cyrilzakka/clinical-trials huggingface dataset:
A Study of Avutometinib (VS-6766) V. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer with and Without a KRAS Mutation

This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven LGSOC (ovarian, peritoneal)
* Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
* Measurable disease according to RECIST 1.1
* An Eastern Cooperative Group (ECOG) performance status ≤ 1.
* Adequate organ function
* Adequate recovery from toxicities related to prior treatments
* Agreement to use highly effective method of contraceptive, if necessary

Exclusion Criteria:

* Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
* Co-existing high-grade ovarian cancer or another histology
* History of prior malignancy with recurrence \<3 years from the time of enrollment
* Major surgery within 4 weeks
* Symptomatic brain metastases requiring steroids or other interventions
* Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy
* For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor
* Active skin disorder that has required systemic therapy within the past year
* History of rhabdomyolysis
* Concurrent ocular disorders
* Concurrent heart disease or severe obstructive pulmonary disease
* Subjects with the inability to swallow oral medications
Effectiveness of the Universal Prevention Program Super Skills for Life in Schools

This study aims to evaluate the effectiveness of a 12-session cognitive-behavioral transdiagnostic protocol for Spanish children aged 8 to 12 within an educational context, Super Skills for Life. The program, designed to enhance emotional management and social interaction skills, will be delivered in a group format and supplemented with multimedia materials. The study will compare outcomes between an intervention group and a wait-list control group.

A 2 x 4 factorial design will be employed, with the intervention condition (intervention or waiting list) as the intergroup factor and the evaluation phase (pretest, posttest, 6-month follow-up, and 12-month follow-up) as the intragroup factor. Both parents and children will complete the same assessments at baseline, post-treatment, and follow-up stages. The researchers will analyze the changes in emotional and social variables from pre- to post-assessment in children who participate in the program.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8 to 12 years.
* Be Spanish-speaking.
* Accepting informed consent to participate in the study.

Exclusion Criteria:

* Intellectual disability, behavioral symptoms or autistic spectrum symptoms whose severity prevented the continuation of treatment.
* Current psychological or pharmacological treatment for anxiety and/or depression.
* Not accepting or revoking informed consent to participate in the study.
Pain Caregiver Resource (PainCaRe)

Pain is a problem for children with cancer, especially when they are outside of the hospital setting. Younger children with cancer are particularly vulnerable to undermanaged pain because of their inability to self-report pain and their reliance on parents for treatment. One method to help these children to get the best care possible is through the use of smartphone-based mHealth solutions. Smartphone apps can provide treatment advice to patients experiencing pain in real-time and in any environment. This research will use a phased and user-centered approach with family caregivers to co-design and co-evaluate the new cancer Pain Caregiver Resource (PainCaRe) app to achieve the following aims: (1) high-fidelity software development and usability refinement; (2) evaluation of trial feasibility and preliminary effectiveness in a pilot randomized controlled trial (RCT); and (3) systematic analysis of caregiver app usage patterns to refine PainCaRe for optimal engagement prior to a future RCT.


Eligibility Criteria:
1. Be the primary caregiver, or person assuming the majority of care activities, for a child aged 2-11 years undergoing cancer treatment and experiencing above mild pain (≥3/10) in the week preceding study enrolment (pain measured by self or caregiver proxy using a validated numerical 11-point rating scale).
2. Be able to speak and read English.
A Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in Blacks

The overall hypothesis of this study is that a cardiac rehabilitation program with meditation will be more effective than cardiac rehabilitation alone in improving blood flow through the diseased coronary arteries in African Americans. For this purpose, 56 African American men and women with coronary heart disease will be randomly assigned either to standard cardiac rehabilitation plus the Transcendental Meditation program or to standard cardiac rehabilitation alone. The treatment period will be 12 weeks in length.

The overall objective of this study is to conduct a randomized controlled trial to determine the efficacy of cardiac rehabilitation with and without a structured, standardized, and validated stress reduction component in the secondary prevention of coronary heart disease (CHD) in African Americans. In this phase II trial, 56 African American men and women with established CHD will be randomly allocated either to standard cardiac rehabilitation with formal stress reduction training using the Transcendental Meditation program or to standard cardiac rehabilitation alone. The intervention period will be 12 weeks. At baseline and posttest, subjects will be tested by quantitative Positron Emission Tomography (PET) for myocardial perfusion and ischemia. Secondary outcomes comprise physiological, behavioral and psychosocial risk factors for CHD. The field site will be Columbia University Medical Center and the coordinating center will be MUMRI-Center for Natural Medicine and Prevention.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age: No limitations
3. CHD documented by medical history of at least one of the following: a.acute myocardial infarction (MI) within the preceding 12 months b.coronary artery bypass surgery (CABG) c. percutaneous coronary intervention (PCI, PTCA)d. chronic stable angina
4. Written informed consent

Exclusion Criteria:

1. noncardiac life threatening illness
2. Severe cognitive impairment or physical disability
3. History of major psychiatric disorder, i.e. psychosis, dementia, or substance abuse disorder within the past year.
4. Left ventricular ejection fraction less than 40%
5. Conditions that may be a contraindications to PET perfusion imaging with adenosine stress testing, including unstable angina or myocardial infarction in the past week, aortic stenosis, uncontrolled hypertension, uncontrolled atrial or ventricular arrhythmias, second-degree or higher atrio-ventricular block in the absence of a functioning pacemaker, baseline hypotension (systolic blood pressure \< 90 mm Hg), severe obstructive lung disease or decompensated heart failure.
Metabolic Syndrome in Patients with Knee Osteoarthritis

Study the prevalence of metabolic syndrome in patients with knee osteoarthritis and conclude the relationship between metabolic syndrome and the severity of knee osteoarthritis

Osteoarthritis is one of the most common clinical conditions causing severe chronic and restrictive disability, especially in elderly people.

Of those aged 60 years and older, 10% of men and 13% of women had symptomatic knee OA . As the population ages and the prevalence of obesity and overweight generaly rises , the percentage of persons affected with symptomatic knee OA will likely increase.

The clinical manifestations in patients are joint pain, stiffness, and functional limitation .

Among all body joints; knee joint is the most commonly affected joint with osteoarthritis and accounts almost for four-fifth of the osteoarthritis burden worldwide .

Epidemiological research has shown an encouraging relationship between OA and metabolic syndrome , MetS include hypertension, dyslipidemia, hyperglycemia, and obesity .Recently, metabolic OA has been nominated as the fifth component of MetS .

Studies reported that adipokines may contribute to the development of osteoarthritis (OA) by increasing inflammatory cytokines and growth factors, modifying insulin sensitivity, and triggering processes that break down cartilage.

Studies also reported that hypertension can be linked to osteoarthritis through astherosclerosis which cause subchondral bone ischemia accelerating OA progression.

Furthermore, researches have linked glucose levels to knee osteoarthritis , supporting the possibility of pathophysiological mechanisms such oxidative stress in the chondrocytes and Cartilage-associated production of advanced glycation end products (AGEs) .

Eligibility Criteria:
Inclusion

1. Both males and female .
2. Age between 30 and 70 years old.
3. Patient fulfill the criteria of knee osteoarthritis .

Exclusion Criteria:

1. Patients known to have rheumatological disease .
2. Patients with meniscal or cruciate ligament injury .
3. Patients with previous knee surgery .
Raltitrexed in Treating Children With Refractory Acute Leukemia

Phase I trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

OBJECTIVES:

I. Determine the maximum tolerated dose and dose limiting toxicity of raltitrexed given for three weeks to children with refractory acute leukemia.

II. Determine the incidence and severity of other toxic effects of this regimen in these patients.

III. Determine a safe and tolerable dose of raltitrexed, administered in this manner, to be used in phase II studies.

IV. Determine the pharmacokinetics of this regimen in these patients. V. Determine if plasma 2' deoxyuridine concentrations are associated with raltitrexed toxicity or pharmacokinetics.

VI. Evaluate the antitumor activity of raltitrexed against recurrent leukemia.

OUTLINE: This is a dose escalation study.

Patients receive raltitrexed intravenously over 15 minutes once weekly for 3 weeks followed by 1 week of rest. Treatment continues in the absence of disease progression and unacceptable toxicity.

In the absence of dose-limiting toxicity (DLT) in the first cohort of 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of raltitrexed on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose.

Patients are followed every 6 months for 4 years, then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven acute leukemia (M3 marrow) that is refractory to conventional therapy or for which no effective therapy exists
* No CNS leukemia
* No solid tumors
* Performance status: Karnofsky 50-100% OR Lansky at least 50 (for infants)
* Life expectancy: At least 8 weeks
* Bilirubin less than 1.5 mg/dL
* SGPT less than 5 times normal
* Normal creatinine for age OR GFR at least 70 mL/min
* No significant systemic illness such as infection
* No significant third space fluid collection
* Not pregnant or nursing
* Recovered from acute toxic effects of prior immunotherapy
* At least 6 months since prior bone marrow transplant with no evidence of graft-versus-host disease
* At least 10 days since prior biologic therapy
* At least 1 week since prior growth factors
* At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered
* No concurrent steroids
* Recovered from acute toxic effects of all prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior substantial bone marrow radiation
* No other concurrent anticancer therapy or investigational agents
* No concurrent nonsteroidal anti-inflammatory agents
Efficacy and Safety of Lenvatinib as an Adjuvant Therapy for Hepatocellular Carcinoma

Lenvatinib is the standard of care for patients with advanced hepatocellular carcinoma (HCC). The aim of the single-arm, open-label, phase II clinical trial is to evaluate the efficacy and safety of lenvatinib as an adjuvant therapy for patients underwent radical resection of HCC with a high risk of tumor recurrence.

Investigator hypothesize that lenvatinib may be an effective adjuvant treatment for HCC, and 12-month adjuvant treatment with lenvatinib can improve one-year recurrence-free survival rate (RFS) of HCC patients after surgical resection.

There's no widely accepted adjuvant therapy for patients with HCC. Lenvatinib, a multi-targeted tyrosine kinase inhibitor, was approved for advanced or unresectable HCC. In this study, investigators aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent curative resection for HCC with high risk of disease recurrence.

Participants who underwent radical resection for HCC with high risk of tumor recurrence will be recruited in this study. During 4 to 6 weeks after surgery, each participant will receive a screening visit to exclude residual tumors. Each eligible participant will be treated with lenvatinib until tumor recurrence, intolerant adverse effect, participant' refusal, or completing 12-month treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18-75;
2. Histological diagnosis of HCC;
3. Tumor stage before surgery: IIb/IIIa stage (\>3 tumor nodules, or vascular invasion) HCC according to China Liver Cancer Staging System (or BCLC B/C/PVTT);
4. Underwent R0 resection (microscopic or macroscopic tumor clearance) in four to six weeks before recruitment; no residual tumor before recruitment by imaging study (MRI/CT), nor metastases to other organs;
5. Adequate liver, renal functions;
6. Written informed consent;
7. ECOG 0-1 and Child-Pugh A.

Exclusion Criteria:

1. WBC\<4.0\*10\^9/L, HB\<80 g/L, and PLT\<75\*10\^9/L at blood screening;
2. Coagulation function: (prothrombin time) international normalized ratio (INR) \>2.3, or extension of prothrombin time\>6 seconds;
3. Liver function: serum albumin (ALB)\<2.8 g/dl, total bilirubin (TBIL)\>51.3μmol/L, alanine aminotransferase and aspartate aminotransferase (ALT and AST)\>5 times the upper limit of normal range;
4. Renal function: serum creatinine (Cr)\>1.5 times the upper limit of normal range;
5. lymph node metastases;
6. The participant has uncontrolled ascites, hepatic encephalopathy, Gilbert's syndrome, and sclerosing cholangitis, etc.;
7. The participant was included in other clinical trials 30 days before the selection;
8. Other conditions that the investigators considered that not unsuitable for inclusion.
Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients

The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.

This was a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients at 60 centers in the U.S., Canada and Brazil.

The study consisted of a 1-year post-transplant efficacy and safety study with a clinical continuation phase of a minimum of 2 years or until commercial availability of tacrolimus modified release, unless the Data Safety Monitoring Board or sponsor specified otherwise.

Eligibility Criteria:
Inclusion Criteria:

* Recipient of a primary or retransplanted non-human leukocyte antigen (HLA)-identical living or non-HLA-identical cadaveric kidney transplant
* Age greater or equal to 12 years

Exclusion Criteria:

* Recipient or donor is known seropositive for human immunodeficiency virus (HIV)
* Has current malignancy or history of malignancy
* Has significant liver disease
* Has uncontrolled concomitant infection or any other unstable medical condition
* Is receiving everolimus or enteric coated mycophenolic acid at any time during the study
* Received kidney with a cold ischemia time of equal or more than 36 hours
* Received kidney transplant from a cadaveric donor equal or more than 60 years of age
* Received intravenous immunoglobulin (IVIG) therapy prior to randomization
Myeloid-derived Suppressor Cells in Sepsis

This study is designed for septic patients, to isolate MDSCs and the correlation of prognosis of sepsis. The purpose of this study hopes to explore the phenomenon and possible mechanisms of MDSCs in patients with severe sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have known origin of infection .
* Systemic inflammatory response syndrome.

Exclusion Criteria:

* age less than 18 years
* pregnancy
* known anaphylactoid reaction to colloid fluids
* a life expectancy less than 24 hours,
* inability to provide informed, written consent
* Patients receiving nephrotoxic drugs,
* admitted to the hospital following a surgical procedure,
* sepsis more than 72 hours when screening .
To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma

This is a randomized, assessor-blind, placebo controlled, multicenter, clinical endpoint bioequivalence study to compare the efficacy and safety of generic fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd) to Flovent HFA (fluticasone propionate inhalation aerosol) 44 mcg (GSK group of companies) in treatment of patients with bronchial asthma.


Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female subjects aged between 18 to 65 years of age (both ages inclusive)
2. Diagnosis of asthma for at least 12 months prior to screening
3. Pre-bronchodilator FEV1 of more than or equal to 45 % and less than or equal to 85 %.
4. Subjects should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to screening
5. Currently non-smoking;
6. More than or equal to 15 % reversibility of FEV1 within 30 min following 360 mcg of Albuterol/salbutamol inhalation (pMDI) at screening
7. Ability to discontinue their asthma controller medication safely
8. Ability to replace short-acting β agonists (SABAs) ongoing at screening with Albuterol/salbutamol inhaler.
9. Women of childbearing potential must be willing to consistently use an appropriate method of contraception.
10. Willingness to give their written informed consent to participate in the study.
11. Is willing to comply with all aspects of the protocol.
12. Ability to follow training given for study related procedures and assessments in the opinion of the Investigator.

Exclusion Criteria:

1. Patients with life-threatening asthma,
2. Significant respiratory disease other than asthma
3. Evidence or history of clinically significant medical, surgical or psychiatric disease or laboratory abnormalities.
4. Known hypersensitivity to any sympathomimetic drug.
5. Subjects receiving β2-blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to the screening.
6. Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within 4 weeks prior to the screening visit
7. Subjects who required biologic agents for asthma systemic or oral corticosteroids (for any reason), within the past 6 months prior to screening
8. Evidence or history of oral candidiasis, active tuberculosis, hypercorticism, adrenal suppression, or eye problems.
9. Female subjects who are pregnant or breast-feeding or planning to be pregnant.
10. Currently enrolled in another clinical study or used any investigational product (study drug), study drug, or device within 30 days or 5 elimination half-lives, whichever is longer, preceding informed consent.
11. Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance with this protocol.
Study of the Immunological Infiltrate and Immunometabolic Immunometabolic Profile of Patients with Acute Leukaemia

LThe main aim of this project is to provide an immunophenotypic and immunometabolic characterisation of patients with Acute Leukaemia, before and after therapy, and to understand how changes in the immune system impact the response to therapy.

Specifically:

1. The association between the molecular and metabolic characteristics of leukaemic cells and those of the surrounding immune system will be assessed, in order to identify immune-modulatory metabolic mechanisms activated by malignant cells.
2. The association between immunometabolic signatures and response to therapies will be assessed.
3. The role of EVs as a vehicle for metabolic units capable of regulating the metabolism of immune system cells will be explored.

Multicentre biological study, aimed at collecting and characterising human tissue isolated from acute leukaemia patients. In the context of routine care visits, peripheral blood (PB) and bone marrow (BM) samples will be taken from these patients at different time-points, which will be compared with samples obtained from healthy control subjects.Patients belonging to the haematology OU of the IRCCS AOU of Bologna and to the haematology OUs of the participating centres, suffering from acute leukaemia, will be enrolled. They must be eligible for a treatment scheme that includes either conventional chemotherapy or innovative therapies, such as monoclonal antibodies, molecular therapies with specific targets, metabolic and immunological therapies, as part of the normal care pathway. It is also planned to enrol healthy donors whose samples will be provided by:

* IRCCS AOU of Bologna Immunohaematology and Transfusion Medicine Service (buffy coat)
* Italian Association against Leukaemia, Lymphoma and Myeloma in Bologna (AIL BOLOGNA ODV), within the Haematology Unit of the IRCCS AOU of Bologna (peripheral blood).

Eligibility Criteria:
Inclusion Criteria:

PATIENT

* Diagnosis of Acute Leukaemia.
* Eligibility for a treatment scheme involving either conventional chemotherapy or innovative therapies, such as monoclonal antibodies, molecular therapies with specific targets, metabolic and immunological therapies.
* age ≥ 18 years.
* Signature of informed consent by patients at the time of diagnosis.

Healthy donors (AIL BOLOGNA ODV volunteers)

* age ≥ 18 years.
* Signature of informed consent.

Exclusion Criteria:

* no one
Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy


Eligibility Criteria:
Main Inclusion Criteria:

* Newly diagnosed AML (according to WHO 2022 or ICC 2022 criteria) with a minimum BM blast count of \>=20%, excluding APL
* FLT3 mutation at initial diagnosis
* Ineligibility of standard induction chemotherapy
* Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only)

Main Exclusion Criteria:

* R/R AML
* Previous treatment for AML (except HU and/or one cycle VEN+AZA according to SOC)
* Previous treatment with Gilteritinib
* Known active CNS involvement
* QTcF \>450 ms or long QT Syndrome at screening
* Treatment with concomitant strong CYP3A inducers or St. John's wort