cyrilzakka/clinical-trials huggingface dataset:
Using fMRI to Evaluate Instructional Programs for Children With Developmental Dyslexia

Dyslexia is a common reading disorder. Specialized instructional programs can improve reading ability in children with dyslexia. This study will use functional magnetic resonance imaging (fMRI) to examine changes in the brains of children who have taken part in these programs.

Reading is a uniquely human endeavor and failure to develop this skill can lead to serious educational and emotional consequences. Reading more slowly or less accurately, as is the case in developmental dyslexia, occurs in between 5% and 15% of individuals in the United States. Developmental dyslexia significantly interferes with academic achievement and with activities of daily living that require reading skills. Although dyslexia is considered a reading disorder, dyslexia's clinical signs are varied and include deficits in the sensory domain, abnormal phonological awareness, and problems in related linguistic skills. Phonological awareness training and visual perceptual training can improve reading ability in children with dyslexia. Recent functional imaging studies on sensory and language processing in dyslexia have demonstrated involvement of the posterior temporal and inferior parietal cortical systems of the brain. However, how these brain areas are changed as a result of dyslexia treatment has not been determined.

This study will investigate the neurophysiologic changes before and after treatment in 11- to 14-year-old children immersed in Lindamood-Bell training utilizing either phonological (LiPS) or visual (Seeing Stars) strategies. These training programs have successful behavioral outcomes, but neurophysiologic changes have not been evaluated. The study will determine whether behavioral changes in reading skills result in physiological differences in the brain identifiable with functional brain imaging and whether initial physiological observations are indicative of the degree of success of the intervention.

Participant will be randomized to receive either Lindamood-Bell training, a math intervention (active control), or no intervention (passive control). The intervention will last 6 weeks; children will have both pre- and post-intervention behavioral testing and fMRI scans.

Eligibility Criteria:
Inclusion Criteria

* Developmental dyslexia diagnosis
* English speaking
* Right-handed
* General good health

Exclusion Criteria

* Metal implant, braces, or other device that prevents child from undergoing fMRI
Transabdominal Electrical Stimulation for Constipation

Several transabdominal electrical stimulation studies have been reported for constipation in childhood. This study aims to assess the efficacy of this technique in adults with chronic constipation and compare two different electrical therapies.

Patients with Rome III defined constipation unresponsive to medical and behavioural treatment will be randomised in a double-blind prospective trial to receive either four weeks of transabdominal electrical stimulation (TENS) or Interferential stimulation (IFC). Treatment will be self-administered at home for sixty minutes a day. The response to treatment will be assessed with the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL), the Patient-Assessment of Constipation Symptoms (PAC-SYM) tool and a bowel visual analogue scale (VAS). A bowel diary will be kept a week before and during the final week of stimulation, recording daily bowel frequency.

IFC stimulation is an effective, cheap and low risk intervention which has demonstrated efficacy for dysphagia, urinary incontinence, overactive bladder syndromes and chronic pain. The precise mechanism of its analgesic and pro-kinetic effect is unknown. The intervention is delivered by two separate continuous alternating electrical currents. Two pairs of pad electrodes are arranged in a quadripolar manner where each pair delivers a different frequency of current. It is suggested that this arrangement of stimulation improves colonic propagation. However as direct massage of the abdomen has demonstrated benefit in constipation it is argued that IFC is not a specific requirement and that non-IFC electrical stimulation over the abdomen is sufficient to evoke the same colonic and clinical responses. Owing to these questions the efficacy of this intervention will be further evaluated in adults.

This study has two aims. The primary aim is to evaluate the effectiveness of transabdominal electrical nerve stimulation (TENS) in adult patients with chronic constipation. The secondary aim is to establish whether IFC was superior to non-IFC (TENS) electrical stimulation in adults with chronic constipation.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Rome III defined constipation (frequency of defecation of less than three times a week, straining or sense of incomplete emptying associated with at least 25% of defecations. Lumpy, hard stools or anal digitation for at least 25% of defecations
* Failed Biofeedback
* Competent and willing to complete stimulation at home
* Competent and willing to complete the questionnaires and bowel diaries

Exclusion Criteria:

* Rectal prolapse
* Active inflammatory bowel disease
* Pregnancy or intention to become pregnant during trial
* Spinal cord injuries/cauda equina syndrome
* Other implanted electrical devices
* Allergy to device components
* Neurological disorders
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.


Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 or older at the time of consent
* Meets the following audiometric criteria for the ear to be implanted: clinically established sensorineural hearing loss (SNHL) defined by a four frequency pure tone average (PTA) at 500, 1000, 2000, \& 4000 Hz of: ≥60 dB HL and compromised functional hearing in the aided condition defined as \<50% correct on a word recognition test
* Meets the following audiometric criteria for the non-implanted contralateral ear: clinically established SNHL defined by a four frequency PTA at 500, 1000, 2000, \& 4000 Hz of \>30 dB HL
* Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Meets current indications on audiometric thresholds for traditional adult CI candidates (i.e., bilateral moderate to profound hearing loss in the low frequencies and profound \[≥ 90 dB HL\] hearing loss in the mid to high speech frequencies)
* Absence of cochlea development or a cochlear nerve
* Presence of active middle ear infection in the ear to be implanted
* Tympanic membrane perforation in the presence of active middle ear disease in the ear to be implanted
* Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation.
* Existing contralateral cochlear implant or medical plan to implant a contralateral cochlear implant during the clinical investigation.
* Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation.
* Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator.
* Additional disabilities that may affect the participant's participation of safety during the clinical investigation.
* Unable or unwilling to comply with all of the requirements of the clinical investigation as determined by the investigator.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Employees of Cochlear.
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.
Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet

The purpose of this study is to understand how the reduction in dietary carbohydrates in a very-low carbohydrate ketogenic diet impacts the synthesis of cholesterol, fatty acid, and ketones, and the turnover rate of VLDL and chylomicron particles.

Participants will consume a standard American diet for one week followed by a very-low carbohydrate ketogenic diet (VLCKD, \<50 grams carbohydrate/day) for two weeks. Participants will undergo an oral stable isotope tracer study during each diet to measure de novo synthesis of fatty acid, cholesterol, ketone bodies, and for measurement of apolipoprotein B and triglyceride kinetics.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-50 years old

Exclusion Criteria:

* Use of nicotine products
* Has dietary restrictions
* Lactose intolerance
* History of GI disorders, diabetes, liver, kidney, or thyroid disorders
* Taking hypolipidemic, anti-diabetic, anti-hypertensive, or anti-depression medication
* Screening plasma triglyceride \< 50mg/dl or \>500mg/dl
* Screening glucose \> 125mg/dl
* Screening total and LDL-Cholesterol over 95th %tile for age and sex
* BP \> 160/95 mmHg
* Weight loss/gain \> 5% in the previous 3 months (self-reported)
Dermal Profile Analysis Using the NMR-MOUSE

The determination of fluid status in dialysis patients is a major clinical problem. In this study the NMR-MOUSE is used to determine if it can be used to non-invasively determine hydration status of the skin. This evaluation will be performed in dialysis patients and healthy volunteers.

Excretion of urine is impaired in terminal chronic kidney disease patients often requiring dialysis. Fluid management of dialysis patients is solely based on body weight differences before and after dialysis. Patients can suffer from either hypotension if too much fluid is eliminated by dialysis or from fluid-overload symptom (e.g. shortness of breath, edema) if not enough fluid is eliminated.

In this study a mobile non-invasive NMR-MOUSE setup (a nuclear magnetic resonance spectroscopy measurement) is used to measure the hydration status of the skin.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Dialysis
* ability to perform NMR-measurement
* Eligibility to sign informed consent
* signed informed consent

Exclusion Criteria:

* implanted cardiac device
* implanted cranial device
* implanted cochlea device
* intrauterine device
* other metallic implants
* tattoo, any skin disease or scars from surgery (in the area of measurement)
* previous skin treatment with cosmetics (of any kind) 24 hours prior to measurement
* wearing of earrings, piercings or hearings-aids during measurement
* participation in other clinical trials 30 days prior to participation in the SHN study
* no written informed consent
* any conditions, as determined by the examiner, that excludes the patient from participation in the study
* subjects with legal guardian
* pregnancy or lactation (a possible pregnancy of a participant before menopause will be excluded before inclusion in the study)
* subjects under employment or with any relation to the the sponsor or the investigator
* participation in any other study
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria

The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies on women that present to the hospital with a suspicious breast mass. Before performing biopsies on patients, the Nigerian radiologists will have already successfully completed a competency-based mobile health ultrasound-guided breast biopsy-training program. This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older female
* Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.

Exclusion Criteria:

* Participants unwilling to sign consent
* Participants under the age of 18.
Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

This study evaluates the safety and performance of a new vascular graft made of POSS-PCU as a vascular access conduit for haemodialysis. 30 patients requiring access for dialysis will be enrolled and monitored at regular intervals for 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Subjects requiring vascular access for haemodialysis
* Subjects with no suitable vein.
* Subjects aged 18 - 80 years old
* Subjects are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
* Patients of child bearing potential, who are sexually active, must agree to the use of 2 highly effective forms of contraception throughout their participation in the study and for 6 months after completion of treatment:

  * Condom with spermicide.

AND 1 of the following:

* Oral contraceptive or hormonal therapy (e.g. hormone implants).
* Placement of an intra-uterine device.

Exclusion Criteria:

* Subjects with predicted short-term survival (less than 18 months) or poor prognosis (this will be on the discretion of the clinician in charge)
* Subjects with left ventricle ejection fraction (LVEF) \<20% diagnosed on ECHO either pre-procedure or documented within the previous 3 months prior to consent.
* Pregnant or lactating
* Allergies to any constituents of the graft material
* Patients who are infected or colonized with Methicillin Resistant Staphylococcus Aureus (MRSA).
School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities

Purpose of the study. The purpose of the project is to evaluate the feasibility, acceptability, and cost effectiveness of providing influenza vaccine in schools to children in grades Kindergarten through 6th grade.

Hypothesis 1: School based influenza vaccination (SIV) will increase the overall rate of influenza vaccination in school children.

Hypothesis 2: Higher intensity parent notification about school based influenza vaccination does not increase immunization rates compared to low intensity.

Hypothesis 3: School based vaccination from the perspective of mass vaccinators is cost neutral.

Background. The ACIP (American Committee on Immunization Practices) has now recommended influenza vaccination for all children 6 months to 18 years of age. While many school-aged children will be vaccinated in the medical home, the large number of children for whom the vaccine is now recommended exceeds the capacity of many primary care settings. Schools have been recommended as potential sites for influenza vaccination, yet little is known about the feasibility, implementation requirements, costs, or effectiveness of school-based influenza vaccination (SIV) programs. This project will implement and rigorously evaluate the feasibility, acceptability, billing and reimbursement components, costs, cost-effectiveness, and overall effectiveness of an SIV program that targets diverse populations and different intensity of interventions.

Eligibility Criteria:
Inclusion Criteria:

Children in grades K through 5 enrolled in schools that agreed to participate in the randomized trial of school based influenza vaccine

Exclusion Criteria:

Children and schools not enrolled in school based influenza vaccine program Children in participating schools in grades other than Kindergarten through 5th grade.

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Smart Phone Application for Enteral Nutrition

Internal medicine resident physicians were provided an ipod with the EN application to assist them in choosing EN formulas for patients during their ICU rotation. The primary outcome was improved initiation of EN within 24 hours of admission. Secondary outcomes include, time to initiate EN, goal calories reached, infections rates, length of stay, mortality, and concordance with clinical guidelines.

Background: Resident physicians are frequently uncomfortable ordering enteral nutrition (EN) and are unaware of the variety of formulas and supplements available for different disease processes. Many depend on a clinical dietitian to assist with recommending EN formulas and patient energy requirements which may not be readily available upon patient admission. This creates a barrier to early initiation of EN and non-compliance with Society of Critical Care Medicine and American Society of Parenteral and Enteral Nutrition clinical guidelines. Objective: Internal medicine resident physicians were provided an ipod with the EN application to assist them in choosing EN formulas for patients during their ICU rotation. The primary outcome was improved initiation of EN within 24 hours of admission. Secondary outcomes include, time to initiate EN, goal calories reached. Design: This study is a retrospective chart review to evaluate the impact of a smart phone/device application (EN application) to assist resident physicians when ordering EN. The study is a single center trial conducted at an academic teaching facility. All patient data was obtained by a retrospective chart review of patients admitted to the intensive care unit (ICU) at The University of Oklahoma Medical Center.

Eligibility Criteria:
Inclusion Criteria:

1. Admitted to the ICU
2. Require Mechanical Ventilation
3. Physician plans to order enteral nutrition for the patient

Exclusion Criteria:

1. Death likely within 24 hours
2. Needing parenteral nutrition
3. Cannot tolerate enteral nutrition for any reason
Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

Epithelial ovarian cancer constitutes one of the most common gynecological malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA.This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.

Epithelial ovarian cancer constitutes one of the most common gynecological malignancies, with an incidence rate of 3-12/100 000 woman per year. Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage. Liquid biopsy, which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.

ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the ctDNA originates from tumor tissue. This, and the fact that ctDNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer.

This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.

Eligibility Criteria:
Inclusion Criteria:

* people aged 18years to 80years;
* Diagnosis of ovarian cancer is confirmed by two Pathologists independently;
* Pregnancy tests are negative.

Exclusion Criteria:

* With other type of malignancies;
* someone who refuse to participate the study.
Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation

This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial fibrillation.

One group of subjects will have the procedure performed with intracardiac echo maneuvers to assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of subjects who will receive the standard medical treatment with fluoroscopy and angiography.

Surgical and catheter based technologies target triggers that initiate atrial fibrillation located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency energy or freezing is used to destroy the atrial tissue which propagate electrical impulses into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and efficacious under fluoroscopic guidance with contrast angiography. The objective of this study is to identify methods to reduce radiation dose and radio opaque contrast use while maintaining PVI efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal atrial fibrillation refractory to treatment with anti-arrhythmic drugs
* Must be able to undergo pre-operative cardiac CT angiogram or cardiac MRI to define pulmonary vein anatomy.

Exclusion criteria:

* Planned use of radiofrequency cardiac ablation
* Presence of a cardiac implantable electronic device
* Conditions where manipulation of the catheter would be unsafe such as intracardiac thrombus
* Patients with active systemic infections
* Patients with cryoglobulinemia
* Pregnant and/or breast-feeding females are excluded from this study.
Study to Evaluate SYN115 in Parkinson's Disease

This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a function test is administered.

This is a randomized, double-blind, placebo-controlled, two-way crossover study in which each patient will act as their own control. Each patient enrolled will receive both SYN115 (20 mg or 60 mg) and placebo separated by a minimum of one week washout between periods. An adaptive design will be used to determine if SYN115 elicits effects relevant to PD in the fewest number of patients by performing interim analyses in successive cohorts of patients receiving 60 or 20 mg.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease
* Hoen and Yahr stage 1-3
* On stable dose of anti-parkinsons treatment for 30 days prior to screening
* Age 40 to 75 years
* Sign an IRB approved informed consent
* Men and women agree to use adequate birth control
* ECG measurements are within normal limits
* Able to understand study requirements

Exclusion Criteria:

* Secondary Parkinson's (drug induced or post stroke)
* Received treatment with other investigational drug 30 days prior to study entry
* Using disallowed medications
* Significant neurological illness other than Parkinson's
* IQ less than 70 on IQ test
* MMSE score \< or = 23
* History of psychosis or on anti-psychotic medication
* Current serious medical illness
* History of substance abuse
* History of head injury with loss of consciousness
* History of brain surgery
* Contraindications to MRI like claustrophobia, metal implants or other implantable devices
* Abnormal liver function tests and/or hepatitis or cholangitis
* Gilberts disease
* Pregnant or nursing
* Known hypersensitivity to SYN115