cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy

Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill patients receiving continuous renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-89
* Acute renal failure or end-stage renal disease necessitating CRRT
* Admitted to the MICU service
* If on vasopressor/inotropic agent, norepinephrine as only intravenous pressor
* If on vasopressor/inotropic agent, at stable pressor dose for at least four hours
* If on IV fluids, stable dose of crystalloids \<= 100cc/hour and is not receiving colloids for 4 hours or more prior to initiation of CRRT
* Mean arterial pressure (MAP) \>= 65
* Arterial catheter present for continuous blood pressure monitoring
* CRRT duration of 48 hours or less using NxStage System One dialysis system
* successfully tolerated CRRT for at least 4 hours without clotting or hemodynamic instability
* no other procedures, blood products transfusion, or additional medication administration are anticipated during the study period

Exclusion Criteria:

* listed for organ transplant
* atrial fibrillation, other irregular heart rhythm, unstable arrhythmia
* need for more than one intravenous vasopressor agent
* intravenous vasopressor/inotropic agent other than norepinephrine (ie dobutamine, dopamine, vasopressin, epinephrine)
* therapeutic anticoagulation being administered
* known acute myocardial infarction as defined by elevated troponin along with a documented clinical diagnosis during current hospitalization
* known acute stroke, intracerebral hemorrhage, intracranial mass effect, or elevated intracranial pressure within the last 30 days.
* dialysis catheter malfunction and unable to maintain target blood flow rate
* fluid removal (ultrafiltration) rate \> 100mL/hour
Effects of Recruitment Maneuvers in Early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) Patients

The purpose of this study is to evaluate the effect of lung recruitment maneuver in patients with early ALI/ARDS

The acute respiratory distress syndrome (ARDS) was first described in the medical literature in 1967. Patients with ARDS mostly require mechanical ventilatory support due to hypoxic respiratory failure. Mechanical ventilation can induce lung injury (ventilator-induced lung injury, VILI) by causing overdistention and repetitive opening and closing of unstable lung units. Data from a number of randomized controlled trials indicate that a lung protective ventilatory strategy with small tidal volume and low plateau pressure reduces mortality in acute lung injury (ALI) and acute respiratory distress syndrome. Lung recruitment maneuvers are being used in the management of ALI and ARDS, but recruitment maneuvers are still controversial. Lung recruitment maneuver is aimed to open the collapsed lung and keep the lung open. The maneuver briefly increases the alveolar pressure to open recruitable lung, sustained with adequate positive end-expiratory pressure(PEEP) after lung recruitment, to avoid derecruitment. We want to enroll 120 patients with early ALI/ARDS in this randomized controlled study. The study group use recruitment maneuver and lung protective ventilatory strategy, and the control group use lung protective ventilatory strategy only. Concerning about both safety and efficacy, we design a modified recruitment maneuver protocol which has never been published in previous medical literature. The primary outcome is ventilator-free days and ICU-free days, and secondary outcomes include ventilator weaning rate, and 28-day mortality and cost effectiveness analysis. Since no randomized controlled trials clearly establish benefit from recruitment maneuvers, we hope this study would be able to provide some evidence on whether lung recruitment should be used in the routine management of ALI/ARDS.

Eligibility Criteria:
Inclusion Criteria:

* met criteria of ALI/ARDS
* PaO2/FiO2 less than or equal 250 mmHg after standard ventilator setting (FiO2 more than or equal 0.5 and PEEP more than or equal 10 cmH2O)at least 30 mins

Exclusion Criteria:

* age less than 18 years
* duration of mechanical ventilator more than 72 hours
* Pneumothorax or subcutaneous emphysema or bullous lung disease
* severe chronic respiratory disease
* intracranial hypertension or received craniotomy surgery
* longterm dependent ventilator
* Neuromuscular disease
* premorbid conditions with an expected 6 month mortality risk exceeding 50%
Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.

Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal and flare reaction.


Eligibility Criteria:
Inclusion Criteria:

* Male and female allergic volunteers: Diagnosed allergy based on medical history and on positivity to skin tests to at least one of the standardized allergen including grass pollens, tree pollens, house dust mites, cat and dog dander and with a positive RAST for the specific selected allergen ≥ class 2

Exclusion Criteria:

* Pregnancy or lactating females, or females with childbearing potential without reliable contraception
* History or presence of any chronic or acute illness or disorder capable of altering the absorption, metabolism or elimination of drugs, or constituting a risk factor when taking the trial medication
* Heavy caffeine drinker (\> 5 cups of coffee, tea, cola, etc ... per day)
* Any drug treatment, including prescribed or non-prescription medicines (except hormonal contraceptives or post-menopausal hormonal replacement therapy for females and occasional use of paracetamol not exceeding 2 g/day with a maximum dose of 10 g per 14 days), taken from 14 days before study drug administration; the wash-out period after intake of systemic corticosteroids is at least 4 weeks
* Known allergy/intolerance to the study drug or any medicine chemically related to study drug or its excipients (lactose, cellulose...)
* Participation in another clinical trial, blood donation or significant blood loss (\> 450 mL) less than 12 weeks before the study drug administration
* Skin irritant or 48 hours UV exposure before each visit
* Immunotherapy received during the current year
* Any clinical conditions that, in the opinion of the Investigator, would make the subject unsuitable for the trial
Exercise to Slow Cardiovascular Ageing Progression

In ageing, deleterious alterations in cardiovascular (CV) structure and function increase risks of ageing-related cardiovascular disease (CVD). Investigators found that these CV alterations were associated with circulating serum metabolites, suggesting a metabolic basis to CV ageing. Investigators hypothesize that modification of these metabolites by intervention, such as exercise, may retard CV alterations and reduce CVD in ageing.

Participants from each stratum will be randomized to receive either an exercise program intervention or no exercise. At the start and end of study, participants will undergo cardiovascular imaging and metabolic profiling. Investigators will determine if exercise can reverse high-risk metabolic profiles and improve cardiovascular structure and function.

Without clear mechanisms to explain cardiovascular ageing nor interventions known to retard cardiovascular ageing, our approach will provide much needed translational evidence to incorporate targeted interventions aimed at reducing cardiovascular disease risk in older populations.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=21 years old
* Outdoor ambulant

Exclusion Criteria:

* Wheelchair or bed-bound
* Dementia
* Residing in sheltered or nursing home
* Cancer
* Participation in ongoing clinical trials that involve interventional drugs or devices
* Aneurysms
* Acute infections (in the last six months)
* Uncontrolled thyrotoxicosis
* Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise
* Uncontrolled asthma or chronic lung disease
* Restrictive lung disease
RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of ADX-102 1% Topical Dermal Cream in Subjects with Sjögren-Larsson Syndrome (SLS).


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged 3 years or older
* Subject has a genetically-confirmed diagnosis of SLS.
* Subject has active ichthyosis that is Grade 2 or higher on the Visual Index Ichthyosis Severity (VIIS) score.
* Females of child-bearing potential: Negative pregnancy test at Screening and Baseline Visits.

Exclusion Criteria:

* Subject has evidence of a serious active infection.
* Systemic or topical retinoids or other topical medications, not including emollients, within the past 30 days Baseline Visit 1.
* Subject has received an investigational systemic or topically administered drug within the past 30 days prior to Baseline Visit 1.
* Subject is currently receiving immunosuppressive therapy, including intermittent or low-dose systemic corticosteroids.
* Subject has a known allergic reaction to any ingredients of study drug formulation.
* Subject has any clinically significant laboratory test abnormalities or a history of any other condition that, in the opinion of the Investigator, could compromise the subject's ability to comply with the protocol or that could compromise the subject's safety or the interpretation of the study results.
The Innervation of Human Gut Sensory Epithelial Cells

The study has two objectives:

1. To obtain endoscopic and colonoscopic biopsies to harvest and culture intestinal crypts from human tissue to produce organoids. These organoids will be used to study the biology of innervated sensory epithelial cells.
2. to collect subject data relating to clinical management and demographic characteristics of patients undergoing upper endoscopy or colonoscopy to learn the mechanisms behind visceral hypersensitivity, and neurodegenerative diseases that may arise in the gut.

Throughout the gastrointestinal tract there are specialized sensory epithelial cells that recognize stimuli from nutrients and bacteria. These cells have been traditionally known for their endocrine function. However, it was recently discovered using mouse models that these cells receive synaptic inputs from enteric and peripheral neurons, such as those with cell bodies in dorsal root ganglia or the vagal nodose.

This finding opened a few possibilities, including the following: 1) sensory function of the gastrointestinal tract is modulated by neural activity; 2) gut bacteria influences brain function through a direct neural circuit; and 3) viruses that preferentially infect neurons access the central nervous system through this neural circuit \[1,2\]. To translate findings in animal models to humans, the investigator must test the hypotheses in which the physiology of gut sensory epithelial cells resembles that of humans.

Visceral hypersensitivity is a core symptom for several gastrointestinal and brain behavior disorders, including irritable bowel syndrome, autism and anorexia. Unfortunately, the basic mechanisms of sensory processing in the wall of the gut are non-existent. This lack of knowledge precludes the development of therapeutic strategies to treat disorders linked to visceral hypersensitivity. The investigator's efforts to translate animal research into human models will be a foundation to develop target therapies for visceral hypersensitivity.

Today, it is possible to derive organoids from intestinal crypts harvested from human intestinal or colonic tissue. The organoids have all epithelial cell types, including gut sensory cells. Here, the investigator's goal is to use de-identified human tissues to culture intestinal organoids in the laboratory, and use it as a platform to study the biology of innervated sensory epithelial cells. This work is significant because it will open the possibility to learn the mechanisms behind visceral sensation and neurodegenerative diseases that may arise in the gut.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing either endoscopy OR colonoscopy OR both procedures will be eligible for inclusion in this study.
* adult males and females 18 years of age or older who have been seen by the GI clinic or who have been scheduled for direct-to-procedure appointment in the GI clinic.

Exclusion Criteria:

* Subjects who are not competent to give consent
* Males and females under 18 years of age
* Women who are pregnant
Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study

This study is a multicenter, non-randomized, retrospective study to collect long term (4 years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05 study (NCT00466804) to evaluate participant and graft survival.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects previously enrolled in the CTOT-05 study
2. Subjects 4 years post-transplant (+/- 6 months).

Exclusion Criteria:

1. Withdrawal of consent from the CTOT-05 study.
Survival of BCS vs Mx in Asymptomatic Screen-detected NPBC

We performed this study on a consecutive cohort of women with asymptomatic screen-detected NPBC. The clinicopathological characteristics, 10-year relapse-free survival (RFS) and overall survival (OS) were compared between BCS and Mx patients among different subgroups.


Eligibility Criteria:
Inclusion Criteria:

Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.

Age of at least 18 and at most 90 years. Performance status (Karnofsky-Index) \>80%. Chemotherapy is necessary before or after surgery. No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.

Life expectancy of at least 2 years, disregarding the diagnosis of cancer. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.

Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.

Exclusion Criteria:

Known hypersensitivity reaction to the investigational compounds or incorporated substances.

Local recurrence and/or metastasis of breast cancer. No need of chemotherapy. Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.

Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.

Concurrent treatment with other experimental drugs or any other anti-cancer therapy.

Males.
Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation

This randomized clinical trial studies pulmonary rehabilitation in improving lung function in patients with locally advanced non-small cell lung cancer undergoing chemoradiation. Individualized exercise rehabilitation programs may reduce breathing problems and improve quality of life in patients with non-small cell lung cancer. It is not yet known whether pulmonary rehabilitation is more effective when started during or after cancer treatment.

PRIMARY OBJECTIVES:

I. To determine feasibility of pulmonary rehabilitation (PR) in patients with locally advanced unresectable non-small cell lung cancer (NSCLC) undergoing definite chemotherapy and radiation therapy.

II. To measure exercise capacity and respiratory symptoms in lung cancer patients receiving chemotherapy and radiation before and after pulmonary rehabilitation.

III. To compare if there are any differences in symptom relief, exercise capacity, and cancer treatment tolerability between performing pulmonary rehabilitation during chemo-radiation versus after completion of lung cancer treatment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Beginning within 2 weeks of starting chemoradiation, patients undergo an individualized rehabilitation program comprising aerobic exercise and strength training, including treadmill walking, stationary bicycle, NU-Step, upper body resistance training and breathing retraining, 3 times per week for 8 weeks (36 sessions).

ARM II: Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with locally advanced unresectable NSCLC undergoing definite chemo-radiation with curative intent
* Patients must be able to sign informed consent
* Patients who qualify for pulmonary rehabilitation as part of the standard of care and are covered by medical insurance
* Patients must be able to ambulate a minimum of 100 feet prior to enrollment in pulmonary rehab
* Patients must be willing and able to travel to the pulmonary rehabilitation site at the Morehouse Medical Plaza

Exclusion Criteria:

* Tumor resection candidates
* If survival is deemed less than 6 months for any medical condition
* If they have angina or unstable coronary disease
* Congestive heart failure refractory to medical management
* Malignancy with bone instability
* Inmates
Vitamin D Level vs Semen Parameters

* Infertility is defined as the inability of a sexually active couple to conceive after 1 year of regular intercourse without contraception, affects approximately 15% of couples, and male factors are the cause in 20% -50% of cases.
* Infertility of unknown origin is classified into idiopathic male infertility and unexplained male infertility according to semen quality.

-Idiopathic male infertility is known as idiopathic oligoasthenoteratozoospermia, which indicates that the men have an unexplained reduction of semen quality.

In contrast, unexplained male infertility is defined as infertility of unknown origin with normal sperm parameters.

Furthermore, optimal strategies for treating idiopathic male infertility have also remained unclear.

* Data from studies in humans suggest that vitamin D receptors are present in testis, epididymis, prostate and seminal vesicles. The level of expression varies, being higher in epididymis and seminal vesicles.
* Vitamin D receptors expression was also evident in Leydig cells, as well as in normal and abnormal sperm, with the acrosomal region and the neck being the sites with the most abundant messenger ribonucleic acid expression.
* The 1,25(OH)2 D3 molecule increases intracellular calcium concentrations, sperm motility and acrosin activity, and reduces triglyceride content in sperm, actions that significantly contribute to fertilising capacity within the female reproductive tract.

Eligibility Criteria:
Inclusion Criteria:

* infertile male patients without any detectable cause with normal clinical examination and abnormal semen parameters.

Exclusion Criteria:

* Cases with known etiology or apparent physical finding ,leukocytospermia, diminished testicular volume ,varicocele or an abnormal hormonal profile.
* couples with combined male and female factor will be excluded.
Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial.

The purpose of this study is to compare the oxygen consumption and energy expenditure during the spontaneous breathing trial.

Patients is going to submit to the 2 spontaneous breathing trial ( Automatic tube compensation plus continuous positive airway pressure and continuous positive airway pressure without automatic tube compensation. The oxygen consumption and energy expenditure is going to measure during the spontaneous breathing trial by indirect calorimetry.

Eligibility Criteria:
Inclusion Criteria:

* IMPROVEMENT OR RESOLUTION OF THE UNDERLYING CAUSE OF DISEASE
* INTUBATED PATIENTS\>24h
* PaO2 GREATER THAN 60 mmHg WITH FiO2 LESS THAN 40%
* PEEP=5 cmH2O

Exclusion Criteria:

* CARDIOVASCULAR INSTABILITY
* FEBRILE OR HYPOTHERMIA
* CHEST DRAINAGE
* RESPIRATORY RATE/TIDAL VOLUME RATIO GREATER THAN 105
* PREGNANCY
* FAIL IN THE SPONTANEOUS BREATHING TRIAL
* LEAKS IN THE CIRCUIT
* AGITATION
* NOT ACCEPT PARTICIPATE IN THE STUDY
A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2

A study to investigate the prevention of COVID-19 with VYD222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2


Eligibility Criteria:
Inclusion Criteria:

* Is an adult aged ≥18 years or an adolescent aged 12 to \<18 years and weighs at least 40 kg at the time of Screening.
* Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at the time of Screening.
* For Cohort A, has significant immune compromise from causes including solid tumor or hematologic malignancies, chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic stem cell transplant, primary immunodeficiency, advanced HIV infection, or receiving qualifying immunosuppressive therapies.
* For Cohort B, is at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings.
* Agrees to defer receipt of any COVID-19 vaccination or booster for a minimum of 28 days after dosing.
* Note: unless specified by Cohort, the criteria apply to both Cohorts

Exclusion Criteria:

* For Cohort B: Prior receipt of a COVID-19 vaccine or booster within 120 days before randomization.
* Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants, including in the setting of a clinical trial, within 120 days before randomization.
* Prior known or suspected SARS-CoV-2 infection within 120 days before randomization.
* Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before randomization.
* Is acutely ill or has any symptoms suggestive of infection, in the opinion of the Investigator.

Note 1: Other protocol defined inclusion/exclusion criteria apply Note 2: Unless specified by Cohort, the criteria apply to both Cohorts