cyrilzakka/clinical-trials huggingface dataset:
Midazolam Drug-Drug Interaction Study With Lurasidone HCl

A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.

lurasidone 120 mg, midazolam 5 mg

To compare the single-dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered with a single-dose of lurasidone 120 mg.

To compare the single dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered after steady state dosing with lurasidone 120 mg.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders
2. Females who participate in this study:

   are unable to have children -OR- are willing to remain abstinent from Day -5 to 90 days after discharge; -OR- are willing to use an effective method of double-barrier birth control from Day -5 to 90 days after discharge.
3. Males must be willing to remain sexually abstinent or use an effective method of birth control from Day -5 to 90 days after discharge.
4. Able and agree to remain off of prior antipsychotic medication for the duration of the study.

Exclusion Criteria:

1. Known presence or history of renal or hepatic insufficiency.
2. A history or presence of abnormal electrocardiogram (ECG5. Known history or presence of clinically significant intolerance to antipsychotic medications.
3. Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing).
4. Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
5. Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
6. Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day -5 to follow-up including but not limited to those listed in Appendix 19.5.
7. Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.
8. Difficulty fasting or consuming the FDA high fat meals.
9. At risk with midazolam dosing with respiratory disease or impaired gag reflex, in the opinion of the investigator.
The Effect of Sensory-enhanced Beverages on Satiety Following Repeated Exposures

The study will be a 3-way crossover design: it will assess the impact of consuming a beverage enhanced with satiety-relevant properties on subjective ratings of appetite and on energy intake compared with a low energy version with the same sensory characteristics, and a non-sensory enhanced high energy control.

In addition, saliva samples will be collected at regular intervals for the identification of novel biomarkers of energy intake.

The study will be a 3-way crossover design: it will assess the impact of a high-energy, sensory-enhanced beverage on energy intake through ad libitum food consumption and subjective feeling of appetite using visual analogue scales (VAS) compared to 2 control beverages following repeated exposures. Each participant will consume each beverage 10 times. This includes 2 satiety-testing sessions on site at Leatherhead Food Research, and 8 occasions consuming the product as a mid-morning snack during the participants' normal routine. Each participant will attend the Nutrition Unit on 6 different occasions (plus one screening visit) before and after repeated exposures to the beverages at home. The order in which participants receive the beverages will be counterbalanced and randomised. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations. Participants will fast overnight before each visit and consume the same evening meal before each test day. Participants will be instructed to avoid consuming food or calorific beverages for one hour before or after consuming the beverage. Following the last satiety testing day participants will be debriefed and open questions will be asked about experiences of the beverages in a focus group format.

Eligibility Criteria:
Inclusion Criteria:

* Gender: male or female
* Age at start of the study ≥ 18 and ≤ 65 years
* Body Mass Index (BMI) ≥ 18 and ≤ 29.9 kg/m2
* Apparently healthy: measured by questionnaire (APPENDIX 3): no reported current or previous metabolic diseases or chronic gastrointestinal disorders
* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eating 3 meals a day
* Reported intense sporting activities ≤ 10h/w
* Reported alcohol consumption ≤14 units/w
* Informed consent signed
* Recruitment form filled out

Exclusion Criteria:

* Smoking
* Dislike, allergy or intolerance to test products or study meals
* Possible eating disorder (measured by SCOFF questionnaire score \>1)
* Reported medical treatment that may affect eating habits/satiety
* Eating habits questionnaire score \>14
* Reported participation in another biomedical trial 1 month before the start of the study
* Food allergies or intolerance to ad libitum meals
* Pregnant and/or breast feeding
Prevalence and Epidemiology of Nosocomial Candidaemia and Antifungal Susceptibility Patterns in an Italian Tertiary-Care Hospital

During the past two decades, the frequency of invasive fungal infections has increased dramatically in hospitalised patients throughout the world, and Candida has now emerged as one of the leading causes of bloodstream infections (BSIs). Risk-factors for invasive candidiasis include improvements in intensive care strategies (i.e., central venous catheters, mechanical ventilation, hyper-alimentation), prolonged stays in intensive care units (ICUs), the development of more aggressive surgical techniques, and the prolongation of survival of critically-ill patients. Two other important factors, observed mainly in cancer patients, are colonization of mucous membranes by yeasts, and neutropenia, resulting from increased use of antibiotics and anti-neoplastic agents, respectively. The crude mortality rate of candidaemia is high (38-75%), and the attributable mortality has been estimated at 25-38%. During the past 15 years, the prevalence of infections caused by non-albicans Candida spp. has increased exponentially, so that these organisms now account for \> 50% of episodes of fungaemia in various surveys. The increase in invasive fungal infections, the associated high mortality rate, and the emergence of antifungal resistance, have all driven the search for more potent antifungal drugs. The aims of the present study are to investigate the prevalence and the epidemiology of candidaemia and to determine the antifungal susceptibility patterns of Candida spp. isolates from a tertiary-care hospital in Italy.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with a nosocomial candidaemia at the University Hospital of Modena, Italy, between January 1998 and March 2008
Concordance AUTOFEVG

Clinical ultrasound has become essential in emergency medicine. The guidelines are to use of echocardiography in specific contexts: dyspnea, hypotension or chest pain. The evaluation of left ventricle ejection fraction (LVEF) is one of the basic objectives of echocardiography. The reference assessment in emergency medicine is visual assessment. It suffers from poor inter-observer reproducibility. Pocket ultrasound scanners seem to meet the constraints of point-of-care ultrasound. A new tool is available on a pocket ultrasound device: the automatic evaluation of LVEF. Its interest could be to have a better inter-observer reproducibility than visual evaluation.


Eligibility Criteria:
Inclusion criteria:

* Patient over 18 years of age
* Management in the investigator centre
* Admitted for dyspnea or hypotension or chest pain

Exclusion criteria:

* Age \< 18 years
* Patient not benefiting from a social security system
* Patient deprived of liberty
* Patient under the protection of justice, under guardianship or curatorship
* Patient refusing to participate in the study
* Inability to provide the patient with informed information
Prevalence, Types and Risk Factors of Urinary Incontinence Among Women in Baghdad, Iraq.

The goal of this observational study is to observe and describe the prevalence, types, and risk factors of urinary incontinence (UI) in adult women attending primary healthcare centers in Baghdad, Iraq. The main questions it aims to answer are:

* What is the prevalence of incontinence among the targeted group?
* What are the types of incontinence and what is the frequency of each type among the targeted group?
* What is the effect of several risk factors on the occurrence and severity of urinary incontinence (including age, job, sexual activity, chronic constipation, chronic cough, parity, largest birth weight, and body mass index)? Participants will be asked to fill out a questionnaire consisting of the Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) in addition to questions about the aforementioned risk factors.


Eligibility Criteria:
Inclusion Criteria:

* women
* Attending the primary healthcare centers in Baghdad, Iraq
* older than 18 years

Exclusion Criteria:

* Patients who refuse to participate in the study.
Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)

The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).


Eligibility Criteria:
Inclusion Criteria:

* Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 months
* Men and women must agree to follow methods of contraception

Exclusion Criteria:

* Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator
* Known immunocompromised status or any disease or condition which might compromise participant safety
* Prior exposure to BMS-986263
* Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests
* Hepatic decompensation

Other protocol-defined inclusion/exclusion criteria apply
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.

Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Had at least one leiomyomata lesion that was identifiable and measurable by transvaginal ultrasound.
* Had a regular or steady menstrual cycle lasting from 24 to 36 days.

Exclusion Criteria:

* Post-menopausal
* Subject with documented endometriosis
Efficacy of Modified Ketogenic Diet (Atkins) in Management of Epilepsy

The purpose of this study is to determine whether patients with uncontrolled epilepsy can follow a low carbohydrate diet long-term and if so, how will that diet affect their seizures

In the management of drug-resistant epilepsy, many strategies have been examined. The Ketogenic Diet, high in fats and low in all other nutrients was observed to be of benefit. However, due to its complexedness and unpalatability, this diet is rarely used in the adult population. A recent small study showed seizure reduction with the Atkins Diet.

In this study, patients will be randomized into one of 2 groups- group 1 receiving limited dietary instruction for the Atkins Diet and group 2- receiving detailed dietary instruction. A seizure severity-matched control group will also take part. We will follow these patients over a period of 2 years looking at seizure frequency, weight, sustainability of the diet, effect on anti-epilepsy medication dosage, effect in cognition, quality of life and financial impact of the diet.

Patients will come to clinic to see the dietitian at specific intervals. cognitive testing will also be done at the beginning of the study and every 6 months thereafter. Patients will keep food charts, ketosis charts and seizure diaries.

Eligibility Criteria:
Inclusion Criteria:medically refractory partial epilepsy financial ability to pay for higher priced food

-

Exclusion Criteria:

* Low BMI
Application CT and MRI in Cerebral Venous Sinus Thrombosis

Cerebral venous thrombosis (CVT) is a rare disease, and with poor prognosis. Computed tomography (CT) andmagnetic resonance imaging (MRI) are the most commonly used image modalities for patients with non-specific neurologic symptoms. We are going to assess the accuracy of CT and MRI in the differential diagnosis of CVT and cerebral venous sinus thrombosis (CVST).


Eligibility Criteria:
Inclusion Criteria:

A. The patients were diagnosed with cerebral venous thrombosis or cerebral venous sinus thrombosis; B. The patients completed at least cranial CT or MRI examination upon admission;C. The patients complete at least one of the CTV, MRV or DSA examination.

Exclusion Criteria:

A. Patients with severe cardiopulmonary insufficiency;B. Patients lost to follow-up;C. Patients with incomplete access to imaging data;D. Patients with cerebral venous sinus thrombosis that was not diagnosed at discharge.
Online Spaced Education to Improve Fall Prevention by Patients With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, progressive and neurodegenerative inflammatory disease that affects young adults. In many countries it has been described as the main cause of neurological incapacity in this age group. Due to the neurological impairment, patients with multiple sclerosis have a high incidence of fall. According to studies, MS patients fall three times more than general population. In the present study, the question to be answered is: education of individuals with MS on fall prevention using the method of online spaced education provides better retention of knowledge than the traditional method? This is a clinical trial to compare two methods of education of MS patients for prevention of fall. First stage: Development and validation of materials. Step two: Pilot questions with MS patients. Step three: Intervention and evaluation of outcome.


Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis diagnosis
* Accept to be part in the study
* Have valid e-mail address

Exclusion Criteria:

- Healthcare professionals;
Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression

Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that requires to be treated promptly. Although direct decompressive surgery is the most effective treatment, surgery is only used in selected patients because most patients have a poor overall condition and short life expectancy. Radiation therapy (RT), therefore, is the most commonly used for patients with MESCC, but conventional RT alone can achieve modest neurologic outcomes.

The hypothesis to use stereotactic body radiation therapy (SBRT) for MESCC is that the rapid decompression of epidural mass, durable local control and subsequently improved neurologic outcomes compared to conventional RT are expected when MESCC is treated with SBRT.

The definition of metastatic epidural spinal cord compression (MESCC)

* MESCC is defined as both an evidence of cord compression by radiologic evaluation and a manifestation of clinical feature at the level of cord compression.
* A cord compression by radiologic evaluation is defined as \< 3mm gap between epidural mass and true spinal cord or indentation of thecal sac at the level of clinical feature by MRI.
* Clinical features include any or all of the followings: pain (local or radicular) or motor weakness or sensory change or incontinence.

Simulation -A Computed tomography (CT) scan will be acquired with the use of intravenous contrast and planning MRI will be also performed on the same day of simulation.

Spine SBRT

- One to four sessions of SBRT will be performed.

Follow-up

* Patients need to be assessed at 1 week, 1 month and 3 months after the completion of SBRT and will be followed up at 3 month intervals thereafter.
* Pain score, neurologic examination, adverse events and simple X-ray of involved spine should be evaluated at every follow-up visit.
* MRI of involved spine will be performed at 3 months after the completion of SBRT.

Up to 43 patients will be enrolled in this study in Samsung Medical Center, Seoul National University Hospital, and Gachon University Gil Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* MESCC is present.
* Localized spine metastases (C1 to L5 level); Maximum 3 separate sites and maximum 2 contiguous vertebral bodies
* Performance state before the occurrence of neurologic symptoms : Eastern Cooperative Oncology Group 0-2
* Age ≥20
* MRI within 2 weeks is mandatory
* Paraspinal mass \< 5cm in maximum dimension
* Inoperable patients - refused or medically unfit for decompression surgery
* life expectancy \> 3 months

Exclusion Criteria:

* Retropulsed bony fragment causing cord compression
* Paraplegia ≥ 48 hours
* Histology preferred to perform the chemotherapy as the first option (e.g. lymphoma, myeloma)
Intralesional Treatment of Keloids

Intralesional injection in treatment of keloid

Our study will include 45 patient diveded into three groups , follow up will done before each session , 3month after the last session using photographing assessment , scoring , dermoscope

Eligibility Criteria:
Inclusion Criteria:

Both sex aged 18-60 having keloid

-

Exclusion Criteria:

* pregnancy , lactation Skin disease
Impact of a Communication Toolkit on Antibiotic Prescribed by General Practitioners: a Randomised Trial

This study is a pragmatic, randomised, controlled, before-after interventional study conducted in one region in France in primary care. The GPs in the intervention group will receive a public commitment charter, a non prescription pad and a patient information leaflet to be used when antibiotics are prescribed, while the control group will be not aware of the intervention.

Antimicrobial resistance is a major public health threat and the overuse of antibiotics contributes to its development.

In France, outpatient antibiotic use remains above the European average. Ninety percent of antibiotics are prescribed to outpatients and 70% of these are prescribed by general practitioners.

Eligibility Criteria:
Inclusion Criteria:

* working in the Lorraine region in France
* prescribing more than 25 antibiotic items per 100 patients without a chronic illness, aged 16 to 65 years
* proportion of patients treated with critical antibiotics exceeding 27% (among patients treated with antibiotics)

Exclusion Criteria:

* practicing exclusively alternative medicine, such as homeopathy or acupuncture
* GPs reaching the retirement age in the two years following the beginning of the intervention or who were not working two years before
* GPs who had already displayed a commitment charter promoting antibiotic stewardship in their practice
Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols

The purpose of this study is to investigate the possible antioxidant and anti-inflammatory effects of yogurt enriched with polyphenols after 2-week consumption by healthy individuals.

Eighteen healthy adult volunteers of both sexes consumed yogurt (400g per day) enriched with polyphenols (10mg/100g yogurt) or yogurt (400g per day) not enriched with polyphenols for two weeks in a double-blind, crossover, randomized manner.There was a washout period of at least 10 days. Physiological data and blood samples were collected before and after consumption of each yogurt.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Non-smokers

Exclusion Criteria:

* Current use of dietary supplements or drugs
* Metabolic disease
* Lactose intolerance
* Pregnant, pregnancy intention or breast feeding
A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)

This 2 arm study will assess the impact of bone marker feedback (BMF), using serum carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams \[mg\] per oral \[po\]) in women with post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The anticipated time on study treatment is 3-12 months.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory, post-menopausal women with osteoporosis;
* eligible for bisphosphonate treatment;
* naïve to bisphosphonate therapy, or lapsed users (last bisphosphonate intake greater than or equal to \[\>=\] 6 months ago).

Exclusion Criteria:

* inability to stand or sit upright for at least 60 minutes;
* inability to swallow a tablet whole;
* hypersensitivity to bisphosphonates;
* treatment with drugs, or presence of active disease, known to influence bone metabolism;
* history of upper gastrointestinal disease.
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices

The general objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality Level 3 (or better) data on the performance, safety and clinical benefits of Teleflex's vascular access devices when used in a real-world setting

The primary objective is to provide high-quality Level 3 (or better), data as defined by Medical Device Coordination group (MDCG) 2020-6, on the performance, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting. The hypothesis is that, when used in accordance with the instructions for use (IFU), the vascular access devices will perform safely and successfully.

The Teleflex vascular access devices (index devices and accessories) in scope for this Registry vary in type from central venous access devices (CVAD) to midline catheters to peripheral catheters to hemodialysis catheters to arterial catheters navigation/tip confirmation devices. Many, but not all, of the devices also have antimicrobial and antithrombogenic properties. Also in scope are the accessories routinely used for placement and maintenance of the index devices.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will undergo a procedure that will include use of a Teleflex device covered by this Research.
* Subject is willing and capable of providing informed consent and/or give approval to collect, store and process limited health information by the Sponsor; or such consent is provided by a legally designated representative if required by local law or regulation.
* Subjects is able to read and understand English or Spanish languages

Exclusion Criteria:

* Subject is currently participating in another clinical Registry or investigation that may confound the results of this Registry.
* Subject was previously failed screening or was enrolled in this clinical Registry.
* Subject is imprisoned
* Subject is cognitively impaired and unable to provide informed consent