cyrilzakka/clinical-trials huggingface dataset:
Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF)

The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
* High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
* ECOG of 0 or 1

Exclusion Criteria:

* Subjects who are positive for p53 mutation (Arm 1)
* Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
* Prior treatment with any JAK inhibitor
* Prior splenectomy
* Splenic irradiation within 24 weeks prior to randomization
* Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant
* History of major organ transplant
* Grade 2 or higher QTc prolongation
* Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization
Study of Biomarkers Using Tissue Samples From Older Patients With Diffuse Large B-Cell Lymphoma Treated With Combination Chemotherapy With or Without Rituximab on Clinical Trial ECOG-E4494

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers using tissue samples from older patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab on clinical trial ECOG-E4494.

OBJECTIVES:

* To construct tissue microarrays (TMA) using tissue samples from older patients with diffuse large B-cell lymphoma treated with standard CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without rituximab on clinical trial ECOG-E4494.
* To allow this TMA resource to be included in a large international effort (the Lunenburg Lymphoma Biomarker Consortium \[LLBC\]), partnering with several other similar randomized trials (EORTC, HOVON, GELA, MINT) in order to properly power and bring standardization to the study of biomarkers in lymphoma.
* To evaluate the clinical impact and prognostic importance of a number of biomarkers, including Bcl-2, Bcl-6, CD10, FOXP1, MUM1, Ki-67, CD5, and HLA-Dr.
* To determine the prognostic impact of clinical International Prognostic Index (IPI) variables in a large international study.
* To determine the relationship between different biomarkers and clinical predictors.
* To establish the TMA (using tissue samples from patients treated on clinical trial ECOG-E4494) as a resource for future ECOG-driven studies and for validation of novel biomarkers as they become recognized and available.

OUTLINE: Patients are stratified according to prior treatment (CHOP chemotherapy \[cyclophosphamide, doxorubicin, vincristine, and prednisone\] or CHOP-like chemotherapy vs CHOP chemotherapy with or without rituximab).

Tissue microarrays will be constructed using tissue samples previously collected from patients treated on clinical trial ECOG-E4494. Tissue microarrays will be used for biomarker studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of diffuse large B-cell lymphoma
* Received treatment on clinical trial ECOG-E4494

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Laryngeal Cryotherapy for Refractory Neurogenic Cough

This study aims to evaluate the safety and efficacy of upper aerodigestive tract cryotherapy treatment in patients with refractory neurogenic cough in a prospective pilot study with a validated patient reported outcome measure

This study aims to test a new type of treatment for patients suffering from chronic cough, also known as upper airway cough syndrome. The new treatment involves the use of laryngeal cryotherapy which is the therapeutic freezing of tissue in the throat to numb the overactive sensory nerves in the throat which is believed to reduce cough symptoms. Patients will first undergo a flexible scope of the throat (laryngoscopy) to test for hypersensitive areas in the throat, then undergo the cryotherapy procedure in the office. After that, patients will be followed up in the clinic with the usual standard of care visits and undergo validated cough surveys to track their cough symptoms after the procedure. Possible side effects to this procedure are listed in detail below, and include temporary throat pain and coughing.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years or older with diagnosis of neurogenic cough
* Neurogenic cough is a diagnosis of exclusion applied to persistent cough (8 weeks or longer)
* Negative workup for other causes, including sinonasal allergies/chronic sinusitis, cough-variant asthma, and GERD
* Patient willing to participate in a clinical trial

Exclusion Criteria:

* Uncontrolled reflux (scoring on Reflux Symptom index of 13 or higher)
* Vocal fold abnormalities or impairment
* History of asthma or other underlying lung condition not adequately treated or controlled
* Uncontrolled Allergic Rhinitis (Total Nasal Symptom Score \>6, which would indicate moderate disease32)
* Reported symptom of postnasal drip
* Current smoker
* Current neuromodulator medication use
* Patient unwilling to participate in clinical trial or sign an informed consent
* End stage medical disease with poor life expectancy
* Medical instability deemed by the investigators as a contraindication for enrollment
* Abnormal Chest X-ray
* Abnormal pulmonary function testing (PFTs)
* Positive local allergy panel (combined RAST testing)
COVID-19 Among Egyptian Health Care Providers

The study aims to identify COVID 19 knowledge, working conditions, perception of anxiety and stigma among Egyptian health care providers as well as their predictors.


Eligibility Criteria:
Inclusion Criteria:

* Health care providers include physicians, nurses, and health officers both medical and nursing subjects.

Exclusion Criteria:

* Medical students
fMRI Neurofeedback With Matter Neuroscience App

Study will utilize an app, Matter Neuroscience, designed to help users with depression understand positive emotions and the neurotransmitters that create them. We hope to learn the safety and efficacy of neurofeedback for treating depression and lay the groundwork for a pivotal clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, between the ages of 18 and 80 at the time of screening.
2. Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
3. Must possess an iPhone with iOS 17 or higher.
4. Single-SSRI-resistant depressive disorder patients with a MADRS scale between 20-34

Exclusion Criteria:

1. Contraindication to MRI (ferromagnetic metal in their body)
2. Claustrophobia
3. Severe Major Depressive Disorder (MDD)
4. MADRS scale of \>34
5. Treatment-resistant depression (TRD) from 3 or more treatments.
6. Any other condition deemed by the PD to interfere with the study or increase risk to the participant
Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study

This project will determine the feasibility and validity of measuring elbow muscle flexor stiffness in a population of patients with sub-acute severe acquired brain injury using two measurement methods, the portable spasticity assessment device (PSAD) (Movotec, Charlottenlund, Denmark) and an ultrasound measurement called shear wave sonoelastography (SWE).

The purpose of this study is to investigate the feasibility and validity of measuring hypertonia in the elbow flexors of patients with severe acquired brain injury in their sub-acute rehabilitation and collect data to determine the necessary size for a definitive study to determine the clinimetrics of the test methods. The long-term goal is to establish a valid and clinically feasible method for physiotherapists to quantify muscle tone in patients with neurological disorders.

The study hypotheses are:

1. SWE, PSAD and Modified Ashworth Scale (MAS) measurements can be obtained for elbow flexion hypertonia in all patients (no missing data due to test procedure),
2. SWE and PSAD have a moderate to good intra-day intra-tester reliability (ICC two-way mixed effects model with absolute agreement. ICC\>0.5, Bland Altman)
3. Passive muscle stiffness measured using the PSAD and SWE have a fair concurrent validity with MAS (Spearmans correlation \>0.3)
4. SWE and PSAD are responsive in measuring a reduction of the effect of routine clinical treatment of the hypertonic muscles with botulinum toxin type A (BTX-A) (paired T-test or Wilcoxon test, p\>0.05)

Eligibility Criteria:
The project will include five patients admitted to the clinic for highly specialised neurorehabilitation/TBI. Inclusion criteria for the patients are that they:

1. Fulfil the normal clinical requirements for treatment with BTX-A in at least one of their elbow flexors, (have increased stiffness in at least one of their elbow flexors, MAS greater than 0),
2. Have given the normal informed consent to routine clinical treatment with BTX-A,
3. Have given written informed consent or that proxy consent has been obtained, to participate in the study

Exclusion criteria for patients are that they:

1. Are unable to cooperate with the measurements due to uncontrolled non-voluntary movements
2. Cannot be positioned safely or comfortably for the measurements.
Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan

This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged \<12 months after introduction of the Rotarix vaccination in Japan.


Eligibility Criteria:
Inclusion Criteria:

* A male or female infant aged \< 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
* An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.

Exclusion Criteria:

Not applicable
First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CEL383 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female (of nonchildbearing potential only), 19-64 years of age, inclusive, at screening visit
* Willingness of men of reproductive potential to agree to use a condom with spermicide or abstain from heterosexual intercourse from dosing until at least 90 days after dosing
* Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening visit
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs

Exclusion Criteria:

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
* History or presence of alcohol or drug abuse within the past 2 years prior to dosing
* History or presence of any known primary or secondary immunodeficiency disorder
* History or presence of any signs, symptoms, or diagnosis of infection, including nausea, vomiting, fever, rash, confusion, muscle aches, cough, nasal congestion, or shortness of breath, in the 4 weeks prior to screening or during the screening period.
* History or presence of any known clotting or hemostasis disorder
* Female subject of childbearing potential
Study of Iron Absorption and Utilization in Asymptomatic Malaria

Anemia is still a main public health problem in sub-Saharan Africa. Anemic women have an increased maternal and perinatal mortality and anemic adults have diminished work capacity. In sub-Saharan Africa, the etiology of anemia is multifactoral; the major causes are low dietary bioavailability and chronic parasitic infections such as malaria. These causes are likely to interact because infection and infection-associated inflammation may impair the utilization and absorption of iron. Therefore, the control of parasite infections may be important to improve iron bioavailability from foods.

Malaria infections are endemic in northern Benin. To investigate the contribution of asymptomatic malaria (a positive blood smear for malarial parasites but without clinical symptoms of fever, headache or malaise) to anemia, we are planning a human iron absorption study in Benin. We will recruit adults with asymptomatic malaria infection. The iron absorption and utilization of the study subjects will be studied while infected, then they will be treated to clear their infections, and then iron absorption and utilization will be restudied. Iron absorption will be determined by incorporation of labeled iron into erythrocytes, 14 days after the administration of a test meal containing labeled iron (stable isotope technique). Subjects will be men and non-pregnant, non-breastfeeding women with a body weight \< 65 kg and between the age of 18 - 30 years.

The results of this study will provide important information on the influence of malaria infections on iron absorption and utilization in humans. The study will provide insight into the potential necessity of malaria control to ensure iron bioavailability from foods in developing countries.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 y
* Body weight \< 65 kg
* A positive malaria smear (asexual P. falciparum parasitemia \> 500/μL blood) without clinical symptoms (fever or self-reported fever in last 7 days, headache, malaise)
* If female, not pregnant (tested by pregnancy test) and not breastfeeding
* No mineral and vitamin supplements two weeks before and during the study

Exclusion Criteria:

* Severe anemia (hemoglobin \< 8.0 g/dl)
* Chronic medical illnesses
* Blood donation or transfusion in the last 6 months before study time
* Soil-transmitted helminth infections (positive Kato-Katz-Smear)
* Tuberculosis (TB): The potential presence of TB will be excluded by a short health questionnaire (cough? night sweats? weight loss? close relative with TB?). If this questionnaire raises the possibility that the subject may be at risk for TB, he/she will be referred to the local medical service
Growth and Tolerance of a Partially Hydrolyzed Infant Formula

The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.


Eligibility Criteria:
Inclusion Criteria:

* 10 to 14 days of age at randomization
* singleton birth
* Gestational age of 37 to 42 weeks
* Birth weight of 2500 g (5lbs 8oz or more)
* Exclusively receiving infant formula for at least 24 hours prior to randomization
* Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age
* Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
* Signed informed consent and authorization to use and disclose Protected Health information

Exclusion Criteria:

* History of underlying metabolic or chronic disease
* Evidence of feeding difficulties or history of formula intolerance
* Weight at Visit 1 is \<98% of birth weight
* Infant was born large for gestational age from a mother who was diabetic at childbirth
* Infant is immunocompromised
Efficacy and Safety of Apremilast in Psoriasis

Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study has been done on use of Apremilast in Pakistan. It has recently become available here. Keeping in view all the benefits of this drug, a study has been planned to check its effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque psoriasis based on Psoriasis area and severity index and Body surface area assessments in our population.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed patients of chronic plaque psoriasis
* patients applicant for oral or parenteral treatments and for light therapy
* patients not responding to topical treatments

Exclusion Criteria:

* Patients who show hypersensitive reactions to apremilast to any of its inactive component
* Pregnancy
* Lactating mothers
Efficacy of the Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis

Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration and chronic inflammation. Treatment of plantar fasciitis contains conservative methods like rest, body weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports. ESWT has commonly been used for the treatment of plantar fasciitis. The shock waves can be radial or focused. The aim of this study was to evaluate the effectiveness of the adjuvant use of plantar orthoses in the process of plantar fasciitis when extracorporeal shock waves are applied. The hypothesis porposed was that the use of extracorporeal shock waves together with the use of custom foot orthotics improves the symptoms produced by plantar fasciitis. This study is planned as double-blind, randomized controlled trial. Participants are randomly allocated to two groups: the ESWT group and the custom foot orthotics and ESWT group. Radial ESWT will be applied in this study.

The people receiving the therapy and the people assessing the outcomes are blinded . Both group will recieve ESWT one session per week for three weeks. Each session will last for 2-5 minutes. The primary outcome measure of this study is change in heel pain of affected side assessed using Visual Analog Scale. The secondary outcome measure is Roles y Maudsley scores. The primary endpoint of this study is to determine a decrease in pain score according to Visual Analog Scale.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 - 65 years
* able to understand the explanations about the potential benefits and risks of participating in the study
* both genders
* diagnosis of chronic plantar fasciitis
* duration of symptoms equal or superior to 6 months at the time of enrollment
* Foot Posture Index ≥ +6 (pronated foot in one or both feet).

Exclusion Criteria:

* being younger than 18 years of age
* previous treatments with shock wave devices
* previous surgery on the painful heel; history of calcaneus fracture
* any inflammation at the level of the ankle
* infection in the treated area
* patients with diabetes mellitus or cardiac or respiratory disease
* osteomyelitis
* patients on anticoagulant drugs
* pregnancy
* patients on immunosuppressive therapy
* rheumatoid arthritis or history of rheumatic disease
* neurological deficits
* malignant disease with or without metastases
* significant liver function abnormalities
* neurological or vascular insufficiency in the painful heel; fasciotomy or heel spur surgery
* discrepancy in the length of the foot \> 5 mm; previous back of foot surgery
* patients treated with rigid plantar supports
Survey on the Place of Community Pharmacists in the Detection of Cannabis Use: a Student's Point of View

The objective of this survey will be to evaluate the perception by the students (except for medical students, pharmacies) of community pharmacists concerning the management of cannabis consumption. We want to see if the student population perceives the pharmacist as the public health actor of choice, and if they would more easily turn to him or to another health professional (doctor, nurse) in case they need. Discussing possible problematic consumption or for a simple search for information. It will be assessed whether the pharmacist seems to be a good candidate and an element of choice when young adults want to take an intelligence approach to cannabis consumption.

This observational and transversal study will be conducted as a survey using the REDCap software and the response to this survey will be done online, in real time, with an automatic, secure and centralized data collection (CHU Clermont-Ferrand).

Students of the Auvergne Rhone Alpes region will be contacted by email thanks to the student associations and scholarity departments. Answer to the survey will be done online via the following link https://redcap.chu-clermontferrand.fr/surveys/?s=JMRF9FLRJP.

Eligibility Criteria:
Inclusion Criteria:

- Student following a university path in the Auvergne Rhone Alpes region

Exclusion Criteria:

* Medical student
* Pharmacy student
* age \< 18-year
* Other than student
SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors

Positron emission tomography/computed tomography (PET/CT) is an advanced nuclear medicine scan. This technology allows precise and early cancer to be visualized and measured on whole body images. Patients with Neuro-Endocrine tumors (NETs), require specialized molecular imaging to stage, re-stage and assess eligibility and response to therapy. 68Ga-DOTATATE is a nuclear medicine imaging agent that is not yet approved by Health Canada but used extensively throughout the world. The Ki-67 index, a marker of cell proliferation in NETs, is one of the most important prognostic factors in this disease. The objective of this study is to evaluate if the maximal standard uptake value (SUVmax) on PET/CT in NETs inversely correlates with Ki-67 score on initial biopsy. If this hypothesized correlation between SUV and Ki-67 score is reproduced, then DOTATATE would serve as a non-invasive method to assess cellular proliferation and therefore prognosis of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected somatostatin receptor positive tumor such as: neuroendocrine tumor (carcinoid, gastro-entero-pancreatic neuroendocrine tumors, etc); pheochromocytoma; neuroblastoma; medulloblastoma; ectopic Cushing syndrome/non-pituitary ACTH elevation; tumor-induced osteomalacia. Supporting evidence may include MRI, CT, biochemical markers, and/or pathology report.
* Previous diagnosis of NET with Ki-67 index available or soon to be obtained.
* ECOG performance status 0 - 3, inclusive.
* 18 years or older and able to understand and provide written informed consent
* Patients must be able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 45 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug

Exclusion Criteria:

* Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
* Patients who exceed the safe weight limit or bore of the PET/CT bed
* Patients who are claustrophobic or pregnant