cyrilzakka/clinical-trials huggingface dataset:
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles

The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.

The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.

Participants will:

Receive 3 rounds of treatment and will be followed up for a total of 2 years.

The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.

The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.

Participants will:

Receive 3 rounds of treatment and will be followed up for a total of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Male or female, ≥18 years old.
* Immune-competent individuals.
* Presenting NLF contour deficiencies with a WSRS score between 2 (shallow wrinkle) and 4 (deep wrinkle) on both the left and right side of the face.

Exclusion Criteria:

* Having received a prior facial surgery for NLF correction, and/or received any local therapeutic treatment (e.g., dermal fillers).
* Having received in the past 2 weeks any local therapeutic treatment of the face below zygomatic arch.
* Pigmentation in NLF or having a history of hypo melanosis.
* Susceptibility to keloid formation or hypertrophic scarring.
* History of a known allergic reaction (e.g., any subject allergic to lidocaine or amide anesthetics, has a history of allergy to Gram-positive bacterial protein, or known to be allergic to any of the constituents of the product: PLLA, sodium carboxymethyl cellulose, mannitol, or sodium hyaluronate).
* History of herpes eruption, or a history of malignant skin disorder, or a history of any other serious disease.
* Hemorrhagic disease or receiving anti-coagulant therapy.
* Presenting with acute inflammation, infection, or having a history of chronic or recurrent infection potentially affecting the safety or performance of the device or increasing risk for adverse events.
* Having received in the past 2 months immunosuppressant or systemic steroid therapy.
* Having any disease that may affect wound healing, such as connective tissue disorder or serious malnutrition.
* Female who is pregnant and/or lactating
* Any other condition that as judged by the investigator may make follow-up or Investigation procedures inappropriate
Impact of Formulary Coverage of Entresto (Sacubitril/Valsartan) on Prescription Abandonment/Rejection and Subsequent Treatment and Economic Outcomes in Chronic Heart Failure Patients in the U.S.

This was a retrospective cohort study utilizing IQVIA open-source pharmacy and medical claims data among patients with a sacubitril/valsartan (SAC/VAL) prescription transaction.


Eligibility Criteria:
Inclusion Criteria:

Primary IQVIA Longitudinal Access and Adjudication Data (LAAD) Cohort (for primary objective)

* Patients with ≥1 transaction for SAC/VAL in LAAD between 01 January 2017 and 30 November 2019 (index period). Date of the 1st SAC/VAL prescription transaction during this period was the index date.
* Patients from the Novartis-provided list of 21 plans and formularies of interest (mapping to LAAD data was based data elements such as plan name, payer name, and pharmacy benefit manager \[PBM\] name) as of the index date.
* Patients aged ≥18 years on the index date.
* Patients with 12-months of data visibility pre-index.
* Patients with 3-months of data visibility post-index (to allow for final adjudication/abandonment status confirmation).

For comorbidity data only:

* Patients with linkage of LAAD FIA to LAAD Dx by patient ID.
* Patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period.

Secondary LAAD Cohort (for secondary objective)

* Among patients from the Primary LAAD Cohort remaining in Step 6, patients who abandoned their 1st SAC/VAL prescription or did not receive SAC/VAL due to claim rejection in LAAD between 01 January 2017 and 28 February 2019 (index period). Date of the 1st abandoned/rejected SAC/VAL prescription transaction during this period is the index date.
* Patients aged ≥18 years on the index date.
* Patients with 12-months of data visibility pre-index.
* Patients with 12-months of data visibility post-index.
* For comorbidity data only:
* Patients with linkage of LAAD FIA to LAAD Dx by patient ID.
* Patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period.

Exclusion Criteria:

* Patients with a SAC/VAL transaction during the 12-month pre-index period.
* Patients with data quality issues (e.g., missing gender).
Clinical Trial of Sarilumab in Adults With COVID-19

Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and \<75 years
* Admission for confirmed respiratory symptoms to COVID-19 based on a positive PCR in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring ONAF or mechanical ventilation
* Interstitial pneumonia confirmed by chest radiography or CT
* IL-6 levels\> 40 pg / ml. In its absence, D-Dimer (DD)\> 1500 or\> 1000 may be included if progressive increases are documented
* Negative pregnancy test in women of childbearing age
* Signature of informed consent

Exclusion Criteria:

* SOFA score\> 6 points
* Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation
* Neutrophil count \<2 x 103 / μL
* Platelet count \<100 x 103 / μL
* ALT or AST levels\> 5 times the upper limit of normal
* Severe renal failure (CrCr \<30 ml / min)
* Active bacterial infectious process
* Active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis
* History of intestinal ulcer or diverticulitis
* History of hypersensitivity reactions to Sarilumab or its excipients
* Treatment with TNF antagonists
* Previous treatment with anti-IL6 in the previous 30 days
* Chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. Yes, inhaled and topical corticosteroids are acceptable
* Concomitant treatment with immunomodulators, among which are Vitamin D or statins. Macrolides such as azithromycin are acceptable
* Patients on immunosuppressive treatment for any cause
* HIV-infected patients with CD4 \<200 / mm3
* Past or current history of autoimmune disease or systemic inflammatory disease
* Patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins
* Participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half-lives of the investigational product
* Pregnancy
* Any other condition that, in clinical judgment, prevents adherence to the patient's protocol
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)

The purpose of this study is to determine the safety of an injection of coxsackievirus A21 into a melanoma tumour, and also to see if there is a tumour response.

Coxsackievirus A21, a naturally occurring enterovirus, has shown that in vivo it can infect and lyse melanoma. This study is to assess safety of a single intratumoural injection of the virus into an accessible subcutaneous melanoma metastasis.

Eligibility Criteria:
Inclusion Criteria:

* stage IV melanoma (AJCC classification)
* minimum of 2 sc metastases
* failure or refusal of standard chemotherapy
* ECOG score of 0 or 1
* other

Exclusion Criteria:

* metastatic CNS disease
* ocular or mucosal melanoma
* immunodeficiency
* splenectomy
* other
Effects of Oxytocin on Reinforcement Learning

The main aim of the study is to investigate whether intranasal oxytocin (24IU) influences reward sensitivity and performance monitoring during reinforcement learning.

A double-blind, within-subject, placebo-controlled pharmacological EEG design will be employed. A total of 35 healthy male subjects will be recruited which will receive either intranasal placebo or oxytocin (24IU) on two separate study days (order counter-balanced, washout period at least 2 weeks). 45 minutes after treatment subjects will undergo a probabilistic feedback reinforcement learning paradigm with concurrent EEG acquisition. During the paradigm subjects will learn the reward probabilities of two different visual stimuli from probabilistic feedback provided by social stimuli (positive, negative emoticon). The paradigm includes an initial acquisition phase and a subsequent test phase.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-30
* Male sex
* Right handedness

Exclusion Criteria:

* History of brain injury
* Current or history of psychiatric, neurological or internist disorder
* Current or regular use of medication, psychotropic substances, including nicotine
* Contraindications for Oxytocin
Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria
* Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score ≥10

Exclusion Criteria:

* Significant Neurological Disease other than Alzheimer's disease
* Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
* Clinically significant systemic illness
fMRI Guided TMS Enhancement of Associative Memory Networks

This is a randomized, single-blinded, controlled phase 1 study to demonstrate feasibility and explore the neurophysiologic and clinical effects of repetitive transcranial magnetic stimulation (TMS) interventions in epilepsy patients and healthy controls. The inclusion of a control group will be used to see whether epilepsy patients, who suffer from a higher degree of comorbid memory difficulty presumably from entorhinal-hippocampal dysfunction, can benefit from a TMS intervention can benefit as much as a healthy matched population. Investigators will also be looking at functional connectivity between the hippocampus and cortical regions


Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Right-handed
* Score at least 26 out of 30 on the Montreal Cognitive Assessment (MOCA). Healthy subjects will be matched to age, handedness, and education compared to epilepsy subjects.
* Must be able to provide informed consent.

Exclusion Criteria:

* Any history of a neurological disorder
* Chronic or progressive medical condition
* Any history of severe traumatic brain injury or skull defect
* Metal or devices in the head, including neurostimulators of metal foreign bodies
* Any other implanted metal device, including pacemaker, spinal cord stimulator, VNS.
* Any other ferromagnetic substance in the body (including tattoos, dental prosthetics, etc).
* Taking a medication which may lower the seizure threshold within the 4 weeks prior to the start of the study, including use of neuroleptic (esp. clozapine), antibiotic (penicillin, cephalosporins), and bronchodilating medications.
* Pregnancy
San Francisco Stop Smoking App - Pilot Study

This is an initial pilot study to determine whether people will use a research version of an iPhone Stop Smoking app. The investigators primary measures will consist of rates of recruitment (that is, number of people installing the app), use of the app, and completion of follow-up surveys regarding self-reported smoking status. The investigators secondary measure will be obtained quit rates and number of cigarettes smoked before and after using the app.

To enter the study, participants must download the app from iTunes at:

https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8

The investigators research team has developed smoking cessation self-help tools administered as printed brochures and Internet stop smoking sites. These self-help tools have demonstrated quit rates similar to those obtained with the nicotine patch. The investigators now want to see if mobile device apps might also help people quit.

This is the investigators first pilot study with a research version of the investigators stop smoking app for the iPhone. The investigators want to get estimates of how many people will download the app per month, how many will actually use the app, and how many will provide follow-up information on whether they quit, and if not, how many cigarettes they are smoking now. The investigators will use this information to plan a randomized controlled trial to determine efficacy of the app for stopping smoking.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Must download the iPhone app from iTunes at: https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8

Exclusion Criteria:

* less than 18 years of age
Tinnitus rTMS 2013

Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus affects approximately 10-15 % of the population. The prevalence increases with age and it is estimated that more than 20 % of the older people have tinnitus. Approximately 10-15 % of tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety, depression and sleep disturbances. The treatment of chronic tinnitus is difficult and most therapies focus on alleviating the condition rather than treating the cause. Pathophysiology of tinnitus still remains incompletely understood. Functional brain imaging data in tinnitus patients and animal models suggest that tinnitus is associated with increased neuronal activity, increased synchronicity, and functional reorganization within the auditory cortex either uni- or bilaterally, but there are also functional alterations in brain areas outside the auditory system. Transcranial magnetic stimulation (TMS) is a neuromodulation technique based on the principle of electromagnetic induction of an electric field in the brain by means of magnetic pulses given to the scalp. TMS is a non-invasive, painless, and safe method for modulation of cortical activity. TMS pulses given at low frequencies (≤ 1 Hz) have been shown to decrease cortical excitability both in experimental settings and humans, which forms the basis for using low frequency rTMS to treat chronic tinnitus patients, in whom hyperactivity of the auditory cortex has been observed in functional brain imaging studies


Eligibility Criteria:
Inclusion Criteria:

* chronic tinnitus 6 months-10 years
* age 18-65 years
* tinnitus intensity VAS at least 4/10

Exclusion Criteria:

* pulsatile tinnitus
* objective tinnitus
* epilepsy, brain disease
* severe/recent heart disease
* pregnancy
* alcohol abuse
* metallic implants etc.
Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services

The goal of this project is to explore the feasibility and the efficacy of a online mindfulness-based stress reduction intervention for people with chronic pain waiting for secondary or tertiary health care services


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-85
* Self-reported diagnosis of chronic non-cancer pain
* Chronic non-cancer pain duration of 3 months or more
* Chronic non-cancer pain experienced during 4 days or more per week
* Average pain intensity of 4 or more out of 10 in the last seven days
* French or English fluency
* Access to Wi-Fi
* Be able to attend a weekly two-hour MBSR virtual session for eight consecutive weeks

Exclusion Criteria:

* Cancer-related chronic pain
* Currently receiving or have received in the last 24 months coordinated care in pain clinics, hospitals or rehabilitation centers.
* Current or recent participation (in the last 12 months and more than 12 sessions) of cognitive-behavioral therapy or MBSR program
* Having an unstable psychological conditions such as depression, bipolar disorder, post-traumatic stress disorder, psychotic disorder
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)

This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive);
* Diagnosed with atopic dermatitis;
* Suffering from chronic pruritus;
* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria:

* Chronic pruritus due to condition other than atopic dermatitis (AD);
* A positive test for drugs of abuse at the screening or evaluation visits;
* Exposure to any investigational medication in the past 60 days
Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression

The aim of this study is to gather clinical data related to the use of Plastalgin and Plastalgin Fast, in order to comply with the new medical device regulation. The target population for this study is the same as the intended population specified in the study device's instructions for use: children from 5 years old and adults.

Collection, recording, and reporting of data will be accurate and will ensure the privacy, health, and welfare of participating patients during and after the study


Eligibility Criteria:
Inclusion Criteria:

* Patient fulfilling all the following criteria is eligible for the clinical investigation:
* Male or female patient ≥ 5 years of age.
* Indication of dental impressions for the fabrication of prosthesis such as mouth guards and trays, total or partial dentures, and fixed prosthesis (crowns, bridges, dental veneers).
* Total or partially edentulous patient or patient with disocclusion or patient with misalignment.
* Patient affiliated or beneficiary of a social security system.
* Written informed consent must be obtained before any study-related assessment is performed.

Exclusion Criteria:

* The presence of any of the following exclusion criteria will lead to the exclusion of the patient:
* Inability to comply with study procedures.
* Patient opposing the processing of their data.
Integrative Medicine Impact on Frontline COVID-19 Personnel Wellbeing

Treating COVID-19 hospitalized patients incurred heavy burden of physical and emotional stress. The present study is taking place at Carmel Medical Center in collaboration with the integrative oncology and the internal medicine teams with aim to improve the wellbeing of healthcare providers working in frontline COVID-19 departments. In this prospective preference study, Healthcare providers (HCPs) working inside COVID-19 departments are referred to integrative oncology-trained practitioners for assessment of their two leading concerns followed by 30-minute individually tailored treatment. The study assess, based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire, the impact of personalized integrative oncology modalities on the physical and emotional concerns as well as Heart Rate Variability of participating HCPs in COVID-19 departments.

Background: Treating COVID-19 hospitalized patients incurred heavy burden of physical and emotional stress. The present study is taking place at Carmel Medical Center in collaboration with the integrative oncology and the internal medicine teams with aim to improve the wellbeing of healthcare providers working in frontline COVID-19 departments.

Purpose: To explore the impact of personalized integrative oncology modalities on the physical and emotional concerns as well as physiological parameters (e.g., Heart Rate Variability, HRV) of healthcare practitioners (HCPs) in COVID-19 department.

Methods: In this prospective preference study, HCPs working inside COVID-19 departments are referred to integrative oncology-trained practitioners for assessment of their two leading concerns followed by 30-minute individually tailored treatment, scheduled during the working shift and performed adjacent to the COVID department. Integrative treatment include one or more of the following modalities: acupuncture, manual (e.g., acupressure, anthroposophic medicine, reflexology), movement (QiGong, Feldenkrais and Paula methods), and mind-body therapies. The Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire is used for pre- and post-treatment quantitative and qualitative assessment. HCP's narratives analysis is purposed to identify concerns and impact of the integrative treatment program.

HRV is assessed during the integrative treatment. Three minutes intervals at start and after 20 minutes are used for pre- and post-treatment assessment. The primary outcome is RMSSD (root square of successive differences) indicating parasympathetic activity. Secondary outcomes are further parameters from the time domain analysis (SDNN, pNN50) and frequency domain analysis (LF/HF Ratio).

Eligibility Criteria:
Inclusion Criteria:

\* Healthcare providers and personnel working in frontline COVID-19 hospital departments.

Exclusion Criteria:

\* Personnel not consenting to participate
Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Postterm Pregnancies

Objective: To estimate the value of uterine, fetal cerebral Doppler and oligohydramnios to predict abnormal fetal heart rate tracings in pregnancies at or beyond 41 weeks

This will be a nested case-control study that was conducted at University Hospital Dr. Jose E. Gonzalez after the approval of Institutional ethical committee. Women with low risk late term or postterm pregnancy (at least 41 weeks) with confirm gestational age who will be referred to our Maternal-fetal unit and admitted 1 to 2 days prior to induction of labour according institutional protocol will be recruited and constitute the cohort.

Cases will be patients with abnormal intrapartum cardiotocogram (category III fetal heart rate tracing). For each case, four controls will be matched. The primary outcome will be to obtain odds ratios for the Doppler parameters (middle cerebral artery pulsatility index, mean uterine artery pulsatility index and Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio) and amniotic fluid index that would be associated with intrapartum category III fetal heart rate tracing.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age of at least 287 days (41 weeks)
* Low risk pregnancy (defined as the absence of maternal or fetal complications other than postterm pregnancy)

Exclusion Criteria:

* Twin or multiple gestation
* Uncertain gestational age
* Non vertex presentation
* Estimated fetal weight below the 10th percentile for gestational age (Hadlock´s formula)
* Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).
* Fetal abnormalities found on routine anomaly scan.
* Maternal medical disorder (preeclampsia, chronic hypertension, diabetes, lupus, hyperthyroidism)
* Prelabour rupture of membranes
* Antepartum hemorrhage
* Any fetopelvic disproportion that could create dystocia during labor.