linjc16/ctgov huggingface dataset:
Glucocorticoid-induced Osteopenia in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the skeletal deficits and risk factors for impaired skeletal development in children requiring glucocorticoid therapy. We will compare the bone health of children treated with prednisone for nephrotic syndrome (NS with those treated with prednisone for Crohn's Disease (CD). Childhood NS usually responds to prednisone and is not characterized by pathologies that can impact on bone. In contrast, CD is treated with prednisone, but is independently associated with poor growth and maturation, nutritional deficiencies and inflammation. Due to the differences in the diseases, this comparison will allow us to distinguish between the prednisone-related and disease-related effects on bone in the two disease states.

Detailed Description
-----------------
Prednisone, a glucocorticoid medication, is widely used for many pediatric disorders. Studies have shown that this drug decreases bone formation, decreasing bone density and bone thickness in children. Prednisone induced osteopenia, or low bone density, can be worsened by the effects of the underlying disease, such as delayed growth and maturation, malnutrition, and increased bone resorption (removal) by inflammatory compounds. The combined effects of decreased bone formation and increased resorption may be particularly detrimental to the growing skeleton. Subjects will include 15 newly diagnosed NS patients, 60 patients with pre-existing NS, 90 patients with newly diagnosed CD, 45 patients diagnosed within the last two years and 200 healthy controls of similar age, gender and ethnicity. Participants will visit the Children's Hospital of Philadelphia (CHOP) three times over a 12-month period for assessment of bone mineralization and turnover, fracture history, dietary calcium intake, physical activity, growth, body composition, muscle strength and glucocorticoid exposure.

Conditions
-----------------
Crohn's Disease, Nephrotic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 5-21 clinical and pathological diagnosis of Crohn's Disease within the last 2 years clinical diagnosis of nephrotic syndrome and taking corticosteroids within the last year normal renal function GFR>75 ml/min/1.73m2 healthy controls Exclusion Criteria: other major medical conditions affecting growth and/or bone health significant cognitive or developmental disorders (if child is unable to cooperate sufficiently) nonambulatory

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 21 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 |
| --- | --- | --- |
GER Poses a Potential Risk for Late Complications of BPD

Study Overview
=================
Brief Summary
-----------------
Bronchopulmonary dysplasia (BPD) is a common condition in the low birth weight infants. Although most of the BPD symptoms improved after a regular treatment in infancy, there are still a few late complications left such as the frequent respiratory symptoms, a slower weight gain and even sudden death. These late complications have made so much trouble to the healthcare of BPD infants. How to find the risk factors and to reduce the prevalence of these late symptoms becomes necessary. In this study, a cohort of BPD infants was observed with the late complications obtained by a monthly followed up for 18 months after discharge, the prevalence and risk factors of the late complications of BPD were analyzed by logistic regression. As one of the risk factors, GER was verified whether to play a critical role in these late complications.

Official Title
-----------------
Gastroesophageal Reflux Poses a Potential Risk for Late Complications of BPD: A Prospective Study

Conditions
-----------------
Gastroesophageal Reflux, Bronchopulmonary Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the extremely premature infants with bronchopulmonary dysplasia Exclusion Criteria: other congenital malformations such as gastrointestinal and or neurogenic disease

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

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 |
| --- | --- | --- |
| the Late Complications of BPD Infants | In all patients, complications were evaluated via questionnaires at 3, 6, 9 and 12 months corrected for premature age, including respiratory symptoms (including home respiratory support, respiratory medication administration, cough without cold at least once per week, re-hospitalization due to respiratory diseases), vomiting when feeding, hypoxic ischemic injury, retinopathy of prematurity, rehospitalization and sudden death. | 18 months |
Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot study of a biopsychological intervention program for adolescent chronic fatigue syndrome. The program is related to cognitive behavioral therapy, which has been proven beneficial in this disorders, but includes other mental techniques, such as emotional control and metacognitive elaboration. The aim of this pilot study is to explore a) patients' experiences and b) possible positive effects on symptoms. We hypothesise that the intervention will be regarded feasible by the patients, and that fatigue score will improve during the intervention period.

Conditions
-----------------
Adolescent Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Behavioral: Biopsychological intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of chronic fatigue syndrome Significant school absenteeism Above 12 years of age and below 18 years of age Exclusion Criteria: Other diseases or life events that might explain chronic fatigue Bed-ridden

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 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: Biopsychological intervention<br> | Behavioral: Biopsychological intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chalder fatigue score |  | Up to 3 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' experiences (semistructured interview) | Qualitative data, further analysed by thematic structural analysis | Up to 3 months after inclusion | 
| Quality of Life (PedsQL) |  | Up to 3 months after inclusion |
Autologous Bone Marrow Stem Cell Therapy for Autism

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.

Detailed Description
-----------------
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism of 24 patients at Vinmec International Hospital, Hanoi, Vietnam

Official Title
-----------------
Autologous Bone Marrow Stem Cell Therapy for Autism: An Open Label Uncontrolled Clinical Trial

Conditions
-----------------
Autistic Disorder

Intervention / Treatment
-----------------
* Biological: Autologous Bone Marrow Mononuclear Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for autistic disorder Exclusion Criteria: Epilepsy Hydrocephalus with ventricular drain Coagulation disorders Allergy to anesthetic agents Severe health conditions such as cancer, failure of heart, lung, liver or kidney Active infections Severe psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 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: Stem cell transplantation<br>2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward | Biological: Autologous Bone Marrow Mononuclear Cells<br>* Transplantation of Autologous Bone Marrow Mononuclear Cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Score of Childhood Autism Rating Scale (CARS) | CARS | 3 months and 6 months after transplantation | 
| Number of adverse events | Examples of adverse events to look for: vomiting, increased hyperactivity, fever, bleeding, hematoma, seizures and neurological deficits | Through study completion, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, Stem Cells
Childhood Reactive Thrombocytosis

Study Overview
=================
Brief Summary
-----------------
Reactive thrombocytosis (RT) in pediatric patients is common, but usually without symptoms. The incidence of RT is different depending on age. Mostly, we reasoned that RT is a phenomenon, nevertheless the diagnostic value of RT is little known. Therefore, the aim of this study was to determine the association of RT and clinical or laboratory characteristics in pediatric diseases.

Official Title
-----------------
Childhood Reactive Thrombocytosis (RT)

Conditions
-----------------
Reactive Thromobocytosis in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The platelet counts more than 500x109/l and age less than 18 years old. Exclusion Criteria: repeated hospitalization ( more than 2 times)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum 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 |
| --- | --- | --- |
Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this work is to investigate and then to sequence new biomarkers in the plasma of patients presenting with dyspnea secondary or not to heart failure, and study their diagnostic and prognostic value.

Detailed Description
-----------------
Plasma samples for patients with dyspnea, edema, with or without heart failure; ambulatory or admitted for cardiac decompensation (even with cardiac shock and LVAD) ; or entering a cardiac rehabilitation program, will be prospectively collected. The objective of this work is to investigate and then to sequence new proteins in the plasma of these patients for diagnostic and prognostic purpose.

Official Title
-----------------
Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease

Conditions
-----------------
Heart Failure, Dyspnea, Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with shortness of breath secondary or not to heart failure, even with cardiac shock and LVAD. Patients with valvular disease chronic stable heart failure. post- partum Cardiomyopathy Exclusion Criteria: terminal cancer progressive neurological disease pregnancy opposition of the patient

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 |
| --- | --- |
| Dyspnea cohort<br>Dyspnea cohort | |
| Stable chronic heart failure<br>Stable chronic heart failure | |
| Valvular heart disease<br>Valvular heart disease | |
| Ventricular assist device<br>Ventricular assist device | |
| Cardiac arrest<br>Cardiac arrest | |
| Cardiac rehabilitation<br>Cardiac rehabilitation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term cardiovascular mortality | To detect prognostic values of plasma biomarkers, we assess cardiovascular mortality at 3, 6, and 24 months. | Prospective at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac hospitalization(s) at 3, 6,12 and 24 months | We assess cardiac morbidity within 3, 6, and 24 months months after admission | Prospective at 12 months | 
| Diagnostic value of new biomarkers. | Assess accuracy of new biomarkers to discriminate heart failure from non-heart failure (negative and positive predictive values) | at day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Dyspnea, Heart disease, Pulmonary disease, Natriuretic peptide, Rehabilitation
Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.

Official Title
-----------------
An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject has an HbA1c value <=11.0% The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive Exclusion Criteria: Is currently treated with certain medications, including exogenous insulin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Exenatide<br>Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination | Drug: exenatide<br>* subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination<br>* Other names: AC2993;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit | Change in HbA1c from Visit 1 to each visit up to open-ended study termination | Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) | 
| Change in body weight from Visit 1 to each protocol visit | Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination | Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) | 
| Change in fasting plasma glucose from Visit 1 to each protocol visit | Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination | Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) | 
| Change in lipids from Visit 1 to each protocol visit | Change in lipids from Visit 1 to each visit up to open-ended study termination | Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exenatide, diabetes, Amylin, exendin-4
Effect of Self Assembling Peptide on White Spot Lesion

Study Overview
=================
Brief Summary
-----------------
During re-mineralization of white spot lesion, Will biomimetic self-assembling peptides improve the re-mineralizating effect of the post orthodontic white spot lesion compared to fluoride-based delivery systems?

Detailed Description
-----------------
Conservative dentistry no longer prefers the drill and fill concept and advocates reversal of lesions via remineralization. . Remineralization is the process of restoring minerals - again, in the form of mineral ions - to the hydroxyapatite latticework structure. It is three-dimensional, and the lost ions must be replaced with ions having the exact same shape, size and the same electrical charge as those lost from the lattice. Fluoride and self-assembling peptides have been used as adjuncts to enhance remineralization.

Official Title
-----------------
Evaluation of the Re-mineralizing Effect of Biomimetic Self-Assembling Peptides in Post Orthodontic White Spot Lesions Compared to Fluoride-Based Delivery Systems

Conditions
-----------------
White Spot Lesion of Tooth

Intervention / Treatment
-----------------
* Drug: Self Assembling peptide
* Drug: remineralizing agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with post orthodontic white spot lesion. Patients with good oral hygiene. Patients with good general health. Cooperative patients. Subjects who signed the informed consent. Exclusion Criteria: Patients with tetracycline pigmentation and dental fluorosis. Enamel cavitation. Disable patient. patient with any systemic disease or severe medical complications.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 22 Years

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

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

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: Self Assembling peptide<br>intervention | Drug: Self Assembling peptide<br>* enamel regeneration<br>* Other names: Curodont;Drug: remineralizing agent<br>* enamel regeneration<br>* Other names: floride;|
| Experimental: Fluoride<br>Comparator | Drug: Self Assembling peptide<br>* enamel regeneration<br>* Other names: Curodont;Drug: remineralizing agent<br>* enamel regeneration<br>* Other names: floride;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralizing process | using DIAGNOpen. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment | using ICDAS II | 6 months |
Pro-active Genetic Testing in Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence of genetic mutations that increase the risk of cancer and other medically actionable diseases in kidney transplant patients and to assess the impact of genetic testing on subsequent surveillance for cancer.

Official Title
-----------------
Pro-active Genetic Testing in Kidney Transplant Patients

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Diagnostic Test: Genetic Health Screen Panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Post transplant Kidney and Kidney Pancreas recipients. Exclusion Criteria: Simultaneous Liver Kidney Transplant. Simultaneous Heart Kidney Transplant. Non renal transplant history.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Kidney Transplants<br>Kidney transplant patients who are within one-year post transplant. | Diagnostic Test: Genetic Health Screen Panel<br>* This panel covers cardiomyopathy genes, and cancer genes. The results of this panel are reported as Positive (pathogenic or likely pathogenic mutation identified in one or more genes) or Negative (no pathogenic/likely pathogenic mutations identified).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic mutations of cancer | Number of subjects to have genetic mutations of cancer in kidney transplant patients receiving care at Mayo Clinic Arizona | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of genetic testing | Current guidelines for cancer screening have limitations, as its mostly age based. Immunosuppression can lead to a increased risk of cancer in the kidney transplant population. By utilizing a multi gene panel we'll look for the number subjects with positive findings and see how recommendations of care change vs standard of care as recommended by the National Comprehensive Cancer Network (NCCN). Genetic testing and family history may change the practice regarding cancer screening in subjects undergoing kidney transplant evaluation. | 1 Year | 
| Develop a Biorepository | Create a biorepository based on whole exome sequencing and clinical data for future analysis | 1 year |