cyrilzakka/clinical-trials huggingface dataset:
Functional Outcome Measures With Vibrotactile Feedback to Prostheses

Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on functional outcome measures of upper limb prosthetic users.

Investigators will perform three experiments:

1. Investigators will add vibrotactile feedback to prosthetic users during the execution of a standardized functional test and performance of simple grasping tasks, with a disruption to the normal visual feedback, and examine whether their performance and arm kinematics are improved with tactile feedback;
2. Investigators will examine the effects of adding the feedback to a prosthesis on the performance and visual attention during a dual task assignment in prosthetic users, and
3. Investigators will provide prosthetic users with the feedback, to use it at their natural surroundings for a week, and study the reported activity and satisfaction levels.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral transradial amputee
* Using a transradial myoelectric prosthesis
* Ability to follow simple instructions, understand and sign an informed consent form
* Normal or corrected eyesight

Exclusion Criteria:

* Elbow or wrist disarticulation or partial hand amputations
* Neuropathy or skin ulcers on the amputated limb
Family-Centered Diabetes Project - Sharing Wisdom

This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women

Two hundred American Indian women aged 18 to 40 years were recruited from a large Southwest city to participate in a type 2 diabetes prevention intervention. Half of the women were randomized to participated in the educational intervention and half were assigned to a delayed intervention. Measures were obtained at baseline, 6-months,12-months and 18-months.

Eligibility Criteria:
Inclusion Criteria:

* American Indian women
* Aged 18-40 years
* Living in Albuquerque area
* Not having diabetes

Exclusion Criteria:

* Pregnancy
* Planning to become pregnant within 2 years
* Diagnosed with diabetes fasting blood glucose \> 126 planning to move out of town in next 2 years
Latanoprost Versus Fotil

To compare the intraocular pressure effect and safety of latanoprost 0.005% given every evening versus PTFC given twice daily.


Eligibility Criteria:
Inclusion Criteria:

* adults with primary open-angle or pigment dispersion glaucoma, or ocular hypertension
* untreated intraocular pressure should be between 24-36 mm Hg inclusive
* visual acuity should be 5/50 or better in both eyes

Exclusion Criteria:

* presence of exfoliation syndrome or exfoliation glaucoma
* contraindications to study medications
* any anticipated change in systemic hypotensive therapy
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>=18 to \<= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to \< 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
* Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
* Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
* Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
* Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

Exclusion Criteria:

* Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
* Participant receiving prohibited medications and treatment.
* Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
* Participant with currently known complications of UC (e.g., megacolon).
* No known active Coronavirus Disease - 2019 (COVID-19) infection.
Comparison of Fascial Iliac Compartment Block and Quadratus Lumborum Block for Hip Surgery

Iliac fascia block has a long history of analgesia in patients with hip fractures. A large number of clinical studies have confirmed its efficacy, and there are also randomized controlled studies supporting its effectiveness in analgesia after total hip replacement surgery.Quadratus lumborum block is a new block technique developed in last decade, and there are also a few randomized controlled studies supporting its effectiveness in postoperative analgesia for total hip replacement.The purpose of the present study was to find out whether these two different approaches of fascial compartment block have similar effects on postoperative analgesia after total hip replacement.


Eligibility Criteria:
Inclusion Criteria:

* ASA class 1-3
* BMI between 20-36kg/m\^2
* Scheduled to undergo total hip replacement

Exclusion Criteria:

* A history of chronic opioids or steroid consumption
* Coagulapathy or anticoagulation
* Pregnancy
* Allergic to local anesthetics Neurological dysfunction
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.


Eligibility Criteria:
Key Inclusion Criteria:

* Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of screening visit
* Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months
* Has draining perianal fistulae as a complication of CD, confirmed by magnetic resonance imaging (MRI) at screening
* Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines):

  * Antibiotics AND/OR
  * Immunomodulators AND/OR
  * Tumor necrosis factor α (TNFα) Antagonist
* Is willing and able to undergo MRI per protocol requirements
* Is willing and able to undergo flexible sigmoidoscopy per protocol requirements

Key Exclusion Criteria:

* Presence of current rectovaginal anovaginal or enterovesicular fistulae
* Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
* History of total proctocolectomy, total colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
* Use of any prohibited concomitant medications as described in the study protocol
* Active tuberculosis (TB) or history of latent TB that has not been treated

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Is Music the Food of Anesthesia in Children?

The patients were randomly separated into three groups. Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room noise.

Hundred and five pediatric patients who scheduled for abdominal surgery in ASA I-II risk groups were enrolled in the study. The patients were randomly separated into three groups. Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room noise. The preoperative children's anxiety levels were assessed with the M-YPAS in the operating room. Heart rate (HR) and mid-arterial pressure (MAP) were recorded at 30-minute intervals until the completion of surgery, end of surgery and postoperative. During each measurement, noise level recordings were performed using sonometre. Pediatric Anesthesia Emergence Delirium Score (PEAD) was assessed after extubation, postoperative.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective abdominal surgery with an expected operation time of 60 to 120 minutes, were enrolled in the study.

Exclusion Criteria:

* Children were excluded from the study if they had cognitive disorders, with clinically evident hearing impairment, chronic illness, undergoing emergency surgery, and unstable medical conditions requiring intensive care unit admission.
Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients

cross sectional observational study, aimed to assess the electrophysiological function of the motor units in liver cirrhotic patients.

Liver cirrhosis is a global health problem which could be associated with several neurological manifestations. The associated peripheral neuropathy could be assessed by conventional nerve conduction studies.

Objective: The study aims at early detection of peripheral neuropathy among patients of liver cirrhosis by conventional nerve conduction studies and quantitative EMG methods. In addition, the study aims at finding out correlation between peripheral neuropathy and severity of the liver cirrhosis.

Methods: This a cross-sectional study conducted on fifty-six liver cirrhotic patients, that had been recruited from the Endemic medicine department/outpatient clinics and their age-gender matched sixty-one healthy controls. The recruited patients were clinically assessed .Both conventional nerve conduction studies and quantitative EMG techniques in the form of MUNE calculation, using modified spike -triggered technique and IPA ratio evaluation were performed for the allocated cirrhotic patients.

Eligibility Criteria:
Inclusion Criteria:

* Both genders.
* Age interval range between 18 and 60 years (To avoid maturational changes and aging process on motor unit number).
* Liver cirrhotic patients( including compensated and decompensated patients);

  * Presenting hematemesis/melena and/or ascites.
  * Diagnosis of liver cirrhosis is confirmed by abdominal ultrasound

Exclusion Criteria:

* Patients with identifiable cause of peripheral neuropathy (e.g. diabetic patients) .
* Patients who developed hepatocellular carcinoma (to avoid para-neoplastic syndrome e.g. peripheral neuropathy)
* Patients with other non-hepatic chronic illness such as: patients with renal disease (to avoid other causes of metabolic neuropathies).
Oral Type I Collagen for Relieving Scleroderma

Diffuse systemic sclerosis (SSc), or scleroderma, is a connective tissue disease causing damage to skin and other organs. The purpose of this study is to determine if taking oral bovine type I collagen (CI) will improve the condition of SSc patients.

SSc is a chronic connective tissue disease that is caused by excess collagen deposits that damage the skin and other organs. This study will determine if a daily oral dose of bovine CI will improve the condition of patients with SSc.

Patients will be randomly assigned to one of two groups. The first group will receive 500 mcg bovine CI daily for 15 months; the second group will receive placebo. Study visits will be conducted at Months 4, 8, 12, and 15. Patients will undergo physical examination and blood tests at each visit. Patients will also be evaluated for modified Rodnan skin score (MRSS) and will be given health assessment questionnaires. A chest x-ray will be conducted at study entry and pulmonary function tests will be conducted at study entry and Month 12.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diffuse systemic scleroderma (by American College of Rheumatology criteria 1980) of 10 years or less
* Stable skin involvement by history or physical examination 6 months prior to study entry
* Stable modified Rodnan skin score (MRSS) for 1 month prior to study entry
* Stable MRSS of 16 or more at screening and stable MRSS between screening and baseline visit
* Agree to use acceptable forms of contraception

Exclusion Criteria:

* Participation in another clinical research study involving evaluation of another investigational drug within 90 days prior to study entry
* Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
* Systemic sclerosis-like illnesses associated with environmental, ingested, or injected agents, such as L-tryptophan, tainted rapeseed oil, vinyl chloride, or bleomycin
* Limited and localized (morphea) or linear SSc
* Tenderness or swelling of the extremities (eosinophilic fasciitis)
* Pregnancy
* Use of certain medications
* Allergy to beef or dairy products
* Nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week before baseline visit. Aspirin at 325 mg or less daily for stroke or heart attack prevention is allowed.
* Use of herbal and some alternative therapies
* Any organ transplant or stem cell transplant
Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes

The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* HbA1c \>6.5% and \<10.0%
* FPG \>126 mg/dL (7 mmol/L) and \< 270 mg/dL (15 mmol/L)

Exclusion Criteria:

* History of type 1 diabetes
* History of ketoacidosis
* Current insulin therapy
* C-peptide \<0.5ng/mL
* Imparied hepatic function
* NYHA Class II-IV cardiac status or hospitalization for CHF or EF\<40%
* uncontrolled hypertension
Biobehavioral Determinants of Obesity in Black Women

To examine the biobehavioral determinants of obesity in Black as compared with white women.

BACKGROUND:

Behavioral medicine surveys consistently find that obesity is a treatment-resistant disease that continues to be a significant health problem and that the incidence of obesity is much higher in Blacks relative to whites in general, and even higher in Black women relative to white women. In fact, an NIH Program Announcement (PA-91-99), stated that "Obesity in adults has not declined in the past three decades" and "Obesity is particularly prevalent in minority populations, especially among minority women." Obesity is an independent risk factor for cardiovascular disease, stroke, and hypertension. Obesity is a complex phenomenon involving behavioral, lifestyle, and complex biobehavioral mechanisms. In 1995, there were no prospective studies that simultaneously evaluated a systematic set of psychosocial variables with energy balance (dietary intake, physical activity, resting metabolic rate) determinants that may account for the increased risk for obesity in African-American versus Euro-American women.

DESIGN NARRATIVE:

After subjects were recruited, psychosocial and energy balance (dietary intake, physical activity, metabolic rate) baseline measures were related to levels of body fat as measured by DEXA (dual electron X-ray absorptiometry). The role of these variables were evaluated prospectively to adiposity changes in both white and Black women over a 24-month period.

Eligibility Criteria:
No eligibility criteria
Hand Grip Test and Transradial Coronary Procedures

Transradial coronary procedures are gaining in popularity worldwide. A possible complication of transradial approach is the occlusion of the radial artery that in most cases is asymptomatic. However the investigators do not know if the radial artery occlusion may impact over the muscle force of the hand or fingers.

To evaluate if transradial approach for percutaneous coronary procedures may affect muscle force of the hand, thumb and index finger the investigators use a standardized hand-grip manometer and a pinch gauge before the transradial procedure, the day after the procedures and after few months.


Eligibility Criteria:
Inclusion Criteria:

Stable patients who undergo elective percutaneous transradial coronary procedures

Exclusion Criteria:

* hemodynamic instability,
* acute coronary syndromes,
* haemodialysis patients with an arteriovenous fistula,
* sheath diameter \> 6 French,
* age \< 18 years
Direct Repair Surgery for Spondylolysis of Lumbar in Young Population

Lumbar spondylolysis is a relatively common condition that causes severe and perennial back pain in young populations. Conservative treatment of this condition may be futile, and may eventually require surgical treatment such as direct repair of pars defect and a segmental lumbar fusion with an anterior or posterior approach. Recently, of surgical treatment methods for spondylolysis, direct repair surgery of pars defect has been focused due to its inherited strengths. Most importantly, fusion surgery caused the affected segment to lose the nature range of motion and furthermore adjacent segment to be adversely affecting such as adjacent disc disease or degeneration, while direct repair theoretically could preserve the motion of the affected segment, which do not cause the adjacent segment problems as being the fusion surgery, as well as could produce better surgical outcomes with relatively less invasive technique as compared to fusion surgery. Moreover, previous articles have demonstrated that the direct repair surgery for spondylolysis of lumbar spine could achieve great functional and radiological outcomes. However, most of the previous studies was conducted using lower level designed study such as retrospective and small sample size, thereby prior literature does not provide clear information on the therapeutic outcome of direct repair for lumbar spondylolysis, especially for managing spondylolysis of young population.

Therefore, The investigators aimed to evaluate and determine the outcomes of direct repair surgery for lumbar spondylolysis in young population. To our knowledge, this is the first report that describes the functional and radiological outcomes of direct repair for spondylolysis in young populations with prospective cohort study design and relatively large sample size.


Eligibility Criteria:
Inclusion Criteria:

* patients for whom conservative treatment for six months and three-times injection treatments had failed
* a follow-up period of one year or more after surgery

Exclusion Criteria:

* patients with abnormal muscle activity or ambulation such as parkinsonism and neuromuscular disease.
* patient inability to accurately record results of preoperative and postoperative questionnaires due to problems such as a history of stroke, dementia, or major medical illness that required intensive treatment
* patient follow-up was limited to one year or less
Improving Heart Failure Outcomes Rural

This study will test if standardized care helps patients feel better, if it can be implemented in rural hospitals, and find out which healthcare processes and outcomes are most important to heart failure patients.

The aims of this research are to: 1) Conduct a quasi-experimental study of rural hospitals to test if guideline-based care (standardized patient education, making a post discharge appointment with the patient's provider and calling the patient at 48 hours to reinforce HF education) improves patient outcomes (better self-care, and lower readmissions at 7 and 30 days post discharge); 2) Identify hospital (staffing, practice environment, costs) and provider (evidence-based practices) characteristics associated with better implementation of heart failure patient care processes; and 3) Determine which healthcare processes and outcomes are most important to heart failure patients. A quasi-experimental study with mixed methods will be used. The sample consists of HF patients (N=40, 20 each hospital) and nurses who care for HF patients on study units (N=90, 45 each hospital) from 2 rural hospitals. Survey data will be collected from patients (baseline, discharge, 48 hours and 7 days post discharge) and nurses (baseline, during patient education, on patient discharge). Secondary data will be collected quarterly on nurse staffing and once for patient readmission within 30 days of discharge. Structured patient interviews will be conducted with 10 HF patients in person to determine which health care processes and outcomes are most important to them. Both patients and nurses will be engaged to inform study procedures and outcomes consistent with the tenants of patient-centered outcomes research.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital with a diagnosis of heart failure
* Age \> 20
* Cognitively intact
* English speaking
* Plan for discharge to home, assisted living or intermediate care

Exclusion Criteria:

* Patients with planned discharge to sub-acute or nursing home facilities
* Patients enrolled in another research study to test interventions to improve heart failure knowledge, self-management or reduce readmission to the hospital within 30 days post discharge
* Patients that are cognitively impaired
* Patients that are transferred to another unit in the hospital, and will be discharged from that unit
* Patients who undergo or have a planned surgical intervention during their hospital stay
Develop and Evaluate of Integrated Interactive Self-care APP Among Hematopoietic Stem Cell Transplantation Patient

Background: More than 50,000 hematopoietic stem cell transplants are performed around the world every year. However, HSCT treatment time is long and the treatment methods are complex, and it has a significant impact on the patient's body and mind. Foreign studies have shown that using mobile technology for cancer symptom monitoring and self-care can effectively improve cancer patients' doctor-patient communication, symptom management, and self-care abilities. There are only 7 articles on foreign HSCT-related APPs or online smart projects.

Purpose: To evaluate the use of an integrated interactive self-care APP in hematopoietic stem cell transplant patients Methods: This study is a two-stage explanatory qualitative mixed study. The quantitative study in the second year adopts a non-randomized experimental research design. Pre-test and formal testing are repeated in two groups. The experimental group (APP) will be admitted first according to the patient's wishes. The number of participants will then be included in the control group. Each group is expected to receive 40 subjects. The experimental group will receive general routine care plus the use of an integrated interactive self-care APP. The control group will receive general routine care and will be filled out at 8-time points before and after transplantation. Self-efficacy, self-compassion, and resilience questionnaire.


Eligibility Criteria:
Inclusion Criteria:

1. Conscious, over 20 years old, and able to communicate in Mandarin or Taiwanese dialect.
2. Diagnosed via pathology report with one of the following cancers: acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin lymphoma, or multiple myeloma.
3. Requires HSCT (Hematopoietic Stem Cell Transplantation) treatment.
4. Possesses a smartphone.

Exclusion Criteria:

* All mental disorders as classified in the DSM-IV.