cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)

This is a two part study to compare the PK of preladenant administered to participants with CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the PK of participants with severe CRI to healthy participants. Part 2 will compare the PK of participants with moderate CRI and participants with mild CRI to healthy participants. The primary hypotheses are that the plasma area under the concentration-time curve from time 0 to infinity after single dosing (AUC0-∞) of preladenant in participants with either severe, moderate or mild CRI is similar to that of matched healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Has a body mass index (BMI) between 19 to 34 kg/m\^2, inclusive
* Has mild to severe CRI and not on dialysis (Participants with normal renal function are to be matched to subjects with renal impairment)
* Clinical laboratory tests, electrocardiogram, and vital signs within normal ranges
* Free of any clinically significant disease that would interfere with the study evaluations (except related to his/her renal disease and comorbid conditions)

Exclusion Criteria:

* Females who are pregnant, intend to become pregnant (within 3 months of ending the study), or are nursing/breastfeeding
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
* Had a renal transplant or are on dialysis
* Has a history of any infectious disease within 4 weeks
* Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
* Has donated blood or had a blood transfusions in the past 60 days
* Has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which could interfere with their ability to participate in the trial
* Has a history of malignancy
* Has evidence of suicidality or is at risk for self-harm or harm to others
Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia

This is a phase II randomized, double-blind, placebo-controlled study where eligible subfertile male subjects (age 20 years).


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects who are 20 years old or older
2. Subjects who are diagnosed as idiopathic oligoasthenospermia
3. Subjects who have a normal baseline hormone profile
4. Subjects who were not able to impregnate female partners in the past 12 months under an active and unprotected sexual life
5. Subject's female partner has no endocrine or genital obstructive disorders and is capable of impregnation.
6. Subjects who have an acceptable baseline liver function
7. Subjects who have a normal baseline renal function.

Exclusion Criteria:

1. Subjects who have been diagnosed as male infertility for more than 5 years.
2. Subjects who have a baseline semen white blood cell count of 1\*106/mL.
3. Subjects who have genital/seminal tract obstruction, infection, inflammation or anatomic abnormalities.
4. Subjects whose female partner has been diagnosed as infertility of any kind.
5. Male infertility that is associated with hormonal deficiency/imbalance, poor nutrition, congenital/chromosomal disorders, erectile dysfunction, or psychological disorders.
6. Subjects who plan to undergo artificial insemination of any kind within the study period.
7. Subjects who have been treated with chemotherapy, pelvic irradiation or major pelvic surgery
8. Subjects who will undergo any invasive procedures within the study period
9. Subjects who will undergo any chemotherapy or radiotherapy of any kind during the study period.
10. Subjects who can not or are not willing to undergo the two-week wash-out period for any reasons.
Allogenic Stem Cell Therapy in Patients With Acute Burn

Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation will be evaluated in patients with acute burn.

To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Acute, Moderate-Severe, Full-thickness burn.

Eligibility Criteria:
Inclusion Criteria:

* Between age 18- 65 years, both gender.
* Diagnosed with Acute, Moderate-Severe, full-thickness burn:

Burn occurring within the 72 hours prior to administration. TBSA 20-55%, third degree wounds surface area \< 19 % ;

* Willing to sign the Informed Consent Form.

Exclusion Criteria:

* All other burns except thermal origin.
* Chronically malnourished, poor medical condition or shock
* Systemic inflammatory response syndrome (SIRS) or septicopyemia
* Moderate-severe inhalation injury airways to lung
* HIV+
* Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
* Severe pulmonary and hematological disease, malignancy or hypo-immunity.
* Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
* Pregnancy or lactation
* Enrollment in other trials in the last 3 months.
* Other criteria the investigator consider improper for inclusion.
A Self-care Mobile Health App in Individuals With Heart Failure

This study was designed to determine the potential benefits that individuals with heart failure (HF) could experience from using a mobile application.

The mobile application is called the Heart Failure Health Storylines (HFHS). The potential benefits will be examined by determining the changes in physical activity and quality of life of the participants, who will use the application and compare the results with the participants, who will not use the application.

Eligibility Criteria:
Inclusion Criteria:

* Adults with chronic heart failure, class I - III based on New York Heart Association (NYHA) scale
* Walking independently with/without an assistive device

Exclusion Criteria: The participant will be excluded if one or more of the following is present

* Cognitive impairment (\< 26 on Montreal Cognitive Assessment).
* Uncorrected vision
* Hearing problems
* Neurological disorders.
* Cannot speak and read the English language,
* Not owning a smart cell phone with internet access.
Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia

The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.2.
* Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening and Baseline.
* Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline.
* Willing and able to discontinue all antipsychotic medications prior to baseline visit.

Exclusion Criteria:

* History or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
* Any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
* History of treatment resistance to schizophrenia medications.
* History of allergy/hypersensitivity to KarXT.
* Other protocol-defined Inclusion/Exclusion criteria apply.
A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women

U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.


Eligibility Criteria:
Inclusion Criteria:

* self-identified Black cisgender woman;
* self-reported HIV-negative status, and
* ≥18 years.
* reports unprotected vaginal or anal sex in the past 6 months with a male sexual partner,
* have at least one substantial HIV risk factor in the past 6 months according to the 2021 Centers for Disease Control (CDC) PrEP Eligibility Guidelines (i.e., HIV-positive sexual partner, recent bacterial Sexually Transmitted Disease (STD), 2+ sex partners, history of inconsistent or no condom use, commercial sex work, and residing in high HIV prevalence area or network), and
* never taken PrEP

Exclusion Criteria:

* non-English speaking and
* currently living with HIV
Clinical Validation of InferRead Lung CT.AI

Lung cancer is the second most common cause of cancer-related death in men and women. Early pulmonary nodule screening is an effective means to prevent lung cancer, which is no less important than the diagnosis and treatment of lung cancer. Early lung cancer screening has been investigated and applied as a medical practice. InferRead Lung CT.AI by Infervision is a dedicated post processing application that generates CADe marks as an overlay on the original CT series intended to aid the radiologist in the detection of pulmonary nodules. This study was designed to evaluate radiologists' performance in detecting actionable nodules on chest CT when aided by InferRead.


Eligibility Criteria:
Inclusion Criteria:

* Lung cancer screening eligible patients

Exclusion Criteria:

-
Maternal-fetal Outcomes of Genital Blood Loss Beyond 18 Weeks of Pregnancy

The primary objective is to assess in terms of frequency the adverse outcomes (premature birth, maternal-fetal haemorrhage, maternal fetal-neonatal death) of pregnancies of women attending the obstetric-gynaecological emergency department for genital bleeding beyond the 18th week of pregnancy.

The investigators decided to conduct this study because it is important on the one hand to carefully evaluate maternal-fetal outcomes in pregnancies characterised by genital bleeding in the second and third trimesters and on the other hand to evaluate the sonographic diagnostic capacity for identifying the aetiology of these genital bleedings, in order to understand whether the possibility of identifying a specific cause of the bleeding has also improved over time as sonographic techniques have improved. This could then allow management and subsequent obstetrical controls to be adapted in a more accurate and indivudualised manner.

For the purpose of this study, no study-specific visits are planned. Data collected during pregnancy and delivery data for patients who gave birth at our centre will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy beyond 18 weeks gestational age complicated by genital bleeding;
* Age of the patient ≥18 years;
* Delivery at the O.U. of Obstetrics and Prenatal Age Medicine

Exclusion Criteria:

None
Efficacy and Safety of Losartan/Chlorthalidone vs Losartan/Hydrochlorothiazide in Essential Arterial Hypertension

Phase IIIb, randomized, double-blind, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination of losartan / chlorthalidone compared with losartan / hydrochlorothiazide in the treatment of patients with essential arterial hypertension.

Two groups of patients will be formed, who wil start treatment with the lower dose (Losartan 50 mg + chlorthalidone 12.5 mg; Losartan 50 mg + hydrochlorothiazide 12.5 mg).

Blood pressure (BP) figures will be evaluated and, in those patients who do not reach the therapeutic goal, defined as a decrease in Systolic blood pressure (SBP) / Diastolic blood pressure (DBP) values of 20/10 mmHg with respect to their baseline values or BP \<140 / 90 mmHg, the dose will be escalated to the next available concentration for both treatments (Losartan 100 mg + chlorthalidone 25 mg; Losartan 100 mg + hydrochlorothiazide 25 mg) at 30 days or during an unscheduled visit.

After two months of treatment, the BP figures obtained with the final dose and the proportion of subjects who achieved a decrease in SBP / DBP values of 20/10 mmHg or \<140/90 mmHg with respect to both combinations will be compared, and the frequency of adverse events presented will be described.

Eligibility Criteria:
Inclusion Criteria:

* Any sex.
* That they agree to participate in the study and give their informed consent in writing.
* Age between 18 and 65 years old at the beginning of the study.
* Patients with essential arterial hypertension with BP ≥140 / 90 mmHg and \<180/110 mmHg.
* Women of childbearing potential using a contraceptive method (barrier, oral hormonal, injectable, subdermal), menopausal or surgically sterile.

Exclusion Criteria:

* The drug is contraindicated for medical reasons.
* Glomerular filtration rate ≤30 ml / min x 1.73 m2.
* Hypersensitivity to any of the components of the formula or other sulfonamides.
* Patients treated with other diuretics.
* Patient with a history of vascular disease (cerebrovascular disease, acute coronary syndrome, etc.) and acute renal failure in the last 6 months.
* Patient with severe complications of type 2 diabetes mellitus (Ketoacidosis or hyperosmolar nonketotic coma).
* Patients participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
* Positive pregnancy test, women who are pregnant, breastfeeding or planning a pregnancy while conducting the study.
* Oncological patients (except basal cell skin cancer) or with serious diseases that, in the opinion of the investigator, have a serious prognosis or a life expectancy of less than 1 year, as well as mental illnesses.
* Patients diagnosed with gout.
* Patients whose participation in the study may be influenced (employment relationship with the research center or sponsor, inmates, etc.).
Monitoring Concentration and Pharmacodynamic Effects of Tacrolimus in Peripheral Blood Lymphocytes of Kidney Transplant Recipients

Therapeutic drug monitoring (TDM) of immunosuppressive drugs is used to improve the immunosuppressive effect while minimizing the toxicity related to exposition to high serum levels. Although TDM is widely used in clinical practice, a significant number of kidney transplant recipients have acute allograft rejection in the first year after transplantation. To improve the use of immunosuppressive drugs, new approaches of TDM have been developed. Monitoring drug concentrations at lymphocytes of peripheral blood is considering promising because it indicates the availability of the drug directly in the target sites of immunosuppression. The present study intends to establish the concentration profile of tacrolimus in the peripheral blood in parallel with the concentration profile inside T and B lymphocytes of peripheral blood of kidney transplant recipients, and correlates them with the expected pharmacological effects. The pharmacological effects of tacrolimus in calcineurin dependent and calcineurin independent (mitogen-activated protein kinase (MAPK) dependent) activation pathways will be assessed by measuring activated nuclear factor of activated T cells (NFAT) and p38, respectively, by flow cytometry. The expression of interleukin (IL) - 2 and IL-10 by T and B lymphocytes, respectively, will be also used to monitoring the pharmacodynamic effects of tacrolimus.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients with a well functioning graft (serum creatinine ≤ 2,0 mg/dL at inclusion)
* Must be on tacrolimus therapy
* Must be on short term follow up time (1 to 5 months) after surgery

Exclusion Criteria:

* A concomitant second solid organ transplant
* Immunosuppression not containing tacrolimus
The Effect of a Non-Operating Room Anesthesia (NORA) Safety Video on Clinician Anxiety and Perceived Self-Efficacy

The purpose of this study is to assess the effect of a non-operating room anesthesia (NORA) safety video on clinician anxiety and perceived self-efficacy.

50 anesthesia professionals will be recruited from the Center for Surgical Innovation (CSI) non-operating room anesthesia (NORA) workforce. Participants will be asked to: Complete a five-minute pre-survey, watch a five-minute video, and then complete a five-minute post-survey.

Eligibility Criteria:
Inclusion Criteria:

* Individuals employed at Dartmouth-Hitchcock Medical Center (DHMC) in the Department of Anesthesia who are eligible to work in the Center for Surgical Innovation (CSI).

Exclusion Criteria:

* Individuals who are not employed at Dartmouth-Hitchcock Medical Center (DHMC) in the Department of Anesthesia and who are not eligible to work in the Center for Surgical Innovation (CSI).
Comparison Between a Novel Proning Pillow System and Standard Pillows

During the COVID-19 pandemic, intensive care units (ICUs) across the country have been inundated with increasing numbers of COVID patients. Hypoxic patients in ICU require mechanical ventilation and this can be improved by proning these patients to improve oxygenation and prevent ventilator-induced lung injury. Standard practice is to use standard hospital pillows to support the pelvis and chest of the patient while they are proned. These pillows do not provide much support to the patients and often need to be adjusted due to the patient 'sinking' into them. Prolonged pronation also leads to pressure sores in these anatomical locations which burden the Trust financially and also cause distress to patients.

A new proning pillow system was developed by Dr Sashika Selladurai and manufactured for the ICU in Aintree hospital which is made from polyurethane memory foam designed to relieve pressure on the patients and prevent pressure sores that often occur during prolonged proning. The pillow system is also designed to withstand the load of heavier patients and reduce the risk of 'sinking' into the pillows when proned for long periods of time.

The aim of the study is to compare the performance of the new proning pillow system with standard pillows, particularly in relation to the risk of pressure sores, by evaluating differences in chest and pelvis interface pressures between the two pillow types. This will be done by having healthy NHS staff lie on the pillows in the prone position for a short period of time while recording the pressure distribution on the pillows using pressure mats placed between them and the pillows. This will help understand the relative risk of pressure sores developing when the new pillow system is used. It is hypothesised that the new pillow system does not increase the risk of pressure sores developing.

The new proning pillow system is a Class 1 CE marked medical device. The proning pillow system consists of a chest pillow and a pelvis pillow made from memory foam designed to reduce contact pressures and peak interface pressures in patients and allow patients to be placed in neutral position for ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Work for Liverpool University Hospital NHS Foundation Trust
* Participant is willing and able to give informed consent for participation in the study.
* Agree to have weight, height, chest and waist measurements taken
* Agree to the study protocol
* Aged 18 years or above.

Exclusion Criteria:

* Presentation of skin lesions
* Absence of any limb
* Female participant who is pregnant
* Have a lower back problem
* Pain or injury in shoulders or arms
* History of conditions that would make it difficult to lie prone, such as pressure injury or surgery within six months leading up to the study
* Any conditions that significantly affect movement and sensation such as diabetes or mobility limitations
Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy

This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.

PRIMARY OBJECTIVES:

I. To evaluate the detection of prostate cancer with elastography using the Aixplorer scanner.

SECONDARY OBJECTIVES:

I. To obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy.

II. To compare the Gleason grade of prostate cancers detected with elastography to the Gleason grade of tumors detected by conventional systematic biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Be scheduled for a clinically indicated biopsy of the prostate
* Agree to an ultrasound examination using the Aixplorer system
* Sign an institutional review board (IRB) approved informed consent prior to any study procedures

Exclusion Criteria:

• Recent prostate biopsy within 90 days
The Prehospital Administration of Normobaric Oxygen in Suspected Stroke

The primary purpose of this study is to explore the feasibility and safety of normobaric oxygen therapy (NBO) under pre-hospital condition in patients with suspected stroke.

Despite the application of thrombolytic drugs and endovascular treatment, there is still a gap between the successful recanalization and ideal clinical outcomes for stroke patients. Neuroprotective treatment is considered as a promising adjuvant to ameliorate this situation. Previous researches demonstrated the neuroprotective effects of Normobaric Hyperoxia (NBO) in animal models from multiple perspectives. Moreover, NBO is distinctive for its ubiquity, conveniency, high compatibility, and wide adaptability, making it superior to other neuroprotective interventions in a pre-hospital setting. Therefore, the investigators conducted this pilot study to further explore the feasibility and safety of NBO under a pre-hospital condition in patients with suspected stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or more.
2. Suspected stroke screened by the "Gaze- Face Arm Speech Time" scale (G-FAST score ≥ 1).
3. Within 24 hours of symptom onset
4. SpO2 \> 94%.

Exclusion Criteria:

1. Coma: Glasgow coma score (GCS) \< 8.
2. Hypoglycemia: Blood glucose \< 2.8mmol /L.
3. Known history of seizure.
4. Recent stroke or brain trauma within past 30 days.
5. Previous Modified Rankin Scale (mRS) ≥2.
6. Rapid improvement of neurological dysfunction (deficit present less than 15 min).
7. Unstable vital signs.
8. Known respiratory distress, respiratory dysfunction, or any contraindications to high-flow oxygen inhalation therapy.
9. Patient unable to cooperate with the trial procedure.
10. Any condition which might increase the risk to the patient in the judgment of the investigator.
11. Patient or available legally authorized representative unable to provide written or witnessed oral consent.