cyrilzakka/clinical-trials huggingface dataset:
Parents Reflecting On Hope During Hospice Through Photovoice

In this study, researchers will use Photovoice to learn about how bereaved parents felt and thought about hope when their children were on hospice. 'Photovoice' is a research method that uses participants' photographs as a springboard for discussion.

Primary Objective

* To explore reflections, emotions, and experiences evoked in bereaved parents when reviewing photographs from their child's time on hospice, with photos selected by parents based on a prompt related to their thoughts about hope during that time.

Using a prospective qualitative design, we will enroll parents of children who died on hospice 6-24 months prior. Parents who opt to participate in the study will be asked to review photographs they have from when their child was on hospice and to select 1-5 photographs that communicate what hope meant to them at that time. Their photograph selection will be guided by a brief conversation with the researcher and a written guide that encourages the participant to think about hope broadly and invites an open interpretation of what it means for a photograph to represent hope.

Parents will bring their selected photograph(s) to a one-on-one semi-structured interview. The interview will take place either in person or over a virtual meeting platform. During the interview, the participant will share the photographs with the researcher, discuss why they were chosen, and share any other reflections they have about their experience. It is anticipated that the interview will last about 60 minutes. The audio for the meeting will be recorded. Video will not be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be the parent of a child who:

  * Received any form of care from a clinician at St. Jude, as documented in the electronic medical record, AND
  * Was enrolled on hospice at the time of death, AND
  * Died at least 6 months prior to enrollment, but no more than 24 months prior to enrollment.
* Participants must also:

  * Be ≥ 18 years of age or legally emancipated, AND
  * Be English-speaking or Spanish-speaking.

Exclusion Criteria:

* Insufficient comfort or fluency with either English or Spanish language.
Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy

To assess the toxicity, tumor response rate, and effect on quality of life of daily low-dose etoposide administered for 7 consecutive days every other week in patients with AIDS-related Kaposi's sarcoma that has relapsed or progressed after systemic chemotherapy.

Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time.

Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time.

Patients receive low-dose oral etoposide on days 1 through 7 of every 2-week cycle. Patients who achieve a complete or partial response after two cycles and have no toxicity greater than grade 2 may have their dose escalated for subsequent cycles. If there are no responses to therapy among the first 14 evaluable patients, the study will close; if there is at least one objective response to therapy among the first 14 evaluable patients, enrollment will continue until all 41 patients are enrolled. Patients continue therapy until maximal tumor response (either stable disease or complete response) is achieved or disease progression occurs.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Maintenance therapy for opportunistic infections.

Patients must have:

* HIV infection.
* Kaposi's sarcoma that has relapsed or progressed.
* Mucocutaneous lesions (15 or more) and/or symptomatic mucosal lesions and/or visceral Kaposi's sarcoma (symptomatic lymphedema qualifies patients in the absence of these three conditions).
* NO active acute opportunistic infections requiring treatment with myelosuppressive antibiotics (maintenance for OIs is permitted).
* Consent of parent or guardian if less than 18 years of age.

NOTE:

* This study is approved for prisoner participation.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Other active malignancies except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
* Grade 3 or worse peripheral neuropathy.
* Altered mental status that would prevent informed consent or prevent study compliance.

Patients with the following prior condition are excluded:

Neuropsychiatric history.

Prior Medication:

Excluded:

* Prior etoposide.
* Any other anti-KS drugs within 14 days prior to study entry.
* Any investigational drug other than antiretrovirals within 14 days prior to study entry.
* Any prior investigational agent, if given as the ONLY prior treatment for KS.

Prior Treatment:

Excluded:

* Radiation therapy within 7 days prior to study entry.

Continued alcohol consumption or continued intravenous drug use that would impair ability to comply with study requirements.
Study to Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia.

A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary hypercholesterolemia

Exclusion Criteria:

* The subject not meet the specified LDL-C level
Serotype Distribution of Streptococcus Pneumoniae That Causes Invasive Diseases at Children and Adults in Turkey

The aim of this study is to specify the serotype distribution of Streptococcus pneumoniae that causes invasive diseases at children and adults in Turkey.

Non-interventional observational study Descriptive analysis will be conducted.

Eligibility Criteria:
Inclusion Criteria:

Serotype distribution and antibiotic sensitivity of pneumococcal isolates that causes invasive pneumococcal diseases which are obtained from the blood, CSF, and/or all other sterile body areas (catheter, pleural fluid, parasynthesis fluid, pericardial fluid, synovial fluid, BAL) of the adults of 18 years of age or older with children that are younger than 18 years old at these centers and laboratories will be defined.

Exclusion Criteria:

Isolation of any other microorganism than pneumococcus at the same sample.
Study of Risk Factors for Therapeutic Failure in Chronic Non-Infectious Uveitis After First-Line Immunosuppressive Therapy

Uveitis is an inflammatory disease of the uvea, constituting the 4th leading cause of legal blindness worldwide and the 3rd leading cause of avoidable blindness . It is not a rare condition, with an incidence of 17 to 52 per 100,000 population and a prevalence of 38 to 204 per 100,000 population. In the case of cortico-dependence, it is generally accepted to propose sparing with a conventional immunosuppressant, whose efficacy is estimated at around 70%, compared with biotherapies, which are considered more effective (over 90%) but only available as 2nd-line treatment. However, there are few studies on the failure factors of this first-line treatment, such as macular thickness , gender, or vitamin D deficiency. Risk factors for flare-ups are nevertheless known, notably ethnicity, and smoking. The aim of this study is to identify risk factors for treatment failure after three months of first-line immunosuppressive therapy in patients with chronic non-infectious uveitis at Amiens-Picardie University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Age : \> 18 years old
* Uveitis requiring immunosuppressive therapy.
* Including at least one posterior involvement according to the SUN terminology: posterior, or intermediate and posterior, or anterior and posterior, or panuveitis.

Exclusion Criteria:

* Uveitis associated with multiple sclerosis or systemic lupus erythematosus.
* Ocular involvement in Behcet's disease requiring biologic therapy as first-line immunosuppressive treatment.
* Uveitis without posterior segment involvement.
* Infectious uveitis.
* Patients objecting to the use of their personal data for research purposes.
Yellow Pea Protein and Fibre and Short Term Food Intake

It is hypothesized that yellow pea protein and fiber will reduce short-term food intake, subjective appetite and glycemic response.

A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10 or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea fractions. Food intake was measured at an ad libitum pizza meal served 30 minutes after treatment. Satiety and blood glucose (via finger prick) were measured throughout the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* male 20-30 years old healthy weight

Exclusion Criteria:

* smoking restrictive eating metabolic diseases breakfast skippers dieters
A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets.

The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers.
* Female volunteers have to be of non-childbearing potential

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator

Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Currently, a premature baby has to be ventilated through an endotracheal tube until he/she can fully breathe independently. In the current study, in order to shorten the time with an endotracheal tube, we utilized an alternative, less invasive ventilation procedure, nasal intermittent positive pressure ventilation (NIPPV). This procedure provides help with breathing, but requires only nasal, not endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage in their recovery, when they could not breathe independently yet. Thus, by switching babies at this early stage from a regular respirator to NIPPV, we should be able to shorten the use of an injurious endotracheal tube.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age 24 wks and 0 days through 27 wks and 6 days by obstetric criteria.
* Infants who are intubated for respiratory distress and received surfactant within 48 hrs of life.
* Infants whose ventilator settings are: ventilatory rate ≥ 26 breaths per minute. If the baby is on the high frequency oscillatory ventilator (HFOV) settings are MAP(mean airway pressure) ≥ 9, amplitude ≥ 2xMAP and frequency ≤ 13 Hertz.
* Infants who have never been previously extubated.

Exclusion Criteria:

* Infants enrolled in competing trials.
* Participation refused by parent/attending physician/ parent unavailable for consent.
* Infants with any major congenital abnormality.
* Postoperative patients from any surgery.
* Infants in extremis/decided upon not to receive intensive care.
* Ventilator settings lower than the intervention group.
Mindfulness-Based Cognitive-Behavioral Therapy for Gambling Disorder

To compare two group psychological interventions for Gambling Disorder in terms of effectiveness and efficacy. One group is based in cognitive-behavioral therapy (TAU) and the other group is based in TAU with Mindfulness-Based Relapse Prevention (Chawla, Marlatt \& Gordon, 2011). Both interventions are composed by 14 weekly sessions, and follow-up to a month, three months, six months, one and two years.


Eligibility Criteria:
Inclusion Criteria:

* Gambling Disorder (DSM-5; APA, 2013).
* 18 years or older.
* Males and females.

Exclusion Criteria:

* Current psychosis or other severe/acute mental disorder.
* Current substance abuse.
* Intellectual disability.
* Under 18 years.
Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients with Advanced Solid Tumors

This research is designed to determine if experimental treatment with PARP1 inhibitor, VB15010 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 at the time of screening;
* Histological or cytological confirmation of advanced malignancy ;
* Progressive cancer at the time of study entry;
* Adequate organ and marrow function as defined by the protocol;
* Homologous recombination repair gene mutation.

Exclusion Criteria:

* Major surgery within 4 weeks of the ﬁrst dose of study treatment.
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \>10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
* Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer

RATIONALE: Tetracycline may be effective in preventing skin rash that is caused by treatment with drugs such as gefitinib or cetuximab.

PURPOSE: This randomized clinical trial is studying tetracycline to see how well it works compared to placebo in preventing skin rash in patients who are receiving drugs such as gefitinib or cetuximab for cancer.

OBJECTIVES:

* Compare the 1-month incidence and severity of gefitinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with tetracycline vs placebo.
* Compare the toxicity of these drugs in these patients.
* Compare the quality of life of patients treated with these drugs who develop vs those who do not develop a rash.
* Determine whether patients who discontinue tetracycline at 1 month develop a rash.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior chemotherapy regimen (first-line therapy vs other), concurrent epidermal growth factor receptor inhibitor therapy (gefitinib vs cetuximab vs other), and concurrent corticosteroid therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral tetracycline twice daily.
* Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 4 weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline and then weekly for 8 weeks.

Patients are followed at weeks 4 and 8.

PROJECTED ACCRUAL: A total of 126 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Began therapy within the past 7 days or plans to begin therapy within 7 days after study entry with one of the following epidermal growth factor receptor inhibitors:

  * Gefitinib
  * Cetuximab
  * Erlotinib
  * Monoclonal antibody ABX-EGF
  * ICR-62
  * CI-1033
  * EMD-72000
* No rash at study entry

PATIENT CHARACTERISTICS:

Age

* 18 and over

Hepatic

* Bilirubin ≤ 2 mg/dL

Renal

* Creatinine ≤ 2 mg/dL

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective non-hormonal contraception
* Able to take oral medication
* No history of skin condition that may flare during study treatment
* No prior allergic reaction or severe intolerance to tetracycline or one of its derivatives
* No severe nausea or vomiting that would preclude retaining study drug

PRIOR CONCURRENT THERAPY:

Other

* More than 1 week since prior tetracycline
* No milk products, antacids, or calcium supplements for 2 hours before until 2 hours after drug administration
* No other concurrent tetracycline
A Home Visiting Program for Pregnant Youth to Promote Early Brain Development

Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to tools which will nurture and properly stimulate their baby, thus promoting emotional and cognitive development. Objectives: The "Nurse home visitation program for pregnant youth" aims to promote infant´s healthy development, from pregnancy to the first months of life, in a high-risk population. Methods: Eighty young pregnant women aged between 14 and 20 years were randomly allocated to the intervention or to usual prenatal care program. The "Nurse home visitation program for pregnant youth" was developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s bioecological model, which recognizes the importance of individual and family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of attachment, which involves the care practitioner addressing issues such as environmental health, life course and parenting, bond between mother and infant, and infant´s social and cognitive development. Neuropsychomotor development will be assessed at 3, 6 and 12 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Low socioeconomic status
* Mother's age between 14-19
* Mother being a primapara
* Gestation between the 8th and 16th week

Exclusion Criteria:

* High-risk gestation
* Mother's Intellectual, visual or auditory disability
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

The target population of interest in this study is participants with high-risk HER2-positive early-stage breast cancer. The purpose of this study is to determine the efficacy and safety of T-DXd neoadjuvant therapy.

Participants will be randomised to one of 3 arms: T-DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C).

Eligibility Criteria:
Key Inclusion Criteria:

* Patients must be at least 18 years of age.
* Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or ≥ T3, N0, M0 as determined by the AJCC staging system, 8th edition
* ECOG performance status of 0 or 1 at randomization
* Adequate organ and bone marrow function
* LVEF ≥ 50% within 28 days before randomization
* FFPE tissue block (2 cores) or 20 freshly-cut, serial tumor slides for HER2 assessment by central lab. If blocks are incomplete or fewer than 20 slides are available, participants may be eligible following discussion with the AstraZeneca Study Physician

Exclusion Criteria:

* prior history of invasive breast cancer
* stage IV breast cancer (determined by AJCC staging system)
* any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease) Note: This includes a second current breast primary malignancy (ie, bilateral breast cancer)
* history of DCIS (except those treated with mastectomy \>5 years prior to current diagnosis)
* History of, or current, ILD/pneumonitis
* Prior systemic therapy for the treatment of breast cancer
* Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy
Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis

Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it presents as subacute monocular visual loss that develops over several days.

As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term beneficial effect on vision.

There are a number of factors that contribute to nerve fibre damage including increased level of sodium, so blocking sodium entry could help to protect them against damage.

The main objective of the study is determine whether phenytoin (which blocks sodium entry) can protect nerve fibre and improve final visual function after optic neuritis.


Eligibility Criteria:
Inclusion Criteria:

* isolated, unilateral, first acute optic neuritis (confirmed by neuroophthalmologist)
* willing to receive a steroidal regimen
* no pathologic finding in first oct
* no pathology and history of optic neuritis in contralateral eye
* \<14 days since onset visual loss

Exclusion Criteria:

* Contraindication or known allergy to Phenytoin
* Use of a calcium channel or sodium channel blocker in the past 2 months
* Corticosteroid use in the past 2 months
* Pregnancy
* Significant cardiac, renal or liver abnormalities
* Prior clinical episode of optic neuritis in either eye
* Bilateral acute optic neuritis
* Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
* Refractive error of greater than +5 or -5 diopters
* Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading