cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus

The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.

This is a 2-part study. Part 1 is a 2-sequence, drug interaction study to determine the effect of two different ASP015K doses on the pharmacokinetics of oral tacrolimus. Part 2 is a 1-sequence drug interaction study to determine the effect of the higher dose ASP015K on the pharmacokinetics of IV tacrolimus.

Eligibility Criteria:
Inclusion Criteria:

* Subject weighing at least 45kg and body mass index (BMI) of 18-32 kg/m2, inclusive
* If female, subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
* If male, subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period
* 12-lead ECG is normal or if abnormal, the abnormality is not clinically significant
* Clinical laboratory test results are within normal limits or not clinically significant
* Medically healthy, with no clinically significant medical history or abnormalities

Exclusion Criteria:

* History of any clinically significant disorder, disease or malignancy excluding non-melanoma skin cancer
* Recent history (within 6 months) of drug or alcohol abuse or positive urine screen for drugs of abuse/illegal drugs
* Treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter medication within 1 week prior to study drug administration
* A symptomatic, viral, bacterial or fungal infection within 1 week prior to clinic check-in
* Positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg)
* History of human immunodeficiency virus (HIV) antibody
* Positive tuberculosis (TB) skin test or Quantiferon Gold test
* Vaccinated within the last 30 days prior to study drug administration
* Received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
* Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
* Absolute neutrophil count (ANC) \<2500 cells/mm3
Nidek RS3000 Comparative Study

The primary objective of this clinical study is to compare the Nidek RS-3000 Optical Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of legal age and who have full legal capacity to volunteer on the date the informed consent is signed.
2. Subjects who follow the instructions by Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.
3. Subjects who sign an informed consent form to participate in the clinical study.
4. Subjects who agree to take the qualifying examination and RS-3000 and RTVue data acquisition.

Exclusion Criteria:

1. Diabetes mellitus (DM) and/or diabetic retinopathy
2. Hypertension (HT)
3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
4. Cardiac, hepatic, renal and hematologic diseases
5. Current systemic administration of steroid
6. History of anticancer agent etc.
7. Optically-stimulated epileptic seizure
8. Dementia
9. Subjects who have other life threatening and debilitating systemic diseases

NOTE: Additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist
Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19

Multi-centered, randomized, open label clinical trial to study the safety and effectivity of hydroxychloroquine + azithromycin to treat COVID-19 symptoms in primary care patients.

In the patient group treated with hydroxychloroquine + azithromycin we expect to find a diminution of 20% or more regarding the evolution of acute respiratory syndrome, as opposed to patients who have not been treated with these medicines.

To date, there is no shown effective treatment regime for acute respiratory distress caused by COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Patients with positive semi-quantitative PCR and COVID19 symptoms (fever, cough, diarrhea, dyspnoea, loss of smell).
* Signed informed consent

Exclusion Criteria:

* Retinal degeneration.
* Congenital or acquired long QT syndrome.
* Advanced liver failure.
* Renal insufficiency (incompatible with creatinine clearance less than 50 mL /minute).
* Allergic to hydroxychloroquine or azithromycin.
* Serious interaction with the drugs used.
* Pregnant or breastfeeding.
* Men and women in fertile and sexually active periods, who do not accept a highly effective contraceptive method.
* Inability to follow study procedures.
Detection of IKZF1 Deletion Mutation in Patients With Acute Lymphoblastic Leukemia and Its Impact in Therapy

1. To detect IKZF-1 deletion mutations in patients with ALL.
2. To study the impact of IKZF-1 deletion mutation on therapy of ALL.
3. To study the correlation between IKZF-1 deletion mutations and BCR-ABL.

Acute lymphoblastic leukemia (ALL) a malignant transformation and proliferation of lymphoid progenitor cells in the bone marrow, blood and extramedullary sites. While 80% of ALL occurs in children, it represents a devastating disease when it occurs in adults . predisposing factors include exposure to ionizing radiation, pesticides, certain solvents or viruses such as Epstein-Barr Virus and Human Immunodeficiency Virus. However, in the majority of cases, it appears as a de novo malignancy in previously healthy individuals. Chromosomal aberrations are the hallmark of ALL, but are not sufficient to generate leukemia. Characteristic translocations include t(12;21) \[ETV6-RUNX1\], t(1;19) \[TCF3-PBX1\], t(9;22) \[BCR-ABL1\] . More recently, a variant with a similar gene expression profile to (Philadelphia) Ph-positive ALL but without the BCR-ABL1 rearrangement has been identified. In more than 80% of cases of this so-called Ph-like ALL, the variant possesses deletions in key transcription factors involved in B-cell development including IKAROS family zinc finger 1 (IKZF1) . IKZF1 codes Ikaros, which is a member of a family of zinc- finger nuclear proteins that is required for the earliest stages of lymphoid lineage commitment and acts as tumor suppressor. Most IKZF1 mutations (94%) are deletion mutations, and there are rare point mutations resulting in loss of function of Ikaros .

There are two major deletions occur in the IKZF1 gene:

* The first one was characterized by loss of exons 4 to 7 ( 4-7) with breakpoints occurring in introns 3 and 7 on chromosome 7p12.
* The second deletion involved exons 2 to 7 ( 2-7) with a variable pattern of breakpoints in intron 1 and intron 7 in the same region as those of the 4-7 deletion.

IKZF1 mutations in cases of B-ALL are associated with poor prognosis and high risk of relapse. IKZF1 mutations are found in approximately 15% to 20% of pediatric B-ALL cases and in \>75% of pediatric BCR-ABL positive ALL cases. The incidences of IKZF1 mutations in adults are approximately 50% in B-ALL cases and approximately 65% in BCR-ABL positive ALL cases .

The presence of either IKZF1 mutation or BCR- ABL has been reported to be an independent risk factor of poor prognosis for patients with B-ALL .

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute lymphoblastic leukemia.

Exclusion Criteria:

* patients with any other hematological malignancies.
* patients receiving chemotherapy.
Computational Imaging Research Based on Deep Learning

Computational imaging research based on deep learning

Based on the current technical challenges, subject development and upgrade of knowledge, to avoid the occurrence of adverse medical accidents, simplify the diagnostic process, artificial intelligence has become the alternative method of choice, by constructing training deep learning model, the CTA as model inputs aneurysm detection and diagnosis to improve diagnosis effectiveness, promote the development of medical technology

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-80 years.
2. CT paired imaging data of vessels, including layer-to-layer plain CT and enhanced CT. 2 Time range: January 2010 to December 2021.
3. Scanning sites: CT and CTA of head, neck, chest, abdomen or iliac.

Exclusion Criteria:

1. Unpaired CT image .
2. Severe artifact CT image.
3. enhancement CT failure image (failure to capture arterial phase or poor arterial development, insufficient flow of contrast agent, etc.)
Hamstring/Quadriceps Ratio in CrossFit

Crossfit® is a high-intensity physical training plan based on a program that includes exercises such as running, weight lifting and gymnastic movements. It focuses on the development of 10 physical qualities: strength, balance, cardiovascular and respiratory endurance, coordination, power, flexibility, agility, speed, precision and muscular endurance.Unfortunately, research on its effects is still at the beginning. The time of each session is one hour, which is divided into a warm-up of 10-30 minutes, strength training or skills, endurance work and finally a recovery phase, mobility and stretching. These types of exercises are incorporated into group training sessions called Workout of The Day (WOD).

Muscular strength is the action produced by a muscle or muscle group against resistance. It is one of the fundamental physical qualities for activities of daily living.

Digital isometric dynamometry is a tool to evaluate maximum voluntary isometric contraction (MVIC).

Hamstring muscles are responsible for hip extension and knee flexion. Moreover, they are the main protectors against anterior knee subluxation due to their action in conjunction with the anterior cruciate ligament (ACL).The quadriceps is one of the largest and most powerful muscles of the human body.

The ratio between hamstrings and quadriceps muscles has a strong correlation with lower limb injuries. This ratio, known as "H:Q" has proved to be the most reliable indicator to quantify a neuromuscular decompensation that causes an injury and, in addition, it is used as a prognostic indicator.


Eligibility Criteria:
Inclusion Criteria:

* Regular members of Tuluka Fitness Palermo.
* With at least 1 year of Crossfit training.

Exclusion Criteria:

* Subjects with a history of knee surgery.
* Who have any type of musculoskeletal injury to the dominant lower limb.
* Who suffer from neurological disorders.
Home-based Exercise in COVID-19 Survivors

The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with COVID-19
* Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
* Admitted in intensive care unit

Exclusion Criteria:

* Cardiovascular disease
* Resting dyspnea
* Acute pulmonary embolism or pulmonary infarction
* Deep venous thromboembolism
* Uncontrolled visual or vestibular disorders
* Pregnancy
* Uncontrolled resting tachycardia
* Uncontrolled hypertension
* Uncontrolled Type II diabetes
* Acute infections
* Neurological disorders
* Patients with chronic kidney disease who are in need of hemodialysis
* Recent malignant neoplasm (\<5 years)
* Autoimmune diseases
* Complex ventricular arrhythmias, atrial fibrillation or complete heart block
* Transplant patients
* Any physical disabilities that could hamper physical testing and exercise program
Investigation of Endothelium in Saphenous Vein Grafts

This is a single center prospective study of 30 patients undergoing elective heart bypass surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo study is to evaluate the function of vein grafts from small tissue samples treated with a pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the veins in preparation of bypass grafting. It is unknown if different levels of pressure in the syringe affect the vein or damage the vein. Small sections of tissue samples which are normally discarded will be obtained immediately after retrieval from the leg and before grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no clinical endpoints in this study, however, clinical information will be obtained from the Society of Thoracic Surgeons database and will include demographics, risk factors, and perioperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective coronary artery bypass graft surgery requiring at least 2 saphenous vein grafts

Exclusion Criteria:

* patients undergoing any concomitant surgical procedures
Immediate VS Delayed Cord Clamping on Newborns

The best time of the umbilical cord clamping has not been fully understood. immediate cord clamping (with in 10 seconds after birth) has been standardized practice for many years, while WHO protocol recommends to wait for 60-90 seconds. but the umbilical cord may still pulse for more than 90 seconds. is it best to wait longer until the pulsing ceased? how the time of umbilical cord will affect the newborn? will the longer time be less umbilical bleeding and shorter departure time of the cord? the hypothesis of this study is: to cut the cord after the pulsing ceased is the best time for cord clamping and will result in better quality of life for the newborn and less cord bleeding and earlier departure time of the cord, that means less infections of the cord.

1. for normal newborn (apgar score over 7), regardless term or preterm,normal birth or cesarean section born: experimental group1: waiting for the ceased of the umbilical cord pulsing, then cut the cord.before cutting the cord, the baby is keeping warm and put over mother's abdomen.

   control group 1-1: clamping and cut the cord within 10 second after birth. control group1-2: clamping and cut the cord 90 second after birth.
2. for in case of newborn asphyxia(regardless term or preterm,normal birth or cesarean section born):

experimental group2: resuscitate on bed site with the cord unclamped until the umbilical cord ceased pulsing.

control group 2-1 clamping and cut the cord within 10 second. and resuscitate the baby after transfer to the Irradiation table.

Eligibility Criteria:
Inclusion Criteria:

* all living baby after birth, including term, preterm, normal birth, cesarean section, apgar score over 7 or less than that.

Exclusion Criteria:

* still birth
Safety and Effectiveness of Gamma Capsulotomy in Intractable OCD

A research study of the effectiveness and safety of gamma knife ventral capsulotomy in patients with severe intractable obsessive-compulsive disorder (OCD).


Eligibility Criteria:
Inclusion Criteria:

1. OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Social and Occupational Functioning Assessment Scale (SOFAS) score of 45 or less.
2. Persistence of severe symptoms and impairment for five or more years despite: 1. at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with, 2. adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and 3. augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
3. Age between 18 and 65 years.
4. Able to understand and comply with instructions.
5. Able to give fully informed, written consent in the judgment of the Consent Monitor.
6. Either drug free or on a stable drug regimen for at least 6 weeks.
7. Good general health.
8. A family member or significant other is available and willing to communicate with the research team if the patient's clinical status worsens.
9. The local referring psychiatrist is willing to provide ongoing care.

Exclusion Criteria:

1. Current or past psychotic disorder.
2. Full-scale IQ below 85.
3. A clinical history of bipolar mood disorder.
4. Any current clinically significant neurological disorder or medical illness affecting brain function, other than tic disorders or Tourette syndrome.
5. Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
6. Inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia.
7. Current or unstably remitted substance abuse, dependence, or a positive urine toxicology screen.
8. Pregnancy and women of childbearing age not using effective contraception.
9. Unable to adhere to operational and administrative study requirements (in the investigators' judgment).
10. Clinical history of severe personality disorder.
11. Imminent risk of suicide (in the investigators' judgment).
Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.

The primary hypothesis of SMART CRT is that among cardiac resynchronization therapy defibrillator (CRT-D) patients with prolonged inrerventricular delay between the RV and LV leads, CRT with atrioventricular optimization (AVO) will result in greater reverse LV remodeling compared with CRT programmed at nominal settings (120 ms).

Eligibility Criteria:
Inclusion Criteria:

* Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.
* In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:

  * Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
  * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
* Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
* Subject is willing and capable of providing informed consent
* Subject is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria:

* Subjects with documented permanent complete AV block
* Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
* Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
* Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
* Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc...)
* Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
* Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
* Women of childbearing potential who are or plan to become pregnant during the course of the trial
* Subjects currently requiring dialysis
Effects of Balance Training in Older Adults With Dementia

Purpose -To investigate whether older adults with dementia who have balance and gait problems can improve their balance and gait function after an individualized 4-week tasks-oriented balance training with sensory manipulation.

Hypothesis

-There is significant difference of Timed Up and Go Test, Berg Balance Scale, walking speed, 30-s chair-stand test, Chair sit-and-reach test and Barthel Index between dementia patients who received tasks-oriented balance training and those didn't receive after 4-weeks training and one month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient provides oral consent, and written consent obtains from next of kin
* Older than 65 years
* Diagnosis of dementia, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)
* Can follow order to complete the screening test(Timed Up and Go test)
* Has balance and gait problems
* Can standing independently with/without assistive device or can standing with minimal assistance

Exclusion Criteria:

* Newly developed cardiopulmonary disease and other exercise contraindications
* Other neuromuscular or musculoskeletal disease that might affect the outcome(ex. Recent stroke, fracture or orthopedic surgery)