cyrilzakka/clinical-trials huggingface dataset:
Prescribed Physical Activity in Improving Sleep and Physical Performance in Patients Undergoing Stem Cell Transplant

This research trial studies prescribed physical activity in improving sleep and physical performance in patients undergoing stem cell transplant. A wearable physical activity monitor can be used to record minutes of activity and sleep. Gathering data over time using a physical activity monitor may help doctors learn if prescribed physical activity helps improve sleep and physical performance in patients undergoing stem cell transplant.

PRIMARY OBJECTIVES:

I. Evaluate whether prescribed physical activity, as part of standard care, improves sleep and functional outcomes in hematopoietic cell transplantation (HCT) (stem cell transplantation) patients during a typical 30-day hospitalization period.

OUTLINE:

Data including demographics, type of HCT (e.g., allogeneic or autologous), preexisting physical conditions (e.g., chronic joint injury), chronic renal failure (CRF), steroid use data, Eastern Cooperative Oncology Group (ECOG) and Karnofsky performance status (KPS) scores are collected from patients' medical charts at time of enrollment. Patients are prescribed participation in a primarily self-directed physical activity program which encourages them to spend 6 hours out of bed daily and to perform 30 minutes of light-to-moderate daily aerobic activity. Patients who are able to maintain independent mobility undergo physical therapist assessment 2 times a week until hospital discharge. Patients wear a physical activity monitoring device and daily activity and sleep data are collected continuously during hospital length of stay (LOS).

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Stanford Hospital for HCT
* Able to provide informed consent
* Speaks language supported by interpretative services
* Able to operate and take care of a physical activity monitor

Exclusion Criteria:

* Does not meet inclusion criteria
* Unable to wear a physical activity monitor throughout hospital stay
Manual Therapy Effects on Upper and Lower Esophageal Sphincter Pressures

The aim of this study is to test the influence of manual cervical traction and chest stabilization maneuvers on pressures in upper and lower esophageal sphincters.

High Resolution Manometry (HRM) will be used to measure pressure changes in upper esophageal sphincter (UES) and lower esophageal sphincter (LES) during manual cervical traction and trunk stabilization maneuvers. 50-55 gastroesophageal reflux disease (GERD) subjects will participate in the study. UES and pressures will first be measured in relaxed supine position then, during manual cervical traction and finally, the subjects will undergo manual positioning of the trunk into neutral position and LES and UES pressures will be measured again.

Eligibility Criteria:
Inclusion Criteria:

* Gastroesophageal reflux disease

Exclusion Criteria:

* Previous gastro- esophageal surgery
* Concomitant other chronic disease that would affect esophageal motility
* Esophageal structural pathology
* Massive hiatus hernia
Examining the Effects of Nasal High Flow Oxygen Therapy Compared to Non-invasive Ventilation in Health Volunteers

Respiratory failure is characterized by low levels of oxygen and high levels of carbon dioxide in the blood which causes difficulty breathing. The management of patients with respiratory failure aims at improving oxygenation and changing the effort required to breathe. Mechanical ventilation is a life-saving treatment but may be associated with a high mortality rate, prolonged stay in the intensive care unit (ICU), and infection. Oxygenation techniques to avoid mechanical ventilation include standard oxygen therapy, continuous positive pressure (CPAP), and high-flow nasal cannula oxygen therapy (HFNC). CPAP consists of delivering oxygen through a mask. As compared to standard oxygen therapy, CPAP can promote lung recruitment leading to improved oxygenation and the effect in work of breathing in patients with respiratory failure. Conversely, high-flow nasal cannula oxygen therapy (HFNC) delivers oxygen through nasal prongs. Oxygen is heated and humidified and can be delivered at different flows (from 10 - 60 L/min). As compared to standard oxygen therapy, HFNC can promote some lung recruitment leading to mofiy oxygenation and work of breathing. Therefore, the present study will have 2 phases:

Phase 1:Comparison of the physiological effects of different flows of HFNC to CPAP in healthy volunteers. The investigators hypothesized that the physiological effects of HFNC in the nasopharynx are comparable to that of CPAP at 4 cm H2O.

Phase 2: Comparison of the physiological effects of different nasal interfaces of HFNC (Standard cannula vs. Asymmetrical cannula vs. Single-nostril adapted cannula) in healthy volunteers. The investigators hypothesized that the physiological effects of HFNC in the nasopharynx are comparable to that of CPAP at 4 cm H2O. It was hypothesized that asymmetrical which is the cannula that has a higher cross-sectional area generates higher nasal pharyngeal pressure.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers ≥ 18 y-o,
* No evidence of acute or chronic cardiopulmonary disease

Exclusion Criteria:

* Active epistaxis, sinus problem, nasal trauma, or deviated septum that would preclude the nasopharyngeal catheter insertion,
* Pregnancy, clinical evidence of respiratory illness, history of respiratory disease, body mass of over 50 kg/m2, ribcage malformation,
* Cardiac pace maker or implantable cardioverter-defibrillator according to EIT manufacturer,
* Allergy to topical lidocaine,
* Claustrophobia that would preclude the use of CPAP or HFNC.
Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis with the additive or synergistic effects of the combination of vitamin D + inulin.

Cystic fibrosis (CF) is the most common life-shortening genetic condition among Caucasians in the United States. Individuals with CF have an altered gastrointestinal (GI) microbiota, which may be a result of chronic systemic inflammation and infection, frequent use of antibiotics, and/or medically prescribed and habitual high-fat/high-calorie diets.

The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. male and female patients (age \> 18 years) with confirmed CF by genetic mutation and/or sweat chloride testing,
2. not currently on oral or systemic antibiotics for pulmonary exacerbation,
3. vitamin D deficient/insufficient (25(OH)D, 6 - 30 ng/mL) with most recent 25(OH)D in the past 12 months,
4. use of CFTR modulator therapy is allowed

Exclusion Criteria:

1. severe vitamin D deficiency 25(OH)D ≤ 5 ng/mL or hypocalcemia or hypercalcemia,
2. active GI disease, abdominal pain and/or diarrhea,
3. chronic kidney disease worse than stage 3 (eGFR \< ml/min per 1.73 m2),
4. any vitamin D supplement use \>2,000 IU or vitamin D analogue (patients who are taking more than 2,000 IU of vitamin D must agree to stop the vitamin D for 6 weeks and take less than 2,000 IU of vitamin D during the study),
5. use of immunosuppressants or history of organ transplantation,
6. current use of probiotics or prebiotics
The Association Between Chlorhexidine Bathing and Central Line-Associated Infections in Medical Intensive Care Units

We conducted a retrospective observational cohort study assessing the relationship between regular bathing using 2% CHG wipes every other day and the occurrence of central line-associated infections (CLABSI) in patients within the medical intensive care unit (MICU).

This study defined the post-intervention period as July 1, 2017, to June 30, 2022. During this period, one of the three medical intensive care units (MICUs) in NTUH implemented chlorhexidine gluconate (CHG) bathing as part of their daily care routine (CHG group). This decision was made in response to a higher incidence rate of vancomycin-resistant Enterococcus (VRE) bacteremia observed in that particular MICU during the preceding six months (pre-intervention period: January 1, 2017, to June 30, 2017), compared to the other two MICUs. The remaining two MICUs continued to provide usual care, which involved bathing patients with towels soaked in water and soap on a daily basis.

Eligibility Criteria:
Inclusion Criteria:

* all patients who were admitted to the MICU between January 2017 and June 2022

Exclusion Criteria:

* patients aged under 18 years old
An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor

To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the pharmacokinetics of VX-661 when administered in combination with ivacaftor


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with scheduled visits, treatment plan, study restrictions,laboratory tests, contraception guidelines, and other study procedures
* Healthy subjects, as defined by no clinically relevant abnormalities identified by a detailed medical history and full physical examination, including blood pressure and heart rate measurement, standard 12-lead ECG, and clinical laboratory tests.
* Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening and at the Day -1 Visit.

Exclusion Criteria:

* History of any illness, clinical condition, or other factor that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* Inability to swallow capsules, or inadequate venous access.
* History of febrile illness within 5 days before the first study drug dose
* A screen positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus 1 or 2 antibodies.
* For female subjects: Pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol. For male subjects: Subject has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 120 days after the last study drug dose.
* Any condition possibly affecting drug absorption
* Abnormal renal function at screening
Oral Ketorolac for Arthroscopic Rotator Cuff Repair

1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following arthroscopic rotator cuff repair.
2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following arthroscopic rotator cuff repair.


Eligibility Criteria:
Inclusion Criteria

1. Patients between the ages of 18 and 89 years old, male or female
2. Patients undergoing primary shoulder arthroscopic rotator cuff repair

Exclusion Criteria

1. Patients below the age of 18 or above the age of 89
2. Illiterate or non-English speaking patients
3. Patients with contraindications to Ketorolac
4. History of alcohol of drug abuse
5. Chronic use of analgesic or psychotropic drugs
6. Known peptic ulcer disease or bleeding diathesis
7. Renal dysfunction
Collagenase in the Treatment of Zone II Flexor Tendon Adhesions in the Hand

The purpose of this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery.

In an open label study, collagenase injection therapy was investigated in 3 subjects for it's ability to lyse flexor tendon adhesions in zone II of the hand.

Results indicate that two of three subjects had improved range of finger motion at the PIP and DIP joints. This may obviate the need for patients to have tenolysis hand surgery to correct the finger flexion contracture of the PIP and DIP joints. Detailed controlled studies remain to be done.

Eligibility Criteria:
Inclusion Criteria:

* zone II flexor tendon adhesion of at least one finger

Exclusion Criteria:

* any chronic, serious or uncontrolled medical condition
* inability to conform to study visits (12-15 per year)
Preoperative Anxiety at Oocyte Retrieval

This study evaluated the effects of preoperative anxiety and dosage of anesthesia on IVF success. Half of participants according to the recorded Beck's Anxiety Inventory (BAI) score: a low-anxiety group, while the other half high-anxiety group.

Anxiety is common among women hospitalized for oocyte retrieval. Infertility is usually accompanied by psychological and behavioral changes and can result in preoperative anxiety. Sometimes, preoperative anxiety can be serious. Furthermore, in the absence of premedication for oocyte retrieval, severe degrees of anxiety may occur. Anxiety effects the total consumption of analgesic and anesthetic drugs intraoperatively and has a negative impact on recovery from anesthesia. In addition, the negative effect of anesthetic agents used on fertilization and embryo quality during in vitro fertilization (IVF) has been discussed. However, the impact of any of them on fertilization and embryo quality has not been clearly determined to date. Studies have reported different results regarding the negative effects of anesthetic agents on embryo development and fertilization.

Eligibility Criteria:
Inclusion Criteria:

* oocyte retrieval under sedation
* 25 and 43 years of age
* American Society of Anesthesiologists physical status I-II

Exclusion Criteria:

* history of psychiatric illness
* secondary infertility can be surgically corrected
* not able to communicate well in the native language
* those women who necessitated general anesthesia
Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset

The purpose of this study is to examine the benefit of thrombus aspiration in patients with ST-elevation myocardial infarction presenting late after symptom onset.


Eligibility Criteria:
Inclusion Criteria:

* ST-elevation myocardial infarction \>12 and \<48 hours after symptom onset
* age 18 to 90 years
* informed consent

Exclusion Criteria:

* prior fibrinolysis
* severe comorbidities with limited life expectancy
* pregnancy
* patient unable to give informed consent
* participation in another trial
* contraindications for heparin, aspirin or thienopyridines
* contraindications for cardiac magnetic resonance examination
Evaluation of Surgical Complications

Surgical complications may be very serious and are often under-reported. The aim of this study it to document and study all the postoperative complications at our department during one year using a novel grading system.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing surgery at our department.
* No gender difference.

Exclusion Criteria:

* Age - less than 18.
Feeding Premature Infants During Non-invasive Respiratory Support

A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support


Eligibility Criteria:
Inclusion Criteria:

* Infants \<1500gr, on non-invasive respiratory support
* Feeding\>20 ml/kg/day

Exclusion Criteria:

* Major congenital malformations
* Unstable infants because of sepsis, central nervous system, cardiac or other significant morbidities
* Gastrointestinal morbidity such as spontaneous intestinal perforation (SIP) and necrotising enterocolitis (NEC).
Post-operative Urinary Retention (POUR) Following Thoracic Surgery

Inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. Urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder catheter (Foley). This is uncomfortable, and can lead to bleeding, infection, damage to the urethra and/or bladder and bladder spasm. The goal of this study is to attempt to prevent inability to urinate by giving patients a medication called Flomax (Tamusolin) every day beginning a week before surgery. That medication relaxes the prostate. It's approved by the Food and Drug Administration (FDA) to improve urinary flow in those with enlarged prostates. It is also commonly used in patients with bladder problems due to inability to urinate who have required a Foley.

Post-operative urinary retention (POUR) in older men who undergo a thoracic surgical procedure occurs in a significant proportion of patients (25% at Hackensack University Medical Center in men \>60) and is a significant management problem. Typically, this complication needs to be treated with placement of a bladder catheter (foley). In addition to the discomfort of placing a foley in an awake patient, these patients are at a significantly increased risk of a catheter associated urinary tract infection (CAUTI), potential genito-urinary injury during the placement, and bladder muscle damage due to distention.

The goal of this study is to investigate whether the use of Tamusolin could lower the high incidence of POUR in older men undergoing a thoracic surgical procedure.

The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

Males

≥50 years old Planned surgical procedure of a minimally invasive thoracic surgical procedure (wedge resection, segmentectomy, lobectomy, pleural biopsy, or pleurodesis) Surgery scheduled more than 3 days from the time of consent

Exclusion Criteria:

* Using Flomax already
* Allergy to Flomax or sulfa drugs
* Current use of alpha blockers or alpha agonists
* Resting systolic blood pressure \<100
* Orthostatic hypotension of \>20mm Hg (millimeters of mercury) Systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent
* Known diagnosis of congestive heart failure and valvular heart disease
* History of prostate surgery (prostatectomy, trans-urethral resection)
Surgery in Chronic Cough GERD Related

The effectiveness of surgical fundoplication in treating classical reflux symptoms is well documented, but the role of surgery in alleviating extra-esophageal symptoms allegedly secondary to gastro-esophageal reflux disease (GORD) is far to be assessed.

The effectiveness of anti-reflux surgery on extra-esophageal reflux symptoms varies from 15% to 95%; the spread of these data is largely attributable to disparate study design and methodology, patient selection, and outcome metrics.

In order to assess whether anti-reflux surgery may have beneficial effects on chronic cough allegedly secondary to GERD and to eventually identify the preoperative clinical profile which could predict those positive effects, we considered two groups of patients presenting with 1) GERD associated to chronic cough, 2), typical GERD who underwent anti-reflux surgery.

Pre-operatively, patients routinely underwent the symptoms assessment, barium swallow, upper gastro-intestinal endoscopy and esophageal manometry.

The type and severity of symptoms and the grade of reflux oesophagitis were scored using a questionnaire with semi-quantitative scales.

The upper gastro-intestinal (GI) endoscopy, barium swallow and esophageal manometry were performed according to standard techniques; reflux esophagitis was reported according to the Los Angeles classification. In the absence of Los Angeles grade A or higher esophagitis, patient underwent a 24h pH-recording or intraluminal impedance/pH monitoring. Patients complaining of chronic cough were submitted to a specific work-up consisting of a chest High Resolution Computed Tomography (HRCT) scan, methacholine challenge test and spirometry in order to exclude pulmonary diseases.

Surgery was performed in patients negative for pulmonary diseases on chest HRCT scan, on methacholine challenge test and spirometry, in consideration of the fact that patients had been referred mainly for the therapy of chronic cough.

The study was started in 1995 and it was closed in 2010.

Eligibility Criteria:
Inclusion Criteria:

patients aged \> 18 years, affected by chronic cough (\> 8 weeks)associated with GERD typical symptoms, negative for pulmonary diseases on chest HRCT scan, on methacholine challenge test and spirometry, undergoing anti-reflux surgery

Exclusion Criteria:

patients with chronic cough (\> 8 weeks) positive for pulmonary diseases on chest High Resolution Computed Tomography (HRCT) scan, methacholine challenge test and spirometry; association of GERD with epiphrenic esophageal diverticulum, collagen diseases, undetermined esophageal motility disorders, redo antireflux surgery, previous surgery on the thoracic and abdominal esophagus and stomach,on the diaphragm.
Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma

The folate receptor is overexpressed in many types of cancer, including ovarian and endometrial cancer, and the level of folate receptor expression increases with the stage of the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide an effective method to determine folate receptor-positive (FR+) target tumors, thereby assisting in the identification of those patients who may benefit from folate-targeted therapy.

This phase 2, two-center, open-label, single-treatment group, within-patient-controlled study was conducted to:

* Expand the safety database and gather data on the percentage of patients with known or suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake of FolateScan in tumors (primary objective).
* Calculate the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared with immunohistochemical (IHC) staining (secondary objective).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet the following eligibility requirements to be enrolled in the study.

  1. Subject must be 18 years of age or older.
  2. Subject must have known or strongly suspected ovarian carcinoma or recurrent endometrial carcinoma with at least one identifiable lesion \> 1.5 cm as diagnosed by ultrasonography, MRI, or CT.
  3. Subject must have good kidney function.
  4. Subject must provide written informed consent prior to enrollment.

Exclusion Criteria:

* Subjects must be excluded if any of the following conditions are present:

  1. Subject is pregnant or breastfeeding.
  2. Subject is simultaneously participating in another investigational drug study.
  3. Subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study.
  4. Subject is unable to tolerate conditions for radionuclide imaging.
  5. Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.