linjc16/ctgov huggingface dataset:
Alternate Formula Feedings in Formula Intolerant Infants

Study Overview
=================
Brief Summary
-----------------
This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.

Official Title
-----------------
Efficacy of Alternate Formula Feedings in Formula Intolerant Infants

Conditions
-----------------
Gastrointestinal Tolerance

Intervention / Treatment
-----------------
* Other: Infant Formula 1
* Other: Infant Formula 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance. Infants whose physicians had made a recommendation that the parents change the infant's feeding. Full term infants at birth with a gestational age of 37 to 42 weeks. Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams. Exclusion Criteria: Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse. Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 9 Weeks

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infant Formula 1<br>A standard commercial milk-based infant formula | Other: Infant Formula 1<br>* Feed ab libitum<br>|
| Experimental: Infant Formula 2<br>A standard commercial soy-based infant formula. | Other: Infant Formula 2<br>* Feed ab libitum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Characteristics | Parent questionnaire | Change from Baseline (Study Day 1) to Study Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formula Intake | Parent questionnaire on volume consumed | Change from Baseline (Study Day 1) to Study Day 15 | 
| Incidence of spit up/vomiting | Parent questionnaire | Change from Baseline (Study Day 1) to Study Day 15 | 
| Weight | Measured weight at visits | Change from Baseline (Study Day 1) to Study Day 15 |
Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study

Study Overview
=================
Brief Summary
-----------------
A two-step multi-centre study with 240 rheumatoid arthritis patients.

Detailed Description
-----------------
A two-step multi-centre study containing: A test-retest study including 180 patients filling in questionnaires and performing joint assessments to assess reliability of patient generated data AND An agreement study focusing on questionnaires and joint assessments performed by 60 patients, a medical student, a physician and by an ultrasound-examinator assessing agreement between the four assessors

Official Title
-----------------
Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: instruction
* Other: standard baseline instruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with RA ≥ 12 months DAS28-CRP < 5,1 Exclusion Criteria: Dementia or other linguistic/cognitive/physical deficiency that prevents participation Vision impairment that prevents the use of the devices and computer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: online instruction at followup visits<br>patients in this group will be subjected to view video instructions online prior to performing the follow-up joint scoring at home | Other: instruction<br>* online instruction tutorials at followup visits<br>|
| Active Comparator: standard baseline instruction<br>after the initial training patients in this group will not be subjected to any subsequent instructions prior to performing the follow-up joint scoring at home | Other: standard baseline instruction<br>* self-guidance at followup visits<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrarater reliability of DAS28 done by patients |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interrater agreement of DAS28CRP |  | Baseline | 
| Intrarater reliability of joints counts performed by patients |  | Baseline | 
| Intrarater reliability of joint scores performed by patients |  | 8 weeks | 
| Inter- and intrarater realiabilty of DAS38 |  | 8 weeks |
Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The primary objectives of the study are: To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD） To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.

Official Title
-----------------
A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: MT-1303
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CD (involving small intestine and/or colon), confirmed by both endoscopy and histopathology at least 3 months prior to Visit 1 Previous use of any type of corticosteroids or immunosuppressants for the treatment of CD Moderate to severe active CD defined by a CDAI score of ≥220 to ≤450 points at Visit 1 Exclusion Criteria: Diagnosis of ulcerative colitis, indeterminate colitis, pseudomembranous colitis or coeliac disease Enterocutaneous, abdominal or pelvic active fistulae, abscesses or fistulae likely to require surgery during the study GI surgery (including appendectomy) within 12 weeks prior to Visit 2 (Baseline) or has surgery planned or deemed likely to require surgery for CD during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: MT-1303<br> | Drug: MT-1303<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve a 100-point decrease from Baseline in CDAI(Crohn's Disease Activity Index) score (i.e., CDAI 100) at Visit 6 (Week 12) |  | 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease
Safety and Preliminary Efficacy of the Treatment of Kidney Allografts With Curcumin-containing Preservation Solution

Study Overview
=================
Brief Summary
-----------------
The safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin complex (CDC) solution to graft perfusion solution is studied. CDC has proved safe and highly effective in preventing primary graft non-function, delayed graft function and chronic dysfunction in pre-clinical kidney transplantation animal models. The hypothesis is that addition of CDC to the graft perfusion solution will decrease the incidence of delayed graft function in human kidney transplantation subjects.

Conditions
-----------------
End Stage Renal Failure With Renal Transplant

Intervention / Treatment
-----------------
* Device: CDC solution
* Device: UW-solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ESRD assigned for kidney transplantation, written informed consent Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CDC graft perfusion<br>Flushing of kidney allografts prior to transplantation with UW-solution containing CDC | Device: CDC solution<br>* 2 ml of CDC 12/mg/ml is added to 1 l of UW solution. 500 ml of of this solution is used for flushing the kidney allograft prior to transplantation<br>* Other names: Curcumin-cyclodextrin;|
| Sham Comparator: Sham perfusion<br> | Device: UW-solution<br>* 500 ml of UW solution is used for flushing the kidney allograft prior to transplantation<br>* Other names: Viaspan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed Graft Function |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary non-function |  | 1 year | 
| Acute rejection |  | 1 year | 
| Graft function eGFR |  | 30 days, 90 days | 
| Graft Survival |  | 1 year | 
| Patient Survival |  | 1 year | 
| Length of stay in hospital |  | upto 1 year |
Study of Homocysteine Metabolism in Homocystinuria

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine basal and postmethionine plasma homocysteine in patients with premature vascular disease, cystathionine beta-synthase (CBS) or methylenetitrahydrofolate reductase (MTHFR) deficiency, and in obligate heterozygotes for CBS or MTHFR. II. Determine whole-body homocysteine metabolic rates with isotopically-labeled methionine.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a two-part study of homocysteine metabolism. Age-matched normal controls are entered in both parts of the study. In first part of the study, participants are given oral methionine; baseline and postmethionine studies include amino acid quantitation, analysis of rapidly deproteinized plasma, and total plasma homocysteine. In the second part of the study, participants (men and postmenopausal women only) undergo methionine tracer studies.

Conditions
-----------------
Homocystinuria

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Known or suspected homocystinuria Cystathionine beta-synthase-deficient homocystinuria Obligate heterozygotes for cystathionine beta-synthase deficiency Premature vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
homocystinuria, inborn errors of metabolism, rare disease
Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study was to determine the ability of cardiac magnetic resonance (CMR) to identify cardiac involvement in patients with sarcoidosis. Patients were to undergo CMR in addition to routine clinical evaluation.

Detailed Description
-----------------
In patients with sarcoidosis, cardiac death is a leading cause of mortality which may represent unrecognized cardiac involvement. Cardiovascular magnetic resonance (CMR) can detect cardiac involvement including minute amounts of myocardial damage. Therefore, the objective of this study was to determine the usefulness of CMR and compare it with standard clinical evaluation for cardiac involvement. Patients with documented extracardiac sarcoidosis or clinically suspected cardiac sarcoidosis will be enrolled.

Official Title
-----------------
Detection and Prognostic Significance of Myocardial Damage Visualized by Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

Conditions
-----------------
Sarcoidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven sarcoidosis Suspected cardiac sarcoidosis Exclusion Criteria: Contraindication to MRI

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 |
| --- | --- | --- |
| cardiac mortality |  | > 1year | 
| arrhythmic death |  | > 1year | 
| Pulmonary mortality | only in subset of patients with pulmonary sarcoidosis | > 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | > 1year | 
| arrhythmic events |  | > 1year | 
| Pulmonary Transplant |  | > 1 year | 
| Cardiac Transplant |  | > 1 year | 
| PPM placement/high grade AV block |  | > 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcoidosis, Cardiac Magnetic Resonance
Alere Mycobacterium Tuberculosis Urine Study

Study Overview
=================
Brief Summary
-----------------
Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis specific nucleic acid in urine and blood of patients.

Official Title
-----------------
Evaluation of Various Methods for the Detection of Mycobacterium Tuberculosis Nucleic Acid

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected or confirmed tuberculosis Age >18 years informed consent obtained Exclusion Criteria: Previous participation in the study Simultaneous participation in a clinical trial investigating a new drug Inability to give consent Member of a vulnerable study population

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 |
| --- | --- |
| TB suspects with alternative final diagnosis<br> | |
| Confirmed tuberculosis patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity | ROC analysis to determine the best specificity and sensitivity to differentiate between patients with tuberculosis and patients with an alternative diagnosis | On admission to hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis, Urine, Nucleic acid, Alere, Borstel
Factors Contributing To Cardiovascular Morbidity and Mortality in Patients With Gastrointestinal Bleeding

Study Overview
=================
Brief Summary
-----------------
The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease.

Detailed Description
-----------------
The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease. This study will be conducted at MMC and involve collecting your clinical information from our medical records and computer systems. Approximately 200 adult patients with acute coronary heart disease and acute digestive tract bleeding admitted to MMC will be enrolled and followed up for 1 year after recruitment. We propose to develop criteria and a scoring system that will assist your doctors in caring for patients like you in the future.

Official Title
-----------------
Factors Contributing To Cardiovascular Morbidity and Mortality in Patients With Gastrointestinal Bleeding

Conditions
-----------------
Gastrointestinal Bleeding, Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with acute CS and acute GI bleeding
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute gastrointestinal bleeding, Acute coronary syndrome
Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting

Study Overview
=================
Brief Summary
-----------------
For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting.

Official Title
-----------------
A Phase 2 Randomized, Controlled, Open-label (Dose-blinded), Multi-center, Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting.

Conditions
-----------------
Tibia Plateau Fractures

Intervention / Treatment
-----------------
* Drug: I-0401 (a new bone graft substitute)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiological evidence of a tibial plateau fracture requiring grafting Females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening). Exclusion Criteria: Concomitant ipsilateral fractures of the limb other than the fracture of the tibial plateau. Active or past history of malignant tumor. Evidence of systemic or localized infection at time of surgery. Pregnant or lactating females.

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: 1<br>Experimental - high dose | Drug: I-0401 (a new bone graft substitute)<br>* 1 time application<br>|
| Experimental: 2<br>Experimental - low dose | Drug: I-0401 (a new bone graft substitute)<br>* 1 time application<br>|
| Active Comparator: 3<br>Autograft | Drug: I-0401 (a new bone graft substitute)<br>* 1 time application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Images |  | All Follow-Up Visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessments of the fracture site |  | All Follow-Up Visits | 
| Blood parameters |  | All Follow-Up Visits | 
| Vital signs |  | At several Follow-Up visits | 
| Questionnaires of Life |  | All Follow-Up Visits | 
| Pharmacoeconomic evaluation |  | All Follow-Up Visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone graft substitute, Promotion of bone healing