cyrilzakka/clinical-trials huggingface dataset:
Task Oriented Training and Evaluation at Home (TOTE Home)

Objective: To determine the effectiveness of an upper extremity, task oriented training program delivered at home (TOTE Home) for people who are in the subacute recovery phase of a stroke.

Method: A single-subject AB series design with a follow-up to assess the effectiveness of TOTE Home which includes a maximum of 30, one hour sessions of training conducted in participants' homes. Repeated target measures of accelerometry and level of confidence to be analyzed throughout the study. Change scores from standardized assessments to be evaluated at baseline, post-intervention, and follow-up time periods.

Hemiparesis following a stroke frequently leads to "learned non-use" of the weaker arm and hand. Task oriented training has been suggested as a contemporary neurorehabilitation technique. A single-subject AB series design with a follow-up was conducted to assess the effectiveness of a task oriented training program administered in participants' homes. This intervention, Task Oriented Training at Home (TOTE Home), incorporated current experience-dependent plasticity aspects modeled after the Acquired Skill Acquisition Program (ASAP) protocol parameters and principles of task oriented training as suggested by Lang and Birkenmeier in 2014. Repeated measures of accelerometry and level of confidence on a priority task were analyzed with visual analysis of changes in level, trend, and slope. Change scores from standardized assessments for the upper extremity, Motor Activity Log, Stroke Impact Scale question of recovery, Functional Test for the Hemiparetic Upper Extremity, and Canadian Occupational Performance Measure were evaluated on data collected at baseline, post-intervention, and follow-up time periods.

Eligibility Criteria:
Inclusion Criteria:

* upper extremity hemiparesis due to a stroke but met minimal movement criteria in the affected arm and hand (at least 10 degrees of active movement at the wrist, elbow, and shoulder movement, along with 10 degrees of active movement in the thumb and two other fingers)
* minimal cognitive deficits as demonstrated by a 24 or higher on the Mini-Mental Status Exam
* able to identify at least five specific tasks participants wish to achieve with their affected upper extremity. This was assessed with the Canadian Occupational Performance Measure (COPM)
* at least 21 years of age
* able to communicate in English
* 3-12 months after their stroke which would classify them in the subacute level of recovery
* all formal occupational therapy was completed.

Exclusion Criteria:

* upper extremity pain that interfered with activities of daily living
* requiring maximal assistance for mobility
* arm or hand injury (unrelated to the stroke)
* upper extremity amputations
* inability to participate due to any illness, social or geographical reason, and any other diagnosis or limiting conditions that would affect participation
Helicobacter Pylori and Proton Pump Inhibitor

The purpose of this study is to know the distribution of HP in stomach before use of PPI, during use of PPI, and after stop of PPI.

Endoscopy and biopsy will be performed to investigate the distrubition of HP before, during, and after using PPI.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are indicated to endoscopic resection due to gastric neoplasm
2. Aged between 19 to 65 years
3. Informed consent

Exclusion Criteria:

1. Previous history of HP eradication
2. Previous history of PPI use within 6 months
3. No HP infection
Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit

The aim is to evaluate balance training using Nintendo Wii Fit. The hypothesis is that a period of training will increase balance capacity och self-efficacy.

People with diagnosed multiple sclerosis are invited to participate. Estimation of study power gave that 29 people in each group was necessary to detect a difference in the primary outcome measure, Timed Up and Go test.

Other measures used are the Four square step test, Dynamic Gait Index, Timed stands test, 25 foot walking test, 12-item Walking scale and the ABC scale.

Participants were randomised to either training or control. The training consisted of 6 weeks training with Nintendo Wii Fit 30 minutes 2 times a week.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed multiple sclerosis
* Subjective experience of affected balance and walking
* Being able to walk 100 meters with assistance

Exclusion Criteria:

* Cognitive or language deficits that prevents using the self-rating scales
* Visual deficits that prevents training with television games
* Weight above 149 kg
Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy

Wireless Capsule Endoscopy has been the most reliable diagnostic standard for small bowel Crohn's disease. Endoscopic healing is an important endpoint to measure response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-70 with confirmed Crohn's disease that includes small bowel disease
* Moderately to severely active disease (CDAI score \>220 and \< 450)
* Stable doses of steroids, 5-ASA, antibiotics, Immunosuppressants

Exclusion Criteria:

* Any and all contraindications to the use of certolizumab pegol (including but not limited to hepatitis, infection, abscess, malignancy, congestive heart failure \[CHF\], cytopenia)
* Small bowel obstruction, stricture, or any contraindication for capsule endoscopy
* Previous treatment with certolizumab pegol
* Are pregnant or lactating
Obalon Navigation/Touch System Post-Approval Study

Post-approval study for the Obalon Navigation/Touch System (NTS)

The Obalon NTS PAS is a prospective, observational, open-label and multi-center study with an objective to collect continued safety and performance of the Obalon NTS in a commercial setting and confirm results observed in the supplemental PMA IDE study.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 22 years and older
2. Starting or current therapy BMI of 30.0-40.0 kg/m2
3. Commercially purchased the Obalon Balloon Device

Exclusion Criteria:

1. Known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic removal procedure, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation or any other disorder of the esophagus.
2. Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms.
3. Known history of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (\> 2 cm), cancer or any other disorder of the stomach.
4. Active implantable devices, such as a pacemaker of defibrillator, or with metal implants in the thoracic region.
Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B

* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
* Select the dose of pradefovir for Phase 3 studies

* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
* Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment
* Select the dose of pradefovir for Phase 3 studies
* Determine the pharacokinetic profiles of four oral doses of pradefovir

Eligibility Criteria:
Inclusion Criteria:

* Compensated chronic HBV Infection
* No prior treatment with adefovir dipivoxil
* No interferon or lamivudine treatment for three months prior to enrollment
* HBeAg positive or negative
* HBV DNA viral load greater than 500,000 copies per mL
* ALT between 1.2 and 10 times ULN

Exclusion Criteria:

* Positive HIV, HCV, and/or HDV serology
* History of renal tubular necrosis
* Serum creatinine greater than 2.0 mg/dl
* History of organ transplant or use of immunosuppresive drugs
* Pregnant or breast-feeding females
A Study of Lasmiditan in Healthy Elderly Participants

The purposes of this study are to evaluate the effect of lasmiditan on blood pressure, as well as to look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it in healthy elderly participants. The tolerability of the study drug will also be evaluated. Information about any side effects that may occur will also be collected. This study will take about 11 days, not including screening. Screening is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined through medical history and physical examination
* Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²), inclusive, at the time of screening.

Exclusion Criteria:

* Have known allergies to lasmiditan, related compounds, or any components of the formulation.
* Are persons who have previously received lasmiditan.
* Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias, or have any other abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. appendectomy, splenectomy, and cholecystectomy are considered as acceptable.
* Show a history of central nervous system (CNS) conditions such as strokes, transient ischemic attacks, significant head trauma, seizures, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increase the risk of participating in the study.
* Show evidence of active renal disease (e.g. diabetic renal disease, polycystic kidney disease) or estimated glomerular filtration rate \<60 milliliters per minute per 1.73 meter squared (mL/min/m²).
* Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.
Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care.

A compassionate method of treatment is offered to patients where lesions do not meet acceptable criteria for standard therapy. Visudyne (Photodynamic Therapy) and laser photocoagulation treatment (a treatment using heat from a fine point laser beam) have not been found to be effective in treating the lesions these patients have.

Anecortave acetate is an experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration (AMD).

Patients will receive a sub-Tenon injection of 15mg of Anecortave acetate in their study eye with the use of a counter pressure device. Patients will then be followed for up to 24 months. The patients will have the option of extending their participation in the study for an additional 24 months. Statistical analysis will include comparison of patient follow-up visual acuity and angiographic data.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of patients whose lesions do not meet acceptable criteria for standard of care treatment (PDT or laser).
2. Patients must be 18 years of age or older to receive treatment.
3. Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
4. Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart.

Exclusion Criteria:

1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
2. Patients who have undergone intraocular surgery within last 2 months.
3. Patient participating in any other investigational drug study.
4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
5. Inability to obtain photographs to document CNV (including difficulty with venous access).
6. Patient with significant liver disease or uremia.
7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study.
9. Patient has had insertion of scleral buckle in the study eye.
10. Patient has received radiation treatment.
11. Patient is on anticoagulant therapy with the exception of aspirin.
12. Patient is pregnant or nursing.
Long-term Safety and Efficacy of KUC-7483 in Patients With Overactive Bladder

To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 in patients with overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have successfully completed the Phase III double-blind study.

Exclusion Criteria:

* Patients with serious adverse events or clinically significant adverse events in the Phase III double-blind study.
Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea

This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.

A Phase 2, pilot, proof-of-concept, open label, single arm prospective study to assess the safety, tolerability and efficacy of using crisaborole 2% ointment for adult morphea. Patients identified by their physician, nurse, or other member of their clinical care team as meeting criteria for the study will be asked to apply crisaborole 2% ointment, twice daily, on affected plaques for 12 weeks. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque. Dermal thickness will be measured and compared before and at the end of treatment. Patients will have a clinical assessment at baseline and at weeks 4, 8 and 12. After week 12, patients who need further treatment will undergo standard of care treatment as determined by their primary dermatologist. Physician and patient reported assessment and skin imaging will be performed at baseline, week 4, 8 and 12, and at week 20. Photography will also be performed at baseline and week 12. An optional post treatment follow-up will be performed at week 20.

Medication will be provided free of charge by Pfizer, as part of the grant that is funding this study. These will be dispensed by the study group at baseline and during the subsequent clinic visits.

Eligibility Criteria:
Inclusion Criteria:

1. \>= 18 years of age
2. Clinical diagnosis of morphea.
3. \<20% Total body surface area involvement.
4. Does not require systemic immunosuppressive therapy for morphea.
5. No immunosuppressive systemic therapy 1 month prior to starting the study (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, prednisone \>=10 mg PO daily).
6. No immunomodulating topical therapy (topical steroids or topical calcineurin inhibitor), and no topical vitamin D analogue, 2 weeks prior to starting study.
7. No allergy to crisaborole or vehicle.
8. No known renal disease
9. Able to give informed consent.

Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.

1. Clinical diagnosis of depression or history of suicidal ideation.
2. Pregnant or breastfeeding women, with pregnant women being defined as the state of a female after conception until the termination of gestation, confirmed by a positive urine human chorionic gonadotropin (hCG) laboratory test. Women with a positive urine hCG at any time during the study will be withdrawn from the study.
High-Dose Trivalent Influenza Vaccine in Inducing Immune Response Patients With Central Nervous System Tumors

This pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune response patients with central nervous system tumors. Studying samples of blood in the laboratory from patients receiving trivalent influenza vaccine may help doctors learn more about the effects of trivalent influenza vaccine on cells. It may also help doctors understand how well patients respond to treatment.

PRIMARY OBJECTIVES:

I. To estimate the immunogenicity of high-dose influenza vaccination in patients with central nervous system tumors.

SECONDARY OBJECTIVES:

I. To assess the geometric mean titer (GMT) in patients after administration of high-dose influenza vaccination compared to previously determined geometric mean titer (GMT) among 38 patients receiving the standard yearly influenza vaccination.

II. To assess the seroconversion rates (i.e. four-fold rise in titer) compared to previously determined seroconversion following administration of the standard yearly influenza vaccination.

III. To assess the seroprotection rates (i.e. post-vaccination titer \>= 1:40) compared to previously determined seroconversion and seroprotection following administration of the standard yearly influenza vaccination.

TERTIARY OBJECTIVES:

I. To assess the relationship between serologic markers of immune function and response to high-dose vaccination.

OUTLINE:

Patients receive trivalent influenza vaccine on day 1.

After completion of study, patients are followed up at 28 days and/or 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a clinical diagnosis of a primary central nervous system tumor
* Patients must be eligible to receive the influenza vaccine
* Patients must be willing to receive the Fluzone® high-dose seasonal influenza vaccine
* Patients must be willing and able to sign an Institutional Review Board (IRB)-approved written informed consent document

Exclusion Criteria:

* Patients unable to receive the high-dose influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillain-Barré syndrome, or other contraindication to the vaccine
* Patients who have received the 2013-2014 annual influenza vaccine prior to being considered for enrollment on this study
Improving Outpatient Colonoscopy Bowel Prep with the Orton Score

Colonoscopy is a common endoscopic procedure which the UVA Gastroenterology \& Hepatology department performs on a daily basis for both screening/surveillance and diagnostic/therapeutic intent. As a safety net hospital, the institution also offers open access colonoscopy as a means of allowing outside primary care and urgent care providers a way to have patients receive necessary endoscopy services. However, these patients are not all seen in clinic prior to their procedure but are all prescribed a specific bowel prep by a medical professional who screens the referrals.

Given that the patient population described above are often not well-known to UVA providers, they may be prescribed prep regimens that are not ideal for their comorbidities. Not infrequently, these patients show up to their colonoscopies with an inadequate bowel prep, leading to either cancelled or incomplete procedures, increased healthcare and personal financial costs (such as missed wages from taking off work), suboptimal endoscopy resource utilization, and delay in or missed polyp (or potentially cancer) detection.

The investigators seek to use a novel scoring system designed to predict patients at risk for suboptimal preps (and hence patients that would benefit from an extended prep) and apply it in uniform fashion to a patient population most at risk for suboptimal preps. Because obtaining written consent is not practical given that these patients may not be seen by a UVA provider prior to their endoscopic procedure, the investigators will plan to verbally consent via the telephone in an all-inclusive manner; there will be no randomization but rather the selection of prep to be determined by the novel scoring system. Subjects be prescribed either a standard split-dose GoLytely prep (or SuPrep) or an extended split-dose GoLytely prep. The investigators predict that utilizing this new system will lead to a decreased number of inadequate bowel preps and will increase polyp detection. The investigators will work with a UVA biostatistician to analyze the data and use Chi Square, student's T tests, and logistic regression models to assess significance and help validate the model.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older (up to 100 years)
* Referred for open access colonoscopy from an outside provider/UVA provider
* Able to provide informed consent

Exclusion Criteria:

* Prisoners
Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy

The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required.

This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include:

* evaluation of the palatability and user-friendliness of the new treatment,
* evaluation of the pharmacokinetic parameters of the new formulation,
* PK parameters,
* evaluation of the tolerance,
* measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed infantile spasms (IS) or pharmacoresistant partial onset seizures (POS).
* Infants \> 1 month and \< 6 months; infants \> 6 months and \< 2 years; and children \> 2 years and \< 6 years.
* Patients under Sabril® or naive patients.
* Patients under a twice-a-day posology of Sabril® or patients for whom vigabatrin will be given twice daily.

Non inclusion Criteria:

* Use of more than 2 other antiepileptic drugs as concomitant treatment (including steroids). Ketogenic diet can be in addition to these 2 other antiepileptic drugs.
* Subjects receiving vigabatrin through a gastric tube.
* Weight \< 1.750 Kgs.
* Any planned major surgery within the duration of the trial.
* Participation in any other clinical trial within 3 months prior to V1.