cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations

A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations

Randomized, open-label, 3-way crossover study

Up to 66 healthy, adult male and female subjects will be enrolled.

All subjects will receive Corplex Donepezil TDS patches applied to 3 different locations on each subject (back, buttock, and leg) during 3 different, consecutive treatment periods. For each subject, the location of product administration during each treatment period will be randomized.

During each treatment period, all subjects will receive a once-weekly 10 mg TDS, target dose 10 mg donepezil/day, applied for 7 days (1 week) on either the back, buttock, or leg in accordance with the randomized treatment location for that treatment period.

Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period. The PK sample collection time points are as follows:

Week 1: Pre-TDS application prior to 0 hour and post-TDS application at 2, 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 hours.

Week 2: Pre-Week 1 TDS removal at 168 hours, and post-TDS removal at up to 528 hours

Adhesion and skin irritation will be monitored throughout TDS treatments. Safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female
* Body mass index ≥ 18.0 and ≤ 32.0 kg/m2 at screening
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator
* Have a Fitzpatrick skin type of I, II or III or have skin colorimeter scores equivalent to the allowed Fitzpatrick skin type

Key Exclusion Criteria:

* History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (including piperidine derivatives and other cholinesterase inhibitors)
* Has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitable veins in both arms
* Potential for occupational exposure to anticholinesterase agents
* Estimated creatinine clearance in non-elderly subjects \<80 mL/min at screening and in elderly subjects (i.e., ≥55 years of age) \<60 mL/min at screening
* Hemoglobin value of less than 11.5 g/dl for females, 13.0 g/dl for males at screening and first check-in
* Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
* History or presence of significant skin damage or other skin disturbances as deemed by the Investigator to potentially interfere with patch procedures
* Use of donepezil hydrochloride or related drugs within 60 days prior to the first study drug administration
* Clinically significant depression symptoms or suicidal ideation or behavior as determined by the Investigator
Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection

The LOCARE-Trial is an investigator initiated, randomized-controlled trial with two parallel arms (n=60 each) and investigates the influence of esophageal washout on long-term outcomes in patients undergoing elective esophageal resection for carcinoma. The primary endpoint is defined as local carcinoma recurrence. Secondary endpoints will be locoregional and distant recurrence, disease-specific survival and esophageal cancer specific survival.

Treatment of squamous cell carcinoma and adenocarcinoma of the esophagus has changed rapidly over the last decades due to implementation of multimodal cancer therapies such as radiotherapy or combined radiochemotherapy. Surgery, however, still is the mainstay of curative treatment options for this cancer entity. Due to the significant improvement in surgical technique and perioperative management, the postoperative mortality rate has fallen to about 5% with an estimated 5-year survival of 35%. Nevertheless, patients after esophagectomy are at high risk for local recurrence especially within the first 2 years after treatment. Independent risk factors for the development of carcinoma recurrence are incomplete resection (R1), extracapsular lymph node involvement and postoperative complications. Exfoliated, malignant cells remaining in luminal organs like the esophagus or colorectum could present another important risk factor for local recurrence especially at the site of anastomosis. In the treatment of rectal cancer, data have shown, that intraoperative rectal washout significantly reduces the risk of local recurrence from about 10% to 5%. For this reason, rectal washout during anterior resection has become a standard in many surgical institutions. Besides agents like cetrimide, sodium hypochlorite, formalin or saline, povidone-iodine has also been used for rectal mucosal application in prospective studies. Questions arise, weather similar positive outcomes could be achieved in esophageal surgery. The investigators hypothesize that esophageal washout with a povidone-iodine solution (Betaisodona®, Mundipharma) reduces the risk of local carcinoma recurrence after radical resection.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective esophageal resection or esophagectomy
* Age equal or greater than 18 years
* Written informed consent
* Squamous cell carcinoma of the esophagus (SCC)
* Adenocarcinoma of the gastroesophageal junction (AEG) Type I

Exclusion Criteria:

* Local irresectability or metastatic disease
* Adenocarcinoma of the gastroesophageal junction Type II and III
* Histopathological R1-resection
* Surgery for recurrence
* Iodine allergy
* Hyperthyreosis
Imaging With a Radio Tracer to Guide VT Ablations

Some patients are at risk for life-threatening fast heart rates. These can frequently be treated by using a catheter inside the heart to burn away the cells that create the fast heart rates. The purpose of this study is to image the nerves inside the heart of those patients. The investigators want to find out if abnormalities in the nervous system in the heart can help the physician to find the area that needs to be burnt away.

Ventricular tachycardia is the next frontier in cardiology. Patients that have scar in the heart (for example after heart attacks) are at an increased risk of developing ventricular tachycardia. In these patients ventricular tachycardia represents an electrical wave front that circulates in the heart muscle using the scar in the heart. An increasing number of patients with ventricular tachycardia require cauterization (burning away) of the tissue to treat this life-threatening condition. The goal of this cauterization or ablation is to destroy "highways of surviving tissue" inside the scar, that allow ventricular tachycardia to exist. However, this can be very lengthy procedure (\>5 hours) that has only a moderate success in the long run. Therefore, new treatment approaches are needed to make this procedure better.

The purpose of this study is to assess if radio tracers showing the nerve distribution in the heart (cardiac innervation) can be used in addition to the current technology ("voltage mapping") to identify the area that needs to be ablated (burnt away) to treat life-threatening fast heart rates (ventricular tachycardia)

Certain patterns of nerve distribution in the heart (sympathetic cardiac innervation) have been shown to predict outcome for different heart diseases, like heart transplant, coronary artery disease, heart failure, arrhythmias. One substance that allows visualization of the cardiac innervation is 123I-metaiodobenzylguanidine (123I-MIBG), which could provide additional information to understand and treat ventricular tachycardia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ventricular arrhythmias requiring VT Ablation
* Patients must be 18 years of age or older
* Patient must be able to sign consent form
* Patient must be willing to come back for the 6 month visit for additional study procedures

Exclusion Criteria:

* Patient under 18 years old
* Inability to sign consent
* Pregnant Women
Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya

The neoGuard device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2) in newborns. In this study, researchers will evaluate the feasibility of the neoGuard device at two rural health facilities in Western Kenya and assess the preliminary efficacy of the technology in improving health outcomes for newborns.

This is a pre/post intervention study. The standard-of-care arm (n=223) will be enrolled between 20 Oct - 20 Nov, 2020 and the neoGuard intervention arm (n=223) will be enrolled between 1 - 31 Dec, 2020.


Eligibility Criteria:
Inclusion Criteria:

* Age \<28 days
* Admitted to the neonatal intensive care unit
* Weight at birth/admission ≥2000 g
* Low-to-moderate disease severity as determined by the Signs of Inflammation in Children that Kill (SICK) score card (SICK score ≤2.4 at admission is eligible)
* Parent/guardian willing to provide informed consent for their newborn to participate in study

Exclusion Criteria:

* Age \>28 days
* Has a condition that impairs them from wearing the device, such as hydrocephaly.
* Weight at birth \<2000 g
* Very severe disease status (SICK score \>2.4 at admission)
The Turkish Version of the Vividness of Visual Imagery Questionnaire-2

The Vividness of Visual Imagery Questionnaire-2 (VMIQ-2) is originally developed in English to determine the vividness of visual imagery. The purpose of this study is to translate and cross-culturally adapt the VMIQ instrument into Turkish and investigate its psychometric properties.

The Vividness of Visual Imagery Questionnaire-2 (VMIQ-2) was originally developed in English to determine the vividness of visual imagery. The purpose of this study is to translate and cross-culturally adapt the VMIQ-2 instrument into Turkish and investigate its psychometric properties. One hundred fifty healthy participants will be included. For cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants will complete the Turkish version of VMIQ (VMIQ-2-T) to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlation with the Turkish version of Kinesthetic and Visual Imagery Questionnaire-20 will be determined to check the validity.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old
* ability to read and write in Turkish
* no pathology in visual ability and hearing
* able to follow simple instructions

Exclusion Criteria:

* having a chronic disease
* severe musculoskeletal, neurological or cardiovascular disorders that limit mobility
* having any cognitive problem
Pharmacotoxicology of Trichloroethylene Metabolites

This is a research study to look at how Dichloroacetate (DCA), and investigational drug and chloral hydrate are broken down in the body. The purpose of the study is to better understand how humans metabolize these two common chemicals that are widely present in the environment. The study focuses on how the drug chloral hydrate is broken down and how it effects DCA

The subject's general health is assessed by a history and physical exam and routine blood work. I normal the individual undergoes five nights of receiving 1.5ug/kg of chloral hydrate. On day 6 the individual receives 2.5 micrograms/kg of Dichloroacetate (DCA) and kinetics are drawn. After 30 days the subject comes back and receives 1.5ug/kg of chloral hydrate for five nights and has kinetics drawn on night one and five. On days 6-9 the subject returns for a blood draw. After 30 days the same process as above is done except the subject receives 1gram of chloral hydrate for five nights and 25mg/kg of Dichloroacetate one day then 30 days later the subject receives 1gram of chloral hydrate for five nights and has kinetics done on night one and five and blood samples drawn on days 6-9

Eligibility Criteria:
Inclusion Criteria:

* healthy
* normal screening labs

Exclusion Criteria:

* no gastrointestinal surgery
* no smoking
* no medication
* not pregnant
Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer

As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
* Complete or partial response following standard of care surgery and first line chemotherapy
* May have one disease recurrence with complete or partial response or stable disease following standard of care second line care treatment
* Previous investigational biologic therapy allowed, must be more than 56 days prior to first injection
* Previous treatment with bisphosphonate allowed, must be completed 14 days prior to first injection
* Ambulatory with an ECOG 0-1
* Life expectancy \> 6 months
* Meet protocol-specified lab requirements
* Provide informed consent and have ability to comply with protocol requirements

Key Exclusion Criteria:

* Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout periods as specified in protocol)
* Prior receipt of survivin based vaccines
* Participation in prior therapeutic adjuvant ovarian cancer studies, except for platinum-based adjuvant studies
* Progressive disease (rising CA-125 acceptable)
* More than one course of chemotherapy for recurrent disease
* Concurrent bevacizumab as maintenance therapy
* Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
* History of autoimmune disease
* Recent history of thyroiditis
* Presence of a serious acute infection or chronic infection
* Brain metastases
* Other serious intercurrent chronic or acute illness
* Ongoing treatment with steroid therapy or other immunosuppressive
* Acute or chronic skin disorders
Effectiveness of Mindfulness After a Stroke

Mindfulness is promising for individuals with neurological disorders and caregivers to improve psychological well-being. This study aims to determine the extent to which a 3-week online mindfulness intervention will improve quality of life and psychological well-being for chronic stroke survivors and their caregivers, compared to a waitlist control.

Background: The incidence of depression and anxiety is much higher in stroke survivors and their caregivers compared to age-matched peers. Previous work suggests that mindfulness delivered in an online format is promising for both individuals with neurological disorders and caregivers to improve quality of life and psychological well-being.

Aim: This project aims to determine the extent to which a 3-week online mindfulness intervention will improve quality of life and psychological well-being for chronic stroke survivors and their caregivers, compared to a waitlist control. The primary hypothesis is that participants in the mindfulness group will demonstrate greater improvement in quality of life and psychological well-being post-intervention compared to waitlist control participants. The secondary hypothesis is that these improvements will persist for at least 1-month post-intervention.

Methods: This project uses a pragmatic, randomized, waitlist-control trial design with blinded outcome assessment. Participants (stroke survivors and caregivers) are assigned to a 3-week online mindfulness intervention, or a 2-month delayed waitlist. A battery of self-reported outcome measures and clinical tests are administered pre-intervention, post-intervention and at 1-month follow-up. Participants in the waitlist control group are also assessed at enrollment. A sample of 44 stroke survivors and 44 caregivers is targeted. Changes will be measured using a repeated analysis of variance.

Conclusion: The study constitutes the initial step to understand the role of mindfulness exercises delivered remotely and the potential benefit of the intervention for stroke survivors across a wide range of disability level and their caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Stroke survivor or caregiver of someone who have had a stroke
* Fluent in English
* Have access to Internet using a computer, a tablet and/or a smart phone.

Exclusion Criteria:

* Severe language impairments
* Participation in regular meditation or a mindfulness program in past 3 months
I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders

The goal of this clinical trial is to learn if CBT(Cognitive Behavioural Therapy)-MyOWL(Optimizing Wellness through Literature) is feasible, leads to better patient retention, and has high acceptability by youth psychiatric outpatients with mood and/or anxiety disorder aged 14-19. The main questions it aims to answer are:

Primary Objective (feasibility): To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL / CBT-as-usual.

Primary Objective (acceptability): To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants.

Secondary Objectives:

1. To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual.
2. To determine whether youth who receive CBT-MyOWL have improved scores on all of the following over the course of treatment and endpoint compared to youth who receive CBT-as usual: i) depression and anxiety ii) suicidal ideation, iii) self-harm, and iv) coping and emotional resiliency.

Participants will:

Participate in 12 sessions of either CBT-MyOWL or CBT-as-usual (active control) Completes 4-5 questionnaires at sessions 3,6,9,12 Complete the acceptability and exit interview at session 12


Eligibility Criteria:
Inclusion Criteria:

* Aged 14-19
* Primary diagnosis of a mood disorder or an anxiety disorder
* Ability to understand written and spoken English and to read a novel
* Treating physician considers CBT as indicated for the patient

Exclusion Criteria:

* Patients already participating in active CBT therapy or recently completed CBT treatment (within the past 3 months)
* Active psychosis or mania
Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.

There are two options for postoperative pain management: opioid and non-opioid analgesia. Pain outcomes will be compared in patients undergoing ureteroscopy and percutaneous nephrolithotomy by randomly administering opioid and non-opioid analgesia.

Perioperative pain is often managed by opioids. However, post surgical pain management with opioids can often lead to long-term opioid use; additionally, opioids can cause unwanted side effects including respiratory depression that can lead to hypoxia and respiratory arrest, as well as nausea, vomiting, pruritus, ileus, and constipation. As an alternative to opioid perioperative pain management, non-opioid analgesia has been proven to be as effective as opioid management in acute pain. Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and acetaminophen are often utilized as alternatives to opioid analgesia, and have an increased efficacy when combined. Both NSAIDS and acetaminophen have been proven to decrease opioid requirements and have minimized opiate-induced adverse events.

In this randomized clinical trial, pain outcomes after ureteroscopy and percutaneous nephrolithotomy will be investigated in patients who are treated with opioids versus a non-opioid regimen of ketorolac and acetaminophen. Percutaneous nephrolithotomy and ureteroscopy are minimally invasive surgical techniques to surgically remove kidney stones. This trial will seek to determine whether non-opioid therapy is noninferior to opioid therapy in the determination of pain intensity as measured by an 11-point numeric rating scale, in which 0 indicates no pain and 10 indicates the worst possible pain, one week after the surgery by telephone call.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women age\>18 years old
* Presence of renal or ureteral stones suitable for ureteroscopy or percutaneous nephrolithotomy.
* Uncomplicated ureteroscopy or percutaneous nephrolithotomy

Exclusion Criteria:

* Pregnant/Breastfeeding/Possibly Pregnant Patients
* Pediatric Patients
* Sensitive or Allergic to Opioids, Ketorolac, or Acetaminophen
* Significant Renal Disease
* Peptic Ulcer Disease
* Chronic Pain and recovering opiate use
* Inability to complete questionnaires
* Non-mobile patients
* Patients on methadone
Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin \>= 9.5 and \<= 11.5 g/dL.
* Ferritin \<= 500 ng/ml.
* Serum Transferrin Saturation (TSAT) \<= 25%.
* Stable erythropoietin (EPO) Regimen for 8 weeks.
* No iron for last 4 weeks before randomization.

Exclusion Criteria:

* Known Sensitivity to Iron Sucrose.
* Suffering concomitant severe diseases of the liver \& cardiovascular system.
* Pregnancy / Lactation.
* Inadequate dialysis.
* Current treatment for asthma.
* Significant blood loss.
* Probability of need for transfusion or transfusion within 1 week of enrollment.
* Anticipated major surgery.
* Hemochromatosis / hemosiderosis.