cyrilzakka/clinical-trials huggingface dataset:
Study With Heparin Sodium in Subcutaneous Administration

The purpose of this phase I study is to know the pharmacodynamic profile in humans of the sodium heparin of porcine origin of the company União Química, building from the pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of heparin directly in biological samples. In addition, the toxicity of the product will be evaluated in healthy male participants.

This stage of product development follows the guidelines of the ANVISA (National Health Surveillance Agency) Heparin Development Guide.

Unfractionated sodium heparin is a drug known and widely used in the world for over half a century, thus, no unknown adverse events or any risk of administration are expected in humans, however, this is the first human Biological product developed by União Química. The proposed development of this biological drug follows the individual route, the control heparin used in the present study has the objective of evaluating the results found with the test product, without the obligation to demonstrate bioequivalence among the evaluated products.

Eligibility Criteria:
Inclusion Criteria:

* Eligible healthy participants should sign the Informed Consent Form,
* be between 18 and 60 years of age,
* be male,
* present a BMI ≥ 18.5 and ≤ 29.9 kg / m2,
* be characterized as a voluntary (Normal physical examination)
* no history of current or recent diseases.

Exclusion criteria:

* hemoglobin \<12 g / dL;
* Platelets \<100 x 109 / L;
* Regular or last 30 days use of anticoagulant medications;
* Current or past use of anti-inflammatory or anti-platelet medications;
* History of gastrointestinal bleeding;
* History of venous thrombosis, pulmonary embolism, coagulopathies or any coagulation disorder;
* Any other chronic illness or regular use of drugs that at the discretion of the investigator contraindicates participation in the study,
* serious comorbidity (at the discretion of the researcher) of any nature that could compromise participation in the study or put the participant at risk considered to be unacceptable,
* Laboratory that at the discretion of the investigator contraindicates the participation of the participant in the study;
* Hypersensitivity or contraindication to the components of the medications studied, participation in another clinical study in less than 1 year (unless justified by the investigator)
* donation of blood (\> 500 mL) in the preceding 3 months.
500mg Fulvestrant Versus Exemestane in MBC

500mg Fulvestrant versus Exemestane in MBC

500mg Fulvestrant versus Exemestane in Metastatic Breast Cancer (MBC) resistant to adjuvant Non-steroidal Aromatase Inhibitors in clinical practice- a multicenter retrospective study

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman, age \> 18 years old
* Diagnosed with ER/PR+，HER2- Metastatic Breast Cancer
* Adjuvant treatment of Non-steroidal Aromatase Inhibitors
* First line of Metastatic Breast Cancer is 500mg Fulvestrant or Exemestane for at least one month, starting from 2014.01.01-2017.06.01
* Available medical history

Exclusion Criteria:

* Incomplete medical history
Flow Mediated Dilation in Response to Black Tea

Research indicate that people who regularly drink tea have a reduced risk of stroke or heart disease. In a number of studies in which people that normally do not drink showed that their blood vessels function improved when the drunk tea. The current study tests whether a specific black tea improves vessel function in non-tea drinking hypertensive subjects.

Epidemiological studies indicate that regular consumption of three cups of black tea per day reduces the risk of stroke or myocardial infarction. In a number of previous nutrition intervention studies tea has been shown to improve vascular function as assessed by Flow Mediated Dilation in various populations. The current confirmatory study tests a specific black tea against a placebo in a population of in non-tea drinking hypertensive subjects.

Eligibility Criteria:
Inclusion Criteria:

* Males and post menopausal (\> 1 year) females, not on hormone replacement therapy
* Aged \>18 and \< 65 years
* Body mass index (BMI) of \>=18.0 and =\<35.0 kg/m2
* Hypertension as previously diagnosed by primary care or hospital physician.

  * If untreated, office BP between 140/90 mmHg and 160/100 mmHg on screening
  * If treated, a controlled blood pressure (\<160/100) on stable medication for at least 4 weeks

Exclusion Criteria:

* Tea drinkers: having typically consumed \> 1 cup of black tea per week.
* Current smoker or has stopped smoking less than 6 months before start of study
* Self reported alcohol intake of \>21 units/week
* Established cardiovascular disease other than hypertension
* Clinically significant arrhythmia
* Diabetes mellitus
* Chronic Kidney Disease \> stage 2
* 10-year cardiovascular risk equivalent to 20% or greater using the QRisk2 calculator
* Abnormality of laboratory blood tests considered clinically significant
* Any other significant intercurrent condition/disease
Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache

The aim is to investigate whether opening of ATP-sensitive potassium (KATP) channels induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years of age upon entry into screening
* History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
* ≥ 4 monthly headache days on average across the 3 months prior to screening
* Provision of informed consent prior to initiation of any study-specific activities/procedures.

Exclusion Criteria:

* \> 1 mild traumatic injury to the head
* History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)
* History of moderate or severe injury to the head
* History of whiplash injury
* History of craniotomy
* History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
* Female subjects of childbearing potential with a positive pregnancy test during any study visit
* Cardiovascular disease of any kind, including cerebrovascular diseases
* Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
* Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
* Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
* Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
* Baseline headache intensity of \>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)
* Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features
Multinational Study of Acinetobacter Bloodstream Infection: Clinical Outcomes and Global Epidemiology-PITT Protocol

The objectives of this multinational study are to assess the clinical outcomes of patients with Acinetobacter bloodstream infection and to further assess the predictors of mortality in this patient population. We also aim to characterize the molecular epidemiology of this remarkable organism in an attempt to further understand its transmission dynamics on a global level and to determine whether increased pathogenicity is geographically dependent.

Medical records will be reviewed and information collected to assess the clinical outcomes of patients with Acinetobacter bloodstream infection and to further assess the predictors of mortality in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Acinetobacter infections

Exclusion Criteria:

* Those that do not meet entry criteria
Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

The purpose of this study is to determine the effectiveness of closed loop insulin pump therapy to control blood sugar following total pancreatectomy and islet auto-transplantation (TPIAT).

OBJECTIVES AND HYPOTHESES The main objective of this study is to determine if a closed loop insulin system can successfully achieve tighter blood sugar control than the current multiple daily injection regimen. The investigators hypothesize that the average blood glucose will be lower in the closed loop group than the control group, there will be less glucose variability in the closed loop group than the control group, and there will be less total time spent in hyperglycemia and hypoglycemia in the closed loop group than in the control group. The investigators also will investigate insulin requirements and islet function in the first 6 months post-transplant in the closed loop group The investigators hypothesize that the insulin requirements will be lower and the C-peptide levels higher in the closed loop group than in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total pancreatectomy and islet auto-transplantation.
* Patients ages 21 to 64 years old

Exclusion Criteria:

* Preexisting diabetes
* Use of acetaminophen during study period, which interferes with CGM sensor function
* Any medical condition requiring corticosteroids
* Severe Psychiatric disease or developmental delays, that might interfere with the ability to provide informed consent
* Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial
Ziprasidone in the Treatment of Borderline Personality Disorder

Objective: The aim of this double-blind, placebo-controlled study was to evaluate the efficacy and tolerability of ziprasidone in the treatment of adult patients with Borderline Personality Disorder (BPD).

Method: Sixty BPD patients were included in a 12-week, single-center, double-blind, placebo-controlled study. The subjects were randomly assigned to ziprasidone or placebo in a 1:1 ratio following a two-week baseline period. The Clinical Global Impression scale for use in BPD patients (CGI-BPD) was the primary outcome measure, and other scales and self-reports related to affect, behavior, psychosis, general psychopathology domains and clinical safety were included.

The American Psychiatric Association (APA) Guidelines for the Treatment of Borderline personality disorder recommend that pharmacological treatment for BPD has an important adjunctive role, especially for diminution of symptoms such as affective instability, impulsivity, psychotic-like symptoms, and self-destructive behavior. Studies conducted with low doses of conventional antipsychotics have showed significant improvements in specific symptoms such as hostility, impulsiveness, mood, and psychotic symptoms.

The introduction of atypical antipsychotics, with a more favorable tolerance profile, increases clinicians' options for treating BPD. Olanzapine has proven its efficacy in four double-blind, placebo-controlled clinical trials in patients with BPD. Ziprasidone is an atypical antipsychotic with a pharmacological action on serotonergic, dopaminergic and adrenergic receptors. It has proven to be effective for schizophrenia, schizoaffective and acute mania disorders and the incidence of side effects is low.

Although clinical findings and the pharmacological activity of ziprasidone suggest the drug may have therapeutic benefits in BPD patients, no controlled studies have yet been conducted in these patients. We carried out a randomized, double-blind, placebo-controlled study to evaluate efficacy and tolerability of ziprasidone in the management of BPD patients with moderate-high clinical severity.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of Borderline Personality Disorder
* Age between 18 and 45 years
* Clinical Global Impression of Severity (CGI-S)scores \>4

Exclusion Criteria:

* No comorbidity with schizophrenia, drug-induced psychosis, organic brain syndrome, alcohol or other substance dependence, bipolar disorder, mental retardation, or major depressive episode in course
* current use of medically accepted contraception in the case of female patients.
Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital

Febrile seizures are one of the most common clinical diseases in pediatric neurology. It occurs between 6 months and 6 years of age and occurs in \~2-5% of children. According to the age, frequency, duration, and type of seizures FS is divided into simple febrile seizures and complex febrile seizures Differentiation between febrile seizures and non-ictal events associated with fever such as shivering or dizziness is challenging. Therefore, precise diagnosis of FS after paroxysmal episodes associated with fever is often hindered by the lack of an objective biomarker With the widespread application of technologies, such as molecular biology, in medicine, some biomarkers for predicting or diagnosing FS have attracted attention. Imuekemhe et al in 1989 and 1996 found that lactic acid in the serum and cerebrospinal fluid of children with FS was significantly increased . Arginin-vasopressin hormone AVP released by the pituitary gland, has been shown to be involved in the thermoregulatory response to fever and convulsions Although AVP is unstable in the peripheral blood and, therefore, unsuited for diagnostic use the C-terminal portion of the AVP precursor copeptin has been recognized as a robust marker of AVP secretion . Wellman et al. found that the serum copeptin and Von Willebrand factor of children with FS were significantly higher than those of the control group .


Eligibility Criteria:
Inclusion Criteria:

* Age from 6 months to 6 years.
* Seizures.
* Fever (≥38°C).

Exclusion Criteria:

* Central nervous system infection.
* Epilepsy.
* Previous neurological abnormalities.
* Inborn errors of metabolism.
* Immunological diseases.
* Endocrinal diseases (e.g., diabetes mellitus).
* Obesity.
* Eating disorders.
* Gastrointestinal disorders (e.g., diarrhea).
Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users

Addiction to methamphetamine is a serious health problem in the United States. Right now, there are no medications that a doctor can give someone to help them stop using methamphetamine. More research is needed to develop drugs for methamphetamine addiction. Ibudilast (the study drug) is a drug that could help people addicted to methamphetamine.

Addiction to methamphetamine is a serious health problem in the United States. Right now, there are no medications that a doctor can give someone to help them stop using methamphetamine. More research is needed to develop drugs for methamphetamine addiction. Ibudilast (the study drug) is a drug that could help people addicted to methamphetamine.

The investigators are interested to know if the study drug can help some symptoms that methamphetamine can cause, specifically inflammation in the brain. Inflammation has been shown to affect decision-making. The study drug has anti-inflammatory properties, however it is not yet known whether the drug will reduce inflammation in the brain.

Eligibility Criteria:
Inclusion Criteria:

* abstinent from all drugs except marijuana and methamphetamine and have a negative urine drug screen on test days
* Meet diagnosis for recent Methamphetamine-Use Disorder (DSM-V) or does not meet any substance-use disorders

Exclusion Criteria:

* Known sensitivity to ibudilast
* Left handed
* MRI contraindications
* Clinically significant neurological, endocrine, renal, hepatic, or systemic diseases that would compromise safe participation or confound outcomes
* Any psychiatric diagnoses or primary psychotic or mood disorders (past depression diagnoses allowed)
* Any drug use disorder diagnosis besides methamphetamine or tobacco
* Any recreational or prescriptive use of psychotropic medications
* Claustrophobia
* Women who are pregnant or breast-feeding
* Neurodegenerative diseases that present with neuroinflammation
* More than 4 weeks abstinent from methamphetamine
* rs6971 genotype that confers low translocator protein (TSPO) binding affinity to prevent unnecessary radiation exposure
* Liver disease requiring medication or medical treatment and/or aspartate or alanine aminotransferase levels greater than 3 times the upper limit
* Participation in any drug study in the last 3 months
Analysis of Inhaled Corticoid Prescriptions in General Medicine

Chronic obstructive pulmonary disease (COPD) and asthma are frequent and disabling pathologies. The general practitioner is often at the front line vis-a-vis screening, diagnosis and treatment of these pathologies. There are currently many treatments available, in particular inhaled corticosteroids, and although the recommendations for management appear to be well codified in theory, the adaptation of drug therapy remains complex in general practice.

The prescription of inhaled corticosteroids, often initiated during a general medicine consultation, is not simple. The aim of this study is to analyze the relevance of the prescription of inhaled corticosteroids in primary care and to identify the criteria necessary for the prescription of inhaled corticosteroids available in general practice.

The main objective of our study is to evaluate the rate of consultations where all the elements required for guiding the prescription of an inhaled corticoid are available.

The secondary objectives are:

* Identify other factors associated with decision-making
* Identify the causes of inhaled corticosteroid stopping (de-prescription)


Eligibility Criteria:
Inclusion Criteria:

* Patient with short-term inhaled corticosteroid therapy
* Informed and not opposed to participate in this research

Exclusion Criteria:

* Patient under judicial or legal protection
* Adults under any kind of guardianship -
Outcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery

Due to the anatomic characteristics of the lower calyx, lower pole stones are difficult to be eliminated through the ureter, even if the stones had been fragmented. Retrograde intrarenal surgery (RIRS) can be used to deal with lower pole stones of 1.0-2.0 cm, while percutaneous nephrolithotripsy (PCNL) is mainly used to deal with lower pole stones with larger diameter or when RIRS failed to resolve the stone. This study was conducted to compare mini PCNL and retrograde intrarenal surgery (RIRS) for the management of lower pole kidney stones in terms of efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Renal stone at lower pole of size 10mm -20mm

Exclusion Criteria:

* Patients with positive urine culture,
* Patients with anatomical abnormalities determined by ultrasonography
* Uncontrolled diabetes (HbA1c \>9%)
* Patients undergone previous renal surgery
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).

Primary Objectives:

* To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs
* To determine the factors which are associated with the acute and long-term outcomes of redo TAVR

Eligibility Criteria:
Inclusion Criteria:

* BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR

Exclusion Criteria:

* BVF due solely to paravalvular regurgitation
* Active endocarditis
* Untreated acute valve thrombosis
* Life-expectancy less than 1-year
* Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
* Participating in another study that may influence the outcome of this study
A 2-year Clinical Impact of Bulk-fill Low-viscosity Resin Composite Liners in Class II Restorations.

This randomized clinical trial evaluated the clinical performance of class II resin composite restorations using bulk-fill high-viscosity ormocer versus methacrylate-based with or without a thin layer of bulk-fill low-viscosity (flowable) resin composite liners (BLRC) over 2 years. The null hypotheses in the study were as follows: (1) Different types of matrix structures (ormocer vs. methacrylate) have no effect on the marginal integrity of restorations; (2) A layer of bulk-fill resin compo-site liner of the same category would not affect the marginal or internal adaptation of restorations.

The study was designed following the Consolidated Standards of Reporting Trials (CONSORT) statement. approvement by the local ethics committee of Mansoura University code register was taken code M 11120520. The patients were selected as they searched for treatment in the Conservative Dentistry Department outpatient clinic, in the Faculty of Dentistry, Mansoura University. A group of 30 patients 21 Females and 9 males was chosen from among 92 participants after careful consideration of the inclusion and exclusion criteria. The sample size estimate was made based on the clinical success rate of posterior class II composite restorations observed in a prior study (97.5% at 24 months). The sample size needed per group was 23 teeth using a significance level of 0.05, power of 80%, and equivalency limit of 15%. A total of 30 patients were chosen, for a total of 120 restorations (30 for each group) after taking potential dropouts into account. To ensure adherence of the participants to the study, all volunteers underwent complete dental treatment and periodic follow-ups. The volunteers were contacted by telephone, WhatsApp message, Facebook, and e-mail for the assessments. Four attempts, including visits to the schools, were made to contact a volunteer before he/she was considered a "loss." both participants and examiners were blind to the interventions. An inter-examiner and intra-examiner agreement of at least 90% was requested before the beginning of the evaluation. Clinical evaluation was performed one week after finishing and polishing (baseline), after 6 months, 12 months, 18 months, and 24 months using the World Dental Federation (FDI) criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients having at least 4 posterior teeth with moderate occlusal-proximal carious lesions.
* Patients ranging in age from 18 to 30 years.
* patients with normal occlusion.

Exclusion Criteria:

General exclusion criteria:

* Patients having severe chronic periodontitis.
* Patients with orthodontic appliances.
* Abnormal occlusion, parafunctional habits.
* Allergy to any of the materials used in the study. Specific teeth exclusion criteria
* Teeth with irreversible pulpitis or non-vital.
* Fractured or cracked teeth.
* Previously restored teeth.
* Cavities with isthmus larger than intercuspal distance.
* Teeth with deep sub-gingival cavity margins.