cyrilzakka/clinical-trials huggingface dataset:
Digital Stress Management Intervention for Health Care Providers

The purpose with this study is to test if the app-based stress management program StressProffen, can be of interest and support for stress management among health care providers.

For health care providers, work-related stress can be a major challenge that can lead to frustration, lower motivation, reduced quality of life and burnout, and the last year's COVID-19 pandemic particularly emphasized the challenges in the stressful everyday life faced by health care providers.

There are, however, interventions that can be of support, both for the prevention of stress and for coping with stress in challenging situations, and in recent years there has also been an increased focus on stress in working life in this setting. Several studies have also recently been carried out which aim to deliver such interventions via applications (apps) to promote employees' physical and mental health, as well as their ability to cope with stress. However, there is a need for more research in the field, especially with a focus that content in such apps should be based on evidence-based theory, and that interviews and a similar qualitative approach should be included in studies to gain increased insight into the need for and usefulness of digital tools among health care providers.

This study will therefore test the effect of an app-based program for stress management, StressProffen, among health care providers, in a single arm study. The app contains 10 modules distributed over four weeks, focusing on education of different techniques for reduction of stress and stress reduction exercises.

StressProffen was initially developed and tested for stress management in patients with cancer, with good results. Among other things, a randomized controlled trial showed a statistically significant reduction in perceived stress, anxiety, depression and self-regulation fatigue, as well as increased health-related quality of life, for participants in the intervention group compared to the control group. The aim of this study is to test whether StressProffen can be of interest and support for stress management among health care providers.

Eligibility Criteria:
Inclusion Criteria:

* Health care providers (included but not restricted to, registered nurses, physicians, physiotherapists, occupational therapists, dietitians, social workers, health workers).
* Working with patient treatment or follow up at Oslo University Hospital
* Having their own smart phone or tablet
* Being able to write/read/speak Norwegian

Exclusion Criteria:

* None
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. The trial consisted of four phases: screening (≤ 3 weeks of initial screening and a 4-week baseline phase); the double-blind treatment phase (24 weeks) in which participants received placebo or erenumab 70 mg or 140 mg daily; the active-treatment phase, in which participants underwent repeat randomization and were assigned to receive 70 mg or 140 mg of erenumab (28 weeks); and a safety follow-up phase (12 weeks).

Eligibility Criteria:
Inclusion Criteria:

* History of migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3) classification
* Migraine frequency: ≥ 4 and \< 15 migraine days per month on average across the 3 months prior to screening and during baseline
* Headache frequency: \< 15 headache days per month on average across the 3 months prior to screening and baseline
* Demonstrated at least 80% compliance with the eDiary.

Exclusion Criteria:

* Older than 50 years of age at migraine onset
* History of cluster headache or hemiplegic migraine headache
* Unable to differentiate migraine from other headache
* No therapeutic response with \> 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
* Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase
* Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study
Augmented-reality Based Mirror Therapy in Stroke Rehabilitation

In the proposed study, the investigators assumed that mirror therapy combined with augmented reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either augmented reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke with unilateral side involved;
* A score of Mini-mental state examination greater than 24 for proving higher mental function
* Time of onset \> 6 months before treatment begins; and
* Premorbid right-handedness.

Exclusion Criteria:

* Severe vision impairment;
* Major cognitive-perceptual deficit;
* Other brain disease.
Long Term Follow-up of Comparison of Clopidogrel vs. Aspirin Monotherapy After Drug-eluting Stent Implantation

This is an retrospective extended study of a randomized clinical trial (The HOST-EXAM trial ClinicalTrials.gov Identifier: NCT02044250).

Investigators will perform a retrospective analysis of all participants enrolled in this trial will be performed, until the longest follow-up duration.

The HOST-EXAM trial (ClinicalTrials.gov Identifier: NCT02044250) was an randomized clinical trial that was performed to compare head-to-head, the efficacy and safety between aspirin and clopidogrel monotherapy in patients who received PCI for coronary artery disease and required chronic maintenance antiplatelet therapy. From March 2014 through May 2018, a total of 5438 patients were enrolled, and follow-up was performed upto 24 months after randomization. After this study, randomization was unlocked and patients were followed-up based on the standard protocol.

Afterwards, the current study was planned to perform a extended follow-up of the HOST-EXAM population. The specific drug by the randomization group in the HOST-EXAM trial was not mandatory after the initial 24 months, therefore participants received medication according to the current guidelines, and according to the physicians preferences.

This is a observational, retrospective analysis of all clinical events after the randomization period. The prescribed medications and any clinical events will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were enrolled in the HOST-EXAM randomized clinical trial

Exclusion Criteria:

* None, otherwise the patient refuses to participate in this study, or refuses to provide personal medical information
Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis

The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or Vehicle Ophthalmic Solution.

This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: Auriclosene Ophthalmic Solution 0.3% ("Auriclosene") and Auriclosene Vehicle ("Vehicle").

Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 3 visits:

* Visit 1: Screening, Day 1
* Visit 2: Day 3 (±1)
* Visit 3: Day 5 (+1) Test of Cure/Exit

IP will be dosed OU (both eyes) QID for 4 days. Microbiological specimens will be collected from each eye at each visit.

Visual Acuity will be assessed OU at each visit as well as rating of the ocular signs: lid erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival discharge/exudate.

Eligibility Criteria:
Inclusion Criteria:

* 1 year of age and older
* Bulbar conjunctival injection
* Conjunctival discharge/exudate
* Signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less
* Other inclusion criteria per protocol

Exclusion Criteria:

* Suspected fungal, viral, Chlamydia or Acanthamoeba co-infection based on clinical diagnosis
* Any drug treatment in either eye for the current episode of bacterial conjunctivitis prior to study enrollment
* Other exclusion criteria per protocol
Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC

This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma
2. Clinical staged as T4 or N3 （according to the 8th AJCC edition）
3. No evidence of distant metastasis (M0)
4. Male and no pregnant female
5. ECOG (Eastern Cooperative OncologyGroup) scale 0-1
6. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
7. Normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
8. Normal renal function test ( creatinine clearance ≥60 ml/min)

Exclusion Criteria:

1. Recurrent or distant metastatic disease.
2. History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
3. History of radiotherapy or chemotherapy.
4. History of immunodeficiency disease
5. History of organ transplantation
6. Presence of life-threatening illness
7. Uncontrolled hypercalcemia
8. Severe uncontrolled medical conditions or active infectious diseases
9. Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.
10. Pregnant or breastfeeding female
11. Emotional disturbance or mental illness
12. Refusal or inability to sign informed consent
Beta Testing of a Smartphone App for HIV Prevention in Malaysian MSM

This project will involve beta testing of the JomPrEP app to assess its usability and acceptability among Malaysian MSM.

Given the evolving HIV epidemic among MSM and their challenges with accessing prevention services, we previously proposed to adapt, expand, and refine an existing app (namely the HealthMindr app) to deliver an integrated HIV prevention intervention that will promote HIV testing and linkage to PrEP and that incorporates screening and support for P/SUD for Malaysian MSM. We now plan to conduct expanded beta testing of the newly designed JomPrEP app to assess its usability and acceptability among Malaysian MSM.

Following wireframing and usability testing, Keymind (an experienced mobile app development company that has significant experience in building HIPAA-compliant apps, including HealthMindr) will apply a user interface (UI) design (i.e., colors/branding) to the interactive prototype, followed by the final development of the app (beta version). The objective of this study is to beta test this app to identify potential bugs and to ensure its usability in a real-world setting.

As part of the expanded beta testing, we will also evaluate the design, functionality, and usability of the JomPrEP app. This step is a critical stage of app development and will increase the ability of our research team to develop an acceptable and effective app.

Eligibility Criteria:
Inclusion Criteria:

* HIV-negative MSM
* Age more than or equal to 18
* Cis-gender men
* Condomless sex in the last 30 days
* Own a smartphone

Exclusion Criteria:

* Unable to provide informed consent
* Unable to read and understand English or Bahasa Malaysia
Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

By doing this study, researchers hope to learn if older adults with and without cognitive impairment can adhere to a Mediterranean diet.

Participants will be given instruction on following the study designed Mediterranean diet. Participation in the study will last about 9 weeks. Each person will be asked to follow the study diet for 6 weeks. During the study, participants will be asked to track the food they eat and will be monitored by a registered dietitian.

Potential participants need to be located within the KC metro area.

Eligibility Criteria:
Inclusion Criteria:

* Cognitively normal older adults over the age of 65 or individuals with a diagnosis of MCI or AD (any age)
* Have a study partner, if diagnosed with MCI or AD
* Body mass index (BMI) range between 20 - 35 kg/m2
* Speak English as a primary language

Exclusion Criteria:

* Serious medical risk
* Adherence to specialized diet regimes
* Already consume a Mediterranean diet pattern
Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)

The goal of this study is to determine if there is a significant difference in the quality of care between the investigators' two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. Quality of care will be measured by time spent in the MRI room as well as parental satisfaction, frequency of interruptions of the MRI scan, incidence-severity of respiratory complications, post anesthesia agitation, and time spent in the induction room, MRI room, and Post-Anesthesia Care Unit (PACU).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects presenting as out-patients, scheduled to receive an anesthetic for MRI of body (spine, chest, abdomen, and/or pelvis) and/or extremity (arm and/or leg).
2. The subject must be a candidate for both anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology. This staff member will not be a member of the study team and will obtain the consent for Anesthesia.
3. The subjects must be 12 months to 7 years (inclusive of the seventh year).
4. The subject's legally authorized representative has given written informed consent to participate in the study.

Exclusion Criteria:

1. The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.
2. Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
3. The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
4. The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6).

   * The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is.
   * For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
5. The subject is allergic to or has a contraindication to any of the drugs used in the study.
6. The subject has previously been treated under this protocol.
7. The subject has a tracheostomy or other mechanical airway device.
8. The subject has received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).
9. The subject is not scheduled to receive anesthesia-sedation care for the MRI.
10. The subject received one of the anesthetic regimens for the same MRI during the past six months.
Hyperglycemia in Patients With Takotsubo Syndrome

Patients with Takotsubo cardiomiopathy (TTC) have over-inflammation and over-sympathetic tone. However, these conditions could cause higher rate of heart failure (HF) events and deaths at 2 years of follow-up. Conversely, hyperglycemia vs. normoglycemia could result in over expression of inflammatory markers and catecholamines thta could result in higher rate of HF and deaths at 2 years of follow-up in TTC patients.


Eligibility Criteria:
Inclusion Criteria:

* acute onset of a cardiovascular event, usually associated with substernal chest pain, initially regarded as STEMI/evolving coronary syndrome;
* cardiac biomarker modifications (creatine kinase-MB and troponin I);
* systolic dysfunction, predominantly characterized by akinesia/hypokinesia of the mid-to-distal portion of the left ventricle (LV) chamber, with hyper-contractile basal LV.

Exclusion Criteria:

* patients with previous previous myocardial infarction;
* patients with previous TTC event;
* patients affected by chronic kidney, liver, and cerebrovascular diseases.
Non-invasive Evaluation of the Predictive Value of CEUS and SWE in ACLF, Renal Failure and Hepatorenal Syndrome

Evaluation of non-invasive prognostic parameters in patients developing ACLF and renal failure in patients receiving and not receiving transjugular intrahepatic portosystemic shunt (TIPS). Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

NECTAR consists of patients with ACLF and renal failure with and without receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.

Eligibility Criteria:
Inclusion Criteria:

* All patients with portal hypertension and kidney failure

Exclusion Criteria:

* no consent, no kidney failure, no portal hypertension
Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers

This study is a single-dose, open-label, randomized crossover and multiple-dose, open-label study to evaluate the PK of azelaprag in older adult healthy volunteers.

This study is a single-dose, open-label, randomized crossover and multiple-dose, open-label study to evaluate the PK of azelaprag in older adult healthy volunteers. The study will enroll approximately 16 participants.

Eligibility Criteria:
Key Inclusion Criteria:

Patients who meet ALL the following inclusion criteria will be eligible to participate in the study:

1. Healthy male or female volunteers ≥ 60 years of age
2. No history or evidence of clinically relevant medical disorders
3. Body mass index (BMI) between 18 and 40 kg/m2
4. Acceptable physical examination findings, including vital signs, and electrocardiogram (ECG)
5. Acceptable clinical laboratory values
6. Female participants of non-childbearing potential

Key Exclusion Criteria:

1. Currently receiving treatment with another investigational drug or investigational device within 30 days (or 5 half-lives, whichever is longer)
2. Current or previous malignancy within 5 years, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ, or adenocarcinoma of the prostate
3. Positive test result for COVID (rapid test), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibodies
4. Use of any medications that might affect the metabolism of the study drug as assessed by the Investigator and Sponsor and use of any herbal supplements, vitamins, or nutritional supplements within the 14 days prior to the dose day of each dosing period or during study participation.
5. Planned elective surgery within 30 days prior to Screening, during the study period or before the participant's red blood cell (RBC) have returned to normal levels
6. Systolic blood pressure \> 150 mm Hg or \< 90 mm Hg or diastolic blood pressure \> 95 mm Hg or \< 60 mm Hg
7. Unwilling or unable to abstain from the use of nicotine or tobacco containing products (including but not limited to snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) or the use of cannabis or marijuana
8. Positive urine drug screen or alcohol breath test at screening and/or known history of drug or alcohol abuse within 1 year prior to screening
9. History or evidence of any other clinically significant disorder, condition, or disease, that, in the opinion of the investigator or Sponsor medical monitor, if consulted, would pose a risk to participant safety, or interfere with the study evaluation, procedures, or completion
10. Concurrent or previous use of aspirin within 14 days and NSAIDs within 3 days before the dose day of each dosing period.
The Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision

The purpose of this study is to determine the effects of transcutaneous electrical nerve stimulation (TENS) and transcutaneous acupoint electrical stimulation (TAES) on pain and analgesic drug consumption in patients who had undergone abdominal surgery with a midline incision. Evidence for the effects of and transcutaneous electrical stimulation on pain and analgesic consumption on patients undergoing abdominal surgery with severe pain experience and high levels of neuroendocrine stress response is uncertain.

This research was conducted as a randomized controlled trial. 158 patients who had undergone abdominal surgery with diagnosis of gastric and colorectal cancer were assessed for eligibility. This research sample consisted of 48 patients who underwent abdominal surgery with a midline incision. The patients were randomized into three groups, the first intervention group, which used TENS (around the incision), the second intervention group, which used TAES (ST25, P6, ST36, Lİ4 acupuncture points) and the control group, which did not. Electric stimulation was performed at the 30th minute, second, 18th, 21st, 40th, and 45th hours after the operation. Pain scores and analgesic consumption were assessed in the first 48 hours after surgical intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had an American Society of Anesthesiologists (ASA) score of I-II
* Patients were aged over 18 years
* Patients who could read and write Turkish
* Patients who were scheduled to undergo elective abdominal surgery with a midline incision for a diagnosis of stomach or colorectal cancer
* Patients without any impairment of vision, hearing or speech

Exclusion Criteria:

* Patients who had a pacemaker
* Patients whose skin integrity around the incision was degraded
* Patients had a cognitive disorder, had a history of chronic pain, or were suffering from neurological, renal, cardiac or pulmonary disorders that could affect the test results
* Patients with an opioid addiction
* Patients those who had previously undergone electrical stimulation treatment
* Morbidly obese subjects
* Patients using psychoactive drugs