cyrilzakka/clinical-trials huggingface dataset:
A Two-part Trial Assessing the Effects of 7α-methyl-19-nortestosterone (MENT) on Blood Pressure in Normal Men: an Open-label Pilot Study Followed by a Randomized, Double-blind, Placebo-controlled Study

This is a two-part trial assessing the effects of MENT on blood pressure. The first part of the trial is an open-label pilot study to verify the MENT gel formulation delivers appropriate drug levels. Upon confirming MENT serum levels are within the required range, clinical trial material will be produced and labeled. Consequently, the second part of the trial, the main study, will proceed approximately two months after the conclusion of the pilot study. The main study, is a randomized, double-blind, placebo-controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men age 18-40
* Man has a sperm concentration of greater than or equal to 15 x 106/mL at screening
* Man has not used hormonal therapy in the last six months
* Man has a testosterone level between 270-1070 ng/dL at screening

Exclusion Criteria:

* Man is hypertensive, defined by
* diastolic BP greater than or equal to 85 mmHg or systolic BP greater than or equal to 140 mmHg (the average of the 2nd and 3rd of 3 measurements after 10 minutes rest) at screening or
* a baseline ABPM average of diastolic greater than or equal to 85 mmHg systolic greater than or equal to 130 mmHg or
* is taking any hypertensive medication
* Man has a BMI over 33 kg/m2
* Man has active or a history of cerebrovascular or cardiovascular disease
* Man has chronic or acute liver or renal disease
* Man has a history of a significant psychiatric disorder, including severe depression
* Man has dermatitis, psoriasis or other severe skin disorder
* Man has clinically significant abnormalities of laboratory safety tests
Perspectives on End-of-Life Care for Medically-Fragile Children and Young Adults

Hattie Larlham is a specialized long-term care facility for pediatric and young adult residents who are medically fragile and intellectually disabled, whose daily care is provided by direct care staff, Habilitation Assistants (HA), in conjunction with nurses and other direct care providers. The purpose of this study is to assess the perspectives of HA and parents/legal guardians on end-of-life care in a long-term care facility for pediatric and young adult residents who are medically fragile and intellectually disabled.


Eligibility Criteria:
Inclusion Criteria:

* HA at Hattie Larlham between January 1, 2006 to present
* HA provided care to \> 1 resident whose death occurred between January 1, 2006 through the end of the study period
* HA provided ongoing care to the resident for at least 5 days in the last 30 days at Hattie Larlham before the resident's death
* Parent/legal guardian of a Hattie Larlham resident whose death occurred between January 1, 2006 through the end of the study

Exclusion Criteria:

* HA employed \< 30 days at Hattie Larlham or cared for resident \<5 days in last 30 days prior to the resident's death
* HA or parent/legal guardian who has not experienced a Hattie Larlham resident's death since December 31, 2005
Effect of the Active Cycle of Breathing Technique on Coronary Artery Bypass Graft Patients' Outcomes

Following CABG surgery, patients are at risk for several complications. One of the most common complications is postoperative pulmonary complications, which include atelectasis and dyspnea. These complications cause prolonged ICU length of stay and increased health care costs. Several studies recommended the active cycle of breathing technique as a method that increases secretion removal and improves lung functions, thus reducing the incidence of postoperative pulmonary complications. Our study aims to investigate the effect of the active cycle of breathing technique on coronary artery bypass graft patients' outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient who will undergo CABG

Exclusion Criteria:

* Mechanically ventilated patients on the first postoperative day.
* Patients with preoperative lung collapse or pleural effusion.
Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study

In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits.

There is limited available information on long term TAVR valve function. In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits. Up-to-date echocardiography will be performed and analyzed in a Core Lab to assess valve function yearly.

Eligibility Criteria:
Inclusion criteria for TAVR subjects

a) TAVR performed more than 3 years ago

Exclusion criteria

1. Subjects unable to consent to participate, unless the subject has a legally authorized representative
2. Subjects unwilling to participate
3. Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
4. Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)

Inclusion criteria for SAVR subjects

1. SAVR performed more than 3 years ago
2. Propensity matched to an enrolled TAVR subject

Exclusion criteria for SAVR subjects e) Subjects unable to consent to participate, unless the subject has a legally authorized representative f) Subjects unwilling to participate g) Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure) h) Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-SAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)
The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants

This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of \<1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For infants 1,001-1,250g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the percentage of infants who received any transfusions.

Critically ill preterm infants experience in the first 1-2 weeks after birth daily blood losses that may equal 5-10% of their total blood volume. Such losses and associated anemia typically result in multiple erythrocyte transfusions. This iatrogenic anemia commonly is followed by the anemia of prematurity, prompting additional transfusions.

This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of \<1,250g birth weight. For infants 401-1,000g birth weight (Trial 1), we tested whether early erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For infants 1,001-1,250g birth weight (Trial 2), we tested whether early erythropoietin (Epo) and iron therapy would decrease the percentage of infants who received any transfusions.

Therapy was initiated by day of life 4 and continued through the 35th postmenstrual week. Infants were randomized to receive either Epo and iron therapy or a sham procedure. Treated infants received 400 U/kg Epo 3 times weekly and a weekly intravenous infusion of 5 mg/kg iron dextran until they had an enteral intake of 60 mL/kg/d. Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available. Complete blood and reticulocyte counts were measured weekly, and ferritin concentrations were measured monthly.

Transfusions were administered according to protocol. Infants did not receive a transfusion solely to replace blood lost through phlebotomy. Infants who met transfusion criteria received a transfusion of 15 mL/kg packed red blood cells (PRBC) for a hematocrit of \>25% or 20 mL/kg PRBC for a hematocrit of \<=25%. Blood losses and transfusion data were recorded.

Trial 2 was terminated after enrollment of 118 infants after the Data and Safety Monitoring Committee reviewed the final results of Trial 1 and preliminary results of Trial 2. On the basis of these data, the Committee concluded that it was statistically unlikely that Trial 2 would demonstrate a significant decrease in the percentage of infants who would receive a transfusion during the study.

Eligibility Criteria:
Inclusion Criteria:

* Infants with a birth weight of 4010-1250g, \<32 weeks' gestation, and 24-96 hours old at the time of study entry
* Likely to survive \>72 hours
* Informed consent from a parent or guardian.

Exclusion Criteria:

* Major congenital anomaly
* A positive direct antiglobulin test
* Evidence of coagulopathy
* Clinical seizures
* Systolic blood pressure \>100 mm Hg (in the absence of pressor support)
* Absolute neutrophil count (ANC) of \<=500/micro-L
Adult Intensive Care Units Database of National Taiwan University Hospital

Australian and New Zealand Intensive Care Society (ANZICS) has built an Center of Outcome and Resource Evaluation (CORE) adult patients database (APD) of adult critically ill patients. ANZICS CORE APD has built an international collaboration of intensive care unit (ICU) database. National Taiwan University Hospital has joined this international collaboration and built the data according to the APD data dictionary with same value domain attributes and data element attributes. This database also add expansion of data include hourly vital signs data, more laboratory data, more diagnoses at admission and discharge, data after 24 hours till discharge, and extended information of clinical outcomes more than 30 days after admission to ICU .

This database will retrospectively collect the data of patients discharged from intensive care after March 1, 2019 and will prospectively continue the retrospective collection of data till the patients discharged before June 30, 2043.

The data will be used for the evaluation of quality and resource allocation, quality improvement, education of data science, datathon, and research to predict the clinical outcomes and assist the treatment strategies.


Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients admitted to intensive care units

Exclusion Criteria:

* Patients aged less than 20 years
Improvement of Foodallergy Diagnostic in Gastrointestinal Tract

Currently, diagnostic possibilities for the detection of food allergy in the gastrointestinal tract are scarce. The endoscopic segmental Lavage is the method of choice, but it´s controversial.

Additional to the endoscopic segmental lavage fluid a cytobrush is used for collecting the mucosa cells and biopsies are taken. Comparative to the Lavage specific IgE antibodies, Tumor necrosis factor- alpha, Eosinophilic cation protein and mastcell tryptase were measured.


Eligibility Criteria:
Inclusion Criteria:

* all patients with suspicion of food intolerance and confirmed food allergy

Exclusion Criteria:

* pregnant and patients under allergy medication (antihistaminic, cortison)
Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer

This study tests a novel intervention designed to optimize needed survivorship care for low-risk breast cancer survivors while reducing burdensome care with limited health benefits. This study examines whether the intervention, titled REASSURE, improves survivors' preparedness for survivorship. Up to 110 participants will be on study for up to 18 months.

The investigators plan a single site prospective, randomized, trial that will compare the effect of REASSURE on survivor preparedness against usual care. Survivors will be identified from breast oncology clinics within UW Health.

REASSURE is comprised of three components: 1) the REASSURE PRO assessment, which assesses survivors' symptoms and/or concerns, 2) a recommendation for or against a follow-up visit based on survivors reported symptoms /concerns using pre-established thresholds, and 3) REASSURE survivorship messaging.

* Primary Objective

  * Compare survivors' preparedness for survivorship with REASSURE versus usual care.
* Secondary Objectives

  * Determine the acceptability of REASSURE for survivors living in rural and non-rural areas.
  * Assess changes in survivor reported symptoms and number of follow-up visits with REASSURE versus usual care.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage I, ER and/or PR positive, her2neu negative breast cancer within the last 6-24 monoths
* Willing to complete study procedures using email

Exclusion Criteria:

* Receipt of chemotherapy for the stage I ER and/or PR positive, her2neu negative breast cancer diagnosed within the last 6-24 months
* Participants will be excluded if they are unable to read and write in English or if, in the opinion of a treating clinician, have cognitive impairment that would prevent completion of study procedures
* Pregnancy, based on patient self-report. If a patient becomes pregnant during the study period, they will be removed from the study at that time.
* Diagnosis of a ER and PR negative, her2neu negative breast cancer or a her2neu positive breast cancer within the last 5 years
Feasibility Evaluation of OtoSet

This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.

This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

Total duration of subject participation will be 1 day with a follow up call within 2-4 days after the procedure. Total duration of the study is expected to be 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Mild (1), Moderate (2), or Complete (3) occlusion of the ear canal based on the Degree of Occlusion Scale in one or both ears
* Informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
* Subject has life threatening illness
* Subject has immune deficiency
Obstetrical Repository of Biological Materials

Subjects are being asked to donate blood, urine, vaginal secretions and/or tissue to a repository for research.This repository will store donated specimens for future research. The Department of Obstetrics and Gynecology at the University of Tennessee Health Science Center, under the direction of Dr. Giancarlo Mari, Professor and Chair, is responsible for the operation of the repository.

Additionally, in the case of a stillborn child, the mother will be given the opportunity to donate samples from her stillborn baby's autopsy to a repository for research.

The stored samples will be used in studies to help researchers understand normal events in pregnancy, as well as events that occur when women and/or their babies have a disease or condition during pregnancy. Additionally, the samples may be used in future studies to develop cell lines for research, create tests to diagnose disease, or develop treatments. A cell line is the result of cells grown outside the body in a laboratory. This process will allow those cells to grow continuously when given the appropriate nutrients and conditions for growth, and will result in a permanent cell culture which is the collection of cells that are grown outside the body in a laboratory.

The stored samples will also be used in future studies to help researchers identify genetic influences during pregnancy. Genes are like blueprints in each of your cells that determine traits that you inherit, like eye color and hair color. Genes may also influence what diseases you get and how you respond to treatment. DNA is the substance that makes up your genes.

The subject will sign an informed consent for her participation (Primary Informed Consent). In the situation of a stillbirth occurring, the mother of the stillborn baby will sign an informed consent regarding the tissue samples to be obtained during the hospital's routinely performed autopsy. (Secondary Informed Consent).

Eligibility Criteria:
Inclusion Criteria:

* English speaking female
* patients presenting for medical care at the Regional One Health perinatal clinics or Regional One Health Labor and Delivery Dept. will be asked to participate in the study.

Exclusion Criteria:

* Those not meeting the above criteria.
Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt® Solution with commercially available collection devices (broom-type device or cytobrush/spatula combination) may be tested with the APTIMA HPV Assay either pre- or post-Pap processing. The assay is used with the TIGRIS System and the PANTHER System.

The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Eligibility Criteria:
Inclusion Criteria:

* the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30)
* an aliquot is available and suitable for testing, and
* the sample was randomly selected for inclusion.

Exclusion Criteria:

* sample integrity was compromised (eg, stored under unacceptable conditions)
Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery

Aim of the study is to evaluate the role of postoperative tibial nerve stimulation in the enhancement of the recovery of bowel function and in shortening the hospital stay.

Patients were randomized in two groups. The first group underwent a three days postoperative transcutaneous tibial nerve stimulation. The second group underwent a sham stimulation. Aim of the study is to evaluate the role of tibial nerve stimulation in the postoperative recovery after colorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients that underwent colorectal surgery

Exclusion Criteria:

* Severe comorbidities
* Postoperative or intraoperative complications
Effect of Music Therapy on Cognitive Recovery

Participation in music therapy will result in improvement in cognitive functioning, as measured by neuropsychological testing 9-12 months following surgery.

Music therapy could have a significant impact on clinical outcomes for patients with epilepsy. One study found that epilepsy patients who received music therapy for six months or greater had a significant reduction in number of seizures and could potentially aid in decreasing medication dosage. The investigators would like to contribute to this sort of research, but focus on what effect music therapy has on a patient's cognitive recovery after undergoing epilepsy surgery. Although research exists regarding music therapy on memory and communication, its overall effect on this patient population is unclear.

The Dell Children's Epilepsy program hopes that this research project on memory and communication will have a positive effect on their patients with epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Between 6-16 years of age
* Will undergo either a brain resection or lobectomy

Exclusion Criteria:

* Pre-surgical Full Scale IQ below 70
* Primary language is not English
* Hearing or vision impairments
* Parental consent cannot be obtained
Menstrual Differences in Airway Inflammation in Asthma

Asthma is a chronic inflammatory lung disease characterized by airway hyper-responsiveness and reversible airway obstruction. Over the last decade, the prevalence of asthma is on the rise and it disproportionately affects more women than men. As much as 40% of women with asthma are known to have worsening of asthma symptoms and lung function prior to menstruation. This syndrome is being increasingly recognized as premenstrual asthma (PMA). The pathologic differences in female asthmatics with and without this syndrome are not known. The evidence regarding the role of sex hormones has been contradicting. We propose an observational cohort study to examine the changes in airway inflammation in women with asthma in relation to their menstrual cycle and their association with sex hormone levels. In addition we will include women on oral contraceptives to determine their effect on airway inflammation and asthma symptoms.

We hypothesis that:

* Women with premenstrual asthma will show increased indices of airway inflammation in various phases the monthly menstrual cycle.
* In women with premenstrual asthma, a change in serum estradiol/progesterone ratio during the late luteal phase is associated with worsening of airway inflammation, air flow limitation and asthma symptoms.
* The use of oral contraceptives is associated with suppression of the cyclical changes in airway inflammation due to lack of fluctuations in estradiol and progesterone levels.

Recruited subjects will be asked to record asthma symptom scores, morning Peak Expiratory Flow Rate (m-PEFR) and rescue asthma medication (β2-agonist) used daily during the one month screening period to identify women with and without pre-menstrual asthma. Asthmatic women with regular menstrual cycles will be evaluated in their follicular phase (days 5-8) and luteal phase (days 21-24) and women on oral contraceptive pills (OCP) will be evaluated on days 9-12 of their OCP cycle and during the days 25-28, off of OCP consecutively for a 2-month period.


Eligibility Criteria:
Inclusion Criteria:

* With diagnosis of Asthma (ICD-9 Code 493)
* Requiring low to moderate dose inhaled corticosteroids for control.
* With Pre-bronchodilator FEV1 ≥50% and ≤90% of predicted normal
* With a positive bronchodilator response
* Non smoker or Ex-smoker (Quit \>1 year ago)
* Regular menstrual cycle (24-35 days cycle)
* With and without OCP use
* Constant dose of asthma maintenance medication for at least 30 days prior to enrolment

Exclusion Criteria:

* Recent use of systemic steroids (\<30 days)
* Severe Asthma (FEV1 \<50% or frequent exacerbations or systemic steroid dependence)
* Negative bronchodilator response
* Current Smoker
* Irregular Menses or postmenopausal
* Positive pregnancy test
* Use of hormonal contraceptives other than monophasic OCPs
* Exacerbation or Respiratory Infection or antibiotic use within the last 30 days