cyrilzakka/clinical-trials huggingface dataset:
Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone

To investigate the effect of trazodone on sleep, hippocampal-dependent memory and hippocampal excitability. The investigators hypothesize that trazodone will improve total sleep time and proportion of time in Slow Wave Sleep (SWS).

The REST trial is a randomized, placebo-controlled, double-blind crossover study of trazodone (50 mg at bedtime) in participants with Amnestic Mild Cognitive impairment (aMCI) and sleep complaints. The investigators will randomize 100 subjects and administer trazodone and placebo for 4 weeks each with a 4-week washout period in between. A 4-week washout period is more than sufficient due to trazodone's elimination half-life of 10-12 hours. The crossover design will facilitate recruitment and enable the use of the subjects as a control without requiring a parallel placebo arm.

Eligibility Criteria:
Inclusion Criteria:

1. Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjective memory complaint and/or objective evidence of memory problems;
2. Clinical Dementia Rating (CDR) of 0.5 with a Memory Box score of \>=0.5;
3. Evidence of sleep complaints with Pittsburgh Sleep Quality Index score of \>5 (a well-validated cutoff observed in \>40% of older persons);
4. Memory performance \> 1.5 Standard Deviation (SD) below age-and education-matched control subjects on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) List Recall;
5. Visual and auditory acuity adequate for neuropsychological testing;
6. Good general health with no disease expected to interfere with the study;
7. Able to have Magnetic Resonance Imaging (MRI) scan;
8. Availability of knowledgeable informant (KI)

Exclusion Criteria:

1. Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;
2. Too frail or medically unstable to undergo study procedures;
3. Prior diagnosis of Obstructive Sleep Apnea (OSA) or evidence of moderate-to-severe OSA on baseline Home Sleep Test (HST) as evidenced by an apnea/hypopnea index of \>15;
4. Dementia;
5. Cognitive complaints and deficits better explained by other medical/neurologic conditions;
6. Delirium;
7. Allergic to trazodone;
8. Taking sleep medications including trazodone;
9. Current substance abuse;
10. Current major depressive, manic, or acute psychotic episode;
11. Prior diagnosis of significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol or represent alternate primary cause of memory problems beyond Alzheimer's Disease (AD) pathology:
12. Lack of available KI;
13. Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) \> 470 msec (females) or \> 450 msec (males);
14. Inability to provide informed consent
Healthy Kids I-PAL

Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and healthy weight among children and their parents.


Eligibility Criteria:
Inclusion Criteria for Child:

* Have at least one participating parent
* Be physically capable of exercise
* Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer

Inclusion Criteria for Parent:

* Have a smart phone
* Be willing to use the smartphone for the mHealth intervention

Exclusion Criteria for Child:

* Significant cardiovascular disease or disorders via self-report from parent
* Other significant medical problems that would prevent them from engaging in regular physical activity.
A Safety Study of LY3372689 Given By Mouth to Healthy Participants

This study is being conducted to determine the safety profile of the study drug after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3372689 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive up to 3 doses of LY3372689 or placebo. The study will last about 12 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or a female who cannot get pregnant
* Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for ease of blood sampling

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have long exposure to sunlight routinely or use tanning beds regularly
Evaluation Of Balance And Ankle Proprioception In Calcaneal Spur Patients

this study will be conducted to investigate the difference in balance and ankle proprioception between calcaneus spur patients and age matched normal subjects

A calcaneal spur, also known as enthesophyte, is an abnormal bone outgrowth at the inferior part of the calcaneus, which is the most common site of bony spur occurrence. Although there is consensus that a calcaneal spur is a common cause of heel pain, approximately 20% of calcaneal spurs are asymptomatic and its pathology remains not fully understood.Ankle Joint Position Sense (JPS) refers to the ability to accurately perceive and reproduce the position of the ankle joint in space. Balance, on the other hand, encompasses the ankle joint's positional stability during both static and dynamic activities.Several investigations have demonstrated a significant association between ankle JPS and balance, indicating that individuals with better proprioceptive acuity in the ankle joint tend to exhibit superior postural stability, ). It was found that higher plantar fascia and heel fat pad stiffness and thickness are related to higher postural sway in anterior-posterior and medial-lateral directions based on the single-leg balance tests. These results suggest that the morphological and mechanical properties of plantar fascia and heel fat pad play an important role in balance performance.

Eligibility Criteria:
Inclusion Criteria:

* age will range from 40-60
* both sex male and female
* unilateral calcaneal spur
* Patients with pain and inflammation at the bottom of heel, or the location where the spur is present.
* All subjects have body mass index less than 29 kg/cm2
* sharp pain like a knife in the heel when standing up in the morning
* pain may also appear at the end of the day or after spending long periods of time on the feet
* sharp pain with the first steps in the morning or after a long period of rest and dissipating when weight bearing is initiated.
* All diagnosed patients, were evaluated and confirmed radiologically by specialist doctor, by performing a standard X-ray foot profile image

Exclusion Criteria:

* Surgery within the last 6 months
* Sensory or motor paralysis -Received steroid injections within the last 3 months-
* discrepancy in length of the lower extremities greater than or equal to 1 cm.
* systemic disease in the last six months that may predispose to heel pain(e.g., rheumatoid arthritis and lupus). (Dudoniene V et al.,2023).
* Calcaneal spurs are associated with various medical conditions, including obesity, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, Reiter's disease, and spondylarthritis.
Anticancer Activity of Nicotinamide on Lung Cancer

Nicotinamide is an inhibitor of human sirtuins (HDAC III), and is found to re-activate epigenetically silenced tumor suppressors, RUNX3 (runt-related gene 3) and others, in cancer cells. Nicotinamide was found to be effective in several animal cancer models including lung, bladder, liver, etc. The purpose of this study is to determine whether nicotinamide is also effective in the treatment of human lung cancer.

The standard therapy to the EGFR (epidermal growth factor receptor) mutation positive non-small-cell lung cancer patients who are not eligible to operation is to administer EGFR-TKIs (tyrosine kinase inhibitors, gefitinib or erlotinib). To determine the effectiveness of nicotinamide on lung cancer, nicotinamide or placebo tablet will be co-administered with gefitinib or erlotinib for two years until the event or censoring occurs. The stratified block randomization was designed with 3 covariates (EGFR mutation status, kind of EGFR-TKI, ECOG (Eastern Cooperative Oncology Group) performance status score variation). The size of lesions will be checked every other months by radiology. PD (progressive disease) will be assessed according to RECIST(Response Evaluation Criteria in Solid Tumors)1.1. After observing 36 events, an interim analysis of hazard ratio by Cox proportional hazard regression will be performed. The final analysis will be done by the same protocol after observation of 72 events. The significance level of the interim and final analysis were set to 0.0075 and 0.0209 respectively. Response rate, quality of life (measured by 10 questions at every visit), and overall survival will be analysed together. All other adverse reactions will be analysed and reported, if there.

Eligibility Criteria:
Inclusion Criteria:

* Operation-impossible stage 4 non-small-cell lung carcinoma (NSCLC), or recurred terminal stage NSCLC after previous operation or radiation therapy
* EGFR mutated (exon 19 deletion or L858R mutation)
* Life expectation more than 3 months
* More than 1 measurable lesions by RECIST 1.1 which were not exposed to radiation previously
* ECOG (Eastern Cooperative Oncology Group ) performance status grade 0\~2
* Who signed the informed consent form

Exclusion Criteria:

* Who had received chemotherapy or EGFR tyrosin kinase inhibitors previously, except whom had received operation at least 6 months ago and received supplementary chemotherapy
* Who has metastasized brain lesion that needs operation or radiation therapy
* Above grade 2, CTCAE (Common Toxicity Criteria for Adverse Effects) 4.0 criteria for blood, liver and kidney
* Who does Not agree to contraception
* Who has allergy to nicotinamide
Effectiveness of and Satisfaction With a Pharmacist-managed Travel Medicine Clinic

This study will evaluate the clinical effectiveness of, and patient satisfaction with, pre-travel consultations provided by a pharmacist with specialty training in travel medicine and the authorization to prescribe medications and administer vaccinations.

The study will be conducted at the Travel Health Network, a full-service travel medicine clinic located in St. Albert, Alberta. Care will be provided by a pharmacist with a specialized practice in travel medicine, authorization to prescribe vaccines and prescription drugs, and authorization to administer vaccines by injection.

The study will be a prospective mixed-methods cohort study, describing patients receiving care from a pharmacist-managed travel medicine clinic and their travel health needs, and evaluating their adherence to recommended vaccines and oral therapies, satisfaction with the care provided, and their health status and management of health issues arising while travelling. Chart reviews will elicit descriptive quantitative data related to patients' travel medicine needs and adherence to recommended vaccinations and oral pharmacotherapy, followed by surveys containing open-ended qualitative questions to elicit overall patient satisfaction and the management of any health issues encountered during travel. Due to the nature of the study involving patients presenting to the clinic for a consultation, neither a control group nor blinding is possible.

A convenience sample of 100 subjects will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Receiving a pre-travel consultation at the Travel Health Network clinic in St. Albert, Alberta, Canada

Exclusion Criteria:

* Travellers with an expected return date after September 1, 2016
* Those receiving consultations as part of a group with the same itinerary (e.g., families, group vacations) will be asked to identify one member to participate in order to minimize repetition among participants.
Individualised Informal Caregiver Training for Palliative Care at Home

The purpose of this study is to determine whether a training intervention to improve caregiver confidence for family caregivers of patients with palliative care needs at home, is acceptable to patients and their caregivers.

Many patients with terminal illnesses rely on friends and family for much of their practical day to day care. These friends and family members often lack the skills and confidence to carry out these tasks and studies have shown that many would want more support. Studies have also shown that many patients feel they are a burden.

This study involves carers receiving training to learn the skills they need to care for their loved one. Adult patients with terminal illnesses, currently receiving care from a specified hospice in the South East of England, who have a friend or family member caring for them at home are eligible to be referred for this study.

The training of the carer will be carried out over three sessions by an Occupational Therapist in the patient's own home.The training will focus on goals that the patient and carer have chosen together.

The carer will be asked to complete before and after questionnaires and some will be asked to take part in interviews to see how they felt about the study.

The potential benefits of this study are to increase carer confidence in caring for their loved one.

The overall aim of this study is to test out the research method to see if patients and carers find this training and the outcome measures acceptable. If they do then the investigators plan to learn from this study to design a larger randomised control trial which would be the best way of knowing for sure whether and in what ways this training is helpful.

Eligibility Criteria:
Inclusion Criteria:

* Patient currently at home, reliant on family/friends (lay carers) some or all of the time to help with practical or personal care.
* The carer is aged 18 years or over.
* The carer and the patient have the capacity to consent to being involved in the study.

Exclusion Criteria:

* There is a current plan in place for all care to be provided by paid carers full time.
* The patient currently receiving more than one contact with Hospice Specialist Occupational Therapy or is likely to develop needs requiring more than one contact Hospice Occupational Therapy over the four week study intervention period.
* Patients and carers who are not able to speak or understand adequate English for consent to be obtained, to be able to undertake carer training and to complete the study outcome measures.
Self Abrading Rapidly Applied Electrode Validation

The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one. The investigators believe that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with additional time savings on cleanup. Reducing the hookup time required for the EEG recording will make EEG more feasible in time critical situations and will improve patient care and service. The clinical testing in Phase II will investigate patient acceptance, clinician acceptance, time savings, and signal quality for 3 different environments: the large hospital institution, a small rural hospital setting and in an emergency department.

The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one. This proposed single-use electrode will consist of a Snap Top, Ag/AgCl Snap Conductor, Conductive Adhesive, and Abrader Tines in a custom molded housing and packed on a backing sheet. After removing the backing, the technician simply parts the hair with one hand and with the other hand rubs the electrode back and forth and then presses the electrode into position on the scalp. The proposed system combines the cumbersome and time-consuming skin preparation, electrode preparation and electrode fixation into one easy step. The investigators believe that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with additional time savings on cleanup. Reducing the hookup time required for the EEG recording will make EEG more feasible in time critical situations and will improve patient care and service.

Eligibility Criteria:
Inclusion Criteria:

* adult and teenage

Exclusion Criteria:

* young children
* damaged scalp skin
* sensitive or allergic to electrode paste
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.

A prospective, multicenter, single-arm pivotal study in subjects undergoing a urologic RAS procedure using the Medtronic Hugo™ RAS System. Subjects without an oncologic indication will be followed for 30 days post-procedure. Oncologic subjects will be followed annually through 5 years. The study will be conducted in up to 6 investigative sites in the United States of America (USA).

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects (age ≥ 22 years) as required by local law
2. Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure
3. Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
4. The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form

Exclusion Criteria:

1. Subjects for which minimally invasive surgery is contraindicated as determined by the Investigator
2. Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
3. Subjects diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
4. Non-oncology subjects with an estimated life expectancy of less than 6 months; oncology subjects considered for cystectomy with a life expectancy less than 24 months; oncology subjects considered for nephrectomy with a life expectancy less than 60 months; oncology subjects considered for prostatectomy with less than a 10-year life expectancy.
5. Female subjects pregnant at the time of the surgical procedure.
6. Subjects who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
7. Subjects who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
8. Subjects with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
Urine Omics Predicting IO Therapy Responses in mRCC Patients

The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic renal cell carcinoma.

This is a multi-center single-arm translational study where patients with mRCC who are to receive pre-determined IO-based therapy will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via GS-MS/MS and/or LC-MS/MS to identify potential metabolite and protein markers that are able to predict efficacy and side effects of IO-based therapies. All subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of IO-based therapy will be invited and recruited, but those who have received any IO-based therapy before the study can NOT be recruited.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 20 years
2. Subjects diagnosed as advanced or metastatic renal cell carcinoma (a/mRCC)
3. Subjects who are about to receive IO-based therapy
4. ECOG performance 0, 1, 2, and 3
5. Life expectancy \>3 months
6. eGFR \> 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
7. Willing to sign the informed consent form

Exclusion Criteria:

1. Subjects NOT willing to sign the informed consent form
2. Subjects with active infection or active urinary tract infection, as shown by urinary WBC \> 5/HPF
3. Subjects having co-existing other malignancies that need active treatment. Those subjects with other malignancies that do not need active treatment are allowed to join the study.
4. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
5. Subjects who have taken any IO-based therapy before.
6. Subjects who have received other systemic anti-cancer therapies within 4 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for \>4 weeks are allowed to enroll. Subjects who have received or are receiving targeted therapy are allowed to join the study.