cyrilzakka/clinical-trials huggingface dataset:
Solution-Focused Brief Therapy for Support of Psychological Distress in Adolescent and Young Adult Cancer Survivors

This clinical trial evaluates the how well a virtually delivered solution-focused brief therapy (SFBT-C) works to decrease adolescent and young adult cancer survivors' psychological distress in comparison to enhanced treatment-as-usual care. Cancer and its treatment can have immediate and long-term impacts on adolescent and young adult cancer survivor's lives, including education and employment, financial stability, sexual health, and social, romantic, and family relationships. Consequently, many adolescent and young adult cancer survivors report psychological distress, often manifesting as depression and anxiety, and may benefit from psychotherapy to improve their engagement with medical treatment and overall quality of life. SFBT-C is a theory-driven and brief hope-based psychotherapy designed for the unique psychosocial needs facing adolescent and young adult cancer survivors. Undergoing SFBT-C may work better than treatment-as-usual care for the support of psychological distress in adolescent and young adult cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* 15 - 39 years old
* Diagnosed with cancer
* Receiving active cancer care (6 weeks post initial diagnosis to control for emotional responses to normative stressors) or within 5 years of post-treatment survivorship
* Experiencing psychological distress (i.e., a t-score \>= 57 on the Brief Symptom Inventory - 18 items \[BSI-18\])
* Fluent in English

Exclusion Criteria:

* End-of-life care
* \> 5 years into the post-treatment survivorship
* Major physical challenges (e.g., hearing loss, developmental delay)
* Acute mental health conditions (e.g., active psychosis, suicide risk)
* Receiving or newly initiated psychotherapy for psychological distress during the study period
Echo-Cardiographic Assessment of Cardiovascular Characteristics During Pregnancy and Postpartum Periods

The purpose of this echocardiographic study is to restudy the longitudinal changes in cardiac size and function during and after pregnancy in healthy women using relatively new parameters of systolic and diastolic function as well as classical measures of left ventricle (LV) function using contemporary echocardiographic machines.

We, the researchers at Hillel Yaffe Medical Center, will assess diastolic function and its possible relation to shortness of breath.

A comprehensive echocardiographic study of the heart will be conducted in the first, second and third trimesters of pregnancy and 3 months postpartum.

Determination of left ventricular dimensions, transvalvular Doppler flow, ejection fraction, stroke volume, cardiac output, pulmonary vein flow, tissue Doppler, flow propagation, global and segmental strain parameters, timing of peak strain and various parameters of diastolic function will be obtained.

From these data normal values for various stages of pregnancy will be determined as well as range for changes expected during longitudinal follow-up will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* First trimester of a normal pregnancy
* Normal baseline echocardiogram

Exclusion Criteria:

* Pregnancy with more than one fetus.
* Any hemodynamically significant cardiac condition
* Any known systemic disease
* Poor quality echocardiogram
Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery

Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased incidence of postoperative maladaptive behaviours (POMBs). There is a lack of well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ED. Therefore, our objective is to assess the potential of family-centred perioperative care for anaesthesia (FPCA) in mitigating the incidence of ED in children, compared with routine anaesthesia.


Eligibility Criteria:
Inclusion criteria:

1. Children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours;
2. Receiving first general anaesthesia by inhalation, and American Society of Anaesthesiology (ASA) physical status I to II;
3. A parent signed the informed consent form.

Exclusion criteria:

1. Suffering important organ diseases;
2. History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment;
3. History of severe hearing or visual impairment;
4. Children are not suitable for inhalation anaesthesia considered by the researchers;
5. The parent involving in this trial spends less than three months a year with the child;
6. The parent is not competent for companionship considered by the researchers;
7. Neither father nor mother is able to participate in the screening interview and the trial.
Evaluating Clinical Evaluation Tools for Predicting Risk of Complications After Hematopoietic Stem Cell Transplant

This study evaluates whether clinical evaluation tools such as the six-minute walk test, hand grip strength test, and gait speed test, are useful in predicting risk of complications in patients undergoing hematopoietic stem cell transplants (HCT). Being able to predict who is at increased risk of post-HCT complications can help better inform patients and providers on the risks and benefits of undergoing HCT and determine whether certain patients should have closer post-HCT monitoring due to an increased risk of complications.

PRIMARY OBJECTIVE:

I. To develop novel pre-transplant tools for determining risk of post-HCT pulmonary complications.

OUTLINE: This is an observational study.

Patients undergo a clinical evaluation consisting of a six-minute walk test, hand grip strength test, and gait speed test on study. Patients' medical records are also reviewed for a year on study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \>= 18 years old)
* Undergoing evaluation for autologous or allogeneic bone marrow transplant (HCT) at Mayo Clinic Rochester
* Scheduled for pre-HCT pulmonary function test by the primary team

Exclusion Criteria:

* Limited mobility requiring use of gait aid or wheelchair
* Fall risk
Biomarker Study in Samples From Patients With Malignant Rhabdoid Tumor of the Kidney or Atypical Teratoid Rhabdoid Tumor

This research trial studies biomarkers in samples from patients with rhabdoid tumor of the kidney and atypical teratoid rhabdoid tumor. Studying biomarkers of tissue samples from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. To determine if there are molecular differences between rhabdoid tumor of the kidney (RTK) and the atypical teratoid rhabdoid tumor (ATRT).

OUTLINE:

Archived tumor tissue samples are analyzed for gene expression profile and microRNA profile.

Eligibility Criteria:
Inclusion Criteria:

* Samples of RTK and ATRT provided by the Children?s Oncology Group (COG)
Study to Look for Artifact on Computed Tomography (CT) Representing Kidney Stones

Patients suspected of having a kidney stone are usually evaluated by computed tomography (CT) scan. The investigators hypothesize that ultrasound (U/S) should be sufficient to evaluate kidneys for suspected renal stones.

All patients aged 18 years of age and over who are undergoing a renal stone protocol for evaluation of flank pain will be included.

Pregnant patients will not be included.

Eligibility Criteria:
Inclusion Criteria:

* Adult, able to consent, flank pain

Exclusion Criteria:

* Pregnant, unable to consent
Beet Root Supplement Trial

To examine the effects of two forms of beetroot juice supplementation on exercise performance in trained cyclists.


Eligibility Criteria:
Inclusion Criteria:

* good physical health
* trained or competitive cyclist
* between 18-40 years of age

Exclusion Criteria:

- have used any anabolic or ergogenic supplementation in the last 1-3 months
Establish a CT Images Database of Patients With Congenital Heart Disease

Setup CT images database of congenital heart disease.

Setup CT images database of congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

- congenital heart disease

Exclusion Criteria:

-
Cannabis for Palliative Care in Cancer

Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent
2. Aged ≥25 years at Visit 1 (Baseline)
3. Have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months
4. Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
5. Desire to use cannabis to treat their symptoms
6. Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months
7. Willing to practice acceptable methods of birth control until completing study medication

Exclusion Criteria:

1. Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
2. Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
3. Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide)
4. Current use of anti-psychotic medications
5. Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone)
6. Liver function tests (Alanine transaminase \[ALT\] and Aspartate transaminase \[AST\]) levels ≥2x the upper normal limits
7. Moderate or severe liver disease
8. Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
9. History of seizures
10. For female participant of childbearing potential: Pregnant or lactating at the time of study enrollment or trying to become pregnant. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy
11. Physician response to passive consent indicating contraindications for participation.
12. Unwilling to refrain from cannabis use other than study drug for the entire study duration
13. Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease

This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.


Eligibility Criteria:
Inclusion Criteria:

* Must have biopsy proven grade II-IV acute GVHD refractory to systemic corticosteroids
* No chronic GVHD
* Age ≥ 18 years
* Evidence of myeloid engraftment (ANC ≥ 0.5 x 109/l)
* Performance status 0-3

Exclusion Criteria:

* Patients on mechanical ventilation or who have resting O2 saturation \<90% by pulse-oximetry.
* Patients on renal dialysis or who have an estimated creatinine clearance of \< 30 ml/min/1.73 m2.
* Patients with documented clinical infection (progressive symptoms despite antibiotics or continued fever) cannot be enrolled on study until infection is controlled.
Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia

Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.

This is a randomized, prospective study which will include a total of 200 patients who are scheduled to undergo elective surgery. The research participants will be randomly assigned to

* a control group that will receive a low preemptive volume loading (50 mL of gelatin),
* a protocol group that will receive a high preemptive volume loading (500 mL of gelatin).

Volume loading is preceded by the measurement of stroke volume and cardiac output before and after a passive leg elevation test and followed by a standardized anesthetic protocol.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective surgery.

Exclusion Criteria:

* Difficult peripheral venous access
* Allergy to gelatin
* Symptomatic cardiac disease, rhythm trouble, pace-maker, aortic valvular disease, aortic disease
* Morbid obesity, low BMI,
* hypovolemia,
* Raynaud syndrome or scleroderma,
* Contra-indication to propofol, remifentanil or to the use of Bispectral Index,
* Hematocrit \< 20%.
A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age

This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an investigational treatment for head lice and nits, in normal, healthy infants.

There are millions of children and adults affected with head lice each year in the United States. It has become a major nuisance in school children resulting in many lost school days and frustrated parents. Lice and nit resistance to current OTC products is being widely reported. Compliance with product instructions is thought to be low. Therefore a safe and effective alternative to these products is desirable.

Spinosad (the active ingredient in NatrOVA) and its formulations have been approved as agricultural insecticides in the US, Canada and Australia, and has received provisional approval in the UK, Spain and several other European Union countries.

Spinosad is being formulated into a creme rinse product (NatrOVA) using excipients that are widely used and are "generally regarded as safe" (GRAS)

This study is intended to measure the absorption (or lack thereof) of Spinosad through the scalp of infants aged 6 to 24 months, as well as to observe any adverse events related to use of the study drug. A validated method for determining the levels of Spinosad in plasma will be utilized.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 6 to 24 months of age
2. Individuals in good general health, free of any systemic or dermatologic disorders which will interfere with the study results.
3. Completion of an appropriate Informed Consent Agreement.
4. Subjects must be available to stay in the clinic for blood draws. Parents or guardians must be available to stay in the clinic with the minor subject, for the duration of the study.
5. Subjects must have veins capable of withstanding multiple blood draws.
6. Normal values (at screening) for serum chemistry and hematology for subjects.

Exclusion Criteria:

1. History of irritation or sensitivity to pediculicide or hair care products or ingredients.
2. History of known allergy or sensitivity to topical anesthetics including lidocaine and prilocaine.
3. Systemic diseases that could interfere with the results of this study.
4. Any condition or illness that, in the opinion of the Principal Investigator or designee, may compromise the objectivity of the protocol or the safety of the subject.
5. The use of antibiotics or other systemic medications within two weeks of the screening visit, which in the opinion of the investigator, could interfere with the outcome of the study.
6. Participation in a previous drug study within the past 30 days.
7. Individuals with any visible skin/scalp condition at the treatment site which will interfere with the evaluations according to the opinion of the Investigator.
8. Parents or guardians who, in the opinion of the Investigator, do not understand their child's requirements for study participation and/or may be likely to exhibit poor compliance.
APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results

In both the ASC-US Study and Adjunct Study populations, the objectives are to:

* evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and
* evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.

The APTIMA HPV 16 18/45 Genotype Assay (AHPV-GT Assay) is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18 and 45 in cervical specimens from women with positive results in the APTIMA HPV Assay. The AHPV-GT Assay can differentiate between samples positive for HPV 16 from those positive for HPV 18 and/or 45, but does not differentiate between HPV 18-positive samples and HPV 45-positive samples. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt Solution (Hologic, Inc., Marlborough, Massachusetts) with commercially available collection devices (broom-type collection device or cytobrush/spatula combination) may be tested with the AHPV-GT Assay either pre- or post-Pap processing. The assay is used with the TIGRIS DTS (TIGRIS) System.

In both the ASC-US Study and Adjunct Study populations, the objectives are to:

* evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and
* evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.

Eligibility Criteria:
Inclusion Criteria:

* • the subject attended a colposcopy visit, and

  * the referral Pap sample had a valid APTIMA HPV Assay result, and

    * the sample had an APTIMA HPV Assay positive result, or
    * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 \[CIN2\] or more severe (eg, CIN2, CIN grade 3 \[CIN3\], or cervical cancer; "CIN2+"), or
    * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of normal or CIN grade 1 (\<CIN2) and was randomly selected for inclusion. the referral Pap sample had a valid APTIMA HPV Assay result, and
    * the sample had an APTIMA HPV Assay positive result, or
    * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of CIN2+, or
    * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of \<CIN2 and was randomly selected for inclusion.

Exclusion Criteria:

* Samples from evaluable subjects meeting the sample inclusion criteria will not be tested with the AHPV-GT Assay if there is insufficient volume for AHPV-GT Assay testing or the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).
A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults

The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).


Eligibility Criteria:
Inclusion Criteria:

* In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
* A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
* Agree to not donate blood from the time of vaccination until 3 months after vaccination
* Have a body mass index (BMI) less than (\<) 40 kilogram per meter square (kg/m\^2)
* Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study

Exclusion Criteria:

* Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
* Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
* History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
* Has hepatitis B or C infection, including history of treated hepatitis C infection
* Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization
Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years males and females
* Female subjects of childbearing potential must be using two methods of contraception
* Active, moderate to severe disease
* Poor response to or no toleration of conventional therapy (e.g. steroids, mesalamine)
* Good communication with the investigator, understanding and compliance with the requirements of the study and written informed consent

Exclusion Criteria:

* Allergy to the drug
* Very low or high body weight
* Ongoing treatment with specific other medication (e.g. antibiotics)
* Diagnosis of primary sclerosing cholangitis
* Renal impairment
* Toxic megacolon
* Presence or history of specific other diseases, cancer, cardiac abnormalities, abnormal laboratory findings
* History of alcohol or drug abuse
* Pregnant or breastfeeding women
* Positive HIV, Hepatitis B or Hepatitis C test result

Other protocol-defined inclusion/exclusion criteria do apply
Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.

The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects the participants sleep and how they perceive their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of ADHD
* Baseline ADHD-RS-IV score \>= 32
* Non-pregnant females of childbearing potential must comply with contraceptive restrictions.

Exclusion Criteria:

* Significantly underweight or morbidly obese
* Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
* History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
* Females who are pregnant or lactating