cyrilzakka/clinical-trials huggingface dataset:
Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure

The purpose of this study is to determine whether a combined bone marrow and kidney transplant will be effective in treating stage II or greater multiple myeloma and associated kidney failure. This study will determine whether transplant rejection and the need for immunosuppressive drugs are decreased with this combined transplant approach.

In very limited human testing, a combined kidney and bone marrow transplant appears to be safe and effective in treating multiple myeloma and associated kidney failure. This study will evaluate this approach in 10 patients with kidney failure due to or in association with stage II or greater multiple myeloma. Treatment prior to transplant will include cyclophosphamide, ATGAM (a lymphocyte-specific immunosuppressant), local radiation to the thymus, and cyclosporine (an immunosuppressive drug).

An infusion of donor bone marrow and a kidney graft from a closely matched, related donor will be transplanted simultaneously. An additional infusion of donor white blood cells may be administered between day 45 and 74 after transplant in an effort to eliminate any remaining cancer cells. Patients will remain on cyclosporine for a defined period of time. The cyclosporine doses will be slowly decreased and stopped if graft rejection and graft-versus-host disease do not occur.

Each participant will be involved in the study for 3 years; this includes the intervention phase (time from initial screening at approximately 7 days before transplant through 100 days after the transplant) and continued follow-up visits for at least 2 years following the transplant.

Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease (ESRD) due to or in association with stage II or greater multiple myeloma
* Participants in whom the development of ESRD is not due to the underlying myeloma will be included if they have evidence of active myeloma despite past treatment with standard therapies (e.g., prednisone, melphalan, high-dose radiation therapy with autologous stem cell transplantation)
* On dialysis or have a creatinine clearance greater than 20 ml/min
* HLA-matched or one of six HLA antigen-mismatched related donor

Exclusion Criteria:

* Compromised pulmonary, cardiac, or liver function
* Active infection
Functional MRI of Cognitive Control in Autism

This study aims to investigate the role of fronto-striatal circuits and cognitive control in the perseverative and inflexible behavior that is a defining feature of autism. We hypothesize that deficits in the development of fronto-striatal circuitry may underlie cognitive inflexibility in autism. Specifically, we hypothesize that repetitive, inflexible behavior arises as (1) fronto-striatal systems are capable of learning patterns present in the environment (as in implicit learning paradigms), but are unable to adapt behavior to changing circumstances, related to either (2) decreased ability of basal ganglia to detect violations of expectancy, (3) decreased ability of prefrontal cortex to respond to detected violations, or (4) decreased connectivity of the circuits. We are conducting three functional Magnetic Resonance Imaging (fMRI) studies to address these hypotheses.


Eligibility Criteria:
Inclusion Criteria:

* Aged 6 - 12 years at inclusion

Inclusion criteria for subjects with autism

* DSM-IV (APA, 1994) diagnosis of autism, according to ADI-R interview

Inclusion criteria for controls

* No DSM-IV (APA, 1994) diagnosis, according to DISC interview
* No scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)
* IQ \> 70

Exclusion Criteria:

* Major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
* Presence of metal objects in or around the body (pacemaker, dental braces)
* History of or present neurological disorder
A Prospective Cohort Study for Patients With Adrenal Diseases

The purpose of this study is to investigate the pathologic features, complications, and prognostic factors of functioning adrenal adenoma and suggest follow-up algorithms for adrenal incidentaloma.

The investigators will recruit 150 patients annually for 10 years (adrenal incidentaloma 100 patients, pheochromocytoma 15 patients, primary aldosteronism 25 patients, adrenal cushing syndrome 10 patients, adrenocortical carcinoma 2 patients) and perform hormonal, biochemical, imaging exam according to each disease's clinical guidelines. Based on this, the investigators will identify pathologic features, complications, and prognostic factors of each disease.

Eligibility Criteria:
Inclusion Criteria:

* Adults, male or female aged 19 years or older
* newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma

Exclusion Criteria:

* previous or current history of adrenal diseases
* using oral or intravenous steroids
* history of major depressive disorder
* history of chronic alcoholics
* history of any cancer with suspicious adrenal metastasis
* those with acute illness (ex- patients with acute coronary syndrome within 4 weeks, acute febrile disease)
Study of Oxidized Albumin in Liver Transplant Patients

The overall goal is to describe the oxidation state of albumin before, during and after liver transplantation. This is a pilot observational study in which the oxidative state in 10 patients undergoing liver transplantation will be described. Samples for analysing the oxidation state of albumin, general oxidative damage and anti-oxidant state, the activation of the complement system and factors involved in coagulation will be obtained before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.


Eligibility Criteria:
Inclusion Criteria:

* Patients on waiting list for liver transplantation

Exclusion Criteria:

* none
Reduction of Cancer Related Fatigue in Patients During TKI Therapy

The purpose of this pilot study is to determine the effects of a 12-week resistance training program on cancer related fatigue in cancer patients receiving tyrosine kinase inhibitor (TKI) therapy. It is hypothesized that incidence and severity of cancer related fatigue can be reduced by exercise training in this population which leads to an improved treatment completion rate.


Eligibility Criteria:
Inclusion Criteria:

* Male and female cancer patients
* Prior to tyrosine kinase inhibitor therapy (any substance, any line)
* Age: at least 18 yrs
* Body mass index (BMI): at least 18 kg/m2
* ECOG performance status: at most 2
* Must be able to meet the requirements of the study protocol

Exclusion Criteria:

* Acute infectious diseases
* No ambulatory ability
* Severe neurological disorders
* Severe cardiovascular diseases
* Severe pulmonary insufficiency
* Severe renal insufficiency
* Other current tumor diseases
* Conditions rendering compliance impossible
* Participation in regular strength training
KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component

Bullying is a major problem worldwide and, with no exception, in Chile. Bullying is defined as a systematic aggressive behavior against a victim who cannot defend himself or herself. Victims suffer many consequences such as social isolation, psychological maladjustment, and self-injury behavior. Additionally, bullies have a higher risk for conduct problems and substance use disorders. These problems appear to last in time, affecting mental health even years later since the experience of bullying.

There are few studies in Chile aiming to determine the prevalence of bullying. In one of such studies, 47% of the students reported having been bullied during the last month before the application of the questionnaire. Even though there are many initiatives and guidelines in Chile supported by the government to help schools in order to deal with bullying, there is no any cluster randomized controlled trial (RCT) aiming to assess the effectiveness of an anti-bullying program.

KiVa anti-bullying prevention program contains universal and indicated actions. Main universal actions for 5 to 6 graders consist of 10 two-hours lessons given during a year and an online game, which have the aim to raise awareness of the role of the group in bullying, increase empathy and promote strategies to support victims. Indicated actions consist of a set of discussion groups with the victims and with the bullies with proper follow-up.

The aims of this study are: 1) To develop a culturally appropriate version of the Kiva material, and 2) to test its effectiveness of KiVa program with and without the online game, to reduce bullying behavior among low-income primary schools in Santiago using a cluster RCT design with three arms: i) KiVa full program group, ii) KiVa without online game program group, and iii) Control group.


Eligibility Criteria:
Inclusion Criteria for schools:

* Primary education
* Co-educational
* High vulnerability (measured by the Chilean index IVESINAE \>75%)
* Location: Santiago, Chile.
* Exact two classes per level (5th Grade and 6th Grade), during the intervention.
A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer

A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Male patient aged ≥60 years old at Visit 1 (Screening).
* Patient has non-curative PSMA-positive prostate cancer that has spread outside of the prostate gland and is undergoing or being planned for radioligand therapy.
* At least 1 PSMA-positive lesion that can be outlined on PET or CT and ≥1 cm in the short axis measured on either modality, for the purpose of dosimetry.
* Adequate normal organ function as demonstrated by:

  * Absolute neutrophil count ≥1.5 × 109/L
  * Platelets ≥100 × 109/L
  * Haemoglobin ≥9 g/dL
  * Total bilirubin \<2 × the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome, ≤3 × ULN is permitted.
  * Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤3.0 × ULN or ≤5.0 × ULN for patients with liver metastases.
  * Estimated glomerular filtration rate (using Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation \[2009\]) \>50 mL/min.
* Willing to provide signed and dated written informed consent form (ICF) prior to any study specific procedures
* Male patients must agree not to father children or donate sperm during the study and for at least 14 weeks after the last study treatment.

Exclusion Criteria:

* Known hypersensitivity to lutetium (177Lu) rhPSMA 10.1 or lutetium (177Lu) vipivotide tetraxetan, or any of the constituents.
* Previous treatment with any radiopharmaceutical therapy in the 42 days or 5 half-lives prior to Visit 1 (Screening).
* Any significant metallic implants or objects, which may in the opinion of the investigator, affect image quality and/or dosimetry calculations.
* Severe claustrophobia, inability to lie flat or fit into the scanner, or any other inability to tolerate the SPECT/CT scan protocol
* Any change to prostate cancer medication or new prostate cancer therapy, prostate cancer surgical procedure within 42 days prior to screening or during the study.
* Any medical or psychiatric condition, including rapidly progressive prostate cancer, that in the investigator's judgment, makes the patient unsuitable for the study
* Participation in other studies involving other IMPs within 42 days or 5 half lives (whichever is longer) prior to Visit 1 (Screening) and/or during study participation
A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors

This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced, refractory solid tumors and a histopathologically confirmed diagnosis
* Subjects must have no further standard of care options or have refused standard therapy
* Measurable or evaluable disease
* Age ≥ 18 years
* ECOG performance \< 2
* Life expectancy ≥ 3 months
* If female, neither pregnant or lactating
* If of child bearing potential, must use adequate birth control
* Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
* Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
* Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
* Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
* Serum magnesium and potassium within normal limits (may be supplement to achieve normal values)
* Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
* Able to render informed consent and to follow protocol requirements.

Exclusion Criteria:

* Anticancer therapy within 4 weeks of study entry. Prostate cancer subjects on LHRH hormonal therapy may be enrolled and continue on this therapy.
* Use of investigational agent(s) within 30 days of study entry
* History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
* Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
* The following are permitted but should be used with caution and other suitable agents used if possible:

  * Subjects receiving concomitant medications metabolized by CYP 3A4 and CYP 2D6
  * CYP3A4 inducers
  * CYP3A4 inhibitors
  * Warfarin
Can Administration of Etamsylate Reduce Postpancreatectomy Hemorrhage

In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS.

In this way we try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.

Whipple procedure is usually performed for periampullary malignancies. If the mortality of this intervention has been markedly decreased, it persists a morbid one. Morbidity is mainly due to postoperative leak of the pancreato-digestive anastomosis or postoperative pancreatic fistula (POPF), but also to postpancreatectomy hemorrhage (PPH). In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS. In this case of hemorrhage, blood generally comes from pancreatic stump which is anastomosed or telescoped in the stomac. Incomplete hemostasis , soft pancreatic tissue and vascular fragility can help PPH to occur.

Etamsylate is an antihemorrhagic agent which works by increasing the resistance in the endothelium of capillaries and stimulating platelet adhesion. It also inhibits synthesis and action of prostaglandins causing platelet disaggregation, vasodilation and increased capillary permeability.

In this way, the investigators try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing Whipple procedure regardless the type of pathology and in which a PG is performed.

Exclusion Criteria:

* Patients undergoing Whipple procedure regardless the type of pathology and in which a PJ is performed.
Phase II Trial of Anti-PD-1 Antibody Treatment and Radiotherapy in Early-stage Favorable Classic Hodgkin Lymphoma

By the implementation of the anti-PD-1 antibody pembrolizumab and given its possible synergy with RT, the aim of the present trial is to develop a chemotherapy-free first-line treatment for patients with newly diagnosed early-stage favorable cHL.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven first diagnosis of cHL
* Stage I-II without risk factors

  * Large mediastinal mass
  * Extranodal involvement
  * Elevated erythrocyte sedimentation rate (ESR)
  * Involvement of ≥ 3 nodal areas

Exclusion Criteria:

* Central nervous system lymphoma, nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma,
* Prior cHL-directed treatment
* Prior chemotherapy, RT or allogeneic stem cell/solid organ transplant
* Prior or concurrent disease precluding protocol treatment (for details see section 4.2)
* Pregnancy or breastfeeding
* Non-compliance
A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease

Phase I study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI2338 in subjects with stable, mild to moderate chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 40 years at time of screening.
* Females of non-childbearing potential defined as surgically sterile or at least 2 years postmenopausal.
* Males, unless surgically sterile, must use 2 highly effective methods of birth control from screening through end of trial.
* A diagnosis of mild to moderate COPD.
* Cigarette smoking history of ≥10 pack years.
* Ability to understand and comply with protocol requirements, instructions and restrictions.
* COPD symptoms adequately controlled on a therapeutic regimen that has not changed in the 4 weeks prior to screening.

Exclusion Criteria:

* Current diagnosis of any respiratory condition other than COPD.
* Active or history of any disease or condition that would, in the opinion of the investigator and/or medical monitor, place the subject at an unacceptable risk to participate in this study.
* History of or suspected history of alcohol misuse or recreational substance abuse.
* Treatment with oral or IV corticosteroids within 8 weeks prior to screening.
* Concurrent enrolment in another clinical study.
* Receipt of any investigational drug therapy of use of any biologicals within 6 months prior to screening.
* Known history of allergy or reaction to any component of the investigational product.
Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors

There are data suggesting that the reduction of the diversity of intestinal microbiota caused by the used treatments in the setting of allogeneic hemopoietic stem cell transplant (ASCT), and specially antibiotics, may be related to increased incidence of graft versus host disease (GVHD) and worst clinical outcomes. Present "European Conference on Infections in Leukaemia" guidelines exhort to antibiotic treatment optimization in hematological patients, without excluding ASCT receptors. This study aims to demonstrate that in ASCT receptors a predefined protocol of optimization of the antibacterial treatment will preserve the intestinal microbiota diversity which will correlate with decrease incidence of acute GVHD. And that this procedure is safe because it will not worsen the incidence of infections, transplant related mortality, infectious mortality or global survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to receive their first allogeneic hematopoietic transplant as a treatment of any disease.
* Conformity of the patient to participate by signing the informed consent.
* Patients who have received a previous autologous transplant are not excluded.

Exclusion Criteria:

* Non-compliance of the patient to sign the informed consent.
* Patients who have already started the conditioning (or thereafter) will not be included.
* Allograft recipients who have previously received the transplant will not be included. Second allogeneic transplants are excluded.
Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax

The goal of this no-profit, multicenter, biological, non-pharmacologic study is to evaluate minimal residual disease (MRD) in patients treated with Azacitidine and Venetoclax according to clinical practice.

The main questions it aims to answer are:

1. kinetics of disease response on treatment with Azacitidine and Venetoclax through the evaluation of MRD with both cytofluorimetric and molecular techniques
2. impact of MRD on survival outcomes. To this end, bone marrow samples will be collected at pre-defined time-points during treatment and MRD will be assessed.

This is a multicentric biological study at evaluating MRD kinetics during treatment with Azacitidine and Venetoclax as well as the impact of MRD on survival outcomes.

Newly diagnosed, previously untreated, patients with AML, including de novo, secondary and therapy-related, receiving front-line therapy with Azacitidine and Venetoclax according to clinical practice will be included.

Response assessment will be performed on BM aspirate according to ELN2022 response criteria. MRD evaluation will be performed on BM at pre-defined time-points during treatment. MRD assessment will be performed centrally in order to harmonize response evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥ 18 years of age
* Subject has diagnosis of AML according to WHO 2016
* Subject has newly diagnosed, previously untreated, AML, including de novo, secondary and therapy-related (cytoreduction with hydroxyurea is admitted prior treatment start)
* Subject is planned to receive front-line therapy with Azacitidine and Venetoclax
* Subject is ineligible for intensive induction chemotherapy according to investigator assessment according to clinical practice
* Subject must have assessable MRD by flow cytometry at screening BM evaluation
* Signed written informed consent according to ICH/EU/GCP and national local laws

Exclusion Criteria:

* Diagnosis of BCR::ABL1-positive AML
* Diagnosis of APL
* AML with CNS involvement.
* AML with extra-medullary localizations
* Patients' unwillingness or inability to comply with the protocol requirements.