cyrilzakka/clinical-trials huggingface dataset:
Effect of the New Definition of Epilepsies of the ILAE of 2014 on the Diagnosis After the First Seizure

The present study is a prospective study on the development of seizure frequency, medication adherence, quality of life and cognitive performance after a first epileptic seizure using the new diagnostic criteria for epilepsy of the International League Against Epilepsy of 2014 at the time of diagnosis.

The new diagnostic criteria for epilepsy, which have been in place since 2014, suggest that due to the improved possibilities for early diagnosis and treatment - particularly as a result of improved imaging diagnostics - changes in the incidence rates and severity of the course of epilepsies with different etiologies can be expected.

The group of epilepsies with unclear etiology should now be smaller than in previous studies. The MRI- and EEG-positive patients can now be identified as having structural epilepsy based on the type of lesion, which was not possible in previous studies without differentiated imaging. The fact that these patients can now be treated before a patients can now be treated before a second seizure, the risk of recurrence and the health economic costs should also be reduced and have a positive effect on maintaining cognitive performance and quality of life after a first epileptic seizure.

The aim of the study is to record the consequences of the new epilepsy diagnostic criteria in terms of outcome and treatment. In addition, the investigators will use a questionnaire battery and neuropsychological testing to record the potential neuropsychological deficits, financial and socio-medical consequences of a first seizure or early-stage epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Completion of the 18th year of life
* first epileptic seizure
* Ability to understand the patient information and to give written consent
* Written consent for voluntary participation in the study

Exclusion Criteria:

* Chronic drug or alcohol abuse in the last two years
Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia.

The aim of the study is to compare two methods of oxygen therapy in patients with acute respiratory distress syndrome in the course of SARS-CoV2 pneumonia. The initial method of oxygen supply during coronavirus pneumonia is conventional oxygen therapy using a face mask or nasal cannula. However, there have been reports in the literature that early initiation of high-flow oxygen therapy with a nasal cannula is associated with better prognosis. The study we perform is intended to provide reliable evidence for confirmation this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of a current SARS-CoV2 infection (confirmed RT-PCR test or antigen test \[allowed in Poland, with sensitivity ≥90 and specificity ≥97\]);
2. Hospitalization in the Oxygen Sector of the Temporary Hospital in Szczecin;
3. Pneumonia during SARS-CoV2 infection;
4. ARDS (PaO 2 / FiO 2 ratio ≤300);
5. Oxygen flow 8-12 l / min on mask with reservoir and ≤ 60 mmHg paO2 and / or SpO2 \< 92%;
6. TNo current indications for treatment in the ICU;
7. Permisson of the patient.

Exclusion Criteria:

1. Probable lack of cooperation with patient;
2. Severe Disease disease, eg generalized neoplastic disease;
3. Concomitant pulmonary diseases (eg, fibrosis lungs);
4. Respiratory acidosis - pH \<7.3 with pCO2\> 50 mmHg;
5. Disturbances of consciousness - GCS \< 12;
Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation

The purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment). The study is conducted as a prospective, observational, single-center study. Patients suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred to the University Hospital of Regensburg, Germany, for further diagnostic procedures and heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized stress echocardiography as well as ergospirometry. Additional detailed assessment will be conducted including standardized questionary, clinical examination, transesophageal echocardiography and measurement of biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic, severe mitral regurgitation
* referral for diagnostic work-up and heart team discussion
* declaration of informed consent

Exclusion Criteria:

* contra-indication for cardiopulmonary stress examination (unstable angina pectoris, left main disease, abnormal electrolyte concentrations, acute decompensation)
* pregnancy
* exercise test on treadmill not possible (amputation of lower extremity, severe arthritis of lower extremities)
* no acceptable acoustic window at rest
Calming Alternatives Learned During MRI-Guided Breast Biopsy

The proposed randomized study evaluates whether a controlled breathing intervention could be efficacious for reducing pain in the MRI-guided breast biopsy setting. Support for this intervention stems from experimental and clinical studies on the effects of controlled breathing on pain. Implementing a controlled breathing intervention during MRI-guided breast biopsy has the potential to provide effective pain management in this outpatient setting. The primary study objectives are to assess the feasibility, acceptability, and efficacy of a novel audio-recorded controlled breathing intervention for reducing breast and body pain in women undergoing MRI-guided breast biopsy. The secondary study objectives are to evaluate the effects of controlled breathing on measures of physiological reactivity (i.e., blood pressure and heart rate), pain catastrophizing, and self-efficacy for pain and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing MRI-guided core needle breast biopsy at the Duke Cancer Institute
* Ability to speak and read in English
* Age ≥ 18 years
* Ability to provide meaningful consent

Exclusion Criteria:

* Hearing impairment that is documented in the medical record that would limit the use of the guided intervention or music
* Cognitive impairment that is documented in the medical record or results in being unable to provide meaningful consent
* Undergoing IV-administered sedation
Work-related Musculoskeletal System Disorders Among Female Workers in Hazelnut Factory

The aim of this study is to determine the prevalence of work-related musculoskeletal disorders in female workers in hazelnut factory. The secondary aim is to investigate the relationship between the musculoskeletal disorders severity and working posture, work related factor, psychosocial factor.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years,
* had at least 12 months of continuous working experience in hazelnut selection.

Exclusion Criteria:

* having pregnancy,
* working in a standing position or having a burden job,
* having joint disease, gout, diabetes, and trauma during the last one year
Pre-sleep Macros on Sleep Quality and Recovery

The goal of this clinical trial is to assess the effect of eating before bed (2 hours after dinner, 30mins before bed) and the effects this has on sleep and recovery measures in elite female athletes.

Participants will be randomized to 4 possible groups in a double-blind randomized cross over design. Each group will ingest 40 grams of one of the following nutrients as a liquid shake for 3 consecutive nights:

1. Casein Protein
2. a-lactalbumin Protein
3. Carbohydrate
4. Placebo

There will be at least 1 week washout period between each intervention.

Sleep and recovery outcome measures will be obtained through a WHOOP 4.0 wearable healthy tracking device. Subjective sleep and recovery will be obtained through subjective questionnaires. Food will be logged by participants on intervention days. Blood glucose will be measured using continuous glucose monitors.


Eligibility Criteria:
Inclusion Criteria:

* NCAA Division I female athlete
* Wearing WHOOP 4.0 device for \>3 months

Exclusion Criteria:

* Musculoskeletal injuries limiting participation in regular team practice.
* Cardiometabolic diseases limiting participation in regular team practice.
* Pre-diagnosed sleep condition that would negatively affect sleep quality or quantity (sleep apnea, restless leg syndrome, night-feeding syndrome)
* Allergy to any dietary supplement used in protocol - e.g., lactose intolerant.
* Use of sleep aids such as but not limited to, melatonin.
Oslo Balloon Angioplasty Versus Conservative Treatment

Background: Percutaneous transluminal angioplasty (PTA) has been popularized as a simple, effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with peripheral occlusive disease.. However, the fact remains that the indication for performing PTA are still more based on opinions than on scientific data.

The purpose of the trial was to randomize patients primarily referred for intermittent claudication into two groups: One group was offered conservative treatment; the other group was offered conservative treatment combined with PTA.

Primary outcome: The patient quality of life. Secondary outcome:Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers


Eligibility Criteria:
Inclusion Criteria:

* Age below 75 years
* Symptoms of intermittent claudication with duration \> 3 months
* ABPI \<0.9
* A two-year follow-up is possible

Exclusion Criteria:

* Subjective pain-free walking distance \> 400m
* Critical ischemia
* Previous vascular or endovascular surgery
* Diabetes ulcer
* Other physical disability abrogating organised exercise
* Use of warfarin
* Mentally unable to give informed consent
* Renal insufficiency
* Coagulation disorders Duplex or PTA impossible
Endoscopic Procedures of Children in the Normalization Process of Covid-19 Pandemic

Endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children.

Endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children. In the investigators' center, which is a pandemic hospital, only emergency endoscopic procedures were performed during the pandemic period, while emergency and elective endoscopic procedures are performed in accordance with the recommendations of the Ministry of Health during the normalization process. Staff and patients in endoscopy units are at risk for COVID-19 infection by inhalation of airborne droplets, conjunctival contact, and potential fecal-oral contamination. In order to reduce the risk of contamination, according to the recommendations of the European Gastrointestinal Endoscopy Association (ESGE); proper cleaning of endoscopic devices, non-reuse of disposable devices, cleaning the endoscopy hall with a disinfectant solution, use of gowns FFP2 / 3 masks and jewelry during the procedure, handwashing with soap and hand disinfection is recommended before and after each procedure. In addition, it is recommended that patients who have undergone endoscopic procedures should be followed up or communicated on days 7 and 14 in terms of the development of COVID-19 infection.

It is recommended that patients should be questioned in terms of COVID-19 infection before endoscopy, but rapid antigen testing and serology are not routinely recommended. Molecular diagnosis (PCR, amplification) tests are recommended for patients at risk for COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 1-18 who will undergo endoscopic procedures
* Patients who can be questioned about COVID-19 infection before and on the 7th and 14th days after the procedure
* Patients who volunteered to study

Exclusion Criteria:

* Under 1 year and over 18 years of age
* Patients who could not be questioned about COVID-19 infection before the procedure and on the 7th and 14th days after the procedure
* Patients who not volunteered to study
Coil Embolization of Coronary Artery Fistulas

Background and Purpose: Congenital coronary artery fistula (CAF) is an uncommon anomaly. In some patients they can became symptomatic, associated with significant morbidity and mortality. We report our experience in percutaneous treatment of CAF.

Congenital coronary artery fistula (CAF) can be defined as a direct communication of a coronary artery with a cardiac chamber, great vessel, or other vascular structure, bypassing the myocardial capillary bed.

CAF is an uncommon anomaly, occurring as an incidental finding in 0.1% to 0.2% of coronary angiograms. They are not gender specific. Many patients have symptoms like congestive heart failure, infective endocarditis, myocardial ischemia, or rupture of an aneurismal fistula. Surgical closure of coronary artery fistula was initially reported in 1983 with low rates of morbidity and mortality.

Percutaneous treatment appeared as an alternative to surgery. Transcatheter closure of CAF was first utilized in 1983. Along this years, with experience and improvements in catheterization equipment and occlusion devices, CAF occlusion have been successfully performed using microcoils.

We report our experience in using microcoils to percutaneous treatment of coronary fistulas.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery fistulas
* Clinical diagnosis of angina, myocardial infarction, left ventricular insufficiency, ventricular enlargement

Exclusion Criteria:

* Age \<18 or \> 85 years
* Cardiogenic shock _ severe ventricular enlargement
Comfort and Wearability of Custom-fitted, Mouth-formed and Pre-fabricated Mouthguards for Patients Undergoing Fixed Appliance Therapy

There is no current evidence on the comfort or wearability of orthodontic mouthguards. These mouthguards adapt to the mouth without the need for dental impressions and laboratory facilities and are suggested to be more comfortable for orthodontic patients by allowing the teeth to move during treatment without the need for them to be replaced regularly during treatment. This study aims to assess and compare the comfort and wearability of orthodontic mouthguards with custom-fitted mouthguards. The results of this study will allow orthodontists to provide evidence-based information to individuals undergoing fixed appliance therapy.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing active orthodontic treatment with pre-adjusted edgewise fixed appliances only for a minimum period of 9 months
* Playing sports where the use of a mouthguard is recommended
* Playing at least 120 minutes of sport (match or training) during a 6-8 week period
* Class I, II or mild III (edge-to-edge) incisor malocclusion
* Able to complete a VAS questionnaire
* No diagnosed sensory processing disorder

Exclusion Criteria:

* Undergoing active orthodontic treatment that is not pre-adjusted edgewise fixed appliances, or requires a fixed expander, or treatment is likely to be completed within 9 months
* Playing sports where the use of a mouthguard is not recommended Playing less than 120 minutes of sport (match or training) during a 6-8 week period
* Moderate to severe class III (reverse overjet) incisor malocclusion
* Unable to complete a VAS questionnaire
* Have a diagnosed sensory processing disorder
Evaluation of Salt Status in Patients With Cystic Fibrosis

The results of the annual check-up will be collected to evaluate the best urinary marker for fractional sodium excretion and salt status will be correlated to clinical outcome measures.

Patients with cystic fibrosis need extra salt as they have increased losses through sweat. Current advices are to follow and supplement if needed, however the way to follow salt depletion is unclear.

The best way is to calculate fractional salt excretion. This needs a simultaneous blood and urine sample for electrolytes and creatinin. Urinary surrogate markers have been validated on only 10 patients.

At the annual check-up patients with cystic fibrosis receive these measurements. The investigators will collect the measurements and calculate fractional excretion and the possible surrogate markers on urine. Further this will be correlated to nutritional and pulmonary status and patient subgroups at risk will be identified.

Eligibility Criteria:
Inclusion Criteria:

* all cystic fibrosis patients followed at the Gent University Cystic fibrosis centre
* Providing a paired urine and blood sample at the time of their annual check-up

Exclusion Criteria:

* transplantation
Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome

OBJECTIVES: I. Determine the effect of SYNSORB Pk therapy on mortality and frequency of severe extrarenal complications observed in children with acute stage E. coli-associated hemolytic uremic syndrome.

II. Determine the effect of SYNSORB Pk therapy on the need for the duration of dialysis in these patients.

III. Determine the effect of SYNSORB Pk therapy on the recovery of renal function and resolution of urinary abnormalities in these patients.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to receive either SYNSORB Pk or placebo.

Patients receive oral SYNSORB Pk or placebo three times daily for 7 days. Patients are followed on days 7, 14, 28, and 60 after discharge from the hospital.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinically diagnosed E. coli-associated diarrhea-associated hemolytic uremic syndrome (HUS)
* Diarrheal prodrome within 7 days before onset of disease
* No HUS associated with the following: Hereditary Post-bone marrow transplantation Streptococcus pneumoniae infection
* No prior catastrophic complications

--Patient Characteristics--

* Hematopoietic: Thrombocytopenia less than 140,000/mm3 Fragmented red blood cells
* Renal: Renal involvement (hematuria, proteinuria, or azotemia) No underlying glomerular disease
* Other: HIV negative No pre-existing structural abnormality or dysmotility syndrome of the gastrointestinal tract No inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
Physics Forceps vs Conventional Forceps in Extraction of Mandibular Molars

Our study compared two different forceps for extraction of mandibular molars, the conventional extraction forceps and the Physics forceps. We assesed the relative pain score, patient satisfaction, success of extraction, incidence of alveolar plate fracture and soft tissue healing; post extraction. Our results found statistical significance in comparison of both forceps under relative pain score, patient satisfaction and soft tissue healing post extraction.

Abstract

* INTRODUCTION/ BACKGROUND Tooth extractions are commonly done with conventional forceps. Recent advances like physics forceps help in atraumatic extractions by preserving the buccal plate, having less pain and better gingival healing. The buccal portion of the forceps is a plastic covered bumper which prevents reflection of buccal gingiva and buccal plate fracture. This is the first such comparison study to measure gingival healing in mandibular molar region with D2 bone quality.
* OBJECTIVE To compare the efficacy of Physics Forceps and Conventional Forceps in extraction of mandibular molars by randomly dividing the patients in two groups. The efficacy is determined by comparing the success of extraction, relative pain score, incidence of alveolar fracture, patient satisfaction and soft tissue healing on 3rd post-operative day.
* METHODOLOGY Patients who were indicated for extraction were included in the study. They were divided into two groups of 10 by double blinded randomization. Local Anesthesia was administered and the extraction was carried out using either Physics or Conventional forceps. Post extraction, the pain score was assessed using the VAS. Along with these, the gingival healing, success of extraction and alveolar plate fracture was assessed by the subject expert on the 3rd day post-operative day.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-55 years
* Mandibular molar teeth indicated for extractions with gingival index 1.

Exclusion Criteria:

* Patients with uncontrolled systemic diseases, that compromise dental extraction
* Mandibular 3rd Molars
* Grade 2 and 3 mobile teeth
* Grossly decayed mandibular molars
Pilot of Lifestyle and Asthma Intervention

This is to pilot test a weight loss intervention in obese patients with poorly controlled asthma.

Obesity is a risk factor for the development of asthma (approximately 250,000 cases per year of asthma in the U.S. are related to obesity).

Investigators' ultimate purpose is to test the hypothesis that weight loss through an intensive life style intervention will improve asthma control. But investigators first need to establish whether the weight loss intervention is effective in patients with asthma.

Objectives

1. The primary objective of this study is to determine the effectiveness of an internet-based weight loss intervention in producing weight loss in obese patients with poorly controlled asthma.
2. The ultimate purpose is to implement a multi-center weight loss intervention trial for obese patients with poorly controlled asthma.

This will be a pilot study of a weight loss intervention at two centers, the University of Arizona and the University of Vermont. The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control.

This will be a single arm-phase II futility trial; the "futility" to be assessed is the ability to produce weight loss. Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials. This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss). This is a 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention, which is described in detail below

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of asthma on regular prescribed controller therapy for at least 3 months
* Age: ≥18 years of age
* Obese: BMI \> 30 kg/m2
* Poorly controlled asthma

  * Asthma Control Test Score \< 19,19,20 or
  * Use of rescue inhaler, on average, \> 2 uses/week for preceding month, or
  * Nocturnal asthma awakening, on average,1 or more times / week in preceding month, or
  * Emergency Department (ED)/hospital visit or prednisone course for asthma in past six months
* Ability and willingness to provide informed consent
* Ability to access internet weight loss program for trial period
* Completion of asthma diary cards and weight loss diary cards for same 3 consecutive days at visit 2

Exclusion Criteria:

* Prior history of bariatric surgery
* Any condition that puts the participant at risk from participation in a weight loss study or a condition that precludes participation in regular exercise as judged by the site physician.
* Pregnancy (by patient self-report)
* Participation in another weight loss intervention within the last month
* Weight loss of ≥ 10 pounds in the last 6 months by self-report