cyrilzakka/clinical-trials huggingface dataset:
Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy

Chemotherapy induced nausea and vomiting (CINV) is a major adverse effect of chemotherapy. This study is determining the incidence of vomiting/retching of the standard induction chemotherapy regimen for patients with acute myeloid leukemia (AML) who are also receiving an antiemetic known as aprepitant.

The standard frontline chemotherapy for patients with AML consists of cytarabine given as a 7 day continuous infusion plus 3 days of an anthracycline, most commonly daunorubicin, on days 1-3. This is known as the 3+7 regimen. Antiemetic treatments are usually given to patients for nausea and vomiting. Granisetron (a 5-HT3 receptor antagonist) is used on the 3 daunorubicin days and other antiemetics can be used for breakthrough nausea/vomiting.

This study will test that the prophylactic use of aprepitant, in addition to the standard antiemetic regimen used at Princess Margaret Hospital (PMH), will reduce the incidence of delayed onset vomiting/retching by Day 5 in AML patients receiving the standard 3+7 regimen, compared to retrospective data using this regimen.


Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia (AML), any subtype including acute promyelocytic leukemia (APL). Patients with either de novo or secondary AML are eligible.
* No prior AML induction chemotherapy.
* Due to receive standard 3+7 induction chemotherapy using daunorubicin on Days 1-3, plus cytarabine continuous infusion daily on Days 1-7.
* Age 18 and over.
* Serum bilirubin \< or = 1.5 times the upper limit of normal (ULN).
* Serum aspartate aminotransferase and alanine aminotransferase \< or = 2.5 times the ULN.
* Serum creatinine \< 200 umol/L

Exclusion Criteria:

* Uncontrolled nausea or vomiting within 48 hours prior to start of induction therapy. Grade 0-1 nausea is permitted at the start of induction.
* Known hypersensitivity to granisetron or aprepitant.
* Patients currently receiving treatment with strong CYP3A4 inhibitors or substrates and treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
* Not able to swallow or absorb oral medications.
* Documented active central nervous system (CNS) leukemia or recent CNS hemorrhage.
* Concomitant use of:

  1. Other investigational agents during induction therapy
  2. Radiotherapy during, or one month prior to, induction therapy
  3. Systemic corticosteroids
  4. Other chemotherapy agents on Days 1-8
* Pregnant or breast feeding.
Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds

Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope

The enrolled population will include adults with a history of heart and lung complications. The enhanced sound quality of the electronic stethoscope and its non-inferiority to the traditional/conventional 3M Littmann stethoscope will be assessed through auscultation examination of every patient by a health professional (consultant, medical resident, and house officer) with both the electronic stethoscope and 3M Littmann/traditional/conventional stethoscope

Eligibility Criteria:
Inclusion Criteria:

* Ages: 18 years or older (male and female)
* Hospital admitted or Out Patient Department
* Written consent provided

Exclusion Criteria:

* Age \<18
* ICU admitted
* Written consent not provided
Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians

The objective for the study is to implement a pilot study to establish essential components to address diet quality in healthcare settings and examine what value an integrated service model delivery has for the primary prevention of cardiometabolic diseases with an initial focus on dietary behaviors. This objective will be met by 1: Utilizing a multiphase optimization study design to select and optimize essential components to address diet behaviors and 2: Comparing an integrated and referral-based delivery model for healthcare-based strategies that address structural and psychosocial barriers to a healthy diet for racial/ethnic minority, marginalized and disadvantaged background young to middle aged adult populations in Mississippi.

The study is designed based on the multiphase optimization strategy (MOST), which includes three phases to prepare or screen, optimize, and evaluate multiple components of an intervention. During first optimization phase, study team will conduct essential component selection by pilot testing three common strategies used in healthcare settings to deliver structural and psychosocial interventions that address diet behaviors. The second optimization phase will include pilot testing to examine the optimization of delivery mode for the essential components identified in first phase. In each phase, participants between 25 to 50 years of age who are at risk for CVD-related premature mortality will be recruited to complete a 3-month intervention in a community based clinical setting in Mississippi. The proposed project will provide foundational knowledge for components and delivery models that are the most essential and cost-effective to improve dietary behaviors among racial/ethnic minority and disadvantaged background populations in Mississippi.

Eligibility Criteria:
Inclusion Criteria:

* 25 to 50 years of age
* cardiovascular disease-related premature mortality risk (people living with HIV/AIDS or diagnosed with or familial risk for diabetes, hypertension, obesity, or Metabolic syndrome)
* internet access
* Jackson (Mississippi) metropolitan statistical area residency

Exclusion Criteria:

* cancer with active treatment
* chronic obstructive pulmonary disorder, emphysema, cystic fibrosis or any other major lung disease
* liver or kidney dysfunction, end-stage renal disease, active hepatitis,
* celiac disease, colitis, or other gastrointestinal disorders
* current pregnancy or within six months postpartum at baseline
* heavy drinking
* unintentional weight loss of more than 5% of body weight within the past six months
* recent (in the past 6 months) heart attack, stroke or other major heart surgery or event
* eating disorders (anorexia or bulimia nervosa)
* currently being treated for a fungus, bacteria, viral, or other infection due to weak immune system
* Insulin dependent diabetes
OR PathTrac (Tracking Intra-operative Bacterial Transmission)

Healthcare-associated infections occur frequently and are associated with patient harm. These infections are becoming more difficult to treat due to antibiotic resistance. It is important that healthcare facilities take the steps necessary to prevent the spread of resistant bacteria between patients.

Two patients undergoing sedation in a randomly selected operating room will be evaluated in a serial manner in order to detect transmission of pathogenic bacteria. Patient care will not change due to their participation in this study; the patients will undergo sedation and surgery according to usual practice. This study involves taking microbiology cultures from various places in the operating room before and after each procedure. Cultures will also be taken from the two patients after they are asleep and from their intravenous tubing. From both patients anesthesiologist, surgeon and their surgical team, cRNA, and nursing staff will also have cultures obtained. Each cultures will be de-identified and given a study ID number before transport to the research laboratory for microbiological assay. The patient's medical record will be reviewed for 30 days after surgery to surveil for documentation of a potential hospital acquired infection.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Require peripheral intravenous and/or central venous catheter placement
* Undergoing gynecology/oncology, colorectal, open vascular, total joint or cardiovascular procedures.

Exclusion Criteria:

* Less than 18 years of age
* Does not require peripheral intravenous and/or central venous catheter placement
* Patient refusal to participate
* Incarceration
Snack Food Reinforcement in Obese and Non-obese Women

Food reinforcement, motivation to obtain food, is associated with energy intake and obesity. Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to diets and weight loss. Our previous study in non-obese adults showed that daily consumption of the same snack food (food typically consumed outside of meals) for 14 days significantly decreased its reinforcing value. The purpose of this study was to replicate and extend these findings to obese individuals as well as to examine effects of different portion sizes of snack foods on food reinforcement. Thirty-one obese (body mass index \> 30 kg/m2) and 27 non-obese (BMI \< 30 kg/m2) women had food reinforcement and liking tested at baseline and after two weeks of daily consumption of either 0 kcal, 100 kcals, or 300 kcals daily of the same snack food.


Eligibility Criteria:
Inclusion Criteria:

* women
* non-smoker
* not on a diet
* no restrained eating
* had to like potential snack foods
* willing to visit the laboratory 3 times
* willing to eat snacks provided
* no medications or medical conditions that affect appetite
* no food allergies

Exclusion Criteria:

* see above
At-Home Gait Assessment

The goal of this study is to validate an MS Gait Remote Capture and Analysis (MS-GRCA) system based on wearable shoe-based motion sensors for home-based and repeatable gait assessments.

This is a single-site observational longitudinal study to validate an MS Gait Remote Capture and Analysis system for home-based and repeatable gait assessments. The investigators will recruit 30 participants who will have an in-person baseline visit (informed consent, standard gait assessment, sensor-based gait assessment, self-reported questionnaires), followed by three remote visits (sensor-based gait assessment, SUS questionnaire \[last remote visit only\]).

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70 years old (inclusive)
* Confirmed diagnosis of MS (any MS subtypes, Relapsing Remitting \[RR\], Primary Progressive \[PP\], or Secondary Progressive \[SP\])
* PDSS score from 0 to 5
* Stable and continuous access to internet at home
* Adequate home facilities (enough space, quiet and distraction free area)
* Ability to provide informed consent.

Exclusion Criteria:

* Below average estimated premorbid cognitive functioning (based on WRAT-4 reading recognition standard z-score \< 85).
* Presence of severe cognitive impairment (based on SDMT age normative z-score \< -3.0).
* Presence of primary neurological disorders other than MS or primary psychiatric disorder that would influence ability to complete assessments.
Relationship Between Central Corneal Thickness and Intraocular Pressure Measures Instruments.

The purpose of this study is to evaluate the relationship between intraocular pressure and central corneal thickness using various instruments in ocular hypertension, normal-tension glaucoma, primary open angle glaucoma, keratoconus and normal eyes.

The purpose of this study is to evaluate the relationship between intraocular pressure and ultrasound pachymetry measured central corneal thickness using Goldman tonometry and PASCAL instruments.

Patient groups examined include:

ocular hypertensives normal-tension glaucoma primary open angle glaucoma keratoconus control normal eyes

Eligibility Criteria:
Inclusion Criteria:

Adults over the age of 18 years Clinical diagnosis of glaucoma, open angle; ocular hypertension; glaucoma (low-tension); keratoconus and other healthy volunteers.

Exclusion Criteria:

Children under the age of 18 years Adults with learning disabilities Adults who are unconscious or severely ill Adults who have known terminal illness Adults in emergency situations Adults with dementia Prisoners Young offenders Those who could be considered to have a dependant relationship with the investigator (i.e. those in care homes or medical students) Other vulnerable groups
Neural Operant Conditioning

The goal of this clinical trial is to learn if operant conditioning can reduce spasticity in order to improve walking in stroke patient. The main questions it aims to answer are:

* Can participants self-regulate reflex excitability
* Can participants self-regulate reflex, reduce spasticity and improve walking Participants will undergo surface stimulation to evoke spinal reflexes and will be asked to control these reflexes therefore reducing spasticity.

Researchers will compare result to able bodied participants to see if \[insert effects\]

The study purpose is to investigate the possibility and later effect of spinal reflex self-regulation in post-stroke stiff-knee gait. The intervention will consist of direct current surface stimulation of the peripheral nerves using electrical stimulation. Stimulation will evoke a motor response that will be collected through surface EMG electrodes and processed to depict a measure of the response as feedback to the participant to complete the loop of operant conditioning. The participant will attempt to modulate their responses over multiple sessions to cause this depiction to either increase or decrease its value depending on an established target.

.

Eligibility Criteria:
Inclusion Criteria:

1. Sign and date consent form
2. At least 3 months since stroke event
3. Over 18 years of age at time of eligibility
4. Ability to stand upright and walk for at least 5 minutes
5. Premorbidly independent
6. Mild to moderate gait impairment
7. Reduced knee flexion during walking relative to the unimpaired side
8. Unilateral hemiparesis of the lower limbs
9. Ability to evoke muscle responses through peripheral nerve stimulation, spinal cord stimulation, and transcranial magnetic stimulation
10. Medically stable
11. Skin intact on hemiparetic leg, abdomen, and scalp
12. Ability to evoke muscle responses and/or reflex responses through peripheral nerve stimulation, spinal cord stimulation, and/or transcranial magnetic stimulation

Exclusion Criteria:

1. Co-existing neurological condition other than prior stroke involving the hemiparetic lower limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
2. History of lower limb musculoskeletal injury
3. Functionally relevant osteoarthritis and weight bearing restriction
4. Functionally relevant polyneuropathy resulting in lack of sensation in the lower leg
5. Functionally relevant cognitive impairment
6. Functionally relevant vision impairment
7. Pregnant
8. Botox injection to the ipsilateral leg in the last 12 weeks or taking oral anti-spasticity medications
9. Taking part in physical therapy for any walking-related impairment
10. Cardiac pacemaker or other implanted electronic systems
11. Uncontrolled seizure disorder
12. Use of seizure lowering threshold medications and the discretion of the study physician
13. Deficits in communication that interfere with reasonable study participation
14. Severely impaired cognition and communication
15. Severe lower limb pain
Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer

Breast cancer (BC) is the most frequently diagnosed cancer in women. Systemic cancer treatments are an important contributor to dramatic improvements in the long-term survival of women with BC. However, cancer treatment can lead to cognitive impairment and declines in quality of life in women with BC. Many cancer survivors experience memory and brain function decline following chemotherapy which can last for years. A newer diet pattern, Mediterranean-DASH \[Dietary Approaches to Stop Hypertension\] Intervention for Neurodegenerative Delay (MIND), was shown to help with protecting brain functions. The MIND diet is high in anti-inflammatory nutrients (e.g., omega-3 polyunsaturated fatty acids (PUFAs), carotenoids, B-vitamins, and polyphenols) and limits the intake of brain-unhealthy foods (i.e., butter/margarine, cheese, red meat, fried foods, pastries, and sweets), which may help alleviate negative cognitive outcomes from cancer treatments. This randomized controlled trial aims to investigate the effect of the MIND diet on cognitive functions in women with invasive BC starting systemic therapies.


Eligibility Criteria:
Inclusion Criteria:

* Stage II-IV hormone receptor+, breast cancer diagnosis
* Post-menopausal (defined as at least 1-year post menses, on ovarian suppression medication, or s/p oophorectomy)
* Within +/- 4 weeks of starting initial systemic therapies (e.g. chemotherapy, targeted therapies, endocrine therapy)
* English speaking

Exclusion Criteria:

* History of dementia, stroke, traumatic brain injury, brain metastasis or other conditions that could lead to cognitive impairment
* MIND diet score \>8
* Unwilling/unable to eat \>2 types of MIND food
* Receiving insulin therapy for diabetes
* Diagnosis of triple negative breast cancer
* Unable to give informed consent.
COVIDAR - Arrhythmias in COVID-19

BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify potential modifiable predisposing factors to reduce their incidence and to inform the best arrhythmia management options in this patient population.

MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the SARS-CoV2 infection.

STUDY DESIGN: patient registry (observational). Patients will not undergo any additional investigations. Only data that is generated during routine clinical care will be collected.

STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed COVID-19.

The COVIDAR Registry is an international longitudinal multicentre observational study worldwide which aims to assess the incidence, type and risk factors of arrhythmias in the context of SARS-CoV2 infection, also providing relevant information on events/management and major cardiovascular outcomes. During the course of the registry patients will be followed up according to the usual practice of the centres. Drug prescriptions and indications to perform diagnostic/therapeutic procedures will be completely left to the treating physicians.

The registry population will consist of patients presenting with a suspicion of SARS-CoV2 infection, who are hospitalised in a medical or surgical department of the participating hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19 disease has formally been noted or confirmed in the patient's medical record.

The registry will include all patients and collect data at the following timepoints:

* Admission: evaluation before SARS-CoV2 infection treatment initiation
* On-treatment: evaluation 24-28h after treatment initiation
* At any adverse event: evaluation if any adverse event occurs
* At discharge: evaluation of clinical status at the end of the admission period.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with highly suspected/confirmed infection with SARS-CoV-2.

Exclusion Criteria:

* Formal opposition by the patient to data collection.
Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus

An endoscopic third ventriculostomy is considered to be successful in idiopathic normal pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled, multicenter study.

The traditional treatment for communicating hydrocephalus is a ventriculo-peritoneal shunt insertion and the endoscopic third ventriculostomy (ETV) is reserved for patients with obstructive hydrocephalus. However, in the last decade several reports highlighted an success of an ETV in communicating hydrocephalus as well. Thus, the aim of the present study is to compare ventriculo-peritoneal shunting against ETV in patients with an idiopathic normal pressure hydrocephalus, an subset of communicating hydrocephalus, in a randomized, controlled multicenter study.

Eligibility Criteria:
Inclusion Criteria:

* Age over 50 years
* gait disturbances typical for iNPH
* symptoms Duration less than 36months
* exclusion of obstructive hydrocephalus
* positive spinal TAP-test

Exclusion Criteria:

* no informed consent
* malignant disease
* other diseases of the CNS (Parkinson, dementia)
* secondary communicating hydrocephalus
Study of the Safety and Immunogenicity of NasoVAX Extension

This study is an extension to Study ALT-103-201, a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age.

This study is an extension to Study ALT-103-201 to evaluate immunogenicity of NasoVAX administered by intranasal spray at a single dose of 1×1011 vp at Day 366 (± 60 days). Up to 15 subjects who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 will be screened, and a serum sample will be collected from each eligible subject for evaluation of influenza HAI assay against influenza A/California/07/2009(H1N1), a strain homologous to the one used for NasoVAX (monovalent AdcoCA09.HA). Ad5 antibody neutralization assay may also be performed.

Eligibility Criteria:
Inclusion:

1. Receipt of NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201
2. Adequate venous access for phlebotomy
3. Provision of written informed consent

Exclusion:

1. Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with the subject providing an adequate blood sample or the subject's ability to give informed consent
Alternative Paracetamol Treatments for the Neonate With a hsPDA

Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended. Our standard first line therapeutic approach is enteral acetaminophen. However many extremely low birth weight infants may be on limited or no feeds when PDA closure is determined to be indicated, thus restricting the use of enteral acetaminophen. Several studies have suggested that intravenous acetaminophen is less effective than enteral. Thus, in this study, we propose to compare two alternative modes of administration when enteral acetaminophen is not an option.

Once parental consent for entrance into the study is obtained, eligible babies will be randomized to receive either IV acetaminophen (perfalgen) by continuous infusion at 2.5 mg/kg/h following a loading dose of 15 mg /kg/ over 20 minutes or rectal acetaminophen at 15 mg/kg every 6 hours for a period of 3 days.

Eligibility Criteria:
Inclusion Criteria:

Inborn preterm neonates, \< 1000 gm birth weight; \< 28 weeks' gestational age; who are admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and are diagnosed with a hemodynamically significant patent ductus arteriosus within the first week of life and who are on limited or no enteral feeds -

Exclusion Criteria:

Other congenital heart disease, major congenital anomalies, sepsis; and/or NEC.