linjc16/ctgov huggingface dataset:
Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)

Study Overview
=================
Brief Summary
-----------------
This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).

Detailed Description
-----------------
Young children age 3-5.5 years will be studied. The study includes treatment with different doses of methylphenidate and placebo; all children will receive active medication during the study. Prior to treatment, each child will receive a thorough psychiatric evaluation and each guardian will complete a 10-week workshop (2 hours/week). Throughout the study, parents and teachers will complete forms that report on the child's behavior and possible side effects. Participants will be monitored by regular visits with a study physician. Most participants will be involved in the study for up to 16 months to ensure optimal evaluation, dosing, and monitoring

Official Title
-----------------
Methylphenidate Efficacy and Safety in ADHD Preschoolers

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Drug: Methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Boys and girls who are: Between the ages of 3-5.5 years Qualified as having ADHD by our diagnostic evaluations and clinical staff Otherwise generally healthy Willing, and have parents that are willing, to attend all visits required by the study Enrolled in some type of day-program: day care, preschool, nursery school, kindergarten, for at least 2 half days/week In classrooms with teachers that are willing to participate by completing rating scale

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methylphenidate|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
-----------------
ADHD
Treatment Use of ECMO In Pregnancy or Peripartum Patient.

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to describe the use of ECMO (Extracorporeal Membrane Oxygenation) in the pregnant or peripartum patient.

Official Title
-----------------
Treatment Use of ECMO In Pregnancy or Peripartum Patient.

Conditions
-----------------
Cardiogenic Shock, Peripartum Cardiomyopathy, Complication, Pregnancy

Intervention / Treatment
-----------------
* Device: Extracorporeal Membrane Oxygenation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18 years or greater at the time of ECMO treatment. Pregnant or within 6 months post-partum at the time of ECMO cannulation Exclusion Criteria: No history of pregnancy. No treatment with ECMO.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Cardiogenic Shock Treated with ECMO<br>This cohort of participants required clinical intervention with ECMO for treatment of their index cardiogenic shock episode while pregnant or post delivery of their infant. | Device: Extracorporeal Membrane Oxygenation<br>* Use of ECMO for circulatory / hemodynamic support of peripartum of pregnant patients who developed cardiogenic shock.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome of Mother | Describe clinical course of pregnant or recently postpartum patients with cardiogenic shock treated with ECMO, including the rate of neonate survival | Time of diagnosis -Six Month Survival Rate |
Regulation of Fat-stimulated Neurotensin Secretion in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Context: Cholecystokinin (CCK) and neurotensin are stimulated during meal intake by the presence of fat in the small intestine. The sequence of events suggests that fat hydrolysis is crucial for triggering the release. Objectives: The aim of this study was therefore to investigate whether CCK mediated the effect of intraduodenal (ID) fat on neurotensin secretion via CCK-1 receptors.

Detailed Description
-----------------
Setting: Single center study; 34 male volunteers were studied in consecutive, randomized, double blind, crossover studies. Subjects and Methods: CCK and neurotensin release were quantified in: 1) 12 subjects receiving an ID fat infusion with or without 60 mg orlistat, an irreversible inhibitor of gastrointestinal lipases, in comparison to vehicle. 2) 12 subjects receiving ID long chain fatty acids (LCF), ID medium chain fatty acids (MCF) or ID vehicle. 3) 10 subjects receiving ID LCF with and without the CCK-1 receptor antagonist dexloxiglumide (DEXLOX) or ID vehicle plus IV saline (placebo). Hormone concentrations were measured by specific RIA systems.

Official Title
-----------------
Mechanistic Study (Physiology)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Fat perfusion to the small intestine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A, 3; B, 3; C, 3<br>A, 3: Fat with and without orlistat or placebo. B, 3: LCF vs MCF vs placebo. C, 3: LCF with and without DEXLOX or placebo. | Dietary Supplement: Fat perfusion to the small intestine<br>* Triglycerides, long chain fatty acids, medium chain fatty acids perfused to the small intestine Orlistat perfused to the small intestine DEXLOX as CCK-1 receptor antagonist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurotensin plasma concentrations |  | Change in plasma cocnentrations over 2-3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurotensin, Human, Physiology of neurotensin, fat perfusion, healthy subjects
Intraoperative Imaging of Pulmonary Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
The goal is to improve surgery by preventing tumor cells from being left behind at the time of surgery. This includes finding residual tumor cells in the wound after surgery.

Detailed Description
-----------------
The goal is to improve the intraoperative identification of tumor cells at positive margins and regional metastases that may be missed by a surgeon during a pulmonary resection. Improved identification of tumor cells will result in superior disease clearance and more accurate clinical staging. The investigators hypothesize that targeted fluorescent imaging during surgery will improve identification of positive margins and metastases. Since folate receptor alpha (FR ) is expressed on 55% of resectable lung cancer, the investigators will utilize a fluorescent probe that targets these tumors. As real-time imaging provides more information to the surgeon, more personalized and directed operations can be conducted. This work will allow for more preservation of normal tissue, decreased morbidity, decreased surgical time, increased surgical confidence, improved cancer detection, decreased unnecessary surgery and ultimately improved tumor free survival. This technology should transform clinical surgery from an art that depends fully on the human factor to a procedure that has precision and fail safes.

Official Title
-----------------
Intraoperative Imaging of Pulmonary Adenocarcinoma

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: EC17 imaging contrast agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lung cancer surgical candidate operable resectable Exclusion Criteria: - no allergies to contrast dyes

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>This cohort will receive the contrast agent | Drug: EC17 imaging contrast agent<br>* This is an imaging agent to locate lung adenocarcinoma cancer cells during surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Margin assessment | Percentage of surgeries which detect tumor cells at the surgical margin | At the time of surgery | 
| Lymph node assessment | Number of residual tumor cells in the lymph nodes detected via intraoperative imaging of a FR-targeted fluorescent contrast agent | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, folate receptor
Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up

Study Overview
=================
Brief Summary
-----------------
The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization.

Detailed Description
-----------------
Several studies have demonstrated the short term safety, feasibility and efficacy of cell transplantation in patients with advanced heart failure. There are no data about the long term outcome.

Official Title
-----------------
Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up

Conditions
-----------------
Chronic Ischemic Symptomatic Heart Failure

Intervention / Treatment
-----------------
* Procedure: Autologous bone marrow intracoronary infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with evidence of hibernation and/or ischemia in at least 2 different myocardial segments underwent coronary angiography Exclusion Criteria: Idiopathic or non-ischemic cardiomyopathy Other etiology for heart failure, history of past or current disease involving the bone marrow Patients on dialysis Positive serologic test for HIV, hepatitis B or C or any neoplastic or terminal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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: Autologous Bone Marrow infusion<br>Percutaneous intracoronary autologous bone marrow infusion | Procedure: Autologous bone marrow intracoronary infusion<br>* Percutaneous intracoronary mononuclear bone marrow cell infusion<br>* Other names: Intracoronary mononuclear bone marrow cell infusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure success |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional class improvement |  | 9 months |
Predictors of Reactive Thrombocytosis in Critically Ill Septic Patients

Study Overview
=================
Brief Summary
-----------------
Reactive or secondary thrombocytosis is defined as abnormally high platelet count (≥4,50,000 platelets per micro-liter) in the absence of chronic myeloproliferative disease. In critically ill patients reactive thrombocytosis is not uncommon during recovery phase and an association has been seen with poor outcome and increased risk of subsequent VTE. However, not all patients with infection respond with thrombocytosis. No study has enumerated the risk factors or predictors of reactive thrombocytosis in critically ill septic patients.

Detailed Description
-----------------
All patients admitted to intensive care unit of the department of Critical Care Medicine during one year period will be screened for possible inclusion in this study. In this prospective observational study, demographic and clinical characteristics of all ICU patients who fulfill inclusion criteria will be collected along with relevant laboratory tests done for patient management routinely. ICU prognostication scores, i.e., Acute Physiologic and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score will also be recorded. ICU survivors will be followed up in their routine ICU follow up clinic visits. Sample size was estimated at 10% incidence rate of reactive thrombocytes, two sided 95% confidence interval and 4.5% margin of error of the incidence rate, sample size came out to be 171. Finally in this study investigators have targeted to include at least 180 participants. Sample size was estimated using software power analysis and sample size, 2008 (PASS-8).

Official Title
-----------------
Predictors of Reactive Thrombocytosis in Critically Ill Septic Patients

Conditions
-----------------
Sepsis, Thrombocytosis, Critically Ill

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult (≥18 years) ICU patients with the diagnosis of sepsis will be considered. Exclusion Criteria: Age <18 years Pregnancy H/O Malignancy Thrombocytosis at admission Primary thrombocytosis Post-splenectomy Chronic inflammatory disease (e.g. Connective tissue disorders, IBD, temporal arteritis) Known immunosupressive condition Chronic infectious diseases (e.g. tuberculosis, chronic pneumonitis)

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 |
| --- | --- | --- |
| Reactive or secondary thrombocytosis in critically ill septic patients | Reactive or secondary thrombocytosis (≥4,50,000 platelets per micro-liter) due to the sepsis | From date of inclusion until the date of thrombocytosis or date of ICU discharge (death or alive), whichever came first, assessed up to 3 months |
Database Concerning Patients Consulting the Obesity Clinic

Study Overview
=================
Brief Summary
-----------------
A registry of individuals that visit the Obesity Clinic of the University Hospitals of Leuven will be established. The objective of this registry is to improve the knowledge about obesity, the treatment of obesity and its outcomes.

Detailed Description
-----------------
A registry/database is constructed with data of the individuals that visit the Obesity Clinic of the University Hospitals of Leuven. Data will be obtained from the screening visits and all follow-up visits in terms of sociodemographics, treatment and treatment outcomes, disease impact, biochemistry, questionnaires, QoL, …

Official Title
-----------------
Database Concerning Patients Consulting the Obesity Clinic of University Hospitals Leuven

Conditions
-----------------
Overweight and Obesity, Bariatric Surgery

Intervention / Treatment
-----------------
* Other: Lifestyle therapy - individual
* Other: Lifestyle therapy - group
* Other: Medical therapy
* Procedure: Bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Age 18 years or older Subjects with overweight, obesity or after bariatric surgery

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 |
| --- | --- |
| Patients with overweight, obesity or after bariatric surgery<br>Patients with overweight, obesity or after bariatric surgery | Other: Lifestyle therapy - individual<br>* Individual therapy<br>Other: Lifestyle therapy - group<br>* Group therapy<br>Other: Medical therapy<br>* Medical therapy<br>Procedure: Bariatric surgery<br>* Surgical and endoscopic therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...) | The objective is to develop an Obesity Clinic registry to collect routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...) using the electronic medical record to improve the knowledge on obesity, the treatment of obesity and its outcomes. | up to 100 years |
(TIMP-2)x(IGFPB7) to Predict Acute Kidney Injury (AKI) in Aortic Surgery

Study Overview
=================
Brief Summary
-----------------
New biomarkers that predict the development of renal dysfunction in patients with aortic surgery are urgently needed. The investigators investigate whether urinary (TIMP-2)x(IGFBP7) predicts postoperative Acute Kidney Injury and/or need for Renal Replacement Therapy (RRT) in patients after aortic surgery (including EVAR).

Official Title
-----------------
(TIMP-2)x(IGFPB7) as Early Renal Biomarker for the Prediction of Acute Kidney Injury in Aortic Surgery - an Observational Study (TIGER)

Conditions
-----------------
Renal Failure, Dialysis, Aortic Surgery, Biomarker, Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: does not apply


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in need of emergency or elective abdominal aortic surgery (infra- or suprarenal clamping or EVAR) are eligible for study inclusion. Exclusion Criteria: Patients unable to give informed consent Age < 18 Patients not speaking German or French.

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 |
| --- | --- |
| Group of patients after aortic surgery<br>with subanalysis of patients with/without supra-/infrarenal surgery | Other: does not apply<br>* biological sample taking: urine, blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistically significant difference in mean total (TIMP-2)x(IGFBP7) values of patients with/ without AKI (as defined along Kidney Disease Initiative for Improvement of global outcomes (KDIGO) definitions: stages 1-3) at the first postoperative day. |  | 24 hours following ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AKI
Sun May Arise on SMA : Newborn Screening of Spinal Muscular Atrophy in Belgium

Study Overview
=================
Brief Summary
-----------------
Medico-economic study of Newborn screening of Spinal Muscular Atrophy

Detailed Description
-----------------
The aim of this project is to demonstrate the feasibility and the medico-economic impact of a spinal muscular atrophy neonatal screening in a European country. We propose a 3-year-neonatal screening program in Southern Belgium (Wallonia-Brussels Federation) where there is 59.000 newborns/year, among whom 6 are affected by spinal muscular atrophy.

Official Title
-----------------
Sun May Arise on SMA : Newborn Screening of SMA in Belgium

Conditions
-----------------
Spinal Muscular Atrophy

Intervention / Treatment
-----------------
* Diagnostic Test: test for SMN1 exon 7 deletion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All newborns in southern Belgium Exclusion Criteria: Newborns whose parents refuse screening

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All newborn from Southern Belgium<br>All newborns except newborns for which parents refuse newborn screening will be tested for exon 7 deletion in survival motor neuron 1 (SMN1) | Diagnostic Test: test for SMN1 exon 7 deletion<br>* Newborns are screened for SMN1 exon 7 deletion through standard NBS practice Positive case are promptly referred to reference centers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cases detected | Number of cases detected, false negative and false positive cases | march 2018-March 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SMA | to gather epidemiological data on SMA in Wallonia-Brussels Federation (carrier frequency, number of cases/year). | March 2018-March 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
newborn screening