linjc16/ctgov huggingface dataset:
Efficacy of Probiotics on Excessive Gas Accumulation

Study Overview
=================
Brief Summary
-----------------
Efficacy of probiotics on excessive gas accumulation

Official Title
-----------------
Efficacy of Probiotics on Excessive Gas Accumulation

Conditions
-----------------
Flatulence, Bloating

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic supplement
* Dietary Supplement: Placebo supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults 18-50 years, at the time of signing the informed consent. Willing and able to give written informed consent for participating in the study Willing to comply with all study procedures Exclusion Criteria: Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator Known gluten intolerance, lactose intolerance, milk protein allergy Vegetarian diet Intake of antibiotics within four weeks prior to the start of the study Hypersensitivity to any of the ingredients in the investigational product (IP) Regular intake of probiotics within four weeks prior to the start of the study History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Intake of a probiotic capsule once daily | Dietary Supplement: Probiotic supplement<br>* Probiotic supplement<br>|
| Placebo Comparator: Placebo<br>Intake of a placebo capsule once daily | Dietary Supplement: Placebo supplement<br>* Placebo supplement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath hydrogen | The level of breath hydrogen is measured after a challenge with lactulose | 4 hours |
Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary

Study Overview
=================
Brief Summary
-----------------
This is a randomized phase III trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary and a predicted favorable prognosis. The purpose of this trial is to compare the overall survival rates of patients with carcinoma of unknown primary (CUP) and a predicted favorable prognosis according to the French classification treated with cisplatin with or without gemcitabine.

Official Title
-----------------
A Randomized Phase III Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary and a Predicted Favorable Prognosis

Conditions
-----------------
Carcinoma

Intervention / Treatment
-----------------
* Drug: cisplatin
* Drug: gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years Evidence of CUP based on histologic examination Negative search for the primary tumor site using recommended guidelines Disease classified as good prognosis according to the French classification criteria: *performance status >2 and *normal serum LDH No prior chemotherapy No previous carcinoma, except basal-cell carcinoma of the skin Adequate renal function: measured or calculated creatinine clearance > 60 ml/min Absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold the upper normal value Signed informed consent Exclusion Criteria: Patients infected by the Human Immunodeficiency Virus (HIV) CUP belonging to one of the following subgroups: 1) Axillary lymph node of an adenocarcinoma in a woman; 2) Serous adenocarcinoma of the peritoneum in a woman; 3) Undifferentiated carcinoma of the middle line in a young man; 4)Squamous-cell carcinoma; 5) Neuroendocrine carcinoma; 6) Bone metastases with elevated serum prostate specific antigen (PSA) in a man Patients who do not fit inclusion criteria.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Progression-free survival |  |  | 
| Toxicity |  |  | 
| Quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with Carcinoma of Unknown Primary and a Predicted Favorable Prognosis
Dynamic EchoCardiographic Optimisation REsponse Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effects of heart rate optimization and guided A-V and V-V delay from color Doppler echocardiography, in subjects affected by heart failure with reduced ejection fraction and CRT-D device wearers who did not respond to device implantation in clinical, electrophysiological, and other terms.

Official Title
-----------------
Dynamic EchoCardiographic Optimisation REsponse Study (Studio Sulla Risposta All'Ottimizzazione Dinamica Ecocardiografica)

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be 18 to 85 years of age inclusive, at the time of signing the informed consent form; Heart failure with ventricular ejection fraction left <45%; Presence of CRT-D devices in a non-responder patient for cardiac resynchronization NYHA >II; Resting heart rate <65 beats per minute; Biventricular pacing >97%. Exclusion Criteria: Age <18 and >85 years; Insufficient functional capacity to complete the tests required by the research protocol; Permanent Atrial Fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Change in the number of acute heart failure episodes | Number of worsening HF episodes requiring hospitalization | Baseline to 12 months post discharge | 
| Change in left ventricular ejection fraction (LVEF) | An echocardiogram will be performed at specific study visits and LEVF will be measured | Baseline to 12 months post discharge | 
| Echocardiofic changes of diastolic left ventricular function | An echocardiogram will be performed at specific study visits and LVESV and LVEDV will be | Baseline to 12 months post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) | This is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and quality of life limitation due to HF. Scores range from 0 to 100. For the KCCQ overall summary score, a small but clinically meaningful change is ≥ 5 points. | Baseline to 12 months post discharge | 
| Change in NYHA class | Measures of New York Heart Association functional class stratified I to IV at baseline and at each scheduled time. | Baseline to 12 months post discharge |
Air Purifier to Improve Endothelial Function and Carotid Intima Thickness

Study Overview
=================
Brief Summary
-----------------
Background: There is epidemiological evidence or link ambient air pollution exposure to the incidence of dementia. Aims or hypotheses: It is hypothesized that reduction in indoor pollutants from air purification improves endothelial function and carotid intima thickness in older diabetic people with cognitive impairment. Subjects and method: People with clinically diagnosis mild cognitive impairment or early dementia will be recruited. After obtaining written consent, the subjects will be assessed cognitive function and arterial health. After baseline measurements, the subjects are randomly assigned to have either filter or no filter installed in the air purifier. The air purifier will be placed in living room of the household of the subject for one year. At one year, the measurements will be repeated. Statistical analysis: Intention to treat analysis will be adopted.

Official Title
-----------------
A Randomized Controlled Trial of Air Purifier to Improve Endothelial Function and Carotid Intima Thickness in Older Diabetic People With Cognitive Impairment

Conditions
-----------------
Endothelial Function, Cognitive Impairment

Intervention / Treatment
-----------------
* Device: Air purifier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic people Mild cognitive impairment or early dementia Exclusion Criteria: Current smoker The presence of a smoker in the household The absence of a reliable family caregiver The lack of mental capacity to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 70 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Filter<br> | Device: Air purifier<br>* Air purifier with filter at automatic mode on all time<br>|
| No Intervention: No filter<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FMD% | Endothelial function will be assessed by Flow mediated dilatation of brachial artery | 12 months |
Physiological Parameters and Crying Time in the Newborn Bath

Study Overview
=================
Brief Summary
-----------------
Bathing is essential for maintaining and improving the health of the newborn. It has numerous beneficial effects, such as cleaning and protecting the skin, preventing infections, cleaning unwanted substances, regulating blood circulation and the respiratory system, regulating body temperature, relieving pain, providing comfort, and supporting the parent-infant bond. Although bathing has many benefits, it is a stressful experience for newborn babies. Research on the effects of bathing on babies has shown that babies experience behavioral difficulties during bathing, such as crying, restlessness, hiccups, yawning, tremors, body looseness, looseness of the extremities, facial looseness, opening of fingers, and grimacing. Bathing may also lead to some physiological responses, such as hypothermia, hypoxia, dyspnea, cyanosis, desaturation, and tachycardia.Therefore, this study aimed to determine the effect of palmar grasp reflex stimulation during neonatal bath on the physiological parameters and crying time of the newborn.

Official Title
-----------------
The Effect of Palmar Grasp Reflex Stimulation on Physiological Parameters and Crying Time in the Newborn Bath

Conditions
-----------------
Infant, Newborn

Intervention / Treatment
-----------------
* Other: Palmar Grasp Reflex Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 24 hours after birth have a gestational age over 36 not be asphyxiated Feeding at least 1-3 hours before bathing Not receiving analgesic sedation before bathing Stable vital signs Exclusion Criteria: • Ineligible for immersion tub bathing

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 28 Days

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palmar Grasp Reflex Stimulation<br> | Other: Palmar Grasp Reflex Stimulation<br>* The palmar grasp reflex is an involuntary flexion-adduction movement involving the hands and fingers.<br>|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature in Celsius |  | 12 week | 
| Respiratory rate per minute |  | 12 week | 
| Pulse per minute |  | 12 week | 
| Oxygen saturation levels in % |  | 12 week | 
| Crying time in seconds |  | 12 week |
To Demonstrate the Effect of Food on the Bioavailability of Glipizide

Study Overview
=================
Brief Summary
-----------------
To demonstrate the effect of food on the bioavailability of Glipizide.

Official Title
-----------------
The Effect of Food on the Bioavailability of Glipizide

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

Intervention / Treatment
-----------------
* Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.
* Drug: 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.
* Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast. | Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.<br> <br> |
| Active Comparator: 3<br>10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast. | Drug: 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.<br> <br> |
| Experimental: 2<br>10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast. | Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 15 days |
Respiratory Tract Inflammation in Children With Inflammatory Bowel Disease (IBD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether inflammatory bowel disease in children involve the respiratory tract as expressed by increased levels of the Fraction of exhaled Nitric Oxide (FeNO) and spirometry.

Detailed Description
-----------------
Inflammatory bowel disease, Crohn's disease (CD) and Ulcerative colitis (UC) are chronic inflammatory diseases with remissions and exacerbations. CD and UC are associated with a variety of systemic (extra-intestinal) manifestations. In some studies, clinical and subclinical pulmonary abnormalities are described in active IBD as well as in the stable situation. Nitric oxide (NO) is an important mediator of inflammation in several pathological conditions.Patients with lung diseases, like asthma, have higher levels of the Fraction of exhaled Nitric Oxide (FeNO) in active disease in comparison with healthy volunteers. One study in adult IBD patients showed increase in FeNO levels in those patients, with positive correlation with the disease activity and negative correlation between the disease activity and pulmonary functions. We hypothesised that respiratory tract inflammation as expressed by FeNO and spirometry in pediatric IBD patients will correlate to the activity of the primary disease. Methods: FeNO levels and spirometry will be assess for 40 patients with CD or UC (age 4-18 years) during remissions and exacerbations, calculated by the Pediatrics Crohn's Disease Activity Index (PCDAI) and the Pediatrics Ulcerative Colitis Activity Index (PUCAI), respectively. Two aged matched groups, the first of healthy children and the second of chronic abdominal pain will serve a controls.

Official Title
-----------------
Pulmonary Inflammation in Children With Inflammatory Bowel Disease as Expressed by the Fraction of Exhaled Nitric Oxide Levels and Spirometry

Conditions
-----------------
Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4-18 years old children diagnosed with IBD: Histological diagnosis of Crohn's disease Histological diagnosis of Ulcerative colitis Negative stool cultures Exclusion Criteria: Respiratory tract infection during the 6 weeks prior to enrollment Diagnosis of asthma Current treatment with steroids Smoking

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 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 |
| --- | --- | --- |
| Fraction of exhaled Nitric Oxide (FeNO) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry |  | 1 year |
6MWT With and Without Walker

Study Overview
=================
Brief Summary
-----------------
Elderly subjects repeated 6MWT with or without walker

Official Title
-----------------
Comparison of 6 Minute Walk Test With and Without Walker

Conditions
-----------------
Healthy, Elderly

Intervention / Treatment
-----------------
* Diagnostic Test: 6 minutes walking test with walker
* Diagnostic Test: 6 minutes walking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically stable aged over 65 years could walk did not use walker frames in routine Exclusion Criteria: criteria outlined in the European respiratory society/American thoracic society technical standard related to 6MWT impaired cognitive function

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: walker<br>'6 minutes walking test' with a walker | Diagnostic Test: 6 minutes walking test with walker<br>* to walk during 6 minutes with walker<br>|
| Active Comparator: no walker<br>'6 minutes walking test' without walker | Diagnostic Test: 6 minutes walking test<br>* to walk during 6 minutes with walker<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six minutes walking test | distance | six minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Borg scale | dyspnea | six minutes | 
| heart rate | heart beat rate | six minutes | 
| pulsed oxygen saturation | saturation pulsed oxygen | six minutes |
Rapid Computerized Visual Acuity Test

Study Overview
=================
Brief Summary
-----------------
A novel computerized visual acuity test was developed and tested on both healthy persons and patients with ocular conditions. Visual acuity outcomes of the computerized test will be compared to the Early Treatment Diabetic Retinopathy Study (ETDRS) in measures of reproducibility, accuracy and numbers of questions.

Official Title
-----------------
A Novel Rapid, Reproducible and Accurate Computerized Visual Acuity Test

Conditions
-----------------
Vision Disorders, Refractive Errors, Retinal Disease, Cataract, Corneal Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Computerized visual acuity assessment program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - age 18 years old and older Exclusion Criteria: visual acuity <0.2 decimal for the patient group visual acuity <0.5 decimal for the healthy group

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>healthy volunteers with no known ocular condition | Diagnostic Test: Computerized visual acuity assessment program<br>* Each subject underwent visual acuity assessments using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and the computerized program<br>|
| Patients<br>Subjects with diseases of the eye or the orbit | Diagnostic Test: Computerized visual acuity assessment program<br>* Each subject underwent visual acuity assessments using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and the computerized program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | visual acuity was displayed in decimal units in the computerized program and by the number of letters in the early treatment diabetic retinopathy study chart (ETDRS). | through study completion, an average of 1 year |