cyrilzakka/clinical-trials huggingface dataset:
Ellipse Intramedullary Nail High Tibial Osteotomy Study

This study further evaluates the safety profile and efficacy of the Ellipse IM HTO Nail system in subjects with osteoarthritis and varus malalignment of the knee. All subjects will receive treatment with the Ellipse IM HTO Nail System and followed for six months.

The Ellipse IM HTO Nail is intended for open wedge proximal tibial osteotomies. The Ellipse IM HTO Nail is an intramedullary nail that operates on the principles of distraction osteogenesis.

The Ellipse IM HTO Nail is used in valgizing HTO procedures to correct varus malalignment. The Ellipse IM HTO Nail is surgically placed in the intramedullary canal of the tibia. It is lengthened telescopically using the non-invasive external remote control.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has standing varus malalignment benefitting from high tibial osteotomy correction
2. Patient is diagnosed with current osteoarthritis of the knee
3. Patient is eighteen years of age or greater
4. Patient is a candidate to be implanted with an Ellipse IM HTO System
5. If female of childbearing potential, patient presents with a negative pregnancy test and agrees to employ adequate birth control measures for the duration of the study
6. Patient understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements
7. Patient signs informed consent for the use of their personal private data

Exclusion Criteria:

1. Patient declines to sign informed consent for the use of their personal private data
2. Varus deformity greater than 10°
3. Flexion contracture greater than 15°
4. Knee flexion under 90°
5. Medial/lateral tibial subluxation over 1 cm
6. Medial bone loss of over 3 mm
7. Inflammatory arthritis
8. Arthritis in the lateral compartment
9. Patella baja
10. Weight over 114 kg
11. Severe patellofemoral symptoms
12. Unaddressed ligamentous instability
13. Fixed flexion contracture
14. Known or suspected osteoporosis or osteopenia based on medical history and radiographic images
15. Current use of nicotine products.
16. Requires other surgical procedures at the time of the HTO surgery
A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis

To determine whether a new Orally Disintegrating Tablet of Reglan (metoclopramide) is metabolized faster than the conventional Reglan tablet in patients with diabetic gastroparesis, pharmacokinetics following a single 10 mg dose of each formulation are being compared. Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis and agree to withhold medications for gastroparesis for 3 days prior to each dosing. Exclusion criteria include serum glucose \>300 mg/dL, Hb1Ac \>10%, and concurrent illness interfering with gastrointestinal motility. Subjects will stay in the clinic overnight, and pharmacokinetic sampling will continue for 8 hours after the first morning dose. The time (Tmax) and amount (Cmax) of peak concentration and the area under the curve (AUC) from time zero to 8 hr will be compared for the 2 formulations.

See approved Package Insert for Adverse Event information.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis

Exclusion Criteria:

* Serum glucose \>300 mg/dL, HbA1C \>10%, and concurrent illness interfering with gastrointestinal motility
A Study to Evaluate the Effect of Renal Impairment on JNJ-42847922 in Adult Participants

The purpose of this study is to evaluate the pharmacokinetic of a single oral dose of JNJ-42847922 in adult participants with renal impairment compared with healthy participants with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI; weight \[kilogram {kg}\]/height \[meter {m}\]\^2) between 18 and 40 kilograms per meter square (kg/m\^2) (inclusive) with a body weight not less than 50 kg
* All female participants (regardless of childbearing potential), must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day 1
* Must not donate blood for up to 3 months after study
* Participants with normal renal function (Group 1) must meet the following additional inclusion criteria to be enrolled in the study: Must have normal renal function defined as: estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 90 milliliter (mL)/minute (min) at screening
* Participants with moderate (optional Group 3) or severe (Group 2) renal impairment must meet the following additional inclusion criteria to be enrolled in the study: Must have a eGFR of less than (\<) 90 mL/min with the following classification used at screening: Moderate renal impairment (eGFR \>= 30 to 59 mL/min); Severe renal impairment (eGFR \>= 15 to 29 mL/min)
* Participants with moderate (optional Group 3) or severe (Group 2) renal impairment must meet the following additional inclusion criteria to be enrolled in the study: Must have stable renal function, that is, no significant change in renal function as evidenced by the (mean) screening serum creatinine value within plus minus (+ -) 25 percent (%) from the determination obtained at least 3 months prior to screening, and expected to remain stable during the study, and not planning to initiate dialysis

Exclusion Criteria:

* Participants who: are on a vegetarian diet or who take creatine supplements, have a non-standard muscle mass, such as, amputation, malnutrition, or muscle wasting, because these factors are not accounted for in the prediction equations for glomerular filtration rate (GFR)
* Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
* Received an experimental drug or used an experimental medical device within 1 month or within a period less than 5 times the drug's half-life, whichever is longer, before study drug is scheduled
* Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
* Participants with renal impairment (Cohort 2 and Cohort 3) have kidney failure, requiring dialysis
Effect of Selected Types of Breathing Exercises on Different Outcome Measures in Covid-19 Patients

Coronavirus disease 2019 (COVID-19) infection leads to significant respiratory that have negative impact on function and quality of life (QoL). Breathing exercises are effective and important in patients with COVID-19.

Coronavirus disease 2019 (COVID-19) infection leads to significant respiratory symptoms that have negative impact on function and quality of life (QoL). Breathing exercises are effective and important in patients with COVID-19.

This study aimed to evaluate the effect of Buteyko breathing versus Bhastrika Pranayama on different outcome measures in COVID-19 Patients.

Sixty patients of both genders with age range from 40-50 years old were recruited from El Khankah Centeral Hospital with positive nasopharyngeal swab samples and presence of ground-glass opacification in their chest computed tomography scan (CT-scan). Patients were assigned randomly into two groups A \& B and took their medications. Group A received traditional physical therapy program (mobility exercises and Postural drainage) with Bhastrika Pranayama breathing exercise. Group B received traditional physical therapy program with Buteyko breathing exercise. Patients were assessed by Modified Borg Dyspnea Scale (MBS), blood samples (levels of CRP and d-dimer), six-minute walk test (6MWT), Pittsburgh Sleep Quality Index (PSQI), 36-Item Short-Form Health Survey (SF-36) Questionnaire.

Eligibility Criteria:
Inclusion criteria:

* Their age ranged from 40 to 50years old.
* with confirmed COVID-19 by positive nasopharyngeal swab samples and presence of ground-glass opacification in their chest computed tomography scan (CT-scan).
* Moderate hospitalized covid-19 patient.
* full consciousness and oriented.
* BMI 20-25 kg/m2.

Exclusion criteria:

* presence of any type of musculoskeletal disorder prohibits the patient from participating in the study
* history of chronic diseases as (diabetes, hypertension and heart diseases)
* Any type of obvious clinically mental or cognitive impairment.
* History of previous other respiratory disease.
Clinical Evaluation for Sarcoma Originated From Bone

Response Evaluation Criteria in Solid Tumors (RECIST) are insensitive in evaluating primary sarcoma originated from bone treated with chemotherapy or targeted therapy, which did not have the definition of measurement methods either. This study evaluates whether clinical imaging findings of sarcoma after preoperative chemotherapy correlate with tumor responses by pathological evaluation by Huvos classifications and develops reliable, quantitative, clinical response criteria.

A total of 1570 lesions were evaluated by clinical imaging including X-ray, computed tomography, magnetic resonance imaging and bone scan or PET/CT preoperatively treated with chemotherapy. All patients had surgery in our center and get pathological evaluation by tumor necrosis rate. Statistical diversity analysis was performed by different pathological groups and Receiver Operating Characteristic Curves，ROC were done to find the dividing clinical parameters (Cut-off values) to distinguish different pathological groups.The cut-off values of change rate of maximum diameters of tumor located in extremities were 86%, 50.7% and 0.02% for Huvos Ⅳ,Ⅲ,ⅡandⅠgroups. The differentiation was not obvious using bone scan to distinguish different pathological responses. And the cut-off value for SUVmax value for Huvos Ⅲ,ⅡandⅠgroups were 60.7% and 31.4%.After Multidisciplinary discussion in multiple sites of China, we finally designed a evaluation system based on our data. This study is desgined to prospectively compare the sensitivity and specificity of this Clinical evaluation of primary sarcoma originated from bone with other clinical evaluation system,such as RECIST 1.1, Choi and PERCIST.

Eligibility Criteria:
Inclusion Criteria:

* 1) histologically confirmed high-grade osteosarcoma;
* 2) initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital, Xijing Hospital or The Second Hospital affiliated to Zhejiang Hospital;
* 3) imaging evaluation should be available;
* 4) completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy;
* 5) expected to live longer than 3 months with Eastern Cooperative Oncology Group performance status of 0 or 1;
* 6) acceptable hematologic, hepatic, and renal function.

Exclusion Criteria:

* 1) Patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy;
* 2) lost to follow-up.
TheraBracelet Phase I

This project aims to test a new technology that may improve hand function impaired from a stroke, thereby improving independence and quality of life.

Post-stroke hand impairment is highly prevalent and severely restricts functional ability and independence. Yet, there is no assistive device to help hand function at home, every day, during activities of daily living. Existing devices such as hand-opening orthoses are expensive, uncomfortable, bulky, and meant for use during short therapy sessions as opposed to during daily living. Thus their impact is limited. Consequently, the development of efficacious and affordable assistive device is of importance. This project addresses this critical gap by providing an innovative patent-pending technology. The "TheraBracelet" is a wristband applying imperceptible vibration to skin. TheraBracelet is efficacious, as it has been shown to immediately improve chronic stroke survivors' touch sensation and hand dexterity in previous studies. TheraBracelet is affordable by using only a low-cost vibrator. TheraBracelet is also translational, because a vibrator strategically placed at the wrist does not interfere with dexterous finger motions, and it is low-risk by involving only imperceptible vibration on skin. These practicalities assure easy adoption in home environment for large impact on sensorimotor impairment. The essential next step, thus the objective of this Phase I project, is to determine the feasibility and safety of using this assistive device all day every day for a month during daily activity. This objective will be accomplished in a double-blinded, randomized, controlled, crossover design study. Feasibility (compliance of using the device everyday) and safety will be assessed for the real vibration condition compared to the sham vibration condition (wearing the device without vibration). The feasibility and safety level comparable to those of wearing a watch and of a comparable FDA-approved device will support viability of TheraBracelet with necessary regulatory approvals. This project is expected to lead to an assistive wristband that increases hand function during activities of daily living for a large number of stroke survivors with hand impairment.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older
* Time since stroke: \> 3 months
* Those with at least some movement in the affected upper limb
* Ability to put on the device at home
* Ability to perform the Box and Block Test with a score \> 0

Exclusion Criteria:

* Comorbidity such as neuropathy, orthopaedic conditions in the hand
* Compromised skin integrity of the hand/wrist.
* Participation in an upper limb rehabilitation program concurrently
* Pregnancy
* A language barrier or cognitive impairment that precludes following
* Individuals whose swelling changes dramatically during the day
* Participant has received Botulinum toxin injection in the past 3 months
* Inability or unwillingness of subject or legal guardian/representative to give informed consent
Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure

To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator (DIEP) flap reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* be 18 years of age or older
* be in good general health (with no conditions that would, in the opinion of the surgeon, exclude them from a drain-free donor site approach)
* have a body mass index (BMI) \< 28
* have received a DIEP flap breast reconstruction procedure

Exclusion Criteria:

* current smoker
* have a body mass index (BMI) \> 28
* taking active SSRI medication prescriptions
Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).

To evaluate the safety, immune-response and efficacy of GSK Biologicals' EBV vaccine in a population at risk of developing infectious mononucleosis. Each subject will receive three doses of vaccine or placebo during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescent/adult subjects between and including 16 and 25 years of age at the time of screening.

  * Written informed consent obtained from the subject prior to enrolment.
  * Seronegative for EBV antibody.

Exclusion Criteria:

* Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period.

  * Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  * Family history of congenital or hereditary immunodeficiency.
  * Major congenital defects or serious chronic illness.
  * History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood.
  * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  * History of intravenous drug abuse within the past 2 years.
  * Known or suspected allergy to any vaccine component.
Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media

This pilot study will be a clinical trial to test the feasibility and effectiveness of an educational intervention and a mobile health intervention in adults with end stage renal disease (ESRD) who have not yet identified a potential live donor.

Transplant candidates are hesitant to discuss their illness and the difficulties associated with dialysis, and are therefore reluctant to pursue live donor kidney transplant (LDKT). The investigators will conduct a prospective 3-arm randomized controlled trial with two novel interventions to increase live donation. Arm 1 includes LDC program and the Facebook app, Arm 2 includes just the Facebook app, and Arm 3 includes standard of care. The investigators primary objective is to demonstrate the the effectiveness of these interventions in increasing live donor transplantation rates for candidates with no prior potential live donor.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant candidates aged≥18 added to the waitlist in the last year with no potential live donors are eligible.
* If there is an individual willing to donate, but the candidate is unwilling to consider this option or this particular individual, the candidate is eligible for the trial and may still benefit from identification of new donors or increased comfort accepting donation from others.
* Participants at Johns Hopkins University or University of Alabama must speak English. Participants at Northwestern University must speak English or Spanish.

Exclusion Criteria:

* Candidates with live donors currently under evaluation for donation will be excluded.
* Those with a previous kidney transplant will be excluded
Evaluating Taste and Health Messaging in Short Nutrition Education Videos to Improve Diet Quality

The purpose of this study is to develop and evaluate the effectiveness of taste vs. health messaging using nutrition education videos. The nutrition education videos teach Americans the benefits of using herbs and spices to increase diet quality. The investigators aim to test the effectiveness of 10 short videos (5 taste-based messaging and 5 health-based messaging) that translate previous findings of how spices can improve diet quality. These objectives will be pursued via the following hypothesis:

Hypothesis 1: Are taste messaging videos more effective in improving consumer interest, knowledge, and confidence in using herbs and spices compared to health messaging focused videos? Hypothesis 2: Will consumers rate the taste messaging videos higher for liking, engagement, and acceptability of herbs and spices compared to health messaging focused videos?

Participants will be randomly assigned to one of two groups: the first group (n=500) will receive the taste messaging focused videos emphasizing taste and flavor, while the second group (n=500) will receive the health messaging focused videos emphasizing the importance of using herbs to improve health. Randomization will occur through REDCap and the randomization feature will be embedded in the survey. Both groups will have access to similar educational content but the focus of the messaging will differ according to the taste or health focused arm. The participants will also complete screening questions first, and if eligible, an online consent form, demographics questionnaire, pre implementation questionnaire via REDCap, data on the participants interest, knowledge and confidence in using spices and herbs before watching the video and then watch 5 videos of either the taste or health focused messaging video (dependent on randomization). Once completed, participants will then complete a post implementation questionnaire, and a post-intervention REDCap survey that will ask about their interest, knowledge and intent in using spices and herbs as well as their feedback on the effectiveness of the videos. The investigators will use the pre and post intervention surveys for analysis. All participants will complete the survey questions online using their own device. The survey will also include more detailed participant information and gather feedback on the implementation of recipes in their own kitchens.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 18-75 years of age
* Reside in the United States
* Fluent in English
* Have access to internet, a video viewing device (computer, phone, tablet, etc.), and a grocery store
* Able to cook at home at least 2x/week or more

Exclusion Criteria:

* Outside of the 18-75 year age range
* Resides outside the United States
* Are not fluent in English
* Does not have access to internet or video viewing device (computer, phone, tablet, etc.), or a grocery store
* Unable to cook at home at least 2x/week
Exploring the Mental Health of Parents Having Children With Cancer

Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. Poor quality of life and mental health problems such as depression and anxiety were found in this population. The psychological status of them is still waited to be improved. As a dominant term in positive psychology, resilience is commonly regarded as the ability to move forward or keep normal under adversity. It was proved to be associated with psychological outcomes in adolescents and chronic illness patients, enhanced resilience usually along with improved mental health, while little evidence was available in the parents of children with cancer.

A cross-sectional study will be conducted to explore the level of resilience and psychological outcomes such as quality of life, depression, anxiety and well-being in parents of children with cancer using questionnaires. Such results will be compared with normal population to help evaluate the psychological status of those parents. The relationship between resilience and these psychological outcomes will also be examined. Lower resilience and higher resilience of the parents will be determined by the lowest and highest quartile of The Connor-Davidson Resilience Scale (CD-RISC) scores. Subsequently, a qualitative study will be conducted to explore the experience of those parents with lower resilience and higher resilience.

It is anticipated that risk parents of children with cancer could be identified from the inferior outcomes of resilience and psychological outcomes. Both the results of cross-sectional study and qualitative study will guide the development of interventions designed to enhance resilience and promote positive psychological outcomes among targeted parents of children with cancer under risk.


Eligibility Criteria:
Inclusion Criteria:

* have a child (0-19 years old) with cancer diagnosis. Chinese resident and can read Chinese and speak Mandarin.

Exclusion Criteria:

* have physical impairment or cognitive and learning problems identified from family history of medical records.

attending other researches.