linjc16/ctgov huggingface dataset:
Physical Exercise and Coronary Artery Plaque Composition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of two different physical exercise protocols on changes in coronary artery plaque composition and development of in-stent restenosis in patients treated with percutaneous coronary intervention with stent implantation. The investigators will compare aerobic interval training and moderate continuous training. Both exercise protocols have a duration of 12 weeks. The investigators hypothesize that aerobic interval training is superior to moderate continuous training regarding effects on the composition of coronary artery plaques and a reduction in the development of in-stent restenosis.

Official Title
-----------------
Physical Exercise and Coronary Artery Plaque Composition

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Behavioral: Moderate continuous training
* Behavioral: Aerobic interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable or unstable coronary artery disease treated with percutaneous coronary intervention with stent implantation, informed patient consent Exclusion Criteria: ST-elevation myocardial infarction, inability to give informed consent, inability to participate in regular training due to residency, work situation or comorbidity, any known chronic inflammatory disease other than atherosclerosis, planned surgery within the next four months
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: Aerboic interval training<br> | Behavioral: Aerobic interval training<br>* Three training sessions per week in a total of 12 weeks<br>|
| Active Comparator: Moderate continuous training<br> | Behavioral: Moderate continuous training<br>* Three training sessions per week in a total of 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Artery plaque composition evaluated by intravascular ultrasound and virtual histology | Findings at 12 weeks will be compared to baseline results | After 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of in-stent restenosis related to endothelial dysfunction, inflammatory biomarkers and the dimension of the main left coronary artery | Findings at 12 weeks will be compared to baseline results | After 12 weeks |
Iron Status and Myelination in Premature Infants

Study Overview
=================
Brief Summary
-----------------
Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.

Official Title
-----------------
Double Blind Randomized Placebo Controlled Trial of Iron Supplementation in Premature Infants

Conditions
-----------------
Neurodevelopmental Outcome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Babies less than or equal to 33 weeks gestational age Exclusion Criteria: Infants with cranio-facial malformations Torch infections Infants with hearing disorders Infants receiving erythropoietin Infants with subnormal vitamin E levels Infants with severe anemia Infants who are not on full feeds Infant with in-utero exposure to cocaine

Ages Eligible for Study
-----------------
Maximum Age: 32 Weeks

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

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 |
| --- | --- |
| Placebo Comparator: 1<br>low iron dose | Dietary Supplement: iron<br>* High, intermediate and low iron dosage orally for 2 months<br>|
| Active Comparator: 2<br>intermediate iron dose | Dietary Supplement: iron<br>* High, intermediate and low iron dosage orally for 2 months<br>|
| Experimental: 3<br>High Iron dose | Dietary Supplement: iron<br>* High, intermediate and low iron dosage orally for 2 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean interpeak latency Auditory Neural Myelination | This will be measured using auditory brain stem response. | 43-45 weeks PMA | 
| mean visual neural myelination | Visual myelination will be evaluated by visual evoked response. | 43-45 weeks PMA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with executed function | Using a standardize test. | 3-5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premature infants iron neurodevelopment
An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose.

Detailed Description
-----------------
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Official Title
-----------------
A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With Avonex

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
-----------------
* Drug: Betaferon/Betaseron
* Drug: Betaferon/Betaseron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RRMS patients that are receiving treatment with Avonex 30 µg once weekly Exclusion Criteria: Primary Progressive or Secondary Progressive MS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Arm 1<br> | Drug: Betaferon/Betaseron<br>* Betaseron 250 µg SC every other day<br>|
| Active Comparator: Arm 2<br> | Drug: Betaferon/Betaseron<br>* Avonex 30 µg IM once per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of first relapse |  | Time to onset of first relapse | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients relapse free at week 104 |  | At week 104 |
Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Study Overview
=================
Brief Summary
-----------------
Swallowing dysfunction and delay of oral feeding skills in premature infants significantly delay discharge from the hospital. Thickening oral formula or breast milk feeds with commercial thickeners and rice cereal has been used in some nurseries with the goal of promoting development of adequate feeding skills. The objective of this pilot study is to examine the effect of thickened feeds on premature infants with oral feeding difficulties due to dysfunction secondary to immature swallowing. Hypotheses: Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in 32-40 weeks gestational age infants when compared to non-thickened feeds Thickened feeds will promote transition to hospital discharge.

Official Title
-----------------
Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Conditions
-----------------
Swallowing Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: Simply Thick


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: apneas and bradycardias with oral feedings oxygen desaturations with oral feedings excessive coughing or gagging with oral feedings Exclusion Criteria: less than 32 weeks adjusted gestational age greater than 40 weeks adjusted gestational age

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thickening of feeds<br> | Dietary Supplement: Simply Thick<br>* Simply Thick® added to each bottle of formula or beast milk to create nectar or honey consistency<br>* Other names: Simply Thick®;|
| No Intervention: Removal of thickener<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination of symptoms associated with immature swallowing |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Promotes transition to discharge from hospital |  | one week |
Intergenerational Transmission of Terror

Study Overview
=================
Brief Summary
-----------------
Our aim is examine avenues by which mothers can transmit their trauma to their children.

Detailed Description
-----------------
The goal of the study is to test for genetic bases and Gene x Environment interactions on the development of difficulties, particularly stress disorders, in young children whose mother were exposed to terror before they were born.

Official Title
-----------------
The Intergenerational Transmission of Trauma From Terror: A Developmental Perspective

Conditions
-----------------
Anxiety, Trauma, Stress Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who were exposed to terror in the last 5 years Matched Controls Exclusion Criteria: Does not speak Hebrew or English
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma, anxiety, antenatal, mothers, children, Gene x Environment Interaction
Respiratory Muscle Function After Thyroid Hormone Replacement Therapy in Nonthyroidal Illness Syndrome

Study Overview
=================
Brief Summary
-----------------
Although it is now recognized that a variety of respiratory abnormalities, such as diaphragmatic dysfunction, can be present in primary hypothyroidism and reverse with adequate hormone treatment, the role of thyroid hormone replacement therapy on respiratory system in patients with the nonthyroidal illness syndrome (NTIS) remains to be clarified. The NTIS has been found to be an independent risk factor for prolonged (> 13 days) mechanical ventilation. It is unclear, however, whether the NTIS is only a biochemical prognostic marker or it actually contributes to the development and progression of respiratory failure. The aim of this study will be to assess respiratory muscle function after thyroid hormone substitution therapy in mechanically ventilated patients with the NTIS.

Official Title
-----------------
Diaphragmatic Efficiency After Thyroid Hormone Replacement Therapy in Ventilated Patients With the Nonthyroidal Illness Syndrome: a Physiological Study

Conditions
-----------------
Thyroid Diseases, Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients under mechanical ventilation for more than 48 hours who experience a spontaneous breathing trial and have a diagnosis of nonthyroidal illness syndrome Exclusion Criteria: • age <18 yr; pregnancy or estro-progestinic therapy; tracheostomy; neurological or neuromuscular pathology and/or known phrenic nerve dysfunction; previously diagnosed intrinsic thyroid disease; known or suspected pituitary-hypothalamic disease; severe obesity; ischemic cardiopathy; complex ventricular arrhythmias; serum cortisol level below 80 ng/ml; renal or hepatic failure (respectively, creatininemia ≥ 3.5 mg/dL and bilirubinemia ≥ 6.0 mg/dL); transfusion of plasma within 48 h prior to thyroid hormone assessment; use of amiodarone in the previous 8 weeks; use of iodine contrast agents in the previous 8 weeks; hemodialysis; expected poor outcomes

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline neuromechanical efficiency (obtained immediately before starting thyroid hormone therapy) at 3, 6, and 24 hours |  | 24 hours (study points at 3, 6, and 24 hours) |
A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
To investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks.

Official Title
-----------------
A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared With Latanoprost 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (Angel-J1 Study)

Conditions
-----------------
Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: STN1012600 ophthalmic solution 0.002%
* Drug: Latanoprost ophthalmic solution 0.005%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older. Diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT. Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better in each eye. Exclusion Criteria: Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye. History of severe ocular trauma in either eye. Any condition that prevents clear visualization of the fundus in either eye. Known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications. History of ocular surgery specifically intended to lower IOP in either eye. History of keratorefractive surgery in either eye. Females who are pregnant, nursing, or planning a pregnancy. Subjects with known or suspected drug or alcohol abuse. Participation in other investigational drugs or device clinical trials within 30 days prior to Screening. Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STN1012600 0.002%<br> | Drug: STN1012600 ophthalmic solution 0.002%<br>* 1 drop STN1012600 ophthalmic solution 0.002% once daily for 3 months<br>|
| Active Comparator: Latanoprost 0.005%<br> | Drug: Latanoprost ophthalmic solution 0.005%<br>* 1 drop Latanoprost ophthalmic solution 0.005% once daily for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean diurnal intraocular pressure | Change from baseline in mean diurnal intraocular pressure at Week 4 | 4 weeks |
Acne Detection Software (AcneDect)

Study Overview
=================
Brief Summary
-----------------
This study is to create a self-learning software that can detect acne lesions. Patients take a picture of their face every single day for 3 months with a secure mobile phone and fill out a pre-designed questionnaire. After 3 months, the mobile will be collected back and the pictures will be evaluated by 3 dermatologists. The software is able to learn from the dermatologists' evaluation and -using machine learning- a mechanism that should be able to automatically detect acne to some extent will be established.

Official Title
-----------------
Acne Detection Software (AcneDect); AcneDect: a Software to Detect Acne Lesions

Conditions
-----------------
Acne Lesions, Acne Vulgaris

Intervention / Treatment
-----------------
* Other: Self- learning software that can detect acne lesions
* Other: Patient reported outcomes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acne vulgaris Exclusion Criteria: Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Self- learning software that can detect acne lesions|Self- learning software that can detect acne lesions from patients who take a picture of their face every single day for 3 months with a secure mobile phone.|
|Other: Patient reported outcomes|Collection of patient reported outcomes and clinical data via a mobile electronic case report form|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pictures to train the AcneDect software | Collection of pictures to train the AcneDect software to detect change in acne lesions | every single day from baseline for 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AcneDect questionnaire regarding acne burden (Visual Analogue Scale (VAS) scale ranging from Not bad at all to Very bad) | Collection of patient reported outcomes via a mobile electronic case report form | every single day from baseline for 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
machine learning, self-learning software, image-detecting software
Endoscopic Resection of Bladder Tumors

Study Overview
=================
Brief Summary
-----------------
To confirm the benefit of endoscopic resection under fluorescence and blue light of high grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection recommended nowadays can be deleted.

Official Title
-----------------
Endoscopic Resection of High Grade(TA, T1, Cis)Non-muscle Invasive Bladder Tumors: Modification of Usual Management of This Resection by Using the Blue Light and Evaluation of the Outcome: Should we Maintain the Dogma of Second Endoscopic Resection as a Principle?

Conditions
-----------------
Bladder Tumor

Intervention / Treatment
-----------------
* Other: Endoscopic resection under blue light (Hexvix®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 18 year-old and older male and female subjects having high grade non-muscle invasive bladder tumor, with urinary cytology , imaging examination (Ultrasound, urography, or scan) and endoscopic examination Exclusion Criteria: - Less than 18 years of age, and having no: Non-muscle invasive tumor, and of low grade. Bladder tumor infiltrating the muscular layer shown by pre-operative test, with absence of urinary cytology No blue light source in sustainable way

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resection under blue light<br> | Other: Endoscopic resection under blue light (Hexvix®)<br>* Endoscopic resection<br>|
| Active Comparator: Resection under white light<br> | Other: Endoscopic resection under blue light (Hexvix®)<br>* Endoscopic resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of extra lesions revealed by blue light compared to the resection performed in white light |  | 2 to 6 weeks after resection |