cyrilzakka/clinical-trials huggingface dataset:
Sensitivity to Intravenous Nicotine: Genetic Moderators

To determine if the mu opioid receptor gene (OPRM1) A118G polymorphism moderates the subjective-rewarding effects of intravenous (IV) nicotine in male and female smokers. The subjective effects of nicotine will be measured with a Drug Effects Questionnaire, including the ratings of "good effects" and "drug liking". We hypothesize that smokers with the AG/GG genotype for the OPRM1 A118G will have attenuated subjective-rewarding effects from IV nicotine when compared to those with AA genotype.

Increasing evidence suggest that MOR contribute to nicotine's rewarding effect. Further, the functional OPRM1 A118G variant has been linked to rewarding effects of alcohol in alcohol users and to nicotine in female smokers. Since no previous studies examined the influence of the A118G variation on pure nicotine responses, the next logical step is to evaluate how this genetic polymorphism affects nicotine's rewarding, cognitive, and physiological effects using IV nicotine administration in male and female smokers. In addition, the association of the G398A polymorphism of the CHRNA5 gene (rs16969968) with maximal response to nicotinic agonists justifies examination of this SNP as a moderator of IV nicotine sensitivity in humans (Bierut et al. 2008). This SNP will be examined in an exploratory fashion since it is not feasible to fully stratify the study sample for multiple SNPs. The frequency of rs16969968 SNP ranges from 35%-42% among those of European ancestry, making it feasible to examine this variation in our subject sample.

Currently this study is active and enrollment is continuing. Currently there are 205 completers and on going.(June 2014)

Eligibility Criteria:
Inclusion Criteria:

* Female and male smokers, aged 18 to 50 years;
* History of smoking daily for the past 12 months, 10-25 cigarettes daily;
* Not seeking treatment at the time of the study for nicotine dependence;
* Have a FTND score of at least 5 and CO level \> 10ppm;
* In good health as verified by medical history, screening examination, and screening laboratory tests;
* For women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

* History of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study;
* Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder;
* Abuse of alcohol or any other recreational or prescription drugs.
Psycho-biological Substrates of Therapeutic Benefit of Thermal Cure on Generalized Anxiety Disorders

Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of Generalised Anxiety Disorders

Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of Generalised Anxiety Disorders

Main objective is to quantify the therapeutic benefit of a thermal cure on generalized anxiety disorders and to understand the psycho-biological substrates of this improvement.

Secondary objectives:

* A decrease of Insula activity at rest during the answers to aversive pictures and during the task of subjective measurement of heartbeat.
* A decrease of sensibility to emotional interference by subliminal presentation of emotional words thanks to a lexical task and a color recognition task associated to simultaneous measurement of physiological indicator of emotional activity ( dermal resistance)

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic of generalized anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
* No treatment by antidepressant for at least 2 months
* No treatment by anxiolytic/neuroleptic/bete blockers/antipsychotic for at least 3 weeks
* Global score of Hamilton Anxiety Scale (HAM-A) is greater or equal to 20
* Score of HAM-A symptoms greater or equal to 8
* Score of Hamilton Depressive Scale (HAM-D) lower or equal to 7
* Age: Participants will be males and females, 18-75 years of age included.
* For women, no ongoing pregnancy/ negative pregnancy test
* No wounds
* Affiliation to a social security system (recipient or assignee)
* Signed written inform consent form

Exclusion Criteria:

* Treatment by antidepressant for at least 2 months or a treatment by anxiolytic, neuroleptic for at least 3 weeks
* Psychotropic treatment (antidepressant, anxiolytic and neuroleptic) between the preinclusion and inclusion
* Psychotherapy during the 3 months prior to the inclusion
* Thermal cure during the 6 months prior to the inclusion
* Treatment by paroxetine for at least 1 month with dose equal or superior to 20 mg per day during the 12 months prior to the inclusion
* Contraindication to paroxetine
* Enhanced protection (minors, pregnancies women, nursing women,people deprived of liberty by administrative or judicial decision, ...)
* Blood donation during the 3 months prior to the inclusion
A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product.

Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.


Eligibility Criteria:
Inclusion Criteria:

* age \>=19
* a daily cigarette smoker of \>=10 cigs/day
* English speaking
* live in the contiguous U.S.
* unmotivated to quit smoking in the next 30 days

Exclusion Criteria:

* no use of smokeless tobacco in past six months
* not breastfeeding, pregnant, or planning a pregnancy
* devoid of any recent (past 6 months) cardiovascular trauma
* no quit attempt of \>=1 week in past 6 months
* no use of pharmacotherapy to quit smoking in past 3 months
EVLA and Optimal Timing of Sclerotherapy

The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.

The study inclusion criteria is patients with main trunk (VSM, SSV, AASV) reflux to be treated with EVLA, suffering C2-C3 varicose disease, age 18-years and no severe co-morbidities.

Patients with written consent will be randomized to two primary treatments groups; EVLA only and EVLA combined with sclerotherapy of varicose tributaries. The primary outcome is the requirement additional sclerotherapy on 3 month control visit. Other study outcomes are pain, quality of life (veins questionnaire), severity score and also recurring of varicose disease at 1, 3 and 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Varicose disease of lower extremity caused by reflux of VSM, SSV or AASV to be treated with EVLA. Age over 18 years. Clinical symptoms C2-3.

Exclusion Criteria:

* No severe comorbidities. Previous DVT.
A Ketogenic Diet Acts on Cortical But Not Subcortical Responsivity in Migraineurs

A short ketogenic diet (KD) treatment can prevent migraine attacks and correct excessive cortical response. Here, investigators aim to prove if the KD-related changes of cortical excitability are primarily due to cerebral cortex activity or are modulated by the brainstem.

Through the stimulation of the right supraorbital division of the trigeminal nerve, there will be concurrently interictally recorded the nociceptive blink reflex (nBR) and the pain-related evoked potentials (PREP) in 18 migraineurs patients without aura before and after 1-month on KD, while in metabolic ketosis. nBR and PREP reflect distinct brain structures activation: the brainstem and the cerebral cortex respectively. It will be estimated nBR R2 component area-under-the-curve as well as PREP amplitude habituation as the slope of the linear regression between the 1st and the 2nd block of 5 averaged responses.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine
* Kept a headache diary for at least 1 month
* Headache onset before the age of 50

Exclusion Criteria:

* over consumption of acute pain-killers (triptan, analgesic, or ergotamine)
* pregnancy or lactation
* type I diabetes
* serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.
Comparison of Methodology Proposed by the SFAR for the Detection by Videoconference of Obstructive Sleep Apnea.

The SFAR (French society of anesthesiology and ICU) proposed a method to detect OSA (Obstructive Sleep Apnea) patients via videoconference. The aim of this study is to compare the result of this method with the results of polysomnography (PSG) which remains the gold standard in the detection of OSA patients.

The SFAR (French society of anesthesiology and ICU) proposed a method to detect OSA (Obstructive Sleep Apnea) patients via videoconference. The aim of this study is to compare the result of this method with the results of polysomnography (PSG) which remains the gold standard in the detection of OSA patients.

Other methods, such as a predictive score, also exist. The accuracy of the French method compared to PSG and the predictive scores is to be determined.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted in the Clinique Saint-Luc of Bouge for a polysomnography

Exclusion Criteria:

* Patient's refusal
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss

This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.

This study will enroll two cohorts. Cohort 1 (n=9) will be enrolled first to rapidly assess safety and drug exposure. After the sponsor completes an unblinded safety review, Cohort 2 (n=27) will be enrolled to continue safety evaluation of FX-345.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 18-67 years (inclusive)
* Documented medical history consistent with acquired, adult onset, sensorineural hearing loss
* At the Screening, Lead-in (Visit 2) and Treatment (Day 1) Visits, a pure tone average of 40- 80 dBHL at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the potential study ear to be injected
* Female participants must not be pregnant, breastfeeding, or lactating. Women of child-bearing potential must agree to use a highly effective contraceptive method and must have a negative urine pregnancy test.
* Male participants must refrain from donating sperm and agree to be either abstinent or use a barrier method of contraception

Exclusion Criteria:

* Randomization in a FX-322 (laduviglusib and sodium valproate) clinical trial
* Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in study ear. This includes a current tympanostomy tube.
* Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening, Lead-in (Visit 2) or Treatment (Day 1) Visits, based on the investigator's judgment.
* Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
* Within 3 months of screening visit any of the following: 1) an intratympanic injection in either ear 2) treatment with steroids 3) onset of sudden sensorineural hearing loss
* Evidence of or previous diagnosis of traumatic brain injury, Meniere's disease, or genetic hearing loss
* History of head or neck radiation, significant systemic autoimmune disease, and/or chronic, recurrent clinically significant vestibular symptoms
* Exposure to another investigational drug within 28 days prior to screening visit
House Dust Mite Observational Study

A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.

The proposed observational study is designed to gather information on subjects with HDM-related rhinoconjunctivitis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years
* A history of moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage, and/or itchy/watery/red/sore eyes) consistent with allergy to HDM for at least 1 year.
* Non-asthmatic, or asthma controlled by Step 1 or 2 treatment as defined by GINA for at least one month.
* Subjects must have a 7-day reflective TRSS (i.e., reflective over the previous 7 days) of ≥12 and must have a score of ≥2 in at least two of the individual symptom components.
* Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.
* Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.

Exclusion Criteria:

* Clinically significant confounding symptoms of allergy to relevant local seasonal allergens (e.g., ragweed, mugwort, tree, grass, mountain cedar, mould) and cannot complete the Screening and Observation period outside the respective allergy seasons.
* Previous immunotherapy treatment with any HDMA for more than 1 month within 5 years prior to screening
Erector Spinae vs. PENG Block for Total Hip Arthroplasty

Effect of PENG block and ESPB on pain management, and NLR and PLR following knee arthroplasty

Hip arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, very few studies have evaluated the effect of various methods of anesthesia on the NLR.

This is the first study to investigate the effect of regional anesthesia on the NLR and PLR in patients undergoing hip replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for hip arthroplasty under spinal anesthesia.

Exclusion Criteria:

* Patients who have a history of bleeding diathesis, Take anticoagulant therapy, have a History of chronic pain before surgery, have Multiple trauma, cannot assess their pain (dementia), have been operated on under general anesthesia, have an infection in the area and do not accept the procedure
The Individual Therapy for Patients With Wilson's Disease

Based on the genotype characteristics and genotype-phenotype-treatment prognosis data of Chinese WD patients, this study intends to further optimize the treatment regimen of Chinese WD patients and formulate individualized treatment regimens for each genotype, so as to further improve the prognosis of patients.

The purpose of the study is to evaluate treatment regimen efficacy based on different mutations, and Zinc treatment in presymptomatic WD patients.

Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of Wilson's disease
* Presymptomatic patients with Wilson's disease

Exclusion Criteria:

* Movement disorder due to other definite causes instead of Wilson's disease
* Severe Lung, kidney or liver disease
* Neoplastic Disease
Couples HIV Counseling and Testing for Male Couples in the United States

This is a study to determine whether testing for HIV together as a couple, as opposed to testing separately, in acceptable to men in male couples, and is a safe prevention service. Testing of couples together has been provided for decades in Africa, but has never been tested in the United States. In this study, male couples will be enrolled and randomly assigned to be tested together in the same room, or separately. At the time of testing, investigators will ask questions about how they felt about the service they received. Three months later, investigators will survey the men again, and determine whether they had any problems after the testing, like violence in the relationship or the relationship breaking up. The main outcomes are being satisfied with the testing service, and safety (lack of intimate partner violence or relationship termination). Although the study is not designed to determine if the service reduces risk behaviors for HIV transmission, investigators will examine data on risks just to explore that topic. The main hypotheses are: (1) men will be at least as satisfied with couples testing as they are with individual testing; and (2) men tested as couples will not experience higher rates of intimate partner violence or relationship dissolution, relative to men tested separately.


Eligibility Criteria:
Inclusion Criteria:

* male at birth
* currently self-identify as male
* at least 18 years of age
* have been in a couple with a man for at least 3 months
* willing to complete a follow-up study visit in 3 months
* able to complete study assessments in English.

Exclusion Criteria:

* known to be HIV-positive
* over 39 years of age
* either partner being unwilling to accept randomization to the couples testing arm
* either partner planning to move from the Atlanta area within 3 months of the initial study visit
* either partner reporting a history of intimate partner violence
* either partner reporting feeling coerced to tested with his partner
Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

This will be a prospective, registry study of an investigational procedure for at least 12 standard of care visits up to 1 year after subject consents for study. Subjects will be enrolled between 8/1/2018 and 8/1/2023. Subjects will undergo a clinically indicated endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care.

Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.

All procedures, barring research activities such as consenting and data collection from Electronic Health Record , will be either clinically indicated and/or standard of care. Subject data will be collected and recorded in a registry which will allow for the prospective review and collection of clinical data related to Endoscopic Sleeve Gastroplasty for safety and efficacy assessment.

Study duration: At least 12 standard of care visits up to 1 year for each subject.

Standard of care follow up visits for Endoscopic Sleeve Gastroplasty are usually 2 weeks, 3 months, 6 months and 12 months post procedure with the physician and 8 follow-up visits over the year with a dietitian. No additional research related visits will be requested. All data will be collected from Electronic Health Record.

Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able to comprehend and provided written informed consent
* Willing to comply with the substantial lifelong dietary restrictions required by the procedure
* History of failure with non-surgical weight-loss methods
* Willing to follow protocol requirements, including providing informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
* Women of childbearing potential ( not post-menopausal or surgically sterilized) must agree to use adequate birth control methods

Exclusion Criteria:

* Below 18 years of age
* Prohibitive anesthetic risk
Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical removal, pterygia can recur. One way of minimizing recurrence is by applying a medication called mitomycin C to the surface of the eye during pterygium surgery. However, mitomycin is associated with certain side effects, such as thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of action and there is some evidence that it may be useful in preventing pterygium recurrence. In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and mitomycin C for preventing pterygium recurrence will be directly compared.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80
* Presence of primary or recurrent pterygium
* Pterygium grows greater than 2mm onto cornea from limbus (using slit lamp light beam to measure size)
* Pterygium is inducing astigmatism greater than 1 diopter compared to the fellow eye (to be determined by automated keratometry and manifest refraction)
* The pterygium is symptomatic (irritation, inflammation, strabismus, decreased visual acuity)

Exclusion Criteria:

* Age less than 18
* Age greater than 80
* Any systemic rheumatologic or autoimmune disorder (autoimmune hepatitis, bullous pemphigoid, celiac disease, Crohn's disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, systemic lupus erythematosus, mixed connective tissue disease, pemphigus vulgaris, psoriasis, polymyositis, rheumatoid arthritis, scleroderma, Sjogren's disease, ulcerative colitis, vasculitis, Wegener's granulomatosus)
* Women who are potentially child-bearing (no possibility of pregnancy for at least one month after surgery)
* Any use within the past two months of topical eye drops other than artificial tears in the study eye
* Any previous intravitreal injections of any medication in the study eye
* Any previous use of systemic, topical, or intravitreal bevacizumab in either eye
* Any history of subconjunctival injections in the study eye within the past year
* Any history of scleral or corneal laceration in the study eye
* Ocular surgery within the past 3 months in the study eye
* History of scleral buckle placement in the study eye
* History of glaucoma