linjc16/ctgov huggingface dataset:
Galactose Supplementation for the Treatment of MOGHE

Study Overview
=================
Brief Summary
-----------------
Mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (MOGHE) is a new entity frequently associated with refractory epilepsy and neurodevelopmental disorders. Recently, it has been associated to SLC35A2 (Solute Carrier Family 35 Member A2) brain mosaic pathogenic variants. In addition, patients with germline SLC35A2 pathogenic variants improve with galactose supplementation. Therefore, the investigators aim to elucidate whether d-galactose as an add-on treatment might improve epilepsy and developmental outcomes in patients with MOGHE.

Official Title
-----------------
Galactose Supplementation for the Treatment of Patients With Mild Malformation of Cortical Development With Oligodendroglial Hyperplasia in Epilepsy (MOGHE): a Pilot Trial

Conditions
-----------------
SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation, Refractory Epilepsy

Intervention / Treatment
-----------------
* Dietary Supplement: D-Galactose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MOGHE diagnosis at histopathological examination of the epilepsy surgery tissue. Epilepsy refractoriness or ongoing epileptiform activity at EEG. Exclusion Criteria: Allergy to galactose or supplement components.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 20 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
Interventional Model Description: Before-and-after pilot clinical trial with a single group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm group<br>Galactose supplementation | Dietary Supplement: D-Galactose<br>* Galactose supplementation, once per day, up to 1.5g/kg per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency | Seizure diary | 6 months | 
| Epileptiform activity at EEG | Epileptiform activity quantification (per epoch) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral assessment | Teacher and Parent Rating Scale (SNAP-IV) and Conners Continuous Performance Test (CPT-II) | 6 months | 
| Cognitive assessment | Evaluated with Wechsler Intelligence Scale for Children (WISC-IV) and Behavior Rating Inventory of Executive Function-2 (BRIEF-2) | 6 months |
Evaluation of High-Frequency Chest Wall Oscillation

Study Overview
=================
Brief Summary
-----------------
To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy

Official Title
-----------------
Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital

Conditions
-----------------
Airway Secretion Clearance

Intervention / Treatment
-----------------
* Device: Airway clearance Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute or chronic disease requiring secretion mobilization as per hospital protocol Exclusion Criteria: Absolute contraindications for positional changes Absolute contraindications for chest percussion Women visibly pregnant Previous enrollment in study Previous CPT or Vest 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFCWO Arm<br>Airway clearance provided by the Vest Airway Clearance System | Device: Airway clearance Device<br>* Provided by the Vest Airway clearance system<br>|
| No Intervention: CPT Arm<br>Airway clearance provided by manual CPT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | an average of 10 days | Admission to Discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mucus Clearance, Secretion Clearance, HFCWO
Burden of Illness in Hypoparathyroidism

Study Overview
=================
Brief Summary
-----------------
Long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium homeostasis leading to increased morbidity, emergency events and reduced subjective health status. To further investigate general morbidity, hypocalcemic events, subjective and daily life performance in patients with chronic hypoparathyroidism a disease specific questionnaire, as well as the SF-36 are handed out.

Detailed Description
-----------------
Design: In a cross-sectional trial the subjective health status and burden of illness in patients with chronic hypoparathyroidism will be evaluated by using a disease specific questionnaire as well as the SF-36. Patients: Patients will be recruited out of the patient population of the participating five medical centers. Statistical Analysis: Documentation and analysis will be performed at the Department of Medicine I, Endocrine and Diabetes Unit, University of Würzburg, Germany. Data will be documented after pseudonymisation in a data base. For further analysis data will be compared to sex- and age-matched controls.

Official Title
-----------------
Burden of Illness and Disease Associated Emergencies in Chronic Hypoparathyroidism

Conditions
-----------------
Hypoparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic hypoparathyroidism (>12 months) under established therapy chronic pseudohypoparathyroidism (>12 months) under established therapy written informed consent Exclusion Criteria: age <18 years no detailed documentation of hypo- or pseudohypoparathyroidism

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 |
| --- | --- | --- |
| Burden of illness | Assessment of the burden of illness due to chronic hypoparathyroidism using a disease specific questionnaire to further investigate impairment in daily and professional life in comparison to the general German population (DEGS1, SHIP-2). | 12 - 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypocalcemia | documentation of frequency of hypocalcemia under standard treatment | 12 - 24 months | 
| Psychological disorders | documentation of frequency of anxiety and depression under standard treatment | 12 - 24 months | 
| Subjective Health Status | Assessment of the subjective health status due to chronic hypoparathyroidism by Assessment of subjective health status in patients with chronic hypoparathyroidism | 12-24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoparathyroidism, Parathyroid Disease, Burden of Illness, SF-36, Quality of Life
Lymphangioleiomyomatosis (LAM) Registry

Study Overview
=================
Brief Summary
-----------------
To establish a registry of individuals with LAM by forming a consortium of six clinical centers and referring physicians who treat LAM patients.

Detailed Description
-----------------
BACKGROUND: LAM is a rare multi-system disease that can affect the lungs of young women, is of uncertain cause, is usually progressive, and can cause debilitating lung disease which may be corrected with lung transplantation. Several hundred women with the disease have been identified, largely through a LAM Foundation in Cincinnati, Ohio. DESIGN NARRATIVE: The Data and Coordinating Center is located at the Cleveland Clinic Foundation. The registry has six major clinical centers: Cleveland Clinic Foundation, Mayo Clinic-Rochester, National Heart, Lung, and Blood Institute, National Jewish Medical and Research Center, New England Medical Center, and Stanford University Medical Center. Data and lung tissue collected by the registry will be used to characterize the clinical features and natural history of the disease and to determine the efficacy of lung transplantation in this disorder. Eligible patients are to be seen yearly for up to 4 years at the Clinical Centers or, in some cases, by individual referring physicians. Tissue collected by the LAM Registry will be stored at a central NHLBI repository. Outcome events include measures of pulmonary function (eg, spirometry and, when available, lung volumes and diffusing capacity), arterial blood gases or oximetry, walking and resting oxygen titration, cardiopulmonary stress testing, cause-specific mortality, functional status, and clinical events associated with lung transplantation. The Office of Research on Women's Health provided funding in FY 1997 in the amount of $100,000. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Lung Diseases, Lymphangiomyomatosis

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to analyse the on-going coagulation process after aSAH. For investigation the investigators use the rotational thromboelastometry (ROTEM) which is a point-of-care test using a variety of activators to provide a targeted and a dynamic analysis of coagulation cascade. This is a prospective, observational clinical study done in 16 aSAH patients treated in Tampere University Hospital intensive care unit and 16 control patients (elective craniotomy due to non-ruptured intracranial aneurysm.

Official Title
-----------------
Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage

Conditions
-----------------
Aneurysmatic Subarachnoid Haemorrhage

Intervention / Treatment
-----------------
* Other: ROTEM analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, or cerebrospinal fluid erythrocyte count over 1000 x 106/l) AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA) Onset of symptoms ≤ 12 hours Expected to stay 72 hours in the ICU Exclusion Criteria: Pregnancy Any long-term anticoagulant medication, except for low-dose aspirin (<150 mg/day) Known active cancer

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 |
| --- | --- |
| Aneurysmatic subarachnoid haemorrhage<br>Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, or cerebrospinal fluid erythrocyte count over 1000 x 106/l) AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA) | Other: ROTEM analysis<br> <br> |
| Control patients<br>Elective craniotomy due to non-ruptured intracranial aneurysm | Other: ROTEM analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROTEM analysis: MCF (mm) by EXTEM activators |  | 12 hours |
Effect of Platelet Storage on Complement Activation

Study Overview
=================
Brief Summary
-----------------
Platelet units are stored and complement factors are evaluated

Detailed Description
-----------------
Ten units of platelets will be selected from the regular inventory of the Central Blood Transfusion Services/Assiut University Hospitals . All units of platelets will be collected, processed, and tested following the standard procedures. Thesis units will be stored on a platelet rotator with the temperature controlled between 22 and 24c. Samples will be obtained using a sterile technique . The investigators will take basal sample and samples on day 2,3,4 and 5. Complement components will be assayed : C4 (classical pathway), C3 (common pathway) and C5 (terminal pathway). This evaluation will be done using ELISA technique

Official Title
-----------------
Effect of Platelet Storage on Complement Activation

Conditions
-----------------
Platelet Storage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Negative screening and confirmatory tests will be done for all platelet donors Exclusion Criteria: Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the platelets.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelets can be used after storage upto 5 days instead of using in the same day of donation without complement activation. |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
complement system
Kidney Damage In Patients With Severe Fall In eGFR

Study Overview
=================
Brief Summary
-----------------
This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration [eGFR] < 30 mL/min/1.73 m2. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Official Title
-----------------
A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Severe Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320

Conditions
-----------------
Coronary Artery Stenosis

Intervention / Treatment
-----------------
* Drug: Iopamidol 370
* Drug: Iodixanol 320


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provides written Informed Consent Is at least 18 years of age; Is scheduled for or likely to undergo percutaneous coronary intervention; Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment. Exclusion Criteria: Is a pregnant or lactating female Has a history of severe congestive heart failure Has a history of hyperthyroidism Has unstable renal function Has a history of hypersensitivity to iodinated contrast agents

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IOPAMIDOL injection 370<br> | Drug: Iopamidol 370<br>* one time administration for PCI<br>* Other names: Isovue 370;|
| Active Comparator: Iodixanol 320<br> | Drug: Iodixanol 320<br>* Iodixanol 320 single injection for percutaneous coronary injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media. | Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media. | Baseline and 2,4,6,24, 48, and 72 hours post-dose |
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia

Study Overview
=================
Brief Summary
-----------------
Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with cachexia.

Detailed Description
-----------------
Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.

Official Title
-----------------
A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase II Study Comparing the Safety, Tolerability and Beneficial Effects of Daily Doses of RC-1291 and Placebo in Patients With Cancer Anorexia/Cachexia

Conditions
-----------------
Cancer Cachexia

Intervention / Treatment
-----------------
* Drug: RC-1291
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer. Involuntary loss of body weight greater than 5% within the past 6 months Exclusion Criteria: Presently hospitalized or in a nursing care facility. Inability to increase food intake from secondary causes. Liver disease If female-pregnant, breast-feeding or of childbearing potential.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br> <br> |
| Experimental: 2<br>RC-1291 50mg | Drug: RC-1291<br> <br> |
| Experimental: 3<br>RC-1291 100mg | Drug: RC-1291<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight; Lean body mass; Functional performance |  | 4 weeks |
Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes

Study Overview
=================
Brief Summary
-----------------
This study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes.

Official Title
-----------------
Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes

Conditions
-----------------
Cerebellar Lesions, Stroke, Ischemic

Intervention / Treatment
-----------------
* Device: Additional MRI sequences
* Other: Neuropsychological assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form Being able to pass initial neuropsychological tests within 10 days after stroke Exclusion Criteria: Previous central neural system/psychiatric/eye disease (including severe cranial trauma) Chronic alcoholism MRI contraindication.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Additional MRI sequences<br> | Device: Additional MRI sequences<br>* Additional MRI sequences (3D T2 SPACE sequence, 4/5 minutes approximatively)<br>Other: Neuropsychological assessment<br>* Neurovisual function assessed with neuropsychological tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Neuro-Visual Disorder | Presence of neuro-visual disorder will be confirmed by obtaining at least 2 pathological scores at following neuropsychological tests: Rey & Taylor figures (score from 0 to 36, maximum) Judgment of Line Orientation (score from 0 to 36, maximum) Weschler Adult Intelligence Scale (final score is intelligence quotient, with an average score is fixed at 100) Test of Attentional Performance Visual Object and Space Perception Battery (eight tests each designed to assess a particular aspect of object or space perception, while minimising the involvement of other cognitive skills) Visual agnosia assesment protocole (noted on 10 points) | Month 3 |