cyrilzakka/clinical-trials huggingface dataset:
Comparative Effects of Different Noninvasive Ventilation Mode on Neural Respiratory Drive in Recovering AECOPD Patients

Background: The efﬁciency of Neural respiratory drive (NRD)expressed by a ratio of ventilation to the diaphragm electromyogram (EMGdi) decreases in patients with COPD .Improving the neural respiratory drive efficiency of COPD will help to relieve the clinical symptom and make the patients feel comfort.Noninvasive positive pressure ventilation(NPPV)is a good treatment to AECOPD patients.It is unknown the effects of different mode of noninvasive positive pressure ventilation(NPPV) such as proportional assist ventilation (PAV) and pressure-support ventilation (PSV) on the efﬁciency of Neural drive of AECOPD and which mode benefit the patients more.

Objective: To compare the short-term effects of mask pressure support ventilation (PSV) and proportional assist ventilation (PAV) on Neural respiratory drive in recovering patients of AECOPD

Methods: After the baseline data of spontaneous breathing was collected, 20 hypercapnic recovering AECOPD patients were placed on different mode of noninvasive positive pressure ventilation(NPPV, such as the PAV or PSV mode) randomly. For each mode, three levels (PA-, PA, PA+or PS-, PS, PS+), ) of support were applied.PS and PA are set for the patient's comfort . On the basis of these two levels, 25% increase and reduction assisted level of pressure were set both for PS and PA (PA-, PA+or PS-, PS+). At each level, the patients were ventilated at least 20 minutes until the breathing was stable. The respiratory frequency (RR), tidal volume (VT), transdiaphragmatic pressure (pdi) the pressure-time product (PTP) and root-mean-square(RMS) of EMGdi were calculated. Esophageal and gastric balloon-catheters were used to detect the intra-thoracic and abdominal pressure. Airway pressure was also measured simultaneously. EMGdi was recorded from a multipair esophageal electrode .During ventilation Airflow and ventilation were measured with pneumotachograph.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of the COPD (Chronic Obstructive Pulmonary Disease) the COPD patients were all in stable condition during recovery from acute exacerbation.

Exclusion Criteria:

* severe Cardiovascular disease
* Pneumonia
* neuromuscular and chest wall deformity
* Respiratory arrest
* Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
* Change in mental status; uncooperative patient
* High aspiration risk
* Viscous or copious secretions
* Recent facial or gastroesophageal surgery
* Craniofacial trauma
* Fixed nasopharyngeal abnormalities
* Burns
* Extreme obesity
Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer

T cell activating therapy DPX-Survivac, low dose oral cyclophosphamide, and IDO1 inhibitor epacadostat will be tested together for the first time in patients with recurrent ovarian, fallopian tube, or peritoneal cancer to determine the safety and potential immune-modulating activity of the combination of these agents.

The Phase 1b component is a multicenter, non-randomized, open label, uncontrolled, safety and effectiveness study to identify the recommended Phase 2 dose (R2PD) of epacadostat in combination with DPX-Survivac and cyclophosphamide.

The Phase 2 component was initially a multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac + cyclophosphamide with or without the RP2D of epacadostat. The design of the study has been amended to a single arm study in which up to 16 evaluable subjects will be enrolled to received DPX-Survivac plus intermittent low dose cyclophosphamide (i.e. treatment arm 2).

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed, stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
* Platinum-resistant or -sensitive subjects after completing first-line treatment (debulking surgery and adjuvant or neoadjuvant treatment with standard of care treatment such as carboplatin and paclitaxel). Subjects may have had any number of subsequent lines of chemotherapy.
* Must have evidence of progressive disease with either biochemical (i.e. rising CA-125) and/or radiologic progression
* Must have measurable disease by RECIST v1.1, a successful pre-treatment tumor biopsy, and be willing to undergo tumor biopsy during treatment
* Ambulatory with an ECOG 0-1
* Life expectancy ≥ 6 months
* Meet protocol-specified laboratory requirements

Key Exclusion Criteria:

* Eligible for otherwise curative treatment or undergoing concurrent therapy
* Prior receipt of survivin based vaccines or immune checkpoint inhibitors (e.g. anti-CTLA-4, anti-PD-1, anti-PD-L1, or any other antibody or drug specifically targeting T cell co-stimulation) or an IDO inhibitor
* Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
* Clinical ascites
* Any single lesion greater than or equal to 4 cm (per RECIST v1.1)
* Malignant bowel obstruction
* History of autoimmune disease requiring treatment within the last two years (except vitiligo or diabetes)
* Recent history of thyroiditis
* Presence of a serious acute infection or chronic infection
* Active central nervous system (CNS) or leptomeningeal metastasis (brain metastases)
* GI condition that might limit absorption of oral agents
* Other serious intercurrent chronic or acute illness, including myocardial infarction or cerebrovascular event within 6 months
* Ongoing treatment with steroid therapy or other immunosuppressive
* Receipt of monoamine oxidase inhibitors (MAOIs) or UGT1A9 inhibitors
* Receipt of live attenuated vaccines
* Acute or chronic skin and/or microvascular disorders
* Edema or lymphedema in the lower limbs \> grade 2
Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

Despite the importance of nutritional status in patient's outcome, there is no gold standard for nutritional assessment. Traditional techniques used in healthy subjects to assess nutritional status cannot be used in cirrhotic patients due especially to ascites and peripheral edema, and altered rates of biochemical markers due to liver failure.

Bioelectrical impedance vector analysis has emerged as a useful method to assess body composition and nutritional status especially in patients at the extremes of body weight (fluid overload, excess of adipose tissue, etc.).

With previous results from our research group, BIVA showed to be useful for evaluating cirrhotic patients.

The aim of this study is to validate our previous results and validate BIVA for nutritional assessment in patients with liver cirrhosis


Eligibility Criteria:
Inclusion Criteria:

Diagnose of liver cirrhosis by two or more of the following criteria:

* Albumin \< 3.4 g/dL
* INR ≥ 1.3
* Total bilirubin ≥ 2 mg/dL
* Portal hypertension (esophageal varices, splenomegaly, ascites, etc.)
* Liver biopsy
* Ambulatory patients

Exclusion Criteria:

* Personal history of surgery in the last four weeks
* Thyroid disorders without replacement therapy
* Pregnancy
* Active alcoholism with alcohol ingest in the previous 6 months.
* Acute or chronic renal failure
* Hepatic or renal transplant
Myocardial Minimal Damage After Rapid Ventricular Pacing

This study aims to investigate the impact of antitachycardia pacing ( ATP) on the myocardial tissue with respect to its potential micro damage measured by several myocardial markers, especially by high-sensitive TroponinT.


Eligibility Criteria:
Inclusion Criteria:

* All patients for de-novo implantation of a transvenous ICD (single chamber, dual chamber or cardiac resynchronization tehrapy) with left pectoral device position and planned apical location of the right ventricular defibrillation electrode.

Exclusion Criteria:

* Resuscitation, cardiac surgical procedure, acute coronary syndrome, acute myocardial infarction, coronary revascularisation, cardioversion or ablation during the past 4 weeks, if baseline high-sensitive Troponin T is elevated
* Known stenosis of coronary vessels with indication for coronary intervention or operative revascularisation
* Intracardiac thrombus or general contraindication against ventricular burst stimulation or intraoperative ICD-testing
* Atypical lead implantation with indication for defibrillation threshold testing by induction of ventricular fibrillation
* Right sided implantation of ICD
* Planned electrical cardioversion
* Lead explantation or -extraction during procedure
* Redo procedure (except of additional implantation of a right ventricular ICD lead)
* Present temporary pacemaker electrode
* ASA \>= IV or NYHA IV
* Cardiogenic shock
* Pulmonary embolism, cerebrovascular insult or dialysis in the past 4 weeks
* Lack of consent of patient
* Minority of patient
Impact Evaluation of the Reducing the Risk Program

The purpose of this study is to evaluate the effectiveness of an eight-hour version of Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use, number of sexual partners, and pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* 9th grader
* Attends participating school
Clinical Trials of VitalPLANT and Helichrysum Infusions in Adults ( VitalPlant_SMILJ )

The study evaluates the effects of VitalPLANT and Helichrysum italicum on different components of the metabolic syndrome. The components of metabolic syndrome will be measured at baseline and one week after daily consumption of either VitalPLANT alone or either VitalPLANT+Helichrysum italicum after one week of washout.

"VITALPLANT" medicinal plant mixture, aimed at body weight regulation and metabolism enhancement was formulated in order to be incorporated as an ingredient in functional food formulations on the basis of known biological activity of the alder buckthorn bark, peppermint, caraway and parsley. Medicinal plants have long been known as sources of biologically active substances.Oil component apiole - a proven kidney stimulant and parsley (Petroselinum crispum (Mill.) A.W. Nym. ex Hill) are known for their diuretic action. Peppermint (Mentha x piperita L.) and caraway (Carum Carvi L.) essential oils are frequently used in herbal drugs for treatment of abdominal discomfort and pain, while the alder buckthorn bark (Rhamnus Frangula L.) contains anthraquinone glycosides with purgative effects. "Vitalplant" mixture was found to be beneficial for the reduction of body weight and improvement of antioxidant status of the erythrocytes, and its antihyperlipidemic property was highly active for enhancing the profile of plasma lipids in rats.

Similarly, Helichrysum italicum (HI) is also widely used in traditional medicine. Lately, it has been shown that HI infusion consumption had a beneficial effect on anthropometric traits. Indeed, significant reductions in body weight, body mass index, and visceral and total body fat were observed in adults. Moreover, after four weeks of intervention, LDL decreased and serum antioxidant properties were improved. Therefore, consuming infusion could thus be recommended as a simple, profitable habit for individuals with traits of metabolic syndrome.

Therefore, the aim of our study is to evaluate the effects of VitalPLANT alone and VitalPlant+Helichrysum italicum on different components of the metabolic syndrome in adults presenting at least two components of metabolic syndrome and yet not receiving any medication. The components of metabolic syndrome (lipid profile, blood pressure, antrophometry, inflammation status, glucose levels) will be measured at baseline and one week after daily consumptions of either VitalPLANT alone or VitalPLANT+SMILJ. In between there will be one week of washout period.

Eligibility Criteria:
Inclusion Criteria:

* stable weight in the last 3 months
* BMI more than 25
* clinical diagnosis of at least two components of metabolic syndrome

Exclusion Criteria:

* consumption of dietary supplements
* medications for any component of metabolic syndrome
AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

A prospective, single-arm, non-blinded study, intending to treat and collect and evaluate data in up to ten (10) human subjects who are currently being treated with hemodialysis and who present with acute thrombosis in their arteriovenous (AV) grafts, treated with the CAPERE® Thrombectomy System.


Eligibility Criteria:
Inclusion Criteria:

* Dialysis patients who are ≥ 18 years of age
* Dialysis patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms ≤ 14 days

Exclusion Criteria:

* Dialysis patients who are ≤ 18 years of age.
* Grafts with aneurysmal degeneration
* Central venous occlusion
* Patients with infection of the vascular access
* Patients with active cancer under current therapy, myeloproliferative syndromes, hyperhomocysteinemia, and heparin-induced thrombocytopenia.
* Patients with pulmonary embolism (PE) with hemodynamic compromise
* Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
* Known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated
* Imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention (e.g. recent access site creation where there are concerns of leak or disruption of the suture line)
* Female who is pregnant or nursing
* Concurrent participation in another investigational drug or device treatment study
IMUNOR® Preparation in the Prevention of COVID-19

The aim of the study is to achieve prevention of COVID-19 disease in healthcare professionals with the administration of the IMUNOR® preparation, and decreasing the symptoms should the disease appear.

This prospective study is designed to collect data for evaluation of the preventive and therapeutic effect of the IMUNOR® preparation, which is commonly used to treat patients with laboratory or clinical manifestations of immunity disorders. Administration of immunomodulation treatment will be based upon a willing informed consent with the administration of the drug and based upon random selection. The study subjects will receive IMUNOR® preventively; the anticipated preventive effect when using one packing (4 vials) is 6 weeks, and 12 weeks when using two packings. Should any signs of acute illness appear (increased body temperature, cough, loss of smell and taste, etc.), a treatment dose of IMUNOR®, i.e. 1 vial/day (total of 4 vials) will be administered immediately. Monitoring of individual patients will take 6 weeks (1 packing) or 12 weeks (2 packings) from the beginning of IMUNOR® administration. The clinical condition of study subjects will be monitored on a daily basis. At the same time, the possible onset of symptoms will be recorded.

The obtained data will be compared with a control group consisting of patients followed by the Department of Preventive Medicine, University Hospital Ostrava.

Eligibility Criteria:
Inclusion Criteria:

* Study subjects 18-60 years old
* Ability to cooperate upon the study and to give informed consent

Exclusion Criteria:

* Use of any other immunomodulation treatment one month prior to enrolment and in the course of the study
* Acute disease of the cardiovascular, urogenital, respiratory or nervous system
Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying at biomarkers in tissue samples from patients with stage I or stage III endometrial cancer.

OBJECTIVES:

* To identify microRNA expression patterns associated with lymph node metastasis in samples from patients with endometrial cancer.

OUTLINE: Banked tumor tissue specimens are analyzed for microRNA expression profiling by microarray analysis and reverse transcriptase-PCR assays.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed endometrioid endometrial cancer

  * Stage IA, IB, IC, or IIIC disease
  * Any grade
* Enrolled and evaluated on GOG-0210 Molecular Staging Study of Endometrial Cancer

  * Consented to allow their specimens and clinical data to be collected and stored for future research
* Underwent complete surgical staging, including the following:

  * Hysterectomy
  * Bilateral oophorectomy
  * Washings as well as pelvic lymphadenectomy (sampling of four left and four right pelvic lymph nodes)
  * Para-aortic lymphadenectomy (sampling of one left and one right para-aortic lymph node)
* Sufficient high-quality frozen primary tumor for testing with ≥ 75% tumor cellularity and ≤ 10% necrosis

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Ketone Esters for Appetite, Cognition, and Cardiovascular Function in Individuals With Obesity and Insulin Resistance

The goal of this single-blind randomized placebo-controlled trial is to test the effects of an oral ketone supplement on appetite, cognition, metabolism, and cardiovascular function in individuals with obesity and insulin resistance.

The main question\[s\] it aims to answer are:

* Does taking the ketone supplement reduce appetite and improve cognition?
* How does the ketone supplement alter metabolism and cardiovascular function?

Participants will be asked to consume a randomly assigned ketone ester supplement or a placebo and testing will be done to see how the supplement affects the following compared to a placebo:

* appetite,
* cognition,
* metabolism
* cardiovascular function

Researchers will compare individuals with obesity and insulin resistance to individuals with normal weight and no insulin resistance to see if the ketone supplement affects groups differently.


Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18-50 years of age.
* Presence of metabolic sydnrome

Control Participant Eligibility:

* A waist circumference of \< 102 cm for males and \< 88 cm for females, and
* No indication of metabolic syndrome

Exclusion Criteria:

* Pregnant
* Breastfeeding or lactating
* Missing any limbs or part of a limb
* Having a substantial amount of metal implants (metal plates or complete joint replacements)
* Having a pacemaker or any other electrical implant
* Type I diabetes
* Gestational diabetes
* Taking insulin
* Any history of severe traumatic brain injury or mild traumatic brain injury within the last two years
* Kidney disease
* Liver disease
* Thyroid disease
* Any diagnosed neurological or neurodegenerative diseases
* Any surgeries that would impact swallowing and/or digestion
* Being on a ketogenic diet or having been on a ketogenic diet in the last 6 months
* Having received ionizing radiation from a medical procedure within the last 30 days
* Being on a medically prescribed diet
Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia

This is a Phase 2, multiple ascending, dose-finding, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, health-related quality of life, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity, of up to 3 dose regimens of ALXN1830 administered subcutaneous(ly) (SC) in the treatment of WAIHA.

This study will include 2 randomized, double-blind, placebo-controlled cohorts (Cohorts 1 and 2) to evaluate an 8-week treatment regimen, and an optional third open-label cohort (Cohort 3) to evaluate an alternative 12-week dosing regimen. Participants may continue participation in this study at the participant's and investigator's discretion in an open-label extension (OLE) period, consisting of monthly visits to observe participants for relapse, which will require going back on active treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with primary or secondary WAIHA at least 6 weeks prior to Screening.
* Failed or have not tolerated at least one prior WAIHA treatment regimen, for example, corticosteroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, or vincristine.
* Hemoglobin \< 10 g/dL and ≥ 6 g/dL at Screening.
* Positive direct antiglobulin test (Coombs) (IgG positive who are positive or negative for the presence of complement C3) at Screening.
* Evidence of active hemolysis including any one of the below:

  * LDH \> upper limit of normal (ULN) or
  * Haptoglobin \< lower limit of normal or
  * Indirect bilirubin \> ULN
  * Total IgG \> 500 mg/dL at Screening
  * Platelet count ≥ 75 x 10\^9/liter (L)
  * Absolute neutrophil count greater than 1.0 x 10\^9/L

Key Exclusion Criteria:

* Participants with Evan's syndrome.
* Human immunodeficiency virus (HIV) infection (positive HIV 1 or HIV 2 antibody test).
* Positive hepatitis B surface antigen or hepatitis C antibody test.
* Inability to travel to the clinic for specified visits during the Primary Treatment Period or fulfill the logistical requirements of study intervention administration.
Mindfulness Rounds Initiative - A Short Mindfulness-Based Program for A Busy Workplace

An 8 week course of mindfulness education and practices will be presented to all staff, patients, and visitors voluntarily attending the thrice weekly presentations. The goal is to reduce staff stress, improve communication, enhance patient satisfaction, and improve quality of care.

"Mindfulness Rounds" Care-giver well-being is recognized as an important goal in decreasing burnout, increasing job satisfaction, and may have implications in improving quality of care and patient satisfaction. Mindfulness training is a well-studied tool used to enhance care-giver well-being. The impact of a Mindfulness training experience for caregivers, support staff, and patients and their families working together in a hospital unit on patient satisfaction has not been well studied, if at all. The researchers propose instituting a pilot program of Mindfulness Rounds on a given hospital unit and assessing the effect on employee well-being, patient satisfaction, and quality of care.

Introduction:

The physical and mental health of healthcare practitioners (HCPs) has become an area of attention and research in recent years as HCP burnout and suicide are now openly discussed concerns in medicine. Well-being education is now a required curricula component by the Accreditation Council for Graduate Medical Education (ACGME). Mindfulness is a technique and philosophical concept which has received significant attention in the medical literature as a tool for increasing HCP well-being.

Mindfulness describes the idea of maintaining a conscious presence in the present, of avoiding obsessing about the past or the future, and of continuously being aware of, and grateful for, the things we have in life as opposed to the things we don't. Mindfulness-Based Stress Reduction (MBSR) is one particular system, developed by Jon Kabat-Zinn over 30 years ago, which has been built into a well-structured certified training program for teaching mindfulness. Numerous studies have used MBSR or similar techniques to advance HCP psychologic well-being, and while some have investigated a variety of HCP training techniques to improve the patient experience, few have sought to explore a relationship between the impact of mindfulness training for HCP on patient satisfaction, quality of care outcomes, and HCP overall health. To the investigators' knowledge, no one has sought to bring mindfulness education to an entire hospital unit - physicians, nurses, support staff, as well as patients and their families wherever possible - with the goal of improving both HCP and the overall patient experience.

The researchers propose instituting a pilot program of Mindfulness Rounds on a given hospital unit and assessing the effect on employee well-being, patient satisfaction, and quality of care.

Eligibility Criteria:
Inclusion Criteria:

- Employees on the Units

Exclusion Criteria:

- none