cyrilzakka/clinical-trials huggingface dataset:
Mila Blooms Intervention Study

This study is focused on the development and pilot/feasibility testing of a smartphone application to promote a healthy diet, increase physical activity, and prevent weight gain in adolescent survivors of childhood cancer.

While successful advancements in treatment for childhood Acute Lymphoblastic Leukemia (ALL) have resulted in a growing cohort of survivors, these survivors are at risk for a number of long-term health problems. This study proposes to develop and conduct feasibility testing for a smartphone application that would deliver a health behavior intervention to this population.

A formative phase focused on intervention and software development will be followed by a pilot/feasibility test of the intervention. Participants in the intervention will receive a customized study-designed mobile phone app with a social networking component in which users will be able to support one another. They will also receive personal support from a health counselor to help set goals and discuss areas of concern.

Eligibility Criteria:
Inclusion Criteria:

* Participants must speak \& read/write fluent English;
* Adolescent must be between 12 and 19 years of age;
* Adolescent must have a previous diagnosis of childhood Acute Lymphoblastic Leukemia;
* Adolescent must be "off-therapy" (i.e., not in active or maintenance phase of cancer therapy) for at least 2 years;
* Adolescent must be cleared by his/her physician to participate (defined by obtaining a score of 80 or greater on the Karnofsky Scale as determined by their physician);
* Participants must have a working phone number;
* Adolescents must live at home with parents in order to facilitate parent involvement via support materials.

Exclusion Criteria:

* Physician reports that the patient has deficits in neurocognitive functioning that would preclude him/her from participating in a cognitive-oriented intervention;
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer

This is a Phase 1b/2, multiple-dose study designed to describe safety and efficacy, and to assess PK and immunogenicity of XmAb18087 monotherapy and in combination with pembrolizumab in participants with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and mAb18087 monotherapy in participants with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies.

This study was terminated by the sponsor. No participants enrolled in Part B.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Adult participants ≥ 18 years
* Disease measurable by RECIST 1.1 criteria using either computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* All participants must have adequate archival tumor sample (slides or archival formalin-fixed paraffin-embedded \[FFPE\] block\[s\] containing tumor that has not been previously irradiated
* Female participants of childbearing potential must agree to use a highly effective method of birth control during and for 4 weeks after completion of study. success), or sexual abstinence
* Fertile male participants must be willing to practice a highly effective method of birth control for the duration of the study and continuing for 4 weeks after the last dose of XmAb18087 or pembrolizumab (when applicable
* Able and willing to complete the entire study according to the study schedule

Additional Inclusion Criteria for Part A and Part B Cohorts:

• Histologically or cytologically confirmed metastatic MCC or locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy.

Additional Inclusion Criteria for Part A Cohorts:

• Participants must have progressed on or been ineligible for treatment with anti-PD1 or anti-PDL1 therapy.

Additional Inclusion Criteria for Part B Cohorts:

• Participants must be eligible to receive pembrolizumab as standard of care.

Additional Inclusion Criteria for Part C Cohorts:

• Histologically or cytologically confirmed extensive-stage SCLC that has progressed following standard therapies

Exclusion Criteria:

Additional Exclusion Criteria for Part B Cohorts: XmAb18087 in Combination with Pembrolizumab

* Prior treatment with therapeutics directed at anti-programmed cell death 1 (anti-PD1) or anti-programmed cell death ligand 1 (anti-PDL1)
* Have severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
PNT2258 for Treatment of Patients With r/r DLBCL (Wolverine)

This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a multi-center, nonrandomized, open label, phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed diffuse large B-cell lymphoma that is refractory to prior therapy or relapsed after prior therapy.

FDG PET-CT (disease) positive baseline scan with measurable disease.

The patient must have received prior therapy that included:

* CD20-targeted therapy (for example, rituximab),
* Alkylating agent (for example, cyclophosphomide), and
* Steroid, unless the patient is steroid intolerant

Exposure to at least 1 or 2 (but no more than 3) prior systemic cytotoxic chemotherapeutic regimens.

Note: Only those subjects who are not eligible for high-dose chemotherapy and autologous stem cell transplant (HD-ASCT), or who refuse HD-ASCT, are eligible with exposure to only 1 prior cytotoxic chemotherapeutic regimen.

ECOG performance status of 0-1.

The patient must be a stable baseline with CTCAE grade ≤ 2 regarding any acute or chronic toxicity associated with prior therapy, and have discontinued prior anti-cancer therapy for ≥ 14 days prior to C1D1; mitomycin-C for at least 6 weeks prior to C1D1; SCT ≥ 2 months prior to C1D1.

Note: Palliative steroids for control of disease-related symptoms are allowed and maintenance hormone therapy is allowed.

Adequate organ function including:

* Hematologic: ANC ≥ 0.5 x 10\^9/L. and platelets ≥ 50 x 10\^9/L.
* Hepatic: Total Bilirubin ≤ 2 x ULN (patients with Gilbert's syndrome must have total bilirubin ≤ 3 x ULN) and serum transaminase levels ≤ 2.5 x ULN. In the case of known liver metastasis (i.e., radiological or biopsy documented), serum transaminase levels must be ≤ 5 x ULN.
* Renal: Serum creatinine ≤ 2 x ULN, or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with serum creatinine levels above 2 x ULN.

Willingness to: 1.) undergo pre-treatment biopsy to obtain adequate tissue for analysis (e.g., core needle, excisional or incisional tumor biopsy) or 2.) provide archived tumor (e.g., FFPE block) for analysis.

Exclusion Criteria:

Eligibility for high-dose chemotherapy (HDT) and stem cell transplant (SCT). Note: Subjects who progressed ≥ 2 months after HDT/SCT are eligible

Concurrent malignancies requiring treatment.

Primary mediastinal (thymic) large B-cell lymphoma

Symptomatic CNS or leptomeningeal involvement of lymphoma.

Concurrent clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram or laboratory finding that, in the opinion of the investigator, could adversely affect the safety of the patient or impair the assessment of the study results.

Signs or symptoms of heart failure characterized as greater than NYHA Class II or other significant cardiac abnormalities.

Pregnant or breast-feeding.

Prior exposure to PNT2258.

Life expectancy less than 3 months.
A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India

The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter \[mL\]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged \>= 65 years of age
* Participants and/or legally acceptable representative (s) (LAR) who in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits
* Written or witnessed/thumb printed informed consent obtained from the participant and/or participant's LAR(s) after the study has been explained according to the local authority requirements and prior to performance of any study-specific procedure

Exclusion Criteria:

* History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine.
* Receipt of licensed vaccine, immune sera and/or any blood products, or an investigational trial agent within previous 30 days or planned during their participation in the trial.
* Receipt of any flu vaccine within 6 months before trial start or any other vaccine within 30 days before the trial.
* Receipt of any dose of a Coronavirus Disease 2019 (COVID-19) vaccine within 15 days of trial start.
* History of Guillain-Barré Syndrome.
* Altered immune status or chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within six months prior to administration of trial vaccine.
* History of acute infectious disease or acute respiratory illness needing antibiotics or antivirals in the previous 7 days, based on investigator's judgement.
* If a participant candidate has fever, the trial vaccination should be postponed to when the fever has resolved for at least 2 days (temporary exclusion criterion). Fever is defined as temperature \>=38.0 degree Celsius (°C) (100.4 degrees Fahrenheit \[°F\]) by any route. The preferred location for measuring temperature will be oral route.
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination, or laboratory screening tests.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the trial.
Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).

Eligibility Criteria:
Main inclusion criteria include:

* Patient with histological proven metastatic GIST or non-operable locally advanced GIST
* Patient with c-Kit (CD117) positive tumor detected immuno-histochemically
* Patient after at least one progression with imatinib at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment.

Main exclusion criteria include:

* Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
* Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
* Pregnant, or nursing female patient
HPV Message Testing and Social Media Campaign

This project involves a social media campaign to increase parent's knowledge and acceptance of the HPV (human papillomavirus) vaccine. The current vaccine protects against nine types of HPV, including seven that are known to cause cancer. The Centers for Disease Control and Prevention (CDC) estimates that the current HPV vaccine could prevent 90% of cancer cases caused by HPV, including cases of cervical cancer, oropharyngeal (mouth and throat) cancer, anal cancer, and others. About 150 and 104 cases of HPV-associated cancers are diagnosed each year in New Hampshire and Vermont, respectively-many of which could be prevented through vaccination. Currently, only 49.8% of New Hampshire adolescents and 44.3% of Vermont adolescents were not up-to-date for HPV vaccination as of 2016. This social media campaign is testing a set of campaign messages with parents locally and nationally to see which messages are most effective in improving their knowledge and acceptance of the vaccine. A study survey link will monitor the number of people reached and will measure parental intention to get their children vaccinated against HPV.


Eligibility Criteria:
Inclusion Criteria:

* parents of children 9-14 years old

Exclusion Criteria:

* non-parents
Pro-coagulant Markers and Anticoagulant Failure in Cancer Patients at Risk for Recurrence of Venous Thromboembolism

The presence of clots in the veins of arms and/or legs or lungs of Cancer patients decreases their quality of life, delays their treatment and may cause death. The best way to avoid new clots is by giving blood thinners before clots are formed, but even some patients who are taking blood thinners may form blood clots. A major problem is that it is difficult to know which patients form clots while they are receiving blood thinners, a situation called treatment failure. Several studies have shown that by doing blood tests that measure the formation of clots, the investigators could know if the patient is responding to the blood thinners. If this is proven, the investigators will be able to apply these tests to all patients.

Therapeutic failure in cancer patients at high risk for recurrence of Venous thromboembolism (VTE) may be as high as 20% and the risk of death from a recurrent episode of pulmonary embolism is at least 8%. Studies that have used pro-coagulant and thrombin generation markers support the notion that cancer is associated with a hypercoagulability state and that intensified doses of anticoagulation may be necessary to suppress this state. Thus, it may be possible that by using these tests, we would identify the patients that do not respond to standard doses of anticoagulation. To date, only few small studies have evaluated the use of pro-coagulant markers in cancer patients but this data is promising. Our study will measure pro-coagulant markers in cancer patients at risk for VTE recurrence to determine if there is a relationship between the changes in the levels of pro-coagulant markers and VTE recurrence while taking anticoagulation with low-molecular weight-heparin (LMWH). The evaluation of the pro-coagulant markers may enable new treatment strategies in cancer patients who fail their initial treatment. Patients will be stratified by a risk model developed by our group and will be validate with this study. This new approach has the potential to improve the recovery of patients, to reduce death and disability due to clots in the veins of legs or arms and/or lungs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with any type of cancer (except basal cell and squamous cell carcinoma of the skin) and at any stage of the disease or treatment
* Confirmed newly diagnosed acute symptomatic VTE (proximal DVT, PE, Arm DVT, Multiple SSPE only)
* Planned treatment of VTE with low-molecular weight heparin (LMWH)
* Age 18 years old or older.

Exclusion Criteria:

* Planned cell transplant
* Patient receiving anticoagulation due to other clinical indications
* Patient who has received more than one therapeutic dose of LMWH
* Unable or unwilling to provide written, informed consent.
rTMS Add on Value for Amelioration of Negative Symptoms of Schizophrenia

Treatment of depression with repetitive transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. The treatment of negative symptoms with the same protocol in schizophrenia is considered as possible effective. Theta burst stimulation is a new protocol which is characterized by shorter sessions showing first evidence that it's efficacy is comparable to the high-frequency rTMS. In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated.

In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated. The active study arms are high-frequency rTMS and iTBS of the left dorsolateral prefrontal cortex to treat negative symptoms in schizophrenia. The control arm will include the same number of patients as each active arm and includes both sham rTMS and sham iTBS in the same proportion as the active treatments.

Standards of the trial will be harmonized across four clinical centers with the aim to pool data for analysis. Each center is responsible for ethical approval and adherence to good clinical practice by itself (Sponsor).

Interim analysis: Several meta-analyses of the effect of rTMS/iTBS on negative symptoms in schizophrenia showing heterogeneous effect sizes have been published since begin of the trial. Thefore, an interim analysis after inclusion of at least 15 patients in each arm was added to the protocol. In case of null findings and low effect sizes (no differences of either rTMS or TBS vs. sham in the primary outcome), the trial will be terminated.

Eligibility Criteria:
Inclusion Criteria:

* ICD-10: schizophrenia with primarily negative symptoms
* Age: 18-75 years
* at least 35 Points at the composite score of the SANS
* stabe medication during the last 2 weeks (at the investigator's discretion)
* written informed consent (by the patient or guardian)

Exclusion Criteria:

* clinically relevant unstable concomitant somatic diseases
* previous treatment by rTMS
* conditions in which TMS may not be applicated, as e.g., cardiac pacemakers or ferromagnetic implants
* history of epileptic seizures
* current substance or alcohol abuse, or clinically relevant comorbidity (according to M.I.N.I. interview)
* unacceptable concomitant medication (benzodiazepines in higher doses, e.g., Lorazepam \> 2 mg/d, Diazepam \> 10 mg/d)
* insufficient knowledge of the language of the country of the treatment site
* pregnancy and nursing period
* current statutory hospitalisation
Excimer Light in Psoriasis

The aim of this study is to determine the standard tissue levels of SP and its receptor in lesional skin of psoriasis patients in both developing and stationary stages before and after excimer light therapy.


Eligibility Criteria:
Inclusion Criteria:

* Type of Psoriasis: plaque psoriasis.
* Less than 10% surface area.

Exclusion Criteria:

* Erythrodermic psoriasis
* Pustular psoriasis
* Topical treatment for psoriasis for the past 2 weeks.
* Systemic retinoids in the last 2 years.
* Systemic treatments (including any drugs that affect SP level as Aprepitant) in the last 3 months.
* Contraindications to excimer light therapy (history of skin malignancy or precancerous conditions like xeroderma pigmentosum or photosensitivity)
Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma

RATIONALE: Ganciclovir may ease some of the side effects of cancer treatment. Vaccines made from a person's modified malignant mesothelioma cells may make the cancer more sensitive to ganciclovir.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus ganciclovir in treating patients who have stage I, stage II, or stage III malignant mesothelioma.

OBJECTIVES: I. Determine the safety and side effects of intrapleurally administered PA-1-STK modified ovarian carcinoma vaccine and ganciclovir in patients with stage I, II, or III malignant mesothelioma. II. Determine the maximum tolerated dose and dose limiting toxicities of this vaccine in these patients. III. Determine the immunologic response to this treatment regimen in these patients. IV. Determine the intrapleural pharmakokinetics of ganciclovir in these patients.

OUTLINE: This is a dose escalation study of PA-1-STK modified ovarian carcinoma vaccine. Patients receive PA-1-STK modified ovarian carcinoma vaccine intrapleurally on day 1 followed by ganciclovir IV over 1 hour for 7 days beginning on day 1. Patients in the first 2 cohorts receive 1 course of treatment only. In all subsequent cohorts, treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of PA-1-STK modified ovarian carcinoma vaccine until the maximum tolerated dose is determined.

PROJECTED ACCRUAL: A total of 3-16 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed stage I, II, or III malignant mesothelioma Must have adequate pleural space in which to place chest tube or catheter

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hematocrit greater than 30% WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT and alkaline phosphatase less than 1.5 times normal Renal: Creatinine less than 1.5 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: No significant history of heart disease No frequent angina No myocardial infarction within the past 6 months No congestive heart failure requiring daily treatment Pulmonary: No evidence of moderate to severe pulmonary disease (i.e., FEV1 less than 40% predicted) Other: No prior malignancy except squamous or basal cell carcinoma of the skin No patients with childbearing potential

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior chemotherapy Endocrine therapy: No concurrent steroid treatment Radiotherapy: At least 6 weeks since prior radiotherapy Surgery: Not specified
Improving Outcomes for Hypertensive Children

Approximately 200 children age 6 - \<18 years receiving medications for essential hypertension (HTN) will be recruited from the Pediatric Hypertension Clinic at the time of a routine clinic visit. Participating subjects will be asked to wear the ambulatory blood pressure monitor (ABPM) for 24 hours within 2 weeks of the qualifying visit. Measurements obtained with the ABPM will be compared to measurements obtained by routine clinical procedures documented in the subject's clinical chart. Kappa statistic will be utilized to compare differences in documented BP control between the two measures as well as changes in therapeutic management decisions by treating physicians with the addition of the ABPM readings. The overall goal is to confirm that ABPM leads to an increased detection of uncontrolled HTN along with a similar increase in adjustments increasing anti-hypertensive medication regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Age 6-17 years (up to 18th birthday) receiving anti-hypertensive medication(s) by subject history at presentation for the qualifying clinic visit
2. Arm circumference measurement of 15-50 cm (limits of SpaceLabs ABPM cuffs).

Exclusion Criteria:

1. Severe HTN which in the opinion of the treating physician would prevent the subject from delaying changes in therapy to complete the study.
2. Secondary HTN from all causes (excluding obesity-related HTN). This includes but is not limited to renovascular HTN, chronic kidney disease, coarctation of the aorta, and monogenic forms of HTN.
3. Physical limitations prohibiting placement of the ABPM monitor.
4. Significant arrhythmias or known disruptions in cardiac output which may interfere with the monitor's ability to detect BP accurately.