linjc16/ctgov huggingface dataset:
Language and Deglutition in Children

Study Overview
=================
Brief Summary
-----------------
The first years of life are considered essential to child development, as there is greater brain growth and formation of more neural connections. Therefore, the stimulation of children in various fields of development becomes relevant to the acquisition of knowledge and skills.

Detailed Description
-----------------
Child development, food and language, particularly in young children in different socioeconomic and cultural, as this is the basis for the growth conditions, socialization and learning.

Official Title
-----------------
Feeding and Sociolinguist Profile in Children

Conditions
-----------------
Child, Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged one to three years of chronological age, of both genders, enrolled full-time, ie more than six hours in childcare elected for search Exclusion Criteria: children with minor changes or deviations in child development, who did at least one major meal (lunch or dinner) in the nursery, or other educational institution attended, in addition

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 3 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
-----------------
Child Development, Child, Daycare centers, Language
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.

Official Title
-----------------
A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.

Conditions
-----------------
Colitis, Ulcerative

Intervention / Treatment
-----------------
* Drug: SPD476 (mesalazine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have completed all assessments of SPD476-301 or SPD476-302 End of Study/Early Withdrawal Visit Subjects who did not achieve remission at the End of Study/Early Withdrawal Visits in Study 301 or 302 will be eligible to enter the Acute Phase; subjects who did achieve remission at the End of Study Visits in Study 301 or 302 will be eligible to enter directly into the Maintenance Phase Women of childbearing potential must use an acceptable contraceptive method while on study treatment Exclusion Criteria: Subjects who withdrew from Study 301 or 302 before Study Visit 3, or who withdrew due to a possible or probably related severe adverse event or serious adverse event are not eligible to enter this study

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPD476 (mesalazine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent adverse events |  | Throughout the study period of approximately 2 year, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to relapse |  | Up to 12-14 months | 
| Participant compliance |  | Up to 12-14 months | 
| Number of participants in remission |  | 12 months | 
| Ulcerative colitis disease activity index (UC-DAI) score |  | Baseline, Month 2, and Month 12 | 
| Patient questionnaire |  | Month 6, and Month 12 |
Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.

Study Overview
=================
Brief Summary
-----------------
The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC).

Detailed Description
-----------------
Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.

Official Title
-----------------
Blood Collection Sub-Study of Exact Sciences Protocol 2018-10: An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now

Conditions
-----------------
Colo-rectal Cancer

Intervention / Treatment
-----------------
* Other: Blood Sample Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is currently enrolled in Exact Sciences Protocol 2018-10 Subject is willing and able to provide a blood sample. Subject is willing and able to sign informed consent. Exclusion Criteria: 1. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 49 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject aged 45-49 with Average CRC Risk<br>Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. Subjects will provide a blood sample at time of enrollment. | Other: Blood Sample Collection<br>* Subjects participating in the study will have blood drawn at enrollment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood-based biomarkers associated with genetic and epigenetic alterations. | Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk for development of colorectal cancer. | Point in time blood collection (1 day) at enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Draw
Assessment of the Therapeutic Utility of hMG-HP

Study Overview
=================
Brief Summary
-----------------
To assess the effectiveness of a protocol of ovarian hyperstimulation with urinary gonadotrophins, to achieve clinical pregnancy in females undergoing IVF. Study hypothesis: to assess the effectiveness of a protocol of urinary gonadotrophins

Official Title
-----------------
Assessment of the Therapeutic Utility of hMG-HP Within a Protocol of Controlled Ovarian Hyperstimulation in IVF in Normoresponders Women Undergoing Downregulation With GnRH Antagonist

Conditions
-----------------
Sterility

Intervention / Treatment
-----------------
* Drug: hMG-HP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-38 years Body mass index (BMI) between 18 and 30 Women classified as normogonadotrophin patients. Not more than 3 previous cycles of ART (assisted reproductive technology) Testosterona, FSH (follicle-stimulating hormone) LH (luteinizing hormone) and Prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range No administration of clomiphen citrate or gonadotropins during the month prior to the start of the study Exclusion Criteria: Failure in previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) Seminal samples not apt for IVF-ICSI (according to the criteria of each center). Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months Data suggestive of possible ovarian failure Antecedents of severe ovarian hyperstimulation syndrome (OHSS) Important systemic disease Pregnancy or contraindication to pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hMG-HP<br>Patients with a condition | Drug: hMG-HP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical pregnancy rate |  | 16 days |
Probiotics and Recovery From Gastrointestinal Surgery - 2

Study Overview
=================
Brief Summary
-----------------
This prospective randomized trial is designed to test a pragmatic simple intervention in a community hospital. The trial will test the hypothesis whether patient recovery after a major elective abdominal operation can be improved and/or accelerated with postoperative use of probiotics.

Official Title
-----------------
Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings - 2

Conditions
-----------------
Surgical Recovery

Intervention / Treatment
-----------------
* Drug: SuperBio probiotic
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged ≥18 years undergoing elective major abdominal operation Functional GI tract expected after operation Exclusion Criteria: Current episode of acute necrotizing pancreatitis as defined by surgeon Palliative decompressive GI tube Life expectancy ≤ 6 months Systemic immune-mediated disease active requiring systemic therapy: Prednisone ≥20 mg QD IV immunoglobulins Anti-rejection medication Presence of functional transplanted organ Systemic collagen-related disease treated with immunomodulating agents, including rheumatoid arthritis, SLE, scleroderma, etc. Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed Patient taking probiotics, synbiotics, or cobiotics as part of their lifestyle Need for full systemic anticoagulation postoperatively.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Comparator<br> | Drug: Placebo<br>* One capsule po BID for 28 days<br>|
| Experimental: probiotic<br> | Drug: SuperBio probiotic<br>* One capsule po BID for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Functional Assessment of Cancer Therapy (FACT) G7 score: higher value corresponds with better QoL, range 0-28 points | up to 2 months |
An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.

Official Title
-----------------
A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056 Must have received pregabalin/placebo under double-blind conditions. Exclusion Criteria: Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081056 which was determined to be related to the study medication by the investigator or the sponsor.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There are no secondary outcome measures |  |  |
Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

Study Overview
=================
Brief Summary
-----------------
In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient burden. Aspects of cost effectiveness will be included in the final analysis. Results of the study would allow decision-making based on Evidence Based Medicine on the best therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

Detailed Description
-----------------
In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient burden. Aspects of cost effectiveness will be included in the final analysis. The results of the study would allow decision-making based on Evidence Based Medicine on the best therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

Official Title
-----------------
Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

Conditions
-----------------
Hemochromatosis

Intervention / Treatment
-----------------
* Procedure: Phlebotomy
* Procedure: Erythrocytapheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hereditary haemochromatosis patients Exclusion Criteria: Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Phlebotomy | Procedure: Phlebotomy<br>* Removal of 500 ml whole blood<br>* Other names: Bloodletting;Procedure: Erythrocytapheresis<br>* machinal removal of erythrocytes<br>* Other names: Therapeutic erythrocytapheresis;|
| Active Comparator: 2<br>Erythrocytapheresis | Procedure: Phlebotomy<br>* Removal of 500 ml whole blood<br>* Other names: Bloodletting;Procedure: Erythrocytapheresis<br>* machinal removal of erythrocytes<br>* Other names: Therapeutic erythrocytapheresis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration and number of treatments |  | Ferritine value 50 microgr/l | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs |  | Ferritine value 50microgr/l |
The Role of Vitamin D3 in Pediatric Bronchiectasis Severity

Study Overview
=================
Brief Summary
-----------------
Vitamin D3 therapy was effective in decreasing the frequency of pulmonary exacerbations and preserving lung functions , thereby improving the disease severity even more in non CF than CF bronchiectasis patients

Detailed Description
-----------------
Objectives: To compare the effect of vitamin D3 on modifying the disease severity in CF and non CF bronchiectasis pediatric patients. Patients and Methods: This was a randomized clinical trial evaluating the role of oral vitamin D3 supplementation for 6 months in forty patients with CF and non CF bronchiectasis under the age of 18 years with vitamin D deficiency or insufficiency . The primary outcome was to reach the sufficient Vitamin D level. The secondary outcome was to follow up the frequency of pulmonary exacerbations and lung function after vitamin D3 supplementation.

Official Title
-----------------
The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis)

Conditions
-----------------
Cystic Fibrosis and Non CF Bronchiectasis

Intervention / Treatment
-----------------
* Drug: Cholecalciferol (vitaminD3)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages less than 18 years . Patients with documented diagnosis of CF (by the presence of a twice positive sweat chloride test and or paired CFTR DNA genetic mutations). Patients with non CF bronchiectasis diagnosed clinically and radiologically ( sweat chloride test negative) with a high resolution CT-confirmed diagnosis and clinical history consistent with bronchiectasis . Vitamin D deficient or insufficient CF and non CF bronchiectasis patients Exclusion Criteria: if they had sufficient Vitamin D level . chronic lung diseases other than CF and non CF bronchiectasis , liver or renal diseases. reported taking vitamin-D supplements or steroid therapy in the last 6 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D 3<br>oral vitamin D3 drops and tablets | Drug: Cholecalciferol (vitaminD3)<br>* Theraputic vitamin D3 for CF and non CF bronchiectasis children<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reach sufficient vitamin D level | vitamin D more than 30 ng/dl | 6 months | 
| decrease disease severity | decrease excerbations and increase lung function | 6 months |
Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study

Study Overview
=================
Brief Summary
-----------------
Systolic Pressure Intervention Trial (SPRINT) is a large scale randomized trial of   9250 adults aged 50 years or older with high cardiovascular risk sponsored by NIH. The study is designed to recruit 45% of the study population with Chronic Kidney Disease (CKD). The trial will test the effects of low systolic blood pressure (SBP) goal of < 120 mm Hg versus the standard goal of < 140 mm Hg on the primary composite of cardiovascular events and death. One of the pre-specified secondary outcome is the progression of kidney disease. In this ancillary named SPRINT - Factors affecting Atherosclerosis STudy (FAST), the investigators plan to take advantage of the unique opportunities afforded by the parent study to examine issues that are of significant public health importance. This is an observational study in SPRINT participants. This study will examine mechanistically, the factors affecting the progression of atherosclerosis in CKD.

Official Title
-----------------
Systolic Pressure Intervention Trial (SPRINT)-Factors Affecting Factors Affecting Atherosclerosis Study (FAST)

Conditions
-----------------
Hypertension, Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Systolic Pressure Intervention Trial (SPRINT) participants Exclusion Criteria Contraindications to MRI (such as intracranial metal prostheses, weight > 300 pounds, claustrophobia and certain types of hardware used in pacemakers, prostheses, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Observational - SPRINT trial subjects<br>Subjects in the Systolic Pressure Intervention Trial (SPRINT) observed to examine factors that affect atherosclerosis in chronic kidney disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development Rate of Atherosclerosis | Correlation of the presence of CKD and rate of progression of atherosclerosis as assessed by magnetic resonance imaging (MRI) of the carotid artery. | Baseline and 30 months |