cyrilzakka/clinical-trials huggingface dataset:
PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)

Preterm infants are at high risk of developmental delay or disabilities and they do benefit from early intervention programs. Many programs aiming at improving preterm infants' developmental outcome have been proposed with mixed results. In low to middle-income countries, clinically relevant and effective low cost interventions empowering parents have yet to be established.

Education and intervention programs targeting parents of premature infants are lacking in low to middle income countries (LMIC) and in Arabic countries in particular. The main concept of this proposal is to develop a program in Arabic for parents of premature infants with the aim to increase their knowledge about short and long term problems of prematurity, increase their involvement in the care during their stay in the neonatal intensive care unit (NICU) and promote responsive and sensitive parenting in the NICU and after discharge. This is to empower parents and have them become active contributors to enhancing their infant's development through play activities and tracking of developmental milestones.

Eligibility Criteria:
Inclusion Criteria:

* Couplets of parents and their preterm infants admitted to the NICU, who are \<35 weeks gestation at birth and who are deemed medically stable by their treating neonatologist.

Exclusion Criteria:

* Infants with significant neurologic disorder precluding meaningful interaction with the parents as determined by the neurologist
* Infants with major congenital anomalies precluding meaningful interaction with the parents as determined by the neurologist
* Infants with systemic medical and/ or surgical conditions precluding interaction with the parents, other than preterm-related intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL).
* Parental refusal to participate
* Absence of clearance from the neonatologist
* Infants planned to be transferred to another facility for their NICU care.
Nerve Transfer to Improve Function in High Level Tetraplegia

The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury.

Participants will:

* undergo standard of care pre- and post-op testing and study exams
* complete pre- and post-questionnaires
* undergo standard of care nerve transfer surgeries
* follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months
* attend therapy at local therapist for up to 2 years postop.

Restoration of function in patients with high tetraplegia has been an elusive clinical challenge. There is a critical need to find an effective reconstructive therapy/procedure which improves the upper extremity function in patients with high tetraplegia.

One pure motor nerve - spinal accessory nerve (SAN) remains a viable donor in high tetraplegia patients to successfully restore elbow flexion or extension. Elbow function can provide profound independence in mobility, ventilator management and may broaden the application of assistive therapies.

The two objectives of this study are:

* Determine if SAN nerve transfer surgery can improve the reinnervation of bicep or tricep muscles in high tetraplegia patients.
* Determine if SAN nerve transfer surgery can reanimate upper arm function and improve functional independence in patients with high tetraplegia.

Study Activities (including standard of care (SOC))

* Electrodiagnosis pre-op (SOC)
* Upper extremity maximum muscle testing (SOC)
* Questionnaires (SOC and study-related (SR))
* Exams by a study therapist (SR)
* Neurological exam - ISNCSCI - (SOC)
* Nerve Transfer Surgery to be determined by surgeon (SOC)
* Follow-up visits with surgeon at 6/12/18/24/36 and potentially 48 months
* post-op electrodiagnostic testing (SR)
* post-op upper extremity maximum muscle testing (SOC)
* post-op questionnaires
* post-op therapy exams (SR)

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* High cervical SCI (motor level C1-C4)
* Motor complete SCI AIS grade A-B
* Plateaued spontaneous recovery for at least 6 months of non-operative therapy
* SCI greater than 6 months and fewer than 60 months since injury
* At least MRC 4/5 donor strength
* Mentally and physically willing and able to comply with evaluations

Exclusion Criteria:

* Active infection at the operative site or systemic infection
* Any return or ongoing recovery of distal motor function
* Significant joint contractures and/or limitations in passive range of motion in the arm
* Mentally or physically compromised making it impossible to complete study activities
* Immunologically suppressed
* Currently undergoing long-term steroid therapy
* Active malignancy
* Pregnancy
Improving Metabolism With HDL Cholesterol

High levels of good cholesterol (HDL) in our blood decreases our chance of having a heart attack. This relates in part to the role good cholesterol plays in reducing build up of fat in the arteries. However, good cholesterol has many other protective effects. We have recently identified three enzymes (proteins) activated by HDL in cells lining the blood vessels, which may be responsible for some of HDL's protective actions.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 65 years
* Free of overt coronary disease
* Body mass index \<35 kg.m-2
* Fasting plasma glucose \> 7 mmol/L-1
* No major illness

Exclusion Criteria:

* Unable to give informed consent
* Smokers
* Abnormal LFT, U\&E, FBE or creatinine
Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD

Investigators want to learn the role of indoor environmental exposures on respiratory symptoms, and, separately, on lung function deficits in school-aged children with bronchopulmonary dysplasia (BPD).

Bronchopulmonary dysplasia (BPD) is the most common respiratory disease affecting children born prematurely and leads to long-term respiratory symptoms and lung function impairment throughout childhood. This study will, evaluate the contribution of indoor sources of respiratory irritants to respiratory health impairment in school-aged children with BPD. State-of-the-art measures of indoor air quality constituents will assess the relationship of nitrogen dioxide (NO2), particulate matter (PM2.5), as well as, concentrations of allergens (mold, mouse, cockroach, pet), endotoxin, air temperature and humidity with concurrently measured respiratory symptoms and lung function in a well-characterized cohort of children with BPD. This research will identify specific harmful components of the indoor environment associated with respiratory morbidity and poor lung function in children with BPD.

Investigators will ask the participants to come in for a one time clinic visit for undergoing procedures as well as answering questions regarding health and home environment. During the 1 year of participation there will also be 2 home assessment visits where investigators will take a sample of the home environment as well record home characteristics.

Eligibility Criteria:
Inclusion Criteria:

* children 6-12 yrs old
* born \<32 wks gestational age
* diagnosis of BPD or \> 28 days of oxygen or respiratory support

Exclusion Criteria:

* major airway or chest surgery
* physical or mental impairment that will prevent from doing spirometry
* plans to move out of state within the next 9 months
Citrulline, Exercise Training and Muscle Strength in the Elderly

The aim of this study is to assess the effect of citrulline supplementation on muscle strength in elderly institutionalized subjects undergoing a resistance exercise training program. The primary endpoint is the outcome of maximum strength of knee extensor muscles.

Maintaining muscle strength is mandatory for elderly persons to keep autonomy. Resistance exercise increases muscle strength in old and very old subjects, but there seems to be little effect on muscle mass. Citrulline is an amino acid that stimulates muscle protein synthesis, but its effect on muscle strength and mass remains to be determined. The aim of this study is to assess the effect of citrulline supplementation on muscle strength in elderly institutionalized subjects undergoing a resistance exercise training program.

All the subjects (84) will undergo a resistance exercise training program for 12 weeks. The subjects will have a regimen of high-intensity progressive resistance training of the knee extensors 3 days per week. These muscle groups were chosen because of their importance in functional activities. The subjects will be randomized into two groups. An intervention group will receive orally citrulline at 10 g/day, and a control group will receive an isonitrogenous amount of nonessential amino acids (alanine, aspartate, glycine, serine, histidine and proline in equimolar quantity). During the 12 weeks of supplementation, clinical tolerance will be evaluated. Strength testing will be repeated every two weeks for 12 weeks. The primary endpoint is the outcome of maximum strength of knee extensor muscles. Fat-free mass (DEXA), gait velocity, timed get up and go, spontaneous physical activity (activity monitors), nutritional status (weight, albuminemia, TRANSTHYRETINEMIA) and quality of life will be measured at inclusion and at the end of the study. The number of falls during the study will be recorded.

Eligibility Criteria:
INCLUSION CRITERIA:

* Aged over 75 years
* Able to walk at least 6 meters without human assistance.

EXCLUSION CRITERIA:

* Moderate to severe cognitive disorders (MMSE \< 20)
* Severe malnutrition (BMI \< 18 or weight loss \> 10 % in 1 month or \> 15 % in 6 months, or albuminemia \< 30 g/L),
* Inflammation (CRP \> 30 mg/L),
* Severe renal failure (creatinine clearance \< 30 mL/mn),
* Stage 4 cardiac failure,
* Respiratory failure,
* Corticoid treatment,
* Participation in another trial
Spinal Cord Stimulation for Gait in Parkinson Disease

Balance and gait impairment increases the risk of falls and contributes to a reduced quality of life and shorter survival in Parkinson disease (PD) and atypical Parkinsonism patients. In preliminary case studies, electrical epidural spinal cord stimulation (SCS) has been shown to significantly improve gait, postural instability, rigidity, and tremor. Controlled studies for optimizing which stimulation settings produce the best clinical response for mobility and gait, and achieving these results chronically are all significant unmet needs. Using quantitative laboratory and mobile technologies to test a range of stimulation settings, this research study aims to determine which SCS parameters or combination of parameters is best suited to effectively alleviate disabling symptoms experienced by each patient.


Eligibility Criteria:
Inclusion Criteria:

* Consenting male and female participants, aged 18 years to 80 years
* Idiopathic PD with II-IV Hoehn-Yahn stage
* A history of frequent falls, gait and balance dysfunction and postural instability
* ON-freezing
* Ability to perform a gait/walking task (under close supervision),
* PD participants referred by Dr. Jog to the functional neurosurgeon for SCS implantation for treatment of their gait and balance dysfunction and/or for their freezing of gait.
* SCS eligibility has been confirmed by neurologist and neurosurgeon
* Patients who receive SCS for their gait and mobility must participate in this study in order to determine which SCS parameters provide the patient with the best outcome for their PD symptoms.
* able to give informed consent
* Able to attend all clinic visits and assessments
* No dementia or psychiatric abnormalities on neuropsychological testing
* No significant secondary causes (such as cerebrovascular disease, normal pressure hydrocephalus, peripheral neuropathy, severe degenerative lower limb or back disease).

  * we had a few devices to include exploratory trial in atypical PD (MSA, PSP, and CBD confirmed diagnosis from clinic).

Exclusion Criteria:

* History of stroke

  * History of ALS or Myasthenia Gravis
  * Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol).
  * Persons prescribed zonisamide
  * Women reporting that they are pregnant
  * Persons medically unstable with contraindications to SCS will be excluded
  * Previous brain surgery or cardiac pacemaker
  * Eligibility for deep brain stimulation surgery
  * Moderately severe parkinsonism in the context of unstable pharmacological treatment
  * Dementia as assessed by DSM criteria or severe cognitive disturbances
  * Severe psychiatric symptoms (in particular, hallucinations and depression)
  * Bad general health
  * Lack of compliance at follow-up
  * Severe dyskinesias
  * Significant cognitive impairment
Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock

Cardiogenic shock is associated with a high mortality. The microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. The significance of the enteral micobiome on cardiovascular mortality of patients with cardiogenic shock is still not known.

This study aims to provide a deeper understanding of the role of the enteral microbiome and microbiome dependent metabolites in mortality and disease progression of patients with cardiogenic shock.


Eligibility Criteria:
Inclusion Criteria:

* \>18y
* signs of cardiogenic shock regardless of etiology

  * lactate \>3mmol/L
  * and signs of organ dysfunction (urine output \<30 ml/h, cold extremities, altered mental status)
  * and systolic blood pressure \<90 mmHg for \>30 minutes or need for vasopressor therapy

Exclusion Criteria:

* pregnancy/lactation period
* antibiotic treatment within \>24h
* chronic inflammatory bowel disease
* short bowel syndrome
* artificial bowel outlet
* persistent diarrhea or vomiting in the past 3 months
* simultaneous participation in another interfering nutrition study
* active chemo or radiation therapy
Active and Passive Cervical Flexion-rotation Tests

Motion limitations have been previously reported in people with headaches originating from the neck/cervicogenic headaches. A test involving flexing and rotating the neck has been found useful to diagnose this type of headache. This observational study investigates this neck motion test when performed actively by the patient and passively by the examiner, then compares the results of motion attained.


Eligibility Criteria:
Inclusion Criteria:

* One-sided headaches
* Headaches caused by neck movement or sustained head positioning
* Neck, shoulder, or arm pain
* Intermittent headaches at least one headache per week for greater than 2 months
* Headaches of moderate intensity

Exclusion Criteria:

* A diagnosis of rheumatoid arthritis
* Current pregnancy
* International Headache Society criteria for other headache forms (such as tension or migraine)
* Cervical radiculopathy
* Treatment for headaches by a physical therapist, chiropractor, massage therapist, or osteopath in the past month
* Positive test for vertebral artery insufficiency or cranial-vertebral ligament instability
A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed

An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.

Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease.
* Decision to treat with adjuvant nivolumab therapy has already been taken
* At least 18 years of age at the time of treatment decision
* Patients who provide written informed consent to participate in the study (for retrospectively enrolled patients who are deceased at time of study start, a consent waiver will be sought)

Exclusion Criteria:

* Any patient with a diagnosis of persisting advanced melanoma prior to first administration of nivolumab
* Any patient currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for Overall Survival (OS)/ Relapse Free Survival (RFS) can be enrolled. In case of a blinded study, the treatment arm needs to be known).

Other protocol defined inclusion/exclusion criteria could apply
Vitreous Surgery With Intraocular Assistance

To Assess the Safety of Vitreous surgery with intraocular assistance (VISIA) \& to identify and document with video evidence and surgeon's case report forms intraocular maneuvers that are facilitated by VISIA.

Standard care surgery will be done with a few novel additions to facilitate the surgical procedure. Currently 3 ports are inserted by creating holes in the sclera (white part of the eye) to enter into the posterior part of the eye. When complex dissection is needed, a fourth port will be inserted. The assistant will insert light source through the 4th port. This eliminates the need for the surgeon to hold the light in one hand. Hence allows freeing of both hands for the surgeon to use a forceps in one hand to grasp and elevate membranes and a scissors in the other to cut connections between the retina and the membranes. When membranes are particularly thick, it can be difficult to dissect with a single forceps holding up the membrane. In this situation, a 5th port will be inserted allowing the assistant to insert a light source through one and a forceps though another. The surgeon will have a forceps in one hand and a scissors in another making dissection process more efficient.

Eligibility Criteria:
Inclusion Criteria:

All subjects must meet the following criteria to be eligible for study entry:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age ≥18 years
* Subject will have complex retinal pathology for which it is judged that surgical objectives could be facilitated by VISIA

Exclusion Criteria:

Subjects who meet any of the following criteria will be ineligible for study entry:

• Patients with disease processes such as macular pucker and macular hole that are generally well-managed by standard two-handed vitrectomy.
Pilot Study of Probiotics in Pre-diabetic Adolescents

This study evaluates the feasibility and effect of probiotics on glycemic control in obese adolescents.

Diet-induced intestinal dysbiosis in obese children contributes to the development of type 2 diabetes mellitus (T2D). Probiotic treatment has been proposed to alleviate glycemic dysfunction and prevent/delay development of T2D. The investigators will test probiotics to improve insulin sensitivity and preserve beta cell function in obese children.

The probiotic strains are known to improve glycemic control.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 13-19 y. of age at Visit 1.
* BMI: 99th percentile or greater
* Acanthosis nigricans
* Pubertal Tanner stage ≥3

Exclusion Criteria:

* Secondary diabetes (i.e. post-transplant diabetes mellitus (DM) or cystic fibrosis DM), monogenic forms of diabetes (i.e. MODY), autoimmune diabetes or presence of islet autoantibodies.
* Known severe immunodeficiency, or immune compromised.
* Current or previous history for insulin or metformin therapy (within last 3 months).
* Antibiotic or probiotic therapy 3 months prior to enrollment.
* Start of new dietary intervention within 1 month prior to enrollment.
* Diagnosed food hypersensitivity or active gastrointestinal disease
Assessment of Ability of Breath Hold for Left-sided Breast Cancer Radiation Therapy to Reduce Side Effects to Heart

The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart.

The primary objective of this study is to estimate the rate of radiation-associated regional myocardial perfusion defects in patients 6 months after breast/chestwall radiation with DIBH for left-sided breast cancer. Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation.

Eligibility Criteria:
Inclusion Criteria:

* signed an Institutional Review Board (IRB)-approved informed consent document for protocol
* age \>= 18 years
* histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy
* stage 0-III left-sided breast cancer (including DCIS)
* SPECT score of 0 at baseline
* radiation oncologist agrees target volume coverage will not be compromised via use of the DIBH technique along with conformal field shaping

Exclusion Criteria:

* active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
* symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
* concurrent chemotherapy
* prior receipt of mediastinal radiation therapy
* pregnant or lactating women
* inability to understand and follow breathing instructions for the DIBH procedure
The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers

The purpose of this study is to assess the effect of food on the absorption of canagliflozin in the body when canagliflozin is taken with and without food by healthy volunteers

This is a single-center, single-dose, open-label (volunteers will know the identity of assigned treatment), randomized (one of 2 study drug sequences assigned by chance) study to evaluate the oral bioavailability (the degree to which the drug is absorbed in the body when taken orally by mouth) of canagliflozin when taken with and without food in healthy volunteers. Healthy Volunteers will take 1 canagliflozin tablet orally for 1 day in 2 treatment periods (canagliflozin will be taken with food in 1 treatment period and canagliflozin will be taken without food in 1 treatment period); the 2 treatment periods will be separated by a 10- to 14-day washout period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg

Exclusion Criteria:

* of or current medical illness deemed clinically significant by the Investigator (study physician)