cyrilzakka/clinical-trials huggingface dataset:
A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System

RR2 is a medical, home-care, digital therapeutic, wearable device. Its main purpose is to deliver prescheduled, non-invasive, peripheral neuromodulation therapy, in conjunction with standard medical care, to relieve AF symptoms, recurrence and overall burden.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged ≥18 with ECG documented and symptomatic recent onset atrial fibrillation (AF), lasting less than 48 hours
2. Symptoms related to AF with high probability
3. Recent conversion or cardioversion to normal sinus rhythm (NSR) as evident by a documented electrocardiograms (ECG)
4. Participants are able and willing to provide a signed informed consent
5. Participants are able and willing to use RR2 homecare device and wear an ECG patch or a Holter monitor for 24 hours.

Exclusion Criteria:

1. Hemodynamic instability (systolic blood pressure \<100mmHg or heart rate \>170 bmp)
2. An active myocardial infarction evident from ECG signs
3. Presence of pre-excitation syndrome
4. History of sick sinus syndrome
5. History of persistent AF with documented episodes of \>7 days
6. Heart failure, acute or chronic
7. Participants currently enrolled in another study
8. Recurrent vaso-vagal syncopal episodes
9. Pregnancy or breast feeding
10. Pacemaker or Cardiac resynchronization therapy defibrillator (CRT-D) or any implantable electrical stimulating device
11. History of epilepsy or seizures
12. Peripheral neuropathy affecting the tested upper extremity
13. Participants unsuitable for participating in the study according to attending physician
14. Know allergy to .. (all materials that are in contact with patient's skin)
Effectiveness of Zinc Supplementation in Management of Patients With Symptomatic Benign Migratory Glossitis

Effectiveness of Zinc Supplementation in management of patients with symptomatic Benign Migratory Glossitis.

Zinc supplements seems to be a therapeutic option as Migratory glossitis is a chronic disease knowing that it needs no treatment. Zinc deficiency can probably be a causative factor in filiform papillae atrophy. Studies have mentioned the role of zinc in wound healing and maintaining a healthy epithelium, as well as regeneration of filiform papillae. Geographic tongue is a disorder that affects the lingual papillae. It has been shown that zinc sulfate can contribute to the treatment of geographic tongue positively.

Forty-eight patients diagnosed with symptomatic benign migratory glossitis will be selected from Oral Medicine, Periodontology and Oral Diagnosis department, Faculty of dentistry, Ain shams university. Research ethical committee will review the protocol and the procedure will be explained to the patients and they will sign an informed consent.

Seven days after the diagnosis and selection of patients with (BMG), the atrophic areas will be determined and the patients will attend a control checkup in order to exclude those with constant changing patterns of the red atrophic areas with raised keratotic margins. Only those patients who presented with constant atrophic areas with keratotic margins at the control checkup will be included during the study evaluation process, then the selected patient according the following inclusion and exclusion criteria will be randomly allocated into two groups. Patients met the eligibility criteria will be randomly assigned for 2 different groups using computer generated allocation concealment. Group I: Will include 24 patients with symptomatic BMG receiving Zinc Supplementation once daily and zinc rich diet for one month. (study group).Group II: Will include 24 patients with symptomatic BMG receiving zinc rich diet only For one month. (control group). Intensity of the discomfort will be monitored by the patients using the Visual Analogue Scale (VAS). Saliva will be collected from all included patients to evaluate zinc levels before treatment and one month after treatment only.

Eligibility Criteria:
Inclusion Criteria:

1. Both genders are eligible.
2. Adults above 18 years old.
3. Patients who presented at the control checkup with constant atrophic areas with raised keratotic margins.
4. Patients who diagnosed with symptomatic geographic tongue.

Exclusion Criteria:

1. Patients with anemia, oral candidiasis, and indicators for localized irritations (dental caries, affected teeth, sharp teeth edges, dental calculus, faulty dental fillings, and faulty prosthetic procedures).
2. Psoriatic patients.
3. Vulnerable patients (Prisoners, persons with mental disabilities or physical handicaps, children, neonates and pregnant women)
Antibiotic Prescription for Children With Acute Upper Respiratory Tract Infections in Assiut District

Antibiotics are one of the most commonly prescribed drugs in pediatric care all over the world. Over prescription of antibiotics is a major public health problem and the most important factor in the emergence of antibiotic resistance. It is important to study physicians' antibiotic prescribing behavior to understand its determinant and for further planning of appropriate interventions to optimize antibiotic prescription.

Antibiotics are one of the most commonly prescribed drugs in pediatric care all over the world. Over prescription of antibiotics is a major public health problem and the most important factor in the emergence of antibiotic resistance.

In Egypt, a recent study conducted in El-Minya governorate to investigate antibiotic use in PHC centres and in governmental hospitals, revealed that physician prescriptions of antibiotics for ARIs were extremely high as 82% of pediatric visits for ARIs resulted in an antibiotic prescription. Most of these infections are caused by viruses and do not require antibiotic treatment.

Numerous interventions to improve antibiotic prescribing practices have been reported from various countries with varying results. No single intervention appears to have superior efficacy, but combinations of interventions are typically more effective, and strategies that target health care professionals and/or patients (or parents of young children) have achieved success at reducing antibiotic prescriptions for ARIs.

Despite the emergence of antibiotic resistance and international efforts to reduce antibiotic use, prescription still high and inappropriate. Children are a vulnerable group and inappropriate antibiotic prescription may affect their health and may contribute to development of many diseases as allergies beside emergence of antibiotic resistance. Also, most of acute respiratory infections in children are viral infections and they receive antibiotic for it. So,, it is important to study physicians' antibiotic prescribing behavior to understand its determinant and for further planning of appropriate interventions to optimize antibiotic prescription.

Eligibility Criteria:
Inclusion criteria:

1. Physicians dealing with pediatric cases.
2. GPs, pediatrics, or otolaryngology (ENT) residents.

Exclusion criteria:

1. Physician who didn't work at outpatient clinics.
2. Physicians who are specialized and hold a degree.
MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs

This is a single-institution, phase II study to determine the event-free survival at 1 year post allogeneic transplant and serial mesenchymal stem cell (MSC) infusions from a related donor (HLA identical, mismatched or haploidentical) or matched unrelated donor for the biochemical correction of severe epidermolysis bullosa (EB).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe form of EB characterized by collagen, laminin, integrin, keratin or plakin deficiency (by immunofluorescence staining with protein specific antibodies or Western blotting and by mutation analysis).
* Adequate organ function within 4 weeks of study registration defined as:

  * Renal: glomerular filtration rate within normal range for age
  * Hepatic: Hepatic: bilirubin, AST/ALT, ALP \< 5 x upper limit of normal
  * Pulmonary: adequate pulmonary function in the opinion of the enrolling investigator
  * Cardiac: left ventricular ejection fraction ≥ 45%, normal EKG or approved by Cardiology for transplant
* Sexually active participants must agree to use adequate birth control for the during the study period (from before the start of the preparative chemotherapy through 1 year post-transplant)
* Available donor per section 5: targeted MFI \< 1,000 (MFI exceeding 1000 must be approved by the PI and treatment team.)
* Voluntary written consent - adult or parent (with information sheet for minors, if applicable) prior to any research related procedures or treatment

Exclusion Criteria:

* beta 3 laminin JEB mutants
* Active untreated systemic infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days)
* History of HIV infection
* Evidence of squamous cell carcinoma
* Pregnant or breast feeding. Females of child-bearing potential must have a negative pregnancy test prior to study registration as the agents administered in this study are Pregnancy Category C and D.
Computerized Contraceptive Decision Aid

The purpose of this study is to conduct a randomized clinical trial of a web-based contraceptive decision aid compared to routine contraceptive counseling to evaluate the effect of the contraceptive decision aid on the contraceptive method selected by the participant.

The investigators primary hypothesis is that women utilizing a computerized Contraceptive Decision Aid (CDA) will be more likely to choose highly effective contraception than women who undergo standard clinical contraceptive counseling.

Our primary specific aim is to test the CDA by conducting a randomized clinical trial comparing the CDA to routine contraceptive counseling. Our primary outcome of interest will be selection of highly effective contraception including the intrauterine device (IUD), the implant, and injectable contraception compared to all other reversible contraceptive methods.

We will also complete the following secondary specific aims:

1. We will use the validated Decisional Conflict Scale to measure decisional conflict pre- and post-intervention and compare the change in decisional conflict score in women randomized to the CDA to women undergoing routine counseling.
2. We will also evaluate satisfaction with contraceptive counseling and contraceptive continuation and satisfaction at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-45 years old
* At risk for unintended pregnancy and seeking reversible contraception at Center of Advanced Medicine or Washington University Resident's Clinic
* Willing and able to complete Contraceptive Decision Making tool
* English speaking

Exclusion Criteria:

* Have had a hysterectomy, bilateral oophorectomy, have undergone female sterilization
* Unable to give informed consent secondary to language barrier or cognitive limitation
Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block

This study was a prospective, randomized, controlled, and double-blind trial. Major assessments were made during the operation and 48 h postoperatively.

The prime outcomes were the time in minutes from leave the postoperative care unit to the first patient-controlled intravenous analgesia press.The secondary outcomes were to compare the following: (1)blood concentrations of ropivacaine was measured at 0.5 h, 1 h, 2 h, 3 h, and 24 h after paravertebral nerve block; and (2) the patient's intraoperative opioid use, phenylephrine use, fluid intake, urine output, dry mouth score, and 24 h and 48 h visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* (1) age 18 to 65 years,
* (2) scheduled to undergo video-assisted thoracic surgery,
* (3) American Society of Anesthesiologists risk classification I-II.

Exclusion Criteria:

* (1) patient refusal;
* (2) known hypersensitivity to the study medication (ropivacaine);
* (3) long-term use of opioids;
* (4) liver or renal insufficiency;
* (5) a history of psychiatric or neurological disease;
* (6) deafness;
* (7) regular use of acetaminophen, nonsteroidal anti-inflammatory drugs, corticosteroids, or antiemetics; and
* (8) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score higher than 6.
Sepsis Post Market Clinical Utility Simple Endpoint Study - Indiana University Hospital

The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form. Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians. This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 to 89 years)
* All race and ethnicities
* Presenting to the emergency department with suspicion of infection
* Whose assessment includes a CBC with differential
* Meets EMR Sepsis Definition

Exclusion Criteria:

* Pregnancy
* Prisoners
* Transfers from other ED
* Previously enrolled
Early Intervention in Cognitive Aging

Nutritional intervention in overweight middle aged individuals with subjective memory complaints.

Late-onset AD develops over many years during a preclinical period in which neuropathological changes accumulate before dementia is evident. Deposition of amyloid-beta (Aβ) in the brain is the earliest recognized biomarker of AD pathology, and, demographically, Aβ accumulation begins to accelerate at age 50, a period when the incidence of metabolic disturbance increases as well. Hyperinsulinemia associated with insulin receptor resistance has been associated with AD pathololgy, and metabolic disturbance in mid-life increases risk for subsequent dementia. There are indications that subjective memory complaints can be an early indicator of developing neuropathology and may be the first manifestation of future dementia. This research involves intervention studies in different samples of individuals from this population to investigate the extent to which berry fruit supplementation and ketone metabolism might improve cognitive performance in association with enhancement of metabolic function and related factors. The ultimate goal of this research is to develop interventional approaches that might be applied with at-risk individuals in the preclinical period of dementia to forestall or prevent progression of neurocognitive decline.

Eligibility Criteria:
Inclusion Criteria:

* overweight; subjective memory complaints

Exclusion Criteria:

* diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse
Post-Exposure Prophylaxis in Health Care Workers

Objective: The objective of this study is to determine the safety and tolerability of Post-exposure Prophylaxis (PEP) with a regimen of Truvada + Kaletra among health care workers (HCWs) at Henry Ford Hospital.

Hypothesis: Raltegravir is safe and better tolerated compared with Kaletra, each in combination with Truvada, as assessed by review of completion rates of PEP and also review of completed safety data.

Health Care Workers that have occupational exposure to blood are at risk for HIV infection. Prevention of blood exposure, through safer practices, barrier precautions, safer needle devices, and other innovations, is the best way to prevent infection with HIV and other bloodborne pathogens.

Though these strategies have been successful in reducing the frequency of blood exposure and needlestick injuries in the past decade, the hazard has not been eliminated. As of December 2001, the CDC had received voluntary reports of 57 documented cases of HIV seroconversion temporally associated with occupational exposure to HIV among U.S. health care personnel. An additional 138 infections among health care personnel were considered possible cases of occupational transmission. Because there is no cure or effective vaccine for HIV, optimal post exposure care, including the administration of antiretroviral drugs to prevent HIV infection, remains a high priority in protecting health care workers.

Eligibility Criteria:
Inclusion Criteria:

* Adult (at least 18 years of age)employees of HFH
* History of occupational exposure to bodily fluids
* Negative HIV test
* The ability to understand a written informed consent form, which must be obtained prior to initiation of any study procedures

Exclusion Criteria:

* Positive pregnancy test
* Females who are breastfeeding
* History of renal disease
* Contraindication for treating patient with components of PEP regimen
* Greater than one dose of PEP medication for this exposure event
Telecoaching Plus a Portion Control Device for Weight Management in the Primary Care Setting

The purpose of this study was to evaluate the impact of telecoaching conducted by a counselor trained in motivational interviewing paired with a portion control device for obese patients receiving care in a certified patient-centered medical home. The investigators will conduct a randomized, controlled clinical trial evaluating the effectiveness of a telecoaching intervention with a portion control device.

The intervention will be provided during a 3-month period with follow-up through 6 months after randomization. Body mass index (BMI) and waist circumference measurements will be collected at baseline and at 6, 12, 18, and 24 weeks. Participants will also complete measures assessing eating behaviors and physical activity at baseline and at 12 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 years and ≤ 55 years of age
* A BMI of ≥ 30 and ≤ 44.9 kg/m2
* Motivated to lose weight
* Able to participate fully in all aspects of the study;
* Have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

* Unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia
* A history of a gastric bypass procedure or planned gastric bypass
* Baseline systolic blood pressure \> 180 or diastolic \> 100
* Another member of their household already participating in this study
* Current treatment with another investigational drug for obesity (within 30 days of study entry)
* Are pregnant or lactating
* History of anorexia or bulimia
* Current binge eating disorder as assessed by the Patient Health Questionnaire eating disorder module (PHQ-ED)
* Schizophrenia or bipolar disorder or have a PHQ-2 ≥ 337
* Have been diagnosed with cancer within the past 5 years
* Are currently participating in a program specifically to lose weight or are on a weight loss medication (last 30 days)
Novel Complex Radiodiagnostics of Peripherial Arthropathies

Chronic peripherial arthritides are common diseases with soaring public health consequences. Our goal is to assess the role of photon-counting detector computed tomography in the diagnostics of peripherial arthropathies.

Background:

Chronic peripherial arthritides include immune-mediated (rheumatoid arthritis, psoriatic arthritis) and crystal deposition diseases (gout, pseudogout, hydroxiapatite-deposition disease).

Conventional radiographs are utilized to screen arthritis-associated deformities, bone erosions and joint space narrowing. MRI is able to detect bone marrow edema, synovitis and the swelling of soft tissues. Sonography can also detect synovitis and soft tissue involvement but does not provide information about bone marrow edema and poorly assess erosions. Photon-counting detector computed tomography (PCD-CT) is a novel type of CT device which provides many advantages like improved signal-to-noise ratio, intrinsic spectral information, lower radiation exposure, and better spatial resolution. PCD-CT is a type of X-ray computed tomography in which X-rays are detected using a photon-counting detector. These detectors are able to directly transform X-ray photons into electrical signals. Compared to previous generation scintillation detectors, photon-counting detectors have several advantages: being able to count the charges created by individual x-ray photons and measuring their energy level also providing multi- energy spectral sensitivity. 0.2 mm slice thickness potentiates the detection of bone erosionss. Collagen-rich structures like cartilage, ligaments, and tendons are easier to identify on PCD-CT images. Bone marrow edema can be visualized with virtual non- calcium reconstruction. PCD-CT could both detect and differentiate cristal deposits.

Aims: To assess the possible role of PCD-CT technique in the diagnostics of peripherial arthropathies.To compare the role of PCD-CT in the detection of arthritis-related pathologies with other imaging modalities like MRI and conventional radiography.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis (EULAR/ACR Criteria) / Psoriatic arthritis (CASPAR Criteria)/ Crystal arthropathies
* signed informed consent

Exclusion Criteria:

* age: \<18 years, \> 100 years
* pregnant
* breastfeeding
J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation

The primary objective of this post marketing survey is to prospectively investigate patients with hypertension treated with Micardis Tablets (hereinafter "this drug") in routine clinical settings for 3 years in order to determine the following:

1. Adverse events and adverse drug reactions under long-term use
2. Blood pressure measurements during the survey period
3. Determination of the incidence of cerebrovascular and cardiovascular events under use of this drug in routine clinical settings
4. Patient's lifestyle and background factors that are considered to affect the occurrence of cerebrovascular and cardiovascular events


Eligibility Criteria:
Inclusion criteria:

Hypertension patients unadministered Micardis.

Exclusion criteria:

1. Patients with a history of hypersensitivity to any ingredient of this product.
2. Pregnant woman or possibly pregnant woman
3. Patients with extremely poor bile secretion or patients with serious hepatic disorder