cyrilzakka/clinical-trials huggingface dataset:
Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation

The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation in patients with frequent (\>3 episodes/month) or infrequent \<3 episodes/month)atrial fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.

The ability of a saline irrigated catheter to deliver RF energy at higher power with a lower electrode-tissue interface temperature, combined with the anatomical guidance of electroanatomical mapping should allow:

1. Isolation of the pulmonary veins at the LA-PV junction with the same or lower risk of pulmonary vein stenosis;
2. Creation of continuous, transmural linear left atrial lesions with the same or lower risk of thromboembolism;
3. These two factors will eliminate documented episodes of symptomatic sustained AF in patients with frequent (\>3 episodes/month) or infrequent (\<3 episodes/month);
4. Patients with interruption of the vagal response (sinus bradycardia or AV block) during stimulation at the sites of left atrial autonomic ganglionated plexi (GP) will have lower recurrence of atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater or equal to 18 years
2. At least one documented episode of atrial fibrillation (AF) within the previous 6 months.
3. Failure of at least one antiarrhythmic drug (Class I or III) defined as recurrence of AF or adverse effect.
4. Informed consent obtained.

Exclusion Criteria:

1. Left atrial thrombus
2. Acute myocardial infarction within eight (8) weeks
3. Atriotomy within eight (8) weeks
4. Decompensated heart failure (unless the AF is thought to be a significant etiologic factor and AF ablation is clinically indicated)
5. Pregnancy
6. Ablation in a pulmonary vein within 4 months.
7. Occurrence of perforation during an ablation procedure performed less than two months prior to the planned ablation date.
8. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in the study.
9. Enrolled in an investigational study evaluating another device or drug
10. Unwilling to participate in the study or unavailable for follow-up visits.
11. Incarcerated
Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia

This is a single site pilot randomized, controlled, trial randomizing patients with PE with severe features to one of 2 groups:

* 24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
* Using the Cheetah® device to aid in an individualized duration of magnesium sulfate.


Eligibility Criteria:
Inclusion Criteria:

* Preeclampsia with severe features, diagnosed using the American Congress of Obstetricians and Gynecologists (ACOG) standard criteria 4 requiring magnesium sulfate
* Females older than 18 years of age
* Singleton pregnancy
* Gestational age greater than 24 0/7 weeks
* The patient is physically and mentally able to understand the informed consent and is willing to participate in this study
* Able to speak English or Spanish

Exclusion Criteria:

* Multiple gestation
* Prisoners
* Patients with chronic renal insufficiency or epilepsy
* Known cardiovascular disease
* Patients with contraindications to magnesium sulfate use (e.g. myasthenia gravis)
* Patients with eclampsia or HELLP syndrome
* Contraindications for magnesium sulfate
Virtual Reality Exposure for Dental Fear

The purpose of this study is to compare an intervention for dental fear to the usual approach (i.e., whatever your dentist typically does to help you manage fear) in reducing patient fear and making dentist appointments more tolerable. The dental fear intervention (called neVR Fear the Dentist™) has two separate steps. Step 1 involves using a mobile app that is based on research-backed approaches to handling dental fear on your smartphone or device. Step 2 is a 1-hour self-administered virtual reality intervention to be completed in the dental office.

This is a randomized study. Participants will be randomized to either the intervention group or an active control.

Investigators hypothesize that participants in the intervention condition will show greater declines in self-reported dental fear and improved oral health-related quality of life during post-treatment and follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 13 years of age
2. Report dental fear of 4 or higher on a scale of 0-10 on the Gatchel dental fear item
3. Be able and willing to comply with study procedures
4. Provide a signed and dated informed consent form an/or assent form (if applicable)
5. Proficient in English because the intervention is in English
6. Have access to a smartphone or tablet
7. Attending dental appointments at one of our participating dental practices.

Exclusion Criteria:

1. Hearing or visual impairment such as stereoscopy blindness or nystagmus
2. Known mental disorders such as psychosis, post-traumatic stress disorder (PTSD), developmental or intellectual disability, cognitive impairment
3. Known balance disorders such as vertigo and cybersickness
4. Previous history of epileptic seizures
5. A history of cardiac problems
6. Are in pain, require urgent care, or whose necessary treatment will be delayed by participating in the study
Study of Synapsis and Recombination in Male Meiosis and the Implications in Infertility

The aim of this study was to assess meiotic recombination in primary spermatocytes, synaptonemal complex length and the correlation with chromosomal abnormalities in testicular spermatozoa from infertile men with idiopathic non-obstructive azoospermia (NOA).

During the first meiotic division in spermatogenesis there are two critical events. First, synapsis between homologous chromosomes and formation of the synaptonemal complex (SC), which regulates sister chromatid cohesion and provides the template for localization of recombination machinery proteins. Secondly, recombination between homologous chromosomes, which is essential for the correct segregation. Errors during these two processes may induce incorrect segregation of chromosomes and are a major cause of gamete aneuploidy. The aim of this study was to assess meiotic recombination in primary spermatocytes, synaptonemal complex length and the correlation with chromosomal abnormalities in testicular spermatozoa from infertile men with idiopathic non-obstructive azoospermia (NOA). Prospective cohort study to assess meiotic progression, total length of SC, frequency of recombination and sperm aneuploidy in samples obtained from testicular biopsies from NOA patients. The study group was compared with a control group from post-vasectomized (OA) patients. Immunocytogenetics with SCYP3, CREST and MLH1 antibodies for meiotic progression, SC length, and recombination. Fluorescence in situ Hybridization (FISH) for chromosomes 1, 4, 6, 13, 16, 18, 21, 22 in primary spermatocytes and chromosomes 13, 18, 21, X, Y on sperm. MicroMeasure 3.3 program was used for SC length.

Eligibility Criteria:
Inclusion Criteria:

* NOA patients undergoing ICSI with testicular sperm
* OA post-vasectomized patients undergoing ICSI with testicular sperm

Exclusion Criteria:

* Abnormal Karyotype
AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery

Treatment of vertigo after removal of a tumor of the balance and hearing nerve after neurosurgery, which damages or cuts the vestibular nerve (balance).

This trial explores the efficacy and safety of AM-125 in the treatment of acute vertigo. In this proof of concept trial patients experiencing vertigo after neurosurgery (vestibular schwannoma labyrinthectomy and vestibular neurectomy) will receive AM-125 or placebo. It evaluates the potential of AM-125 versus placebo in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery.


Eligibility Criteria:
Main Inclusion Criteria:

1. Scheduled for neurosurgery (vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy).
2. Small to moderately large vestibular schwannoma (Koos grade I-III; Samii grade T1-T3b; ≤ 30 mm in diameter in cerebellopontine angle) that does not displace the brainstem, documented by magnetic resonance imaging not older than six months or Indication for labyrinthectomy or vestibular neurectomy.
3. Confirmed vestibular function on both sides.

Main Exclusion Criteria:

1. Prior radiotherapy (gammaknife, intensity modulated radiation therapy) irradiating the brain-stem with more than 4 Gy.
2. Any ongoing other peripheral vestibular disorder (e.g. Meniere's disease, benign paroxysmal vertigo, vestibular neuritis) or central vestibular disorder (e.g. vestibular migraine, central vertigo).
3. Vestibular rehabilitation therapy or presurgical gentamicin therapy (i.e. "pre-habilitation therapy") within the past three months prior neurosurgery.
4. Any clinically relevant nasal obstruction or pathology precluding effective and/or safe intranasal delivery.
HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma

This is a phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+) and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase I dose/schedule finding component using the maximum tolerated dose identified during the previous phase I study, but with a higher number of doses and a two-stage phase II extension component to confirm safety and make a preliminary determination of the activity level by disease using the dose identified in phase I.


Eligibility Criteria:
Inclusion Criteria:

* Histologic verification of B-cell lineage leukemia or B cell non-Hodgkin lymphoma and evidence of relapse/refractory disease with the presence of CD19 and/or CD22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy
* Relapsed refractory disease that has failed conventional therapy and other therapies of higher priority
* Karnofsky Performance status of ≥ 60% or, if less than 16 years of age, Lansky Play Score of ≥ 60 (appendix II)
* Recovered from effects of prior therapy
* Peripheral blast count under 50 x 10\^9/L
* Adequate organ function within 14 days (30 days for cardiac and pulmonary) of treatment start
* Women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study
* Voluntary written consent with appropriate parent/guardian consent and minor information sheet for participants \< 18 years of age

Exclusion Criteria:

* Presence of leukemic or infectious pulmonary parenchymal disease
* Presence of active CNS leukemia
* Presence of any uncontrolled systemic infection
* Documented uncontrolled seizure disorder- a seizure disorder controlled with medication
* Active neurologic disorder - peripheral neuropathy alone does not exclude a patient
* Active Hepatitis B or Hepatitis C (virus detectable by PCR)
* Documented penicillin or cephalosporin allergies
* Pregnant or lactating
Effects of an ACT-based Psychological Treatment in Relatives of People With Intellectual Disabilities

Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of parental stress in relatives of people with intellectual disabilities

After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

Patients who meet eligibility requirements will receive psychological intervention consisting in 3-session group ACT-based treatment.

The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.

The clinical trial will include a control group.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* High level of understanding of Spanish
* Having children diagnosed with intellectual disability

Exclusion Criteria:

* Current psychological and/or psychiatric treatment,
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry

This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria: - Informed consent obtained before any data collection - Woman with a positive pregnancy test - Diabetes mellitus type 1 or 2, diagnosed prior to conception - Currently treated with Levemir® or other injectable antidiabetic treatment(s) - Unchanged basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception Exclusion Criteria: - Women who have been pregnant for more than 16 weeks at baseline visit will be excluded from the study
The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.

Objective:

To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.

Methods:

A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyze at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.

Background: Metformin has anti-inflammatory properties, as it suppresses the inflammatory process by down-regulating the transcription factor, nuclear factor kappa B (NF-kB), through AMP-activated protein kinase (AMPK)-dependent and independent pathways.

Objective:

To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.

Methods:

A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyzed at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.

Eligibility Criteria:
Inclusion Criteria:

* gouty patients who fulfilled the American College of Rheumatology clinical criteria.
* gouty patients with active inflammatory arthritis.

Exclusion Criteria:

* Patients with any type of inflammatory arthritis.
* Patients with systemic disease as diabetes, hypertension,
* Patients with hyperlipidemia, coronary artery disease,
* Patients with renal or hepatic insults,
* pregnant and lactating females
The Effects of Guided Imagery on Postoperative Pain Management

This study was conducted to determine the effects of guided imagery on postoperative pain management.

The sample of the study consisted of 60 patients (30 in the experiment and 30 in the control groups) undergoing lower extremity operations at the orthopedics clinics of the Kahramanmaras Necip Fazil City Hospital. The study was conducted between April and September 2018.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients at and over the age of 18
* Patients who were able to speak Turkish
* Patients who received spinal anesthesia

Exclusion Criteria:

* Patients who had not previously used guided imagery
* Patients any disease that could cause pain outside the surgery
Detection of Colistin-resistant Isolates From Patients of Intensive Care Units and Oncohaematology Wards.

The increasing use of colistin in multidrug resistant strains, as Enterobacteriaceae producing extended-spectrum β-lactamases or carbapenemases, is associated with the emergence of colistin resistant isolates. The main objective of this project is to estimate the diagnostic accuracy (sensitivity and specificity) of a new rapid detection test of colistin resistant strains (Rapid Polymyxin NP test) isolated in clinical settings.

For 15 years, the prevalence of the extended-spectrum β-lactamases producing Enterobacteriaceae (ESBLE), resistant to the 3rd generation cephalosporins, has constantly increased worldwide. Since 2010 an additional threat appeared with the emergence of the bacteria resistant to carbapenems, the antibiotic of choice in case of infection due to ESBLE. To treat the infection due to these extremely resistant strains, there are still only few molecules, as the colistin. Very quickly, the colistin resistance appeared, especially a plasmid-born resistance described in December 2015 and which has already spread a lot, most probably from an animal reservoir. The control of the resistance dissemination requires reliable tools for detection of colistin resistant isolates, in particular in immunocompromised patients, as those of intensive care unit (ICU) or oncohaematology ward, that are often exposed to multidrug resistant strains. Currently, the colistin resistance is difficult to detect and that is probably why it was underestimated for a long time and has already diffuse worldwide. Some recent tests for the detection of colistin resistant isolates have been developed and tested in laboratory. They have now to be evaluated in clinical situation in order to be correctly used and interpreted. From rectal swabs of patients admitted in ICU and oncohaematology ward, investigators will use first a new culture medium (SuperPolymyxin) for screening the colistin resistant Gram negative bacteria and then a new rapid test (Rapid Polymyxin NP test) to confirm this resistance. These tests will be compared to the reference test of MIC (Minimal Inhibitory Concentration) determined by the broth micro-dilution (BMD) method. The isolates will be collected on the screening medium, during 12 months, from 4 centers (Mont de Marsan, Limoges, Dax, Bordeaux) and sent to Bordeaux University Hospital where the rapid test and the BMD method will be centralized.

Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 18 years old
* patients admitted in ICU or in oncohaematology ward

Exclusion Criteria:

- Patients under protection of justice
Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck

To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment

Conventional radiotherapy (65-70 Gy, 1.8 Gy per day) concurrently with weekly cisplatin (40mg/m2) (group A, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2, after initial dose of 400mg/m2) (group B, n=25) is applied (in a 1:1 randomization ratio). Groups will be matched age, sex, PS, and disease site.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed HNSCC of oral cavity, larynx, oropharynx or
* hypopharynx; age of 18 years or more
* adequate liver (SGOT, SGPT, ALP ≤ 3x normal)
* kidneys (creatinine clearance ≥ 60ml/min
* heart (no arrythmias, no heart failure) and
* bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥ 100,000/μL) function
* ECOG performance status 0 or 1 and
* stage III or IVa to b with measurable lesions
* written informed consent

Exclusion Criteria:

* prior radiotherapy
* chemotherapy
* concurrent active malignancies
* pregnancy
* breast-feeding
Role of Sugammadex and Neostigmine for Recovery From Rocuronium

evaluation the reversal of neuromuscular blocking by sugammadex versus neostigmine through assessing the residual neuromuscular blocking effect by ultrasound imaging of expiratory muscle strength and diaphragmatic excursion.

All patients will be assessed preoperatively by careful history taking (history of allergy to rocuronium, neostigmine, or sugammadex), full medical history taking , ASA classification and surgical history Premedication with 2mg midazolam. Anesthesia will be induced with propofol 1-2 mg /kg and fentanyl 1-2 mic/kg. After calibration of TOF (train of four) rocuronium 0.6 mg/kg will be administered, and tracheal intubation will be performed in the absence of train-of four (TOF) count. Rocuronium 0.15mg/kg and Sevoflurane will be used for maintenance of anesthesia.

At the end of the surgery, patients in group A will receive sugammadex (2 mg/kg) and patients in group B will receive neostigmine (50 μg/kg, maximum 5 mg) combined with atropine (25 μg/kg, maximum 2.5 mg) after TOF counts at least exceeding 1 and extubation will be performed in the operating room when the patient is fully awake and fulfilled clinical criteria for extubation.

Diaphragm excursion (DE), reflecting the expiratory and inspiratory muscle strength, respectively, will be measured via ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiology (ASA) physical status classification I and II

Exclusion Criteria:

* 1. American Society of Anesthesiology (ASA) physical status classification III-V 2. renal impairment 3. Significant liver disease (Child-Pugh B or C class) 4. History of chronic obstructive pulmonary disease 5. Known or suspected neuromuscular disease. 6. Cardiac arrhythmia or use of antiarrhythmic drugs.