cyrilzakka/clinical-trials huggingface dataset:
Reliability of Measuring Blood Pressure With a Smartwatch

The aim of this study is to verify the long-term accuracy of blood pressure and heart rate measurements by Samsung smartwatches between two consecutive calibrations compared to a standard digital tonometer used in clinical practice and for home measurement of these vital parameters.

Recently, smartwatches can measure a wide range of biological signals, including heart rate and blood pressure. The short-term reliability of blood pressure measurements after the required calibration has been studied, but long-term reliability is still a question. The aim of the project is to experimentally evaluate the reliability of long-term blood pressure measurement with a Samsung smart watch between two consecutive calibrations over a period of 28 days in comparison with a digital tonometer (Omron) approved as a medical device. Volunteers will measure blood pressure and heart rate manually twice a day from a smartwatch and a digital tonometer simultaneously. The agreement of the measurements of both devices will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* any acute illness
* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* diabetes
* hypotension or hypertension
Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment

Lewy body diseases (LBDs) represents a group of neurodegenerative disorders characterized by the abnormal accumulation of aggregates of α-synuclein protein leading to the formation of Lewy bodies (LB) and Lewy neurites resulting in cell death. LBDs consists of two major clinical entities - Parkinson's disease (PD) and dementia with LB (DLB). Vast majority of patients with LBDs either already have mild cognitive impairment (MCI) at the time of the diagnosis or will develop it during the course of the disease. Language dysfunctions in LBDs patients with MCI are often unrecognized, which are difficult to treat, but even subtle changes might lead to impairment of social and occupational functioning with profound effect on their quality of lives. Current pharmacological or surgical strategies are effective for tackling the motor issues of LBDs with very limited effects on other symptoms such as language dysfunctions. Therefore, non-pharmacological approaches are gaining more attention. One of these non-pharmacological strategies is the use of noninvasive brain stimulation (NIBS) techniques that are able to modulate the brain functions with the effects on human nervous system plasticity. In this proposed project the investigators aim to first describe specific alterations in the language domain in LBDs patients with MCI as compared to healthy controls (HC) and identify the neural underpinnings of these changes using novel combination of advanced multimodal imaging techniques and various analytical methods. Secondly, the investigators aim to use NIBS as a supervised and individualized home-based therapeutical approach to tackle the language dysfunctions.


Eligibility Criteria:
Inclusion Criteria:

* right-handedness
* Czech as their first language
* age (60-80 years)
* presence of PD-MCI (Litvan et al. 2012) or MCI-LB (McKeith et al. 2020) for LBD subjects

Exclusion Criteria:

* cardio pacemaker
* any MRI-incompatible metal in the body
* epilepsy
* any diagnosed psychiatric disorders
* alcohol/drug abuse
* for HC group the presence of LBDs or other neurodegenerative disorder or MCI/dementia
Safety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults

This study is the first study in humans with CVT-427 (zolmitriptan inhalation powder) and is designed to evaluate the safety, tolerability, and PK of single ascending doses of CVT-427 in adult healthy volunteers.

Objectives:

* To evaluate the overall safety and tolerability of single, inhaled doses of CVT-427 (zolmitriptan inhalation powder) in healthy adults, with special emphasis on cardiopulmonary effects.
* To describe the pharmacokinetics (PK) of single, inhaled doses of CVT-427, Zomig® Tablet, and Zomig® Nasal Spray in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men or women volunteers aged 18 to 65 years, inclusive;
* Triptan-naïve;
* Body mass index (BMI) between 18 to 30 kg/m2;
* Forced expiratory volume in one second (FEV1) greater than 80% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio greater than or equal to 70%;
* No history of asthma;
* Non-smoking for at least 5 years;
* In good general health with no clinically significant abnormalities or recognized cardiovascular risk factors that preclude use of triptans and that would interfere with participation in this study as determined by medical history, physical examination, electrocardiogram, and clinical laboratory test results; and negative tests for drug and alcohol, serology, and for pregnancy for female subjects of childbearing potential.

Exclusion Criteria:

* Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
* Any cardiovascular risk factor including clinically relevant ECG parameter (e.g., PR interval, QRS deviation) or other clinically significant ECG abnormality;
* History of asthma (including exercise-induced asthma and cold-induced asthma) or chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years;
* Any flu-like syndrome or other respiratory infections within 4 weeks of CVT-427 administration;
* Unable to tolerate blood draws.
Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents with Poorly Controlled Type 1 Diabetes

Adolescents with Type 1 Diabetes (age 13-18 years, T1D duration \>6 months managed on insulin) and poor glycemic control will wear a blinded CGM to obtain baseline data. After assuring adherence to CGM wear, participants will receive a non-blinded CGM and will share their blood glucose levels with the study team. Clinical personnel will remotely monitor patients in real-time for 3 months and communicate regularly over secure text messaging with participants and their parents. Following active remote monitoring, the participants will wear a non-blinded CGM for 3 months. Primary outcome assessment will be the change in HbA1c after 3 months of real-time remote continuous glucose monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Age between 13-18
* Diagnosis of type 1 diabetes for at least six months.
* Both sexes and all ethnicities included.
* Subject and at least one parent able to communicate in English.
* Poorly controlled T1D as evidenced by a \>40% annual risk of developing DKA in the following year
* Treated with subcutaneous insulin, either with a basal/bolus insulin regimen or a continuous subcutaneous insulin infusion (CSII) device.
* Willing to wear CGM and utilize the share function to clinician and guardian, with measuring blood glucose checks as required by the CGM.
* Owning a smartphone compatible with Dexcom G6 software to allow the use of share/follow features with internet access capabilities
* Willing to participate in secure text messaging with study personnel.
* Female participants must have a negative pregnancy test.

Exclusion Criteria:

* Type 2 diabetes, secondary diabetes or CF related diabetes.
* Other severe chronic disease (e.g., cancer) which in the judgment of the investigator is likely to significantly affect glycemic control.
* Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but we will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
* Patients with hypothyroidism or hyperthyroidism must be clinically euthyroid and have free T4 and TSH within age-appropriate reference ranges at last medically indicated testing. Patients with out of range values may be retested after medication dose adjustment.
* Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with study activities. Severe uncontrolled depression defined as PHQ-9A \>9 at time of enrollment is an exclusion criterion.
* Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with study activities.
* Regular CGM for the month preceding study period.
* Pregnancy, planned pregnancy or breast feeding
* CGM adhesive allergy
* Skin condition that makes CGM placement contraindicated.
* Sickle cell disease or hemoglobinopathy
* Red blood cell transfusion within 3 months prior to study enrollment
Comparing Operative vs Non Operative Treatment for Pilonidal Disease

The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation.

The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation. Patients with pilonidal disease can have significant pain and drainage at the gluteal cleft, and recurrent disease in this teenage and young adult population often leads to social embarrassment, isolation, and time off from work or school. Effective therapy to prevent recurrent disease is urgently needed.

The current standard of care is excision of pilonidal cyst. The research will consist of randomized 1:1 controlled trial comparing regular epilation regimen only vs. regular epilation regimen with surgical excision. The research will consist of patient surveys and clinical notes. Surgical excision is not needed to be part of this research.

All patients will receive surveys and their charts will be reviewed. At the point of treatment decision making, the patients will be randomized to one of the two options.

Eligibility Criteria:
Inclusion Criteria:

* Patients at Stanford Healthcare with pilonidal disease.
* Patients over the age of 8yrs.

Exclusion Criteria:

* Inability to read, write or understand English \*\*\*or Spanish
* Intellectual disability precluding the patient from being able to comprehend or respond to the questionnaire
Optimal Remifentanil Concentration and Thyroidectomy

The study is aimed at determining the remifentanil effect site concentration suppressing the cough at extubation after surgical thyroidectomy, performed under remifentanil/desflurane based general anesthesia, expressed as median and 95th percentile effective dose.

Possible hemodynamic instability, respiratory depression or prolongation of awakening time are also sought.


Eligibility Criteria:
Inclusion Criteria:

* 18\<age\<67
* 6 hrs fasting
* American society of anesthesiology (ASA) Physical Status I o II
* Informed consent

Exclusion Criteria:

* Absence of inclusion criteria
* Use of cough suppressors, angiotensin converting enzyme-inhibitors, sedatives 4 weeks before surgery
* Arhythmia, pacemaker or unstable cardiovascular disease
* Hepatic or renal failure
* Anticipated difficulty in airways management
* Chronic obstructive pulmonary disease (COPD), Asthma, increased risk for inhalation, airway infection in the previous 4 weeks;
* Smoker
* Obesity (BMI \>35)
* Pregnancy
* Hypersensitivity to drugs administered for the study
Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection

It is traditionally considered that the development of Latent Tuberculosis Infection (LTBI) is due to the M. tuberculosis ability to develop a dormancy state within well-structured lesions (granulomas), which can remain in the lung of the host even for life. A new original hypothesis has been developed in the Experimental Tuberculosis Unit based on scientific evidence that take into account the idea that a lesion cannot be held forever, because the host tends to remove any lesion in order to rebuild the original parenchyma, in a healing process. Even if M. tuberculosis can remain in a dormant/non-replicating state for a long period, this is an important but not sufficient factor to explain the LTBI. The Dynamic Hypothesis tries to explain the existence of LTBI in spite of the healing process that could remove it by a constant reinfection of the host's tissue. While the "Static" view defends the induction of active TB after the reactivation of the bacilli from and old lesion; while the "Dynamic" view wants to demonstrate that there is a constant induction of new granulomas. In case one of these new lesions takes place in the upper lobe privileged zone, the possibility to induce a cavity would appear, developing an active Tuberculosis (TB).


Eligibility Criteria:
Inclusion Criteria:

* being at least 18 years old
* to be M.tuberculosis infected (diagnosed by a positive TST with or without a positive result in the QuantiFeron-TB-Gold In tube assay)

Exclusion Criteria:

* active TB
* individuals not willing to participate in the study and or not willing to sign the informed consent form
* individuals not able to decide their participation in the study
Influence of the Operative Day on the Average Duration of Stay in Primary Hip and Knee Replacements

Reducing the length of stay (LOS) after primary arthroplasty is a relatively new target that arouses the attention of orthopedic surgeons in order to return home early through the fast recovery protocols but this goal is also wanted in public health for the sake of overall decline health spending in public costs.

Reducing the length of stay (LOS) after primary arthroplasty is a relatively new target that arouses the attention of orthopedic surgeons in order to return home early through the fast recovery protocols but this goal is also wanted in public health for the sake of overall decline health spending in public costs.

Reducing the LOS after primary hip arthroplasty and knee is studied through many publications that found an LOS influenced by the own medical factors of patients (ref) However, no study to our knowledge research the influence of the operative day and the LOS.

For historical reasons, the organization of care is modified on the weekend (Saturday and Sunday) in particular by reducing the caregiver and also the lack of physical therapist to make the early postoperative get up (D0 or D1).

The hypothesis is that a patient operated the friday did not have the same care the first 48 hours that a patient who had surgery at the beggening of the week and that his recovery was therefore extended.

The investigator can also suppose that LOS was shorter for patients returning home for those who were transferred to a rehabilitation center or other structure.

The results will be adjusted according to the literature data on the age more than 80 years, sex, diabetes, cardiovascular diseases, respiratory diseases.

Eligibility Criteria:
Inclusion Criteria:

* All major patients operated at the University Hospital of Amiens between 1 January 2015 and 31 December 2016 for primary hip and knee arthroplasty

Exclusion Criteria:

* All patients undergoing surgery for hip or knee surgery (reoperation).
* All patients undergoing total arthroplasty on fracture of the femoral neck from all causes.
An Intergenerational Community Based Participatory Research (CBPR) Intervention to Reduce Appalachian Health Disparities

The study purpose is to evaluate the effectiveness of a culturally appropriate, faith-placed lay health advisor intervention aimed at increasing fruit and vegetable intake and physical activity among intergenerational Appalachian individuals and families.

The developmental phase of this project incorporated community based participatory research (CBPR) principles to identify the needs and preferences of community members with regard to energy balance. In the intervention phase, this group-randomized trial administers and evaluates an intergenerational, culturally appropriate energy balance intervention aimed at increasing fruit and vegetable intake and increasing physical activity among participants in 6 distressed Appalachian counties. Faith institutions are recruited and randomized to treatment or wait-list control conditions, and participants are recruited and enrolled within those institutions. Focusing on Appalachian children, parents, and grandparents, local lay health advisors deliver a series of group presentations, adapted from We Can! and Media Smart Youth. In addition, the project provides culturally consonant leave-behind "booster" activities, including square dances, cooking classes, and community gardens.

Eligibility Criteria:
Inclusion Criteria:

* Age 8 years or above
* Able to provide informed consent/assent
Comparison Study of Operation and PEIT for Small, Solitary Hepatocellular Carcinoma (HCC)

The purpose of this study is to choose the preferred treatment modality for solitary, small hepatocellular carcinoma.

To compare the below things between operation group and percutaneous ethanol injection therapy (PEIT) group:

1. Survival

   * 5 year overall survival rate
   * Disease free survival rate
2. Recurrence

   * Cumulative recurrence rate

Eligibility Criteria:
Inclusion Criteria:

* The evidences of hepatitis B virus (HBV)\&/or hepatitis C virus (HCV) infection or liver cirrhosis
* Single tumor nodule with Child-Pugh classification A (serum albumin ≥ 3.2 g/dL)
* The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm
* Only for the newly detected HCCs which were not treated before
* It should be compatible with the typical finding of hepatocellular carcinomas (HCCs) radiologically (MD CT or dynamic MRI)
* Without portal hypertension

Exclusion Criteria:

* In case of hepatic vein or portal vein invasion radiologically (CT or MRI)
Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia

The purpose of this study is to determine whether calcium and vitamin D supplementation, over a nine-month period, optimizes bone mineralization in boys with risperidone-induced hyperprolactinemia. We hypothesize that, by the end of the stuy, children in the supplementation group will have higher bone mineral density compared to those in the placebo group.


Eligibility Criteria:
Inclusion Criteria:

1. Males (age range: 5-17yo; inclusive), in treatment with risperidone for ≥ one year.
2. The participants must have two measurements of prolactin ≥ 18.4 ng/ml, obtained within a week.
3. IQ \> 35-40 (≥ Moderate intellectual disability).
4. An adult parent/guardian must be available to provide consent and dispense study medication.

Exclusion Criteria:

1. Chronic disorders involving a vital organ (heart, lung, liver, kidney, brain), metabolic diseases (e.g., diabetes, hypo- or hyperparathyroidism, hypo- or hyperthyroidism, growth hormone deficiency), other skeletal diseases (e.g., Paget's disease, osteogenesis imperfecta, rheumatoid arthritis), chronic use of drugs affecting bone metabolism (e.g., corticosteroids), and malnutrition conditions (e.g., chronic diarrhea, inflammatory bowel disease), congenital disorders, or lead poisoning.
2. Participants receiving calcium or multivitamins in the previous three months.
3. A history of renal calculi and fasting random urine calcium/creatinine ratio \> 0.2 or any other medical disorder that contraindicates the use of calcium or vitamin D (e.g., hypercalcemic states, hypercoagulability disorders, vitamin D toxicity, malabsorption syndrome, or hypersensitivity to vitamin D products).
4. Laboratory values outside the normal range, except for prolactin, unless the deviations were not clinically significant (e.g. TSH \< 10 μIU/ml (76)).
5. Inability to cooperate with the BMD measurements.
6. Bilateral wrist or forearm fractures.
7. Eating disorders.
8. Non-compliance with the prescribed psychiatric treatment as reflected by an undetectable combined risperidone and 9-hydroxy risperidone blood concentration.
9. Plans to move out of State within the next 9 months.
Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor

This trial studies how well pharmacist-led transitions of care works in the outpatient oncology infusion center for patients with solid tumor. Having a pharmacist in the outpatient oncology infusion center may help to identify and correct medical related problems and improve overall patient and staff satisfaction. Patients receiving education may benefit from gaining a better understanding of their antineoplastic therapy. Understanding the side effects associated with the therapy may also help patients better be prepared to manage any adverse effects they may experience.

PRIMARY OBJECTIVE:

I. To demonstrate the effectiveness of a clinical oncology pharmacist in the outpatient infusion center through education, and the identification and correction of medication related problem (MRP)s.

SECONDARY OBJECTIVE:

I. To evaluate overall patient and staff satisfaction with the added clinical oncology pharmacy education.

EXPLORATORY OBJECTIVE:

I. Estimate the cost avoidance utilizing the pharmacy services provided in the prospective trial.

OUTLINE:

PHASE I: Patients' medical records are reviewed.

PHASE II: Patients receive pharmacist-led education on antineoplastic therapies including what to expect during infusion, general drug facts, common adverse effects, side effect management, and when to contact provider.

After completion of study, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Solid tumor diagnosis
* Starting day 1 of new antineoplastic infusion
* English speaking (and/or English-speaking primary caregiver/proxy)

Exclusion Criteria:

* Metastasis to the brain and/or central nervous system (CNS) with evidence of impaired cognition
* Severe cognitive impairment including dementia with inability to consent to the study
Dual Reinforcement Contingency Management for Alcohol Use Disorders

Phosphatidylethanol (PEth) is a direct biomarker of alcohol that can detect moderate to heavy drinking with high sensitivity and specificity over 3-week periods. Reinforcing negative PEth results alongside attendance may increase the proportion of participants who respond to CM during and post treatment. In the proposed study, the investigators will collect PEth samples every 3 weeks for 12 weeks in 150 participants initiating outpatient treatment for alcohol use disorders. Using a two-group randomized design, participants will be assigned to standard care with PEth monitoring alone or with CM for attending treatment and submitting PEth negative samples. Compared to standard care and monitoring, the investigators expect that the CM intervention will result in greater attendance, more PEth negative samples, and higher proportions of self-reported non-drinking days, along with lower proportions of heavy drinking days, over the short term and the long term, measured throughout a 12-month follow-up. The investigators anticipate that the reinforcement intervention may decrease other drug use and sexual risk behaviors that spread HIV, reduce psychiatric symptoms, and improve quality of life as well.


Eligibility Criteria:
Inclusion Criteria:

* in intensive outpatient treatment
* DSM-5 diagnosis of an alcohol use disorder

Exclusion Criteria:

* have a condition that may hinder study participation