cyrilzakka/clinical-trials huggingface dataset:
Narval CC Mandibular Repositioning Device in the Second-line Treatment of Severe Obstructive Sleep Apnea Hypopnea (OSAH)

The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with severe Obstructive Sleep Apnea Hypopnea (OSAH) syndrome who refuse or are intolerant to Continuous Positive Airway Pressure (CPAP) treatment.

OSAH is a common condition which occurs in between 1 and 4% of the adult population. Respiratory obstruction may be complete (apnea) or incomplete (hypopnea). This disorder disturbs the architecture and quality of sleep, and is a known risk factor in the development of cardiovascular and metabolic diseases. CPAP is the standard treatment, however in some cases patients are unable to use it (rejection, intolerance, etc.). In such circumstances, treatment using a MRD may result in an improvement of symptoms.

Very few long-term clinical data are available on treatment of OSAH by MRD. This study should allow to have a precise and representative vision of 5 years results of ORM Narval MRD treatment in conditions of good practices (titration, controls of efficacy).

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with severe OSAH (AHI \> 30 or AHI of between 5 and 30 along with severe daytime sleepiness),
* intolerant to or having refused CPAP therapy,
* no dental, parodontal or articulatory contraindications,
* no experience of any mandibular advancement device therapy,
* medical insurance.

Exclusion Criteria:

* severe psychiatric disorders or severe neuromuscular disorders
* \> 20% of central apneas during the baseline assessment,
* severe OSAH with an AHI \> 30 associated with another sleep pathology (narcolepsy with or without cataplexy, idiopathic hypersomnia, severe restless legs syndrome),
* pregnant or breastfeeding woman,
* Informed consent not signed,
* patient requiring special protection such as patients with appointed guardians and patients without legal or administrative rights,
* patient who is completely or partially edentulous
Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance

Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance

Single center study in ICU patients with augmented renal clearance comparing glomerular filtration rate (GFR) as measured by iohexol plasma clearance to that measured by creatinine clearance. Primary objective is to compare the GFR estimates made by iohexol plasma clearance (as reference method) and creatinine clearance using Bland-Altman method.

Secondary objective are to compare GFR as measured by iohexol plasma clearance to that calculated with the most commonly used renal clearance estimating formulas (Cockcroft and Gault, MDRD and CKD-EPI ), evaluate clinical determinant of the observed differences and evaluate determinants of extracellular volume.

Eligibility Criteria:
Inclusion Criteria:

* ICU patient
* 24h Creatinine clearance \>130ml/min/1.73m2
* Urinary catheterization
* Affiliation to a social security scheme

Exclusion Criteria:

* Pregnancy
* CT-scan with contrast media infusion the day of inclusion
* Documented allergy to contrast media
* Patient under guardianship / curatorship
* Patient benefiting from the "State Medical Assistance"
Zhongshan Iridocorneal Endothelial Syndrome Study (ICEs)

This is a multi-center study to report the demographic profile, clinical features, and management in patients with Iridocorneal endothelial (ICE) syndrome in China.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ICE syndrome;
* Those willing to sign the informed consent.

Exclusion Criteria:

* Patients who don't sign the informed consent or abide by the study procedure.
Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure

To compare continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in supine position.

Analysis of number and magnitude of BP changes Adjust endpoint calculation definitions and methods based on this lead in results Estimate sample size for main study Demonstration of capability to quantify and annotate interference in the arterial line signal and detect and changes in patient orientation Parallel recording of SentiCor-300 PPG sensor

Main study:

Validate SentiCor-300 noninvasive blood pressure against direct arterial pressure measurements.

Up to 200 (10 run-in, the balance- study) Run in phase will be performed with Senticor-100, data will be used for sample size estimation of balance study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for arterial catheter insertion;
* Age ≥18 years;
* American Society of Anesthesiologists (ASA) physical status class ≤3;
* Enrollment will be adjusted as necessary so the final population includes at least 40% men and 40% women;
* Planned length of surgery \>60 minutes;
* Anticipated supine positioning;
* Anticipated initial recovery in the post-anesthesia care unit.

Exclusion criteria:

* Severe peripheral vascular disease;
* Surgery that involves manipulation of large arteries
* Bypass surgery
* Positive Allen's test
* Inability to insert a catheter into an upper extremity artery;
* Patients with an arterial-venous shunt for hemodialysis;
* Inability to measure NIBP on the arm with the arterial catheter;
* Atria l fibrillation;
* Body Mass Index (BMI) \>35kg/m2;
* Esophageal or nasopharyngeal pathology, coarctation of the aorta;
* Emergency surgery.
* Surgery which involves manipulation of major arteries
Long-term Fasting in Patients With a History of PCI

Patients in this prospective cohort study were selected if they had a history of PCI more than 1 year previously. 405 patients were divided based on their preferences to fasting and non fasting and after 1 month of fasting major adverse cardiovascular events were measured

Between 18 March 2019 and 18 April 2020, patients seen at Professor Kojuri Cardiovascular Clinic in Shiraz, Iran (email:kojurij@yahoo.com, webpage: http://kojuriclinic.com) for their annual check-up were selected. We explained the research project to them, and volunteers were selected. Patients were assigned to the fasting or non-fasting group according to their preference. All volunteers were informed about the details of this research, and provided their written informed consent. Patients who declined to participate in the study were excluded.

Patients were instructed how to divide their medication across the two daily meals before dawn and after sunset during the month of Ramadan. We informed patients to immediately stop fasting and consult the clinic if they experienced any signs of cardiovascular disease, including shortness of breath, chest pain, or palpitations. At the end of Ramadan, patients were contacted by telephone and asked about their symptoms, including chest pain and dyspnea, hospitalization, and MACE. The MACE were defined as acute myocardial infarction, hospitalization due to congestive heart failure, new-onset atrial fibrillation, stroke, or cardiac arrest \[19, 20\]. Symptomatic patients were referred to the clinic for cardiovascular examination.

The study was double-blinded. To blind the researchers, the clinic secretary contacted the patients and asked them not to specify their group (fasting or non-fasting), and then passed the phone to the researcher. We used alphabetical order in each group to blind the statisticians. Patients who fasted during Ramadan were designated with the letter X, and patients who did not fast during Ramadan were designated with the letter Y.

For statistical analyses we used IBM SPSS software version 25. We used the chi-squared test to compare categorical variables and Student's t-test to compare the mean values of continuous variables. The Mann-Whitney U test and Kruskal-Wallis test were used for nonparametric variables.

Eligibility Criteria:
Inclusion Criteria:

* history of PCI, and a minimum of 1 year between angioplasty and enrollment in this study

Exclusion Criteria:

* Heart failure (ejection fraction \<50 %)
* Advanced kidney failure (glomerular filtration rate \<60 mL/min
* Unsuccessful revascularization
* Coronary artery bypass graft
* Liver cirrhosis
* Any acute conditions such as infection
* Needed repetitive treatment
* Diabetes who were on insulin treatment
OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study

The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on the rate of anterior orthodontic alignment.


Eligibility Criteria:
Inclusion Criteria:

* Presence of permanent dentition
* Eligible and scheduled for full mouth fixed orthodontic treatment
* Class I or Class II malocclusion (no more than ½ cusp in Class II)
* Non-extraction in all quadrants
* Non-smoker
* Good oral hygiene as determined by the investigator
* No adjunct treatment such as extra- or intra-oral appliances

Exclusion Criteria:

* Pregnant females
* Patient is currently enrolled in another clinical study
* Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable)
* Periodontally involved teeth
* Use of bisphosphonates
* Unerupted or partially erupted maxillary teeth
* Teeth blocked out of alignment and unable to engage initial arch wire
* Spaces present in the maxillary arch
Study of ATX-01 in Participants with DM1

The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated. The trial will compare the safety and tolerability of ATX-01 and a matching placebo.

There will be a single-ascending dose part of the trial and a multiple-ascending dose part. In the single-ascending dose, participants will receive one dose of ATX-01 or placebo. In the multiple-ascending dose part, participants will receive three doses of ATX-01 or placebo.

ATX-01 is a novel anti-miR (synthetic single stranded oligonucleotide) that inhibits a microRNA called miR-23b.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants with a documented clinical diagnosis of DM1 (CTG expansion of \>150 repeats in DMPK gene measured in peripheral blood mononuclear cells)
* Ambulatory, defined as able to complete a 10-meter walk/run test at screening without the use of assistive devices such as canes, walkers, or orthoses, except for ankle-foot orthoses
* Presence for \>3 seconds of grip myotonia as confirmed by a central reader

Key Exclusion Criteria:

* Participants with congenital DM1
* Medical Research Council Muscle Scale score of less than 4 on ankle dorsiflexion or significant tibialis anterior atrophy that prevents a muscle biopsy
* Use of mexiletine or other agent for myotonia within 21 days or 5 half-lives, whichever is longer, prior to screening
Headache in Juvenile Onset Systemic Lupus Erythematosus

The aim of our study was to compare individuals with juvenile onset systemic lupus erythematosus with and without headache in terms of pain, pain catastrophizing behavior, demographic and individual disease-related factors that may affect headache and temporomandibular joint dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with Juvenile Onset Systemic Lupus Erythematosus by the Pediatric Rheumatology Clinic
* Being between the ages of 8-25,
* Having stable symptoms and medications
* Being willing to participate in the study

Exclusion Criteria:

* Patients with neuropsychiatric disorders not associated with Juvenile Onset Systemic Lupus Erythematosus (such as history of epilepsy, electrolyte imbalance, or medication side effects)
* History of headache before juvenile onset systemic lupus erythematosus diagnosis
* Presence of another concomitant rheumatic disease
* Having cognitive impairment to the extent of not being able to cooperate
Integrated Care Approach for Rheumatoid Arthritis Patients

The goal of this study is to learn about the long-term effects of integrated care approach in persons over the age of 20 who take part in integrated care approach to treat their rheumatoid arthritis (RA). The main question is to explore whether adding the integrated care approach into routine care can lower pro-inflammatory cytokines and depressive symptom in RA persons over age 20 when taken long-term to treat RA?


Eligibility Criteria:
Inclusion Criteria:

age of at least 20 years; willingness to participate in the survey; having the physician-diagnosed RA with the International Classification of Diseases, 9th Revision, Clinical Modification code of 714.0

Exclusion Criteria:

* having physician-based diagnosis of cognitive impairment and with the ability to express opinion
FACE-Q in Blepharoplasty

The aim of this study is to assess the effect of two different suturing techniques in patients undergoing bilateral upper eyelid blepharoplasty on the results of the FACE-Q Eye Module questionnaire for measuring patient-reported outcomes as well as on the blinded objective assessment by two experienced surgeons using the same questionnaire.

We aim to investigate the differences of the 2 most common techniques of skin closure with running cutaneous or subcuticular Nylon (6-0 Prolene) sutures in upper blepharoplasties and their effect on postoperative complications and scar formation. Besides the functional outcomes (visual field) and objective postoperative results, we aim to measure the patients' satisfaction using the FACE-Q Eye Module as a comprehensive, procedure- and disease-specific patient-reported outcome instrument.


Eligibility Criteria:
Inclusion criteria

* Women and men between 18-99 years
* With bilateral dermatochalasis and resulting visual field restriction
* Willingness and ability to comply with regular visits
* Signed informed consent form

Exclusion criteria

* Any disease affecting wound closure/healing such as diabetes, connective tissue disease or non-medically induced bleeding disorders, known autoimmune disease, known tendency for hypertrophic scars or keloids;
* Untreated hypertension or metabolic syndrome,
* Smoker
* Asymmetric brow ptosis,
* Previous surgery on the eye lids
* Sequelae after facial nerve palsy
* Allergy or adverse reaction to any substance or material used.
* Active or chronic eyelid inflammation

Pregnant or breast-feeding women:

Women of childbearing potential (18-50) are not excluded form this study. Breastfeeding or pregnant women are however excluded, as bilateral upper eye lid blepharoplasty can be easily postponed.
Peer Education as a Strategy to Promote Vaccine Acceptance

Effective interventions to improve uptake of vaccines among hesitant groups are urgently needed. Peer education is an effective intervention in modifying health behaviors in other conditions and may be effective in promoting vaccine confidence but has not been studied. To fill this knowledge gap, we will enroll approximately 152 parents of children age 0-18 months who are eligible for pneumococcal conjugate (PCV-13) vaccine and randomize them 1:1 to a peer-led vaccine education intervention or usual care.


Eligibility Criteria:
Inclusion Criteria:

1. A parent of a child aged 0 to 18 months born at ≥35 weeks' gestation who is eligible for a dose of PCV-13. Eligibility by age defined as follows:

   1. Age 0-6 months: never received first dose or is \>8 weeks from last dose (3 doses scheduled in this age group at 2, 4, and 6 months)
   2. Age 7-11 months: never received first dose or is \> 8 weeks from last dose (2 doses scheduled in this age group if started at 7 months)
   3. 12-18 months: never received first dose, is \>8 weeks from last dose (2 doses scheduled in this age group if started at 12 months) or is due for booster at 12-18 months having received primary series between age 2-11 months.
2. Self-identifies as Orthodox Jewish.
3. Is able to provide informed consent.

Exclusion Criteria:

1. Unable to communicate verbally in English or Yiddish
2. Unwilling or unable to utilize a Yiddish in-person or telephone interpreter
3. Has already participated in this study as an eligible adult or parent. A parent will only be able to participate in this study once (i.e. for only one child in the family that is eligible)
4. Has an appointment at clinic that day to specifically receive vaccines.
Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC

The purpose of this study is to assess the maximum tolerated dose of low-dose radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer for second-line therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or greater.
* Histologically or cytologically proven non-small cell lung cancer that is either metastatic or recurrent and failed at least one prior platinum-based chemotherapeutic regimen.
* Patients who have recurred after previous surgery and/or radiation may participate in this trial.
* Patients may have had prior neoadjuvant or adjuvant therapy.
* Patients with known brain metastases are eligible for this clinical trial if their disease has been treated and they are clinically stable and documented by a stable or improved pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 28 days prior to registration.
* Measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). Measurable or non-measurable disease must be present outside the area of surgical resection. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease.
* Progression after at least one prior platinum-based chemotherapy.
* Greater than 3 weeks since surgery and must have recovered from all associated toxicities at time of registration.
* ANC ≥ 1,500/µl and platelet count ≥ 100,000/µl obtained within 28 days prior to registration.
* Adequate hepatic function documented by a serum bilirubin ≤ 1.5 times institutional upper limit of normal and liver enzymes (SGOT or SGPT) ≤ 2.5 x the institutional upper limit of normal obtained within 28 days prior to registration.
* Patients requiring lung radiation must have an FEV1 of \> 1000 liters obtained within 28 days prior to registration and must have pulmonary function tests with DLCO.
* Zubrod Performance Status of 0,1 or 2.

Exclusion Criteria:

* No prior single-agent, weekly Docetaxel chemotherapy.
* Peripheral neuropathy ≥ Grade 1.
* Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 years.
* Pregnant or nursing women.
Safety and Efficacy Study of Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS)

Pain remains the most debilitating symptom for adult patients suffering from complex regional pain syndrome (CRPS). Most CRPS patients gain little to no relief from current painkillers. The purpose of this study is to evaluate the efficacy and safety of ethosuximide in search of much-needed adjunctive therapy to relieve the pain and suffering associated with CRPS.

This is a single centre, parallel-group, double-blind, randomized, placebo-controlled pilot clinical trial for adults suffering from complex regional pain syndrome (CRPS).

Twelve (12) subjects diagnosed with CRPS will be enrolled and randomized to receive orally, either ethosuximide or placebo. If the maximum trial medication dosage (1500mg) is reached, the subject will be in the study for a maximum of 10 weeks from screening (Clinic Visit 1) to the end of the drug cessation period. The minimum period a subject could complete the study would be 4 weeks presuming they were not previously on any disallowed drugs and only found the 500mg dose tolerable.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥18 years old;
* Diagnosis of Complex Regional Pain Syndrome (CRPS) using International Association for the Study of Pain criteria \>6 months;
* Normal liver function (AST level \<3x normal level);
* Normal kidney function (serum creatinine \<133µmol/L);
* Full blood count, haematocrit \>38%;
* Willing and able to give informed consent and of completing study questionnaires;
* Stable (no change in past two months) but suboptimal pain pharmacotherapy (i.e. additional pain control felt by patient and physician to be necessary);
* Able to attend research centre according to the visit schedule;
* Women of child-bearing potential must be using a reliable form of contraception i.e. oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or abstinence.

Exclusion Criteria:

* Optimal response to opioids, antidepressants, anticonvulsants or anti- inflammatory medications;
* Any history or indication of kidney or liver disease;
* Any history of alcohol abuse;
* Presence of diabetes;
* Subjects taking other anti-epileptic drugs, including gabapentin, pregabalin, topiramate, phenytoin, carbamazepine, and oxcarbazepine;
* Pregnancy (a serum bHCG pregnancy test will be performed as part of the initial blood panel);
* Known or suspected allergy to succinimides, ethosuximide, methsuximide (Celontin®), phensuximide;
* Any history of mental illness or disorder, which in the investigators opinion, interferes with the subjects ability to accurately report treatment response;
* Participation in other clinical trial in the 30 days prior to enrolment.