cyrilzakka/clinical-trials huggingface dataset:
A Study of ION251 Administered to Patients With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION251 in patients with relapsed/refractory multiple myeloma.

This is a two-part, multi-center first in human study of ION251 in up to 80 participants. Part 1 will use a 3+3 dose-escalation scheme in sequential cohorts to determine the MTD and RP2D during repeated 28-day treatment cycles. MTD will be determined by the number of participants with AEs meeting the dose-limiting toxicity (DLT) criteria during Cycle 1. The MTD determined in Part 1 will be used with other variables to inform a RP2D for participants proceeding to Part 2 for further assessments in the safety, tolerability and anti-myeloma activity.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years at the time of informed consent
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Measurable multiple myeloma (MM)
4. In need of systemic treatment for MM and either is refractory to or has failed treatment with, is intolerant to or has refused, or is not otherwise a candidate in the opinion of the Investigator, for any of the currently available established therapies known to provide clinical benefit in relapsed/refractory MM. Refractory to treatment is defined as documented MM disease progression while on or within 60 days from the last dose (LD) of treatment

Exclusion Criteria:

1. Screen laboratory results as follows, or any other clinically significant abnormalities in screen laboratory values that would render a participant unsuitable for inclusion

   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 × upper limit of normal (ULN)
   * Total bilirubin \> 1.3 × ULN
   * Absolute neutrophil count ≤ 1.0 1000/cubic millimeter (k/mm\^3)
   * Platelet count \< 50 k/mm\^3
   * Hemoglobin \< 8.0 g/dL
   * Estimated glomerular filtration rate (eGFR) \< 50 milliliters per minute (mL/min)/1.73 square meter (m\^2)
   * Urine albumin creatinine ratio \> 100 mg/g
2. History of or current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone or extramedullary plasmacytoma as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm
3. Uncontrolled hypertension (systolic pressure ≥ 160 mm of mercury (mm Hg) and/or diastolic pressure ≥ 100 mm Hg)
4. Presence of a bleeding disorder or an underlying disease state associated with active bleeding.
Magnetic Resonance Imaging of Human Biometrics

The primary objective is to collect high quality MRI data (un-processed or processed) from participating subjects for Medtronic research purposes.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Subject is willing and able to undergo study requirements

Exclusion Criteria:

* Subject has a medical condition that precludes the subject from participation
* Subject has any magnetizable foreign object (e.g. jewelry) which cannot be removed for the duration of the study
* Subject is claustrophobic
* Subject is unable to stand without assistance
* Subject requires sedation for MRI scans
* Subject is implanted with non-Magnetic Resonance conditional or other medical device:

  * Non-MRI conditional pacemaker, Implantable Cardiac Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or an implantable hemodynamic monitor
  * Metal clips (i.e. brain aneurysm clip)
  * Artificial heart valve
  * Implanted neural stimulator
  * Gastric capsule camera
  * Swan Ganz catheter
  * Stent
  * Inferior Vena Cava (IVC) filter
  * Orthopedic implant
  * Eye prosthesis
  * Vascular access port
  * Penile prosthesis
  * Intrauterine device
* Subject has a cochlear implant, middle ear prosthesis, or has had ear surgery
* Subject has ocular foreign bodies (i.e. metal shavings)
* Subject has any type of device held in place by a magnet (i.e. dentures)
* Subject has an insulin pump
* Subject has metal shrapnel
* Subject is pregnant or lactating
* Subject has magnetizable implant
* Subject requires legally authorized representative to sign Patient Informed Consent (PIC)/ Informed Consent (IC) form
* Subject has other contraindication for an MRI scan as defined by the study site
Gastroparesis in Cystic Fibrosis

The purpose of this research is to determine if an investigational device called the 13C-Spirulina Gastric Emptying Breath Test (GEBT), can accurately diagnose gastroparesis (delayed emptying of the stomach) in patients with Cystic Fibrosis (CF).


Eligibility Criteria:
Inclusion Criteria:

* Patients age 4 years\* and above with a genetically confirmed diagnosis of CF (\*This age was chosen as patients younger than 4 years rarely undergo GES)
* Actively being followed at the University of Miami CF Center (i.e. seen within the past 5 years at a University of Miami pediatric or adult pulmonology clinic)

Exclusion Criteria:

* History of abdominal surgeries involving gastrointestinal luminal resection (i.e. small bowel or colonic resection that increases risk of post-operative strictures or narrowing of the lumen). Nissen fundoplication, gastrostomy tube placement, gynecologic surgeries, appendectomy, and/or cholecystectomy are not excluded.
* Gastrointestinal comorbidities that impact absorption such as Inflammatory Bowel Disease and Celiac Disease
* Known hypersensitivity to Spirulina, egg, milk or wheat allergens
* Patients not able to consume at least 50% of a standard test meal
* Pregnant women
* Adults unable to consent
* Prisoners
Capoeira Training and Flexibility

Background: Nowadays, a commonly used sport that helps enhancing physical fitness components, including flexibility, is Capoeira. This modality is defined as an athletic sport composed by an individual attack and defensive system, which was originally created in colonial Brazil. Capoeira is characterized by its main movement, the "ginga", and by other several dodging, unbalancing, traumatizing and acrobatic movements. The literature empirically discusses that Capoeira contributes in general physical fitness by modulating several variables of human movement. Among these variables it is possible to highlight the influence of Capoeira in the amplitude of movement of the practitioner's joints. However, no study with a control group has investigated the alterations in flexibility of beginners using an experimental protocol based exclusively in basic techniques of Capoeira, without applying any usual stretching exercises that are commonly used, independently of the specificity of the sport. Objective: To analyze the effects of eight weeks of basic training in Capoeira on the flexibility of beginners in the sport. Methods: Twenty-one individuals, divided in two groups \[Capoeira, n=13; 26.1±7.2 years; 22.7±2.7 kg.m2(-1) and Control, n=8; 27.1±0.5 years; 24.3±3.3 kg.m2(-1)\] participated in the study. The Capoeira group performed eight weeks of basic training (two sessions per week lasting 60 minutes each). The experimental protocol used was exclusively based in basic techniques of a programmed Capoeira training system. Before and after the intervention measurements were performed aiming to analyze: trunk flexion flexibility, through a sit-and-reach test using a Wells' Bench (WBtf); and passive tension (PThf) and maximum amplitude of hip flexion (MAhf) through goniometry. The hypothesis of this study is that the group Capoeira (beginners) will increase the linear and angular flexibility after eight weeks of basic training in the sport.


Eligibility Criteria:
Inclusion Criteria:

1. All participants had at least a 24 month period without practicing Capoeira;
2. To participate in at least 80% of the experimental sessions (Capoeira group); 4) Not having any kind of bone, muscle or joint impairment that would preclude participating in the study and performing the flexibility evaluations before and after the intervention;
3. Not participating in another physical activity program during the intervention and; 4) Not having any kind of heart disease.

   -

   Exclusion Criteria:

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HSD3B1 Gene Polymorphisms With Outcomes in SARS-CoV-2 Infected Patients

The study includes 2 sub-projects.

Sub-project 1: The aim is to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2 entry and spreading in the local population of Ticino.

Sub-project 2: The aim is to investigate the association between the HSD3B1 gene variations and outcome of COVID-19 in the local population of Ticino.

Sub-project 1:

This is an observational retrospective study that aims to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2 entry and spreading in the local population of Ticino. The level of expression of these factors will be compared between infected and non-infected subjects. The sub-project will examine RNA samples from nasopharyngeal swabs taken from subjects tested for COVID-19.

Sub-project 2:

This is a haplotype- and diplotype-based case-control retrospective study that aims to investigate the association between the HSD3B1 gene variations and outcome of COVID-19 in the local population of Ticino. The gene status of HSD3B1 will be defined and compared between two groups of patients: the patients who experienced a severe SARS-CoV-2 infection (severe pulmonary insufficiency, ICU admission, eventually death) and the group with a mild-moderate COVID-19 disease without pulmonary insufficiency and oxygen need.

Eligibility Criteria:
Sub-project 1

Inclusion Criteria:

* Availability of RNA extracted from nasopharyngeal swabs taken from subjects tested for COVID-19;
* Subject is aged 18 years or over;
* Written informed consent (for SARS-CoV-2 positive patients only; see §5 for further details).

Exclusion Criteria:

- Documented refusal.

Sub-project 2

Inclusion Criteria:

* Female and male hospitalized SARS-CoV-2 patients;
* Patient is aged 18 years or over;
* Availability of archival tissue samples collected at any time before SARS-CoV-2 infection for any clinical reason;
* Clinico-pathological characteristics of the COVID-19 and clinical outcomes recorded in the EOC and Clinica Luganese Moncucco database;
* Written informed consent (see §5 for further details).

Exclusion Criteria:

- Documented refusal.
The Validity of Novel Non-invasive Inflammatory Markers for Monitoring of Patients With Ulcerative Colitis

Ulcerative Colitis (UC) is a disease known for repeated relapses and remissions. So, meticulous follow-up is required to individualize treatment plans according to the status of each patient. The currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up.

Aim: To evaluate the viability of fecal lactoferrin, serum ferritin, and IL6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission.

Introduction: Ulcerative Colitis (UC) is a disease known for repeated relapses and remissions. So, meticulous follow-up is required to individualize treatment plans according to the status of each patient. The currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up.

Aim: To evaluate the viability of fecal lactoferrin, serum ferritin, and IL6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission.

Patients and Methods:

This is a prospective cohort study will include 160 patients. The study will be aMulticenterthat will be held in different Egyptian governorates. The patient must be, firstly, confirmed to be an ulcerative colitis patient by complete physical examination, laboratory evaluation by fecal calprotectin and CRP. Also, colonoscopy will be done for all included patients and they will be classified according to the Modified Mayo Endoscopic Score (MMES). Biopsies will be taken to confirm the diagnosis with histopathological examination. Fecal lactoferrin, S ferritin, and IL6 (the investigated markers) will be conducted for patients with confirmed diagnosis with UC. . All investigations, including colonoscopy, will be done once again after 3 months to follow up the included patients. The results of all tests will be correlated to the clinical and endoscopic findings of included patients to detect a cut off values to be used during remission and activity.

Eligibility Criteria:
Inclusion Criteria:

- Patients who are newly diagnosed to be ulcerative colitis. Patients \>18 years old.

Exclusion Criteria:

* Patients who are \>18 years old. Pregnant patients . Patients with colonic malignancies.
Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy

The purpose of this study is to determine if the triplet combination of dalpiciclib, fulvestrant, and pyrotinib is safe and effective in the treatment of hormone receptor-positive, HER2-low locally advanced/metastatic breast cancer following treatment with an aromatase inhibitor plus a CDK4/6 inhibitor (palbociclib abemaciclib or ribociclib).

The study will employ a Bayesian Optimal Phase II (BOP2) design which explicitly controls the type I error rate, thereby bridging the gap between Bayesian designs and frequentist designs, and has favorable operating characteristics with higher power and lower risk of incorrectly terminating the trial than some existing Bayesian phase II designs.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women at least 18 years of age with histologically or cytologically confirmed adenocarcinoma of the breast with unresectable or metastatic disease.
2. Most recent tumor biopsy or surgical resection specimen must be either estrogen-receptor (ER) positive, progesterone receptors (PgR) positive, or both, as defined by immunohistochemistry (IHC) ≥1% (as per the American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines).
3. HER2-low breast cancer defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested). (as per the ASCO-CAP guidelines).
4. Postmenopausal status or receiving ovarian ablation with a GnRH agonist such as goserelin. Postmenopausal status is defined by any one of the following criteria:

   * Prior bilateral oophorectomy.
   * Age ≥60 years.
   * Age \<60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH, LH, and estradiol in the postmenopausal range per local normal If the patient does not meet criteria for postmenopausal status but is receiving ovarian ablation therapy with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin, the patient is eligible for this study, provided that the GnRH agonist is started at least 2 weeks prior to C1D1 of anti-estrogen therapy.
5. Patient must have either measurable disease by RECIST 1.1 or only bone lesions in absence of measurable disease.
6. Eastern Cooperative Group (ECOG) performance status of 0 or 1.
7. Previously treated on CDK 4/6 inhibitor(palbociclib, abemaciclib or ribociclib) with AI for at least 6 months
8. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Patient with symptomatic visceral disease or any disease burden.
2. Patient has received more than one line of chemotherapy for advanced disease.
3. Previous treatment with Dalpiciclib /Pyrotinib /ADCe for advanced disease.
4. Progressed on more than one CDK 4/6 inhibitor
5. Patients with persistent symptoms and unstable brain metastases;
6. Any condition that makes the patient ineligible for endocrine therapy per the investigator's best judgment
Combination of TATE and PD-1 Inhibitor in Liver Cancer

This is a multi-center, open-label phase IIA study that investigates the preliminary efficacy of Trans-arterial Tirapazamine Embolization (TATE) treatment of liver cancer followed by a PD-1 checkpoint inhibitor (nivolumab). Patients with two types of cancers will be enrolled, advanced hepatocellular carcinoma (HCC),and metastatic gastric cancer. All enrolled patients need to have liver lesions and have progressed on a prior immune checkpoint inhibitor.

The goal of the study is to investigate whether tumor necrosis induced by Trans-arterial Tirapazamine Embolization (TATE) treatment can boost anti-tumor immunity and enhance the therapeutic efficacy of immune checkpoint inhibitor. Patients with advanced liver cancers (primary HCC or metastatic gastric cancer) who have progressed on a prior immune checkpoint inhibitor will be enrolled in the study. Liver lesions will be treated with up to 4 TATE treatments for optimal debulking, which also serve as a vaccination process toward tumor. Lesion not treated with TATE will be used for monitoring the response toward a PD-1 inhibitor (Nivolumab) for abscopal effect. If a patient subsequently develops an "escape" to the PD-1 inhibitor, patient can have another 2 TATE treatments of the escaped tumor lesion. Dosing of the PD-1 inhibitor is per standard FDA-approved dosing schedule and continues until progressive disease. The efficacy will be assessed by the response rate (RR) using RECIST.

Eligibility Criteria:
1. Patients with a confirmed diagnosis of (1) advanced HCC or (2) metastatic gastric cancer.
2. Patients between ages 18 and 80
3. If HCC patients, they should have progressive disease (PD) on an immune therapy for advanced HCC. For patients with metastatic gastric cancer, they should have failed at least one line of systemic chemotherapy and an immune checkpoint inhibitor.
4. Patients with liver tumor lesions with at least one with a diameter of 2 cm or bigger, which is amendable for (super-)selective TATE as the target lesion.
5. ECOG score 2 or less
6. Child-Pugh scores 5-7 for HCC patients
7. All prior chemotherapy at least 4 weeks prior to study treatment. Immunotherapy not subject to this limitation.
8. No major GI bleeding in the prior 2 months.

8. Hgb\>=8, platelet \>= 50,000, Cr =\< 2, AST and ALT \< 10 X ULN, t-Bilirubin \< 3, 9. Patients with a history of major autoimmune disorders excluded.
Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy

Objective The objective of the study is to assess the structural and functional cardiac effects of treatment with losartan in patients with hypertrophic cardiomyopathy (HCM).

Design The study is a randomized, placebo-controlled, double-blinded trial. The follow-up period is 12 months. 130 patients with HCM will be included in predefined subgroups. Genotype positive relatives with borderline hypertrophy (\> 13 mm) will also be included. Data on individuals with borderline hypertrophy will be analysed separately from the rest of the cohort.

Primary outcome Ventricular hypertrophy assessed as left ventricular mass and maximal wall thickness.


Eligibility Criteria:
Inclusion Criteria:

* Hypertrophic cardiomyopathy
* \> 18 years
* Sinus rhythm

Exclusion Criteria:

* EF \< 50 %
* Treatment with RAS-inhibitor
* Contraindications to losartan
Observational Study for the Evaluation of Tracheal Stenosis in COVID-19 Patients

Define the actual incidence of tracheal stenosis in patients who underwent either prolonged intubation or tracheostomy and to compare incidence, clinical course and outcome between COVID-19 and non-COVID-19 patients.

The TS1 is a national observational, multicentric, case-control clinical aiming at defining the actual incidence of tracheal stenosis in patients with COVID-19 that underwent prolonged intubation or tracheal stenosis.

Information regarding anamnestic data, demographics, smoking or alcohol habits, comorbidity, previous history of prolonged ventilation or tracheostomy, and data about intensive care unit stay and treatment will be collected before discharging patients from hospital.

All patients enrolled will perform an initial evaluation with a chest CT scan without contrast-enhancing at 2 months from hospital discharge along with pulmonary function test. If tracheal stenosis is detected, treatment according to currently available guidelines will be performed.

Patients with no signs of clinical, functional and radiological evidence of tracheal stenosis will perform a 3 and 6 months clinical follow-up from initial evaluation.

A chest CT scan with pulmonary function test will be administered if symptoms of tracheal stenosis arise during clinical follow-up. If necessary, treatment according to currently available guidelines will be performed.

Patients will be followed-up for 8 months after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* prolonged intubation, defined as the permanence of naso or oro- tracheal tube for more than 7 days
* tracheostomy, whether surgical or percutaneous
* minimum of 2 months follow-up from hospital discharge
* Positivity to SARS-CoV-2 infection confirmed using PCR on either nasal swab or bronchoalveolar lavage will be not an inclusion criterion; patients tested negative will be used as a control group

Exclusion Criteria:

* Pediatric patients (\< 18 years of age)
* Patients without a minimum of 2 months follow-up from hospital discharge
Quality of Life and Rehabilitation Pathway in Northern Norway and Denmark.

The aim of this study is to analyze and describe rehabilitation pathways of stroke patients in a region of North Norway and Central Denmark Region in relation to how patients perceive quality of life, health and functioning one year post stroke.

The study will consist of 1) Translate, cross-cultural adapt and validate a stroke-specific health-related questionnaire 2) Describe the level of quality of life and rehabilitation pathway in the two countries 3) In-depth interviews of a smaller group of patients for a more complex understanding

The study is part of a larger prospective observational multicenter-study of two patient cohorts with stroke.

Anticipated: 500 patients from Norway and 500 patients from Denmark are included in the national stroke-register datasets, and 250 patients from each country in the questionnaire-based datasets.

The questionnaire includes demographic data, the Stroke-Specific Quality of Life (SS-QOL) scale, Hospital Anxiety and Depression Scale (HADS), The EuroQol Quality of Life scale (EQ-5D), the EuroQol Visual Analogue Scale (EQ-VAS), the Quality of Life After Brain Injury, Overall Scale QOLIBRI-OS, modified Rankin Scale (mRS), and additional questions about satisfaction on treatment and rehabilitation.

5-6 patients from each country will be selected for semi-structured interviews with both priori questions and exploratory questions.

The mixing of methods will balance the goals of generality and complex understanding in how patients describe their quality of life and rehabilitation-chain.

Eligibility Criteria:
Inclusion Criteria:

All patients admitted to the hospitals; UNN Tromso,Harstad, Narvik (Norway) and Aarhus (Denmark).

Exclusion Criteria:

Unverified stroke and residence outside of the studyregion.