cyrilzakka/clinical-trials huggingface dataset:
Predictive Monitoring - IMPact in Acute Care Cardiology Trial

Hypothesis: display of predictive analytics monitoring on acute care cardiology wards improves patient outcomes and is cost-effective to the health system.

The investigators have developed and validated computational models for predicting key outcomes in adults, and a useful display has been developed, implemented and iteratively optimized. These models estimate risk of imminent patient deterioration using trends in vital signs, labs and cardiorespiratory dynamics derived from readily available continuous bedside monitoring. They are presented on LCD monitors using software called CoMET (Continuous Monitoring of Event Trajectories; AMP3D, Advanced Medical Predictive Devices, Diagnostics, and Displays, Charlottesville, VA)

To test the impact on patient outcomes, the investigators propose a 22-month cluster-randomized control trial on the 4th floor of UVa Hospital, a medical-surgical floor for cardiology and cardiovascular surgery patients. Clinicians will receive standard CoMET device training. Three- to five-bed clusters will be randomized to intervention (predictive display plus standard monitoring) or control (standard monitoring alone) for two months at a time. In addition, risk scores for patients in the intervention clusters will be presented daily during rounds to members of the care team of physicians, residents, nurses, and other clinicians. Data on outcomes will be statistically compared between intervention and control clusters.


Eligibility Criteria:
Inclusion Criteria:

* Assigned for clinical purposes to a beds which is part of a randomized cluster

Exclusion Criteria:

* none
An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects

The purpose of this study is to evaluate the effects of steady-state telotristat ethyl on the pharmacokinetics (PK) of single-dose fexofenadine in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects aged ≥18 to ≤55 years of age at screening
* Body mass index ≥18.0 to ≤32.0 kg/m\^2
* Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute
* Willingness to adhere to the restrictions outlined in the protocol
* Able to comprehend and sign the Informed Consent Form

Exclusion Criteria:

* Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator
* Use of any medications, herbal tea, energy drink, herbal products, or supplements within 14 days of Day 1
* Receipt of any investigational agent or study drug within 30 days or 5 half-lives prior to Screening
* Receipt of any protein- or antibody-based therapeutic agent within 3 months of Screening
* Prior exposure to telotristat etiprate
* Use of tobacco, smoking cessation products, or nicotine products within 3 months prior to Screening
* History of major surgery within 6 months prior to Screening
* History of any GI surgery that may induce malabsorption
* History of any serious adverse reaction or hypersensitivity to any component of fexofenadine
* History of renal disease, or significantly abnormal glomerular filtration rate (\<90 mL/min as calculated using the Cockcroft-Gault equation) at Screening
* History of hepatic disease, or significantly abnormal liver function tests at Screening
* History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or GI abnormality
* History of any active infection within 14 days prior to first dosing
* History of alcohol or substance abuse within 2 years prior to Screening
* Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
* Concurrent conditions that could interfere with safety and/or tolerability measurements
* Donation or loss of \>500 mL of blood or blood product within 3 months prior to Screening
* Women who are breastfeeding or are planning to become pregnant during the study
* Positive serum pregnancy test (females only)
* Positive urine screen for selected drugs of abuse and cotinine
* Consumption of alcohol within 48 hours prior to study start
* Consumption of caffeine- and/or xanthine-containing products within 72 hours of study start
* Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 72 hours prior to study start
* Unable or unwilling to communicate or cooperate with the Investigator for any reason
* Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of CYP3A4 within 30 days prior to the first dose
Ranibizumab for the Treatment of Choroidal Neovascularisation (CNV) Secondary to Pathological Myopia (PM): an Individualized Regimen

This study is designed to provide efficacy and safety data in patients with choroidal neovascularisation (CNV) secondary to myopia using an individualized as-needed (PRN) dosing schedule. Eligible patients who have provided written agreement to take part in the study will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following eye examinations and tests at monthly clinic visits, the study doctor will repeat the injections on a monthly basis as required for an additional 11 months, in accordance with specified retreatment criteria.

Patients will be in the study for approximately 12 months and will visit the hospital clinic 14 times over that period. The main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography and fluorescein angiography (FA), measurement of intraocular pressure, blood pressure and pulse measurements and completion of health-related questionnaires'.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients of any race, aged 18 years or older
* Diagnosis of active primary or recurrent subfoveal or juxtafoveal CNV secondary to PM
* Diagnosis of high myopia of at least -6 dioptres in the study eye spherical equivalent. For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye must have been at least -6 dioptres
* Patients who have a BCVA score between 78 and 24 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS)-like grading charts (approximately 6/9 - 6/96 Snellen equivalent)
* Patients must give fully informed consent and be willing and able to comply with all study procedures

Exclusion Criteria:

* History of any surgical intervention in the study eye within two months preceding screening
* Previous macular laser photocoagulation, treatment with intravitreal steroids, verteporfin with photodynamic therapy (Visudyne®) or anti-VEGF agents ranibizumab, bevacizumab or pegaptanib sodium (Macugen®) in the study eye
* Previous treatment with intravenously administered bevacizumab (Avastin®)
* Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
* History of allergic reaction to fluorescein
* Concurrent use of systemic anti-VEGF agents

Other protocol-defined inclusion/exclusion criteria may apply
Relationship Between Stress, Anxiety, Depression, Sexual Function and Marital Adjustment in Nurses

One of the factors that increase harmony in marriage is sexual life and sexual satisfaction (Erdinç, 2018). Sexual intercourse is one of the pillars of a successful family; accordingly, functionality in this area greatly affects marital adjustment (Atrian, 2018). Studies show an important relationship between sexual adjustment and marital adjustment (Türkseven et al., 2020; Begdeş, 2021). Negative workplace factors such as occupational stress and long working hours affect the physical and mental states of nurses (Oyeleye et al., 2013; Chesak et al., 2019).

This study was planned to determine the relationship between stress, anxiety, depression, sexual function and marital adjustment in nurses.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the research,
* Over the age of 18,
* Married,
* Those whose spouse is alive and living with their spouse will be included.

Exclusion Criteria:

* Having a chronic disease (hypertension, diabetes),
* Nurses who are pregnant,
* Those who use drugs that may affect sexual function (beta-blockers, antihypertensives, antidepressants, antipsychotics, etc.) will be excluded from the study.
A Study to Evaluate the Effect of a Single Dose of Digoxin on the Actions in the Bodies of Healthy Subjects After Having Taken Several Doses of YM178

A study that evaluates the interaction in healthy subjects of the heart drug Digoxin on YM178, when the latter is taken on a continuous basis, in order to establish that there is no risk to patients who may take this combination of drugs.

Subjects receive a single oral dose of digoxin on Day 1. A full pharmacokinetic profile of digoxin is obtained for up to 144 hours post-dose. On the morning of Day 7, after the scheduled assessments are done, the subjects leave the clinic and return on Day 9.

From Day 10 up to and including Day 23, subjects receive daily oral doses of YM178 q.d. A single dose of digoxin is given in combination with YM178 on Day 18 (8 days after the first dose of YM178). On this day, a complete pharmacokinetic profile for digoxin is obtained up to 144 hours post-dose.

From Day 16 up to and including Day 19, blood samples for bioanalysis of YM178 are taken regularly. In addition, vital signs, safety ECG (Electrocardiogram) measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.

Subjects return for a Post Study Visit 7-14 days after the last dosing occasion.

Eligibility Criteria:
Inclusion Criteria:

* Female subject must be of non-child bearing potential, i.e. post menopausal, surgically sterilized (e.g. tubal ligation), hysterectomy in medical history, or must practice an adequate (double barrier) non-hormonal contraceptive method to prevent pregnancies
* Body Mass Index ≥ 18.5 and \< 30 kg/m2

Exclusion Criteria:

* History or presence of cardiac diseases, including arrhythmias (including 1st and 2nd degree atrioventricular heart blocks)
* History of hypokalemia, hypercalcemia or hypomagnesemia
* Any of the liver function tests (i.e. ALT, AST and Alkaline phosphatase) above the upper limit of normal at repeated measures
* Any clinically significant history of asthma, eczema, any other clinically significant allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
* Any clinically significant history of gastrointestinal symptoms in the 4 weeks prior to admission to the clinical unit
* A marked baseline prolongation of QT/QTc interval after repeated measurements of \> 450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
* Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the clinical unit
* Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2
Effects of Massage Therapy on Sleep After Heart Surgery

The purpose of this study is to evaluate the effects of Massage Therapy for improving the quality of sleep in patients on postoperative period of coronary artery bypass graft surgery (CABG).

Patients We evaluated patients admitted to the ward waiting for elective CABG surgery.

Preoperative evaluation The preoperative clinical assessment consisted of obtaining information regarding demographics and personal characteristics.

Postoperative protocol and evaluation After discharge from the intensive care unit to the ward during the postoperative period, the patients were randomized to 3 nights of sitting for 10 minutes, with no intervention (Control) or to MT. Briefly, MT consisted of massage of the neck, shoulders, and back. The massage was initiated with light manual compression and progressed to deep compression. The compression was performed with the inner region of the fingers, hand-shaped clamp, and friction (digital compression with the thumb) on trigger points, cervical traction, and mobilization in all planes (front, back, and sides). The massage was finished with light manual compression. During the study period, all patients completed a sleep diary containing the time they went to sleep, woke up, and took daytime naps. The patients completed a VAS for pain and fatigue (similar to the preoperative evaluation described previously) as well as a VAS for sleep on days 1, 2, and 3, corresponding to the morning following the intervention that was performed on the previous night.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria included patients of both genders, between 40 to 80 years of age which were waiting for Coronary artery bypass graft surgery.

Exclusion Criteria:

* Patients with body mass index (BMI) ≥35kg/m2
* Regular alcohol consumption
* Chronic use of hypnotics
* A previous diagnosis of sleep disorders
* Previous surgeries performed in the last 24 months
* The inability to read and write. We also excluded patients who underwent valve surgery combined with CABG, the presence of a thoracic drain, and ICU stay longer than 5 days in the postoperative period
OMT to Improve Feeding After Hypothermia

The goal of this study is to determine if infants with neonatal encephalopathy will achieve full oral feeds faster after therapeutic hypothermia has completed if they are treated with osteopathic manipulative treatment. The treated infants will be compared to matched historical controls.

Infants affected by neonatal encephalopathy (NE) have been shown to have better survival rates and improved long term neurodevelopment following treatment with therapeutic hypothermia. However, a barrier to hospital discharge for these infants is a successful transition from gavage to either breast or bottle feeding.

Often, the factor delaying hospital discharge is slow transition to full oral feeds. Osteopathic manipulative treatment (OMT) helps to effectively stabilize and regulate the autonomic nervous system as well as the cranial nerves important in the sucking and latching reflexes, which may in turn help to ease the transition to full oral feeding. We hypothesize that infants who receive OMT will accelerate the transition to full oral feeds, thus decreasing their overall length of hospitalization compared to historical matched controls.

Eligibility Criteria:
Inclusion Criteria:

* Neonate \> 37 weeks gestational age at birth
* Neonate been diagnosed with neonatal encephalopathy or hypoxic ischemic encephalopathy and treated with therapeutic hypothermia
* Neonate with mild to moderate encephalopathy
* EEG without seizure activity
* Brain MRI without basal ganglia injury

Exclusion Criteria:

* Neonate \< 37 weeks gestational age at birth
* Neonate with severe encephalopathy (as defined by Sarnat)
* EEG demonstrated seizure activity or evidence of status epilepticus during therapeutic hypothermia treatment
* Brain MRI demonstrating moderate or severe basal ganglia injury
* Neonate affected by neonatal abstinence syndrome (NAS)
* Neonate affected by intrauterine growth restriction (IUGR)
* Neonate born with major congenital anomalies (i.e., cleft palate)
* Prenatal history of maternal insulin dependent gestational or type 1 diabetes
* Moribund status (i.e., infants unlikely to benefit from or are not responsive to aggressive life support)
Study of Homocysteine Metabolism in Homocystinuria

OBJECTIVES: I. Determine basal and postmethionine plasma homocysteine in patients with premature vascular disease, cystathionine beta-synthase (CBS) or methylenetitrahydrofolate reductase (MTHFR) deficiency, and in obligate heterozygotes for CBS or MTHFR.

II. Determine whole-body homocysteine metabolic rates with isotopically-labeled methionine.

PROTOCOL OUTLINE: This is a two-part study of homocysteine metabolism. Age-matched normal controls are entered in both parts of the study.

In first part of the study, participants are given oral methionine; baseline and postmethionine studies include amino acid quantitation, analysis of rapidly deproteinized plasma, and total plasma homocysteine.

In the second part of the study, participants (men and postmenopausal women only) undergo methionine tracer studies.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Known or suspected homocystinuria Cystathionine beta-synthase-deficient homocystinuria Obligate heterozygotes for cystathionine beta-synthase deficiency Premature vascular disease
RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers

This is a first-in-human, open label, single dose, dose-escalation phase 1 study to evaluate the safety and pharmacokinetics of a combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein in healthy volunteers.

The study has a standard 3+3 phase 1 dose escalation design. Study participants will receive subcutaneous injections of C144-LS and C135-LS at 4ml (approximately 100mg of each antibody administered separately) or 8ml (approximately 200mg of each antibody administered separately), or sequential intravenous infusions of C144-LS and C135-LS, at one of three increasing dose levels (1.5 mg/kg, 5 mg/kg and 15 mg/kg of each antibody).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older.
* If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use one effective method of contraception from 10 days prior to the antibody administration until 6 months after investigational product (IP) administration.

Exclusion Criteria:

* Weight \> 110 kg for groups S1 and S2 only
* History of prior positive SARS-CoV-2 RT-PCR or SARS-CoV-2 serology.
* Active respiratory or non-respiratory symptoms consistent with COVID-19.
* Medically attended acute illness or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening.
* Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[COPD\], asthma exacerbations, or uncontrolled hypertension, as defined by a systolic blood pressure \> 180 and/or diastolic blood pressure \> 120, in the presence or absence of anti-hypertensive medications) in the past 6 months prior to screening.
* Use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months.
* Other clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation.
* Laboratory abnormalities in the parameters listed:

  * Absolute neutrophil count less than 1,500 K/mcL;
  * Hemoglobin less than 10.5 gm/dL if female; less than 11 gm/dL if male;
  * Platelet count less than 125,000 K/mcL;
  * ALT less than 1.25 x ULN; AST less than 1.25 x ULN;
  * Total bilirubin less than 1.25 x ULN;
  * Creatinine less than 1.1 x ULN;
* Pregnancy or lactation.
* Any vaccination within 14 days prior to SARS-CoV-2 mAbs administration (except influenza vaccine).
* History of prior receipt of any SARS-CoV-2 vaccine or antibodies, including convalescent plasma.
* Known allergy/sensitivity or any hypersensitivity to components of the investigational agents.
* History of severe reaction to a vaccine or monoclonal antibody administration or history of severe allergic reactions.
* Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
Evaluation of the Effectiveness of Different Toothbrushes in Children

Control groups will be formed in the 2-12 age group using standard manual toothbrushes, and the effectiveness of 360-degree bristle toothbrushes will be compared.

Study design: Experimental study

In this randomized controlled, single-brushing study, children were assigned to a treatment sequence involving a 360-degree toothbrush and a control brush.

Subjects were randomly assigned to a treatment sequence involving a 360-degree toothbrush and a classical manual control toothbrush. Parents brushed the teeth of their children aged 2-5 years, whereas children aged 6-12 years brushed their own teeth under the supervision of clinic staff, unaided by a mirror. Clinical examination of each participant was carried out by the principal investigator. Assessments were done pre- and post-brushing using the "Silness and Löe Plaque Index" (PI), Gingival Index (GI), and the Simplified Oral Hygiene Index (OHI-S). Plaque indices were expressed as means and standard deviations (SD). Within each toothbrush group, the follow-up scores were analyzed using a paired t-test. p \< 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged 2-12.
* Children without systemic disease or developmental dental anomalies.
* Children not undergoing orthodontic treatment.
* Children with no decay on the labial surfaces of upper anterior incisors.
* Patients or their parents accepting participation in the treatment.

Exclusion Criteria:

* Children with decay on the labial surfaces of upper anterior incisors.
* Children undergoing orthodontic treatment.
* Children who, along with their parents, do not agree to participate in the treatment will be excluded from the study.
Adapting BA for Minimally Verbal Autistic Adults

The present study aims to adapt and evaluate the feasibility of the BeatIt-2 behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with minimally verbal autistic individuals.

Aim 1. The first phase of the project will focus on adapting the BeatIt-2 manual to consider specific needs of MV autistic adults. This procedure includes an intervention development group (IDG), for which MV autistic adults and their supporters (i.e., someone identified as a source of support they can work with) will be recruited. Aim 2. During the following phase of the project, a feasibility trial will be conducted. Using the treatment manual and study procedures adapted and refined in phase 1, the trial will examine the feasibility and acceptability of BeatIt-MV.

Eligibility Criteria:
Inclusion Criteria:

* Minimally verbal
* Aged 18 years or older
* Diagnosis of Autism Spectrum Disorder and clinically significant depression based on clinical best estimate diagnosis using DSM-5 or Diagnostic Manual - Intellectual Disability criteria
* Have a support person willing to participate
* Live in New Jersey or New York, or be within travel distance to Rutgers University

Exclusion Criteria:

* Not able to engage in treatment in English
* current engagement in other treatment for depression
* conditions that may preclude engagement in treatment sessions (e.g., active psychosis, unmanaged seizures)
* high suicide risk (i.e., with a clear plan, expressed intent or recent documented attempts)