cyrilzakka/clinical-trials huggingface dataset:
The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations

The relationship of developing metabolic acidosis with antiepleptic drugs in craniotomy operations

Metabolic acidosis is a life-threatening complication in the perioperative, intraoperative and postoperative period. It can cause decreased cardiac output, electrolyte imbalance, surgical bleeding and neurological complications, even coma and death in surgical patients.

Topiramate and zonisamide are sulfonamide derivative compounds used in the treatment of epilepsy. It has been shown in studies that both drugs have a strong inhibition of carbonic anhydrase enzyme. Recent case reports suggest that both drugs may cause metabolic acidosis by lowering serum bicarbonate levels in some patients.

Aim in this study is to determine the relationship between preoperative, intraoperative and postoperative metabolic acidosis and to emphasize the importance of anesthesia management in patients who have undergone craniotomy and use antiepileptic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing intracranial surgery with craniotomy and using antiepileptic drugs
* ASA I-III
* Patients undergoing elective surgery

Exclusion Criteria:

* Patients with a surgical procedure time of more than 5 hours
* Patients who received more than 2 units of blood transfusion during the operation
* Patients taking other drugs that can cause metabolic acidosis
* Patients with diabetes mellitus, diabetes insipidus, hepatic or renal disease
Evaluate DF-003 in ex Vivo Assays Using Peripheral Blood Mononuclear Cell From Subjects With ROSAH Syndrome

Alpha-1 kinase (ALPK1) has been reported as a potential causative gene for ROSAH Syndrome.

Genetic variants including T237M have been found in ROSAH Syndrome patients. Our in-house study has found that T237M mutation leads to hyperactivity of ALPK1, which may be the cause of the inflammatory syndromes found in ROSAH Syndrome patients. We hypothesize that T237M mutation ALPK1 cause ROSAH Syndrome and an ALPK1 inhibitor can be a potential therapy for treating this disease. To test our hypothesis, we designed an experiment in which ex vivo peripheral blood mononuclear cells (PBMCs) from ROSAH Syndrome patients will be exposed to a potent ALPK1 inhibitor (DF-003) or placebo. We expect to see downregulation of activated inflammatory genes, chemokine/cytokines and acute phase proteins in the ROSAH Syndrome patient samples that are exposed DF-003.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged over 18
* Patient with ROSAH syndrome with the confirm T237M mutation

Exclusion Criteria:

* person under legal protection or under protectives measures
* person unable to express consent
* person in emergency situation (vital or not)
* person infected by Human Immunodeficiency Virus and/or Hepatitis B Virus and/or Hepatitis C Virus
An Evaluation of Healthcare Providers' Adherence to Pharmacovigilance Practices in an African Community

Egypt's several regions-rural, mixed, and urban-were given pre-designed surveys pertaining to drug adverse events and the role of pharmacovigilance in detection and reporting. The three sections of the survey were dedicated to studying health care professionals' knowledge concerning pharmacovigilance concepts and practices, as well as demographics and people reported or not reported. The survey also asked more questions regarding adverse occurrences that were reported.


Eligibility Criteria:
Inclusion Criteria:

* all health care providers are invited to share in the study
* minimum experience required is one year in health carrier.
* accept sharing in the study

Exclusion Criteria:

* health care providers who refuse to complete all data required in the survey.
* fresh experience or participants who left health carrier
Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

This pilot study will evaluate Scrambler therapy and Sham treatment on levels of low back pain, pain sensitivity and mRNA expression of pain sensitivity candidate genes.

This pilot study will evaluate the feasibility of the experimental protocol and provide sufficient pilot data to estimate statistical power and sample size requirements. The study will include 30 individuals (15 per group) diagnosed with persistent low back pain who will receive a standard protocol of Scrambler therapy or sham treatment. Participant data will include subjective measures of low back pain, pain sensitivity using quantitative sensory testing, and mRNA expression levels of pain sensitivity candidate genes at baseline (prior to treatment) and 1 and 3 weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* be 18-50 years of age
* diagnosed with persistent nonspecific LBP
* comprehend English

Exclusion Criteria:

* \<18 or \>50 years of age
* chronic pain at another site or associated with a painful condition
* pregnant or within 3 months post-partum
* implanted drug delivery system
* heart stents or metal implants such as pacemakers, automatic defibrillator, aneurysm clips, vena cave slips, or skull plates
* history of myocardial infarction or ischemic heart disease within the past six months
* history of epilepsy
* skin conditions such as open sores that would prevent proper application of electrodes
Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

A multicentre, prospective observational study to develop, evaluate and validate Patient Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic cardiac arrhythmias

This study aims to develop, evaluate and validate disease specific PROMs for patients in the UK treated with cardiac ablation for cardiac arrhythmias. The potential benefits include support for clinicians to improve their performance, assisting patients in making informed choices and strengthening audit and research.

Phase 1 of the study will involve patient interviews with approximately 30 patients from 2 sites. These, together with input from a multidisciplinary team, will aim to improve drafts of disease specific questionnaires. This will be followed by Phase 2 which will trial the questionnaires in a group of approximately 600 patients from three sites. In Phase 2 patients will be asked to complete a pre-procedure questionnaire relating to their symptoms, quality of life and procedure expectations. They will also be sent post-procedure questionnaires relating to procedural outcomes, symptoms and quality of life at 8-16 weeks post procedure and at 1 and 5 years post-procedure.

The responses obtained from these PROMs will be used to undertake recommended statistical tests of reliability and validity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic cardiac arrhythmias
* Consented to and awaiting a cardiac ablation procedure
* Able to read, write and understand English or Welsh
* Capable of giving informed written consent

Exclusion Criteria:

* Not able to read, write and understand English or Welsh
* Not able to provide informed written consent
Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke

The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

Intravenous thrombolysis with alteplase is recommended in treatment guidelines for patients with acute ischemic stroke. Previous studies showed that intravenous tenecteplase (0.25 mg/kg) is a reasonable alternative to alteplase for all patients presenting with acute ischemic stroke who meet standard criteria for thrombolysis. After thrombolysis-induced recanalisation, reocclusion occurs in 14-34% of patients, probably because of platelet activation. Early administration of antiplatelet therapy after intravenous thrombolysis could reduce the risk of reocclusion and improve outcome. The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

Age 18-80 years Ischemic stroke with measurable deficit on NIH Stroke Scale Treatment within 4.5 hours of stroke onset Be able to engage in daily life independently before the onset of this ischemic stroke (mRS score: 0-1) Patients awakening with symptoms are defined by the time last observed normal Written informed consent by patient or proxy

Exclusion Criteria:

Patients with premorbid modified Rankin Scale (mRS) score ≥3 Patients for whom a complete NIH Stroke Score cannot be obtained Hemiplegic migraine with no arterial occlusion on CTA Seizure at stroke onset and no visible occlusion on baseline CTA Intracranial haemorrhage on baseline CT Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal Large areas of hypodense ischaemic changes on baseline CT Patients with systolic blood pressure \>185 mm Hg or diastolic blood pressure \>110 mm Hg Female, pregnant or breast feeding Known bleeding diathesis Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist Use of oral anticoagulants and International Normalized Ratio (INR) ≥1,4 Use of new oral anticoagulants (NOAC) within the last 12 hours Heparin \<48 hours and increased Activated partial thromboplastin tike (APTT) Low molecular weight heparin(oid) \<24 hours Any other investigational drug \<14 days Sepsis Patients with arterial puncture at a noncompressible site or lumbar puncture \<7 days Major surgery or serious trauma \<14 days Gastrointestinal or urinary tract hemorrhage \<14 days Clinical stroke \<2 months History of intracranial haemorrhage Brain neurosurgery \<2 months Serious head trauma \<2 months Pericarditis Any serious medical illness likely to interact with treatment Confounding pre-existent neurological or psychiatric disease Unlikely to complete follow-up Pregnancy
Renalase(rs10887800) Genotyping & Leucocytes Telomere Length in Postpartum. Hypertension

This is an observertional study aimed at Study the association between Renalase(rs10887800) Genotyping \& Leucocytes telomere length in patients with postpartum hypertension whether new onset( denovo) or persistent following pregnancy complicated by hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are18 years or above, and have a diagnosis of postpartum hypertension(regardless of where they received their antenatal care) attended to Sohag university hospitals

Exclusion Criteria:

* All pregnant women with medical disorders in pregnancy other than Hypertensive disorders during pregnancy (e.g., sickle cell disease, heart disease, kidney and other connective tissues disorders) will be excluded from the study. Also we excluded measurements taken during scheduled or unscheduled surgical encounters given potential for interaction with anesthetic agents
Safety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

The purpose of this study is to assess the safety and efficacy of bimatoprost in patients with glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of glaucoma or ocular hypertension in both eyes
* Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

* Uncontrolled medical conditions
* Ocular seasonal allergies within the past 2 years
Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

Pilot study for assessing the effectiveness of a Navigator program to aid in clinical trial participation amongst the Chinese demographic


Eligibility Criteria:
Inclusion Criteria:

Cancer patients for Focus Group must meet the following criterion:

* diagnosis of any gynecologic or breast cancer and be pursuing treatment here at Stanford within the last 2 years
* must read and speak Chinese
* willing and able to participant in group discussions

Cancer patients to receive Navigator Support must meet the following criterion:

* Newly diagnosed with gynecologic or breast cancer -pursuing treatment at Stanford Cancer Center
* must read and speak Chinese
* willing and able to have an individual relationship with a Navigator

Health Professional must meet the following criterion:

-must currently work in the Stanford gynecologic Oncology Clinic

Navigators must meet the following criterion:

* Chinese and English speaking
* willing and able to participate in training and to serve as a Navigator
* preferably a Cancer survivor

Exclusion Criteria:

Cancer patients must have a GOG performance status of 0-2 (see attached document for further details). Focus Group participate MAY be able to be participating in another study but patients who are already participating in a clinical trial will not be assigned a Navigator.

No Exclusionary criterion for Health Professionals or Navigators.
Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)

The goal of this cluster randomized controlled trial is to determine the optimal treatment for community aquired pneumonia (CAP). The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 18 years old diagnosed with severe CAP. The main question is whether there is a difference in all cause mortality within thirty days.

Participants will be randomized to receive treatment with either hydrocortisone or prednisolone.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosis of severe CAP for who the physician in charge decides for corticosteroid therapy for severe CAP.

Exclusion Criteria:

* Admitted \>24 h
* Pregnant or breastfeeding women
* Active tuberculosis or fungal infection
* Pneumonia caused by influenza
* Intolerance to either study drug
Tissue Drug Levels of HIV Medications

The aim of this study is to find out why HIV continues to make copies in people taking HIV drugs. The investigators want to know if the medications most people use to treat HIV get into the lymphatic tissue where HIV persists.


Eligibility Criteria:
Inclusion Criteria:

* HIV+
* Treatment naive or \>30 days off ARV therapy
* Documented sensitivity to prescribed antiretrovirals
* Age ≥ 18 years
* Negative pregnancy test for eligible women of childbearing potential
* Ready to start ARV therapy

Exclusion Criteria:

* Contraindications to surgical \& endoscopy procedures (as judged by PI)
* Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
* Pregnancy
Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

The purpose of this study is to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.

This is a prospective double arm study aiming to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.

Dapagliflozin will be prescribed in a group of randomly selected patients in addition to the optimized medical therapy for heart failure with reduced ejection fraction.

Changes in quality of life indicators, symptoms, biohumoral markers, exercise capacity and echocardiographic parameters of systolic right ventricular function will be evaluated in comparison with the control group, which will continue standard heart failure therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18years
* Optimal medical therapy or at least 3months
* Systemic right ventricle ejection fraction≤40%, assessed on echocardiography

Exclusion Criteria:

* Univentricular physiology
* Systolic blood pressure\<90mmHg
* Glomerular filtration rate(GFR)\<30ml/min
Observational Study Aimed at Evaluating the Trend of Neuropathic Pain

The present study aims to evaluate the trend of neuropathic pain in patients treated with Peacetil for a period of two months.

Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score.


Eligibility Criteria:
Inclusion Criteria:

* Patients with new or recent diagnosis of acute or chronic neuropathic pain in which the clinician decides to introduce treatment with PEACETIL according to common clinical practice, belonging to one of the following categories:
* Dysmetabolic polyneuropathy (e.g. diabetic neuropathy),
* Chemotherapy treatment neuropathy,
* Compressive mononeuropathy,
* Radiculopathy,
* Postherpetic and non-postherpetic trigeminal neuralgia;

  * The patient must be able to understand the informed consent of the study;
  * Must adhere to the procedures established by the study;
  * DN4 score \>4 at T0 (month 0);

Exclusion Criteria:

* Neurological disorders confounding the primary objective;
* Clinical condition which during the observational study requires the introduction or modification of the dosage of drugs which are also indicated for the treatment of acute or chronic pain
* Introduction or modification of the dosage of drugs used to treat acute and chronic neuropathic pain (including other nutraceuticals) from 30 days before the start of the study until the end of the study.
* Presence of unstable psychiatric illness, cognitive impairment, dementia, or substance abuse that would compromise the participant's ability to provide informed consent, as judged by the investigator;
* Clinically significant unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, serious laboratory test abnormality, or clinically significant ECG changes) that would pose a risk to the participant if they were to participate in the study, in the judgment of the 'investigator.
The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients

Adequate sleep is an important aspect of any healing process, and because it is known that children recovering from burns suffer long term sleep disruptions, the investigators believe that Healing Touch may improve the quality and quantity of sleep in the pediatric burn population.

This study examines the impact of Healing Touch on the quality and quantity of sleep in pediatric burn survivors. Polysomnography recordings are obtained in order to assess nocturnal sleep in conjunction with Healing Touch; which is done on 1 of 2 nights during Polysomnography. Soft background music is played on both nights.

Healing Touch is performed by one of 2 Healing Touch Certified Practitioners.

Eligibility Criteria:
Inclusion Criteria:

1. All pediatric patients (from 5 to 21 years of age) admitted for treatment (following an acute burn injury) to Shriners Hospitals for Children - Cincinnati Burns Hospital will be screened.
2. Include electrical, flame, scald and chemical burns.
3. Signed informed consent

Exclusion Criteria:

1. Patients admitted for treatment unrelated to a burn injury.
2. Patients admitted for less than 2 nights.
3. Patients with face and head grafting if they interfere with the lead placements
4. Neurological disorder
Impact of Diet on Functional Gastrointestinal Symptoms

This cross-sectional survey study is to determine the prevalence of functional gastrointestinal (GI) disorders in the general population and to describe common triggers for food-related GI symptoms.

Functional gastrointestinal disorders, involving symptoms such as gas/bloating, diarrhea, constipation and abdominal pain, are estimated to impact between 35 and 45 million Americans, an overwhelming 15-20% of the population. These symptoms are responsible for upwards of 20 billion dollars in healthcare costs and extensive loss of quality of life for sufferers. Moreover, many patients suffer in silence, with 67% of subjects waiting more than a year before treatment, and 11% waiting over 10 years. Irritable bowel syndrome is the most prevalent functional gastrointestinal disorder, and several recent studies support the idea that dietary modifications may be key to alleviating this condition.

The purpose of this study is to document gastrointestinal symptoms among the US population, as well as to ascertain awareness and utilization of dietary treatments that exist.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Visual impairment
* Inability to read
* Inability to understand English
* Inability to use a computer to respond to questions.
The Effect of Orally Administrated Nitrate on Renal Parameters and Systemic Haemodynamics

Treatment with nitrate has shown to lower blood pressure in both healthy subjects and hypertensive patients.Beside this nitrate have also shown to decrease arterial stiffness and improve endothelial function.But the effect of nitrate on renal blood flow, kidney function, water and salt balance and vasoactive hormones is still unclear.

Therefore, the purpose of this study is to investigate the effect of orally administered nitrate on these parameters.

This will be done in a double-blinded, placebo-controlled, crossover study. 20 healthy subjects will be treated, in a randomized order, with both potassium nitrate and placebo separated by at least 4 weeks wash-out.

Inorganic nitrate reduces blood pressure and improves endothelial function in both healthy subjects and hypertensive patients.

This effect is thought to be caused through bioconversion to nitric oxide. Thus improving risk factors of cardiovascular decease by increasing vasodilatation, salt regulation and vasoactive hormones.The purpose of this study is to investigate the effect of inorganic nitrate on kidney function, hormones and circulation, which is still unknown.

The effect of 4 days treatment with 24 mmol potassium nitrate capsules on heart rate, blood pressure, vasoactive hormones and urinary excretion of sodium and water will be measured in a randomized, placebo controlled, double blinded, crossover study in 20 healthy subjects. Each subject attends 2x2 examination days at least 4 weeks apart. The examination days are divided into 8 clearance periods of 30 min. each. The first 3 are baseline periods and in period 4 1 Liter of saline is administered to detect any difference in renal parameters after NaCl load.

If inorganic nitrate supplementation is found to lower blood pressure in addition to favorable renal effects, it could lead to changes in the general treatment of high blood pressure and cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-64 years
* BMI 18,5-30
* Normotensive
* Women must use contraception

Exclusion Criteria:

* Tobacco smoking (Non-smokers in more than 3 months can be included)
* Medicine- or drug abuse
* Alcohol abuse \>7 units for women \>14 units for men
* Medical treatment (over the counter medication will evaluated whether or not it is grounds for exclusion) within 2 weeks before the trail period starts except contraception.
* Pregnancy or nursing
* Neoplastic disorders
* Significant clinical signs of heart-, lung-, liver-, kidney-, endocrine- or brain disorders
* Clinically significant abnormal findings in screening blood samples, urine sample or ECG - Donation of blood within 1 month of the first day of investigation.
* Allergy against compounds in investigational medicine