cyrilzakka/clinical-trials huggingface dataset:
The Study of Bemnifosbuvir in Healthy Japanese Subjects

This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* Willing to comply with the study requirements and to provide written informed consent
* The subject must have been born in Japan and have both parents and 4 grandparents of Japanese descent
* The subject must have lived outside of Japan for no more than 10 years

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean Volunteers

This study investigates safety and pharmacokinetic comparison of Seoul Pharma's orally disintegrating film (ODF) formulation of sildenafil (test formulation) and Pfizer's "Viagra® (sildenafil)" Film Coated Tablet (FCT) formulation (reference formulation) in healthy volunteers.

* Background: An orally disintegrating film (ODF) formulation of sildenafil was recently developed in Korea. This formulation is expected to enhance the dosing convenience and increase patient compliance while yielding pharmacokinetic profiles comparable to the conventional film coated tablet (FCT) formulation.
* Objective: The goal of present study is to compare the pharmacokinetic (PK) profiles of a newly developed ODF formulation with a FCT formulation of sildenafil in healthy Korean male volunteers.
* Methods: This is a randomized, open-label, 2-period cross-over, single-dose study conducted in 2 parts. Eligible subjects were healthy male volunteers between the ages of 20 and 50 years and within 20% of their ideal body weight, and are equally divided into parts 1 and 2. Each subject will be received a single -dose of ODF and FCT formulations of sildenafil orally in a fasted state (part 1, 50mg; part 2, 100mg), with a 7-day washout period between the formulations. Blood samples are collected up to 24 hours. Pharmacokinetic parameters are determined for sildenafil and its active metabolite (N-desmethyl sildenafil). Adverse events will be also evaluated based on subject interviews and physical examinations.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects were healthy male volunteers between the ages of 20 and 50 years and within 20% of their ideal body weight, and
* With no congenital abnormality or chronic disease.

Exclusion Criteria:

Key exclusion criteria included:

* history of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic, or hemorrhagic disease;
* anatomical abnormality of penis or factors that cause priapism (e.g., sicklemia, multiple myeloma, leukemia);
* clinically significant findings on routine laboratory (serology, hematology, serum chemistry, and urinalysis), ECG or color blindness tests \[8, 16\];
* history of hypersensitivity reaction to PDE5 inhibitor including sildenafil;
* use of prescription drugs within 14 days before the study that had the potential to interact with the study medication; and
* use of any substance that could induce or inhibit cytochrome P450 3A4 synthesis (eg, St. John's wort, other herbal medications).
Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

This study was terminated after 60 weeks due to the commercial availability of valbenazine.

Eligibility Criteria:
Inclusion Criteria:

* Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
* Participants of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently throughout the study and until 30 days after the last dose of valbenazine.
* If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorder, or other conditions, be on stable doses.
* Be in general good health.
* Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

Exclusion Criteria:

* Have an active, clinically significant unstable medical condition within 1 month prior to screening.
* Have a known history of substance dependence, substance (drug) or alcohol abuse.
* Have a significant risk of suicidal or violent behavior.
* Have a known history of neuroleptic malignant syndrome.
* Have a known history of long QT syndrome or cardiac arrhythmia.
* Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
* Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than valbenazine) during the study.
* Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
* Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
* Are currently pregnant or breastfeeding.
Ga-68-PSMA-11 in Men With Prostate Cancer

The purpose of this study is to provide access to Ga-68-PSMA-11 PET for evaluation of male veterans with newly diagnosed or biochemically recurrent prostate cancer. All patients will receive conventional imaging (MRI, CT, and/or a molecular imaging bone scan) as well as Ga-68-PSMA-11 PET in order to evaluate the utility of diagnostic testing in patients with positive PSA status, a comparison of results from conventional imaging and PSMA PET imagining will be performed.

Participants (male veterans) with initial diagnosis of prostate cancer or biochemically recurrent disease that consent to participate in the study will receive both conventional imaging (MRI, CT, and/or molecular imaging bone scan) as well as Ga-68-PSMA-11 PET/CT. Following baseline assessment (Visit #1), Ga-68-PSMA-11 (3-7 mCi) will be administered as a single intravenous administration with PET/CT performed approximately 60 minutes after injection (Visit #2A). At approximately 120 minutes after injection of Ga-68-PSMA-11, the final evaluation for safety and tolerability will occur (Visit #2B)

Eligibility Criteria:
Inclusion Criteria:

* Able to tolerate PET/CT imaging and one or more of the following:
* Patients with newly diagnosed prostate cancer with primary staging classified at high/intermediate risk per NCCN guidelines OR
* Biochemical Recurrence: Patients with rising PSA after definitive therapy with prostatectomy or radiation therapy or other local therapies

Exclusion Criteria:

* Claustrophobia or any other condition that would preclude PET/CT imaging.
* Any constellation of medical conditions that indicate expectancy of less than one year
Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus

Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled cavities in the brain. The clinical symptoms are gait disturbance, mental decline and incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to be able to induce regression of the symptoms in many cases meaning that ICAH is a classic, curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is complicated: improvement is often incomplete and there is no consensus on either how to assess the symptoms or how they change after CSF depletion. In consequence, the decision whether not to undertake surgery often depends on the neurosurgeon's clinical impression.

Over recent years, the cognitive profile of patients with ICAH has become better characterised and reproducible, objective techniques have been developed to assess motor function and CSF flow in the brain.

The investigators project aims to define the value of these new investigative techniques in the positive diagnosis of ICAH, in comparison to current decision-making tools.


Eligibility Criteria:
Inclusion Criteria:

* Adult 65 years or older
* Hospitalized patients (at the University Hospital of Tours) requiring the assessment of chronic hydrocephalus in adults, suspected clinically
* Patient undergoing Lumbar Puncture subtractive
* Informed consent form signed
* Affiliated to a medical insurance

Exclusion Criteria:

* Contraindications to MRI
* Inability to walk or to stand before having lumbar puncture
* Patient under trusteeship and guardianship, or judicial protection
Positive Psychology for Smoking Cessation

This study will examine how Positive Psychotherapy (PPT) may help people interested in quitting smoking, quit.

This project aims to adapt the Positive Psychotherapy (PPT) practice for smoking cessation in adults with severe mental illness (SMI), testing its usability, feasibility, and acceptability in a mixed-methods feasibility pilot study. Qualitative interviews will be conducted to obtain usability and acceptability input on the adapted PPT manual from 4-5 Peer Providers. Then, in partnership with The Mental Health Center of Greater Manchester (MHCGM), 6-8 adult smokers with SMI will be recruited who want to quit smoking in the next month and are willing to use nicotine replacement therapy (NRT). The 16-week PPT adaptation ("Positive Recovery for Smoking") will be tested progress on cessation assessed through interviewer-administered quantitative assessments at baseline, 8, and 16 weeks. Self-reported cigarettes per day (CPD) and carbon monoxide (CO) will be collected prior to each group treatment session. Informed by the weekly group check-in of cessation progress (quitting status), qualitative interviews will be conducted at 16 weeks to obtain a more nuanced description of the uptake of the intervention, successful quitting strategies, and barriers to cessation with this new method. The manual and materials will be adapted based on the feedback from the first group and another group of 6-8 participants will be recruited to receive the refined intervention and protocol. The result of this feasibility pilot will provide data on the adapted PPT's feasibility and acceptability, alongside a deep description of strategies used and why and how the treatment was perceived as useful or not to the enrolled participants.

Eligibility Criteria:
Inclusion Criteria:

* age 21+;
* Serious Mental Illness (SMI) diagnosis;
* smoking ≥10 CPD;
* breath CO ≥10;
* desire to quit in the next month;
* willingness to use NRT daily;
* English speaking and literate to engage in the treatment.

Exclusion Criteria:

* legal guardian;
* active substance use disorder.
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma

his is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39P in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-G39P injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
2. Aged 18-75 years (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.

Response to prior therapy is consistent with one of the following:

1. Primary refractory.
2. Relapsed or refractory after 2 or more lines of therapy.
3. For LBCL, 3B FL. t-iNHL:

   * Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
   * Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;

     7. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria

   Exclusion Criteria:

   Subject eligible for this study must not meet any of the following criteria:
   1. Prior antitumor therapy with insufficient washout period ;
   2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy;
   3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy;

   5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).

   6. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39P CAR-T cell or its excipients, including DMSO.

   7. Pregnant or lactating women;

   -
Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)

To be able to have data on brain activity during an acupuncture session, this pilot study is necessary to evaluate the kinetics of the bispectral index. This research aims to evaluate the kinetics of the bispectral index in healthy volunteers during an acupuncture session, Sham acupuncture or resting in a lying position.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Over 18 years old and less than 65.
* Having given his express consent
* Affiliated to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Medical history of psychiatric disorders
* Psychotropic treatment
* narcolepsy
* Obstructive sleep apnea syndrome
* Symptoms that may correspond to COVID 19
* Nickel allergy
* Refusal to participate in the study
* Protected subjects : Adults under guardianship, curatorship or other legal protection deprived of their liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Subject hospitalized without consent
Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED

The KetMo study is an investigator-initiated, randomized, parallel group, double blinded trial investigating if ketamine as an adjunct to morphine improves pain treatment in the ED.

Patients in pain (assessed on NRS, 5 or more) will be randomized to low-dose ketamine or placebo as an adjunct to morphine. Patients with or without prior use of opioids will be randomized separately.

The primary outcome will be pain reduction, assessed on NRS, after 10 minutes. Secondary outcomes include pain reduction until 120 minutes after injection of study medicine, need for rescue opioid, side effects and patient- and provider satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Emergency Department admission
2. Age ≥ 18 years
3. NRS ≥ 5
4. Stable vital signs defined as systolic blood pressure ≥ 90 mmHg, heart rate between 60 and 150 per minute, respiratory rate between 8 and 26 per minute, oxygen saturation greater than or equal to 92%

Exclusion Criteria:

1. Initial management by trauma-team
2. Systolic blood pressure ≥ 180mmHg, severe untreated arrhythmia, unstable angina, recent myocardial infarction (\< 30 days), severe heart-failure (Ejection fraction \< 40 %)
3. Symptoms of untreated hyperthyroidism
4. Cirrhosis with ascites
5. Known/suspected pregnancy or breastfeeding
6. Patients for whom consent is not obtainable or psychiatric forced treatment.
7. Previously enrolled in the trial
8. Psychiatric illness prior to admission defined as prior psychosis/schizophrenia
9. Untreated diagnosed glaucoma
10. Known hypersensitivity to ketamine or to any excipient or prior use of ketamine with a negative experience (i.e. hallucinations)
11. Patient clearly influenced by drugs or alcohol
Vitamin D and Blood Pressure

Vitamin D is a natural nutrient in normal daily diet. It can also be made in the skin after exposure to sunlight and is essential for maintaining normal calcium balance. One past study has suggested that vitamin D may be helpful for blood pressure. This study will test whether pills containing cholecalciferol (a form of vitamin D) or calcitriol (the active form of vitamin D) can treat high blood pressure. The investigators plan to enroll up to 80 subjects at the Atlanta VA Medical Center. Participation in the study is expected to last up to 4 weeks. Subjects will be assigned to cholecalciferol, calcitriol or placebo). A 24-hour blood pressure monitor will be worn at the beginning and end of the study to determine blood pressure changes. Renin, PTH, angiotensin-II, and aldosterone levels will also be measured at the beginning and end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be over the age of 18
* Vitamin D levels between 10 and 30 ng/ml
* Systolic blood pressure between 130 and 150 mmHg

Exclusion Criteria:

* Current use of anti-hypertensive medication
* Inability to understand the consent form
* Inability to return ABP monitor within 24-48 hours after visit
* Alcohol dependence
* Diagnosis of chronic kidney disease
* History of heart disease
* History of stroke
* Inability to comply with study protocol
* Current treatment for cancer
* Narcotic dependence
* Current use of greater than 2000 IU of vitamin D
* Pregnant
Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation for Female Cancer Patients

Ovarian Tissue Cryopreservation will be provided to cancer patients to allow them to have their fertility preserved.

This project hopes to provide Ovarian Tissue Cryopreservation to patients who do not have adequate time for ovarian stimulation in oocyte or embryo freezing and in prepubertal girls where oocyte freezing is not possible. All the patients will have fertility preservation consultations with a fertility specialist in our unit to go through the details of ovarian Tissue Cryopreservation service and risks related to ovarian tissue cryopreservation procedures. After undergoing ovarian tissue collection via surgery, the collected ovarian tissue will be cryopreserved either by slow freezing or vitrification in our unit.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 0-35 years old and diagnosed with cancer e.g., leukaemia, myeloproliferative or myelodysplastic diseases, lymphoma, bone tumours, neurological neoplasms and sarcoma, Paediatric bone marrow transplant patients
* Patients with any illness or who will undergo any type of treatment that may cause irreversible damage to their fertility, such as extensive abdominal surgery, high toxicity medication and treatments;
* Patients suffering from hormone-sensitive malignancies who will undergo medical treatment, such as radiotherapy and chemotherapy that is liable to damage their ovaries and deter them from conception in the future.

Exclusion Criteria:

* Patients with no anticipated oncologic therapies
* Patients who are pregnant
* Children with one ovary
* Children deemed high risk for perioperative complications
* Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)
Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices

Background:

Hypertension (HTN) is a major risk factor for cardiovascular disease (CVD), the leading cause of death in the United States and New York City (NYC). One in 4 NYC adults has hypertension, with higher prevalence in both Blacks and Latinos compared to Whites (Angell 2008). In NYC, only 65% of all adults with HTN and on treatment are controlled (Angell 2008).

Self-blood pressure monitoring (SBPM) is associated with reduced blood pressure in patients with hypertension (Cappuccio 2004). Studies suggest that SBPM may increase control either by inducing clinicians to titrate medication more actively, (Agency for Healthcare Research and Quality 2002) by engaging patients to participate in their own health care, (Taylor 2007) or a combination of the two.

However, minimal research has been done to evaluate the effectiveness of SBPM in different racial and/or ethnic groups or in low income populations or to discern effective patterns of SBPM use by patients. Best practices for integration of self monitoring into HTN into regular treatment have also yet to be established.

Objectives:

The goal of this study is to assess the impact of SBPM under conditions consistent with existing community health clinic resources and infrastructure in NYC's medically underserved neighborhoods using commonly available automated home BP monitors. By using a community clinic's electronic health record (EHR) and automated BP monitors with the capability to transmit readings to a research database, we can facilitate a more rigorous evaluation of a pilot SBPM intervention and assess patterns of home monitor use and clinical management and their association with outcomes.

The three specific aims of this intervention are to:

1. Assess whether use of SBPM reduces elevated BP and increases HTN control to similar levels in two historically understudied minority populations, Blacks and Latinos.
2. Confirm pilot findings by assessing the impact of SBPM on BP and HTN control compared to usual care using randomized controlled trial methodology.
3. Develop standards and refine guidance for the effective use of SBPM that can be easily communicated to key stakeholders.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients attending one of the participating primary care clinics
* Diagnosis of hypertension for at least 6 months
* Ethnicity or Race of Latino, Black or White
* Physically and mentally able to monitor BP at home
* \*Uncontrolled BP at last office visit
* \*Uncontrolled BP at current office visit

Note: \*Uncontrolled BP is defined as systolic BP ≥ 140 and/or diastolic BP ≥ 90, or systolic BP ≥ 130 and/or diastolic BP ≥ 80 mm Hg for participants with chronic kidney disease or diabetes.

Exclusion Criteria:

* Arm circumference greater than 17.5 inches (maximum size of large BP cuff)
* Already monitoring BP at home at request of health care provider
* No access to a land line telephone line (to upload home readings)