linjc16/ctgov huggingface dataset:
The Effect of Feeding Infant Formula With Enriched Protein Fractions in the US

Study Overview
=================
Brief Summary
-----------------
This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.

Official Title
-----------------
The Effect of Feeding Infant Formula With Enriched Protein Fractions

Conditions
-----------------
Declarative Memory

Intervention / Treatment
-----------------
* Other: Cow's milk-based infant formula
* Other: Cow milk-based infant formula with enriched protein fractions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton, 0-90 days of age at randomization Term infant with birth weight of a minimum of 2500 grams Receiving at least 75% of the recommended caloric intake from cow's milk-based infant formula Parent or legally authorized representative attending study visits reads, understands, and speaks English Signed Informed Consent and Protected Health Information authorization Exclusion Criteria: History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised Feeding difficulties or formula intolerance Infant born small for gestational age Infant born from a mother who was diabetic at childbirth History of seizures or neurological disorders or infant with known head/brain disease/injury

Ages Eligible for Study
-----------------
Maximum Age: 90 Days

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cow's milk-based infant formula<br> | Other: Cow's milk-based infant formula<br> <br> |
| Experimental: Cow milk-based infant formula with enriched protein fractions<br> | Other: Cow milk-based infant formula with enriched protein fractions<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequence Recall using 3-dimensional props |  | 365 days of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalogram response to stimuli |  | 180 days of age | 
| Sequence Recall using 3-dimensional props |  | 300 days of age | 
| Infant Behavior Questionnaire Revised, Short |  | 240 days of age | 
| MacArthur-Bates Communication Development Inventory |  | 365 days of age | 
| Bayley Scales of Infant and Toddler Development, Third Edition |  | 365 days of age | 
| Achieved Weight |  | 52 weeks | 
| Achieved Length |  | 52 weeks | 
| Achieved Head Circumference |  | 52 weeks | 
| Formula Intake |  | 52 weeks | 
| Medically-confirmed Adverse Events |  | 52 weeks |
Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to assess the effect of 1) redesigned immunization card, 2) center-based education to mothers, and 3) redesigned card with center-based education to mothers, provided at DPT1, on DPT3 completion in a randomized controlled trial at rural Expanded Programme on Immunization (EPI) centers in Karachi, Pakistan.

Official Title
-----------------
A Randomized Controlled Trial of Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule in a Low Literacy Population in Pakistan

Conditions
-----------------
Childhood Immunization Completion, Childhood Immunization Dropout, Immunization Card, Center Based Education

Intervention / Treatment
-----------------
* Other: Redesigned immunization card
* Other: Center based education to mothers/caregivers
* Other: Redesigned immunization card with center based education to mother/caregivers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children visiting the selected EPI centers for DPT1 immunization Exclusion Criteria: Not residing in the same area for last six months.

Ages Eligible for Study
-----------------
Maximum Age: 365 Days

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Redesigned immunization card | Other: Redesigned immunization card<br>* A low cost nad simplified redesigned immunization card<br>|
| Experimental: 2<br>Center based education to mothers/caregivers | Other: Center based education to mothers/caregivers<br>* A 2-3 minute center based education to mothers/caregivers<br>|
| Experimental: 3<br>Redesigned immunization card with center based education to mothers/caregivers | Other: Redesigned immunization card with center based education to mother/caregivers<br>* Redesigned immunization card with center based education to mother/caregivers<br>|
| No Intervention: 4<br>Standard care only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study outcome in each study group was the immunization status categorized into DPT3 completed and DPT3 not completed. |  | 90 day follow-up after enrollment at DPT1 visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunization dropout, Immunization card, Center based education
Evaluation of Prostate-Specific Antigen (PSA) Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide

Study Overview
=================
Brief Summary
-----------------
Prospective, non-comparative, non-interventional, observational study to collect and analyse real life environment data on advanced prostate cancer patients receiving combination treatment of medical or surgical castration and bicalutamide according to routine medical practice in Croatia. The main aim is to evaluate change of PSA level and prescribing practices based on prostate cancer stage.

Official Title
-----------------
Non-interventional Observational Study to Evaluate Change of PSA Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide in Combination With Medical or Surgical Castration

Conditions
-----------------
Advanced Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of advanced prostate cancer Patients who are already treated with bicalutamide for at least 4 weeks and maximum 12 weeks Patients capable of signing ICF Exclusion Criteria: Patients with hypersensitivity to bicalutamide Patients on therapy with terfenadin, astemizol or cisapride Participation in a clinical study during the last 30 days

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

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

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 |
| --- | --- | --- |
| To evaluate change in PSA level following 4-9 months of bicalutamide therapy |  | PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bicalutamide prescribing practice based on prostate cancer stage |  | 1 measure (at the time of bicalutamde th introduction) | 
| to evaluate PSA level after 4-12 weeks of bicalutamide therapy |  | PSA - 1 measures (1-3 m following bicalutamide) | 
| to asses time to disease progression based on PSA values |  | PSA - 3 measures (at the time of bicalutamdie introduction, 1-3 m and 4-9 m following bicalutamide) | 
| to evaluate percentage of patients with disease progression |  | 2 measures at 1st and 2nd visit | 
| to evaluate withdrawals due to adverse events |  | 2 measures, at 1st and 2nd visit | 
| to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription |  | 2 measures, at 1st and 2nd visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PSA, bicalutamide, advanced prostate cancer
Adherence to Opioids in Oncology Out Patients

Study Overview
=================
Brief Summary
-----------------
Cancer pain is undertreated despite a good access to opioids in France. Although many factors are involved, the barriers related to the patient (and his family) are often reported .the reluctance of the patient or the family to take the prescribed medication is linked to misconceptions about the opioids , cultural barriers; or the lack of explanations provided by the physician. Some patients can have undiagnosed slight cognitive impairment .The situation is now more complicated as appear on the market the new form of opioids for the cancer breakthrough pain drug, adding one more opioid formulation in the prescription. The goal of the study is to measure the adherence to opioids in cancer out patients and the associated factors.

Official Title
-----------------
Adherence to Opioids in Oncology Out Patients

Conditions
-----------------
Cancer Out Patients With Opioids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer out patients with opioids by mouth prescription Prescription than more than 8 days Exclusion Criteria: Patient not at home, but in nursing home or other setting were the treatment are given by medical staff Patient unable to answer at the questionnaire Opoids given Intravenous or other way than mouth.

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 |
| --- | --- | --- |
| Rate of cancer out patients with a low adherence to the opioids treatment |  | One day |
TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
Clinical studies have established that implantation of bone marrow mononuclear cells (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases collateral vessel formation. We, the investigators at Nagoya University, further investigated the efficacy and safety of autologous implantation of BM-MNCs or PB-MNCs in patients with severe ischaemic limbs who have no other alternative therapeutic options. We also examined a potential limiting factor which reduced the efficacy of therapeutic angiogenesis using cell transplantation (TACT).

Official Title
-----------------
Therapeutic Angiogenesis Using Cell Transplantation (TACT) Study at Nagoya

Conditions
-----------------
Buerger Disease, Arteriosclerosis Obliterans

Intervention / Treatment
-----------------
* Procedure: Autologous Bone Marrow Mononuclear Cell Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have chronic limb ischemia, including rest pain, non-healing ischemic ulcers, or both, and who are not candidates for nonsurgical or surgical revascularisation. Exclusion Criteria: Poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] > 6.5% and proliferative retinopathy) Evidence of malignant disorder during the past 5 years Subjects who cannot survive more than 1 year with other complications Malignant rheumatic arthritis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Autologous Bone Marrow Mononuclear Cell Implantation|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
-----------------
critical limb ischemia, bone marrow mononuclear cells, angiogenesis, vasculogenesis, Arteriosclerosis Obliterans (ASO), Ischemic ulcers
Exercise Perceptions and Preferences Among Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to analyse exercise behaviour of rheumatoid arthritis patients.

Official Title
-----------------
Perceived Exercise Benefits, Barriers and Preferences Among Swiss Rheumatoid Arthritis Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis Age 30 to 80 years Exclusion Criteria: Language difficulties and no help from family members or friends

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- |
| RA patients<br>Patients with Rheumatoid Arthritis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise status | Trained Active Irregularly active Partially active Inactive |  | 
| Exercise stages of change | Prochaska 1992: Precontemplation Contemplation Preparation Action Maintenance |  | 
| Perceived exercise benefits | Questionnaire developped by YH based on existing qualitive studies |  | 
| Perceived exercise barriers | Questionnaire developped by Brittain et al. 2011 |  | 
| Exercise preferences | Developped by YH based on previous studies |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status | Health Assessment Questionanire (Guillemin et al. 1991) |  | 
| Pain | Visual analogue scale (VAS) |  | 
| Fatigue | VAS |  | 
| Disease activity | Disease activity score 28 (DAS 28), based on the number of tender and swollen joints and the erythrocite sedimentation rate (ESR) |  | 
| Quality of life | Arthritis Impact Measurement Scales 2 |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Barriers, Benefits, Preferences, Stages of change
Regulation of Retinal Bloodflow Pressure

Study Overview
=================
Brief Summary
-----------------
Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale studies have shown that reduced ocular perfusion pressure is an important risk factor for the prevalence, the incidence and the progression of primary open angle glaucoma. There is also evidence that autoregulation is impaired in patients with primary open angle glaucoma. To gain more insight into these phenomena in humans is the primary goal of the present study. The present study aims to investigate the pressure/flow relationship as a measure for retinal blood flow autoregulation during an experimental increase in intraocular pressure by the use of the suction cup technique. Retinal blood flow will be measured by Doppler OCT.

Official Title
-----------------
Regulation of Retinal Blood Flow in Response to an Experimental Increase in Intraocular Pressure

Conditions
-----------------
Retinal Bloodflow

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged between 18 and 35 years Non-smokers Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmic findings, ametropy < 1 Dpt. Exclusion Criteria:- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study Treatment in the previous 3 weeks with any drug (except contraceptives) Symptoms of a clinically relevant illness in the 3 weeks before the first study day Blood donation during the previous 3 weeks Pregnancy, planned pregnancy or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- | --- |
| Retinal pressure-flow-relationship as assessed with FDOCT |  | 01.02.2018-31.12.2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal Bloodflow Pressure
Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared.

Detailed Description
-----------------
Influence of the following procedures will be examined: Application of Atropin Application of Fentanyl Application of Mivacurium possible desaturation and / or bradycardia during intubation attempts restoration of arterial oxygen saturation and / or heart rate after succesful intubation We aim to examine the change of the following parameters by the use of electrical cardiometry: stroke volume cardiac output We compare two different premedication protocols and we evaluate the impact of these protocol on the time needed for intubation and on intubation difficulties .

Official Title
-----------------
The Influence of Two Different Premedication Protocols for Endotracheal Intubation in Neonates on Cerebral Oxygenation

Conditions
-----------------
Newborn, Preterm, Intubation

Intervention / Treatment
-----------------
* Drug: Atropine, Fentanyl, Mivacurium
* Drug: Atropine, Fentanyl, Mivacurium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborn infant below 44 weeks postmenstrual age indication for elective or semi-elective endotracheal Intubation parental informed consent Exclusion Criteria: emergency intubation

Ages Eligible for Study
-----------------
Maximum Age: 44 Weeks

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: Relaxation followed by analgosedation<br>Give Atropin, then Mivacurium, immediately followed by Fentanyl | Drug: Atropine, Fentanyl, Mivacurium<br>* Atropin 10µg/kg Mivacurium 200µg/kg immediately followed by Fentanyl 2µg/kg<br>|
| Active Comparator: Analgosedation followed by Relaxation<br>Give atropin, then Fentanyl, then Mivacurium | Drug: Atropine, Fentanyl, Mivacurium<br>* Atropin 10µg/kg Fentanyl 2µg/kg, repeat max. two times Mivacurium 200µg/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cerebral tissue oxygen saturation during premedication and intubation | A baseline value of cerebral tissue oxygen saturation before first application of premedication drugs is determined. Change of cerebral tissue oxygen saturation is defined as area under this threshold from first drug application until recovery. | from 1 minute before first study drug until 10 minutes after end of procedure |
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research

Study Overview
=================
Brief Summary
-----------------
This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.

Detailed Description
-----------------
The purpose of this study is to provide a central mechanism for monitoring access to peripheral blood, urine, and skin specimens obtained from CTCL, eczema, and atopic dermatitis patients to monitor: immunologic assays/flow cytometry tumor progression/regression genomic studies proteomic studies others germane to the advancement of CTCL treatment

Official Title
-----------------
Peripheral Blood, Urine and Skin Sample Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research

Conditions
-----------------
Sezary Syndrome, Cutaneous T-cell Lymphoma, Mycosis Fungoides, Eczema, Atopic Dermatitis

Intervention / Treatment
-----------------
* Other: Blood draw, skin biopsy or urine collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 or older able and willing to provide informed consent diagnosed with CTCL diagnosed with either atopic dermatitis or eczema Exclusion Criteria: Lack of CTCL, atopic dermatitis, or eczema diagnosis in medical record

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 |
| --- | --- |
| CTCL, atopic dermatitis, eczema<br>Those subjects with cutaneous t-cell lymphoma and Sezary syndrome, atopic dermatitis, or eczema may participate as appropriate with the potential for blood, tissue or urine sampling. | Other: Blood draw, skin biopsy or urine collection<br>* Up to 9 blood draws/year of 60 ml of whole blood. One 6 mm punch biopsy may be obtained up to 4 times per year.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteomics of Cutaneous T-cell lymphoma | Proteomic variables will be measured in blood and tissue of consented CTCL patients. | Ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides, Blood/tissue banking, eczema, atopic dermatitis