linjc16/ctgov huggingface dataset:
Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study

Study Overview
=================
Brief Summary
-----------------
This study is to examine the association between maternal omega3 and other polyunsaturated fatty acids (PUFAs) during pregnancy and autism spectrum disorder (ASD) as well as other non-typical development (Non-TD) in the prospective Markers of Autism Risk in Babies-Learning Early Signs (MARBLES) cohort.

Official Title
-----------------
Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: Maternal Supplemental PUFA Intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother or father had a biological child with ASD Mother is at least 18 years old Mother is pregnant or planning a pregnancy, and biologically able to become pregnant Mother is living within 2 hours of the MIND Institute Mother is sufficiently fluent in English Exclusion Criteria: Mothers with diseases which will influence on their study participation

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- |
| Mother-child pairs<br>Families were recruited from lists of children receiving autism services obtained via the California Department of Developmental Services (DDS), from other studies at the Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, or by self-referrals. The inclusion criteria were: a) mother or father had a biological child with ASD, and the mother was b) at least 18 years old; c) pregnant or planning a pregnancy, and biologically able to become pregnant; d) living within 2 hours of the MIND Institute; e) sufficiently fluent in English. | Behavioral: Maternal Supplemental PUFA Intake<br>* Maternal Supplemental PUFA Intake included sources from the questionnaires and plasma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autism spectrum disorder group (ASD) | number of people with ASD | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A group of typically development (TD) people | number of typically developed people | 36 months |
Study Evaluating Mitoxantrone in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients.

Official Title
-----------------
A Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple Sclerosis

Conditions
-----------------
Secondary Progressive Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Mitoxantrone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Secondary progressive MS in an active stage EDSS between 3 and 6 Exclusion Criteria: Benign or primary progressive MS Patients with cardiac risk factors Patients who have already received mitoxantrone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1st group: 12 mg Mitoxantrone/m² | Drug: Mitoxantrone<br>* dosage<br>|
| Experimental: 2<br>2nd group: 9mg Mitoxantrone/m² | Drug: Mitoxantrone<br>* dosage<br>|
| Experimental: 3<br>3rd group: 5mg Mitoxantrone/m² | Drug: Mitoxantrone<br>* dosage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS) |  | 3 years | 
| deterioration, change of ambulation index, time to first relapse requiring corticoid treatment |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| derivations of EDSS and relapses; MRI (baseline, 2 years) |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis
Myocardial Injury is Not Related to Training Levels Among Recreational Participants in the Silicon Valley Marathon

Study Overview
=================
Brief Summary
-----------------
To determine if pre-race training effects heart damage induced by marathon running.

Detailed Description
-----------------
Investigations have shown increases in cardiac markers consistent with myocardial injury and left ventricular dysfunction in both recreational and elite athletes after endurance exercise. Pre-race training is an important component of endurance events, yet its effect on cardiovascular injury is unclear. The present study aimed to evaluate the correlation between myocardial injury and training level in recreational marathon runners utilizing both objective and subjective measures.

Official Title
-----------------
Myocardial Injury is Not Related to Training Levels Among Recreational Participants in the Silicon Valley Marathon

Conditions
-----------------
Troponin, Natriuretic Peptide, Brain, Exercise, Echocardiography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any healthy male or female aged 18-65 planning to run the 2006 Silicon Valley Marathon. Exclusion Criteria: Hypertension Hyperlipidemia Diabetes History of myocardial infarction or acute coronary syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Troponin, Natriuretic Peptide, Brain, Exercise, Echocardiography
Oxytocin Effects on Self and Other Processing

Study Overview
=================
Brief Summary
-----------------
To determine whether the neuropeptide oxytocin (OXT) influences self-processing by investigating whether it increases the endowment effect in relation to both self and others.

Detailed Description
-----------------
In a double-blind, between- subject placebo (PLC) controlled design, investigator aimed to measure the effect of intranasal OXT on the endowment effect. All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety before self-administration: Positive and Negative Affect Schedule (PANAS) , State-Trait Anxiety Inventory (STAI) , Beck Depression Inventory (BDI), self-esteem scale (SES). Subjects were asked to decide whether to buy or sell their own or others' (their mothers'/ fathers'/ classmate'/ strangers') possessions at various prices. Indifference point and brain activation were inluded into analysis as dependent variables.

Conditions
-----------------
Social Behavior

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects without past or current psychiatric or neurological disorders Exclusion Criteria: history of head injury; claustrophobia; medical or psychiatric illness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 27 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>Oxytoxin nasal spray | Drug: Oxytocin<br> <br> |
| Placebo Comparator: Placebo<br>Placebo nasal spray | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared the indifference point between buy and sell conditions during the price phase and the specific brain region activation between oxytocin and placebo groups | Indifference point is the gap between willingness to accept and willingness to pay ;focus on the specfic brain region relasted to self-processing, such as medial prefrontal cortex, precuneus, posterior cingulate cortex, ventral striatum. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
self-processing, endowment effect, neuroimage
Aflibercept in Patients With Pigment Epithelial Detachments (PED)

Study Overview
=================
Brief Summary
-----------------
Uncontrolled single site non randomized non interventional study to determine the safety and efficacy of intravitreal injections of Aflibercept in patients with recent vision loss due to retinal pigment epithelial detachment secondary to AMD

Official Title
-----------------
Intravitreal Aflibercept in Patients With Retinal Pigment Epithelial Detachment (PED) Secondary to Age Related Macular Degeneration (AMD)

Conditions
-----------------
Pigment Epithelial Detachment

Intervention / Treatment
-----------------
* Drug: Aflibercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with vascular PED due to AMD Male or female patients with the age > 50 years Angiographic and via OCT ensured PED ≥ 200 µm in the eye for treatment Written informed consent Best corrected visual acuity (ETDRS-Visus): 24 - 73 letters within Exclusion Criteria: Patients that do not fulfill the a. m. inclusion criteria Patients which have been treated with steroids or with verteporfin via photodynamic therapy or focal lasercoagulation treatment until 3 months before, Anti VEGF therapy until 1 month before screening Patients with other retinal vascular diseases including diabetic rethinopathia or retinal vein occlusion Other ocular operative procedurs 3 months before Screening Anamnesis of non controlled glaucoma Active or intraocular Inflammation or Inflammation of ocular adnexa Subfoveal fibrosis within study eye Larger surgical interventions 1 month before Screening Anamnesis of serious cardiovascular diseases or stroke 6 months before srceening Allergy of components of the study medication Patients which might be not compliant Patients participating at another clinical trial at the same time Pregnancy, breastfeeding, women in child-bearing years without using a safe contraception method Chronical alcohol- or drug abuse within the last year lack of capacity and/or knowledge of German language Neurologic disease i. e. multiple sclerosis

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aflibercept|Patients are treated according to authorization of Aflibercept|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention and improvement of visual acuity | Visual acuity after treatment completion compared to baseline | Screening until 1 month after last injection within study eye (Month 12) | 
| Height of Pigment Epithel Detachment | The height of PED after treatment completion compared to baseline | Screening until 1 month after last injection within study eye (Month 12) |
DePuy Global Unite Shoulder System

Study Overview
=================
Brief Summary
-----------------
To collect medium to long-term survivorship implant outcomes on the DePuy Global Unite Shoulder System

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Total Shoulder Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient greater than 18 years of age and skeletally mature Patient qualifies for primary or revision total or reverse shoulder arthroplasty based on diagnosis of investigator of osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, un-united humeral head fractures, irreducible 3- and 4- part proximal humeral fracture, avascular necrosis, or gross rotator cuff deficiency. Patient is willing and able to provide written informed consent and to complete scheduled follow up visits/evaluations/questionnaires Exclusion Criteria: Patient has one of the following compromise the affected limb; a significant injury to the upper brachial plexus, paralysis of the axillary nerve, or a neuromuscular disease compromising the affected limb Patient has a known or suspected infection Patient is known to be pregnant Patient has a sensitivity or allergic reaction to one or more of the implanted materials Patient is unwilling or unable to provide consent or comply with follow up visits

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Total Shoulder Arthroplasty|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survivorship |  | 10 years post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder
Role OF Geometric Mean in Estimation OF Differential Renal Function in DMSA Scintigraphy

Study Overview
=================
Brief Summary
-----------------
Renal scintigraphy is an imaging method that uses small amount of radioactive materials called radiotracers, a Gamma camera and a computer to evaluate kidney functions and its anatomy. The relative renal function (RRF), expressed as a percent of total renal function, is important in the initial assessment and treatment of patients having renal diseases. RRF has traditionally been measured by radionuclide renal scintigraphies using different tracers for a long time . Different radiopharmaceuticals such as technetium-99m-diethylenetriaminepentaacetic acid (99mTc-DTPA), technetium-99m-dimercaptosuccinic acid (99mTc-DMSA), technetium-99m-mercaptoacetyltriglycine (99mTc-MAG3). 99mTc-DMSA is a static agent that is actively taken up by the proximal and distal renal tubular cells, directly from the peritubular vessels and accumulates in the renal cortex. Its binding level to protein in mammals is 90% which prevents significant glomerular filtration. DMSA renal scan images provide a good definition of the cortical outline, as well as they show the relative distribution of functional tissue. Determination of the left to right dimercaptosuccinic acid (DMSA) uptake ratio is theoretically one of the easiest quantitative procedures in nuclear medicine. The quantification can be performed on the posterior view, with or without the lateral view for correction of kidney depth. The geometric mean can also be determined using both the anterior and the posterior views.

Official Title
-----------------
Role OF Geometric Mean in Estimation OF Differential Renal Function in DMSA Scintigraphy

Conditions
-----------------
Patients Referred for Renal DMSA Scintigraphy

Intervention / Treatment
-----------------
* Diagnostic Test: Renal DMSA Scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred for renal DMSA scintigraphy Patients aging 2 to 70 years Exclusion Criteria: Single kidney patients Patients with a major uncontrollable medical illness.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Renal DMSA Scintigraphy|patient injected with Tc99mDMSA then imaged after 2-4 hours by gamma camera|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| geometric mean of both anterior and posterior views of gamma camera | . We evaluate the discrepancy between function measured by conjugate anterior and posterior views in relationship to posterior view in DMSA scan . | 6 months |
Transoral Gastric Volume Reduction as an Intervention for Weight Management

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System

Official Title
-----------------
Transoral Gastric Volume Reduction as an Intervention for Weight Management (TRIM): A Non-Randomized Multicenter Feasibility Study of Subjects With Class II or Low Grade Class III Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: RS2 (RESTORe Suturing System)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, Female; ages >18yrs - £ 60 yrs BMI 30-45 kg/m2 History of obesity for 5 yrs; attempts at weight control ineffective Weight stable Willing to comply with study requirements Agrees to not have any additional weight loss surgery, reconstructive surgery or liposuction for one year following procedure Sign informed consent form Exclusion Criteria: Women of childbearing age not practicing effective birth control method or pregnant or lactating Mallampati score = 4 Uncontrolled hypothyroidism Previous interventional/surgical treatment of obesity; any prior gastric surgery History of diabetes for > 10 yrs or difficult to control diabetes Presence of hiatal hernia Congenital or acquired anomalies of the GI tract Severe cardiovascular, cerebrovascular, or cardiopulmonary disease Chronic or acute upper gastrointestinal bleeding conditions Helicobacter pylori positive Immunocompromised Subjects with eating disorders Acute or chronic infection Significant movement limitations Not a candidate for conscious or general anesthesia Active substance abuse Life expectancy < 2 years Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: 1<br>Transoral Suturing | Device: RS2 (RESTORe Suturing System)<br>* Suturing in stomach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success of test procedure. |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Loss, Transoral Suturing, Experimental
Islet Transplantation for Patients With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with stable renal allografts by islet transplantation.

Detailed Description
-----------------
We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be transplanted into the portal vein of patients with T1DM who have stable renal allografts to achieve insulin independence for the recipient. The protocol will employ a defined islet isolation procedure, percutaneous islet infusion into the recipient's portal vein via an intra-portal catheter, tight glycemic control during the peri-transplant period, and an immunosuppressive protocol that avoids glucocorticoids.

Official Title
-----------------
Islet Transplantation for Patients With Type 1 Diabetes and Stable Renal Allografts Using Steroid Sparing Immunosuppression

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Procedure: Islet transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with type 1 diabetes with stable renal allografts

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Islet transplantation|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
-----------------
diabetes, autoimmunity