cyrilzakka/clinical-trials huggingface dataset:
Supportive Wheelchair Back Compared to Fabric Back

This study tests using a wheelchair back that supports the spine in a neutral position and one that allows the spine and pelvis to fall into a posterior pelvic tilt.

Individuals will randomly start with the supportive back vs the unsupportive back. Measurements of the spine and pelvis will be taken. Forward upward reach, one stroke push, times forward push and ramp skills will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* complete spinal cord injury with levels
* Full time wheelchair users
* English speaking in order to understand the consent

Exclusion Criteria:

* Over 250 pounds in body weight
* Inability to grip a wheelchair push rim
* Individual with pressure ulcer
* Individual with shoulder pain
An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers

An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C\>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers


Eligibility Criteria:
Inclusion Criteria:

* Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures

Exclusion Criteria:

* A subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
Maternal Heartbeat Sounds and Therapeutic Touch on Heart Rate,Comfort and Behavior in Newborns

This randomized controlled study aims to evaluate the effects of maternal heartbeat sounds and gentle human touch (GHT), a form of therapeutic touch, on heart rate, comfort, and behavioral scores in neonates born between 32 and 40 weeks and admitted to the neonatal intensive care unit (NICU).

This parallel, randomized controlled trial will be conducted in the Neonatal Intensive Care Unit of a regional hospital. The sample will consist of 120 neonates with gestational ages of 32 to ≤40 weeks and randomly assigned to four groups (maternal heart sound, therapeutic touch, maternal heart sound + therapeutic touch, and control group). The data of the study are Newborn Information Form, Anderson Behavioral Status Scoring System and Newborn Comfort Behavior Scale. Demographic data will be compared between groups (maternal heartbeat sound group (Group 1), light human touch group (Group 2), combined maternal heartbeat sound and light human touch group (Group 3), and control group (Group 4)). chi-square and t-tests. Video recordings will be used to compare heart rate, behavioral status and comfort scale scores obtained before, during and after the interventions. The time it takes to fall asleep will also be evaluated. A t test will be applied to evaluate the score differences between groups.

Eligibility Criteria:
Inclusion Criteria:

* • Newborns between \>32 and ≤40 weeks gestational age.

  * Admission to neonatal intensive care unit (NICU) after birth.
  * Parental consent form obtained.

Exclusion Criteria:

* • Absence of neurological and cardiac problems.

  * No use of corticosteroids.
  * No use of muscle relaxants.
  * Not past the postnatal 10th day.
  * Not receiving non-invasive or invasive respiratory support.
Erythropoietin in Premature Infants to Prevent Encephalopathy

The main goal of this trial is to investigate whether early administration of human erythropoietin (EPO) in preterm infants improves neurodevelopmental outcome at 18 months corrected age. This study is designed as randomized, double-masked, placebo controlled multicenter study involving at least 312 patients.

EPO has been safely used for prevent preterm anemia and recent studies have shown the neuro-protective effect. Our hypothesis is that EPO could prevent preterm brain injury and reduce the rate of premature death and disability from encephalopathy. The aims of this study include: to investigate the safety and efficacy of EPO by using 1000u/kg higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on neurodevelopment in preterm infants; to detect biological and imaging indicators of EPO. Eligible premature infants will be enrolled in this double-blind, placebo-controlled randomized trial from the neonatal neurological intensive care unit (NNICU) at 7 Children's Hospital in 6 provinces of China. Subjects will be enrolled within the first 24 hours of life and randomly assigned to receive Epo or saline vehicle placebo. Standard NICU care will be provided to all subjects. Pharmacokinetic data, serial brain electrophysiologic and imaging exams, circulating inflammatory mediators, biomarkers and complications like polycythemia, neutropenia, thrombocytopenia, hypertension, sepsis, hemorrhage, seizure, necrotizing enterocolitis (NEC), persistent ductus arterious (PDA), apnea of prematurity, pulmonary haemorrhage, pulmonary hypertension, Prolonged blood coagulation time, retinopathy of prematurity (ROP), cardiac arrhythmia, major venous thrombosis, Renal failure treated with dialysis, pneumonia, pulmonary airleak and chronic lung disease will be collected at established time points during the study period. At 18 months corrected age, subjects will undergo a neurodevelopmental evaluation assessing for cerebral palsy, Bayley Scores of Mental Development Index (MDI) use.

Eligibility Criteria:
Inclusion Criteria:

1. Birthweight less or equal 1500 grams
2. Less than 32 weeks gestation at birth
3. Less than 48 hours of life at time of enrollment
4. Written informed consent of parent or guardian

Exclusion Criteria:

1. Intrauterine Growth Retardation
2. Severe Congenital Anomalies adversely affecting life expectancy or neurodevelopment
3. Genetic Metabolic Diseases
4. Seizures within first 24 hours of life
5. Severe neutropenia (ANC \< 500 cells/microL) within first 24 hours of life
6. Polycythemia (Hct \> 65%) within first 24 hours of life
7. Thrombocytopenia (platelets \< 50K cells/microL) within first 24 hours of life
8. Hypertension (SBP \> 100mmHg) without vasopressor support within first 24 hours of life
9. Microcephaly
10. Grade III-IV intracranial hemorrhage

Termination

1. Required by parent or guardian;
2. Polycythemia through blood transfusion can not be relieved
3. Oliguria（\<0.5mL/kg/h for at least 24 hours）
4. Progression of azotemia
5. Pulmonary hypertension or Cardiac arrhythmia
An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy

The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Patients who completed CAT-1004-201 or CAT-1004-301 or siblings of these boys from 4-12 years of age (up to 13th birthday) will be enrolled.

Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is a key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

The study includes a 104-week open-label treatment period with edasalonexent. Patients who completed CAT-1004-201 or CAT-1004-301 and eligible siblings of these boys will be enrolled in this trial.

Eligibility Criteria:
For Patients who Completed CAT-1004-201 or CAT-1004-301:

Inclusion Criteria:

* Written consent/assent by patient and/or legal guardian as per regional and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements
* Completion of either CAT-1004-201 or CAT-1004-301

Exclusion Criteria:

* In the Investigator's opinion, unwilling or unable for any reason to complete all study assessments and laboratory tests and comply with scheduled visits, administration of drug, and all other study procedures

For Siblings of Patients who Completed CAT-1004-201 or CAT-1004-301:

Inclusion Criteria:

* Written consent/assent by patient and/or legal guardian as per regional and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements
* A sibling of a patient who completed either CAT-1004-201 or CAT-1004-301
* Diagnosis of DMD based on a clinical phenotype with increased serum creatine kinase (CK) and documentation of mutation(s) in the dystrophin gene known to be associated with a DMD phenotype
* Followed by a doctor or medical professional who coordinates Duchenne care on a regular basis and willingness to disclose patient's study participation with medical professionals

Exclusion Criteria:

* Use of oral corticosteroids at screening; use of inhaled, intranasal, and topical corticosteroids is permitted
* Use of another investigational drug, idebenone, or dystrophin-focused therapy within 4 weeks. Exception: Patients who are currently on or plan to initiate treatment with approved oligonucleotide exon-skipping therapies, and expected to continue treatment throughout the study, will be eligible
* Use of the following within 4 weeks prior to Day 1: immunosuppressive therapy, anticoagulants, cyclosporine, dihydroergotamine, ergotamine, fentanyl, alfentanil, pimozide, quinidine, sirolimus or tacrolimus
* Use of human growth hormone within 3 months prior to Day 1
* Other prior or ongoing significant medical conditions
Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT

Tinnitus, hearing loss and vertigo are the three major diseases of otology, affecting hundreds of millions of people in our country, and are major health problems. Ear structures and lesions are deeply embedded in the bone, and CT is the preferred examination technique. The key structures of the ear are small and the lesions are hidden. Spiral CT is "not visible" and "undiagnosed" due to insufficient spatial resolution. The ultra-high-resolution CT independently developed by our team has a spatial resolution of 50 μm, which is 6 times higher than that of high-end spiral CT, and solves the problem of "not showing" ear diseases. However, with the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable. It is urgent to carry out systematic research to create matching imaging plans, imaging anatomy standards and disease assessment standards to solve the problem of "undiagnosed". problem. This project plans to build an adult and pediatric imaging solution based on ultra-high-resolution CT to optimize image quality and radiation dose; comprehensively evaluate conduction, sensory, and surgical-related fine structures of the ear, and establish a new 0.1mm-scale image anatomy atlas; A prospective study conducted by the center analyzes the hidden pathological changes of tinnitus, deafness and vertigo, evaluates the diagnostic efficacy of ultra-high-resolution CT for the above diseases, and establishes new diagnostic criteria for lesion detection, symptom correlation, and efficacy evaluation. This project will bring new changes to the practice of otology clinical diagnosis and treatment


Eligibility Criteria:
1. For healthy volunteers

   Inclusion Criteria:
   * Meet the ethical requirements of U-HRCT examination
   * Can cooperate to complete U-HRCT examination
   * There is no relevant medical history in the side ear scanned

   Exclusion Criteria:
   * Clinical symptoms related to middle and inner ear lesions, such as conduction deafness, sensorineural hearing loss, mixed deafness, vertigo, etc.
   * Congenital inner ear malformation
   * Diseases causing bone changes around the middle and inner ear, such as otitis media, tumors , otosclerosis, fibrous dysplasia, etc.
   * history of previous ear surgery and trauma
   * CT image artifacts or incomplete scan coverage
   * incomplete clinical data
2. For patients with otological diseases

Inclusion Criteria:

* Due to tinnitus/deafness/peripheral vertigo/peripheral facial paralysis in the ENT department of our hospital
* Meet the ethical requirements of U-HRCT examination
* Can cooperate with the completion of U-HRCT examination
* Surgery in the ENT department of our hospital
* At least one follow-up or re-examination after discharge

Exclusion Criteria:

* History of previous ear surgery and trauma
* CT image artifacts or incomplete scanning coverage
* Incomplete clinical data
Chemical Peels and Fractional Laser on IGF-1 Levels in Skin

The purpose of this study is to evaluate the impact of fractional laser versus chemical peels on IGF-1 levels in skin.

This study is designed to assess the feasibility of using a fractional non ablative laser and chemical peels to wound skin, and thereby elicit a change in IGF-1. Our hypothesis is that fractional non ablative laser and a TCA chemical peel can induce similar effects as the fractional ablative laser at three months. In other words, our theory is that these approaches can stimulate the production of IGF-1 in older skin and restore UV damage repair and response mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects \>55 years old
* Fitzpatrick type I-II
* Able to provide informed consent.
* Cutaneous photodamage of 3 or above on the Larnier photodamage scale (see Appendix).

Exclusion Criteria:

* Prior laser or peel treatment in the area evaluated in the current study in the past year.
* Currently taking immunosuppressant medications known to interfere wound healing or anti-inflammatory medications (such as NSAIDs, or steroids).
* Subjects who have underlying diseases that could alter wound healing response (such as Diabetes).
* Currently taking insulin.
* History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study.
* History of abnormal scarring such as Keloids.
* History of vitiligo.
* Allergy or sensitivity or allergy to topical anesthesia
* Inability to use sunscreen.
* History of smoking in the last 10 years
* Scar or prior surgery in the area of treatment.
* Use of isotretinoin in the prior 6 months
* Subjects who have bleeding disorders or who are taking anticoagulants
Miracle Messages Evaluation

The project will conduct a randomized control trial (RCT) of an innovative program for people experiencing homelessness (PEH) that initially designed to address social isolation and loneliness among people experiencing homelessness but subsequently paired with an economic poverty-reduction intervention. The social support intervention, known as "Miracle Friends," pairs an unhoused person with a volunteer "phone buddy." The poverty reduction intervention, known as "Miracle Money," provides guaranteed basic income of $750 per month for 1 year to Miracle Friends participants.

The project will conduct a randomized control trial (RCT) of an innovative program for people experiencing homelessness (PEH) that initially designed to address social isolation and loneliness among people experiencing homelessness but subsequently paired with an economic poverty-reduction intervention. The social support intervention, known as "Miracle Friends (MF)," pairs an unhoused person with a volunteer "phone buddy." The poverty reduction intervention, known as "Miracle Money (M$)," provides guaranteed basic income of $750 per month for 1 year to MF participants. The RCT will have 3 arms of PEH who expressed interest in the phone buddy program: (1) those assigned to Miracle Friends; (2) those assigned to Miracle Money, which is not disclosed until after they actively engage in the Miracle Friends program; (3) And those assigned to a waitlist for Miracle Friends. To recruit for the study, the Miracle Friends program engage PEH through a variety of homeless services partners and introduce the MF program. Anyone who is interested in the MF program is provided information about a 15-month longitudinal study and referred to the research team to complete an eligibility screener. The research team explains the interview protocols that include receiving a $30 incentive each time a survey is completed that includes a baseline and 5 quarterly surveys. Participants will also be notified about being randomly selected to either be offered MF or put on a waitlist. Those assigned to the M$ are not notified about receiving monthly income until after they engage in the MF program. Information about frequency of contact with the MF social support volunteer and volunteer demographics will be provided directly from the Miracle Friends administrative data records.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years old or older;
* speaks English;
* currently experiencing homelessness;
* has expressed interest in signing up for the Miracle Friends ("phone buddy") program.

Exclusion Criteria:

* not meeting the inclusion criteria;
* not able to provide informed consent.
Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy.


Eligibility Criteria:
Inclusion criteria:

* Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
* Evaluable tumour deposits
* Age 18 years or older
* Life expectancy of at least six months
* Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
* Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
* Full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

Exclusion Criteria:

* Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
* Pregnancy or breastfeeding
* Active infectious disease
* Known brain metastases
* Second malignancy requiring therapy
* Absolute neutrophil count less than 1500/mm3
* Platelet count less than 100 000/mm3
* Bilirubin greater than 1.5 mg/dl (\> 26 μmol/L)
* Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
* Serum creatinine greater than 1.5 mg/dl (\> 132 μmol/L)
* Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
* Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
A Real-World Study of Biologic Therapy for Subclinical Psoriatic Arthritis

Psoriatic arthritis (PsA) is one of the most common comorbidities in patients with psoriasis (PsO). Current research suggests that the progression from PsO to PsA can be divided into five stages of the disease: PsO, preclinical PsA, subclinical PsA, prodromal PsA, and clinical PsA. Subclinical PsA refers to psoriasis participants who do not exhibit any clinical symptoms of arthritis but show evidence of synovio-enthesitis on ultrasound (US). However, there is currently no definitive biomarker that can accurately predict the progression from PsO to PsA. Synovitis and enthesitis are considered important features of PsA. Musculoskeletal ultrasound, using B-mode ultrasound and power Doppler (PD), can visualize synovitis and enthesitis, allowing for the early detection of subclinical PsA, as confirmed by multiple studies. Biologics are currently widely used in the treatment of PsA, with current treatment interventions primarily focusing on patients already diagnosed with PsA. In this study, we conducted a rigorous screening process to identify potential subclinical PsA patients among those with moderate to severe psoriasis. We treated these subclinical PsA patients with biologics and used musculoskeletal ultrasound as a method of efficacy assessment to observe the improvement of synovitis and enthesitis in subclinical PsA patients after 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* diagnosed with moderate to severe plaque psoriasis
* no inflammatory arthritis manifestations
* Psoriasis Epidemic Severity Tool (PEST) score ≤ 2
* negative rheumatoid factor
* no prior use of any biologic treatments for psoriasis
* abnormal findings on musculoskeletal ultrasound screening

Exclusion Criteria:

* a previous diagnosis of any other type of arthritis, including rheumatoid arthritis, osteoarthritis, gouty arthritis, ankylosing spondylitis, or similar conditions
* patients with contraindications to the use of biologics
* pregnant or breastfeeding women, and women of childbearing potential who do not agree to use contraception.
Trial of Oral Lenalidomide Stewardship Program for Veterans

To address the challenge of oral chemotherapy stewardship in the Veteran population, this study outlines the implementation and evaluation of a pilot program for the delivery and management of lenalidomide to increase the adherence rates. Our goal is to utilize a team-based multi-disciplinary approach using existing technological resources such as the tele-oncology program at the Salisbury VA and other VA medical centers to provide cancer care that is safe, effective, compassionate, and cost-effective. Subject will be prescribed a Lenalidomide based therapy per standard of care. Eligibility is based only on a prescription for Lenalidomide and is independent of any other concurrent treatments for myeloma. The objectives are as followed: 1. To describe the demographics and baseline clinical characteristics of veterans with newly diagnosed multiple myeloma treated with oral lenalidomide. 2. To evaluate the impact of the stewardship program (intervention) on the adherence to oral lenalidomide.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with myeloma or Initiating lenalidomide maintenance therapy after transplant or transplant ineligible patients that are started on lenalidomide until progression or intolerance.
* Myeloma diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification \[ICD-10-CM\] codes:vC90.00 or associated diagnosis )
* Prescription for lenalidomide
* Planned or Currently treated with lenalidomide as part of a treatment regimen for newly diagnosed myeloma
* Renal function assessed by calculated creatinine clearance as follows (see Appendix: Cockcroft-Gault estimation of CrCl):

Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula. (See Appendix C). Dosing for patients with creatinine clearance between 30ml/min-60ml/min will be based on lenalidomide package insert.

* Total bilirubin 1.5 x ULN
* AST (SGOT) and ALT (SGPT) 3 x ULN.
* All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
* Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
* Able to take prophylactic anticoagulation such as aspirin, warfarin, low molecular weight heparin or direct oral anticoagulant.
* Personal Computer with internet Capability.

Exclusion Criteria:

* \< 18 years of age as of the index date
* Newly diagnosed with myeloma and not started on lenalidomide
* Known hypersensitivity to thalidomide or lenalidomide (if applicable).
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
* Females who are pregnant.