linjc16/ctgov huggingface dataset:
Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive magnesium sulfate IV over 1 hour on day 3. Patients then receive oral magnesium gluconate supplementation daily. Treatment with magnesium sulfate repeats once at 3-6 months.

Conditions
-----------------
Alagille Syndrome, Cholestasis, Biliary Atresia

Intervention / Treatment
-----------------
* Drug: magnesium gluconate
* Drug: magnesium sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of liver disease with chronic cholestasis Nonsyndromic intrahepatic cholestasis Alagille's syndrome Extrahepatic biliary atresia Direct bilirubin greater than 2 mg/dL OR Bile acids greater than 20 micromoles/L No hepatic decompensation defined as one or more of the following: Ascites Peripheral edema PT at least 4 seconds longer than control Albumin less than 3 g/dL --Patient Characteristics-- Renal: No significant renal disease Cardiovascular: No significant cardiovascular disease Pulmonary: No significant pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 3 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: magnesium gluconate|nan|
|Drug: magnesium sulfate|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
-----------------
Alagille syndrome, biliary atresia, cholestasis, gastrointestinal disorders, rare disease
SynapDx Autism Gene Expression Analysis Study

Study Overview
=================
Brief Summary
-----------------
This study will prospectively enroll approximately 660 children, at least 18 months and less than 5 years of age, who have been referred to a pediatric developmental evaluation centers. Enrolled children will have blood drawn for RNA gene expression analysis and undergo a clinical evaluation to determine the presence or absence of a diagnosis of ASD. The sequential co-primary objectives of this study are: To develop an algorithm to classify blood RNA gene expression patterns to maximize agreement between the classification and a clinical assessment of presence or absence of Autism Spectrum Disorders (ASD). To prospectively assess the clinical sensitivity and specificity of the blood RNA gene expression classification algorithm (the SDX-002 test) in children referred to a developmental evaluation clinic for a possible developmental disorder.

Official Title
-----------------
SynapDx Autism Spectrum Disorder Gene Expression Analysis Study

Conditions
-----------------
Autism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred to a developmental evaluation centers for evaluation of a possible developmental disorder, other than isolated motor problems. Age >= 18 months and < 5 years. Parent/legal guardian has been informed about the study and has signed an informed consent form. Exclusion Criteria: Prior reliable diagnosis of Autism Spectrum Disorder (i.e. prior evaluation by a multi-disciplinary team has already reliably established Autism Spectrum Disorder diagnosis). Unable or unwilling to complete study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 5 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 |
| --- | --- |
| Development group 1<br> | |
| Development group 2<br> | |
| Development group 3<br> | |
| Validation group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RNA gene expression in peripheral blood |  | within 30 days of collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autism, autism spectrum disorders, RNA, gene expression, developmental delay
Post-operative Crohn's Endoscopic Recurrence Study

Study Overview
=================
Brief Summary
-----------------
This randomised, controlled study aims to evaluate the impact of endoscopic assessment, and adjustment of therapy, after surgery in patients with Crohn's disease. The primary endpoint is the severity of endoscopic recurrence. In addition, tissue will be collected for microbiological and immunological analysis.

Official Title
-----------------
Post-Operative Crohn's Disease Endoscopic Recurrence POCER Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause

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

Intervention / Treatment
-----------------
* Procedure: endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of Crohn's and proven history of disease patient undergone surgical resection with creation of a primary anastomosis Exclusion Criteria: endoscopically inaccessible anastomosis by standard colonoscopy presence of an end stoma pregnancy suspected perforation of the gastrointestinal tract presence of certain unsuitable comorbidities

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active arm<br> | Procedure: endoscopy<br>* patients receive best treatment and care with an additional endoscopy<br>|
| No Intervention: Standard care arm<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic recurrence of disease |  | 18 months |
Drug Use Investigation of Kovaltry in Hemophilia A Patients

Study Overview
=================
Brief Summary
-----------------
The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.

Detailed Description
-----------------
This company-sponsored study is a single-arm, prospective, observational study in hemophilia A patients administered Kovaltry. 200 cases will be planned to be registered as safety analysis set in three-year period. Within 200 cases, 50 cases less than 12 years old will be planned to be registered. Target population are all hemophilia A patients. The treatment should be performed based on the product label in Japan. The standard observation period is two years.

Official Title
-----------------
Drug Use Investigation of Kovaltry in Hemophilia A Patients

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female hemophilia A patients. Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study. Exclusion Criteria: Patients participating in an investigational program with interventions outside of routine clinical practice. Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAY81-8973<br>Hemophilia A patients who require Factor VIII replacement therapy | Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)<br>* Treatment parameters following the physician's decision based on the summary of product characteristics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as measure of safety and tolerability |  | Up to 2 years | 
| Number of participants with serious adverse events as measure of safety and tolerability |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of annual bleeds |  | Up to 2 years | 
| Efficacy of controlling of bleeds | The efficacy is evaluated by the investigator and given on a four point scale: Excellent, Good, Moderate and Poor. | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kovaltry, hemophilia A, Japan, Post-marketing surveillance
Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Fibrinogen plays an important role in the coagulation cascade. Low levels of preoperative fibrinogen have been associated in adults with higher blood and transfusion requirements during surgery. Guidelines from the European Society of Anesthesiology and Intensive Care recommends fibrinogen substitution based on viscoelastic tests in adult cardiac surgery. Cardiopulmonary bypass results in a profound hemodilution and dilution of all coagulation factors. This is especially true in children where the priming volume of the cardiopulmonary bypass circuit is much higher compared to the patient's weight than in adults. Cardiopulmonary bypass generates high levels of tissue plasminogen activator resulting in a hyperfibrinolysis, further lowering fibrinogen levels. The aim of this retrospective study is to explore a possible relationship between preoperative fibrinogen levels and perioperative blood loss, as well as transfusion requirements in children undergoing cardiac surgery.

Official Title
-----------------
Influence of Preoperative Fibrinogen Levels on Blood Loss and Transfusions in Pediatric Cardiac Surgery

Conditions
-----------------
Cardiac Surgery, Congenital Heart Disease, Cardiopulmonary Bypass, Fibrinogenemia

Intervention / Treatment
-----------------
* Procedure: Congenital cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all children with cardiac surgery under cardiopulmonary bypass between 2008 and 2018 Age < 16 year Exclusion Criteria: preoperative coagulopathy Jehovah's witnesses patients with fresh frozen plasma in the priming of the cardiopulmonary bypass circuit

Ages Eligible for Study
-----------------
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Congenital cardiac surgery|All children who underwent congenital cardiac surgery with cardiopulmonary bypass between 2008 and 2018|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Blood loss in mL during surgery and postoperatively during the first 24h (day 0) will be extracted from our database | Day 0 | 
| Transfusion requirements | Transfusion requirements of packed red cells ( in mL), fresh frozen plasma (in mL) and platelets (in mL) during the first 24h (day 0) will be extracted from our database | Day 0 |
Using a Patient-Centered mHealth Intervention to Improve Adherence to Oral Anticancer Medications

Study Overview
=================
Brief Summary
-----------------
This study is being done to determine if sending reminder text messages helps patients take their Oral Anticancer Medication (OAMs) when they are supposed to.

Official Title
-----------------
Using a Patient-Centered mHealth Intervention to Improve Adherence to Oral Anticancer Medications

Conditions
-----------------
Sarcoma, Lung, Solid Tumor Gastrointestinal

Intervention / Treatment
-----------------
* Other: SMS/MMS text messaging
* Other: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient in the Sarcoma, Solid Tumor Gastrointestinal (ST GI), and Thoracic Medicine service at MSK. Starting a new treatment regimen that includes a single oral anticancer medication Patients must have a mobile phone that can send and receive SMS/MMS messages and is internet-enabled. Age 18 or older. Ability to speak and read English because we do not have the resources to translate the text messages into other languages. Exclusion Criteria: Patient expresses inability or unfamiliarity with using SMS/MMS messaging on their phone and is unwilling to be trained in the use of this technology.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS/MMS text messaging<br>Patients will be able to tailor their SMS/MMS reminders with respect to when (i.e., what time of day) they wish to receive the reminders, as well as how often the messages are sent (e.g., morning and evening). | Other: SMS/MMS text messaging<br>* text messaging reminders on oral chemotherapy medication adherence<br>|
| Active Comparator: usual care<br>This includes physician and nursing assessment and intervention for any identified AEs. Of note, there is not currently standard follow-up that patients receive from nursing or physician staff while on an OAM treatment. Patients are encouraged to call their physician's office with any questions or changes in their medical status but are not called routinely by MSK staff. | Other: usual care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective pill count | is greater or less than the amount of OAM that the patient should have in their possession. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
texting, Adherence to Oral Anticancer Medications, 16-810
Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
Treatment of patients with diabetic neuropathy by intraarterial progenitor cell transplantation.

Detailed Description
-----------------
Goal is: Stimulation of angiogenesis and induction of vasa nervorum in order to improve nerve function

Official Title
-----------------
(Restoration of Nerve Functions by Intra-arterial Transplantation of Bone Marrow Progenitor Cells in Patients With Diabetic Poly Neuropathy (PNP)

Conditions
-----------------
Diabetic Neuropathies

Intervention / Treatment
-----------------
* Procedure: Intraarterial bone marrow progenitor cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with distal symmetrical diabetic neuropathy of the legs Type 1 or Type 2 Diabetes Stable Glucose control over last 3 months (Hba1c <7.5) Written informed consent Exclusion Criteria: Patients with peripheral arterial disease (ABI <0.9) Neuropathy of other origin Myopathy Asymmetrical neuropathy Active infection oder fever Chronic inflammatory disease (z.B M. Crohn, Rheumatoid Arthritis) HIV or hepatitis Neoplastic disease without complete remission within last 5 y Stroke or myocardial infarction within last 3 months Renal failure (creatinine > 2 mg/dl) Liver disease (GOT > 2 upper limit or spontaneous INR > 1,5). Anemia (hemoglobine < 8.5 mg/dl) Platelets <100.000/µl HbA1c >7,5 % Allergies to Aspirin, Clopidogrel, Heparin Bleeding disorder Surgery or trauma within the last 2 months Pregnancy Mental retardation Participation in another study within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Intra-arterial stemcell therapy<br>Patients were treated with intra-arterial stemcells delivered via catheter examination | Procedure: Intraarterial bone marrow progenitor cell transplantation<br>* catheter delivery of stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of neurological score: modified NIS(LL)+7 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Toronto Clinical Scoring System |  | 1 year | 
| Heart rate variability |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with symmetric peripheral diabetic neuropathy
Prospective Evaluation of the Covered Self-expandable Metal Stents (CSEMS) for Incomplete Biliary Stone Clearance

Study Overview
=================
Brief Summary
-----------------
The current standard of care for bile duct stone are endoscopic sphincterotomy and stone extraction. Placement of plastic stents is an option for incomplete biliary stone clearance. This study will use the CSEMS in patients with complex biliary stones who failed stone extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing measure that allows more successful subsequent stone clearance. However, their use in benign condition has been limited especially for biliary stone removal. The purpose of this study is to determine the feasibility, safety, easy removability, stent-stone formation rate, and migration rate of CSEMS for complex biliary stones.

Detailed Description
-----------------
same as brief summary

Official Title
-----------------
Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents

Conditions
-----------------
Choledocholithiasis

Intervention / Treatment
-----------------
* Procedure: ERCP with metal stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Bilary stone unable to be extracted with balloon, basket, large balloon dilation of the ampulla or mechanical lithotripsy. Stone can be bridged by the metal stent Subject must be able to give informed consent. Exclusion Criteria: Any contraindication to ERCP Patient refuses consent for the 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Incomplete biliary stone extraction.<br> | Procedure: ERCP with metal stent<br>* ERCP will be used so that a metal stent can be placed to facilitate the removal of the biliary stone<br>* Other names: see above information;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete biliary stone clearance | This is an observational study where the ERCP being done is part of the standard of care for choledocholithiasis. There are no study interventions | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other techniques used for stone clearance | This will include the number of ERCP's needed to achive the complete biliary stone clearance, Use of mechanical Lithotripsy, use of cholangioscopy, procedure duration and any adverse events safety | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Choledocholithiasis, metal stents, biliary duct stent
Mothers With a History of Depression and Their 10-14 Year Old Daughters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. The investigators are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters.

Detailed Description
-----------------
The purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. We are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters. We use a range of methodologies to evaluate these processes, including self-report measures, information-processing performance, HPA-axis functioning and reactivity, and neural responses to emotional stimuli following exposure to stressful experiences.

Official Title
-----------------
The Neural Correlates of Mood and Cognitive Bias in a Population at Risk for Depression: Maternal Cognitive and Emotional Functioning

Conditions
-----------------
Depression, Depressive Disorder, Major

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible mothers must read and speak English fluently and have a child between the ages of 9 and 15 years old. Mothers must either have no history of psychopathology or have a history of depression during their child's lifetime. Exclusion Criteria: Eligible mothers cannot: currently be in treatment for drug or alcohol abuse have significant symptomatology related to psychopathology outside of depression have a medical history of neurological injury or impairment. Mothers who meet the requirements for inclusion in the control group must not have a history of any Axis I disorder.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children at risk for depression<br>children at familial risk for depression | Other: No intervention<br>* there is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of depression | participants are interviewed in an 18-month follow-up session | 18 months |