cyrilzakka/clinical-trials huggingface dataset:
Management of Non Convulsive Status Epilepticus

Non convulsive status epilepticus is a persistent change in behavioural and or mental process from baseline associated with continuous epileptiform activity in electroencephalograph,it occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in intensive care unit patients

Early recognition and treatment of non convulsive status epilepticus are essential to optimize response to treatment and to prevent neurological sequelae, over diagnosis and aggressive use of anticonvulsants can contribute to morbidity and mortality.It displays great diversity in response to anticonvulsants,therefore treatment in intensive care units is required for selected cases .The aetiology and clinical forms are strong predictors for the overall prognosis.Treatment is poorly understood and follows the standard regimen for convulsive status epilepticus

Eligibility Criteria:
Inclusion Criteria:

* patients who have generalized tonic colonic convulsions and prolonged post ictal state more than 30 minutes
* patients presented with un explained psychic or speech disorder
* patients presented with stupor or confusion
* Patients presented with un explained coma

Exclusion Criteria:

* patients with progressive neurological disease
* Patients with severe cerebral anoxia
* Patients with liver or hepatic impairment
Hypnotherapy to Improve Coping With Stress

This prospective controlled study aims to test a 5 week group hypnosis training as intervention to improve coping with perceived psychological stress.


Eligibility Criteria:
Inclusion Criteria:

* Healthy or health-stable participants between 18 and 65 years with increased perceived stress for at least 3 months
* Perceived stress in the last week on the visual analog scale\> 40 mm (VAS 0 - 100 mm)
* Ability to consent and sign declaration of consent

Exclusion Criteria:

* Current or planned participation in a stress management exercise within the next 17 weeks
* Current use of psychotherapeutic treatment
* Presence of moderate or severe acute or chronic disease
* Presence of an acute or chronic mental disorder
* Participation in a study within the last 2 months prior to enrollment
* Lack of understanding of the German language
The Efficacy of Stellate Ganglion Block as Post-traumatic Stress Disorder (PTSD) Therapy: A Pilot Study

RATIONALE: A stellate ganglion nerve block may help relieve symptoms of post-traumatic stress disorder (PTSD).

PURPOSE: This pilot clinical trial is studying the efficacy of a stellate ganglion nerve block in veterans to reduce the symptoms of PTSD in relatively long-standing (Vietnam era) induced or relatively recently induced PTSD (from deployment in Afghanistan or Iraq as part of Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND).

Objectives:

1. Stellate ganglion blocks will be performed in a small sample (n = 12) of the local patient population that suffers from PTSD in order to replicate other preliminary findings.
2. The parameters that lead to a successful treatment response will be evaluated by comparing and contrasting the results obtained in younger (n=6) OEF/OIF generation veterans versus older (n=6) Vietnam generation veterans.
3. The individual difference variables that might lead to successful treatment responses will be studied by obtaining correlative measures of psychological and psychometric data and responses to standardized tests.

Research Design:

This is an open label unblinded clinical pilot case series study to determine the efficacy of stellate ganglion blockade for relief of PTSD symptoms in the Long Beach VA healthcare population.

Eligibility Criteria:
Inclusion Criteria:

* Include significant PTSD symptoms with severe hyper-arousal symptoms.
* Clinician Administered PTSD Scales (CAPS) score, with a total score ≥ 50 needed for enrollment.
* Hyper-arousal severity identified by a high score on the CAPS D scale and a ≥ 10 beat per minute increase in heart rate during the subject's verbal recollection of a standardized version of their traumatic exposure.

Exclusion Criteria:

* Include psychiatric and medical conditions that would make patients poor candidates for an outpatient procedure.
* Subjects must be able to be cooperative for the procedure and free of significant medical problems that would pose a constant threat to life.
Gastric Ultrasound in Elective Surgical Diabetic Patients

The aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients.

Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. The overall incidence of gastric content aspiration ranges between \<0.1% and 19% and aspiration pneumonia account for 9% of all anesthesia-related mortality. Mendelson described the pathophysiological mechanisms of pulmonary aspiration, which led to the development of strategies to prevent pulmonary aspiration.

Consequently, American Society of Anesthesiologists (ASA) released preoperative fasting guidelines for healthy patients undergoing elective surgery, in order to reduce gastric content volume and minimize the risk of aspiration. However, there are still many situations where the ASA fasting guidelines may be not suitable, including urgent or emergency situations and medical conditions such as diabetes mellitus.

Ultrasound is widely available and has been proven to be a reliable, bedside assessment tool for real-time evaluation of gastric contents. As diabetic patients are prone to have an inadequately empty stomach even after an adequate fasting, ultrasound can be used prior to induction for screening the fasting gastric volume (GV) of diabetic patients and see if it is more than the recommended safe limit.

As a novel point-of-care application, ultrasound sonography allows anesthesiologists to evaluate a patient's gastric content and volume at the bedside and helps guide anesthetic and airway management.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* Undergoing elective surgery.

Exclusion Criteria:

* American Society of Anesthesiology (ASA) physical status \>III.
* Body mass index (BMI) outside the range of 18.5-40 Kg/m2.
* History of upper gastrointestinal disease or previous surgery on the esophagus, stomach, or upper abdomen.
* Abnormalities of the upper gastrointestinal tract, such as gastric tumors and recent upper gastrointestinal bleeding (within the preceding 1 month).
* Taking preoperative medicines that may delay gastric emptying (e.g., anticholinergic agents, opioids).
* Hypothyroidism.
* Current smoking history.
* Pregnancy.
A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).


Eligibility Criteria:
Inclusion Criteria:

* Are ambulatory.
* Diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
* Participants have a history of back pain ≥3 months with age at onset \<45 years.
* In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS.
* If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization.
* Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

Exclusion Criteria:

* Have total ankylosis of the spine.
* Have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
* Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
* Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.
* Have a compromised immune system.
* Have any other serious and/or uncontrolled diseases.
* Have either a current diagnosis or a recent history of malignant disease.
* Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
* Are pregnant or breastfeeding.
NSAID Drug Interaction Study

This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and leinurad on the non-steroidal anti-inflammatory drugs.

Naproxen and indomethacin are non-steroidal anti-inflammatory drugs (NSAIDs) used both prophylactically for the prevention of, and as a treatment for, acute gout flares. RDEA594-126 is an open-label study designed to assess the potential effect of multiple doses of naproxen and indomethacin on the single-dose PK of lesinurad, and to assess the potential effect of multiple doses of lesinurad on the multiple-dose PK of naproxen and indomethacin.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
* Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
* Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values.

Exclusion Criteria:

* Subject has clinically significant pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
* Subject has a history or suspicion of kidney stones.
* Subject has a history of asthma.
* Subject has undergone major surgery within 3 months prior to Day 1.
* Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
The Aim is to Estimate the Total Amount of Insulin-producing Cells in the Pancreas by MRI.

Assess pancreatic beta cell function using MR imaging.

The study was terminated on July 31st, 2007. The study was discontinued, as we have not met the primary end point, differentiation between normal volunteers and subjects with type 1 diabetes mellitus. There were no safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Normal Volunteers
* T1DM and T2DM subjects

Exclusion Criteria:

* Concomitant severe conditions
A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma

The primary purpose of this study was to see how tasisulam-sodium affected metastatic melanoma when compared against paclitaxel as measured by overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Have a histologic and/or cytologic diagnosis of metastatic melanoma (Stage IV).
* Have the presence of evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
* Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
* Have progressed after 1 previous systemic treatment containing dacarbazine or temozolomide for metastatic melanoma.
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia).
* Have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) or greater than or equal to 30 grams per liter (g/L).

Exclusion Criteria:

* Have received greater than or equal to 2 previous chemotherapy-containing systemic treatment regimens for metastatic melanoma. An immunotherapy or antibody-based regimen (including biologic agents and vaccination-based treatments), or treatment with a targeted agent (for example, BRAF or c-Kit inhibitor is not counted as a prior treatment regimen for determining study eligibility, unless either was combined with a cytotoxic drug).
* Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. Participants with a history of a solitary CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) and not requiring steroids are eligible.
* Are receiving warfarin.
* Have primary ocular or mucosal melanoma.
* Any previous treatment with paclitaxel or a paclitaxel-containing regimen for metastatic melanoma.
* Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
* Have previously completed or withdrawn from this study or any other study investigating tasisulam-sodium.
* Have a known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil).
* Are pregnant or lactating.
* Have received a recent (within 30 days before enrollment) or are receiving concurrent yellow fever vaccination.
* Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
* Are unable to withhold dosing of non-steroidal anti-inflammatory drugs (NSAIDs) or proton-pump inhibitors (PPIs) for at least 72 hours before and after treatment with tasisulam-sodium.
Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities

Our hope is that the information from this retrospective study will provide information to better serve our patients and their parents with risk stratification (levels of risk) and clinical expectations of patients after cardiac surgery who have genetic abnormalities and those who do not have genetic abnormalities.

Screening for genetic/chromosomal abnormalities has become more frequent both pre-natally and post-natally. Therefore, we plan to review the outcomes in newborns with genetic abnormalities after cardiac surgery compared to those newborns without genetic abnormalities after cardiac surgery.

We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities. We will compare morality rates and co-morbidities in each group.

We will retrospectively review the cardiac surgical database and patient medical records for all neonates (newborns \< 30 days of age) who underwent cardiac surgery from January 1, 2002 through May 31, 2006 at Children's Healthcare of Atlanta. We plan to collect data on approximately 1000 patients including date of birth, age, weight, gestation, prenatal diagnosis, genetic abnormality, cardiac defect, surgery, operative details, pre-op and post-op complications, length of time on ventilator, hospital stay and mortality for these patients.

We will review the patient outcome data available after their initial surgery through May 31, 2006. No patients will be contacted.

Eligibility Criteria:
Inclusion Criteria:

* neonates (newborns\< 30 days of age)
* cardiac surgery between 1/1/02 - 5/31/06
* at Children's Healthcare of Atlanta

Exclusion Criteria:

* those who do not meet inclusion criteria
Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria®

This is prospective observational study of long-term pathogenic treatment of Elizaria® in patients with paroxysmal nocturnal hemoglobinuria.

Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare, acquired, life-threatening, progressive clonal blood disease that is developed as a result of the expansion of one or more clones of hematopoietic stem cells with a somatic PIG A gene mutation. The main pathogenic mechanism of PNH development is a dysregulation of the complement system, in which there are no complement inhibitors CD55 and CD59 that are bounded by the GPI-anchor on the surface of blood cells, or there is a deficiency of them.

Eculizumab is the first drug for the pathogenetic therapy of PNH, a recombinant humanized monoclonal antibody against the C5 component of complement. Binding with high affinity to C5, eculizumab prevents the cleavage of C5 into C5a and C5b, thereby inhibiting the formation of pro-inflammatory cytokines (via C5a) and Membrane attack complex (MAC) (via C5b).

Using of eculizumab in patients with PNH leads to a significant decrease in hemolysis, the incidence of thrombosis and increasing of the quality of life of patients. It increases life expectancy with long-term using of eculizumab.

The drug Eculizumab, developed by JSC "GENERIUM", Russia, is a biological analogue (biosimilar) of the original drug Soliris®.

The population of the study is the patients with an established diagnosis of PNH who have indications for pathogenic treatment and are receiving Elizaria®.

The study duration for each patient will be at least 54 weeks for previously treated patients, and 58 weeks for previously untreated patients, including the Screening period and the observation period.

The study will include the Screening Period and the Observation Period:

* Screening Period - 2 weeks (Days 1 - 14);
* Follow-up is 52 weeks for previously treated patients and 56 weeks for previously untreated patients.

The screening period can be extended until the results of laboratory and instrumental studies are obtained, but no more than 14 days.

During the observation period, for the purpose of routine examination, it is planned to conduct a number of intermediate visits, approximately every 8 weeks (an acceptable interval of 6-10 weeks) between the Screening Visit (Visit 1) and the Study End Visit (Visit 13) in accordance with the plan of the dispensary observation of the patient. Additional visits and examinations may be carried out by the decision of the research physician.

If the patient is previously untreated, the patient undergoes induction therapy with Elizaria® at a dose of 600 mg weekly for 4 weeks with a further transition to maintenance therapy at a dose of 900 mg from the 5th week and then every 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 2 years with an established diagnosis of PNH;
2. Prescribing Elizaria® as a pathogenetic therapy;
3. Signing by the patient of the informed consent form for participation in the study.

Exclusion Criteria:

1. Intolerance to eculizumab or other components of the drug.
PSOREAL - Managing PSOriasis in the REAL World

Multinational real-life study of current psoriasis treatment strategies, topical treatment patterns and treatment outcomes of these treatments, including the newly introduced calcipotriol/betamethasone dipropionate aerosol foam fixed combination product Enstilar® (calcipotriol/betamethasone dipropionate).

This multinational study aims to describe current treatment patterns and outcomes in the diversity of the real life setting: local differences in access to drugs and current treatment practices, and regional cultural differences, covering adult patients of all backgrounds, sex, socio-economic standing, health background, comorbidity and co-medication. A total of around 400 real-life prescribers in 3-8 countries are expected to participate over the years, with each country contributing data to the study for around 2 years, starting data collection within the first year after local market introduction of Enstilar®.

The real-life prescribing and utilization patterns of topical prescription products approved for treatment of psoriasis vulgaris in the individual participating countries will be mapped and performance of the products in real life will be investigated based primarily on baseline data from investigators and patient reported data contributed by the individual patient for 1 year. Patients are expected to enter data on their electronic device at baseline and at times of treatment changes and other key events, and investigators are expected to contribute data after each contact with the patient.

Patients will be approached for informed consent to participate in the study after their individual treatment plan has been decided. The study aims to include two patients on other topical treatment for every patient planned to receive Enstilar® in order to ensure a sufficient sample of Enstilar® treated patients to capture the diversity of real-life prescription patterns in patients not on Enstilar®, and to allow for sufficiently powered comparisons between Enstilar® and other real-world treatment strategies. A systematic approach will be used to select eligible patients to be approached for study participation in order to minimize selection bias and control seasonal variations.

Eligibility Criteria:
Inclusion Criteria:

* Adult age
* Psoriasis vulgaris
* Plaques on the body (trunk and/or extremities) of at least mild severity at time of inclusion
* Decision to prescribe a topical psoriasis treatment for body use where the prescription is NOT a routine renewal of the prescription of an ongoing therapy
* Signed and dated informed consent
* Willingness and ability to enter personal disease and treatment information onto a secure webpage during the one year individual study period, using their existing access to a PC or electronic device and a personal access code.

Exclusion Criteria:

* Participation in the active treatment phase of a clinical trial
* Previous enrollment in the study
IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases

This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.

This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.

All patients recruited will be randomly assigned into two groups. Patients in experimental group will receive daily IMRT at 45 Gy in 15 fractions to brain metastases, combined with daily erlotinib of 150mg for three weeks. Patients in control group will receive daily whole-brain radiotherapy at 30 Gy in 10 fractions.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed NSCLC and wild type EGFR
* 4-10 brain metastases on high quality CT scanning or MRI.
* No previous EGFR-TKI treatment.
* No previous brain radiotherapy.
* More than 4 weeks from last chemotherapy.
* Expected Survival of at least 2 months.
* KPS≥ 70
* RTOG RPA performance status 0-1
* Lab tests should meet these criteria: White blood cell count ≥3×10\^9 /L;Platelet count≥100×10\^9 /L;Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; Serum creatinine 1.5 times or less the ULN or creatinine clearance rate(CCR) greater than or equal to 60 ml/min.
* Pregnancy test (-)
* Be able to sign informed consent form.

Exclusion Criteria:

* With unstable systematical diseases (concluding acute infection, grade 4 hypertension, unstable angina pectoris, congestive heart failure, hepatopathy, nephropathy, metabolic diseases)
* With metastases on meninges.
* Taking antiepileptics (phenytoin sodium etc.) at the same time
* Unable to oral medication.
* Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ