cyrilzakka/clinical-trials huggingface dataset:
Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

Physical activity and exercise have become an accepted and valued component of cystic fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance quality of life. However, motivating people to be more active is challenging. Supervised, facility-based exercise programs are expensive and labor intensive (since groups of patients with CF cannot exercise together in the same physical location). Home-based exercise using an interactive exergame device may be an effective way to improve adherence to an exercise program for patients with CF. Therefore, the primary objective of this study is to evaluate the effects of a 12-week, home-based exergame exercise intervention on aerobic capacity (peak VO2). The secondary endpoint is nasal potential difference, an indicator of how well sodium and chloride flow across the mucous membranes in the nose. Other outcomes include patient-reported quality of life and habitual physical activity level. Following baseline assessments participants will be begin a 12 week, partially-supervised exercise program consisting of at least 90 minutes per week of aerobic and resistance exercise training using the Nintendo Wii Fit Plus exergaming device. Participants will receive at least monthly follow-up phone calls to provide additional exercise counseling and motivation. After 12 weeks, they will continue with the exergame intervention for another 12 weeks, but without external supervision.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of CF
* currently sedentary (\<60 min/week of physical activity)
* stable clinical condition (no exacerbation in last 6 weeks)

Exclusion Criteria:

* nasal surgery for polyposis in the past 2 years
* participating or have participated (in the past 30 days) in another clinical trial which can affect the outcomes of the proposed study
* unable to read/speak English
* recurrent pneumothorax (in the past 6 months)
* hemoptysis (hospitalized in the past 6 months)
* uncontrolled CF-related diabetes (HbA1c \> 10%)
Magnetic Resonance Imaging of Vascular Function

A major function of blood vessels is to control blood flow by dilating or constricting depending on the demand. Vascular dysfunction is a state in which blood vessels fail to carry out its normal roles such as regulating blood flow. Diabetes is a risk factor for vascular dysfunction. Dysfunction may involve the smaller and/or larger blood vessels. Failure in the ability of large (conduit) blood vessels to control blood flow may be an early feature of atherosclerosis, a leading cause of stroke and heart attack. Measures of blood vessel dilation give an indication of the health of the vessel. Ultrasound and MRI can assess vascular function by measuring changes in blood vessel dilation. Diabetes may also affect tiny vessels in the kidney. These vessels become porous allowing albumin (a protein in the blood) to leak into the urine. The investigators can easily measure the presence of albumin in the urine.

This study aims to explore if MRI can demonstrate an association between vascular health in tiny and larger (conduit) blood vessels, by testing for an association between blood flow regulatory capacity of large vessels and presence of albumin in the urine.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with type 2 diabetes who:

  * are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks
  * have diabetes diagnosed \>6 months
  * have maintained stable weight for 2 months (within 3%)
  * have a valid Ontario Health Insurance Plan (OHIP) card and a family physician
  * if prescribed lipid medication, have taken a stable dose for at least 2 weeks
  * if prescribed blood pressure medication, have taken a stable dose for at least 1 week
  * can keep written food records
  * carotid intima-media thickness (cIMT) \< 1.2 mm and ankle brachial index (ABI) of \>0.9.

Exclusion Criteria:

* Individuals who

  * take insulin
  * take steroids
  * have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's Disease, IBS)
  * have had a major cardiovascular event (stroke or myocardial infarction) in the past 6 months
  * take warfarin (Coumadin)
  * have had major surgery in the past 6 months
  * have a major debilitating disorder
  * have clinically significant liver disease ( liver transaminase levels \> 130 U/L), excluding Nonalcoholic fatty liver (NAFL) disease or NASH
  * have hepatitis B or C
  * have renal failure (high creatinine \> 150 mmol/L)
  * have serum triglycerides ≥ 6.0 mmol/L
  * have a history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)
  * have food allergies to study food components
  * have acute or chronic infections (bacterial or viral)
  * have chronic inflammatory diseases (e.g. rheumatoid arthritis, lupus; ulcerative colitis)
  * have other conditions which in the opinion of any of the investigators would make them unsuitable for the study
  * Any condition or circumstance which would prevent an individual from having an MRI (e.g. individuals with prostheses or metal implants, or those who are excessively claustrophobic)
Trident II Revision Outcomes Study

The purpose of this study is to review the performance and success rate of an FDA cleared cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.


Eligibility Criteria:
Inclusion Criteria:

A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.

B. Patient is a male or non-pregnant female age 18-85 years of age at the time of study device implantation.

C. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.

D. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.

Exclusion Criteria:

E. Patient has a Body Mass Index (BMI) \> 45. F. Patient is diagnosed with Inflammatory Arthritis. G. Patient has a non-Stryker retained stem. H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.

I. Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.

J. Patient has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.

K. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.

L. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). M. Patient has a known sensitivity to device materials. N. Patient is a prisoner.
Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome

The study includes adult patients with SAPHO syndrome (ORPHA: 793), meeting the modified classification criteria according to Kahn (2003), with the ineffectiveness of standard treatment (patient's global assessment of the disease on the VAS scale greater than or equal to 4 cm with accompanying pain on the VAS scale greater than or equal to 4 cm) treated with non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and/or classical disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003.
2. Age over 18.
3. Patient overall disease and pain assessment on VAS both ≥ 4 cm.
4. Expressing informed consent to participate in the study.

Exclusion Criteria:

1. According to the Summary of Product Characteristics (SmPC) for Enbrel.
2. Pregnancy, breastfeeding, inability to use effective contraception during the examination.
3. Change in the dose of NSAIDs treatment in the last 4 weeks.
4. Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12 weeks.
5. Use of biological drugs / synthetic targeted drugs in the last 12 weeks.
6. Use of corticosteroids (orally or local injections), bisphosphonates and/or antibiotics in the last 4 weeks.
7. Any medical condition that the investigator judges to contraindicate etanercept treatment.
Early Intervention Following Mild TBI

The objective of the study is to implement and measure the efficiency of a standardized acute and brief non-pharmacological intervention (Cognitive interventions on Sleep - Anxiety - Attention - Memory) following mild TBI and observe their impact pre- and post-treatments. The ultimate goal is to have patients be re-integrated to their activities faster with lesser symptoms and have patients present lesser post-concussive symptoms. Specific objectives: 1) Measure the effect of an acute and brief non-pharmacological intervention on PCS symptoms, sleep, headaches, affect, cognition and functional outcome following mild TBI; 2)To redefine a model of outcome prediction following mild TBI.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Mild TBI

Exclusion Criteria:

* Psychiatric diagnosis
Dorsal Versus Volar Approach for CapFlex-PIP© Implantation

The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.

This is a randomized controlled trial including 70 patients with PIP OA indicated for CapFlex arthroplasty.

The CapFlex-PIP© implant is a modular gliding surface proximal interphalangeal (PIP) joint prosthesis. For implantation, there are two approaches available: The dorsal central split approach according to Swanson and the volar approach described by Simmen.

Our experiences and data from our prospective registry indicate, that the active extension of the PIP joint is better after the dorsal approach, but sometimes related with hyperextension of the PIP joint and secondary swan-neck deformity. Extension is supposed to be better after the volar approach, but associated with active and passive extension lag. Evidence of theses experiences will assist the surgeon in the preoperative planning to select the appropriate approach according to the patient's needs.

The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.

This is a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Indication for CapFlex-PIP© arthroplasty
* Patient aged 18 years and over
* Informed Consent as documented by signature

Exclusion Criteria:

* Revision surgery
* CapFlex-PIP© arthroplasty at the thumb IP joint
* Major surgery at the same finger (e.g. DIP arthrodesis)
* Ulnar/radial deviation of the PIP joint \> 15°
* Patients in which a reconstruction of the collateral ligaments has to be performed
* General medical contraindication to surgery
* German language barrier to complete the questionnaires
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* Pregnancy
* Surgery not planned by Dr. Herren, Dr. Schindele or Dr. Bodmer
* Legal incompetence
Effect of CES on Parasympathetic Tone

The hypothesis is that CES stimulation will dose dependently increase parasympathetic tone. Healthy subjects will have three 20 minute sessions of CES stimulation, at three different intensities of stimulation, with each session occurring on a separate day. Effect on parasympathetic tone will determined by measuring high frequency heart rate variability before, during and after the stimulation. The Fisher Wallace Stimulator (FW100) which delivers a low dose alternating current a varying frequencies will be used for the stimulation.

Healthy subjects will have three 20 minute sessions of bitemporal CES stimulation, at three different intensities of stimulation (sham, 1 milli Amp, 2 milli Amp), with each session occurring on a separate day. The Fisher Wallace Stimulator (FW100) which delivers a low dose alternating current a varying pulsed frequencies (5 Hertz, 500 Hertz, and 25000 Hertzz) will be used for the stimulation. ECG will be recorded continuously for 15 minutes before stimulation, during 20 minute stimulation and for 15 minutes following stimulation. Effect on parasympathetic tone will determined by measuring high frequency heart rate variability before, during and after the stimulation. Effect of CES of heart rate and low frequency heart rate variability will also be examined. Subject side effects will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer

Exclusion Criteria:

* daily psychotropic medication,
* use of beta blocker,
* pacemaker,
* other metal in body,
* history of seizures
Bladder Preservation for Patients with Muscle Invasive Bladder Cancer (MIBC) with Variant Histology

This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +/- IO (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT. This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC +/- IO and is therefore a viable option in patients who are risk of systemic disease spread.

Trimodal therapy (TMT) is accepted as an NCCN category 1 alternative to radical cystectomy (with neoadjuvant chemotherapy) in patients with cT2N0M0 muscle-invasive urothelial cell bladder cancer (MIBC). Not all patients with MIBC have pure urothelial cell carcinoma; urothelial carcinoma with variant histology (VH) described any morphologic variant of conventional urothelial carcinoma that is believed to be derived from urothelial carcinoma and is typically admixed with conventional urothelial carcinoma in the same tumor. Variant histologies described include squamous differentiation, glandular differentiation, micropapillary, sarcomatoid, small cell/neuroendocrine, plasmacytoid and nested variant. This is a rare tumor type and understudied. For patients with variant histologies there is limited data on the use of trimodal therapy. There are a couple single institution retrospective studies and data from the NCDB, but no prospective data.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Evidence of diffuse cis on pathology
* Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral)
* Prior radiotherapy to the pelvis
* History of systemic therapy for MIBS
* Presence of concurrent cancer (remote history of cancer (\>5 years) allowed if the patient is without evidence of disease)
HYPONATREMIA IN COVID-19 PATIENTS

SYSTEMIC INFLAMMATION HAS BEEN ASSOCIATED WITH SEVERE COVID-19. HYPONATREMIA CAN RESULT FROM INFLAMMATION DUE TO NON-OSMOTIC STIMULI FOR VASOPRESSIN PRODUCTION. IN THIS PROSPECTIVE COHORT STUDY WE ANALIZED DATA FROM PATIENTS WITH COVID-19 AND THE ASOCIATION WITH HYPONATREMIA AND CLINICAL OUTCOMES.


Eligibility Criteria:
Inclusion Criteria:

* PATIENTS WITH SARS-CoV-2 INFECTION CONFIRMED BY PCR OF NASOPHARYNGEAL SWABS.

Exclusion Criteria:

-
A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -

The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117 ophthalmic solution (one drop once daily for 7 days) in healthy male adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male adult volunteers

Exclusion Criteria:

* Subjects with any history of severe diseases that preclude participation in this study for safety reasons
* Subjects with any diseases that preclude participation in this study for safety reasons
A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande Valley

The purpose of this study is to investigate the feasibility of a mobile telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke survivors with community health worker (CHW) at-home support and to estimate the functional health, mental health (depression), and caregiver burden outcomes of this new CHW-supported, at-home rehabilitation service delivery model and to identify salient barriers to and facilitators of adopting and delivering the new rehabilitation delivery model to further disseminate the model in real-world communities.


Eligibility Criteria:
Inclusion Criteria:

* A resident of the Brownsville, Texas (Cameron County) area
* SINGLE and FIRST qualifying stroke event with the ability to enroll and begin study activities within 3 months of onset of stroke event
* Pre-stroke modified Rankin score of ≤3 (less than moderate disability at baseline)
* Currently uninsured
* Spanish or English speaker
* Able to follow instructions (without aphasia that interferes with following instructions)
* Safe to perform basic strengthening rehabilitation exercises
* Able to stand with or without assistance

Exclusion Criteria:

* Aphasia or cognitive impairment (e.g., dementia) that interferes with following instructions or prevents following the study-related activities)
* Pre-stroke motor deficits
* Current psychiatric disorders, including substance use disorder
* Underlying brain pathologies inclusive of brain malignancies, multiple sclerosis
* Insured patients as insured patients are referred for standard-of-care clinical rehabilitation.
* Medical instability to participate in basic strengthening rehabilitation exercises
* Inability to access internet from home to access at-home rehabilitation software for intervention arm participants
* Having received any outpatient rehabilitation services prior to study enrollment for intervention arm participants
Stepped Care for Mandated College Students

This project provides stepped care to college students mandated for alcohol-related offenses. Students are first provided with a minimal intervention, a 15-minute discussion of their alcohol use. Students who continue to drink in a risky manner are provided with a more intensive, hour-long brief motivational interview. By providing more intensive treatment to the students who exhibit risky drinking, we hope to maximize the efficiency of campus alcohol programs.

Colleges and universities have seen a large increase in the number of students referred to the administration for the violation of alcohol policies. However, research indicates that the majority of mandated students may not require extensive treatment. Stepped care assigns individuals to different levels of care according to their response to treatment. Encouraging research indicates that minimal interventions and BMIs may reduce heavy drinking in mandated college students. Thus, implementing stepped care using these interventions could maximize treatment efficiency and reduce the demands on campus alcohol programs.

Participants will be students mandated to attend an alcohol program at a northeastern private university. All participants will receive Step 1, a 15-minute minimal intervention including a discussion of the referral incident and the provision of a booklet containing advice to reduce drinking. Participants will be assessed six weeks later, and those continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments. The three groups will be compared on two outcome measures: frequency of binge drinking episodes and alcohol-related problems in the past 30 days. Predictors of treatment response (readiness to change, alcohol expectancies, age of first drink, sensation seeking, descriptive norms, and reaction to the referral) will also be evaluated for both steps of the intervention. Research findings will assist college alcohol programs in determining the most effective and efficient allocation of their limited resources in treating mandated students. The long-term objectives of this research are to inform preventive intervention research about the utility and cost-effectiveness of stepped-care approaches and to identify individual and situational factors that qualify these effects.

Eligibility Criteria:
Inclusion Criteria:

* Male and female students 18 years of age or older.
* Participants will have signed a witnessed informed consent.
* Participants will have been referred for an alcohol-related offense

Exclusion Criteria:

* Participants who meet current DSM-IV criteria for substance use disorder
* Participants who are currently in treatment for substance use.
Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients

The randomized, controlled trial is to investigate and evaluate the effects of short-term continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.

The UK Prospective Diabetes Study has shown that β-cell function progressively deteriorates over time in people with type 2 diabetes mellitus, irrespective of lifestyle and existing pharmacological interventions. The progressive nature of type 2 diabetes is one of the major challenges in the treatment of affected patients, and agents that could alter the natural history of this condition would add greatly to current treatment approaches. Short-term intensive insulin therapy of newly diagnosed type 2 diabetes will improve beta-cell function and usually leading to a temporary remission time. The effect of GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis. It is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis. Exenatide is synthetic exendin-4, GLP-1 receptor agonist. Exenatide exerts direct effects on β-cell, which indicates that may contribute to delay disease progression. However, no study has evaluated effect of short-term intensive insulin sequential exenatide therapy model on β-cell function and glycemic remission rate in newly diagnosed type 2 diabetic patients. This current study is thus designed to evaluate effect of short-term intensive insulin sequential exenatide therapy model on β-cell function , glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

1. newly-diagnosed type 2 diabetic patients, drug naïve
2. age 30\~70 years
3. FPG 7.0\~16.7mmol/L
4. BMI 20\~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
5. female patients of reproductive age should practice a reliable method of birth control throughout the study

Exclusion Criteria:

1. acute or severe chronic diabetic complications
2. Recently suffered from MI or CVA.
3. severe gastrointestinal disease
4. other severe intercurrent illness
5. serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)
6. tested positive for glutamic acid decarboxylase antibody
7. use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug
8. history of pancreatitis
9. Pregnant or lactation women.