cyrilzakka/clinical-trials huggingface dataset:
Anxiety Associated With the Use of the Electrocardiogram Function in Smart Watches

The integration of electrocardiography (ECG) functionality into smartwatches is primarily intended to screen for atrial fibrillation, a frequent cause of ischemic stroke, among people aged 50 years and older. However, it should be noted that recommendations for atrial fibrillation screening are controversial, and several organizations and communities do not recommend screening outside of at-risk groups.

Some smart device manufacturers do not recommend using the ECG function for anyone under the age of 22. However, young people are frequent users of wearable devices. One of the most common cardiologic diseases at the age of 18-30 is benign heart rhythm disorder, which often does not require diagnosis or treatment and can be considered normal.

That said, notification of the detection of atrial fibrillation can affect psycho-emotional well-being, particularly anxiety.

This study will assess the level of psycho-emotional health (anxiety level) of the study participants. Participant observation will provide an opportunity to identify associations between the use of the ECG recording function on wearable devices and levels of anxiety and depression. It is hypothesized that the use of smartwatches with the ECG function activated will not lead to a change in anxiety levels on the GAD-7 scale among the study participants. This assumes that after 30 days of use, the mean value of the GAD-7 scale in the intervention group and the control group will be the same.


Eligibility Criteria:
Inclusion Criteria:

* Status of a student or employee of ITMO University;
* Availability of a smart watch with ECG function (Apple Watch Series 4 and newer, Galaxy Watch Active2, Samsung Galaxy Watch Series 3 and newer or similar with ECG function);
* Availability of a Galaxy smartphone running Android 7.0 or newer or availability of an iPhone 8 and newer smartphone with the latest version of iOS.
* Signed Informed consent and Consent for Data Processing of Personal Data;
* Absence of previously diagnosed clinically significant cardiovascular pathology.

Exclusion Criteria:

* Participants under the age of 22 cannot be included in the study;
* Participants in the acute phase of any disease or in the exacerbation of chronic diseases are excluded from the study.
Effects of Packed Red Blood Cell Storage Duration on Pediatric Living Donor Liver Transplantation

The patients assigned to either short-storage leukoreduced RBCs group (stored for ≤ 14 days) or longer-term storage leukoreduced RBCs group(stored for ≥21 days).When the hemoglobin concentration fell below 7.0 g per deciliter, PRBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0/dL. The primary outcome : Death from all causes in1-year after randomization. Secondary outcomes included: Intraoperative blood transfusion, Postoperative blood transfusion, Postoperative inflammatory reaction, Mechanical ventilation time in the intensive care unit, Lengths of stay in the intensive care unit and the hospital were also recorded.


Eligibility Criteria:
Inclusion Criteria:

* Our study included pediatric patients (6 months\< the moon's age \<36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.

Exclusion Criteria:

* The exclu¬sion criteria of the study were a congenital sufferer from heart, lung, kidney, nervous system or blood disease,active Lung infection，a history of liver transplantation，Multivisceral transplantation , refused to participate the study.
Chemotherapy in Treating Patients With Retinoblastoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with retinoblastoma.

OBJECTIVES: I. Estimate the response rate to adjuvant carboplatin (CBDCA) alone in children with intraocular retinoblastoma. II. Assess the overall survival, disease-free survival, and time to treatment failure in these patients. III. Attempt to maintain a 90% disease-free survival rate with this treatment. IV. Estimate the percentage of disease-free survivors who do not require the use of radiotherapy after adjuvant CBDCA. V. Assess the toxicity of this treatment. VI. Estimate the percentage of functional eyes salvaged using this radiation-sparing protocol and compare these results, in a nonrandomized manner, with historical treatment results in this population.

OUTLINE: Patients are stratified according to vitreous disease (yes vs no). Patients receive carboplatin IV over 1 hour on day 0. Treatment repeats every 2-3 weeks for 2 courses. Patients achieving complete response (CR) proceed to local control measures consisting of cryotherapy, laser photocoagulation, etc. (except brachytherapy). Patients not achieving CR continue with carboplatin until local control measures feasible. Patients with vitreous disease achieving CR receive 2 additional courses and then receive local control measures. Patients with vitreous disease not achieving CR receive intensive chemotherapy. Patients receive intensive chemotherapy consisting of vincristine IV on days 0, 7, and 14, cisplatin IV over 6 hours on day 0, etoposide IV on days 1 and 2, followed by cyclophosphamide IV over 60 minutes on days 1 and 2. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 3 and until blood counts recover. Treatment repeats every 2-4 weeks for 2 courses beyond CR. Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-6 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Intraocular retinoblastoma Ophthalmologic exam under anesthesia within 3 weeks prior to registration No pathologic confirmation required No evidence of extraocular disease, i.e.: Negative head MRI or CT (contrast not required) Negative CSF cytology Negative bone marrow aspiration and biopsy

PATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dl SGOT or SGPT less than 5 times upper limit of normal Renal: Creatinine normal for age OR Creatinine clearance greater than 50 ml/min

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth in Adults

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.

The intent is to treat 110 subjects, with enrollment balanced evenly between the 2 study sites, 2:2:1 randomization within each study site and an overall goal of 44 subjects treated with Kovacaine Mist, 44 treated with Tetracaine alone, and 22 treated with Placebo. Recruitment will be from diverse dental patient populations.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older.
* Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology.
* Normal lip, nose, eyelid, and cheek sensation.
* Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol.
* Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
* Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
* Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.

Exclusion Criteria:

* Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg).
* Inadequately controlled active thyroid disease of any type.
* Frequent nose bleeds (≥ 5 per month).
* Having received dental care requiring a local anesthetic within the last 24 hours.
* History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
* History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.
* Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
* Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
* Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation.
* Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
* History of congenital or idiopathic methemoglobinemia
Prediction of Persistent Postsurgical Pain After Video-assisted Thoracic Surgery (VATS)

Prospective cohort study of factors predisposing to persistent post surgical pain after video-assisted thoracic surgery


Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years old
* Elective lung cancer surgery (VATS)

Exclusion Criteria:

* do not understand Danish
* cognitive reduction
* bilateral procedure planned
* previous thoracic surgery
* pregnant or nursing
* known nerve affection from other cause
* alcohol/substance abuse
* inability to cooperate to pain scoring/sensory examination
* \> 5 mg methylprednisolone/day
Narcolepsy - New Potential Treatment

The overall aim of the study is to investigate the effect of a new, non-pharmacological method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the use of medications with potentially serious side effects in patients with this disease.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Diagnosed with narcolepsy (diagnose code G47.4)
* 16 - 60 years of age
* MSLT has shown hypersomnia (sleeping latency \< 8 min) \& 1 episode REM
* HLA-type associated with increased occurrence of narcolepsy

Exclusion Criteria:

* Reduced cognitive function
* Other relevant organ disease (that could affect the study results or put the patient at risk)
* Ongoing bacterial infection in the nose
* Comorbidity that can increase the risk of bleeding
* Has received treatment with an implantable stimulator or other implantable product in the head and / or in the neck
* Known pronounced septal deviation
* Known allergy to polyvinylchloride or medicinal liquid paraffin
* Women not using adequate contraceptives
* Participated in a clinical investigational drug trial within the previous 30 days
Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)

Rates of cigarette smoking in the military are high. Tobacco telephone quit lines are telephone-based services that provide information and guidance to people who want to quit smoking. This study will evaluate the effectiveness of a tobacco quit line program, in addition to nicotine replacement patches, at helping people in the military quit smoking cigarettes.

Active duty military personnel are at high risk of cigarette smoking. Despite strong efforts by the Department of Defense to reduce tobacco use, rates of smoking among people in the military remain high. The military lifestyle presents unique challenges to implementing smoking cessation programs, including the high mobility of troops, remote locations, and limited access to healthcare services. Because of these challenges, many smoking cessation programs that are effective in the non-military population are often ineffective in the military population. Tobacco telephone quit lines are telephone-based tobacco cessation services that provide easy access to educational materials, referrals to local programs, and individualized telephone counseling. Because tobacco quit lines are remotely based and can fit into varying schedules at convenient times, they may be effective among people in the military. Nicotine replacement patches are another effective smoking cessation tool and can be used in addition to telephone quit lines. The purpose of this study is to evaluate the effectiveness of tobacco quit lines, in addition to nicotine replacement patches, at improving smoking cessation rates among members of the Air Force.

This study will enroll military healthcare beneficiaries who have smoked at least five cigarettes a day in the year before study entry. Participants will be randomly assigned to either a proactive group, in which study researchers will initiate contact with the participants, or a reactive group, in which participants will initiate contact with the researchers. In this six-session program, phone calls will occur at 1- to 2-week intervals over an 8-week period. The phone sessions will focus on cutting down on cigarette smoking, setting a quit date, and relapse prevention. All participants will receive nicotine replacement patches after the second session is completed. The reactive group will receive two weeks of nicotine replacement patches and the proactive group will receive 8 weeks of nicotine replacement patches. At the end of session four and 1 year later, study staff will call participants to collect information on tobacco abstinence, nicotine replacement patch use adherence, and other smoking cessation medication use.

Eligibility Criteria:
Inclusion Criteria:

* Department of Defense healthcare beneficiary
* Has smoked five or more cigarettes per day for at least 1 year before study entry
* Must be at least eighteen years old

Exclusion Criteria:

* Known allergy or sensitivity to nicotine replacement therapy
* No telephone
* Inability to understand consent procedures
* Basic Military Trainee
Treatment Patterns, Outcomes and Testing in EGFRm NSCLC Patients With EGFR TKI 1L Across Europe (REFLECT)

Multinational, multi-center medical record review to describe the treatment patterns, clinical outcomes, and EGFR / T790M testing practices in EGFR-mutated advanced NSCLC patients receiving first-line EGFR TKI therapy in Europe.

The aim is to generate real-life data on treatment patterns of the EGFR-mutated advanced NSCLC patients receiving first- or second-generation EGFR TKI in first line of therapy as provided per routine practice in eight countries. An approximate number of 820 patients will take part in the REFLECT study.

It is anticipated that data, generated from the proposed large cohort across centers in Europe, will facilitate a better understanding of unmet medical needs in first line of treatment and will provide a platform for improving patients' management.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of locally advanced unresectable or metastatic NSCLC;
* Aged at least 18 years at first diagnosis of locally advanced/metastatic NSCLC;
* Lab-confirmed EGFR mutation;
* Received a first- or second-generation EGFR TKI as first-line treatment for advanced/metastatic disease;
* First-line EGFR TKI (afatinib, gefitinib, erlotinib) initiated between January 1, 2015 and June 30, 2018;
* Patients may be alive or deceased at the time of medical record review.

Exclusion Criteria:

* Patients enrolled at any time in an interventional clinical trial for an experimental treatment related to EGFR-mutated NSCLC;
* Patients receiving any systemic therapy for locally advanced or metastatic NSCLC prior to first-line EGFR TKI treatment in the locally advanced/metastatic setting;
* Missing or unknown data on any of the following key study dates:

  * Date of initial NSCLC diagnosis;
  * Date of first diagnosis of or progression to advanced/metastatic NSCLC;
  * Date of first-line EGFR TKI initiation for advanced/metastatic disease;
  * Date of death or last available follow-up.
Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)

A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Dyslipidemia and Type II Diabetes
* 19 years later, men and women under the age of 80

Exclusion Criteria:

* Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
* Subject with type I Diabetes
* Subject with hypertension which does not controlled by treatment(have blood pressure \> 180/110mmHg)
European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study

University of Schleswig-Holstein Campus Kiel is sponsoring the European TauroPace Registry. This investigator-initiated local, prospective, non-interventional, multi-center study includes patients undergoing cardiac implantable electronic placement including and not limited to placement, revision with the aim to upgrade or downgrade, generator substitution, additional lead placement, revision or extraction (procedure) with adjunct TauroPace. It is planned to include a total of at least 2300 procedures (valid for safety analysis).

This study is performed as an all-case investigation. The treatment is performed based on the SOPs (Appendix Study Protocol). The standard observation period is 3 months from the 1st treatment. Safety and effectiveness are evaluated at 3rd and 12th month. In addition, the extension observation is carried out once a year for 3 years at the longest to collect information on safety and effectiveness as long as CIED treatment continues. When the treatment ends (extraction of all hardware), observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using a unique Case Report Form (CRF) system. The duration of the study is estimated at 10 years (registry).

Eligibility Criteria:
Inclusion Criteria:

* Use of TauroPace™ is indicated and not contra-indicated according to its current Instructions For Use (IFU)
* Participant is eligible for a CIED related surgery procedure.

Exclusion Criteria:

* Age\<18years
* Participant incapable of signing Patient Informed Consent (mentally or physically) or does not sign.
Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?

This is a three-center, randomized, double-blind, fixed dose study designed to assess the efficacy, safety, and tolerability of a switch to vilazodone for sexual dysfunction associated with use of a selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI)compared to switching to sertraline in patients with Major Depressive Disorder (MDD).

Vilazodone is a newly introduced, FDA approved antidepressant that is a combined serotonin specific reuptake inhibitor and serotonin 1A receptor partial agonist. In contrast to the SSRIs and SNRIs, appears to have low adverse effects on sexual functioning when compared to placebo.

The design will be a randomized, double blind study with patients being randomized to switching to either vilazodone or sertraline. This will consist of a 1-week Screening phase, a 2-week Cross Taper phase, an 8-week Treatment phase, and an optional 2-week Down taper phase. The total duration of each patient's participation will be 13 weeks.

Seventy-two patients will be randomized at the Baseline visit to either vilazodone or sertraline, 24 at each of the 3 sites. Patients will be recruited over 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use;
2. Patients with major depressive disorder who are being treated with a selective serotonin reuptake inhibitor (citalopram, escitalopram, fluvoxamine, or paroxetine) or serotonin-norepinephrine reuptake inhibitor (desvenlafaxine, duloxetine, venlafaxine) for a minimum of 8 weeks.
3. The current episode of MDD is in remission (MADRS score \< 10 and CGI score of 1 or 2)
4. The duration of the current MDD episode is less than 2 years
5. Presence of antidepressant-associated sexual dysfunction (i.e., absence of sexual dysfunction prior to becoming depressed and presence of significant dysfunction while on the SSRI or SNRI despite being in remission from the depression).
6. Patient is at least 18 years old and not more than 65 years old
7. Patients must have the opportunity for sexual activity during the study period (in the form of availability of a suitable partner for sexual activity and/or openness to masturbation)
8. Patients must be willing to attempt some sexual activity (including masturbation) at least once every two weeks during the study

Exclusion Criteria:

1. Patients who have previously failed to respond to or to tolerate either vilazodone or sertraline.
2. Patients with a history of severe discontinuation symptoms on tapering off the current antidepressant
3. Patients with other known causes of sexual dysfunction
4. Use of prohibited medications during the study period
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease

The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported stool frequency and abdominal pain.
* Inadequate response or failure to tolerate at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD.

Exclusion Criteria:

* Have complications of CD such as strictures, stenoses, or any other manifestation for which surgery might be indicated, or that could confound the evaluation of efficacy.
* Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.
* Have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening.
* Are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation.