linjc16/ctgov huggingface dataset:
Probiotics and Intestinal Microbiome in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is associated with increased feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial populations and decrease intestinal disease in preterm infants. There is limited data linking clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW preterm infants. Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the other no) of infants less than 1000 grams birth weight and < 29 weeks gestation. A comparison of stool microbiome analysis and the incidence of feeding intolerance and time to reach full feeds in the two groups will be made.

Official Title
-----------------
Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?

Conditions
-----------------
Microbial Colonization

Intervention / Treatment
-----------------
* Dietary Supplement: Florababy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born less than 29 weeks gestation and <1000 g birth weight admitted to the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre in Calgary. Exclusion Criteria: Infants with major congenital anomalies, hypoxic-ischemic injury, NEC or bowel perforation before 72 hours of life.

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 29 Weeks

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Florababy probiotic (0.5g per day) will be started at or after 72 hours of life and will be administered in 1ml sterile water prior to feed. | Dietary Supplement: Florababy<br>* Probiotic supplement<br>|
| No Intervention: Control<br>Standard of care arm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Microbiome | difference in stool microbiome after Florababy or no drug administration | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Microbiome | difference in stool microbiome after Florababy or no drug administration | 2 weeks | 
| Feeding intolerance | Incidence of feeding intolerance | 4-6 weeks | 
| Full Feeds | Time to reach full feeds. | 4-6 weeks |
French National Registry of Children Born Small for Gestational Age Treated With Somatropin

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)

Official Title
-----------------
French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)

Conditions
-----------------
Growth Disorder, Small for Gestational Age

Intervention / Treatment
-----------------
* Drug: somatropin
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born small for gestational age
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase I<br> | Drug: somatropin<br>* Patients are to fill in a questionnaire at inclusion in registry<br>|
| Phase II<br> | Drug: somatropin<br>* Patients are to fill in a questionnaire 6 months after inclusion into registry and then annually until adult height is reached<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth in height |  | 6 months after inclusion into registry and then annually until adult height is reached | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure: Systolic and diastolic |  | 6 months after inclusion into registry and then annually until adult height is reached | 
| Bone age |  | 6 months after inclusion into registry and then annually until adult height is reached | 
| Insulin-Like Growth Factor 1 (IGF-1) |  | 6 months after inclusion into registry and then annually until adult height is reached |
Non-Invasive Estimation of Hemoglobin Levels in Blood Using Combined Deep Learning Methods

Study Overview
=================
Brief Summary
-----------------
Hemoglobin is an important protein that gives the blood its red color and helps transport oxygen to organs. There are quite a lot of people in the world who need to have their hemoglobin levels checked regularly, especially anemia patients. It is important to keep the hemoglobin levels in the blood of these individuals under control. For this, it is necessary to measure in frequent periods. A large group, from adults to children, needs to take these measurements. Most of these are invasive measurements made with blood that require devices and trained people. These painful methods are quite uncomfortable. In this study, non-invasive hemoglobin level measurement was aimed with a combined DL model created by using nail images with age, height, weight, BMI, and gender information of the volunteers.

Official Title
-----------------
Non-Invasive Estimation of Hemoglobin Levels in Blood Using Combined Deep Learning Methods

Conditions
-----------------
Hemoglobin Level Measurement, Hemoglobin Level Estimation

Intervention / Treatment
-----------------
* Diagnostic Test: hemoglobin estimation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals need to be healthy. Individuals should not have any active hand or nail disease. Individuals should know their hemoglobin level. Exclusion Criteria: -In case of any condition that hides the natural nail color, such as henna, nail polish, protective or trauma-induced dents, bruises on the nails of individuals, it is removed from the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: hemoglobin estimation|In this method, in which different deep learning models are used together, the age range is intended to be as wide as possible to provide a quick solution with a high accuracy and low error values.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bland-Altman analysis | Bland-Altman analysis was performed to make the results simpler and more understandable. This analysis is especially used in the simple and graphical expression of measurements in which two methods are compared. | 1 day | 
| Estimation accuracy analysis | It is an analysis that compares the estimated hemoglobin values with the measured hemoglobin values. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-invasive, deep learning, hemoglobin level estimation
Phase II Study of Ribose, Uridine, and Thymidine for a Complex Syndrome Involving Excessive 5'-Nucleotidase Activity

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the efficacy of oral ribose in patients with a complex 5'-nucleotidase syndrome who have not received uridine (UR) and thymidine (TDR). II. Evaluate the efficacy of UR/oral ribose and UR/TDR. III. Evaluate the efficacy of oral ribose given in combination with UR/TDR.

Detailed Description
-----------------
PROTOCOL OUTLINE: Newly identified patients receive ribose daily for 8 weeks. Patients who improve continue therapy. If improvement then reaches a plateau, uridine (UR) and thymidine (TDR) are added to the regimen. Patients who receive no benefit after 8 weeks of ribose are treated with UR/TDR. Patients who improve after 8 weeks of this combination continue therapy. Ribose is added to the treatment regimen for patients on UR/TDR at entry. At maximal improvement, TDR and UR are sequentially tapered.

Conditions
-----------------
5'-Nucleotidase Syndrome

Intervention / Treatment
-----------------
* Drug: ribose
* Drug: thymidine
* Drug: uridine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Complex syndrome with excessive skin fibroblast 5'-nucleotidase activity characterized by: Recurrent infection Seizure disorder Speech impairment Attention deficit and behavior problems --Prior/Concurrent Therapy-- Concurrent uridine and thymidine therapy allowed --Patient Characteristics-- Other: No pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ribose|nan|
|Drug: thymidine|nan|
|Drug: uridine|nan|

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
-----------------
5'-nucleotidase syndrome, inborn errors of metabolism, rare disease
Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

Study Overview
=================
Brief Summary
-----------------
This research is being done to study whether using of topical tretinoin can help prevent the common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I) medications such ascetuximab or erlotinib. Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and topical or oral antibiotics. However, there has not yet been a study looking at a way to prevent this common side effect from occurring, and topical tretinoin may be useful in reducing the rash. Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing rashes associated with EGFR-I's.

Official Title
-----------------
Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin

Conditions
-----------------
Medication Reaction

Intervention / Treatment
-----------------
* Drug: Tretinoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or over Scheduled to begin treatment with an EGFR inhibitor drug Exclusion Criteria: Pregnant or nursing History of bleeding disorder History of keloids or large, thick, puffy-looking scars in the last 10 years Used topical retinoids in the last year (e.g. tretinoin/Retin-A, adapalene/Differin, tazarotene/Tazorac)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tretinoin pre-treatment<br> | Drug: Tretinoin<br>* tretinoin 0.025% cream<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EGFRi rash severity |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, chemotherapy, EGFR inhibitors, tretinoin, EGFRi drug rash
Influence of Drainage on EVD ICP-signal

Study Overview
=================
Brief Summary
-----------------
This observational study investigates ICP signals obtained through an external ventricular drain in the brain connected with an external transducer. In particular, the study investigates how drainage influences the monitored signal: influence of flow rate, reservoir height and initial ICP before draining.

Official Title
-----------------
Influence of Drainage of Cerebrospinal Fluid on ICP Signals Obtained Through an External Ventricular Drain.

Conditions
-----------------
Head Injury, Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TBI/SAH patients with need for ICP monitoring Exclusion Criteria: -
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 |
| --- | --- | --- |
| ICP signal changes | changes in magnitude and amplitude of ICP pulse during drainage of CSF | immediate during drainage | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intracranial pressure, cerebrospinal fluid drainage, waveform analysis
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.

Study Overview
=================
Brief Summary
-----------------
To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.

Official Title
-----------------
Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury

Conditions
-----------------
Brain Injuries

Intervention / Treatment
-----------------
* Drug: Genotropin (PN-180,307) Somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have had a previous traumatic brain injury (more than 1 year and less than 5 years) prior to the screening visit. Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5. Exclusion Criteria: Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers. Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Genotropin (PN-180,307) Somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the change from baseline in the CogState™ composite score at Week 36. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change CogState™ at Week 12, 24, 60 and 72. Change in lean body mass and fat mass at Week 36 and 72. Change in the Extended Glasgow Outcome Scale at week 36 and 72. Change in quality of life at week 24, 36, 60 and 72. Summary of change in cardiovascular |  |  |
How Does Altering the Timing of Pre-exercise Low-dose Caffeine Ingestion Affect Endurance Exercise Performance

Study Overview
=================
Brief Summary
-----------------
Investigate how manipulating the time between caffeine ingestion and exercise may alter exercise performance and cognition

Official Title
-----------------
How Does Altering the Timing of Pre-exercise Low-dose Caffeine Ingestion Affect Endurance Exercise Performance

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

Intervention / Treatment
-----------------
* Other: Caffeine powder -60
* Other: Caffeine powder -30
* Other: Caffeine powder 0
* Other: Placebo powder -60
* Other: Placebo powder -30
* Other: Placebo powder 0


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: vo2max > 55 ml/kg/min females on contraceptive pill Exclusion Criteria: recent skeletal muscle injury cardiovascular injury metabolic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caffeine -60<br>Caffeine at 60 minutes prior to time trial | Other: Caffeine powder -60<br> <br> Other: Placebo powder -30<br> <br> Other: Placebo powder 0<br> <br> |
| Active Comparator: Caffeine -30<br>Caffeine at 30 minutes prior to time trial | Other: Caffeine powder -30<br> <br> Other: Placebo powder -60<br> <br> Other: Placebo powder 0<br> <br> |
| Active Comparator: Caffeine 0<br>Caffeine immediately prior to time trial | Other: Caffeine powder 0<br> <br> Other: Placebo powder -60<br> <br> Other: Placebo powder -30<br> <br> |
| Placebo Comparator: Placebo<br>Placebo drink at all time points | Other: Placebo powder -60<br> <br> Other: Placebo powder -30<br> <br> Other: Placebo powder 0<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work done in kilojoules (kJ) during a 15 minute time trial on a cycle ergometer |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole body fuel substrate utilisation measured using indirect calorimetry |  | 10 minutes | 
| Change in plasma caffeine concentration and metabolites |  | 2 hours 45 minutes | 
| Change in cognitive function measured using stroop test |  | 2 hours 45 minutes | 
| Collection of saliva for genotyping of CYP1A2 |  | 30 mintes |
Association of Vitamin D, Parathyroid Hormone and Fibroblast Growth Factor-23 With Infarction-related Arrhythmia in Patients With Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of vitamin D deficiency on the development of arrhythmia in patients with acute myocardial infarction.

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥20 years diagnosed with acute myocardial infarction (confirmed by cardiac enzyme and EKG) subjects who agreed with informed consent Exclusion Criteria: previous history of arrhythmia before onset of acute myocardial infarction currently taking anti-arrhythmic drugs severe condition of comorbid diseases that can cause more serious effects on patients than acute myocardial infarction does (e.g., cancer, cerebrovascular diseases, acute bleeding etc.)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| SACS cohort<br>patients with acute myocardial infarction at Severance hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Events of acute myocardial infarction-associated arrhythmia | incidence of acute myocardial infarction-associated arrhythmia types of arrhythmia, duration of arrhythmia, persistence of arrhythmia | first 48 hours after onset of acute myocardial infarction |
Phase II Study of KWA-0711 in Patients With Chronic Constipation (CC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of KWA-0711 in Chronic Constipation (CC) patients.

Official Title
-----------------
Phase II, Randomized, Open-label Study of KWA-0711 Administrated Orally for 2 Weeks to Evaluate Its Safety and Efficacy in Patients With Chronic Constipation (CC)

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: KWA-0711


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who experienced fewer than three Spontaneous Bowel Movements (SBMs) per week for more than 6 months prior to the enrollment The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation Exclusion Criteria: Patients who have secondary constipation caused by systemic disorder Patients who have organic constipation Patients who received intestinal resection

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

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

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: KWA-0711 High dose<br> | Drug: KWA-0711<br> <br> |
| Experimental: KWA-0711 Low dose<br> | Drug: KWA-0711<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting and postprandial blood glucose levels |  | 2 weeks | 
| Change in fasting and postprandial insulin levels |  | 2 weeks | 
| ECGs, vital signs, and clinical labs |  | 2 weeks | 
| Improvement of signs and symptoms associated with constipation |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CC, Chronic Constipation