cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-1 and BR1015-2 in Healthy Volunteers Fed Conditions

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015 and co-administration of BR1015-1 and BR1015-2 in healthy volunteers under fed conditions


Eligibility Criteria:
Inclusion Criteria:

* Those weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(Except for hormone drugs) from the date of consent to 14 days after the last administration and disagrees to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients

Study to investigate whether a smart technology intervention can improve clinical and cost-effectiveness of one-year follow-up in patients who suffered from acute myocardial infarction.

Rationale: Smart technology could improve quality of care in patients after acute myocardial infarction (AMI) with either ST or non-ST elevation.

Objective: The objective of this study is to measure the effect of a smart technology intervention on patients after AMI.

Study design: The design of the study is a single-center, open randomized-controlled trial.

Study population: The study population consists of patients who have been discharged from the ward of the cardiology department of the Leiden University Medical Center after primary percutaneous coronary intervention (PCI) for either ST or non-ST elevation myocardial infarction.

Intervention: Patients will be randomized to either "The Box" or regular follow-up. Patients who have been randomized to The Box will receive a box containing a smartphone compatible electrocardiogram (ECG) monitor, a weight scale, an activity tracker and a blood pressure monitor. If patients are randomized to The Box, two of the four outpatient clinic visits will be replaced by an e-consult, in which a patient does not have to go to the hospital, but talks with his or her doctor or nurse practitioner via a secured video connection.

Main study parameters/endpoints: The primary endpoint of the study will be the percentage of patients with controlled blood pressure in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patient is admitted with acute myocardial infarction
* Patient is able to communicate in English or Dutch at B1 level

Exclusion Criteria:

* Body Mass Index \> 35 kg x m-2
* Included in another randomized controlled trial
* Patient is \<18 years of age
* Patient is considered an incapacitated adult
* Patient is pregnant
* Patient is unwilling to sign the informed consent form
A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia

This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed, acute myelogenous leukemia (all subtypes except acute promyelotic leukemia) according to WHO criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to NCI-CTC AE Grade \< 2, except alopecia
* Adequate hepatic and renal function
* Patient must be willing to submit blood and bone marrow samples for PK and PD analyses and exploratory biomarkers

Exclusion Criteria:

* Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea
* History of allergic reactions attributed to components of cytarabine and/or the formulated product
* Current evidence of CNS leukemia
* Increased QTc interval (QTc \> 470 ms), baseline resting bradycardia \< 45 beats per minute, or baseline resting tachycardia \< 100 beats per minute
* Family history of long QT syndrome or other risk factors for torsades de pointes, and/or the use of concomitant medications that prolong QT/QTc interval
* Uncontrollable intercurrent illness
* Pregnant or breast-feeding women
* HIV-positive patients receiving anti-retroviral therapy

  * Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
Characterisation of Fundamental Decision Making in People Suffering From a Characterised Depressive Episode

The investigators will include patients suffering from Major Depressive Disorder (MDD), in episode. The patients will undertake neuropsychological tasks evaluating executive function and clinical assessment related to depressive symptoms, anxiety, transdiagnostic symptoms and psychological skills.

The investigators will include patients suffering from MDD, in episode. The patients will be evaluated with the MINI-7 interview. Then, the participants will undertake different neuropsychological tasks evaluating executive function: the stroop task, the D2 tasks, the finger tapping test and the mindpulse. The participants will also undertake clinical evaluation the MADRS, the Transdiagnostic Skills Scale, the Symptomatic Transdiagnostic Test, the STAI and the Severity Insomnia Indexes. The investigators will perform correlational analysis between the neuropsychological tasks and the clinical evaluations. The investigators will also compare the predictive power of the different neuropsychological tasks on depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Diagnosis of a depressive episode according to DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0 according to DSM-5).
* No evidence of bipolar disorder or schizophrenia, confirmed by the MINI.
* No dementing neurological disease.
* No guardianship or trusteeship

Exclusion Criteria:

* Opposition to data processing
* Depressive episode in the context of a known bipolar disorder or schizophrenic illness
SVT-15652 Otic Solution for the Treatment of Otomycosis.

Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.


Eligibility Criteria:
Main Inclusion Criteria:

* At least 18 years of age
* Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
* Signs/symptoms of pruritus, otalgia and ear fullness.
* Debris or drainage clinically consistent with fungal infection.

Main Exclusion Criteria:

* Known bacterial otitis externa or malignant otitis externa.
* Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.
* Structural ear anomalies which may difficult the evaluation of the therapeutic response.
* Uncontrolled diabetes mellitus.
* Any infection requiring systemic antimicrobial or systemic antifungal therapy.
* Concomitant medicines that may interfere with the study evaluations.
Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome

The purpose of this study is to determine if peripheral nerve ultrasound can be used as a supplemental tool to diagnose Guillain-Barre syndrome (GBS) in the acute setting and aid in prognostication.


Eligibility Criteria:
Inclusion Criteria:

* For GBS group: Inpatients with acute, progressive weakness and no alternative diagnosis, with onset less than 30 days prior to examination.
* For control group: Hospitalized patients on the inpatient neurology service who are being treated for non-peripheral nerve disorders (e.g. epilepsy, multiple sclerosis, or stroke).
* For all subjects: 18+ years of age

Exclusion Criteria:

- Patients with any history of multifocal motor neuropathy (MMN), prior Guillain-Barre syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), or hereditary neuropathy (e.g. Charcot-Marie-Tooth)
A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients

The current study examines the effects of a 3-week, at-home mindfulness mediation intervention (MMI) to address psychological and physical distress in patients with gynecologic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Must be ≥ 18 years old
* Have a diagnosis of Stage III or IV, progressive or recurrent GC (endometrial, ovarian, fallopian tube, primary peritoneal, cervical, vulvar, vaginal, or other)
* Be native English speakers
* Report ≥ 4 on the National Cancer Care Network (NCCN) Distress Thermometer at the time of recruitment;
* Not currently be practicing weekly meditation
* Be willing to create (or already have) an email address
* Have access to internet via a personal electronic device (or be willing to borrow an internet-enabled tablet from the study team).

Exclusion Criteria:

* \<18 years old
* Distress Thermometer ratings ≤ 3
* Non-native English speakers
* Individuals with severe depression, and individuals who are having suicidal thoughts.
* Individuals who are also not willing to create an email address for the purpose of the study (or individuals who do not have an email address already)
* Individuals who are currently practicing weekly meditation
* Due to overlap in surveys for other ongoing trials in the Division of Gynecologic Oncology, patients may not be currently enrolled on protocol IRB#: 201511102 (chemoresistance) or IRB# 201804169 (Cytokine-induced depression).
Clinical Trial of Topical ABL01 Treatment of Onychomycosis

This clinical trial seeks to investigate if an experimental medical device, ABL01, can be used to treat onychomycosis. In a 1-year trial the effectiveness of ABL01 will be tested against placebo in 70 study subjects with onychomycosis of the big toe nail. The endpoint of the trial is clinical improvement and cure at the 6 and 12 month time-point.

The purpose of this clinical trial is to determine the safety and effectiveness of the medical device ABL01. The intended use of ABL01 is to reduce and treat onychomycosis, fungal nail infection. ABL01 is a solution intended to be topically administered weekly to infected nails. The trial is designed as a double blinded randomized placebo controlled clinical trial. The trial involves 70 study subjects, half of which will receive ABL01 and the other half placebo. The inclusion criteria for study subjects are adult men and women that present with distal lateral subungual onychomycosis (DSU) on the big toe nails. Furthermore, the extent of DSU should not involve more than half of the area of the nail.

The study subjects will themselves apply the study solution weekly to the treated nail. The trial will run for 6 months with a possible extension to maximum 12 months. There will be a total of 4 study visits at baseline, 3, 6 and 12 months to follow up the progress of the trial. The primary objective of the trial is to determine if ABL01 treatment are able to reduce and treat onychomycosis. Secondary objectives are to collect safety data, determine if the ABL01 are perceived as easy to use and assess long term effects of the treatment. The endpoint of the trial is reduction in clinical signs or complete cure of onychomycosis at the 6- or 12-month time-point.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Men and women above age 18 weighing over 40 kg
* Present with distal lateral subungual onychomycosis of any of the big toe nails
* The onychomycosis should involve less than 50 % of the nail bed and may not have reached the cuticle

Exclusion Criteria:

* Unable to come for study visits
* Known allergy to any of the components in ABL01
* Not willing to participate in the trial or not able to understand the content of the trial
* Present with proximal subungual onychomycosis or superficial onychomycosis.
* Present with distal lateral subungual onychomycosis of other nails than the big toe.
* More than 50 % of the nailbed affected by onychomycosis or the cuticles infected
* Known conditions (like psoriasis) that cause abnormal nail appearance
* Nail damage caused by trauma, pressure or other mechanical reasons
* Currently on immunosuppressive therapy
* Showing signs of poor peripheral blood circulation
* Used another topical antifungal treatment within 1 month of screening
* Used a systemic antifungal treatment within 3 months of screening
* Participated in any other clinical onychomycosis trial in the previous 3 months
Intensive Care Therapy of Covid-19 Disease in Germany

Multi-center retrospective and prospective observational study of Covid-19 patients with severe or critical illness treated on a German ICU


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Covid-19 disease (positive SARS-CoV-2 PCR)

Exclusion Criteria:

-none
The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran

The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran

The participants will be children aged 3 months to 3 years.The zinc group received oral zinc supplementation; 2.5 ml every 12 hours for children aged \<1 year and 5 ml every 12 hours for older children; the probiotics group received oral probiotics; 1 probiotic sachet; and the control group received nothing.

Eligibility Criteria:
Inclusion Criteria:

1. children aged 3 months to 3 years
2. prescribed antibiotics for various medical conditions

Exclusion Criteria:

1. Diarrhea, Dysentery
2. Underlying chronic disease
The Comparison Between the PVAM and CPVI for the Patients of PAF

To compare the efficacy and safety of circumferential pulmonary vein isolation without contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial fibrillation.

This is a single centre, prospective control study. The study will enroll 180 patients with 2:1 grouped.

Eligibility Criteria:
Inclusion Criteria:

* patients with paroxysmal atrial fibrillation refractory to drugs
* with consent

Exclusion Criteria:

* LVEF\<50%
* history of cardiac surgery
* valvular heart disease
* abnormal thyroid function
* left atrial thrombus
The Utility of Multiplex PCR for Detection of DNA in Neutropenic Patients With Hematological Malignancies

Objectives: Invasive infections are the leading cause of morbidity and mortality in patients treated for hematological malignancies. Blood cultures are often negative in neutropenic patients because of low-burden of organisms, previous antibiotic therapy or non-infectious reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.

Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for multiplex PCR at admission and 3x/week thereafter until discharge or recovery from neutropenia


Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥18 years
* autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy performed

Exclusion Criteria:

* No blood samples were taken
Characterize Differences in Force Patterns Used by Different Endoscopists and Trainee Endoscopists

The study is to evaluate how doctors in training are different from very experienced doctors when using force to perform colonoscopy with a device that monitors the amount of force applied to the colonoscope during colonoscopy.

The study consists of two sequential observational studies designed to identify which instrument should be used to assess trainee performance and to quantify trainee skill development in performance of colonoscopy over the course of their training program.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing diagnostic or screening colonoscopy ASA Class I or II
* All ethnic and racial groups will be included
* Able to comprehend, sign and date the written informed consent form (ICF)
* English is their primary language

Exclusion Criteria:

* Chronic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor
* Specific pathology that would limit the extent of examination
* ASA class 3 or greater
* Pregnancy
* Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity
Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children

This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single tertiary pediatric intensive care unit (PICU). The study will include children with RSV infection who were admitted to the pediatric intensive care unit and require respiratory support via positive pressure ventilation (invasive and noninvasive).

Eligible participants include all children admitted to the PICU at Children's of Alabama with a diagnosis of RSV infection and requiring positive pressure ventilation, invasive or noninvasive, including bilevel positive airway pressure (BiPAP) or high flow nasal cannula (HFNC) oxygen (ie, \>1 L/kg/min of flow, with 5 L/min flow for children weighing \<5 kg). During hospitalization, all patients will be treated according to the American Academy of Pediatrics guidelines for the management of bronchiolitis, primarily supportive care. Participants will then be randomized according to a permuted-block design to receive either placebo (saline) or AZM (Fresenius Kabi) at 10mg/kg/d (ie, standard dose) or 20mg/kg/d (ie, high dose) intravenously every 24 hours for 3 days. All biologic samples collected will be analyzed in the PI's lab at the University of Alabama at Birmingham. Drug pharmacokinetics will be performed at the Pharmaceutical Sciences Research Institute of Samford University, Birmingham, AL.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the PICU with RSV infection
* Need for positive pressure ventilation (invasive and non-invasive)
* Randomization and drug/placebo initiation within 48 hours of admission to Pediatric Intensive Care Unit

Exclusion Criteria:

* Azithromycin use within 7 days of PICU admission
* Contraindication to azithromycin use including:

  * Patients with electrocardiogram QT interval corrected for heart rate (Qtc) ≥ 450 ms
  * Patients with significant hepatic impairment (direct bilirubin \>1.5 mg/dL)
  * Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug
  * Cardiac arrhythmia
* History of pyloric stenosis
* Immunocompromised children (any cause)
* Current use of any medication known to cause QT prolongation
MK6186 in HIV-1 Infected Patients (MK-6186-007 AM2)

This study will evaluate the safety and tolerability of MK6186 and the change from baseline in plasma HIV-1 RNA after seven consecutive days of dosing.


Eligibility Criteria:
Inclusion Criteria:

* Other than HIV infection, patient's baseline health is judged to be stable
* Patient is documented HIV-1 positive
* Patient has not received an investigational agent or licensed ART with in the past 30 days

Exclusion Criteria:

* Patient has a history of stroke, chronic seizures, or major neurological disease
* Patient has a history of cancer
* Patient has used any immune therapy agents or immunosuppressive therapy within the past month
* Patient requires or anticipates the use of any prescription or non-prescription drugs during the study
* Patient has a current diagnosis of acute hepatitis, has a history of Hepatitis C or has positive Hepatitis B surface antigen
* Patient consumes excessive amounts of alcohol (greater than 3 servings per day) or caffeine (greater than 6 servings per day)
* Patient is an excessive smoker (more than 10 cigarettes per day)
* Patient has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
Interval Versus Continuous Exercise During Pregnancy

The objective of this randomized cross-over design was to investigate the fetal well-being and maternal glycemic response to an acute bout of aerobic high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) with pregnant individuals.


Eligibility Criteria:
Inclusion Criteria:

* Carrying a singleton pregnancy (i.e. greater than or equal to 20 weeks of gestation).
* Has access to a stationary bike
* Located within Canada and/or within Edmonton Alberta

Exclusion Criteria:

* History of smoking within the last year
* Taking medications that may interfere with cardiovascular function.
* High-order pregnancies, e.g. twins or above.
* Females with absolute contraindications (as outlined by the Canadian Guidelines for Physical Activity throughout Pregnancy and the PARMed-X questionnaire)