cyrilzakka/clinical-trials huggingface dataset:
Verily Watch Cardio (AF and ECG) Study

This study is designed to evaluate the performance of the Verily Watch Cardio for recording electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial fibrillation (AF) episodes, in a free-living environment, in participants at risk for having an AF event.


Eligibility Criteria:
Inclusion Criteria:

* At least 22 years old
* Able to read and speak English
* Participant understands the study requirements and is able and willing to sign written Informed Consent
* At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one or more of the following:

  1. Scheduled or to be scheduled to undergo AF ablation
  2. AF burden of ≥25% in the 3 months prior to consent date as confirmed via an implantable loop recorder (ILR), holter monitor, or adhesive monitoring patch
  3. CHA2DS2VASc score ≥3
  4. Left atrial diameter ≥4.4 cm as confirmed by transthoracic echo (TTE) within one year of consent
* Without significant limitation in ability to participate in the study, in the opinion of the Investigator

Exclusion Criteria:

* Have a pacemaker or implantable cardioverter defibrillator (ICD)
* Currently on class Ic or class III antiarrhythmic medication that has been successful in eliminating AF (no documented AF of more than 30 seconds since the initiation of the medication). Should be at least one week off medication.
* Had successful AF ablation (no documented AF of more than 30 seconds post procedure)
* Known severe allergy to nickel or metal jewelry
* Known allergic reaction to polyester, nylon, spandex, adhesives or hydrogels; or with family history of adhesive skin allergies
* Are diagnosed with persistent AF
* Have an implantable neuro-stimulator
* Currently wearing an ECG patch that prevents the use of the FDA-cleared wearable ECG patch, at the discretion of the Investigator.
* Have discolored wrists (e.g., tattoos, ink), at the discretion of the Investigator.
Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke

After stroke, patients frequently suffer from arm or hand weakness. There are numerous rehabilitation methods to stimulate recovery, amongst which mirror therapy (MT). It is particularly interesting in cases for which impairment is severe, as many other forms of therapy are often impossible.

During MT, a mirror is placed in the midsagittal plane, so as to hide the impaired limb. Thereafter, the subject is asked to move his unimpaired limb while looking at its reflection in the mirror, thereby creating the illusion that the contralateral, impaired limb is moving.

The objective of this study is to better determine the efficacy of MT. The investigators will therefore compare recovery of arm function in two groups of patient, that perform a regimen of 30 minutes of therapy, 5 times a week, for 4 weeks on top of conventional therapy. One group performs MT and the other one performs a therapy in which the same movements are performed, but without the use of a mirror, with unrestricted view of both limbs. Allocation to each group will be randomized. Arm function will be evaluated by use of a scale before, during and after the 4 week period. The assessor for the primary outcome measure will not know in which group the patient is. There will be a total of 30 patients included over a one year study period.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke, diagnosed clinically and by imagery, more than one month after onset;
* Severe upper limb paresis with Upper-Extremity Fugl-Meyer Score \< 19/60 .

Exclusion Criteria:

* Significant limitation in upper limb function predating the recent stroke, caused by former symptomatic stroke and/or an orthopedic/rheumatologic disease;
* Neuropsychologic or psychiatric impairment with significant interference with participation in therapy;
* Severe visual impairment.
Comparing Effects of Various Combinations of 6 Hertz(Hz) rTMS & LFrTMS on Motor Recovery Due to Cerebrovascular Disease

To compare the effects of various combinations between 6 hertz(Hz) rTMS \& LFrTMS on the limb motor dysfunction due to cerebral vascular disease.

It is the basic principle for functional recovery after cerebrovascular disease to restore the original balance in reciprocal inhibition between affected hemisphere and unaffected hemisphere.

repetitive transcranial magnetic stimulation (rTMS) is a noninvasive neuroplastic technique rebalancing interhemispheric competition after stroke. Low frequency rTMS (LFrTMS) on contralesional hemisphere or high frequency rTMS (HFrTMS) on lesional hemisphere might be the basic choice.

6 hertz(Hz) primed LFrTMS on lesional primary motor cortex has the stronger effect than LFrTMS alone does on one hand; the other newly-developed combination, i.e. HFrTMS on lesional primary motor cortex and LFrTMS on contralesional primary motor cortex might also be more effective than they do respectively on the other hand.

The main aim of our research is to find out which combination is better by considering both safety and efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 30 to 90 years;
* Newly onset cerebral infarction or brain hemorrhage confirmed by MRI or CT;
* the disease duration is less than 20 weeks when recruited into the trial;
* no existence of limb motor dysfunction before this onset, and new occurrence of unilateral limb motor dysfunction after this onset;
* the physical and mental condition are good enough to cooperate with the assessment and treatment;
* the NIHSS score: total 5-20,1a,1b,1c=0;
* the subject or legal guardian sign the consent form.

Exclusion Criteria:

* during pregnancy;
* with skull defect;
* with metal implants, cardiac pacemaker, cochlear implantation;
* epileptiform discharge in EEG.
Assessment of Maxillary Sinus Septum and Its Prevalence in a Sample of Egyptian Population (CBCT)

a cross-sectional study to estimate the prevalence of maxillary sinus septum and assessment of it in a sample of Egyptian Population using cone beam computed tomography through retrospective data analysis

Setting and location:

1. The data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University, Cairo, Egypt.
2. CBCT images will be obtained from Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning.

Participants:

A total sample of 111examined sinus belonging to Egyptian individuals will be included.

Variables:

1. Prevalence of maxillary sinus septa.
2. Location of maxillary sinus septa.
3. Orientation of maxillary sinus septa in dentulous \& edentulous individual.

Data Sources / Measurements:

* Retrospective Data collection will be performed after the CBCT images are pooled from the computer database.
* All the CBCT examinations will be scanned using CBCT machine (Planmeca promax 3D Mid).
* CBCT scans using different fields of view, and different voxel resolutions .
* CBCT images will be interpreted by two oral radiologists independently; blinded from demographic data of the patients and from the results of each other.
* Each one will evaluate the images separately twice with a period of two weeks between the two reading sessions.
* Then inter-observational and intra-observational variability between the observers will be evaluated.

Bias:

No source of bias.

Study Size:

The results showed that a total sample size of 111examined sinus will be adequate to detect sinus septum prevalence of 24.6% with an 8% margin of error, a significance level of 5% and a 95% confidence interval.

Quantitative Variables:

The number of CBCT scans of Egyptian individuals with maxillary sinus septa will be counted to estimate the variations in the Egyptian population.

Statistical methods:

Data will be analysed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 21 (SPSS Inc., Chicago, IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages.

Eligibility Criteria:
Inclusion Criteria:

* • CBCT scans of partially, fully edentulous and dentulous population.

Exclusion Criteria:

* • CBCT scans that not displaying all the extension of the lower one third of the maxillary sinus.

  * Presence of large pathological lesions involving the maxillary sinus or affecting the confines of the sinus floor.
  * Images exhibiting changes in the morphology of sinus walls due to trauma.
  * Presence of technical artifacts that make difficult the maxillary sinus evaluation.
A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

Eligible participants will be administered inclacumab or placebo intravenous (IV) every 12 weeks.

The total duration of treatment for each participant will be 48 weeks.

Participants that complete the study through Week 48 will be provided the opportunity to enroll in an open-label extension (OLE) study.

Eligibility Criteria:
Inclusion Criteria:

1. Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype).

   Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening.
2. Participant is male or female, ≥ 12 years of age at the time of informed consent.
3. Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history. A prior VOC is defined as an acute episode of pain which:

   * Has no medically determined cause other than a vaso-occlusive event, and
   * Results in a visit to a medical facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and
   * Requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics.
4. Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin \[EPO\]) must be on a stable dose for at least 90 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.
5. Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.

Exclusion Criteria:

1. Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).
2. Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to the Screening Visit
3. Participant weighs \> 133 kg (292 lbs.).

Other protocol-defined Inclusion/Exclusion may apply.
Nutritional Health and Satisfaction After Bariatric Surgery: a Five-Year Retrospective Study

A retrospective study analyzing long-term outcomes of metabolic bariatric surgery (MBS) with a focus on weight loss, nutritional deficiencies, and patient satisfaction over a five-year follow-up. This study evaluates outcomes for different surgical procedures, including Laparoscopic Sleeve Gastrectomy (LSG), Roux-en-Y Gastric Bypass (RYGB), and other MBS techniques. The findings aim to provide insight into optimal nutritional management and patient care following bariatric surgery.

This study retrospectively examines 249 patients who underwent metabolic bariatric surgery at a specialized center between 2012 and 2017. It evaluates long-term outcomes including weight loss, excess weight loss percentage (%EWL), and nutritional deficiencies, with a specific focus on the effectiveness of targeted supplementation protocols to improve nutritional health post-surgery. The study analyzes different surgical procedures, including LSG, RYGB, and others, comparing primary and revision surgeries. Nutritional deficiencies in essential vitamins and minerals are assessed, highlighting the need for individualized supplementation based on the type of surgery and patient adherence.

Key objectives include:

1. Assessing long-term weight loss and maintenance across different MBS procedures.
2. Identifying the prevalence of nutritional deficiencies, particularly for iron, vitamin D, and B12.
3. Evaluating patient satisfaction and quality of life improvements following MBS.

Data were collected from electronic clinical records and include anthropometric data, biochemical markers, and self-reported supplement use. Findings emphasize the importance of targeted supplementation and regular monitoring to address persistent deficiencies. The study contributes to understanding optimal long-term care strategies for MBS patients and underscores the importance of personalized nutritional support post-surgery.

Eligibility Criteria:
Inclusion criteria: Patients aged 18 to 65 years who underwent metabolic bariatric surgery (MBS) at the Specialized Bariatric Center between 2012 and 2017, with a follow-up period of at least five years post-surgery.

Exclusion criteria: Individuals with a history of alcoholism, severe social anxiety impacting post-operative care participation, recent neoplastic disease diagnoses, neurocognitive disorders, or other systemic diseases potentially affecting quality of life and long-term outcomes.
Effects of Individual, Dyadic, and Collaborative Plans on Physical Activity in Parent-Child Dyads

AIMS: The project aims at investigating of the effects of three types of planning (individual planning, collaborative planning, and dyadic planning) on physical activity.The influence of three planning interventions are compared with an active control condition, including physical activity education.

PARTICIPANTS: The effects of the interventions are evaluated among parent-child (aged 10-14) dyads, with a minimum of 50 dyads enrolled into the each arm of the trial (a total of 200 dyads). The interventions consist of six planning sessions.

DESIGN: The dyads are randomly assigned to one of four experimental conditions. The assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after the first intervention session, at post-intervention (after six intervention sessions are completed), and at 6-, and 12-month follow-ups.

OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of planning (individual, dyadic and collaborative) are secondary outcomes.

Individual planning (also known as implementation intentions or action and coping planning) is a regulatory strategy, which refers to making plans on when, where, and how to perform an intended behavior. In dyadic planning, a target person is setting plans together with a partner on when, where, and how the target person will individually engage in behavior change. The concept of dyadic planning differs from the conceptualization of collaborative plans, where two individuals make plans on how to enact a behavior together.

The study will evaluate the effects of a short-term planning intervention. The intervention includes a total of six sessions: two face-to-face sessions with the experimenter (delivered over two weeks) and three sessions delivered over phone (over the following three weeks), one face-two-face session (delivered at one month after the third session delivered over the phone). The delivery has an individual format (the experimenter + the dyad). The total time from first to sixth session is 2 months. The setting for the interventions will include schools (school nurse office) or/and participant's home. The same format, schedule, delivery, and setting will be used for conducting active control group procedures.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children (age 10-14) and one healthy parents (any gender) or legal guardians
* Child or parent/legal guardian with chronic conditions but without contraindications for moderate intensity physical activity

Exclusion Criteria:

* Children younger than 10 years old
* Parents who declared plans for changing residence during the following year (e.g., due to moving to another region of the country)
* No parental consent at the baseline
* No child consent at the baseline
* Existing diseases with contraindications for moderate intensity physical activity
Safety and Efficacy of Albuterol in Individuals With Late-onset Pompe Disease

In this study the study team proposes to investigate the efficacy of albuterol on motor function of individuals with Late Onset Pompe Disease (LOPD) who are receiving enzyme replacement therapy, given albuterol was well-tolerated in patients with Late Onset Pompe Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Pompe disease by blood acid alpha-glucosidase assay and acid alpha-glucosidase gene sequencing,
2. Age: 18+ years at enrollment.
3. Receiving enzyme replacement therapy at standard dose (20 mg/kg every 2 weeks) for at least 52 weeks.
4. Subjects are capable of giving written consent.

Exclusion Criteria:

1. Continuous invasive ventilation (via tracheostomy or endotracheal tube).
2. Clinically relevant illness within two weeks of enrollment including fever \> 38.2 C, vomiting more than once in 24 hours, seizure, or other symptom deemed contraindicative to new therapy.
3. Chronic heart disease (Myocardial infarction in the past 2 months, arrhythmia, cardiomyopathy).
4. History of seizure disorder.
5. History of diabetes.
6. Hypokalemia.
7. History of hyperthyroidism.
8. Pregnancy.
9. Patients on a non-standard schedule for enzyme replacement therapy; for example, weekly infusions as opposed to infusions every two weeks.
10. Anti-rhGAA antibody titer \> 1:100,000
11. History of hypersensitivity to Beta 2-agonist drugs such as albuterol, levalbuterol (Xopenex), bitolterol (Tornalate), pirbuterol (Maxair), terbutaline, salmeterol (Serevent)..
12. The use of the following medications:

    * diuretics (water pill);
    * digoxin (digitalis, Lanoxin);
    * beta-blockers such as atenolol (Tenormin), metoprolol (Lopressor), and propranolol (Inderal);
    * tricyclic antidepressants such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine, Tofranil), and nortriptyline (Pamelor);
    * Monoamine oxidase inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or
    * bronchodilators such as albuterol, levalbuterol (Xopenex), bitolterol (Tornalate), pirbuterol (Maxair), terbutaline (Brethine, Bricanyl), salmeterol (Serevent), isoetharine (Bronkometer), metaproterenol (Alupent, Metaprel), or isoproterenol (Isuprel Mistometer) within 12 weeks prior to enrollment.
Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients

This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female and at least 18 years of age.
* Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). Non-pregnancy will be confirmed by pregnancy tests conducted at Screening and Pre-treatment.
* Patient is scheduled for bunionectomy surgery, meets the criteria of an ASA Class I to III, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.
* To be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point Likert scale or at least 4 on the 11 point NPRS scale).

Exclusion Criteria:

* In the opinion of the Investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the Investigator, would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
* Used opiates continuously (including tramadol) for more than ten days in the past year.
* Hypersensitivity or poor tolerance to ibuprofen or short term opioids.
* Currently receiving any medications that are not at a stable dose (the same dose for \> 2 months prior to date of surgery).
* Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q8003.
* Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia).
* Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality

The influence of hemodialysis on oxidative stress, endothelial activation, inflammation and on the redox state of lymphocytes should be clarified as well as the putative relationships between all these parameters.

Up to now, no anti-oxydative treatment has been able to reduce the mortality of the patients with Kidney Failure. Thus it is necessary to have a better knowledge of oxydative stress mechanisms in patients with KF in order to find more efficacious treatments. The influence of hemodialysis upon oxidative stress is not well known.

Eligibility Criteria:
Inclusion Criteria:

* 18 and 80 years old man or woman dialysing at least 3 times a week for at least 6 months and having no residual renal function
* Rate of haemoglobin \> 11 g / dl
* Clinically stable patient that is having had no considerable event (cardiovascular problem, infection, surgical operation) with the exception of angioplasty of fistula or prosthesis vascular, in the previous 3 months the entrance to the study
* Patient capable of understanding and of following the essay, in particular knowing how to read the note of information.

Exclusion Criteria:

* Pregnant woman
* Treatment by corticoids or immunosuppresseurs
* hemopathy sly
* chronic cancer or infection in evolution
* Cardiovascular event (infarct, unstable angor, coronary bypasses, confusions of the rhythm, AVC, amputation) or infectious (blood-poisoning, pneumopathie, meningitis) or surgical operation in the previous 3 months the inclusion in the study.
A Study of DLX105-DMP in Subjects With Plaque Psoriasis

A Pilot, Open-Label Study in Subjects with Mild-to-Moderate Plaque Psoriasis to Investigate the Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion


Eligibility Criteria:
Key Inclusion Criteria:

* Signed and dated informed consent.
* Subjects aged 18-75 years.
* Male subject, or if female, must be surgically sterile, post-menopausal, or using acceptable birth control.
* Stable chronic mild-to-moderate plaque psoriasis.

Key Exclusion Criteria:

* Non-plaque-type psoriasis only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, or plantar) at Screening.
* Drug-induced psoriasis (i.e., new onset or exacerbation from beta-blockers, calcium channel inhibitors or lithium) within 3 months prior to Day 1.
* Ongoing use of psoriasis treatments or inadequate duration of washout prior to Day 1