cyrilzakka/clinical-trials huggingface dataset:
Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study

This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable Cardiac Monitor (ICM) device.

The study's intent is to generate long-term real-world data on the safety, performance, and clinical benefits of the Assert-IQTM ICM device system. This clinical investigation is sponsored by Abbott Medical.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet ALL study inclusion criteria to participate in the study.

1. Have an approved indication AND are scheduled to receive an Assert-IQTM ICM device prior to enrollment in the study.
2. Diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF prior to enrollment in the study and scheduled to undergo a first-time atrial fibrillation ablation.
3. Have a cellular phone or the ability or willing to use a mobile transmitter that is compatible with the myMerlin™ App and able to communicate with the Assert-IQTM ICM device. If a subject doesn't have a cell phone or loses their cell phone, then the site can provide a mobile transmitter to the subject. The study will not provide cell phones.
4. Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
5. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria:

If ANY study exclusion criteria are met, the patient is excluded from the study and cannot be enrolled (recruitment failure).

1. Subject is currently participating in another clinical investigation that could confound the results of this study, without documented pre-approval from Abbott.
2. Subject is implanted with a cardiac implantable electronic device (CIED) with pacing capability.
3. Have a life expectancy of less than 1 year due to any condition.
A Study of VIS410 to Assess Safety and Pharmacokinetics

The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Body mass index between 18 and 33 kg/m2, inclusive
* Normal labs
* Volunteers agree to use acceptable contraceptive measures

Exclusion Criteria:

* Prior receipt of antibody or biologic therapy
* History of cancer, heart disease, diabetes, respiratory condition (eg asthma), autoimmune disorder, blood dyscrasias
* Any chronic condition requiring daily prescription or over the counter medication
* History of a previous severe allergic reaction
* Drug or alcohol abuse within previous 12 months
* Positive serology for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
* Positive pregnancy test
* Breast feeding
* Positive drug or alcohol test at screening or check-in
* Receipt of licensed vaccine (within 30 days) or other investigational product within 30 days or 5 half-lives, whichever is longer, before study product administration
Virtual Reality Analgesia During Pediatric Physical Therapy

We would like to determine whether Virtual Reality (VR) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).

This study is done in a hospital for inpatients pediatrics. By randomization some subjects will immersive Virtual Reality (VR) during a painful procedure on daily basis up to 10 days to see whether this will reduce the pain and anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 8 years up to 20 yrs old
* Compliant and able to complete subject evaluation
* A minimum of 3 days of physical therapy, one physical therapy session per day
* No history of psychiatric (DSM-IV-R Axis I) or developmental disorder that would interfere with decisional capacity
* Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder that would interfere with decisional capacity
* Able to communicate verbally
* Able to take oral medications
* English-speaking

Exclusion Criteria:

* - Age less than 8 years, or greater than 20 years.
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Hospitalization of fewer than 3 days
* Evidence of traumatic brain injury
* History of psychiatric (DSM-IV-R Axis I) disorder as evidenced in the admitting RN and MD admission notes, if interfering with decisional capacity
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems that would interfere with decisional capacity
* Unable to communicate verbally
* Unable to take oral medications
* History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment that would interfere with treatment or decisional capacity
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability that would interfere with decisional capacity
* Face/head/neck injuries preventing helmet use
* Non-English-speaking
* Extreme susceptibility to motion sickness
* Seizure history
MitraClip® After Surgical Mitral Valve Repair

Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to evaluate the effectiveness and durability of this minimally invasive treatment option in this subset of patients.

In this multicenter retrospective analysis of MitraClip® cases after MVR the effectiveness and durability of this minimally invasive treatment option in this subset of patients will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* All patients with recurrent mitral regurgitation treated with a MitraClip®.

Exclusion Criteria:

* Patient with endocarditis,
* Patients with torn mitral valve ring.
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Dosing Regimens of AL-794 in Healthy Volunteers

The purpose of this study is to evaluate the safety and tolerability (including incidence of central nervous system \[CNS\] related events such as lightheadedness and dizziness), of multiple oral doses of AL-794 in healthy volunteers (HV). Also, to evaluate the pharmacokinetics of ALS-033719 and ALS-033927 in plasma after multiple oral doses of AL-794 in HV.


Eligibility Criteria:
Inclusion Criteria:

* Participant has provided written informed consent
* In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned
* Participant is deemed healthy on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
* Body mass index (BMI) 18 - 32 kilogram per meter square (kg/m\^2), inclusive. The minimum weight is 50 kilogram (kg). No more than 25 percent (%) of participants may be enrolled with a BMI greater than or equal to (\>=) 30 kg/m\^2
* Female participants must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) pregnancy test at screening and on Day -1 (admission)

Exclusion Criteria:

* Female who is pregnant as confirmed by a positive beta-human chorionic gonadotropin (beta-hCG) laboratory test, or who was pregnant within 6 months prior to study start, or who is breast-feeding, or who is planning to become pregnant from signing of the informed consent form (ICF) until 90 days after the last dose of study drug
* Male whose female partner is pregnant or contemplating pregnancy from the date of screening until 90 days after their last dose of study drug
* Participant with one or more of the following laboratory abnormalities at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>= 1.2\*upper limit of normal (ULN); Alkaline phosphatase (ALP) \>= 1.2\*ULN; Total bilirubin \>= 1.2\*ULN; Clinically significant laboratory abnormalities or abnormalities which are deemed to interfere with the ability to interpret study data
* Creatinine clearance less than (\<) 90 milliliter per minute (mL/min) (using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation)
* Positive screening test for human immunodeficiency virus type 1 (HIV-1) or HIV-2 antibody, or for current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen \[HBsAg\]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening
Community Services Navigation to Advance Health Equity in Breast Cancer Screening

The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.


Eligibility Criteria:
Inclusion Criteria:

* English and Spanish speakers
* Received an abnormal result of a screening mammogram
* Self-reports at least one social need on the B-SINCERE Screener

Exclusion Criteria:

-Prior diagnosis of breast cancer
Speech Entrainment for Aphasia Recovery

After a stroke, many people experience a language impairment called aphasia. One of the most debilitating types of aphasia is non-fluent aphasia. Non-fluent aphasia is defined by significantly reduced speech production, with the speaker producing only a few words or even less. Speech entrainment therapy (SET) is a treatment that has been shown to increase fluency in people with non-fluent aphasia. The study looks to define the best dose of SET that leads to sustained improvements in spontaneous speech production.

Participants who are eligible will undergo baseline language testing, an MRI, and will be randomized into one of 4 treatment groups: SET for 3 weeks, SET for 4.5 weeks, SET for 6 weeks, and no treatment (control group).


Eligibility Criteria:
Inclusion Criteria

* Aphasia as a result of a left hemisphere ischemic or hemorrhagic stroke (WAB-R Aphasia Quotient \<93.8).
* Presence of left hemisphere stroke in clinical imaging (CT/MRI) and NIHSS
* Participants must have spoken English as their primary language.
* 21-81 years old
* Pre-stroke modified Rankin Scale (mRS)= 2 or less
* Post-stroke mRS= 4 or less.
* At least 6 months post-stroke.
* Non-fluent aphasia (WAB-R Comprehension score \>4 and WAB-R Fluency score \<6).
* Technological compatibility (to be determined by clinical judgment of SLP)

Exclusion Criteria

* History of chronic neurological or psychiatric diseases (excluding migraines, depression, or post-stroke epilepsy). Self-reported history of learning disability.
* Severe dysarthria (determined via SLP clinical judgment from spontaneous speech tasks on the ASRS 3.0).
* Global aphasia.
* History of right-hemisphere strokes or brain stem/cerebellar strokes with persistent deficits (as evidenced by MRI/CT and NIHSS).
* Uncorrectable hearing as determined by the SLP's clinical judgment.
* Uncorrectable vision.
* Contraindications to MRI or inability to complete the MRI scanning session.
* Women who are pregnant.
Comparing Dental Impression Methods for Children

The precision of dental restorations and the production of dental models has improved due to the acceleration of technical advancement and the introduction of computer-aided manufacturing.

The study's objective is to compare the conventional imprint approach with a digital one in order to compare patients' comfort levels, preferences, and treatment times among pediatric patients.

In this study, 60 volunteers without any prior exposure to traditional or digital impressions took part. Using a C-type impression medium, conventional impressions of the maxillary and mandibular dental arches were taken. Digital impressions are taken using an intra-oral scanner at the same appointment. Following the impressions, a standardized questionnaire was used to assess the individuals' attitudes, preferences, and perceptions of the impression procedures. The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. After taking the impression, the processing phases of the impression techniques (working time, etc.), and parental satisfaction were noted.

Eligibility Criteria:
Inclusion Criteria:

* not to have a history of digital or conventional impression taking
* not to have temporomandibular joint and periodontal discomfort
* not to be using psychiatric or neuropathic drugs

Exclusion Criteria:

* history of digital or conventional impression taking
* TMJ disorder
* Using any kind of drug that interferes pain perception
Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Individuals will be recruited by posted advertisements in the waiting rooms of the PCP offices and by physician referral. After an initial phone screen, research staff will meet with interested individuals in their PCP offices for informed consent, baseline interview and randomization. Participants will be randomized into a Health Education study arm, and receive 7 individual sessions on general health education, or an Intervention study arm, and receive 7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS) intervention.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Pain, defined as pain duration for at least six months with a mean score of 5 or higher on the BPI Pain Interference Scale;
* Pain severity of 40 or higher on a Visual Analog Scale (0-100) indicating "worst pain in the last week";
* Previous attempt at initial steps of PCP guideline pain care: must have had at least one trial of recommended medication (i.e. acetaminophen, NSAIDS, skeletal muscle relaxants) judged through interviews with patients and PCPs;
* QIDS score of ≥ 10 (depression severity)
* If using an antidepressant, the dose must be stable for the previous 2 months;
* Age 18 or older
* Has received buprenorphine/naloxone (Suboxone)for at least the last 3 months;
* Plan to continue buprenorphine/naloxone (Suboxone)for at least 3 months.

Exclusion Criteria:

* Lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition;
* Current DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, or cocaine;
* Suicidal ideation or behavior requiring immediate attention;
* In psychotherapy or in a multidisciplinary pain management program at baseline;
* Anticipate having surgery in the next 6 months;
* Pain thought to be due to cancer, infection, inflammatory arthritis, or associated with severe or progressive neurological deficits;
* SSDI or SSI claim pending;
* Pregnancy.
Micellar Curcumin and Metabolic Syndrome Biomarkers

The purpose of this study is to investigate the effect of micellar curcumin on inflammation and lipid metabolism markers in subjects at risk for the metabolic syndrome.


Eligibility Criteria:
Inclusion criteria:

* Total cholesterol \> 5.2 mmol/L
* LDL cholesterol \> 3.4 mmol/L
* Triglyceride \> 2.26 mmol/L
* CRP \> 2 mg/L

Exclusion criteria:

* Intake of drugs or dietary supplements
* Pregnant women and breastfeeding mothers
* Smokers
* Previous illnesses such as heart attack, cancer or dementia
* Addiction
KatGuide Method Versus Conventional Method at Insertion of Chest Tube

The purpose of this study is to investigate whether if KatGuide (a new developed medical device) improves the placing of a large bore chest tube in the pleural cavity compared to the conventional method.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pneumothorax in the upper pleural space or fluid in the lower pleural space.
* Indication for upper or lower placement of a single chest tube in the pleural cavity
* 18 years of age or older

Exclusion Criteria:

* Fertile women
* Patients who can not give written or verbal consent to participate
* If there is no time or possibility to inform the patient
* Patients who already has a large bore chest tube
* Patients with long lasting (\>14 days) or chronic chest tube
* Patients with both fluid and air in the pleural cavity
* Patients where "the safe area" (front axillary fold, IC 4-5) can not be used for chest tube insertion
Effect of Baby Massage on Postnatal Maternal Attachment and Depression

This study aims to examine the effects of providing infant massage training to mothers in the early postpartum period with the goal of preventing postpartum depression and enhancing maternal bonding.

Postpartum depression is a common and serious mood disorder influenced by various factors. The global prevalence of postpartum depression has been identified as 17.22%. Depressive symptoms experienced by the mother can affect her daily activities and have a negative impact on infant care. Postpartum depression can also affect mother-infant bonding. A healthy bond between the mother and the baby supports the baby in feeling secure, emotionally satisfied, and adapting to the world. Infant massage has been encouraged in recent years for mothers as it can create positive effects on both depression and maternal attachment. This study provided infant massage training to mothers in the early postpartum period with the aim of preventing postpartum depression and enhancing maternal attachment. The Edinburgh Postnatal Depression Scale (EPDS) was administered to participants on the 14th day postpartum, and those with a score of 12 or below were included in the study. A total of 70 participants were randomly assigned to either the experimental group (35 participants) or the control group (35 participants). The experimental group received a 5-week International Association of Infant Massage (IAIM) Infant Massage Program starting from the 14th day postpartum. The control group did not receive any training or intervention. At the end of the 5 weeks, participants were assessed using the Edinburgh Postnatal Depression Scale and the Maternal Attachment Inventory. The study examined whether there were differences in the mean scores of the scales between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous
* Singleton pregnancy
* Delivery at term (37-42 weeks of gestation)
* Edinburgh Postnatal Depression Scale score ≤ 12
* No physical health issues preventing massage
* No history of psychiatric illness (self-reported)
* At least basic literacy
* Residing in Ankara
* No previous training in infant massage
* Speaking the same language as the researcher
* Absence of any anomaly, malformation, or health issue preventing massage (for infants)

Exclusion Criteria:

* Not having completed the infant massage training
* Wanting to withdraw from the study for any reason
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients

To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with:

* Reported duration of the current episode of at least 4 weeks
* MADRS total score \>=26
* At least one previous MDE before the age of 60 years

Exclusion Criteria:

* Mini Mental State Exam (MMSE) \<24
* Any current anxiety disorder as defined in the DSM-IV-TR
* Current or past history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR
* Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
* Presence or history of a clinically significant neurological disorder (including epilepsy)
* Neurodegenerative disorder (Alzheimer's disease, Parkinson disease, multiple sclerosis, Huntington disease, etc)
* Any Axis II disorder that might compromise the study
* Significant risk of suicide according to the investigator's opinion, or has a score \>=5 on item 10 of the MADRS or has made a suicide attempt in the previous 6 months

Other inclusion and exclusion criteria may apply.
Exercise aNd hEArt Transplant

Registry-based randomized clinical trial (RRCT) to assess the safety and efficacy of two different schemes of exercise training in patients who have recently undergone heart transplantation

40 patients who achieved Heart transplantation (HTx) will be randomized in a pilot study to 4 weeks of on-site standard CR (control arm) versus two-four weeks of on-site CR followed by 12 weeks of telerehabilitation (experimental arm). Both surrogate endpoints \[cardiometabolic equivalents (Vo2 peak)\] and clinical endpoint \[primary outcome defined as acute rejection, hospitalization for heart failure, stroke, myocardial infarction, all-cause mortality, at the longest follow-up available (minimum 6-month follow-up)\] will be evaluated.

The rehabilomic approach will be applied in order to identify specific patients' phenotype. To identify the potential variations of circulating molecules levels that could be indicators of the rehabilitation outcome and/or progression of the disease, the research team will focus on the analysis of extracellular vesicles (EVs) isolated from the serum of the 40 patients at admission (T0) and after cardiac rehabilitation (T1). In particular, researchers will detect and analyze the relative amount of serum EVs derived from platelets, endothelium, cardiomyocytes, and macrophages, as their levels are reported to be associated with the occurrence of heart failure.

Eligibility Criteria:
Inclusion Criteria:

* All the patients admitted in the on-site CR after HTx

Exclusion Criteria:

* unable to sign informed consent
Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients

The goal of this observational study is to study the effect of a single nucleotide polymorphism in the CES1 gene (rs2244613) on capecitabine-induced toxicity in Egyptian cancer patients. This study will help in understanding the interindividual variability in the CES1 gene and the effect of a single nucleotide polymorphism in this gene (rs2244613) on capecitabine-induced toxicity in participants already taking capecitabine-based chemotherapy as part of their regular medical care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast or colorectal cancer receiving capecitabine-based chemotherapy
* Age \> 18 years
* ECOG PS 0-2.

Exclusion Criteria:

* Patients treated with irinotecan
* Lack of physical integrity of the upper gastrointestinal tract
* Patients with malabsorption syndrome
* Patients having inability to take oral medication
* Patients with poor performance status
* Patients with chronic diarrhea as ulcerative colitis or Crohn's disease