cyrilzakka/clinical-trials huggingface dataset:
Cardiac Arrhythmias and the Perception of Symptoms

To investigate the differential diagnosis and longitudinal course of medical outpatients complaining of palpitations. Also, to further examine the process of cardiac perception, the psychological factors which influence it, and the accurate awareness of cardiac arrhythmias.

DESIGN NARRATIVE:

One hundred seventy-five consecutive patients referred for continuous ambulatory electrocardiographic (Holter) monitoring because of palpitations were studied. The investigators assessed cardiac symptoms, psychiatric diagnosis, life stress, beliefs about heart disease, somatization, and bodily absorption and amplification. Cardiac awareness, cardiac symptoms and cardiac activity were assessed during Holter monitoring and exercise tolerance testing (ETT). The referring physicians completed instruments rating their diagnostic impressions and clinical interventions. The patients' clinical course was then followed over the ensuing 12 months with telephone interviews and in-person assessments. These data permitted description and distinguished three subgroups of palpitation patients: those with panic disorder, in whom the symptom resulted from sympathetic nervous system arousal; those who were somatizing after a life event caused them to suspect that they had heart disease, in whom the palpitation resulted from a cognitive misattribution of benign bodily sensation; and those with clinically significant arrhythmias, whose symptoms resulted from a major cardiac irregularity. These findings were used to develop a clinical algorithm to aid in the differential diagnosis of palpitations and in identifying the patients most appropriate for Holter monitoring.

The patients' longitudinal course was followed to determine the predictors of continued somatization and chronicity, and to study their medical care by examining the referring physicians' diagnostic impressions and interventions. By comparing cardiac symptoms with concurrent cardiac activity during Holter monitoring and ETT, the investigators hoped to develop measures of cardiac awareness. They would then be able to describe inter-individual differences in cardiac awareness, examine several psychological factors which amplify or modulate awareness, and investigate the relationship between somatization and accuracy of symptom reporting. It was hoped that the findings would ultimately lead to improved cognitive and educational techniques to reassure and palliate palpitation patients, and to the early identification of patients who were unlikely to obtain symptomatic relief from antiarrhythmic therapy.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Research Network for Neonatal Diseases Induced by Tissular Fetomaternal Alloimmunization

Problems of compatibility between a mother and her child are frequent. The most well-known case can be illustrated by the fetomaternal blood group incompatibility (rhesus factor) which can induce severe anemia of the fetus.

The investigators recently proved that incompatibility between mother and child can concern an organ leading to a tissular alloimmunization. For example, neonatal membranous glomerulonephritis (a kidney disease) can result from this mechanism.

The purpose of this network is to detect and study neonatal diseases induced by tissular fetomaternal alloimmunization. The detection of these diseases will be performed by the mother's serum analysis.


Eligibility Criteria:
Inclusion Criteria:

Mothers having a child suffering from:

* Neonatal membranous glomerulonephritis
* Unexplained neonatal tubular defect
* Unexplained thrombotic microangiopathy
* Neonatal hemochromatosis

Exclusion Criteria:

* Any cause explaining the child's disease
Digital Outreach Intervention for Lung Cancer Screening

mPATH-Lung (mobile Patient Technology for Health - Lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. The study will: 1) Determine the effect of mPATH-Lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) Elucidate the drivers of patients' screening decisions and screening behavior; and 3) Explore implementation outcomes that will impact the sustainability and dissemination of mPATH-Lung using program data, surveys, and interviews.

This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.

Primary Objective: Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, Wake Forest Baptist Health and the University of North Carolina at Chapel Hill.

Secondary Objectives:

* Elucidate the drivers of patients' decisions to receive or forgo LCS through a values clarification exercise embedded within mPATH-Lung and supplemental semi-structured interviews of at least 50 patients.
* Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings

Eligibility Criteria:
Inclusion Criteria:

* Meet the Medicare criteria for lung cancer screening, as updated in February 2022:

  * Age 50 - 77 years
  * Smoked at least 20 pack years
  * Current smoker or quit smoking within the past 15 years
* Be scheduled to see a primary care provider within the health network in the next 3-4 weeks
* Have a patient portal account or cellphone number listed in the electronic health record

Exclusion Criteria:

* Patients flagged as needing a language interpreter in the electronic health record (electronic messages and intervention is delivered in English only).
* Those for whom lung cancer screening would be inappropriate:

  * Prior history of lung cancer
  * Chest CT within the last 12 months
  * Those with medical conditions predicting shorter life expectancy
  * Patients whose home address is not within the state of North Carolina. (Due to telehealth guidelines)
Clinical and Radiographic Evaluation of the Entire Papilla Preservation (EPP) Technique Versus Modified Minimally Invasive Surgical Technique (M-MIST) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial

Periodontitis is defined as loss of periodontal attachment due to microbial associated host mediated inflammation. This would lead to the apical migration of the junctional epithelium allowing the bacterial biofilm to undergo apical widespread along the root surfaces of teeth causing bone resorption (Tonetti, Greenwell, \& Kornman, 2018).

The main objective of periodontal surgeries is directed at complete preservation of the interdental soft tissues to achieve primary closure over the intraosseous defected sites during the early phases of wound healing. Evidence shows that surgical techniques are highly predictable in the treatment of pockets associated with deep and shallow intrabony defects affected majorly by the selected flap design. The purpose of the flap design of minimally invasive periodontal surgery is to overcome the drawbacks of conventional periodontal surgeries decreasing the surgical trauma, improving the clot stability, reducing patient discomfort post operatively and minimizing the surgical chair time (Aslan, Buduneli, \& Cortellini, 2017b) Modified Minimally Invasive Surgical Technique (M-MIST) is considered one of the latest minimally invasive techniques that have been used in the treatment of intraosseous defects, this technique however entails an incision over the defect-associated interdental papilla that may jeopardize the volume and complex vascular integrity of the interdental tissues, lacking the special flap design that would emphasis clot stability for better wound healing. Where a new surgical technique turned entire papilla preservation has been developed for protection of the wound without affecting the vascularity of the area. (Pierpaolo Cortellini \& Tonetti, 2015) This randomized clinical trial compared the clinical and radiographic efficacy of entire papilla preservation surgical technique (EPP) to Modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intraosseous defects in stage III periodontitis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients age between 20 and 60 years old.
* Stage III periodontitis patient having 2 or 3 walled or combined 2 and 3 walled intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
* Defect not extending to a root furcation area.
* Vital teeth
* No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
* Patients who are cooperative, motivated, and hygiene conscious.

Exclusion Criteria:

* Any systemic disease that contra-indicates periodontal surgery or may affect healing.
* Smokers
* Pregnant females
* Drug abusers
Impact of Fourier Transform Infrared Spectroscopy (FTIRS) in ICUs

This study will assess the impact of FTIRS typing on the spread of ESBL-E in intensive care units

Multidrug resistant enterobacterales (MDR-E) are a major threat for patients hospitalized in intensive care units (ICUs). To prevent MDR-E spread in ICUs, rectal swabs are routinely performed and cultured on selective media. However, bacterial identification and antimicrobial susceptibility results are not sufficient to diagnose cross transmissions. The gold standard technique is based on genomic analysis that require whole genome sequencing (WGS) of bacteria and followed by multilocus sequence typing (MLST) and Single Nucleotide Polymorphism (SNP) typing. This technology is rather expensive and not applicable in all centers.

Fourier Transform InfraRed Spectroscopy (FTIRS) is a developing method for rapid bacterial typing. This technology is simple and results can be obtained in one hour. It is therefore adapted to continuous surveillance of MDR-E. In France, extended spectrum betalactamase producing enterobacteriaceae (ESBL-E) represent the vast majority of MDR-E. We postulate that early diagnosis of cross-transmission by FTIRS may prevent the spread of ESBL-E in ICUs and favor compliance with hygiene measures. The aim of this study will be to assess the impact of systematic FTIRS typing of ESBL-E on ESBL-E cross-transmissions in ICUs.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients hospitalized in ICU
* ESBL-E carrier

Exclusion Criteria:

* none
BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction

The purpose of this registry (NCT02876042) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO system in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant hypertension that also have evidence of heart failure with preserved ejection fraction (HFpEF).

Summary:

The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria. Subjects must be enrolled within 30 days from implant but prior to therapy activation. Up to 70 subjects will be enrolled at up to 10 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3 and 6 months after the device was implanted, at which time each subject will be exited from the registry.

Eligibility Criteria:

The CE-Mark approved indications and contraindications for the BAROSTIM NEO system in the treatment of resistant hypertension include:

* Indications

  * Systolic blood pressure greater than or equal to 140 mmHg, and
  * Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications
* Contraindications

  * Bilateral carotid bifurcations located above the level of the mandible
  * Baroreflex failure or autonomic neuropathy
  * Uncontrolled, symptomatic cardiac bradyarrhythmias
  * Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
  * Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation

Eligibility Criteria:
Inclusion Criteria:

* Sign an Ethics Committee (EC) approved informed consent form for the registry.
* Implanted with the BAROSTIM NEO system in accordance with CE-Mark approved indications and contraindications for resistant hypertension within 30 days prior to enrollment.
* BAROSTIM THERAPY not yet chronically activated.
* Pre-implant echocardiogram with left ventricular ejection fraction ≥ 50% within 30 days prior to implant.
* On stable, maximally-tolerated, guideline-directed cardiovascular medications for at least 30 days prior to enrollment.
* Objective evidence of heart failure according to the following criteria:

  * Hospitalization for heart failure within 12 months prior to enrollment OR
  * Echocardiographic evidence of diastolic dysfunction (LA Volume Index \>34 ml/m2 OR E/e \>13) within 30 days prior to enrollment OR
  * NTproBNP \> 220 pg/mL or BNP \> 80 pg/mL (in atrial fibrillation, NTproBNP \> 600 pg/mL or BNP \> 200 pg/mL) within 30 days prior to enrollment

Exclusion Criteria:

* Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction.
* Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.
A Multiple Dose Study of DWP05195 in Healthy Adult Subjects

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple administered DWP05195 in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male subjects aged 20 to 45 years
2. The subject has a Body weight ≥50 kg and \<90 kg and Body Mass Index(BMI) ≥19.0 kg/m2 and \< 27.0 kg/m2.
3. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
4. A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)

Exclusion Criteria:

1. A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, gastrointestinal, hematology, neurology and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse 2. A subject who had any allergic history to any drug (prescription drug or OTC medication etc.) 3. A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication

* Within last 1 month : drug or food known CYP1A2 inducer or inhibitor
* Within 2 weeks : Prescribed or herbal or Non-prescribed medicine
* Within 3 days : Consumption of grapefruit juice/grapefruit containing products or orange juice/orange containing products, garlic extracted functional foods
* Within 3 days : Consumption of alcohol or caffeine 4. A subject who had participated in any other clinical study within the last 12 weeks 5. A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks 6. A Subject with the known evidence of the following infections or drug abuse
* HIV, HBs, HCV
* cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine 7. Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test 8. AST or ALT greater than 1.5 times the upper limit of reference range or QTc \> 430 msec base on screening results 9. Blood pressure : SBP≥140mmHg, DBP≤85mmHg 10. A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests
Clinical Audit of Managment of Gausher Disease in Children

clinical audit on managment of gausher disease in children

The main aim of study is to evaluate the management of Gausher disease patient under enzyme replacement therapy in Assuit University Children's Hospital and compare our policy for management with International guideline of management of Gausher disease in children (8)

* Type of study : clinical audit
* Inclusion criteria: All cases with confirmed diagnosis of Gaucher disease type 1 and type 3 receiving enzyme replacement therapy at Assuit University Children's Hospital.
* Site of study :Assuit University children's Hospital Methodiological
* Exclusion criteria 3-New diagnosed cases not on ERT. 2-other lipid storage disease.
* Patient\& method The study will include 42 diagnosed Gaucher disease patient under enzyme replacement therapy attend the hematology unit in Assuit University Children's Hospital in one year Reviewing the proposal will be carried out before starting via the ethical committee of Assuit Faculty of Medicine.
* Ethical consideration The aim of the study will be explained to each patient before beginning of the process.

We will compare our policy in management of Gausher disease with International guideline of management of gausher disease

1-cases of Gaucher type 2.

Eligibility Criteria:
Inclusion Criteria:

* All cases with confirmed diagnosis of Gaucher disease type 1 and type 3 receiving enzyme replacement therapy at Assuit University Children's Hospital.

Exclusion Criteria:

* 1-cases of Gaucher type 2. 2-other lipid storage disease. 3-New diagnosed cases not on ERT.
The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth

The goal of this interventional randomized clinical trial is to test the effect of magnification and clinical experience of the operator on the success rate of full pulpotomy in mature adult molar teeth.

The main questions it aims to answer are:

* Does the use of magnification raise the success rate of full pulpotomy of mature adult molars?
* Does the clinical experience of the operator dentist raise the success rate of full pulpotomy of mature adult molars?

Participants will be asked to do the following:

* Receive the pulpotomy treatment of their target molar tooth.
* Record the pain score in the pain assessment chart.
* Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target molar tooth. Researchers will evaluate the usage of magnification in performing the pulpotomy procedure of adult molar teeth by postgraduate or undergraduate operators in comparison to performing the same pulpotomy procedure without magnification to see if it raises the overall success rate of pulpotomy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients diagnosed with acute irreversible pulpitis related to maxillary or mandibular permanent molar teeth without apical periodontitis.

Exclusion Criteria:

* Non-vital teeth.
* Immature teeth.
* Presence of swelling or sinus tract.
* Teeth with mobility grade II or III.
* Immunocompromised patients.
* Non-restorable teeth.
* Teeth with apical periodontitis seen in periapical radiograph.
* Periodontally affected teeth.
* Teeth with reversible pulpitis
* Extensive non-stoppable bleeding more than 6 minutes
* Teeth with partial necrosis
A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes

The goal of this observational study is to compare the presentation, treatment, and outcomes in patients suffering traumatic pancreatic injuries from blunt or penetrating trauma.

The questions this study aims to answer are:

1. Does a statistically significant association exist between pancreatic injury grade and the following individual factors:

   * Mortality
   * Morbidity
   * Injury severity score
2. Is there an association between post-operative pancreatic complications and operation-specific intervention?
3. Does pancreatic injury score correlate with certain intra-abdominal organ injuries?

Participants meeting criteria are greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center after presenting to the institution's emergency department as tier 1 or 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized at Kern Medical Center after presenting to the institution's emergency department as a tier 1 and 2 trauma activation
* Hospitalized following blunt or penetrating abdominal injury
* Diagnosed with traumatic pancreatic injury during same admission

Exclusion Criteria:

* history of pancreatic surgery
* Iatrogenic pancreatic injuries
Brachial Right Ventricle - Endomyocardial Biopsy

This is an observational study that will recruit NYU Langone patients undergoing standard of care right ventricle endomyocardial biopsy. Patients who undergo planned RV-EMB via transbrachial access will be invited to take part in the study.

Data including severity of tricuspid regurgitation and tamponade from pre and post procedure bedside echocardiograms, total procedure duration, radiation exposure and fluoroscopy time, sedatives used (if any) and bleeding/hematoma formation (if any) will be collected. A post-procedural survey will be administered to patients by study staff to assess comfort level and anxiety during procedure. A post procedure phone call will take place 3-5 days after procedure to assess for bruising, swelling or bleeding at the site of Brachial RV-EMB.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 to 90 years old
* Patient is undergoing standard of care right heart catheterization with endomyocardial biopsy
* Patient has right arm brachial access available
* Patient is willing and able to provide written informed consent.

Exclusion Criteria:

* Peripherally inserted central catheter (PICC) line or arteriovenous (AV) fistula
* Severe untreated tricuspid valve regurgitation
* Female patients who are pregnant