cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Nicardipine for the Control of Blood Pressure After SAH

The purpose of this research is to explore ways to improve and simplify control of blood pressure in patients with SAH or ICH. This research will be done by comparing tow different medications that are routinely used to help control blood pressure. None of the medications used in this study nor any procedures performed are experimental.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old (inclusive)
* Admission to NSICU with a diagnosis of SAH or ICH

Exclusion Criteria:

* Patients who are admitted \>48 hours after SAH or ICH
* Readmission or second SAH
* Readmission or second ICH
* Large (immediately life threatening) associated intraparenchymal or intraventricular hemorrhage
* Women who are pregnant
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings

The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.

The trial was terminated prematurely on 28 March 2013, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns and agreement to close the study in March 2013 was agreed with EMA prior to closure activity.

Eligibility Criteria:
Inclusion Criteria:

* Male patients greater than or equal to 12 years of age with severe hemophilia A (FVIII:C less than 1%).
* Treatment history of greater than 150 EDs to prior recombinant or plasma-derived FVIII replacement products.
* Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products.
* Serum albumin greater than or equal to the lower limit of normal (LLN).
* Platelet count greater than or equal to 100,000/µL.
* Prothrombin time (PT) less than or equal to1.25 × ULN, or international normalized ratio (INR) less than or equal to 1.5.
* HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load less than 200 particles/µL.

Exclusion Criteria:

* Presence of any bleeding disorder in addition to hemophilia A.
* A positive FVIII inhibitor, according to the local laboratory, at screening; or any Bethesda Inhibitor Titer greater than 0.6, regardless of the normal range for the testing laboratory.
* Treated with immunomodulatory therapy (including Immune Tolerance Induction \[ITI\]) during the screening period.
* Prior exposure to moroctocog alfa (AF-CC).
* Known hypersensitivity to hamster protein.
Effects of Diacetylmorphine (DAM) on Brain Function and Stress Response

The aims of the study are to investigate the effects of diacetylmorphin (heroin) on brain using functional magnetic resonance imaging (fMRI), coupled with measurements of cortisol concentrations and neurophysiological stress parameters during the presentation of emotional and cognitive stimuli in patients with heroin dependence.

Background: Heroin dependence (HD) is a chronic relapsing brain disorder that is defined by a compulsion to seek and use heroin, and a loss of control in limiting intake.

The prescription of diacetylmorphine (heroin) itself for maintenance has become an established treatment in several European countries. However, the neurobiological effects of diacetylmorphine (DAM) on brain function and stress response have not been studied so far. Imaging the acute effects of DAM administration during stress stimuli would elucidate the neurocircuitry and neurobiology of substance use in patients with HD.

Working hypothesis: The investigators expect that DAM attenuates the engagement of brain regions involved in response inhibition (prefrontal and anterior cingulate cortex), emotional processing (amygdala) and working memory (frontal and mediotemporal cortex). Additionally, we hypothesize that DAM reduces stress response (cortisol, heart rate, skin conductance) to emotional and cognitive stimuli.

Methods: Thirty heroin-dependent patients on stable heroin maintenance will be examined in a randomized placebo-controlled crossover design. They will be compared with 30 heroin-dependent age- and gender-matched but otherwise healthy volunteers receiving saline. The heroin-dependent patients will administer either their individual dose of prescribed DAM dose or saline through an indwelling intravenous line. Afterwards they will complete four experimental paradigms testing response inhibition, emotional processing and working memory while brain responses are measured with fMRI. Before and after the fMRI investigation cortisol samples, DAM blood levels, neurophysiological and psychological stress parameters, such as skin conductance, heart rate, anxiety, anger, and heroin craving will be measured.

Expected value of the proposed project: DAM effects on brain function and stress will advance our understanding of the mechanisms underlying HD. It is the first neuroimaging study investigating the neural basis of HD after intravenous DAM administration in humans.

Determining the neurofunctional and neurophysiological basis of heroin dependence may facilitate clinical diagnosis and improve clinical interventions such as prevention and treatment.

Eligibility Criteria:
Inclusion Criteria:

* opioid dependence

Exclusion Criteria:

* other psychiatric disorders
Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty

This study aims to evaluate the short and long-term effects of skin-only and skin+muscle excision blepharoplasty on corneal nerves, dry eye parameters, meibomian glands, and eyebrow position.

The study was designed with the approval of the Ethics Committee on Human Research of Marmara University and was conducted following the tenets of the Declaration of Helsinki. Written informed consent was obtained from all patients who received information about the procedure and the postoperative course. The study included 48 eyes of 24 patients older than 18 who applied to Marmara University Oculoplastic and Orbital Surgery Unit due to dermatochalasis and were suggested upper eyelid blepharoplasty for medical or cosmetic purposes. The patients were divided into two groups, Group S (n=12) for skin excision only and Group M (n=12) for skin+muscle excision by the decision of the surgeon. In addition to all ophthalmological examinations, sub-basal nerve plexus parameters with corneal confocal microscopy, Schirmer I test, non-invasive tear break-up time, meibomian gland area loss measurements with infrared meibography, central eyebrow height, and lateral eyebrow height were evaluated at baseline and postoperative 1st week, 1st month and 1st-year follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18.
* Patients with dermatochalasis.
* Patients who were suggested upper eyelid blepharoplasty for medical or cosmetic purposes.

Exclusion Criteria:

* Patients who have had previous periorbital or ophthalmic surgery
* Patients with extensive blepharitis
* History of contact lens use
* History of ophthalmic, endocrinological, neurological, or rheumatological diseases
* History of facial paralysis
* Negative Bell's phenomenon
* Schirmer test \<5mm
* The patients who had been treated with periocular botulinum toxin in the last 1 year were not included the study.
Reaching and Treating Lesbian, Gay, Bisexual, and Transgender (LGBT) Cigarette Smokers

Smoking rates are significantly higher among lesbian, gay, bisexual, and transgender (LGBT) populations compared to the general population. LGBT individuals may be at increased risk for experiencing psychosocial issues, e.g., negative moods, stress, alcohol/drug use, that have been associated with smoking treatment failure in other groups of smokers. Technology, such as the Internet and telephone, can be an effective method to reach a large number of smokers and may be particularly effective in reaching hidden populations. Thus, the study seeks to examine whether Internet-based counseling and/or telephone counseling can improve quit rates for LGBT smokers.

Participants (N=600) will be randomly assigned to one of four conditions: 1) a Mail-based Self Help (MSH) treatment; 2) MSH plus an Internet-based Smoking Treatment (IST); MSH plus Telephone Counseling (TC) or 4) MSH plus IST plus TC. Participants in the MSH condition will receive a self-help smoking cessation manual. In the IST condition, participants will receive the manual plus access to an Internet-based intervention that includes social support. In the TC condition, participants will receive the manual plus 6 telephone-based counseling sessions. In the fourth condition, participants will receive the manual plus access to an Internet-based intervention plus telephone counseling. Before starting treatment, participants will complete questionnaires on smoking, nicotine dependence, demographics, negative mood, and alcohol use. Participants will be contacted at 3, 6, and 12 months after enrollment to determine whether they are smoking. The data will be analyzed to compare the efficacy of the four treatments and to examine the possible influence of existing social networks and level of negative mood on treatment outcome and to examine the possible influence of residency (rural versus urban) on use of the Internet-based treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* identify as lesbian, gay, bisexual, or transgender
* access to the internet
* valid email account
* valid telephone number
* English speaking
* resident of the U.S.

Exclusion Criteria:

-
Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation

The purpose of this study is to compare the efficacy of two controlled ovarian stimulation protocols, the GnRH agonist protocol, widely known as the "long" protocol, and the flexible GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile patients receiving IVF treatment.

The formulation of controlled ovarian stimulation protocols is one of the primary reasons for the successful development of IVF. The "long" GnRH agonist protocol, also known as the gold standard, has been widely used with considerable success. More recently, on the other hand, GnRH antagonist provide a new promising approach for endogenous gonadotrophin suppression by blocking the GnRH receptor. There is conflicting data in the literature regarding the relative merits of the two ovarian stimulation protocols.

COMPARISON: Pregnancy rates and embryological data will by assessed in IVF patients treated with either the "long" GnRH agonist (Arvekap) or the flexible GnRH antagonist (Ganirelix) protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-39 years
* Body mass index 18-29 kg/m2
* Menstrual cycle from 24-35 days
* Normal basal FSH (\<10 IU/ml)
* Normal basal LH (\<10 IU/ml)
* Normal basal estradiol (\<80 pg/ml)

Exclusion Criteria:

* Poor responder patients
* Polycystic ovaries
Concussion in French Amateur Rugby : Survey About the Management and Knowledge of Players

Rugby is a popular contact sport in France the majority of whom are amateur players. Concussion is one of the main risks given its potential severity and frequency (between 2.78 and 10 per 1,000 player hours). Faced with a concussion, stop sport activity, medical evaluation and a progressive resumption of activity are simple things to do to avoid an over-risk of injury and better recovery of the player. For this purpose, the rugby federation implement the blue card and the concussion declaration by clubs. A recent study showed that the directives of the federation are not sufficiently respected. The non-declaration problem is added knowing that around 50% of concussions are not declared. In professional rugby, the presence of a medical staff makes possible to optimize care as much as possible. In the amateur world, there are not always medical or paramedical personnel trained for this problem at the edge of the field when all the participants (player, coach, coaching) lack of knowledge on the subject and that the general practicer remains the referent for the concussion management. We will reach a dozen amateur rugby club to complete a questionnaire about concussions and conduct un formation session about this issue.


Eligibility Criteria:
Inclusion Criteria:

* Male 18 years of age or older
* Amateur rugby players in a club of New Aquitaine region who agreed to participate
* Licensed with the federation for 2019/2020 or 2020/2021 season
* Between the federal 1 and the 4th series

Exclusion Criteria:

- Refusal to complete the questionnaire
Choroidal Thickness in Beta-thalassemia Patients

The purpose of this study is to examine choroidal thickness in beta-thalassemia patients and compare it to the one of healthy controls.

An equal number of transfusion dependent beta-thalassemic patients and age and sex matched healthy volunteers will undergo spectral-domain optical coherence tomography utilizing the enhanced depth imaging application to visualize and measure the choroid.

Beta thalassemia is an inherited hemoglobinopathy, associated with defective production of beta-chain globin resulting in problematic HbA production. It is classified according to the severity as minor, intermedia and major. Patients suffering from beta-thalassemia intermedia and beta-thalassemia major require regular blood transfusions. Transfusion related hemosiderosis in these patients necessitates the use of chelating agents to prevent iron overload in vital organs such as the liver and heart.

A number of ocular abnormalities can present in beta-thalassemia patients. Those are categorized as pseudoxanthoma elasticum (PXE)-like changes that include angioid streaks, peau d'orange like fundus and optic nerve head drusen and non-PXE-like changes such as increased venous tortuosity.

Furthermore, it is well established that prolonged treatment with some of the chelating agents such as deferoxamine are associated with ocular toxicity, namely nyctalopia, colour perception anomalies, visual field disturbances, cataract formation, optic neuropathy and pigmentary retinopathy.

The pathophysiology of those ocular manifestations has not been fully clarified. The role of the choroid has not been determined since this particular tissue was previously unaccessible to imaging. Enhanced depth imaging optical coherence tomography is able to image the choroid providing reasonable clarity compared to spectral domain optical coherence tomography.

The aim of this study is to evaluate possible alterations of choroidal thickness in beta thalassemia as compared to healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Beta thalassemia patients undergoing blood transfusions

Exclusion Criteria:

* History of glaucoma, keratoconus, retinal disease, ocular trauma, ocular surgery, uveitis, amblyopia, strabismus, ocular vascular abnormalities
* Spherical refractive error greater than 4 diopters or cylindrical refractive error greater than 2 diopters
* History of other systemic disease such as uncontrolled hypertension, diabetes mellitus, or connective tissue disease.
Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain

The biopsychosocial model is well established in chronic low back pain (CLBP) research. Nevertheless, researchers to date have overlooked the biopsychosocial aspects of Inflammatory Low Back pain (ILBP). Most health care providers are biologically oriented in their treatment of ILBP, neglecting its possible multidimensional nature. It is true that people with ILBP may present with more complex pain and physical limitations than those with chronic non-specific low back pain (CNSLBP), but it remains unexplored whether or not these limitations are affected by the same pain factors that affect CNSLBP patients. This study aims to explore and compare the biopsychosocial back pain profiles of adults with ILBP and CNSLBP.

This is a multicentre case-control study that will compare back pain in patients with ankylosing spondylitis and CNSLBP. A multidimensional pain assessment will be conducted for patients in both groups. Each patient will be assessed on one occasion by the same experienced physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Adult between 18 and 65 years of age
* Low back pain \>3 months
* On stable medication
* Ability to walk independently without an assistive device
* Specific inclusion criteria for AS group: clinical diagnosis of ankylosing spondylitis by a rheumatologist
* Specific inclusion for CNSLBP group: clinical diagnosis by a physician for CLBP

Exclusion Criteria:

* Spinal surgery or compression fracture within the last 6 months
* Cauda equine and conus medullaris syndromes
* Severe musculoskeletal conditions affecting the upper and/or the lower limbs, such as severe inflammatory arthritis of the peripheral joints
* Severe osteoporosis
* Leg-length discrepancy
* Cancer
* Morbid obesity, or pregnancy
* Progressive neurological disease
* Psychiatric disease and/or cognitive limitations that could affect the ability to complete the study questionnaires
* Inability to read and/or understand the English language
* Severe cardiac, respiratory or neurological diseases
* Uncontrolled epilepsy
* Specific exclusion criteria for CNSLBP group: Spondyloarthropathy, or any structural abnormalities in the lumbar spine that result in serious neurological dysfunction, such as stage III-IV lumbar disc herniation, and grade III-IV spondylolisthesis
Linking Women to PrEP Care

Pre-exposure prophylaxis (PrEP) can be very effective at preventing HIV infection among women at high-risk for HIV but is underused in this population. Periods of incarceration represent an opportunity to identify women at risk and link them to PrEP care as they leave jail or prison. This study aims to improve linkage to community-based PrEP care to reduce HIV acquisition in a high-need, underserved community.

Incarcerated women engage in high rates of sex- and drug-related behavior that place them at risk for HIV. Pre-exposure prophylaxis (PrEP) is an efficacious means of reducing HIV acquisition. There is a general lack of knowledge regarding PrEP among women at elevated risk, and only a small percentage of at-risk women are currently engaged in PrEP care. The period of incarceration represents an opportunity to identify at-risk women, initiate PrEP during incarceration, and establish linkage to community-based PrEP care upon release from incarceration. Further, post-release is a time period that is particularly risky, and there are numerous barriers that may impede linkage to community-based care in the absence of intervention.

To date, very little research has been done to improve linkage to PrEP care among US women. The proposed study will examine the acceptability, feasibility, and preliminary efficacy of a psychoeducation and motivational interviewing intervention to promote PrEP initiation during incarceration, followed by a patient navigator intervention to facilitate linkage to community-based PrEP care upon release from incarceration. The long-term goal of this line of research is to disseminate an efficacious PrEP Care linkage intervention for at-risk women post-release from incarceration. The present proposal seeks to develop intervention materials and conduct a small randomized controlled trial (RCT) of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female at birth; at least 18 years of age; not currently pregnant; risk behavior prior to incarceration that meets CDC indications for PrEP; likely to be incarcerated for less than 6 months; able to understand and speak English and to provide written and verbal informed consent
Stent-related Symptoms Comparison: Polaris Loop vs Vortek Double-J Stents

Prospective randomized controlled single-blind parallel-group trial in order to compare symptoms related to loop-tail (Polaris Loop) stents versus conventional double J (Vortek) stents after uncomplicated flexible URS.

Patients undergoing RIRS for a single renal stone \< 2 cm are asked to participate in a prospective randomized controlled single-blind parallel-group study. Ureteral stent is always placed after flexible URS. Patients are prospectively randomized into two groups with a 1:1 allocation: group LT receive loop-tail stents (Polaris ™ Loop - Boston Scientific, Natick, USA), while group DJ receive conventional double J stents (Vortek ® - Coloplast, Humlebaek, DK). Stent removal is planned 4 weeks after the procedure.

Participants are asked to fill in the Italian validated version of the Ureteral Stent Symptoms Questionnaire (USSQ) 2 days and 4 weeks after surgery. The USSQ is further submitted 4 weeks after stent removal (8 weeks after surgery) and these results are used as baseline evaluation, on the assumption that SRS persist for a few days after removal.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones \< 2 cm
* given informed consent
* WHO PS 0-2

Exclusion Criteria:

* significant residual fragments at the end of the procedure
* intraoperative complications (i.e. ureteral damage or ureteral stricture)
* urinary tract infections
* anatomic abnormalities
* chronic diseases or medications potentially influencing pain perception and urinary symptoms (i.e. alpha blockers and antimuscarinics)
* preoperative ureteral stenting.
Factors That Affect Trust Between Physicians and Patients

The goal of this study is to evaluate patient perception and preference in physician attire. Eligible subjects admitted to medical-surgical hospital unit will complete a survey expressing perceptions and preference regarding physician attire.

Hospitalists (internal medicine physicians) work in one week rotations. Each hospitalist will serve as a control.

During one week rotation, the hospitalist will wear surgical scrubs throughout the rotation. At the end of the rotation (or prior to subject discharge, whichever occurs first), the hospitalist will ask subjects seen during that rotation to complete the survey regarding the hospitalist attire.

During a second week of rotation, the hospitalist will wear professional attire with a white coat throughout that rotation. At the end of the rotation (or prior to subject discharge, whichever occurs first), the hospitalist will ask subjects seen during that rotation to complete the survey regarding the hospitalist attire.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of ages or older
* Admitted to LLUMC medical surgical unit, under care of internal medicine physician
* Primary language is English or Spanish

Exclusion Criteria:

* Less than 18 years of age
* altered mental status or severe dementia
* Hearing or vision impairment that would preclude subject from completing survey
Effect of Previous Diet

Meal ingestion induces digestive responses associated to homeostatic and hedonic sensations. The responses to meal ingestion are modulated by conditioning factors. Single-centre, cross-over, random, open label study comparing the effect of a high-fat/low-residue diet versus low-fat/high residue diet on the responses to meal ingestion. In 20 healthy subjects each diet will be administered during 2 weeks in random order; each diet will be preceded by 2 weeks washout, balanced diet. The aim of the study is to compare the effects of each diet on the responses to comfort and flatulogenic meals, intestinal gas production and digestive sensations.


Eligibility Criteria:
Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders