cyrilzakka/clinical-trials huggingface dataset:
A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers

This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and alcohol, and placebo to RO4917838 and non-alcoholic drink.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers, 18 to 45 years, inclusive
* Body Mass Index (BMI) 18 to 30 kg/m2, inclusive
* Non-smoker or smoker of fewer than 10 cigarettes per day
* Females, who are not menopausal must agree to use two adequate methods of contraception

Exclusion Criteria:

* Any current medical condition or disease that would render the volunteer unsuitable for the study, or would place the volunteer at undue risk
* History of alcoholism
* History of drug abuse and/or addiction within one year of study start
* History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
Impact of the Use of Allogeneic Hematopoietic Stem Cell Transplantation in Reunion Island Patients: Quality of Life, Determinants of Choices and Financial Repercussions

This project aims to document and analyse - with a three-fold anthropological, psychosocial and economical approach - the consequences of the geographical distance from mainland France on the alloSCT on both patients, their caregivers and the healthcare system. It is organised in 3 working packages (WP).


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with hematological malignancy (myeloid acute leukemia, lymphoid acute leukemia, non-hodgkin lymphoma, Hodgkin disease, or myelodysplasic syndrome
* candidate to an allogeneic hematopoietic stem cell transplantation in mainland France ;
* Residing in Reunion Island
* Age \>18 year old;
* who accept or not allogeneic hematopoietic
* Able to complete a questionnaire

Exclusion Criteria:

* Opposition to participation and collection of their data
* Person deprived of liberty by judicial or administrative decision, and person subject to legal protection (guardianship or curators)
Electronic Cigarettes in Daily Dependent Smokers

The aim of this study is to measure nicotine cue- and withdrawal-induced craving in current smokers under four distinct conditions: after smoking a conventional cigarette, an electronic cigarette (e-Cigarette) containing nicotine, an e-Cigarette without nicotine, and after taking a nicotine lozenge. Participants will be asked to attend four morning study visits after overnight smoking abstinence. Standardized questionnaires will be used to assess changes under each condition, allowing for the investigation of the efficacy of e-Cigarettes in reducing craving by replacing the behavioral component of smoking with minimal risk of adverse effects.

Many addiction models postulate stimuli to be linked with nicotine intake and reward after prolonged use. As such, smoking becomes more heavily based in habit, initiated by cues. Craving has been found to be a crucial component of continued smoking and relapse in response to various environmental and behavioral cues. Electronic Cigarettes (e-Cigarettes) are new smoking products emerging in consumer markets that often mimic conventional tobacco cigarettes. E-Cigarettes commonly include a cartridge, a heating element, a puff sensor, and a battery. When a user draws on the device, the heating element is activated and the cartridge fluid is vaporized. Users then inhale the aerosol containing droplets of the vaporized fluid. This study will empirically assess the efficacy of e-Cigarettes in alleviating craving by replacing the behavioral component of smoking. Using standardized questionnaires, intra-subject changes in cue- and withdrawal-induced craving after smoking an e-Cigarette without nicotine will be compared with that after either smoking a conventional cigarette, an e-Cigarette with nicotine, or taking a 4mg lozenge.

Eligibility Criteria:
Inclusion Criteria:

* Current daily smoker
* Smoke minimum of 10 cigarettes per day
* Fagerstrom Test of Nicotine Dependence Score equal or greater than 3
* Never used an e-Cigarette prior to the study
* No intention to quit smoking within the next 3 months
* Able to provide written informed consent
* Able and willing to attend scheduled appointments

Exclusion Criteria:

* Any serious medical or unstable psychiatric problems requiring treatment
* Pregnancy or lactation
Prevention in Belgian Hockey : What Does the Staff Really Put in Place?

Purpose: To provide an update on the implementation of prevention among hockey players by their entourage.

Materiel and method: This study will be conducted by the means of a questionnaire. The target population consisted of trainers.

The questionnaire will be validated by experts and published on an online survey website


Eligibility Criteria:
Inclusion Criteria:

* Professions: hockey trainer

Exclusion Criteria:

* /
Size Up Bicuspid with the LIra MEthod: the SUBLIME Study

Transcatheter aortic valve replacement (TAVR) outcomes in patients with raphe-type bicuspid aortic valve (BAV) are still suboptimal for the non negligible rate of stroke and permanent pacemaker implantation. There is still lack of consensus on the optimal sizing method for prosthesis selection in BAV patients.

The objective of the present study is to evaluate the efficacy and safety of the LIRA sizing method in raphe-type BAV patients undergoing TAVR.

Bicuspid aortic valve (BAV) still represents a challenge for percutaneous treatment due to the peculiar anatomy.

BAV patients have been historically excluded from major randomized controlled trials.

Observational data have showed a high rate of paravalvular leak (PVL) with the use of self-expanding prostheses and a non-negligible rate of annular rupture with the use of balloon expandable valves.

More recent data have shown better outcomes with current generation prostheses although the rate of stroke and permanent pacemaker implantation remains high.

These suboptimal results, possibly related to BAV different anatomy, have advocated the use of different sizing method for prosthesis selection in this setting.

Recent evidence has shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe-level, defined as the LIRA (Level of Implantation at the RAphe) plane. Thus, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level, the LIRA-method, has been developed in our center and validated in small cohorts of patients.

The aim of our study is to evaluate the efficacy and safety of the LIRA method in raphe-type bicuspid patients undergoing TAVR.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years old with severe aortic stenosis and type 1 or 2 BAV according to Sievers classification) undergone TAVR with self-expanding supra-annular prostheses sized according to the LIRA method between September 2018 and June 2024

Exclusion Criteria:

* Redo-TAVR
* TAVR performed in emergency setting
* TAVR performed for severe aortic regurgitation
Restaurant Menu Carbon Footprint Labeling

This online randomized clinical trial will test the effects of restaurant menu carbon footprint labels on consumers' choices and perceptions of restaurant menu items.

This online randomized clinical trial will test the effects of restaurant menu carbon footprint labels on consumers' choices and perceptions of restaurant menu items. Participants will be randomized to see a restaurant menu with one of two labeling schemes: 1) Control: calorie labels only; 2) Carbon footprint labels in addition to calorie labels. Participants will be instructed to select an entree to hypothetically order from an online restaurant menu. After selecting, they will be asked to answer questions about their perceptions of menu items and carbon footprint labels.The primary outcome will be the average carbon footprint of menu items chosen from the online menu.

Eligibility Criteria:
Inclusion Criteria:

* US adults aged 18 or older

Exclusion Criteria:

* Younger than 18
* Non-US
Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer

Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.

In this study, our hypotheses are as following:

1. Multimodal method enables to increase identification rate of SLNB
2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome
3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy

Indocyanine green Advantages: provides visualization of sentinel lymph node without incision

Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes

Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only

Eligibility Criteria:
Inclusion Criteria:

* clinically lymph node negative breast cancer patients
* consented patients with more than 20 years

Exclusion Criteria:

* history of breast cancer
* locally advanced breast cancer and metastatic breast cancer
* proven axillary lymph node metastasis
* history of axillary excisional or incisional biopsy, or dissection
* history of neoadjuvant chemotherapy
* pregnancy
* non-consented patients
* younger than 20 years old
MRIPositive Diagnosis of Vestibular Neuritis Using Fluid Attenuated Inversion Recuperation (FLAIR) Sequence on a 1.5 Tesla

Our objective is to allow positive MRI diagnosis of vestibular neuritis by highlighting contrast enhancement of the vestibular nerve on the pathological side of the FLAIR sequence acquired 1h after intravenous gadolinium injection in patients with typical vestibular neuritis. At present, the diagnosis is based on a combination clinical examination / video-head impulse test, and no imaging examination allows the diagnosis to be positive.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Presence of a typical unilateral vestibular neuritis during the ENT examination with videonystagmography
* Subject having his agreement for the use of his medical data for research purposes.

Exclusion Criteria:

* Special clinical forms of the disease: doubtful or atypical forms, especially the presence of deafness
* Treatments and related interfering diseases, antecedents: antecedents of neuritis for controls, presence of vertigo, bilateral involvement
* Impossibility to give the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...)
* Subject under the protection of justice
* Subject under guardianship or curatorship
Clinical Study Of Migraine Evolution

Understanding the speed at which migraine headaches develop is of importance to patients. Determining the proportions in which different headache pain build-up occurs, may provide health care practitioners with valuable information with which to prescribe the most appropriate treatment. Patients who experience a slow pain build-up may gain more benefit from medications which have a slow onset of effect, high tolerability and long action. Conversely, medications with a rapid onset of effect may be of greater benefit to patients who experience rapid onset of migraine pain.


Eligibility Criteria:
Inclusion Criteria:

* Subject is outpatient.
* Subject has a diagnosis of migraine with/without aura according to IHS criteria, of at least 1 years duration.
* Subject is able to comprehend the study procedures and to comply with study requirements.

Exclusion Criteria:

* Subject has other chronic pain condition(s) not associated with migraine
* Subject is unable to understand the schedule/questionnaire.
Developing Interview Questions to Estimate Workplace Exposure to Electric and Magnetic Fields

RATIONALE: Electric and magnetic fields may increase the risk of cancer. Developing interview questions that accurately estimate a person's exposure to electric and magnetic fields may help doctors learn about the long-term effects of workplace exposure.

PURPOSE: This clinical trial is developing interview questions that can be used in estimating workplace exposure to electric and magnetic fields.

OBJECTIVES:

* Validate an interview-based electric and magnetic field exposure (EMF) assessment algorithm against measurements of the time-weighted average magnetic field magnitude used in previous epidemiologic studies.
* Calibrate the parameters in the algorithm in order to improve the exposure estimates.
* Correlate EMF exposure estimates from the algorithm with biologically based metrics measured by new instrumentation.

OUTLINE: Participants respond to questions during a 5- to 15-minute telephone interview concerning workplace exposure to electric and magnetic (EMF) fields. Data is collected during the interview using an exposure assessment algorithm designed to estimate EMF workplace exposure based on participants' responses. The interview-based estimates are then validated against actual field measurements of magnetic field exposure captured by Emdex multiwave monitors located at participating sites.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following occupation criteria:

  * Three occupations that primarily work in offices at Lawrence Livermore National Laboratories (LLNL)
  * Three occupations that do nonelectric manual work (e.g., machinists and laborers) at LLNL

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in myeloid tumors undergoing allo-HSCT are evaluated.

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. BUCY conditioning regimen is the standard myeloablative regimen for myeloid tumors undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in myeloid tumors undergoing allo-HSCT are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Myeloid tumors undergoing allo-HSCT
* 14-65 years

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
ISP-TACE Versus TACE for HCC With PVTT

For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This study aimed to investigate whether TACE in combination with irradiation stent placement (ISP) could prolong the survival in patients with HCC and PVTT.


Eligibility Criteria:
Inclusion Criteria:

* (1) newly diagnosed HCC with type II or III PVTT, (2) Child-Pugh classification grade A or B, (3) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.

Exclusion Criteria:

* (1) type I or IV PVTT, (2) received sorafenib, systemic chemotherapy, or external radiotherapy during the treatment, (3) suffered from malignancy other than HCC, (4) with an incomplete data.
Chemsex Engagement and HIV Biomedical Prevention in MSM

HIV biomedical prevention through treatment-as-prevention (TasP) and pre-exposure prophylaxis (PrEP) is highly efficacious for reducing HIV transmission risk. The benefits could be undermined by the rising HIV transmission risks in men who have sex with men (MSM) who engaged in chemsex. This project aims to assess the impacts of chemsex on the growth of the HIV epidemic by exploring the complex relationships between chemsex engagement and usage of HIV biomedical prevention in MSM in Hong Kong. Participants would be recruited from the community and clinics in 2 cross-sectional studies (500 HIV-negative and 500 HIV-positive MSM), for HIV self-testing and completing an electronic questionnaire. The association of chemsex would be examined between PrEP-naïve and PrEP experienced HIV-negative MSM, and between good and poor adherence to antiretroviral therapy (ART) among HIV-positive subjects in case-control analyses using logistic regression and multilevel models. The main outcomes include coverage of biomedical prevention in MSM, and their drug use patterns.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 or above
* male
* have had sex with men since 2019
* could be communicated in English or Chinese

Exclusion Criteria:

* failed to provide consent
Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses

An open-label study to evaluate the effect of SpotOn balance glasses in non-demented Parkinson's patients with balance disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Female or men
2. Diagnosed with Parkinson's disease (according to Brain Bank UK criteria)
3. Non-demented
4. Age: ≥ 30 years
5. Gait disturbances
6. Patients who are able to perform questionnaires and physical tests (including computerized tests)
7. Gave informed consent for participation in the study

Exclusion Criteria:

1. Unstable (less than 1 month) use of concomitant medications that might affect the balance system
2. Change of PD medications during the past month
3. Any medical condition or disorder that could produce gait or balance disturbances unless well controlled for at least 3 months
4. Blindness
5. Currently taking part in a clinical trial or within 30 days prior to screening
6. Any known condition which in the opinion of the investigator may impair gait or balance and/or limits the successful trial completion
Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Trial of Two Strategies

Labour induction is an obstetrical procedure, which artificially starts the process of cervix dilation, in order to induce labour. Several methods of labour induction exist : mechanical ones (using dilatation balloons) or pharmacological ones (using prostaglandins or oxytocin). This trial aims to compare, in case of non-favourable cervix, the strategy of labour induction using the Propess® method first (Dino-first) versus the strategy beginning with the use of a dilatation balloon (Ballon-first), with respect of the usual practice and the current guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Women with singleton pregnancy
* Fetus with cephalic presentation
* Intact membranes between 37 and 42 weeks of amenorrhea
* Medical indication for labour induction according to the "Haute Autorité de Santé" (HAS) guidelines
* Unfavourable cervix (Bishop scoring \< 7)
* Age \> 18 years-old
* Person affiliated to a healthcare system
* Good understanding of the French language

Exclusion Criteria:

* Previous C-section or uterine incision
* Placenta previa
* Metrorrhagia of unknown origin
* Lethal foetal abnormality
* Hyperreactivity to one of the molecules used for the induction (dinoprostone or oxytocin) or to latex
* Subject participants to another biomedical research
* Subject under legal guardianship or curatorship
Cholestanol in Humans

The treatment of cerebrotendinous xanthomatosis an in born error of bile acid synthesis with chenodeoxycholic acid. Patients with this disease over produce cholestanol and bile acid precursors because of the block in synthesis. Replacement with chenodeoxycholic acid shut down abnormal pathway and reduces elevated level of cholestanol and improves the clinical syndrome.

Cerebrotendinous xanthomatosis is a recessively inherited in born of bile acid synthesis due to a mutation in sterol 27-hydroxylase (CYP27A1). Patients with this disease suffer from xanthomas located in the brain and tendon, accelerated atherosclerosis progression neurologic disease and cataracts. Plasma cholesterol levels are normal but cholestanol and C-27 bile alcohol that precursor of bile acid synthesis accumulate and are believe are responsible for the atherosclerosis, xanthomas and neurologic disease. Analysis of the bile reveal a severe sufficiency of the primary bile acid chenodeoxycholic acid that can not be produce because of the inherited defect. However, replacement of chenodeoxycholic acid in the enterohepatic pool inhibit abnormal bile acid synthesis and reduces the elevated level of cholestanol and C-27 bile alcohol this therapy halt the neurologic disease and prevents symptomatic atherosclerosis developing.

Eligibility Criteria:
Inclusion Criteria:

Patients with clinical and biochemical findings of cerebrotendinous xanthomatosis. Elevated levels of serum cholestanol and bile acid precursors.

Exclusion Criteria:
Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

Antipsychotic drugs are characterized by blocking dopaminergic D2 receptors. They have been found to be effective and safe for the treatment of schizophrenia, bipolar disorders, depressive episodes associated with bipolar disorder, or psychotic symptoms in the context of Parkinson's disease. Atypical antipsychotics have lower blocking potency on D2 receptors, at the time that interact with serotoninergic, adrenergic and histaminergic receptors, among others. Quetiapine extended-release has the same clinical efficacy as the immediate-release formulation, but reduces the amount of daily doses, possibly contributing to increased treatment adherence.

The purpose of this registry is to explore adherence to treatment, the occurrence of adverse drug reactions and the clinical outcomes in a sample of patients under treatment with atypical antipsychotics in several Central American countries. For this study, clinical data will be extracted from the medical records of 1000 patients with schizophrenia, depressive disorders or Parkinson's Disease with hallucinations. Occurrence of adverse drug reactions, namely weight gain, somnolence, extrapyramidal reactions and symptoms of orthostatic hypotension; adherence to treatment; and changes in quality of life and clinical status will be assessed during the first 8 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years-old
* have a diagnosis of schizophrenia, major depressive disorder, bipolar depressive disorder, parkinson's disease with hallucination
* such patients should receive antipsychotics as their usual treatment
* they should give informed consent before participating

Exclusion Criteria:

* no treatment with atypical antypsichotics
* other diseases