cyrilzakka/clinical-trials huggingface dataset:
Virtual Pain Care Management (COVID-19)

The COVID-19 pandemic is exacerbating the challenges faced by Veterans at risk of opioid overdose including Veterans prescribed moderate-to-high dose long-term opioid therapy (LTOT) whose usual treatment resources and coping strategies may be inaccessible. This project combines established VA care components to deploy and evaluate virtual models of care for Veterans on high-risk LTOT to meet the dual challenges of maintaining social distancing and delivery high quality care.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants must currently receive LTOT for chronic pain at 50 mg morphine equivalent daily dose

Exclusion Criteria:

Exclusion criteria at baseline are:

* dementia diagnosis or moderate-severe cognitive impairment
* unstable or severe untreated psychiatric disorder or medical disease that requires hospitalization
* documentation of suspected controlled substance diversion
* inability to communicate by phone
Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition

This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition


Eligibility Criteria:
Inclusion Criteria:

* Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the same on both sides, but must be Grade 2 or 3
* Treating Investigator (TI) considers the subject's jaw amenable to an improvement of at least 1 grade on the scale for the jawline definition
* Written Informed Consent (IC) has been obtained

Exclusion Criteria:

* Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
* Has ever undergone fat injections in the malar, chin or jawline area or is planning to undergo this procedure during the study
* Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) below the subnasale within 36 months before enrollment or is planning to undergo such treatment during the study
* Has received deoxycholic acid treatment in the submental region in the last 6 months
* Has active autoimmune disease
* Females who are pregnant, nursing, or planning a pregnancy during the course of the study
Swallowing and Voice Outcomes After Thyroidectomy

Impairment in voice and swallowing functions are common after thyroidectomy. The investigators aimed to evaluate the objective functional voice and swallowing outcomes in a series of patients undergoing thyroidectomy.

according to the study, even in the absence of recurrent laryngeal nerve injury, subjective and objective swallowing and voice alterations do occur after thyroidectomy.

A total of 43 consenting patients who underwent thyroidectomy were prospectively recruited. Subjective evaluation of swallowing was assessed with 'Swallowing Impairment Score' and 'MD Anderson Dysphagia Inventory'. Fiberoptic endoscopic evaluation of swallowing (FEES) was applied for objective evaluation. Also, functional oral intake scale (FOIS) and functional outcome swallowing scale (FOSS) were used for swallowing assessment. Voice evaluation was assessed with videostrobolaryngoscopy (VSL) and 'The Multi-Dimensional Voice Program (MDVP)' was used for capturing and analyzing the voice samples. All evaluations were performed preoperatively and on 1st day, 2nd week and 6th months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thyroidectomy

Exclusion Criteria:

* Patients who were diagnosed with thyroid carcinoma preoperatively
* Having history of previous neck surgery,
* History of radiotherapy at head and neck region,
* Vocal cord paralysis,
* neuromuscular dysfunction,
* larynx, esophagus and chest pathology
* who did not want to be involved in the study
Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection

This study will assess the next generation of blood tests for latent TB infection, which may be able to indicate how treatment is working as well as in diagnosis infection.

Currently available blood tests for latent tuberculosis infection (LTBI) identify people who have been previously infected with M. tuberculosis. Whilst they are sensitive and specific, they cannot be used to monitor the effectiveness of treatment for LTBI. New blood tests ("fourth generation Quantiferon tests") give a more complete measurement of the workings of the immune system, which may be useful to show whether treatment is working. These new tests have not yet been evaluated in clinical practice, so their usefulness in identifying people at highest risk of TB disease and monitoring treatment is unknown.

Mass gatherings, such as the annual Hajj pilgrimage, may encourage the spread of infectious diseases, including respiratory infections such as influenza, respiratory syncytial virus, and possibly also tuberculosis. However, the risk of TB infection during the Hajj has not been reliably measured. It is important to measure this risk so that pilgrims can be given suitable advice about preventing infection.

Eligibility Criteria:
Inclusion Criteria:

- Contacts: Adult (aged 16 years or older) contacts of smearpositive pulmonary TB patients attending participating TB clinics or primary care centres for screening will be invited to take part. Contacts will include all individuals with a cumulative duration of exposure of greater than eight hours to the relevant index case in a confined space during the period of infectiousness (prior to initiation of treatment). Patients with active TB: Newly diagnosed, microbiologically confirmed tuberculosis disease (pulmonary or extrapulmonary) attending participating TB clinics or primary care centres. Hajj pilgrims: Individuals arranging travel to Saudi Arabia for the Hajj through participating tour operators.

Exclusion Criteria:

- Contacts: Active TB disease. Individuals who are unable to give informed consent. Children aged under 16 years.

TB cases: Individuals who are unable to give informed consent. Children aged under 16 years.

Hajj pilgrims: Active TB disease. Any health indication which would prevent travel to Saudi Arabia. Individuals who are unable to give informed consent. Children aged under 16 years.
Safety and Performance of Muscle Activation for Critical Care Patients

Critically-ill patients who have long stays in the hospital often face prolonged periods of bed rest. It is known that these patient develop profound weakness and debilitation. The effectiveness of existing muscle activation devices that could otherwise prevent the onset of debilitation in an immobilized patient has not been demonstrated widely in this cohort. It is hypothesized that using thermal methods to augment existing muscle activation techniques may demonstrate improved performance with no corresponding change in the safety profile.


Eligibility Criteria:
Inclusion Criteria:

* Patient is enrolled within 60 hours of admission to the ICU
* Patient expected to be subject to bedrest in the ICU for \> 96 hours

Exclusion Criteria:

* Patient is age \< 18 years at time of consent
* Patient is pregnant
* Patient is moribund
* Patient has an implanted pacemaker/defibrillator
* Patient has a documented diagnosis of epilepsy
* Patient has implanted femoral rods
* Patient has leg or pelvic trauma that limits mobility
* Patient has recent trauma resulting in GCS \< 5
* Patient lacks ability to walk without assistance prior to acute ICU admission
* Patient has neuromuscular disease or abnormalities
* Patient is morbidly obese (BMI \> 40)
* Patient has a cognitive impairment or inability to follow commands prior to acute ICU admission
* Patient was transferred after \> 48 hours at another acute care institution
* Enrollment in another investigational device or drug trial that could compromise the conduct or results of the study
* Evidence of disease or condition that, in the opinion of the physician, may compromise the conduct of or results of the study
Melatonin for Cerebral Palsy Children's Sleep and Health

The present study was prospective uncontrolled, single-armed and un-blinded study. Held in the Pediatric neurology clinic, Children's hospital l, Faculty of Medicine, Ain Shams University from June 2016 to June 2018 of 24 months timeframe. All cerebral palsy (CP) patients following up in Pediatric neurology clinic aged between 2 and 12 years. Melatonin given for 3 months. Anthropmetric measures, gastroeintestinal symptoms, Children's sleep habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at enrollment and after the 3-months.

A prospective, cohort study conducted in Pediatric Neurology Clinic, Children's Hospital, Faculty of Medicine, Ain Shams University. Forty children with sCP with sleep and seizure problems, aged 2-12 years were enrolled. The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months. Children's sleep habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at enrollment and after the 3-months. The ethical approval number is (FMASU MD 202/2016).

Eligibility Criteria:
Inclusion Criteria:

* All cerebral palsy children with sleep problem and seizure disorder,
* aged 2 - 12 years

Exclusion Criteria:

* any auditory and peripheral visual impairments
Effects of Intranasal Oxytocin on Cigarette Smoking

Socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and neural processes that encode, interpret, and respond to socially and emotionally relevant stimuli) have been implicated in tobacco smoking and relapse, however this potential target for medication development has not been systematically examined. Evidence from animal and human laboratories indicate that administration of intranasal oxytocin enhances socioemotional processing and may be efficacious for the treatment of drug addiction, including nicotine dependence. In order to evaluate the potential efficacy of intranasal oxytocin for smoking cessation, this laboratory-based proposal will examine whether intranasal oxytocin attenuates smoking lapse, nicotine withdrawal, and socioemotional processing disruptions in regular smokers following overnight abstinence.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-40
* Smoke \>= 10 cig/day for the past year
* English fluency

Exclusion Criteria:

* Current DSM-5 substance use disorder, excluding nicotine dependence (to minimize alcohol or drug withdrawal symptoms during the study sessions)
* Any medical condition that would increase risk for study participation (such as sinus infection or other condition blocking access to the olfactory epithelium)
* Women who are pregnant or nursing
* Current use of psychiatric medication
* Breath Carbon Monoxide (CO) levels \< 10ppm measured during study intake (to exclude individuals who overreport smoking in order to participate in the study)
* Planning to quit or reduce smoking in the next 30 days
* Current regular use of other nicotine products
Continuous Regional Analgesia After Total Knee Arthroplasty

This prospective, comparative and double blind study is aimed to determine if normal saline or dextrose 5% in water will modify the stimulation during the insertion of the stimulating catheter used for continuous femoral and sciatic blocks in total knee replacement.

The operator is blinded to the medium fluid to expand the perineural femoral and sciatic nerves before threading in the stimulating catheter. He records all the electric data of electrolocation of nerve, which will be compared to determine whether or not a difference in intensity is found between normal saline or dextrose 5% in water.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I and II
* Male or non-pregnant female
* 18 - 80 years of age
* Not allergic to iodine or local anesthetics
* Absence of abnormality of coagulation
* Scheduled for total knee replacement
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis

This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of RA meeting the 2010 ACR (American College of Rheumatology) classification criteria, obtained at least 6 months prior to dosing with the trial product. (If the diagnosis was made prior to 2010, a diagnosis meeting the 1987 ACR classification criteria is acceptable)
* Active RA characterised by DAS28-CRP (disease activity score based on 28 joints and c-reactive protein) equal to or above 4.5 and at least five tender and five swollen joints (can be the same joints) of the 28 joint count
* Concomitant treatment with MTX above or equal to 15 mg/week for at least 4 months prior to screening, with stable dose of between or equal to 15 mg/week and 25 mg/week for at least 6 weeks prior to screening (MTX doses between 7.5 and 12.5 mg/week are allowed, if patient had intolerance to 15 mg/week)
* Biologic naïve subjects or subjects having been treated with biologics for RA (biologic experienced) provided they meet one of the following criteria: a. Reason for discontinuation of biologic therapy was intolerance (e.g., unable to receive recommended doses or achieve adequate treatment duration because of drug related side effects), b. Discontinued biologic therapy for other reasons than lack of efficacy (primary or secondary failure) or intolerance (e.g., drug holiday)

Exclusion Criteria:

* Body mass index (BMI) below or equal to 18.0 or above or equal to 38.0 kg/m\^2
* Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome). Subjects with secondary Sjögren's syndrome or stable hypothyroidism are eligible
* Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy (e.g., simple urinary tract infection)
* Any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
* History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy
A Study to Assess the Effects of Cyclosporine on the Pharmacokinetics and Safety of Canagliflozin (JNJ-28431754) in Healthy Volunteers

The purpose of this study is to determine how a single dose of cyclosporin affects the pharmacokinetics (ie, how the body affects the drug) of multiple doses of canagliflozin (JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.

This study will be an open label (all volunteers and study staff know the identity of assigned treatments), single-center, multiple-dose study to determine how cyclosporin (a drug which reduces the activity of a patient's immune system) affects the pharmacokinetics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of study (or follow-up) phase. Each volunteer will participate in the study for approximately 47 days.

Eligibility Criteria:
Inclusion Criteria:

* Must have body mass index between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
* If a woman, must be either postmenopausal, defined as no spontaneous menses for at least 18 months or amenorrhea for at least 6 months or surgically sterile (have had a hysterectomy, or tubal ligation)

Exclusion Criteria:

* History of smoking or use of nicotine-containing substances within the previous 2 months
* Have had history of or current medical illness considered to be clinically significant by the Investigator
Impact of Fish Oil-enriched Lipid Emulsion on Fatty Acid and Inflammatory Response in Infants After Surgery

This study aim to compare the impact of fish oil-enriched intravenous lipid emulsion to standard Intravenous lipid emulsion on fatty acid composition and inflammatory response (IL-1β and IL-8 levels) in infants after gastrointestinal surgery. Our hypothesis is the fish oil-enriched intravenous lipid emulsion can improve the fatty acid composition and lower the inflammatory response.

This study is conducted in infants post gastrointestinal surgery that requires parenteral nutrition for at least 3 days. Subjects are classified into two groups. Group 1 received standard IVFE and group 2 received ω-3-enriched IVFE. The type of intravenous standard and omega-3-enriched fat emulsion used in this study are Lipofundin 20% and SMOFlipid 20%, respectively, both administered for three consecutive days after surgery (72 hours) in 1-4 gram/kilogram/day dosing. The inflammatory response (IL-1β and IL-8 levels) and fatty acid composition are checked from blood plasma. Blood examination is done before the surgery and 3 days after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* willing to participate in this study (through informed consent)
* undergo gastrointestinal surgery
* get parenteral nutrition for at least 3 days

Exclusion Criteria:

* chronic diseases
* allergic to fish, egg, soy and/or nut proteins
Tocolytic Therapy for Preterm Labor in Multiple Gestation

To compare the tocolytic efficacy oxytocin receptor antagonist (Atosiban) with that of calcium channel blockers (Nifedipine) among women with multiple gestation who present with threatened preterm labor.

Preterm birth remains the principal cause of early neonatal death. Infants born preterm (before 37 weeks' gestation) often suffer significant immediate morbidity and need lengthy stays in neonatal intensive care units. Moreover, there is a significant risk of long-term neurological morbidity in a proportion of the survivors. Patients with a multiple gestation are at significant risk for preterm labor and delivery as approximately 60% of all those pregnancies will be delivered preterm.

A number of oxytocin receptor antagonists have been developed, and of these, three, atosiban, barusiban and retosiban have been investigated in humans as tocolytic agents. To date, only atosiban is in use outside of clinical trials. Atosiban is an oxytocin receptor antagonist which was specifically developed for the treatment of preterm labor. Early reports of the use of Atosiban for tocolysis showed promise both in vitro and in animal studies, and preliminary studies in pregnant and non-pregnant humans suggested a very low incidence of maternal side effects .

Eligibility Criteria:
Inclusion Criteria:

1. Twin pregnancy
2. Gestational age between 24+0 and 32+6 weeks
3. Intact amniotic membranes
4. Threatened preterm labor
5. Age 18-50.

Exclusion Criteria:

1. Rupture of membranes
2. Vaginal bleeding resulting from placenta previa or placental abruption
3. Fever above 38°C
4. Severe preeclampsia
5. Maternal cardiovascular or liver diseases
6. Systolic blood pressure less than 90 mm Hg
7. Known uterine malformation
8. Intrauterine growth restriction below the fifth percentile
9. Non-reassuring fetal status
10. Antepartum diagnosis of major fetal malformations
11. Fetal death
12. Previous tocolytic therapy or Betamethasone treatment
Assessment of Spontaneous Baroreflex Sensitivity in Carriers of Implantable Cardioverter Defibrillators: Association With Disorders of the Ventricular Heart Rate. Case-control Study

We must implement 8 implantable cardioverter defibrillators (ICDs) to save a life in 3 years after myocardial infarction (MI) in primary prevention.

Left ventricular ejection fraction (LVEF) is proposed as the one tool predicting sudden cardiac death after MI.

Several studies have shown that impairment of spontaneous baroreflex sensitivity (BRS) after MI was predictor of sudden death.


Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with an implantable cardioverter defibrillator for primary prevention of of cardiac sudden death, ischaemic cardiomyopathy
* Implantable cardioverter defibrillators implantation for at least 3 years
* Age ≥ 18 years

Exclusion Criteria:

* ventricular or atrial pacing ≥1%,
* atrial fibrillation history
* age under 18 years
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.

The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU).

The primary endpoint will be Changes from baseline in the condition of the peri-wound skin measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin


Eligibility Criteria:
Inclusion Criteria:

1. Both gender ≥18 years old.
2. Subjects with type 1 or 2 diabetes mellitus.
3. Texas Grade A1 or 2, C1 or 2
4. Exuding diabetic foot ulcer
5. Ulcer localisation; below the ankle
6. Signed Informed Consent.

Exclusion Criteria:

1. Known allergy/hypersensitivity to the dressing.
2. HbA1c ≥ 10% (86 mmol/mol) (most recent value within 3 months)
3. Wound infection requiring systemic treatment
4. Subjects who will have problems following the protocol.
5. Subjects included in other ongoing clinical investigation at present or during the past 30 days.
6. Toe pressure less than 70 mmHg
7. Clinical suspicion of osteomyelitis (based on probe to bone/radiological changes)
8. Dry wounds
Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment

The aim of this study is to assess outcomes of Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment

The aim of this study is to assess outcomes of Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).

A decrease in the posterior curvature of the femoral metaphysis close to the medial femoral condyle is one of the anatomical alterations that can be seen within the knee joint. When the knee is fully flexed, this curve is typically concave enough to accommodate the posterior horn of the medial meniscus (PHMM). Similar to cam incongruence in the hip joint, a decrease in curvature may cause posteromedial tibiofemoral incongruence, a condition marked by compression of the PHMM in complete knee flexion. If deep knee flexion occurs, clinical symptoms may appear, and PHMM degeneration may be shown to worsen over time. Surgery may be recommended for patients for whom activity modification and conservative therapy have failed. Our team proposed an arthroscopic procedure that allows for the least amount of correction that is still necessary while also providing final intraoperative confirmation of the clinical need to repair posteromedial tibiofemoral incongruence.

Eligibility Criteria:
Inclusion Criteria:

* Pain, snapping or discomfort in posterior part of the knee in deep knee flexion during squat
* Reduced concavity of the femoral metaphysis proximal to the medial femoral condyle confirmed on MRI
* Impingement of posterior horn of medial meniscus with the metaphysis of femur during full knee flexion confirmed arthroscopically

Exclusion Criteria:

* Active knee inflammation
* Chondral injuries ICRS 3-4
* Extraarticular reasons of pain, snapping or discomfort in posterior part of the knee in deep knee flexion during squat
* Cyst or avascular changes within the femoral metaphysis adjacent to the planned localization of the procedure