cyrilzakka/clinical-trials huggingface dataset:
Enpatoran Human Mass Balance and Absolute Bioavailability Study

The purpose of Period 1 of this study is to provide a definitive quantitative characterization of the mass balance, and rates and routes of excretion of enpatoran, and to determine and quantify enpatoran and its metabolites in excreta (urine and feces) and plasma. The purpose of Period 2 of this study is to determine the absolute oral bioavailability of enpatoran. Total minimum duration of study participation for each participant is approximately 50 days.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring (blood pressure, heart rate and 12-lead electrocardiogram)
* Have a body weight within 50 to 110 kilogram (kg) and Body mass index (BMI) within the range ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m\^2)
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
* Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to Screening
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism and excretion (ADME) of drugs, or which may jeopardize the participant in case of participation in the study
* History of any malignancy
* History or presence of epilepsy, neurological disorders with seizure propensity or undiagnosed loss of consciousness, severe head trauma within 6 months or severe depression within 12 months prior to Screening), or neuropsychiatric conditions
* History of chronic or recurrent acute infection or any bacterial, viral, parasitic or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening, or a history of herpes zoster within 12 months prior to Screening.
* History of drug hypersensitivity ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion
* History of alcoholism or drug abuse within 1 year prior to Screening, or evidence of such abuse as indicated by the laboratory assays conducted during Screening
* Any condition, including findings in the laboratory tests, medical history, or other Screening assessments, that in the opinion of the Investigator constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study's objectives, conduct, or evaluation
* Other protocol defined exclusion criteria could apply
Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex

This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex

This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and severe) on the pharmacokinetics of Tenofovir Exalidex

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years of age and over
* Capable of giving written informed consent
* Capable of completing study requirements

Exclusion Criteria:

* Positive result for HIV, HBV, or HCV
* History or medical condition which could impact patient safety
* Current or past abuse of alcohol or drugs
* Participation in another clinical trial within the past 30 days
A Clinical Investigation to Assess the Effectiveness of Benzocaine Condoms in Healthy Adult Men

This investigation is designed to evaluate the effectiveness of two NRL condoms with Benzocaine paste compared with a standard NRL control.

In this clinical investigation, two NRL condoms with Benzocaine paste (Test condom A and Test condom B) will be evaluated against a standard NRL male condom (Control condom) in prolonging time to ejaculation in healthy adult men.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects and their female partners between the ages of \>=18 years and =\<60 years.
2. Subjects and their female partners must have no health condition in their medical history.
3. Subject must be sexually active having regular intercourse (a minimum frequency of once a week).
4. Subjects in a stable, monogamous, sexual relationship with the same female partner for more than or equal to 3 months.
5. Subject's female partner should already be on an established other highly effective form of non-barrier contraception, unless post-menopausal.

Exclusion Criteria:

1. Subject or his female partner with alcohol or drug abuse.
2. Subjects and their female partners with anemia, coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes, and renal or hepatic disease.
3. Subjects and their female partners with a risk of methaemoglobinemia / complications related to ester anaesthetics which could trigger methemoglobinemia.
4. Subject and/or his female partner with urological disease or genitourinary surgery; ongoing significant psychiatric disorder not controlled by medication; history of surgery or injury to the pelvis, retroperitoneal surgery, radiotherapy, multiple sclerosis, spinal cord injury, chronic inflammation of the prostate or urethra; relevant genital surgery; a female partner with vaginal complaints; any broken skin or wounds in the genital area.
5. Subjects on medication that is contraindicated, which may affect erection.
6. Subject and/or his female partner have any medication which may affect the safety of the subject, including but not limited to benzocaine drug interactions such as Sulphonamides and cholinesterase inhibitors.
7. Subject with premature ejaculation, erectile dysfunction, hypo or hyperthyroidism, hypogonadism, hyperprolactinemia, ejaculatory dysfunction, haemorrhagic disorder, hepatitis B or C, human immunodeficiency virus (HIV) infection or having had penile implant surgery.
8. Subjects and their female partners who have any relevant history of allergy including local anaesthetics, parabens, PABA, commercial hair dyes, paraphenylenediamine, lubricants and latex.
Testing SupportGroove: a Novel Mhealth Intervention for Couples Coping with Spinal Cord Injury

The purpose of this study is to test the preliminary effects of an 8-week mobile application-based program (SupportGroove) developed for persons with spinal cord injury and their romantic partners.

Eligible couples who provide informed consent will be enrolled in the study and will be randomized to either immediately start the 8-week SupportGroove program or be waitlisted for 8-weeks before starting the program. While actively participating in the program, couples will use the app to engage in daily "quests" (positive psychology-based activities to be completed on their own or as a couple). Both partners in the participating couple complete self-report assessments at baseline (0 weeks), 8 weeks, 16 weeks, and 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

* cohabitating romantic couples where one partner has sustained a spinal cord injury at least 3 months prior to enrolling in the study
* be able to read and understand printed English instructions
* have a smartphone, tablet, or personal computer with internet access

Exclusion Criteria:

* the partner has a spinal cord injury or other major neurological condition
* either partner is unable to read and understand printed English instructions
* either partner does not consent to participate in the study
68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy

This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

PRIMARY OBJECTIVE:

I. To compare the per-patient detection rate of 68Ga-PSMA-11 PET/CT versus bone scan (BS)/CT for M1b in patients treated with androgen deprivation therapy (ADT) who are referred for the imaging evaluation of disease progression.

SECONDARY OBJECTIVES:

I. To compare the number of lesions rated as positive for bone metastases between the two imaging tests.

II. To compare the detection rate of 68Ga-PSMA PET/CT versus BS/CT for all M1 disease (M1a or M1b or M1c).

III. To compare the positive predictive value (PPV) per-patient in patients with lesion validation (follow-up imaging or biopsy).

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV). After 50-100 minutes, patients undergo whole body PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen \[PSA\] level \>= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart)
* Patients with bone scan scheduled or performed

  * Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between
  * Bone scans performed at University of California, Los Angeles (UCLA) and external institutions are eligible if Digital Imaging and Communications in Medicine (DICOM) images can be obtained, imported, and anonymized
* Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility
* Patients or their legal representatives must have the ability to read, understand and provide written informed consent

Exclusion Criteria:

* Initiation of a new therapy between the PSMA PET/CT and the bone scans
* Inability to provide written informed consent
* Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
Remote Study Collecting Blood Glucose Values and Activity Data in Patients With Type 2 Diabetes on Different Treatments

Earlier protocol ID was NN1250-4630, protocol ID is changed to NN1535-7774. The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approximately 12 weeks using electronic devices in a full virtual clinical setting. Virtual clinical setting means that all data are collected by use of participants' personal smartphone and study-related apps. In other words, everything will be handled without any visits to a hospital or doctor.

For collection of participants' blood glucose values participants will receive two different blood glucose monitors. One where participants cannot see the blood glucose values and one where participants can see the blood glucose values. Participants must wear them consecutively for 2 and 10 weeks, respectively. Further, participants will be asked to self-apply the monitors on their upper arm.

For collection of participants' activity data participants will receive an activity tracker, which participants will wear on the wrist throughout the study.

The study does not include any study medication and participants will continue the current antidiabetic treatment as prescribed to participants by their own physician. If any questions about the treatment and/or health condition while participating in the trial, participants should consult your own physician If participants are in doubt about what the blood glucose values mean or whether participants should react to the blood glucose values, participants need to contact the research staff or their general practitioner.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to consent via the e-consent process before any study-related activities takes place (study-related activities are any procedure related to recording of data according to the protocol)
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Diagnosed T2DM for more than 3 months prior to signing the informed consent
* On one of the following treatments for T2DM:

  1. Metformin ± other OADs
  2. Basal insulin ± OADs
  3. GLP-1 ± Basal insulin (loose and fixed combination) ± OADs
* Willingness to, and capable of applying and using the study devices
* Willingness to follow study procedures
* Fluent in Danish both oral, reading and in writing
* In possession of a compatible smartphone throughout the study, meaning that the smartphone fulfils the criteria to the operating system for using the devices needed for the study

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Participation in any other study investigating diabetes.
* Patients who do not have a blood glucose meter at home
Do Adolescents and Adults Differ in Their Acute Response to Cannabis?

The acute effects of cannabis may differ between adolescents and adults. Furthermore, these effects may be tempered by the presence of cannabidiol. This double-blind, placebo-controlled, crossover experiment investigates the acute effects of cannabis (with and without cannabidiol) on subjective effects, behavioural responses and neural functioning in 16-17 year-olds and 26-29 year-olds who regularly use cannabis (0.5-3 days per week).


Eligibility Criteria:
Inclusion Criteria:

* Adolescents: Aged 16-17
* Adults: Aged 26-29 years
* Self-reported cannabis use between 0.5 and 3 days/week, averaged over the last 3 months
* Adults: Body mass index (BMI) between 18.5 and 29.9
* Adolescents: BMI between 2nd percentile and 98th percentile
* Self-reported ability to consume approximately half a typical joint of cannabis by themselves within 20 minutes
* Willing to be cannulated and have four blood samples taken at every acute session
* Right-handed

Exclusion Criteria:

* Females: Pregnant or breast-feeding
* Adults: Before the age of 18, had a period of 3 or more months when cannabis was used once per week or more frequently.
* Severe cannabis use disorder (DSM-5)
* Illicit drug use of any specific drug more than twice per month, averaged over the last 3 months
* Receiving treatment (pharmacological or psychological) for a mental health problem within the last month
* Lifetime psychosis
* Lifetime psychosis of any immediate family member
* Hypertension (systolic \> 160 or diastolic \> 100)
* Dependent on tobacco or vaping nicotine (\> 1 on the Heaviness of Smoking Index)
* Currently taking a psychotropic medication that will likely affect dependent variables or interact with cannabis
* Any physical or mental health condition, any medication, or any treatment, that the study doctor considers to be an exclusion
* MRI contraindications
* Significant asthma or respiratory problems - severity judged clinically
* Self-reported moderate/severe acute unpleasant effects from cannabis which occur often or always
* Positive alcohol breathalyser reading at any acute session (rearrange session)
* Self-reported use of alcohol within 24 hours at any acute session (rearrange session)
* Self-reported use of illicit drugs (including cannabis) within 72 hours at any acute session (rearrange session)
* Positive saliva drug screen at any acute session (rearrange session)
Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact Lenses

The objective of this 2 hour study is to evaluate the clinical performance of Biotrue ONEday lenses with an alternate packaging solution (EPG03) compared to commercially available Biotrue ONEday lenses. This novel contact lens packaging solution contains known elements in the ophthalmic industry and is safe for use.

Approximately 30 habitual soft contact lens wearing subjects will be enrolled in this two-hour randomized, contralateral, double-masked (subject and investigator masked), repeated measures dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be dispensed study lenses according to unique randomization schedules that will be provided to each Investigator.

Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.
Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population

This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc. Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests) in pediatric subjects who are between 12 and 17 years of age. A minimum of ten (10) known HIV-positive participants will be tested.

In order to achieve the primary objective, clinical trials will be conducted to establish and confirm the sensitivity of the Clearview HIV 1/2 tests in the described pediatric population. Only HIV-1 will be included in the study.

The Clearview HIV tests can be used as a safe and effective screening method to aid in the diagnosis of infection with HIV 1/2 in the pediatric population aged between 12 and 17 years.

The secondary objectives of this study include demonstrating that:

- The Clearview HIV tests detect HIV-1 antibodies in a variety of sample matrices: capillary (fingertip) whole blood, venous whole blood, plasma and serum.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 12 years of age and no older than 17 years of age.
* Must be willing to sign (and be given) a copy of the written Information and Assent Form.
* Must have a parent or guardian present to sign and receive a copy of the Informed Consent Form.
* Must be able to provide one or two fingerstick blood samples.
* Must be able to provide three tubes of blood by venipuncture from the arm or hand only.

Exclusion Criteria:

* Have a life threatening illness (with the exception of HIV or AIDS).
* Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.), as determined by interviewing the study participant or parent/legal guardian.
* Have participated or are participating in a clinical trial for an HIV vaccine (as determined by interviewing the study participant or parent/legal guardian).
* Have previously participated in this clinical trial (no duplicate enrollments).
* Are currently on HAART, except as agreed on a case-by-case basis.
A Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment

The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* BMI ≥ 18 kg/m\^2 and weight ≥ 50 kg at screening (BMI = weight \[kg\]/height \[m\^2\]).
* Participants with normal hepatic function as judged by the investigator
* Participants with hepatic impairment as judged by the investigator

Exclusion Criteria:

* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.
* Any major surgery within 4 weeks of study drug administration
* Previous exposure to BMS-986263

Other protocol-defined inclusion/exclusion criteria apply.
Fluoxetine in KCNC1-related Disorder

This is a single patient study of oral powdered fluoxetine to target developmental outcomes in a child with KCNC1-related disorder. This trial will be conducted at Holland Bloorview Kids Rehabilitation Hospital over 32 to 42 weeks, using a quasi experimental ABA phase design (placebo-fluoxetine-placebo) with randomized and blinded active treatment start and stop moments.


Eligibility Criteria:
Inclusion Criteria:

1. Consent provided by substitute decision maker.
2. In good general health as evidenced by medical history
3. Screening baseline bloodwork (or availability of clinical bloodwork within 3 months of trial start) with values below relevant cut-offs for adequate hepatic and renal function, and baseline electrolytes including potassium within normal range.
4. Ability to take oral medication and be willing to adhere to the daily oral medication regimen

Exclusion Criteria:

1. Current use of monoamine oxidase inhibitors, other selective serotonin reuptake inhibitors, tricyclic antidepressants, or agents that strongly affect metabolism via CYP2D6, CYP2C9 or CYP3A4.
2. Hypersensitivity to fluoxetine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container
3. Treatment with another investigational drug or other medication intervention within 8 weeks of starting the trial.
4. Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.
5. Long QT syndrome including acquired long QT syndrome (e.g., due to concomitant use of a drug that prolongs the QT); a family history of QT prolongation; or other clinical conditions that predispose to arrhythmias.
AI-Supported Occupational Therapy for Handwriting

Aim: This study investigates the impact of an AI-supported occupational therapy program, developed using the Model of Human Occupation (MOHO), on handwriting skills in children at risk for Developmental Coordination Disorder (DCD).

Method: A randomized controlled trial was conducted with 42 children aged 8-12 years, identified as being at risk for DCD using the Developmental Coordination Disorder Questionnaire (DCDQ). Participants were randomized into an intervention group (n=21) and a control group (n=21). The intervention group received an AI-supported occupational therapy program twice weekly for 8 weeks. Handwriting performance was assessed pre- and post-intervention using the Minnesota Handwriting Assessment (MHA).

Keywords: artificial intelligence, occupational


Eligibility Criteria:
Inclusion Criteria:

1. being between the ages of 8-12 years
2. being at risk for DCD according to the Developmental Coordination Disorder Questionnaire (DCDQ)
3. having the ability to understand the questionnaires
4. continuing formal education
5. having similar motor skill performance (having similar results from the Bruininks-Oseretsky Motor Proficiency Test 2 Brief Form (BOT2-BF)) and having similar visual perception level (having similar results from the Motor-Free Visual Perception Test-3(MVPT-3)

Exclusion Criteria:

(1) having another neurodevelopmental, orthopedic and chronic problem (2) continuing any rehabilitation program

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