cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Performance of CardiacSense PPG Sensor

study to evaluate the performance of the CardiacSense1's embedded PPG under different environmental and physical conditions

The clinical study is a Prospective, Open, Single-Center, and Controlled Study to Evaluate the Performance of a PPG sensor in the CardiacSense1 device.

The CardiacSense1 is a wrist worn device designed to detect atrial fibrillation (AF). The AF detection of the device is based on a portable photoplethysmograph (PPG) sensor that is designed for continuous heart rate monitoring. The photoplethysmograph is a noninvasive circulatory signal related to the pulsatile volume of blood in the tissue.

Twenty (20) subjects (female and male) that do not suffer from atrial defibrillation and additional four (4) patients who are diagnosed as suffering from atrial fibrillation will be enrolled to the study.

Comparison of CardiacSense1 PPG individual peak detection to the corresponding recorded activity of an FDA-cleared ECG Holter, on a beat-by-beat basis will be performed on the following conditions:

All subjects will be exposed to 45 minutes of indoor standard office fluorescent light and 45 minutes to outdoor sunlight during mid-day. In addition, Subjects will be asked to walk for 1 minute once every 10 minutes and will be exposed to an indoor environment of 22±3 - 28±3 degree Celsius for 45 minutes and outdoor temperature of at least 15 degree Celsius, on the other 45 minutes.

4 Subjects will be tested in the following conditions: driving a car for 30 minutes; High wrist hair density subjects; Two subjects 65 y/o or older, two subjects 30 y/o or younger; Two subjects with BMI below 18.5 (underweight) and two subjects with BMI over 30 (Obesity); Two subjects with skin type 6 (Fitzpatrick) and two subjects with skin type 5; Four subjects with diagnosed persistent atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* Age of eighteen to eighty-five (18-85) years
* Ability and willing to sign informed consent form
* For subjects in groups other than Heart Arrhythmias- Self-declared not to be diagnosed with any arrhythmia
* Compliance with hair, age, BMI skin and heart arrhythmia variables as defined above

Exclusion Criteria:

* Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.
* Subject with low perfusion indicated by the watch
* Pregnant or breastfeeding woman (women of child-bearing potential must have a negative pregnancy test within screening period).
Full Spectrum Hemp Observational Study

In westernized societies, acne vulgaris is nearly a universal skin disease afflicting 79% to 95% of the adolescent population; older than 25 years - 40% to 54% have facial blemishes and persists into middle age in 12% of women and 3% of men. Standard treatment modalities present with high risk morbidities. Charlotte's Web hemp blemish product is predicted to significantly reduce the risks mentioned above, while improving efficacy as well as imparting other skin benefits.

Charlotte's Web Full spectrum hemp blemish product will contain a mere 0.018% THC and will therefor not impart a psychotic affect. Hemp has been shown to be well tolerated in humans and has a very acceptable dosage, efficacy and safety profile when topically applied. The FDA has labeled hemp as Generally Regarded As Safe (GRAS) and as such reduces the risk of severe adverse reactions to the subject.

Benefits of hemp blemish 'cream" is that it has been formulated in such a way as to promote natural skin balance, and may eliminate skin dryness, inflammation, hyperpigmentation, and scaring.

The primary objective and endpoint of the study is to obtain total eradication of the blemish eruptions. The secondary objective and endpoints is the continued use of the hemp product will continue to prevent further blemish eruptions and provide other skin benefits especially reducing the propensity to scar.

Eligibility Criteria:
Inclusion Criteria:

* Male/female
* Diagnosed acne vulgaris
* Not on current acne treatment(s) or off current treatment for 2 weeks
* 13-70 yrs old

Exclusion Criteria:

* Not willing to stop current acne treatment(s)
* males that present with facial hair
* active TB, HIV or hepatitis
* pregnant or lactating females
Burst Suppression Anesthesia for Treatment of Severe Depression

This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression.

Ten individuals with treatment resistant major depressive disorder will undergo 10 treatments of deep anesthesia via propofol over a 3-week period. Depression will be evaluated before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* • Diagnosis of Major Depressive Disorder (MDD) or bipolar Disorder (I or II, most recent episode must be depression

  * Failed at least 2 anti-depressant treatments and no ECT in past 6 months
  * Age between 18-55 years
  * BMI \< 35
  * Hamilton Rating Scale for Depression (HSRD) score \> 18
  * Quick Inventory of Depression Scale (QIDS) score \> 10.

Exclusion Criteria:

* • Diagnosis of primary psychotic disorder, dysthymia, or personality disorder

  * Significant pre-morbid cognitive impairment
  * Hypertension and current use of ACE inhibitor or AR blocker medications
  * Symptomatic coronary artery disease or congestive heart failure
  * History of transient ischemic or neurologic signs during the past year
  * History of or susceptibility to malignant hyperthermia
  * Contraindication to isoflurane or propofol anesthesia (as determined by anesthesiologist)
  * Diabetes requiring insulin
  * Poor kidney function
  * Chronic use of benzodiazepines or opioids
  * Individuals incompetent to provide consent (e.g. catatonic, psychotic).
TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls

Myasthenia gravis primarily results from neuromuscular junction dysfunction and damage, leading to chronic muscle weakness. While combined traditional and Western medicine treatments are now common, TCM tongue diagnosis remains a simple and practical clinical method. However, results can vary among different practitioners. Therefore, you are interested in using scientific methods to compare TCM tongue diagnosis images between patients with myasthenia gravis and healthy individuals to aid in diagnosis.

In Taiwan, the prevalence of severe myasthenia gravis is approximately 14 per 100,000 people, with an incidence rate of about 2 per 100,000 people.

Currently, combined traditional and Western medicine treatments are very popular. In Traditional Chinese Medicine (TCM), tongue diagnosis is a simple and practical clinical method, focusing on aspects such as the tongue body, coating, color, and sublingual veins. Clinical evaluation often relies on the experience and knowledge of TCM practitioners, which can be influenced by subjective factors like diagnostic skills. As a result, findings may vary depending on the observer.

To improve diagnostic accuracy, using scientific methods to support TCM tongue diagnosis can provide more precise information for practitioners and enhance the clinical application value of tongue diagnosis in TCM.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with myasthenia gravis by a physician.
2. Able to understand and communicate in Mandarin and Taiwanese.
3. Cognitively alert and without a diagnosis of psychiatric disorders.
4. Willing to undergo tongue imaging and instrument measurements.

Exclusion Criteria:

1. Patients with severe organ diseases.
2. Hearing loss patients who are unable to complete the questionnaire.
3. Patients with aphasia who are unable to complete the questionnaire.
4. Have eaten food or drinks that can easily contaminate tongue coating within 2 hours.
Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort

This is a multi-center observational follow-up study to collect saliva samples that allow pharmacogenetic analysis of the subjects that participated in the CC-90007-CP-003 study.

Approximately 28 subjects with moderate and severe hepatic impairment and healthy control subjects with normal hepatic function will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

Each subject must satisfy all of the following criteria to be enrolled in this study:

1. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
2. Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements.
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
4. Subject participated in the CC-90007-CP-003 study.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subject has any condition which places the subject at unacceptable risk if he/she were to participate in the study.
2. Subject has any condition that confounds the ability to interpret data from the study.

Sponsor's medical monitor should be consulted on suspected conditions under this exclusion criterion, prior to exclusion.
Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty

The aim of this study is to assess the effect of oral melatonin versus intraoperative lidocaine infusion on incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty under spinal anesthesia.

Delirium is defined according to The American Psychiatric Association's fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), as disturbance in attention and awareness developed over a short period of time , its severity tends to fluctuate during the course of a day, these disturbances cannot be better explained by other pre-existing neurocognitive disorders and do not occur in severely reduced arousal level such as coma. Delirium can be further classified into hyperactive, hypoactive and mixed.Postoperative delirium (POD) usually occurs in the recovery room and appears up to 5 days after surgery.

The prevalence of POD in elderly patients undergoing surgery varies from 20% to 45%. Patients undergoing hip fracture surgery are at higher risk of POD than patients undergoing other types of surgery. This may be related to their older age, higher incidence of comorbidities, and greater physical weakness.

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone that is discharged by the pineal gland produced from the amino acid tryptophan. Synthetic melatonin has been effectively utilized in the treatment of sleep disorders. It was likewise utilized as a premedication and it provided excellent anxiolysis, sedation, and sympatholytic impacts with the merit of not influencing the patients' cognition in addition to its analgesic effect.

Lidocaine, an amide local anesthetic and class-1 antiarrhythmic with sedative and anti-inflammatory properties, is increasingly used as a part of a multimodal intraoperative anesthetic adjunct in a variety of surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients aged \>65 years old undergoing unilateral total hip arthroplasty.
* Patients with body mass index (BMI) (18-30) kg/m2.
* American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral total hip arthroplasty.

Exclusion Criteria:

* History of mental illness or scoring less than 8 using abbreviated mental test (AMT) before operation.
* Obvious sinus bradycardia (heart rate of \<50 beats per minute) or other serious cardiovascular diseases.
* Symptomatic cerebrovascular disease (such as previous stroke).
* History of liver and kidney dysfunction.
* Allergy to lidocaine or melatonin.
* Metabolic disorders and fluid, electrolytes disturbances.
* Alcohol dependence or drug abuse.
* Redo surgery or infectious complications.
* CNS medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).
* History of deep vein thrombosis.
Outpatient Birth: Pilot Study

The diminution of the average length stay (ALS) in French maternity is a clear evolution, the objective of the draft law on social security is to reduce the ALS to equal other OECD countries. The over-medicalization of maternal health raises the question of relevant and iatrogeny of Professional practices. Furthermore, pregnant woman, future parents expressed their wish for an individual support and more physiological respectful. A more-effective Professional coordination is expected where the midwife is a major player.

The aim of the study is to identify and evaluate an outpatient birth path during the first 24 hours after the birth.

Eligibility Criteria:
Inclusion Criteria:

* With no multiple pregnancy, of less than 20 weeks of gestation
* With a BMI between 17,5 and 35 kg/m²
* is able to understand research's informations
* affiliated member of the social security system
* Have given an informed consent

Exclusion Criteria:

* With psychological vulnerability, social vulnerability, addictions and high dependency
* With an unbalanced chronic pathology or susceptible to contraindicated a physiologic birth
* With history of caesarean, foeto-maternal incompatibility, gestational hypertension, pre-eclampsia, HELLP syndrome or retro-placental hematoma, sphincter tear
* With history of birth with perinatal asphyxia and sequelae or an unexplained perinatal death
* With history of puerperal psychosis
* Under guardianship
Beetroot Juice Doses and Anaerobic Performance

The purpose of this study is to examine the effect of varying nitrate doses of beetroot juice supplementation on dynamic, multijoint resistance exercise performance in active, trained individuals. Performance will be assessed based on parameters including neuromuscular efficiency, anaerobic performance capability, oxygen consumption, plasma nitrate/nitrite levels, specific muscle tissue biomarkers including lactate, and anthropometric measurements of select muscle groups.


Eligibility Criteria:
Inclusion Criteria:

* Minimum 6 consecutive months experience in resistance training, engaging at least 2 times per week.
* Possess sufficient mobility to properly execute movements required in testing protocol

Exclusion Criteria:

* Usage of any banned dietary supplements or performance enhancing drugs (thermogenics, anabolic steroids, prohormones, etc.)
* Any physical condition or malady that would impede participant from performing exercise or by doing so, endanger the individual
Community Awareness, Resources and Education (CARE II) Project: Project 1

The study hypothesis is that the increased incidence of cervical cancer observed in Appalachian women over their non-Appalachian counterparts is due in part to inherited and somatic alterations of key components of the Transforming Growth Factor β (TGFβ) signaling pathway.

This project is a case control study that is designed to determine prevalence of inherited polymorphic and somatically acquired variants of key TGF-ß pathway components in a large cohort of Appalachian invasive cervical cancer (ICC) patients compared to healthy Appalachian women. It will be determined whether these genetic alterations contribute individually or in combination with other known environmental (Human Papillomavirus, Epstein-Barr Virus), behavioral (smoking), and social (stress, social networks) risk factors, to the increased susceptibility of Appalachian women to ICC development. Women will be recruited from several clinics and physician practices in West Virginia, Charleston and Appalachia Ohio and Kentucky. Participants will be women residing in these area who are 18 years and older, not pregnant, speak English, not cognitively impaired and able to provide informed consent. There will be three distinct types of women recruited into the study; 1. ARM 1 - previously treated for invasive cervical cancer; 2. ARM 2 - newly diagnosed with invasive cervical cancer; and 3. healthy controls - without a diagnosis of cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Patients previously or newly diagnosed with invasive cervical cancer
* healthy women without a diagnosis of any type of cancer
* English speaking
* Able to provide informed consent, biological and questionnaire data.

Exclusion Criteria:

* Pregnant women
High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial

The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
* 2. Patients aged 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4

Exclusion Criteria:

* 1. Patients with dementia or cognitive impairment
* 2. pregnant women
* 3. Patients undergoing extracorporeal membrane oxygenation (ECMO)
* 4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
* 5. Patients with current maxillofacial trauma or basal skull fracture
* 6. Patients who had previously undergone rigid bronchoscopy / surgery
* 7. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
Minocycline for Chronic Autoimmune Uveitis

Autoimmune uveitis is one kind of non-infectious, sight-threatening, relapsing and severe ocular disease. Approximately 20%-25% autoimmune uveitis patients suffer from the dilemma of blindness for the chronic and persistent inflammatory state in the eyes, which results in continuous destroy in the structure of the eyes and gradually leads to irreversible damage on visual function. However, it shows limiting efficacy of current treatment including glucocorticoids, immunosuppressant and biologics for chronic autoimmune uveitis. Minocycline has been regarded to have anti-apoptosis and immunemodulatory function for decades and it has been illustrated to be beneficial in several neuro-degenerative and neuro-inflammatory diseases. This trial aims to investigate the efficacy and safety of minocycline for chronic autoimmune uveitis with retinal degenerative changes.


Eligibility Criteria:
Inclusion Criteria:

* Participant diagnosed of autoimmune diseases with visual function damage (decrease of BCVA, loss of retinal structure)
* Participant aged from 18-60 years old.
* Participant that signed the informed consent document and is able to complete the following visits.

Exclusion Criteria:

* Participant is allergy to minocycline or tetracyclines.
* Participant has no contraindications of minocycline or tetracyclines.
* Participant has an abnormal function of liver, heart, kidney and thyroid.
* Participant is using glucocorticoids, immunosuppressants or biologics.
* Female that is pregnant, breast-feeding or planning to become pregnant.
* Participant that is currently using other medications for other diseases.
Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection

Intratympanic steroid injections are an accepted treatment for Meniere's disease and idiopathic sudden sensorineural hearing loss. This treatment is typically performed using local topical anesthesia. There is very limited research on the differences of medications and application procedures effect on patients' pain during the procedure.Topical Tetracaine solution and topical phenol have been shown to be effective as local anesthesia for the tympanic membrane when used for myringotomy. Currently there is no consensus on medication and technique however focally applied phenol is the more widely used technique. We believe this study can provide valuable information given the disadvantages of topical phenol including burning upon application as well as possible increase in persistent tympanic membrane perforation. The objectives are to determine the effectiveness of tetracaine drops for local anesthesia for intratympanic steroid injections compared to focal topical phenol application and to identify if tetracaine drops provides adequate anesthesia for intratympanic steroid injection with less pain on application than focal phenol.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18 years of age or greater)
* Diagnosed with Idiopathic Sudden Sensorineural hearing loss or Meniere's disease
* Care plan includes treatment via intratympanic steroid injection

Exclusion Criteria:

* Having a current tympanic membrane perforation
* Adults unable to sign written consent
* Individuals less than 18 years of age
* Pregnant women
* Prisoners
Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients

The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective in the prevention of depression during interferon and ribavirin treatment for hepatitis C infection.

The treatment for active hepatitis C in both HCV mono-infected and HCV/HIV co-infected patients is a long and difficult course, involving combination therapy of interferon and ribavirin for 6 to 12 months, a therapy with significant side effects. Up to 40% of patients being treated will develop depression due to the medication, which in turn leads to discontinuation of therapy and lost opportunities to prevent end stage liver disease. In fact, the presence of depression prior to interferon treatment often excludes patients from receiving interferon therapy, thereby denying them a potentially life-saving treatment. Non-pharmacological therapies such as cognitive behavioral therapy (CBT) have demonstrated efficacy in treating primary depression in numerous studies including in patients under going treatment with chronic medical illness. CBT is a well-established treatment modality and has been shown in several large randomized trials to be as effective, and in some cases more effective, than antidepressants. CBT has also shown efficacy in preventing the development of depression and other emotional disorders in high-risk populations. Offering CBT prior to and during treatment with interferon to non-depressed patients is a unique method that may reduce rates of depression and increase adherence to treatment without exposing patients to the risk of an additional medication.

Eligibility Criteria:
Inclusion Criteria:

1. \>21 years
2. Speak and read English to 5th grade level of higher.
3. Eligible and ready to begin Peg-Interferon and Ribavirin (PEG-IFN/RBV) therapy for HCV at Mount Sinai's Primary Care practice or JMFC
4. HIV infected patients will need to have a CD4 count \> 100 and have demonstrated compliance to retroviral therapy
5. Not majorly depressed upon entry to study.
6. Signed informed consent to participate in CBT study

Exclusion Criteria:

1. Majorly depressed (based on administration of the PHQ-9, score considered for Major Depressive Disorder).
2. Admit to actively abusing illicit drugs or alcohol
3. Medical contraindications to a standard course of interferon/ribavirin therapy (eg: severe anemia, uncontrolled congestive heart failure)
4. Less than one year of life expectancy
5. Current participation in CBT related psychotherapy
6. Participation in any psychotherapy beginning less than 6 months before CBT sessions begin.
7. Initiated anti-depressant medication less than 6 months before CBT sessions begin
8. Severe comorbid psychiatric disease including bipolar disorder, severe personality disorder, or psychotic disorder
9. Active suicidal ideation