cyrilzakka/clinical-trials huggingface dataset:
Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure

The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.


Eligibility Criteria:
Key Inclusion Criteria:

* Body weight of ≤ 160 kg.
* Subjects with compensated CHF (NYHA Class II - III) at time of screening with a prior documented history of chronic heart failure.
* NT-proBNP \>300 pg/ml (according to central measurement) at visit 1.
* Subjects treated with appropriate and guideline-indicated CHF standard of care.
* Ability to comply with all requirements, including ability to receive at least a 48 hour infusion plus follow-up time required for each dosing visit.

Key Exclusion Criteria:

* Current acute decompensated HF
* Any major solid organ transplant recipient or planned anticipated organ transplant within 1 year.
* Documented history of untreated ventricular arrhythmia with syncopal episodes, ventricular tachycardia, or ventricular fibrillation without ICD (implantable cardioverter defibrillator) with significant hemodynamic consequences within the 3 months prior to screening.
* Presence of hemodynamically significant mitral and /or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation: including significant left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy, severe aortic stenosis)
* Subjects with severe renal impairment defined as pre-randomization eGFR \< 30 ml/min/1.73m2 calculated using the sMDRD equation and/or those receiving current or planned dialysis or ultrafiltration
Enhancement of Physical and Combat Preparedness of SAF Members - Validation Study

The aim of the proposed project is to investigate the reliability, validity, and usefulness of the 30-15 intermittent fitness test in the Slovenian Armed Forces. We will compare the results obtained from a continuous treadmill running test, 2-mile run test, and 30-15IFT.

Since the ability to perform military tasks depends on the physical fitness of soldiers (PF), one of the most commonly measured PF components during routine physical examinations is cardiorespiratory fitness (CRF). There are several tests used to measure CRF in the armed forces. Because of its simplicity, the most commonly used test of CRF is the 2-mile run test, but it has its own limitations when it comes to specificity of battlefield requirements, training prescription and optimization, and estimation of Vo2max. In combat situations, soldiers rarely run long distances on the battlefield. Therefore, the 2-mile run test does not appear to represent any specificity of combat. Furthermore, based on the data collected from this test, it is difficult to prescribe and optimize a training program for an individual subject. Therefore, the goal of the proposed project is to investigate the reliability, validity, and usefulness of the 30-15 intermittent fitness test in the Slovenian Armed Forces.

Eligibility Criteria:
Inclusion Criteria:

Members of Slovenian Armed Forces with no acute and/or chronic neuromuscular and skeletal injuries and/or any other chronic disease or conditions.

Exclusion Criteria:

older than 45 years of age acute and/or chronic neuromuscular and skeletal injuries the existence of any chronic disease or condition
IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants

P1106 is Phase IV prospective pharmacokinetic (PK) study of low birth weight infants who are receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis, tuberculosis (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment containing lopinavir/ritonavir (LPV/r). The study is designed to describe the pharmacokinetics and safety of NVP, INH, RIF, and LPV/r in these infants receiving the drug(s) as part of clinical care.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for Arms 1 and 3 (HIV-exposed infants):

* Breastfeeding infants born to HIV-infected mothers who are receiving either no ARV therapy or ARV therapy that does not include NVP
* Age 7 to 14 days
* Birth weight less than 2500 grams
* Receiving or will be receiving prophylaxis as prescribed by clinical care provider as follows: NVP (Arm 1), NVP plus INH (Arm 2), NVP plus INH plus RIF (Arm 3)
* Parent or legal guardian able and willing to provide written informed consent. \[Note to sites: modify per locally relevant language\].

Inclusion Criteria for Arm 2 (HIV-exposed infants):

* Breastfeeding infants born to HIV-infected mothers who are receiving either no ARV therapy or ARV therapy that does not include NVP
* Age 7 to 84 days
* Birth weight less than or equal to 4000 grams
* Receiving or will be receiving prophylaxis as prescribed by clinical care provider as follows: NVP (Arm 1), NVP plus INH (Arm 2), NVP plus INH plus RIF (Arm 3)
* Parent or legal guardian able and willing to provide written informed consent. \[Note to sites: modify per locally relevant language\].

Inclusion Criteria for Arm 4 (HIV-unexposed but TB exposed infants):

* Age 7 to 84 days
* Birth weight less than or equal to 4000 grams
* Receiving prophylaxis with INH alone or INH plus RIF as prescribed by clinical care provider
* Not receiving any therapy for HIV prophylaxis or treatment
* Parent or legal guardian able and willing to provide written informed consent. \[Note to sites: modify per locally relevant language\].

Inclusion Criteria for Arms 5 and 6 (HIV-infected infants):

* Documentation of HIV-1 infection defined as positive HIV DNA PCR done as part of clinical care. An HIV RNA confirmatory test must be done at study entry but results may be pending at time of enrollment.
* Birth weight less than or equal to 4000 grams
* Age less than or equal to 12 weeks (defined as 84 days)
* Intention by clinical care provider to prescribe LPV/r plus 2 NRTIs and no RIF (Arm 5) or LPV/r plus 2 NRTIs plus RIF (Arm 6)
* Parent or legally acceptable representative able and willing to provide written informed consent. \[Note to sites: modify per locally relevant language\].

Exclusion Criteria:

Any severe congenital malformation or other medical condition incompatible with life or that would interfere with study participation or interpretation, as judged by the examining clinician.
Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Eligible subjects were randomized 1:1 to sorafenib 800 mg daily or matching placebo. Progression was assessed every 8 weeks by modified RECIST criteria. Subjects had the option to unblind study treatment after progression and to receive open label sorafenib regardless of initial treatment assignment. Following discontinuation of study treatment, subjects were followed for survival every 3 months in long-term follow-up. Subjects who terminated study treatment (either double only or double blind and open label) for reasons other than death, lost to follow-up or consent withdrawn entered long-term follow up

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell)
* Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are eligible provided that the histology has no medullary differentiation nor anaplastic features
* Progression within 14 months (RECIST \[Response Evaluation Criteria in Solid Tumors\] should be used as a basis for the assessment of disease progression)
* RAI (radioactive iodine) refractory

Exclusion Criteria:

* Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma)
* Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF (vascular endothelial growth factor) or VEGF Receptors or other targeted agents
* Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose chemotherapy for radiosensitization is allowed) or Thalidomide or any of its derivatives
A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histopathological diagnosis of cSCC.
* Previously untreated or recurrent locally advanced (without nodal metastases) or metastatic (distant or regional metastasis) cSCC not amenable to curative surgery and/or radiotherapy.
* Measurable disease based on either radiographic imaging per RECIST 1.1 or WHO criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Life expectancy \> 3 months.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Known history of an additional malignancy.
* Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
* Toxicity from prior therapy that has not recovered.
* Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
* Received thoracic radiation within 6 months of the first dose of study treatment.
* Participation in another interventional clinical study while receiving INCB099280.
* Impaired cardiac function or clinically significant cardiac disease.
* History or evidence of interstitial lung disease including noninfectious pneumonitis.
* Presence of gastrointestinal conditions that may affect drug absorption.
* Any autoimmune disease requiring systemic treatment in the past 5 years.
* Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent.
* Active infection requiring systemic therapy.
* History of organ transplantation, including allogeneic stem cell transplantation.
* Receipt of systemic antibiotics within 28 days of first dose of study treatment.
* Probiotic usage is prohibited during screening and throughout the study treatment period.
* Received a live vaccine within 28 days of the planned start of study drug.
* Laboratory values outside the Protocol-defined ranges.
* Inadequate organ function.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)

Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.


Eligibility Criteria:
Inclusion Criteria:

* 18 yrs old or older
* moderate to severe pruritus
* end stage renal disease
* 3x weekly hemodialysis

Exclusion Criteria:

* pruritus not due to renal disease
* abnormal liver function
* Ca-P \> 80 mg/dl or HgB \<8.5 g/dl or PTH \> pg/mL
* Within four months spKt/V \< 1.05
COVID-19 and Working Conditions of Dentists

The aim of this study is to evaluate the protective measures and awareness of dentists working in Turkey regarding the COVID-19 pandemic.

Within the scope of the study, patient care protocols in public and private health institutions during and after the pandemic, published on the website of the Turkish Dental Association (http://www.tdb.org.tr/) A survey consisting of 35 open-ended and multiple-choice questions was prepared based on the updated directive titled.

The questions directed to dentists in the prepared questionnaire are distributed as follows:

* Demographic information (6 questions),
* Physical conditions of the unit to be served (5 questions),
* Applications for employees (2 questions),
* Applications for appointment and patient admission (4 questions),
* Study procedure and treatment protocols (10 questions),
* Attitudes towards COVID-19 (8 questions) Existing questionnaire questions were examined by 5 dentists for clarity and finalized.

A pilot study was conducted on a group of 20 dentists before the prepared questionnaire started to work. The reliability of the questionnaire was evaluated by retesting this group of 20 people 10 days later. 20 people included in the pilot study were evaluated within the scope of the study.

Survey questions were shared online. According to the data of the Turkish Dental Association, survey questions were sent to the registered dentists in the chambers.

Before the survey questions appear on the screen, individuals will be informed of the privacy policy for data collection and consent to volunteering is asked. If they answered "no" to the survey, the survey was closed automatically. A second reminder email was sent to those who did not respond to the questionnaire four days later. A reminder e-mail was sent to those who did not respond to the questionnaire, six days after the start date.

Eligibility Criteria:
Inclusion Criteria:

* Graduated from a dentistry faculty,
* Continuing or not continuing postgraduate dentistry education (master, specialty, doctorate),
* Working in a practice or outpatient clinic, private or public hospital, private polyclinic or state oral and dental health center or university hospital,
* All dentists registered in dentistry database in Turkey (37 cities)

Exclusion Criteria:

-
Effect of Acute Supplementation (taurine) on Maximal Strength and Anaerobic Power

This crossover-design study examines the acute effect of taurine on trained individuals aged 18-40 on strength and power outputs.

The purpose of this study is to further investigate any potential ergogenic effects offered by taurine, under specific conditions, namely that of acute supplementation, as opposed to the chronic supplementation protocols of many popular ergogenic aids, such as creatine and beta alanine. Exercise modes investigated include maximal isometric strength, maximal instantaneous power generation, and sustained maximal anaerobic power output, investigated via grip strength, vertical jump height, and the Wingate test, respectively.

Eligibility Criteria:
Inclusion Criteria:

* participants 18 - 40 years of age
* physically active or recreationally active with consistent training more than 3 times per week for at least 6 months
* non-smokers

Exclusion Criteria:

* cardiovascular, respiratory or metabolic diseases
* any musculoskeletal injury in the last six months
* taking taurine and/or creatine supplementation in the past three months
Prognostic Value of RXR-α in Cutaneous Squamous and Basal Cell Carcinoma

Vitamin D has a crucial role in cancer control and prevention.vitamin D receptor (VDR) and its heterodimer Retinoid X receptor (RXR) are equally important in the cell. This ligand (vitamin D) and receptors (VDR-RXR) complex together triggers downstream DNA damage response in the cell.

Retinoid receptors are a superfamily of nuclear receptors. The preferred receptor that attaches to VDR is RXR, with its subunits α, β and γ. RXR α is more frequent in the skin than other tissues, while β occurs in internal organs and γ is frequently related to neural disorders.

the investigator hopes to assess prognosis of SCC \& BCC by using RXR-α biomarker \& attempts to use it in the treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Squamous cell carcinoma and basal cell carcinoma.
2. Incisional \& excisional biopsies.
3. All the studied cases include sufficient materials for the immunohistochemical study 4. Complete clinical data

Exclusion Criteria:

1. Patients with a history of preoperative chemotherapy and/or radiotherapy.
2. Insufficient or tiny tissue biopsies.
ActiPatch Plantar Fasciitis Clinical Trial

Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals in the workplace who must stand for prolonged periods of time, and athletes. It can be disabling. There is no single accepted treatment course that is recommended in the literature.

The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a treatment option in chronic soft-tissue injury due to its ability to reduce pain and inflammation.

The proposed study will investigate the efficacy of the use of a PRFE device for the treatment of chronic heel pain using a double blind randomized placebo controlled design study.


Eligibility Criteria:
Inclusion Criteria:

* All patients with diagnosis of plantar fasciitis agreeing to participate
* Over 18 years old
* Able to wear unit and keep data up-to-date records of use
* Agree to forgo additional treatments during the study period

Exclusion Criteria:

* Patients who have refused, are unable to give or have withdrawn consent
* Patients with heel pain present less than 3 months
Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.


Eligibility Criteria:
Inclusion Criteria:

* female outpatients \> or = 18 years of age
* experience episodes of stress urinary incontinence
* must have an educational level and degree of understanding English
* are free of urinary tract infections
* can use the toilet independently

Exclusion Criteria:

* any in or outpatient surgery in the last six months
* suffer from severe constipation
* extension of any internal organs beyond vaginal opening
* currently breastfeeding
* any nervous diseases affecting normal urinary function
Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)

The goal of this study is to evaluate the efficacy and safety of suvorexant (MK-4305) for reducing the incidence of delirium in Japanese participants who are at high risk of delirium. The primary hypothesis is that suvorexant reduces the proportion of participants with delirium compared with placebo as assessed by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.


Eligibility Criteria:
Inclusion Criteria:

* Is hospitalized for (1) acute disease with severe disease state or decreased daily living function or (2) elective surgery requiring general anesthesia scheduled on the day after or 2 days after admission/Day 1
* Has (1) mild cognitive impairment or mild dementia and/or (2) a history of delirium in any prior hospitalization
* Requires hospitalization for 6 days for acute disease, with treatment starting on day of admission; or 7 days, with treatment starting the day after admission OR
* Requires hospitalization for 6 days for elective surgery scheduled on the day after admission; or for 7 days for elective surgery scheduled 2 days after admission
* Is able to take study medications orally

Exclusion Criteria:

* Has moderate or severe dementia
* Has a history of epilepsy or Parkinson's disease
* Currently uses psychotropic agents or has a mental condition including schizophrenia, other mental disorders, bipolar disorder and major depression
* Has a history of drug or alcohol abuse in the 5 years prior to start of study or has alcoholic disease such as alcoholic liver disease or gastritis alcoholic
* Has a history of narcolepsy or cataplexy
* Has used hypnotics, antipsychotics, mood stabilizers, antidepressants, anxiolytics, psychostimulants, anticonvulsants or tiapride within 2 weeks prior to randomization
* Has delirium as assessed by DSM-5 or DRS-R-98 (total score ≥14.5) before the first dose of study medication
Patients' Perspectives on Identity, Ancestry and Genetics

This study will collect the opinions, understandings and personal health care experiences of multiracial persons of African and European ancestry. Understanding multiracial patients' beliefs and experiences about their race, ethnicity, ancestral origin and the genetic components of diseases can provide important data for developing ways to communicate how human genetic variation is related to self-identified race and ethnicity. The study will:

* Investigate multiracial individuals' beliefs about biological and genetic differences based on race and ethnicity;
* Collect stories of identity, ancestry and clinical experiences of multiracial individuals with one parent of African ancestry and one parent of European ancestry;
* Investigate multiracial patients' experiences regarding family health history and communication of genetic risk of disease.

Persons 21 years of age or older in the Atlanta, Georgia, or Washington, D.C., metropolitan areas who are from a multiracial background and have used health care services in the last 2 years may be eligible for this study. Participants are interviewed one-on-one for about 2 hours to gather information about their background, family ancestry, self-identity, race and ethnicity, health care interactions and genetics and health. Each participant completes a short questionnaire before and after the interview.

...

The complex relationships between self-identified race, ethnicity, ancestral origin and the genetic components of diseases demands a better understanding of patients' conceptions of these identifiers and how they impact their health. The lived experiences of multiracial individuals can provide valuable perspectives on questions of race and ethnicity, the collection of ancestral information in assessing health history and communication of racial or ethnic specific disease risk. Understanding patients' beliefs and experiences will provide important data for developing ways to communicate how human genetic variation is related to self identified race and ethnicity. We aim to conduct semi-structured in-depth interviews with adults at least 21 years of age who identify as having a multiracial background with African and European ancestry. The study will include participants from the Atlanta, Georgia and Washington, D.C. metropolitan areas. This preliminary study uses qualitative methods to capture the personal stories of identity, ancestry and clinical experiences from a population that has not been adequately researched.

Eligibility Criteria:
* EXCLUSION CRITERIA:

Individuals will be excluded from the study if they do not have at least one parent that self-identifies as Black or has African ancestry and another parent that self identifies as White or has European ancestry. Other exclusion criteria include: (1) under 21 years of age, (2) not had at least two clinical visits with a health care professional in the last year and (3) not more than one individual per family.