cyrilzakka/clinical-trials huggingface dataset:
Medtronic Resolute Onyx 2.0 mm Clinical Study

The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries that allows the use of a 2.0 mm diameter stent.


Eligibility Criteria:
Inclusion Criteria:

* Must be an acceptable candidate for percutaneous coronary intervention, stenting, \& emergent coronary artery bypass graft (CABG) surgery
* Must have evidence of ischemic heart disease
* Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent
* Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)

Exclusion Criteria:

* Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
* History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
* History of a stroke or transient ischemic attack (TIA) within the prior 6 months
* Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Concurrent medical condition with a life expectancy of less than 12 months
* Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
* Documented left ventricular ejection fraction (LVEF) \< 30% at the most recent evaluation
Yoga Training in Allergic Rhinitis Patients

The purpose of this study was to investigate effects of yoga training on rhinitis symptoms and cytokines in allergic rhinitis patients. Twenty-seven allergic rhinitis patients, aged 18-45 year old, were randomized into 2 groups: control group (CON; n=14) and yoga group (YOG; n=13). The control group had normal life and the yoga group was required to complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-test and post-test. The dependent variables between pre-test and post-test were analyzed by a paired t-test. The dependent variables between groups were analyzed by independent t-test. One way repeated measures ANOVA was used to compare the variables among pre-test, after 4 weeks, and after 8 weeks. Differences were considered to be significant at p \< 0.05.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of allergic rhinitis diseases
* Clinical symptoms of persistent rhinitis (nasal congestion, sneeze, nasal itching, and running nose) for more than 4 days per week.
* Positive skin prick test (wheal diameter\>3 mm.) to house dust mite (D. pteronyssinus) and using normal saline as the negative control.
* Stopped taking all medicine before the study such as antihistamine for at least 3 days, oral steroid and nasal steroid for at least 2 weeks and luekotriene receptor antagonist for at least a week prior to the study, but the patients could take pseudo ephedrine.
* Subjects were not to have participated in a regular exercise program for at least 6 months prior to the start of the study, and to avoid taking any form of dietary supplement during the course of the study.

Exclusion Criteria:

* Asthma
* Chronic rhino-sinusitis
* Hypertension
* Cardiovascular diseases
* A smoking habit
Allergy and COVID-19 Vaccines

Prospective and retrospective multicenter study to estimate the proportion of patients who tolerated continuation of COVID-19 vaccination (absence of anaphylactic manifestations).

secondly, to determine the proportion of definite anaphylactic reactions in cases of suspected anaphylaxis following administration of a COVID-19 vaccine.

Comprehensive allergological investigations involving clinical, skin and biological tests will enable us to determine whether or not vaccine components, and in particular excipients (PEG2000, PS80 and tromethamine), are responsible for anaphylactic reactions to COVID-19 vaccines.

A biological collection will be set up during this clinical study to study the immunological mechanisms, effector cells and signalling pathways involved in these reactions.

Eligible patients will be identified via the pharmacovigilance centers and allergology hotlines set up in each center, according to the organization specific to each hospital site. .

The patient identified in this way will be contacted by the secretariat of each allergology center to schedule an allergology consultation at least 3 to 5 weeks after the reaction (the usual delay before exploring an anaphylactic reaction to avoid the risk of false negatives). Then, in the framework of a collegial meeting ,the patient's file will be reviewed in order to specify the history of the allergic disease and the modalities of subsequent COVID-19 vaccination.

A follow-up telephonique call at 6months will be made systematically for patients who have continued vaccination to ensure that there are no significant adverse events related to the COVID-19 vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Anaphylactic reaction to a COVID-19 vaccine administered by Pfizer-BioNtech or Janssen or Vaxzevria or Moderna, at least 3 weeks old at the time of the allergology consultation.

An anaphylactic reaction is defined as the occurrence of any of the following systemic manifestations within a few hours of administration of a COVID-19 vaccine:

* skin rash with urticaria and/or angiodema,
* and/or associated with respiratory signs (dyspnea, bronchospasm, desaturation), and/or digestive disorders (intense abdominal pain, diarrhea, vomiting, nausea), and/or neurological disorders (loss of consciousness, feeling of malaise), and/or hypotension, tachycardia.
* Affiliation to a Social Security system
* Signature of the informed consent
* Stop taking antihistamines at least 3 days before skin allergy tests are performed

Exclusion Criteria:

* Other non-anaphylactic systemic reactions after administration of COVID-19 mRNA vaccine (serum sickness, vasculitis, Guillain-Barré syndrome)
* Pregnancy and lactation
* Disorders of hemostasis or severe bleeding considered a contraindication to intramuscular injection
Effect of Exercise on Heart Function in Healthy Elderly People

The purpose of this study is to determine the effect of aerobic interval training on left- and right ventricular diastolic- and systolic function on healthy, sedate people over 70 years. The old sedate cohort will be compared to young, sedate subjects also performing aerobic interval training and old master athletes without intervention.

Aging is associated with a reduced diastolic and systolic function of the heart. Earlier studies have shown that physical exercise can improve both systolic and diastolic function. However the impact on age-related cardiac function is to some extent conflicting. The use of different training intensities will impact on the cardiac result. We have in earlier studies shown aerobic interval training at 90 % of maximal heart rate (4x4 minutes) to have more impact on cardiac function, endothelial function and maximal oxygen uptake compared to moderate intensity.

To our knowledge the effect of aerobic interval training on cardiac function has not been studied in an old, sedate group before.

Eligibility Criteria:
Inclusion Criteria:

* over 70 years, healthy
* not exercising more than twice per week

Exclusion Criteria:

* chronic illness
* chronic use of any medication
* regular smoking
* metabolic or cardiovascular diseases
An Exploratory Trial Investigating the Neurogenic Component in Psoriasis Vulgaris by Use of Botulinum Toxin A

The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum toxin type A compared to that of injected vehicle.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above
* A diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk
* Chronic stable psoriasis vulgaris diagnosed more than 6 months prior to screening.
* Women must use a reliable contraceptive during the trial.

Exclusion Criteria:

* Pregnant or breast feeding women, or women planning to become pregnant.
* Skin infection at injection sites
* Use of biological therapies or small molecules (marketed or not marketed) with a possible effect on psoriasis vulgaris
* Use of systemic treatments with a potential effect on psoriasis vulgaris
* Exposure to phototherapy within 4 weeks for PUVA and 2 weeks for UVB prior to Randomisation
* Use of potent or very potent (WHO group III-IV) corticosteroids for topical treatment of psoriasis within a 4 week period prior to randomisation
* Use of muscle relaxants
* History of dysphagia or aspiration
* Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Tobacco Use in Opioid Agonist Treated Pregnant Women

The primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during pregnancy in methadone treated women. In addition, the impact that this intervention has in reducing the incidence and severity of methadone associated neonatal abstinence syndrome will also be examined.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed pregnancy
* Treatment entry at or before 31 weeks EGA
* Expected to enter drug-free outpatient modality at CAP
* Placed on methadone pharmacotherapy
* Nicotine dependent
* Sufficient literacy and understanding for assessment procedures
* Expected availability for study duration (e.g., complete inpatient stay)
* Able and willing to provide informed consent
* At least 18 years of age
* Confirmed smoker of 10 or more cigarettes

Exclusion Criteria:

* Not pregnant
* EGA of 32 weeks or greater
* 17 years of age or younger
* Undergoing detoxification (non-methadone treatment)
* Unable to provide informed consent
* Currently receiving nicotine replacement products (NRT)
* Current diagnosis of alcohol or benzodiazepine dependence
* Severe medical or psychiatric concomitant conditions that would interfere with treatment or require extended hospitalization.
Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

The investigators will test whether hypotonic (diluted) remodulin solution causes less pain than the eutonic (undiluted) solution supplied by the manufacturer.


Eligibility Criteria:
Inclusion Criteria:

* PAH by standard criteria
* Treatment with subcutaneous remodulin infusion for at least 3 months, with stable dose for 1 month
* Pain at infusion site (defined as \> 8 on McGill Pain Questionnaire)

Exclusion Criteria:

* Known pregnancy or breastfeeding
Prediction of Childhood Epilepsy Outcome in Bangladesh

Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood epilepsy in Bangladesh with particular reference to behavioural side effects.


Eligibility Criteria:
Inclusion Criteria:

* Active epilepsy
* Aged 2-15 years

Exclusion Criteria:

* Excluded absence
* Myoclonic and malignant epilepsy syndromes
* Major motor and cognitive impairments
* Those currently receiving antiepilepsy drugs.
Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers

The purpose of this trial was to evaluate the safety and tolerability of a galenic formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy man or woman, between 20 to 70 years
* Fit to work
* Volunteers have given informed consent and signed the consent form

Exclusion Criteria:

* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, disorders of the calcium metabolism, hypervitaminosis A or D, psychic disorder, etc)
* Treatment with other drugs that might interfere with the evaluation of the safety of the test drug
* Known hypersensitivity to any ingredients of the study drug
* Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive
* Drug and alcohol abuse
* Participation in another trial
* Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)

This is a two-part dose-finding trial of MK-7680 in participants with Hepatitis C Virus (HCV) infection of genotype (GT)1 (Part I) and GT3 (Part 2). The primary hypothesis is that daily administration of a safe and well tolerated dose of MK-7680 will produce a decrease in HCV viral load.

Parts 1 and 2 will each consist of 4 panels. In the first panel, a 200 mg dose of MK-7680 will be administered. In each of the following 3 panels, higher or lower doses of MK-7680 will be administered. Each panel will only begin once the safety and tolerability data from the preceding panel have been evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Is in good health except for HCV infection
* Is male or is a female of non-childbearing potential
* Clinical diagnosis of HCV GT1 or GT3 with no evidence of mixed-GT or non-typeable infection

Exclusion Criteria:

* Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary, or major neurological abnormality or disease
* Has a history of cancer
* Has a history of significant multiple and/or severe allergies
* Is positive for hepatitis B or human immunodeficiency virus
* Has had major surgery, donated or lost 1 unit (500 mL) of blood within 4 weeks prior to screening
* Consumes more than 2 alcoholic beverages per day or is currently a regular user of any illicit drug(s) or has a history of alcohol/drug abuse within 12 months prior to screening
* Has chronic hepatitis not caused by HCV (e.g., nonalcoholic steatohepatitis \[NASH\])
* Has clinical or laboratory evidence of advanced or decompensated liver disease, or evidence of bridging or higher grade fibrosis
A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation

Proper preoperative sedation can reduce patients' anxiety, enhance patients' cooperation and reduce perioperative complications. The investigators would explore the sedative effects of dexmedetomidine (DEX) with the administration of oral, intravenous and nasal drops, and detect DEX blood concentration in 15 participants, respectively. Pharmacokinetic parameters are detected at 8 time points ( before DEX administration, 10 min, 20 min, 30 min, 45 min, 60min, 90min and 120 min after administration). 3 ml arterial blood was collected at each time point. The blood samples are detected by mass spectrometer. The aim of this study is to investigate appropriate administration time and route for DEX sedation.


Eligibility Criteria:
Inclusion Criteria:

* 45 participants who undergo tympanoplasty would be enrolled after signment the informed consent.

Exclusion Criteria:

* The participants were excluded with any diseases about respiration, circulation, liver and kidney.
A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery

Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.

"Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing traditional cataract surgery.

Exclusion Criteria:

* Patients with unusual ocular conditions.
Twinrix Pregnancy Registry

The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy.

This is a prospective, voluntary, observational, exposure-registration study. Twinrix is designated as Food and Drug Administration (FDA) Pregnancy Category C, which means that its safety in human pregnancy has not been determined. The Registry is intended to provide an early signal of potential risks in advance of results from formal epidemiologic studies. Registry statistics can supplement animal reproductive toxicology studies and assist clinicians in evaluating the potential risks and benefits of vaccination for individual patients.

The Twinrix Pregnancy Registry will be maintained by GSK Vaccines Clinical Safety and Pharmacovigilance. Enrolment in the Registry will begin at the time of commercial launch of Twinrix in the United States (US). At the time of initiation of the Registry, pre-existing reports of pregnancy from clinical trials will be evaluated and enrolled when the criteria for registration are met. Reporting of exposed pregnancies is voluntary. Pregnancies will be registered following maternal exposure to Twinrix within 28 days prior to conception or during pregnancy. Registration of pregnancies is prospective, i.e., reported during pregnancy before the pregnancy outcome is known. Retrospective reports, in which the pregnancy outcomes are known at the time of reporting, will also be reviewed to assist in the detection of any unusual patterns that may exist among the reported birth defects. However, because there is no denominator from which risk can be calculated, these reports will be excluded from the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Documentation that Twinrix was administered ≤ 28 days before or during pregnancy;
* Confirmation that the pregnancy is being prospectively reported;
* Report made by a patient or a health care professional;
* The timing of the prenatal exposure to Twinrix (no broader than during which trimester);
* A patient identifier that will allow follow-up to be obtained so that the pregnancy outcome can be ascertained;
* Whether the patient was involved in a clinical trial at the time of the exposure;
* Full reporter contact information.

Exclusion Criteria:

-
Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

The survey is a retrospective study to evaluate the prognotic value of EGFR expression, KRAS mutations and tumor sideness in patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.

Primary objective:

Progression-free survival

Secondary objecive:

Overall survival, best objective response, disease control rate and adverse events

Number of Subjects: 41 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.

Plan of the Study:

1. This is a retrospective study.
2. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
3. Duration of Treatment: Treatment was administered until disease progressed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-85 years old
* Histologically proven metastatic colorectal cancer (mCRC).
* Patients with progressing mCRC who were previously treated with FOLFOX, FOLFIRI, anti-VGFR monoclonal antibody (MoAb), and anti-EGFR MoAb if KRAS-wild-type tumors were identified.
* Patient was able to understand the requirements of the study and written informed consent was obtained from each subject.

Exclusion Criteria:

* Patients who do not meet the including criteria or unwilling to participate
Work-Related Musculoskeletal Disorders Among Otorhinolarngologists

Work-Related Musculoskeletal Disorders Among Otorhinolarngologists

Musculoskeletal disorders(MSD) are one of the most common causes of occupational injuries and disability in industrialized nations and developing countries .with substantial financial consequences due to workers' compensation and medical expenses Otolaryngology (pronounced oh/toe/lair/in/goll/oh/jee) is the oldest medical specialty in the United States. Otolaryngologists are physicians trained in the medical and surgical management and treatment of patients with diseases and disorders of the ear, nose, throat (ENT), and related structures of the head and neck. They are commonly referred to as ENT physicians.

MSD were identified as a significant issue for the profession and Research has recognized that MSD in Otolaryngology contribute considerably to sick leave, reduced productivity and leaving the profession Because there are few studies available about MSD among Egyptian otolaryngologists So, the purpose of this study is to investigate musculoskeletal disorders among Egyptian otorhinlaryngologist and the relationship between the risk factors and the development of musculoskeletal disorders among Egyptian otolaryngologists

Eligibility Criteria:
Inclusion Criteria:

- otorhinolaryngologist in cairo university hospitals ,cairo teaching hospitasl will participate in the study.

1. General and specialized otolaryngologists will be included in the study.
2. Both genders will be included in the study.
3. 1-20 years of experience.

Exclusion Criteria:

* Otorhinologist will be excluded if :

  1. they had musculoskeletal abnormalities due to other causes not work related (i.e. congenital,traumatic,neurological).
  2. They had any systemic diseases such as uncontrolled diabetes, which may influence the musculoskeletal system
  3. Otolaryngologists with previous operation involving locomotors system.
A Retrospective Study About Treatment Strategy After First/Second Line EGFR-TKI Failure

This is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.


Eligibility Criteria:
Inclusion Criteria:

* Patients who was confirmed stage IV (according to International Association for the Study of Lung Cancer（IASLC） TNM staging, 2009) non-small cell lung cancer (NSCLC) by histology or cytology between year 2009 to 2013, harboring EGFR mutant type (19 and/or 21 exon mutation).
* Appraisable disease, that is there must be at least one lesion with the longest diameter\>10mm according to Recist 1.1 criterion (by contrast CT).
* Patients who take EGFR-TKI as first/second line therapy.

Exclusion Criteria:

* Patients who has taken EGFR-TKI before.
* Patients who take EGFR-TKI as third or more line.
* Patients who take EGFR-TKI concurrent with chemotherapy or other anti-tumor drug.
* The evaluated lesions has treated with radiotherapy before or concurrent with EGFR-TKI.
* Patients whose EGFR expression is positive by immunochemical and/or EGFR amplification is positive by Fluorescence In Situ Hybridization(FISH), without mutation detection evidence.