linjc16/ctgov huggingface dataset:
Rare and Undiagnosed Disease Research Biorepository

Study Overview
=================
Brief Summary
-----------------
This research study is being done to find markers and identify causes of rare and undiagnosed diseases by analyzing patient's DNA (i.e., genetic material), RNA, plasma, urine, tissues, or other samples that could be informative of symptoms. Researchers are creating a biobank (library) of samples and information to learn more about treating rare and undiagnosed diseases.

Official Title
-----------------
Rare and Undiagnosed Disease Research Biorepository

Conditions
-----------------
Undiagnosed Disease, Rare Diseases

Intervention / Treatment
-----------------
* Other: Genetic test evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has Mayo Clinic or other medical health system ID, or another unique identifier Able to provide informed consent Must meet one of the following: Individual must have evidence of a rare disease or a suspected genetic disorder as determined by a provider or genetic counselor Biological family member of an enrolled individual Exclusion Criteria: Individuals who have situations that would limit compliance with the study requirements Institutionalized (i.e. Federal Medical Prison)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Genetic test evaluation|Patients with rare and undiagnosed disease and their family members may be evaluated on a case by case basis. The research study may perform multi-omics testing to provide a diagnosis or to provide biomarker discovery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment of Study Participants | 5,000 participants to be accrued | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body-of-Knowledge | To prospectively follow the cohort of Rare and Undiagnosed Disease Biorepository participants to ascertain new health outcomes via medical records and patient contact, update risk factor data, and collect additional biologic specimens. | 5 years | 
| Discovery of Disease Mechanisms and Therapeutic Approaches | To facilitate research projects using the Rare and Undiagnosed Disease Biobank to identify underlying disease mechanisms and potential therapeutic approaches. | 5 years | 
| Diagnostic Yield | To change the rate of diagnosis and level of care for patients with rare and undiagnosed diseases through collaborations with clinical investigators and researchers at Mayo Clinic and globally. | 5 years |
Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
The researchers tested the hypothesis that a protein pulse-feeding pattern was more efficient in improving muscle mass and immune functions than was a protein spread-feeding pattern, after 45 days, in elderly malnourished patients.

Detailed Description
-----------------
To estimate the amelioration of the accretion in protein and the immunizing deficit thanks to a nutrition PULSEE ( to hold on 80 % of the proteic by day in on meal) with a proteic distributed all along the day for old subjects having a denutrition To also estimate that the diminution of the morbidity decrease (infections, bedsores) the average during the stay and the mortality according to 2 modalities of grip nutritional

Official Title
-----------------
Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients

Conditions
-----------------
Protein-Energy Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Protein pulse-feeding
* Dietary Supplement: Spread diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be malnourished Hospitalization into a geriatric rehabilitation care unit Age > 70 years C-reactive protein (CRP) < 50 mg/l Exclusion Criteria: Enteral or parenteral nutrition Renal, cardiac or digestive insufficiency Diabetes Pacemaker Mini-Mental State (MMS) < 15

Ages Eligible for Study
-----------------
Minimum Age: 70 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: 1<br>Protein pulse-feeding | Dietary Supplement: Protein pulse-feeding<br>* Dietary protein (80% of daily intake) was consumed in one meal (12.00h)<br>|
| Active Comparator: 2<br>Spread diet | Dietary Supplement: Spread diet<br>* Dietary protein was spread over the four meals.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA]) |  | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune functions |  | 42 days | 
| Hand-grip strength |  | 42 days | 
| Biological nutritional parameters |  | 42 days | 
| Mortality and morbidity (infections and bedsores) |  | 42 days | 
| Activity of Daily Living (ADL) |  | 42 days | 
| Plasmatic amino acid levels |  | 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Protein pulse-feeding, Nutritional supplementation, Protein-energy malnutrition, Elderly subjects, Body composition
Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.

Study Overview
=================
Brief Summary
-----------------
Patients undergoing a computed tomography are exposed to a relatively high dose of X-rays. Pediatric patients are known to be very radiosensitive with respect to radiation induced cancer. Using the technique of scoring γ-H2AX foci in peripheral blood lymphocytes the most important lesions to the genetic material DNA, double strand breaks induced by CT X-rays can be detected. The technique will be applied in a multicenter setting for evaluation of X-effects induced by a computed tomography examination in a population of pediatric patients. To this end a blood sample will be taken from the patients before and after the examination.

Official Title
-----------------
National Study of Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.

Conditions
-----------------
Pediatric Patients Undergoing a Computed Tomography Examination

Intervention / Treatment
-----------------
* Procedure: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients wearing a catheter Exclusion Criteria:

Ages Eligible for Study
-----------------
Maximum Age: 12 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 |
| --- | --- |
| X-rays<br> | Procedure: Blood test<br>* Analysing X-ray induced genetic effects in pediatric patients directly after a computer tomography scan.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X-ray induced genetic effects in pediatric patients directly after a computed tomography scan. | Assessment of γ -H2AX foci in peripheral blood lymphocytes. | Within 30 min after the computed tomography examination. |
Domperidone Expanded Access Treatment Program

Study Overview
=================
Brief Summary
-----------------
To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.

Detailed Description
-----------------
To provide oral domperidone to patients ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation in patients whom the potential benefit may outweigh the risk of cardiovascular adverse reactions including QT prolongation, Torsades de Pointes, and death.

Official Title
-----------------
Domperidone Protocol - FDA Expanded Access Program

Conditions
-----------------
Gastroparesis

Intervention / Treatment
-----------------
* Drug: Domperidone Oral Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age 12 and older Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events Exclusion Criteria: History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc>470 milliseconds for females). Hepatic dysfunction Renal insufficiency Clinically significant electrolyte disorders. Gastrointestinal hemorrhage or obstruction Presence of a prolactinoma (prolactin-releasing pituitary tumor). Pregnant or breast feeding female Known allergy to domperidone

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Domperidone Oral Product|10-30 mg of oral domperidone administered QID.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Study Overview
=================
Brief Summary
-----------------
Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.

Official Title
-----------------
A Phase II Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Conditions
-----------------
Uremic Pruritus

Intervention / Treatment
-----------------
* Drug: MR13A9
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese with male or female aged ≥ 20 Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week Patient receiving treatment for itch Patient has a baseline NRS score > 4 Exclusion Criteria: Patient has pruritus cause other than CKD or its complications Patients has hepatic cirrhosis Patient has a known history of allergic reaction to opiates

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR13A9 low dose<br> | Drug: MR13A9<br>* Intravenous administration<br>|
| Experimental: MR13A9 medium dose<br> | Drug: MR13A9<br>* Intravenous administration<br>|
| Experimental: MR13A9 high dose<br> | Drug: MR13A9<br>* Intravenous administration<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Intravenous administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numerical Rating Scale (NRS) score of itch | Change from baseline in average NRS score of itch at week 8 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in itching scores of Shiratori severity criteria | Change from baseline in average itching scores of Shiratori severity criteria at week 8 | 8 weeks |
Trendelenburg Maneuver Predicts Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation (TEMPLE)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to verify the efficacy of using trendelenburg maneuver to predict fluid responsiveness in patients with extracorporeal membrane oxygenation

Official Title
-----------------
Hemodynamic Changes Induced by Trendelenburg Maneuver to Predict Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation

Conditions
-----------------
Extracorporeal Membrane Oxygenation

Intervention / Treatment
-----------------
* Diagnostic Test: Trendelenburg Maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with ECMO and mechanical ventilator support hypotension (MAP<65mmHg) required volume expansion by clinical judgement of the intensivists Exclusion Criteria: severe hypotension with high dose of vasopressors severe valve regurgitation cardiac arrhythmia

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: Trendelenburg Maneuver<br>Trendelenburg maneuver is performed to predict fluid responsiveness. Responders are defined by an increase in stroke volume over 15% after infusion of 500ml of crystalloid solution. | Diagnostic Test: Trendelenburg Maneuver<br>* In the Trendelenburg position, the body is laid supine, or flat on the back with the feet higher than the head by 15-30 degrees. The venous return increases in the trendelenburg position which in turn increases the stroke volume.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responders | responders are defined by stroke volume increases over 15% after volume expansion of 500ml crystalloid | within 1 minute after volume expansion | 
| nonresponders | nonresponders are defined by stroke volume increases less than 15% after volume expansion of 500ml crystalloid | within 1 minute after volume expansion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluid responsiveness, trendelenburg, extracorporeal membrane oxygenation
Randomized Controlled Trial of Fiber Post Restorations

Study Overview
=================
Brief Summary
-----------------
This in vivo study examined the contribution of remaining coronal dentin and placement of a prefabricated or customized fiber post to the six-year survival of endodontically treated premolars. A sample of 345 patients provided 6 groups of 60 premolars in need of endodontic treatment. Groups were classified according to the number of remaining coronal walls before abutment build-up. Within each group, teeth were allocated to three subgroups: A) no post-retention; B) LP; C) ES (N=20). All teeth were protected with a crown. Cox regression analysis was applied to assess whether the amount of residual coronal dentin and the type of endocanalar retention had a significant influence on failure risk of the restored teeth.

Official Title
-----------------
Survival of Endodontically Treated and Restored Premolars: A Randomized Controlled Trial

Conditions
-----------------
Restoration Survival

Intervention / Treatment
-----------------
* Procedure: post placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endodontically treated premolars with symptom-free root canal filling and a minimum apical seal of 4 mm, in occlusal function with a natural tooth and in interproximal contact with two adjacent natural teeth. Exclusion Criteria: periapical lesion on the X-ray.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 76 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: post restoration<br> | Procedure: post placement<br>* placement of an endocanalar post<br>* Other names: Customized post, EverStick Post, StickTech;|
| No Intervention: no post restoration<br>no post placement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 2 years |
Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
In 2003, observational growth and bone density data was obtained on children with cerebral palsy (CP) living at Hattie Larlham as part of a study comparing growth with an existing database of children with CP who live at home. The original residents included in that study are now of adult age. Due to the lack of longitudinal bone density measurements in facility-based adults with severe CP, the investigators' objective is to obtain 6-year follow-up data from the residents enrolled in the original study.

Official Title
-----------------
Longitudinal Assessment of Bone Growth and Development in a Facility-Based Population of Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy, Bone Density

Intervention / Treatment
-----------------
* Radiation: Dexa Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident of Hattie Larlham Center for Children with Disabilities (HLCCD) Previously enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study in 2003 Exclusion Criteria: Resident of HLCCD who was not enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexa Scan<br>Eligible patients from 2003 study will receive a follow-up Dexa scan. | Radiation: Dexa Scan<br>* Dexa scan of left and right distal femur, then lumbar spine, and whole body when possible<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual Energy X-ray Absorptiometry (DEXA) scan results |  | 6 years from original DEXA scan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral palsy, DEXA scan, bone density
Comparison of Two Methods to Estimate the Lung Recruitment

Study Overview
=================
Brief Summary
-----------------
In this study the investigators aim to compare two common methods to estimate the lung recruitment in ALI/ARDS patients.

Official Title
-----------------
Comparisons of Two Methods to Estimate the Lung Recruitment

Conditions
-----------------
Acute Respiratory Distress Syndrome, Acute Lung Injury

Intervention / Treatment
-----------------
* Procedure: CT scan and Pressure volume curve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALI/ARDS Exclusion Criteria: Barotrauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| 1<br>ALI/ARDS patients | Procedure: CT scan and Pressure volume curve<br>* CT scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Intra-individual Stability in Electroencephalography (EEG) Parameters

Study Overview
=================
Brief Summary
-----------------
The main objective is to evaluate the stability of EEG features on an individual level.

Official Title
-----------------
Intra-individual Stability in EEG Parameters

Conditions
-----------------
Stability of EEG Features in Humans

Intervention / Treatment
-----------------
* Other: EEG recording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age must be in the range 50 - 90 years Exclusion Criteria: Outside required age range

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: EEG recording|A short EEG recording is performed 10 times over the span of three months.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative EEG (qEEG) features | qEEG features are extracted from 10 separate EEG recordings from each individual in the cohort. | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intra-individual stability, EEG