cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)

The purpose of this study is to evaluate the pharmacokinetics and safety of oral posaconazole tablets in Chinese participants at high risk for invasive fungal infections. Neutropenic participants undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes will be enrolled in the study.


Eligibility Criteria:
Inclusion Criteria:

* Chinese participant
* Female of reproductive potential with a serum hCG level consistent with a nongravid state and agree to use 2 acceptable methods of birth control throughout the study
* Body Mass Index (BMI) \>=15 and \<=30 kg/m\^2
* Anticipated or documented prolonged neutropenia and likely to last for at least 7 days due to: a) standard intensive chemotherapy, anthracycline-based or other accepted regimen (excluding any investigational agent) for a new diagnosis of acute myelogenous leukemia (AML); b)chemotherapy for AML in first relapse; or c) therapy for myelodysplastic syndromes in transformation to AML or other diagnoses of secondary AML (therapy related, antecedent hematological disorders) or chronic myelogenous leukemia in blast crisis
* Free from any clinically significant disease other than the primary hematologic disease that would interfere with administration of study medication or study evaluations

Exclusion Criteria:

* Pregnant, intends to become pregnant during the study, or has been nursing
* Mentally or legally incapacitated, has significant emotional problems, or has clinically significant psychiatric disorder over the last 5 years
* Received systemic antifungal therapy (oral, intravenous, or inhaled) within 30 days of study enrollment for reasons other than antifungal prophylaxis
* Known or suspected invasive or systemic fungal infection
* Taken posaconazole within 10 days prior to study enrollment
* Major surgery, donated or lost 1 unit of blood, or participated in another investigational study within 4 weeks prior to the study
* Type 1 hypersensitivity or idiosyncratic reactions to azole agents
* Significant multiple or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food
* Moderate or severe liver dysfunction
* Chronic active hepatitis, cirrhosis, Hepatocellular Carcinoma (HCC), or other hepatic disease caused by a virus
* Previous electrocardiogram with a prolonged QTc interval
* Prior enrollment in this study or other posaconazole studies within 90 days of study entry
* Eastern Cooperative Oncology Group (ECOG) performance status was \>2 prior to induction chemotherapy for the underlying disease
* Known or suspected Gilbert's disease
Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function

Background

It is uncertain whether subtotal abdominal hysterectomy results in better bladder, bowel, or sexual function than total abdominal hysterectomy.

Methods

The investigators conducted a randomized, double-blind trial comparing total and subtotal abdominal hysterectomy in 279 women referred for hysterectomy because of benign disease; most of the women were premenopausal. The main outcomes were measures of bladder, bowel, and sexual function at 12 months. The investigators also evaluated postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Women having abdominal hysterectomy for benign conditions of the uterus

Exclusion Criteria:

* Suspected cancer
* A body weight that exceeded 100 kg
* Previous pelvic surgery
* Known endometriosis
* Abnormal cervical smears,
* Symptomatic uterine prolapse
* Symptomatic urinary incontinence
Effects of Combined Aerobic and Resistance Training in Patients With Intermittent Claudication

Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium.

The investigators are going to measure EPCs and EMPs in a group of patients with IC and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. Subsequently, a group of IC patients will be randomly assigned to perform a 12-week home-based exercise training program.

The investigators expect a significant increase of EMPs and EPCs after acute and chronic physical activity. We expect also a correlation between the increase of EMPs and EPCs and the improvement in walking capacity. Aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of EMPs and EPCs in patients with IC and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with IC.


Eligibility Criteria:
Inclusion Criteria:

* history of stable intermittent claudication (PAD, stage II Fontaine)
* resting ankle-brachial index (ABI) \<0,9 and the presence of occlusion or significant stenosis at the color-Doppler duplex ultrasound scanning

Exclusion Criteria:

* lower-limb ischemic rest pain or gangrene (Fontaine stages III and IV)
* inability to obtain the ABI value or to perform a walking test
* exercise tolerance limited by factors other than claudication (i.e., arrhythmias, cardiac symptoms or exaggerated blood pressure rise, severe obesity)
* end-stage liver or renal failure
* acute or chronic inflammatory conditions
* history of recent (\<6 months) acute coronary syndrome, cerebrovascular event or inducible myocardial ischemia
* treatment with drugs known to affect walking capacity, including calcium-channel blockers, β-blockers and angiotensin-converting enzyme inhibitors.
Sequential Oxygen Therapy Strategy for Patients With COVID-19

All patients with COVID-19 were divided into three groups according to their illness: mild patient who receive conventional oxygen therapy, severe patients who receive nasal high flow oxygen inhalation or non-invasive positive pressure ventilation，all the oxygen therapy will be used as part of the standard of care. Each group will enroll 10 patients, the treatment of all patients will be continuously optimized during observation, and the incidence of respiratory failure, intubation rate, 28 day mortality rate, ICU hospitalization days, etc will be recorded and analyzed so to optimize the treatment time window of sequential oxygen therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with COVID-19

  * Aged between 18-75 years;

    * Willing to sign the informed consent voluntarily.

Exclusion Criteria:

* Patients with active tuberculosis, idiopathic pulmonary fibrosis, bronchial asthma, bronchiectasis, pulmonary embolism, chronic respiratory failure or other serious respiratory diseases; ② patients with serious cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, cardiac function grade 3 or above, stroke, cerebral hemorrhage, etc.); ③ Patients with serious hepatorenal diseases (serious liver diseases refer to cirrhosis, portal hypertension and varicose bleeding, and serious kidney diseases include dialysis and kidney transplantation); ④ tumor patients who have undergone resection, radiotherapy and chemotherapy within 5 years; ⑤ patients who have difficulty in activity due to neuromuscular diseases; ⑥ patients with serious arthritis; ⑦ patients with serious peripheral vascular diseases; ⑧ Pregnant and lactating women; ⑨ with severe cognitive and mental disorders; ⑩ the clinical researchers who were participating in other interventions within one month before selection;
Identifying Risk Factors for Gram-negative Resistance for HAP/VAP in the Intensive Care Unit

Single center, retrospective chart review. Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP.

Single center, retrospective chart review. Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP. Patients with respiratory culture data signifying a Gram-negative organism as the cause of HAP/VAP will be analyzed as described below if study inclusion criteria is met. Minimum inhibitory concentration (MIC) data will interpreted per Clinical \& Laboratory Standards Institute (CLSI) standards to determine local patterns of resistance. Multivariable logistic regression will be performed to determine risk factors for piperacillin-tazobactam, cefepime or meropenem resistant Gram-negative isolates. Project target date of completion and close-out is May 2021.

Eligibility Criteria:
Inclusion Criteria:

* ICU, Neuro critical care unit admission
* Diagnosis of HAP or VAP
* Respiratory culture positive for Gram-negative organism

Exclusion Criteria:

* ICU length of stay \<48 hours prior to HAP/VAP
* Culture or MIC data unavailable
* Pregnant
Relationship Between Aerobic Prescription Methods

Current literature report 3 ways to prescribe and control aerobic training. Such models require comparison to determine if they really provide the same impact training in a prescription. The aim of this study is to compare the results of different methods of prescription of aerobic training, ie VO2 workload, heart rate (HR), and load self adjusted by perceived effort (PSE) as well as psychological responses activation, and feel depending on the stimuli offered.

36 subjects will undergo two sessions. On the first visit, a maximum aerobic exercise test will be carried on treadmill to determine the maximum oxygen intake and maximum heart rate. Second, the subjects are placed (in a blinded fashion) in 3 situations of moderate effort (60 to 65%) for a total of 5 min and 3 min interval between conditions. In situation 1) will be used to speed regarding the particular metabolic demand from the maximum oxygen intake; In the second situation the reserve of heart rate will be used as reference for prescription aiming to achieve 60-65%; On the last visit will be shown to subjects a perceived effort characterized as moderate and asked to adjust their speed according to the application effort. The final will be recorded each time the FC and the speed and perception of effort that the subject was.

Eligibility Criteria:
Inclusion Criteria:

* 18 at 45 years
* Risk stratification low
* Physically active by American College of Sports Medicine criteria

Exclusion Criteria:

* Use of ergogenic resources
* Use of sympatholytic drugs
* Use of stimulants
mHealth Intervention to Support Diabetes Medication Adherence

This study aims at evaluating the effectiveness of an intervention based on the use of a mobile-device based system delivering automated, tailored brief text messages to offer support for medicine use and lifestyle recommendations alongside usual care to people with type 2 diabetes.

A list of patients registered in primary care centers of the Balearic Islands and potentially meeting the eligibility criteria will be obtained from electronic health records (EHRs). A research assistant will contact the potential participants via phone to invite them to the study and confirm eligibility. All eligible participants will complete informed consent followed by baseline assessment over the phone before randomization. Participants will be randomly allocated using a computer-generated randomization sequence. All participants will continue with their usual diabetes care including all medical visits, tests, and diabetes support programs throughout the study. In addition, the intervention group will receive the text messaging intervention. Control participants will receive usual care only.

After twelve months of follow-up, all participants will complete post-intervention assessments via phone interview. Data on glycemic control (HbA1c) at baseline and post-intervention will be extracted from EHRs, as according to the protocol used for primary care providers in the Balearic Islands, patients with poor glycemic control (HbA1c \>8% ) must request an HbA1c determination every six months. Results of the most recent determination will be extracted from electronic medical records. For those patients with no recorded HbA1c within the previous four months, the research assistant will contact the primary care center to arrange blood test analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patients registered in the Public Health Service of the Balearic Islands
* With type 2 diabetes
* At least one prescription of a glucose-lowering drug
* With results of HbA1c\>8% from 6 months prior to recruitment

Exclusion Criteria:

* Younger than 18 years old
* With insulin treatment
* Participating in another research study
* Not living in the Balearic Islands at some point during the study development
GnRH Antagonist Versus GnRH Agonist in Polycystic Ovary Syndrome During in Vitro Fertilization - Embryo Transfer

GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been accomplished by several randomized controlled trials compared with conventional GnRH agonist long protocol in polycystic ovary syndrome (PCOS) patients. Moreover, there are debating issues that refer to the timing of GnRH antagonist initiation. The purpose of this study is to investigate the laboratory and clinical priority during ovarian stimulation for IVF in patients with PCOS treated with three different protocols.

GnRH Antagonist is Started on Stimulation Day 1 GnRH Antagonist is Started on Stimulation Day 6 Conventional GnRH Agonist Long Protocol

Eligibility Criteria:
Inclusion Criteria:

* PCOS patients (diagnosed as 2003 ASRM(The American Society for Reproductive Medicine)/ESHRE(The European Society of Human Reproduction and Embryology) consensus meeting guideline)
* age 20-40 years
* patients who have normal uterus
* Korean ethnicity

Exclusion Criteria:

* patients who have abnormal thyroid function
* patients who have abnormal prolactin test
* patients who have diabetes, or Cushing's syndrome, or congenital adrenal hyperplasia, or androgen-producing tumor.
* Patients who reject informed consent
* patients who have experience of adverse events for GnRH agonist, antagonist, recombinant FSH(follicle-stimulating hormone).
The Application of Ketamine for Sedation in Patients With Cardiac Arrest - - KetCat (KETamine in Cardiac ArresT) Study

Recent evidence suggests ketamine may attenuate harmful cellular cascades taking place after brain injury that result in permanent damage. The investigators are interested in researching the application of this in the setting of cardiac arrest. Following cardiac arrest, the brain is deprived oxygen for a period of time, leading to the imitation of these harmful cellular processes. The investigators hypothesize that patients who receive ketamine as part of their standard sedation procedures during cardiac arrest treatment have better neurological functioning compared to those who do not.


Eligibility Criteria:
Inclusion Criteria:

* All out-of-hospital cardiac arrests (OHCA) with a "shockable rhythm" (ventricular fibrillation, pulseless ventricular tachycardia) that present to the Royal Columbian Hospital. The patient may be either in active cardiac arrest with shockable rhythm or may have achieved Return of Spontaneous Circulation (ROSC).
* Over 19 years of age
* Patients requiring sedation based on the assessment of the resuscitating physician.

Exclusion Criteria:

* Any other type of cardiac arrest
* Any history of previous, pre-existing neurological deficit
* Started on Extracorporeal Membrane Oxygenation (ECMO)
* Duration of cardiac arrest without ROSC is greater than 30 consecutive minutes
* Known contraindication or hypersensitivity to ketamine
* Awake patient or no standard sedation or no intubation required
* Inability to obtain deferred consent
* Currently enrolled in any other research study involving drugs or devices
* Patients who are pregnant
* Patients who are prisoners
* Patients residing in Long Term Care (LTC) facilities
UNC Pleural Fluid Registry

Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years or older
* Inpatients and outpatients
* Diagnosed with pleural fluid, are referred for and undergo clinically indicated drainage who have clinical evidence of:
* pulmonary infection (such as fever, leukocytosis, new or worsening infiltrate on chest x-ray, or clinical deterioration) with effusion
* malignancy

Exclusion Criteria:

* A subject will not be eligible for inclusion in this registry if, in the investigator's (or treating clinician's) opinion, the patient has any concurrent medical condition that may preclude their ability to undergo pleural fluid drainage safely.
* Incarcerated individuals
Effects of Aripiprazole (LAI) on Phychosocial/Cognitive Functioning, pt Reported AcceptabilityofTreatment in Sch

Nautralsitic, Open-label, Single Arm, Uncontrolled Study Evaluating the Effects of Long Acting Injectable (LAI) on Phychosocial Functioning Congitive Functioning and Patient Reported Acceptability of Treatment 'Reported Acceptability of Treatment' Regarding Quality of Life Subjective Well-being Under Neuroleptic Medication in Schizophrenia Patients

Primary Objective

* To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning, quality of life and patient reported acceptability of treatment. Secondary Objective(s)
* To evaluate the cognitive functioning of the patients
* To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable (LAI),
* To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment,
* To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI).

Eligibility Criteria:
* Inclusion Criteria:

  * Participants 18-45 of years age fulfilling DSM-IV-TR diagnostic criteria of schizophrenia,
  * Disease history of ≤ 3 years (≤ 3 years after the emergence of first psychotic symptoms),
  * A history of symptom exacerbation or relapse when not receiving antipsychotics therefore requiring maintenance antipsychotic treatment,
  * Informed written consent,
  * Not on any antipsychotic treatment at least for 3 months or requiring a switch in treatment for any reason (lack of efficacy/ inadequate response to current antipsychotic(s), intolerance, nonadherence), and with the potential to benefit from extended treatment with an LAI formulation, in the investigator's opinion.
  * Lack of efficacy is defined as subjects with a baseline total PANSS score ≥70 or ≥2 items scoring ≥4 in the Positive or Negative Symptom Subscale
  * Lack of tolerability is defined as the presence of clinically relevant side effects with the previous antipsychotic medication.
  * Being literate in order to be able to answer the self report scales.
* Exclusion Criteria:

  * DSM-IV-TR diagnosis other than schizophrenia or experiencing acute depressive symptoms in the past 30 days requiring ADT depending on the clinical decision of the investigator.
  * Antipsychotic resistant or refractory schizophrenia
  * A history of failure to clozapine treatment or response to clozapine treatment only.
  * Significant risk of violent behavior or risk of self-harm
  * Currently meets DSM-IV-TR criteria for alcohol and substance dependence
  * Any clinically significant medical or neurological disorder
  * Any medically significant abnormal laboratory test or ECG result at screening
  * Pregnant, lactating.
Multiple Myeloma Patient Registry

The purpose of this study is to document the participants characteristics, disease burden, and clinical management of participants in the United States who are treated for relapsed multiple myeloma in routine medical practice with a treatment strategies that include a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments.


Eligibility Criteria:
Inclusion Criteria:

* Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
* Have a diagnosis of relapsed MM \[according to 2014 International Myeloma Working Group (IMWG) criteria\] with 1 to 3 prior lines of therapy. (An induction regimen followed by autologous stem cell transplantation and single-agent maintenance therapy will be considered a single line of therapy.)
* Participants must have initiated a new line of induction therapy that includes a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) within 90 days prior to enrollment. A short course of corticosteroids is allowed prior to initiating the new line of induction therapy
* Must be willing and able to complete the protocol-required patient-reported outcome (PROs)

Exclusion Criteria:

* Participant has plasma cell leukemia \[greater than (\>) 2.0 \* 10\^9 per liter\] circulating plasma cells by standard differential), Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and/or skin changes), or amyloid light-chain amyloidosis
* Participant has a life expectancy of less than 6 months
* At the time of screening, participant is enrolled in an interventional clinical trial for MM using an anti-neoplastic agent that is not currently approved by the United States (US) Food and Drug Administration (FDA)
Local Paclitaxel or Balloon Angioplasty Below the Knee

Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries

After successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. Only patients who require follow-up angiography after 6 months will be included in this study. The primary endpoint (index vessel occluded or still open) is at 6 months - the patients will be also followed for 24 months for clinical endpoints. In addition an MRI is planned at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries
* Rutherford 2-5 patients
* Patients with ≤ 2 BTK lesions (≥ 70% diameter stenosis)
* Lesion length limited to 5-25 cm

Exclusion Criteria:

* Planned or foreseeable amputation
* Previous amputation at the index limb
* Index vessel with no run-off to the foot distal to the index lesion
* Prior treatment of the index lesion with a drug coated balloon
* In-stent restenosis
* Life expectancy \<1 year
* Known creatinine \>1.4 mg% if patient is not on dialysis
* Acute thrombus in the index limb
* Aneurysm in the index leg
* Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel
* Patients with concomitant medical illnesses that require cytostatic or radiation therapy