tolerance Testing After Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
This is an observation study of women with gestational diabetes. Subjects recruited undergo immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an immediate post partum screen for overt diabetes compared to a traditional 6 week test.

Official Title
-----------------
Oral Glucose Tolerance Testing After Gestational Diabetes

Conditions
-----------------
Gestational Diabetes, Obesity, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy Gestational diabetes Exclusion Criteria: Multiple gestations pre-pregnancy diabetes

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gestational diabetes<br>Primary cohort is women with diagnosis of gestational diabetes without evidence of overt diabetes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome: sensitivity of immediate post partum screen | 2 hour fasting 75g OGTT immediately post partum. This is compared to a traditional 6 week post partum 75g OGTT for the sensitivity, positive and negative predictive value of the immediate post partum test | Immediate post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome: physiology | A small sub-cohort of women will undergo an additional 2 hour fasting 75g OGTT in the third trimester with measurements of insulin, cytokines, lipids. | 3 time points: antepatum, immediate postpartum, 6 weeks post partum |
Enteral Nutrition and Amino Acid Absorption

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate amino acid absorption with two different type of proteins.

Official Title
-----------------
Comparaison du Profil d'Absorption Des Acides aminés Entre Une Nutrition entérale Semi-élémentaire et Une Nutrition entérale polymérique

Conditions
-----------------
Malabsorption

Intervention / Treatment
-----------------
* Dietary Supplement: Enteral nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with gastrointestinal disorder : citrulline plasma concentration < 20 µmol/L and/or xylose plasma concentration < 1,7 mmol/L Patient under enteral nutrition at home Patient already receiving 1 L by day Exclusion Criteria: Obese patient BMI > 30 Diabetes Renal or liver failure Glucocorticoids treatment

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enteral nutrition product : product A<br>Administration during 16 hours. | Dietary Supplement: Enteral nutrition<br> <br> |
| Active Comparator: Enteral nutrition product : product B<br>Administration during 16 hours. | Dietary Supplement: Enteral nutrition<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amino acid absorption profile | Area under the curve of amino acid plasma concentration | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance | Description and occurence of adverse events | 48 hours | 
| Nutritional status | Retinol Binding Protein and Transthyretin dosage | 48 hours | 
| Essentials amino acid absorption | Area under the curve of plasma concentration | 48 hours | 
| Insulinemia evolution | Insulinemia dosage | 48 hours | 
| Link between amino acid and insuline | Correlation coefficient | 48 hours |
A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype

Study Overview
=================
Brief Summary
-----------------
This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.

Official Title
-----------------
A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Device: Marketed Nasal Strip
* Device: Prototype Nasal Dilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marketed nasal strip<br>Marketed nasal strip | Device: Marketed Nasal Strip<br>* Breathe Right Nasal Strips - Clear small/medium strip<br>|
| Experimental: Prototype nasal dilator<br>Prototype nasal dilator | Device: Prototype Nasal Dilator<br>* Prototype Nasal Dilator AB2R11<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermal response score of the application site of the nasal strip |  | Baseline through 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal Strip
Lymphatic Drainage of the Breast, a Retrospective Assessment of Data

Study Overview
=================
Brief Summary
-----------------
retrospective evaluation of patients, in whom blue colour was injected into different sites of the breast before breast reduction, to investigate direction and localisation of lymphatic flow. Investigations were performed at the Wilhelminenspital, Vienna, in the years 1998 to 2009.

Official Title
-----------------
Lymphatic Drainage of the Breast, a Retrospective Assessment of Data

Conditions
-----------------
Lymph Drainage of Breast

Intervention / Treatment
-----------------
* Procedure: anatomical examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, who understood and supported the aim of the study and signed the written consent - Exclusion Criteria: language barriers, patients, who did not understand and support the aim of the study -

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| injection behind NAC<br>in 7 breasts dye was injected behind the nipple areola complex before breast reduction | Procedure: anatomical examination<br>* After injection of dye, its distribution along lymphatic clearance paths was investigated<br>|
| Injection into lateral upper quadrant<br>in 5 breasts dye was injected into upper lateral glandular tissue before breast reduction | Procedure: anatomical examination<br>* After injection of dye, its distribution along lymphatic clearance paths was investigated<br>|
| injection into medial upper quadrant<br>in 2 breasts dye was injected into upper medial glandular tissue before breast reduction | Procedure: anatomical examination<br>* After injection of dye, its distribution along lymphatic clearance paths was investigated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphatic flow is guided by the ligamentous suspension | colour gathered along horizontal septum | The ligamentous suspension (horizontal septum, vertical ligaments merging into superficial fascia) is exposed in the course of breast reduction in the technique, that I described usually within about 40 minutes |