cyrilzakka/clinical-trials huggingface dataset:
A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Solid Tumors

This clinical study is being conducted at two sites to determine the optimum dose, safety, and tolerability of GSK1363089 treatment in adults with solid tumors. This study is no longer recruiting subjects.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumor which is metastatic or unresectable with no known effective treatment measures,
* ECOG performance status of \</= 2.
* Adequate bone marrow reserve, hepatic, renal, and cardiovascular function,
* Negative pregnancy test.

Exclusion Criteria:

* Chemotherapy within 4-6 weeks of the start of treatment,
* Radiotherapy within 4 weeks of the start of treatment,
* Known brain metastasis,
* Uncontrolled medical disorder such as infection or cardiovascular disease,
* HIV positive,
* Pregnant or breastfeeding women
Study to Investigate the Added Value of a Rehabilitation Brace in the Treatment at Home After a Fracture of the Ankle

Comparison between immobilisation by a plaster and a rehabilitation brace for the treatment of a fracture of the ankle


Eligibility Criteria:
Inclusion Criteria:

* Fracture of the ankle

Exclusion Criteria:

-
Botulinum Toxin to Improve Lower Blepharoplasty Scar

The combination of Botulinum toxin for crow feet (lateral part of orbicularis oculi muscle) and lower blaphaloplasty might have reduces the tension on the end of lower blaphaloplasty incision whereas the scar is more visible on patient.

The main aim of this trial is to investigate whether the injection of Botulinum toxin into the bilateral orbicularis oculi muscles could improve the appearance of the scar after lower blepharoplasty.

The main aim of this double blind randomized trial is to examine whether immediate post-operative injection of botulinum toxin into lateral part of bilateral orbicularis oculis muscles (the injection technique of crow feet) can improve scar formation for lower blepharoplasty patients.

This is a double blind randomized controlled trial primarily designed to compare the scarring after secondary cleft lip repair with immediate post-operative botulinum toxin injection into the into bilateral lateral orbicularis oculi muscles in patients with lower blepharoplasty. There will be 2 main groups in this study:-

1. Study group (Group I): Immediately after lower blepharoplasty surgery 3 injections of 2.5U of botulinum toxin over lateral part of orbicularis oculi muscle.
2. Control group (Group II): There will be the same amount of normal saline injection after lower blepharoplasty.

Follow-up Assessments Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month Follow Up.

Visual analogue scale They were asked to score the scars on the photographs using a standard visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar).

Photographic measurement:

A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured.

Chi-square will be used to analyze the demographic data ( i.e. Gender) The Independent T-Student test will be used to analyze the statistical significance between the two groups.

The dosage of Botox that the investigators use for crowfeet is very tiny. And this is a common clinic practice. Systemic insult is unlikely to happen. If an allergic reaction occurred it will be treated according to the severity of allergy and Diphenhydramin PO or IV form or systemic corticosteroid will be given.

Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥ 45 years old.
2. Lower eyelid Rhytidosis and dermatochalasis.
3. Lower eyelid steatoblepharon and pronounced nasojugal groove
4. Written informed consent given by patient.

Exclusion Criteria:

1. Less than 45 years old
2. Without written informed consent.
3. Combined other craniofacial anomalies
ETI During Intubation

The objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a novice-physicians.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* maximum 10 clinical intubations

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Probiotics for Alleviating Functional Constipation in Adults

To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese adults who meet the diagnostic criteria of Rome III, aged between 18 and 70;
2. Patients with chronic constipation (disease duration exceeding 6 months, with fewer than 3 bowel movements per week and/or Bristol stool form scale types 1 and 2);
3. Able to complete the study according to the requirements of the experimental protocol;
4. Patients who have signed the informed consent form;
5. Research participants (including male participants) who do not have fertility plans from 14 days before screening to 6 months after the end of the trial and are willing to take effective contraceptive measures voluntarily.

Exclusion Criteria:

1. Individuals who have taken items with similar functions to the tested product within a short period of time, which may affect the judgment of the results;
2. Patients who have changed their diet during the study period;
3. Patients with severe allergies and immune deficiencies;
4. Female patients who are pregnant, breastfeeding, or have plans to become pregnant;
5. Patients with severe diseases in vital organs such as cardiovascular, lung, liver, and kidney, as well as severe metabolic diseases such as diabetes, thyroid disease, malignant tumors, and severe immune system diseases;
6. Individuals who have used antibiotics within the past two weeks;
7. Individuals with severe psychological or mental illnesses;
8. Participants who have not consumed the tested samples as required or failed to follow up on time, resulting in an inability to determine the effectiveness;
9. Other research participants deemed unsuitable for participation by the researchers.
Motion Sickness Medications and Vestibular Time Constant

Sea sickness represents a major limitation on the performance of ships' crew. One of the challenges faced by the physician in the motion sickness clinic when prescribing anti-sea sickness medication is to select the appropriate drug for the patient. Difficulties arise due to high variability in the response to different drugs. In the case of sea sickness, the current procedure is to examine the drug's efficacy in each individual during real time exposure to sea conditions.

A number of studies have documented the presence of sea sickness drug receptors in the vestibular nuclei, which determine the vestibular time constant. Two clinical vestibular tests which evaluate the time constant are the Velocity Step and OKAN tests. The purpose of the proposed study is to evaluate the influence of motion sickness drugs on the vestibular time constant, as a possible bioequivalent of drug potency in the individual subject. Eighty crew members will be recruited and divided into groups responsive and non-responsive to the sea sickness drugs scopolamine and meclizine.

Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and no improvement in symptoms after treatment will be defined as non-responsive to sea sickness drugs. Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and a Wiker score of 4 or less after treatment, will be defined as responsive to drug therapy.

Kwells, Bonine and placebo, will be assigned to each subject in a random, double-blind fashion. Each group will perform the Velocity Step and OKAN tests before, one and two hours after drug or placebo administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy soldiers between the ages of 18 to 40, who suffering from sea sickness
* 48 hours prior to session without any use of medications
* Soldiers who vomit in waves 1.5 meter high without drugs treatment

Exclusion Criteria:

* Anamnestic hearing Impairment
* Ear infection of any kind
* Pathological finding in an otoneurological examination, witch will be done by a trained neurophysiologist / a physician. In any case of pathological finding, patient will be advised to continue medical assesment.
* Vision pathologies the interfere with VNG test.
* Withdrawal of informed consent by the patient of any cause.
Nilotinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation

The purpose of this study is to determine whether nilotinib is effective in the prophylaxis and treatment of CMV reactivation in allo-HSCT patients.

The purpose of this study is to determine whether nilotinib is effective in the prophylaxis and treatment of CMV reactivation in allo-HSCT patients.

Prophylaxis Part: patients will be treated with nilotinib after their hemogram engraftment to prevent CMV reactivation Salvage Part: patients who have had intractable CMV reactivation after gancyclovir therapy will be treated with nilotinib

Eligibility Criteria:
Inclusion Criteria:

Part A:

* Adult patients who have received allo-HSCT
* Performance status ECOG 0-2
* Patients with CMV reactivation (defined as plasma CMV DNA copy numbers of more than 1000 copy numbers/ml by Quantitative-PCR) after allo-HSCT.
* Patients with CMV reactivation that is uncontrollable by conventional first line agent (ganciclovir) for 2 or more weeks, or patients who are intolerable to ganciclovir treatment.

Part B

* Adult patients who have received allo-HSCT
* Performance status ECOG 0-2
* Either the patient or his/her donor are CMV-IgG test positive
* Patients with post-transplantation engraftment: stable myeloid engraftment (absolute neutrophil count 500/mm3) for at least 3 consecutive days, and stable megakaryocyte engraftment (platelet count 20k/uL) for at least 3 consecutive days.
* Patient with no CMV reactivation before enrollment: a negative (undetectable) plasma CMV DNA Quantitative-PCR assay on blood collected within 7 days Patients without previous or current exposure to any prophylactic or therapeutic drugs for CMV reactivation

Exclusion Criteria:

* Patients with renal insufficiency: serum creatinine \> 2.5 mg/dL,
* Patients with significant electrolyte deficiency after suitable supplement: \[K\] \<3.0mmol/L, \[Ca\]\< 2.0 mmol/L(corrected), or \[Mg\] \< 0.6 mmol/L.
* Patients with hepatic dysfunction: alkaline phosphatase ≥2.5 times of the upper normal limit of the normal range (ULN); serum alanine or aspartate aminotransferase levels of \> 5 times ULN; a serum total bilirubin of \> 3 mg/dL
* Patients with serum amylase and lipase \> 1.5 x ULN
* Patients with history of HIV infection
* Patients with unstable medical condition or any other history of serious/significant medical diseases deemed not appropriate to be included to this study as judged by investigators
* Females patient who are pregnant or breast-feeding
* Female patients of childbearing potential not using any reliable and appropriate contraception method(s)
* Patients with life expectancy, as judged by the investigators, is less than 3 months
* Patients with, as judged by the investigators, other contraindications of nilotinib administration, such as prolonged QTc, concurrent usage of drugs that possess possible severe drug-drug interactions with nilotinib, or had severe adverse effects in the previous exposure to nilotinib
* Patients who cannot swallow capsules.
* Patients who are unwilling or unable to give consent
Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study

BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common microorganisms responsible for infectious gastroenteritis (http://filmarray.com/the-panels/) from a stool specimen collected in Cary Blair enteric transport media. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014.

The FilmArray GI Panel offers improvements over conventional laboratory testing which include: reduced turnaround time from specimen to result, reduced laboratory labor costs, increased sensitivity and specificity relative to current clinical reference methods, and larger breadth of organism identification than is available using standard methods. Because of these attributes, the results from this test have the potential to enable clinicians to more accurately diagnose and treat GI illness in a reduced time frame.

Collaborators at the University of Utah, Brown University/Lifespan, and BioFire Diagnostics have designed a study to evaluate health outcomes of pediatric subjects presenting to emergency departments with GI illness before and after establishing the FilmArray GI Panel as the standard of care method for stool pathogen analysis. It is hypothesized that the rapid (\~ 1 hour turnaround time), sensitive, specific, and comprehensive results provided by the FilmArray GI Panel will allow clinicians to more rapidly diagnose GI illness, initiate appropriate therapy and provide guidance when compared to the pre-implementation period.


Eligibility Criteria:
Inclusion Criteria:

* Children (\<18 years) presenting to the ED or onsite urgent care center with symptoms of gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.)
* Duration of symptoms at least 24 hours but \< 14 days
* Able to provide stool specimen at time of enrollment or within the next two calendar days
* Parent or guardian able to provide permission and subject able to provide assent, if appropriate

Exclusion Criteria:

* Undefined onset of illness or symptoms for ≥14 days
* Unable to complete questionnaire or give informed consent because of language barrier
* Those unable to provide stool specimen at time of enrollment or within two calendar days
* Previous enrollment in this study
Ventilation Modes Effect on Intracranial Pressure During Laparoscopic Colectomy by Optic Nerve Sheath Diameter

Patients who undergo laparoscopic surgery often experience increased intracranial pressure (ICP). In laparoscopic colectomy surgery, the duration always exceeds 2h with more liability to changes in arterial blood gases, hemodynamics, also the patient is in Trendelenburg position about 30° head down, Trendelenburg position is believed to create changes in hemodynamics, respiratory mechanics, metabolic response, and ICP as it affects vital organs especially if steep positioning. Various modes of mechanical ventilation have been experimented to achieve good intraoperative oxygenation which may cause changes in arterial blood gas values and hemodynamic parameters that might lead to changes in the ICP. In this study we will measure ONSD, basal, intraoperative, and in the PACU to evaluate the effect of different ventilation modes (both VCV mode and PCV-VG mode) on intracranial pressure.

The aim of the current study is to compare the effect of volume control ventilation (VCV) versus pressure control ventilation-volume guaranteed (PCV-VG) as modes of mechanical ventilation on ICP by US guided ONSD measurement during laparoscopic colectomy,

Eligibility Criteria:
Inclusion Criteria:

* Body mass index less than 30
* American Society of Anesthesiologist physical class I -III.

Exclusion Criteria:

* Patient refusal
* operative time \< 2 hour (h)
* Patients with preexisting eye disease.
* History of eye surgery
* Optic nerve disease.
* Causes of elevated ICP.
Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

The purpose of this study is to evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter.


Eligibility Criteria:
Inclusion Criteria:

* ECG documentation of at least 1 episode of typical atrial flutter

Exclusion Criteria:

* Prior right atrial ablation
* Ferromagnetic implants that may interfere with the magnetic navigation system
* Pregnancy
MI Mortality Risk and Between-hospital Risk Variation in the United Kingdom and Sweden

The study aims to investigate the differences in survival trajectories and hospital variability in myocardial infarction (MI) mortality rates in the UK and Sweden.

Limited evidence is available in comparing hospital level care and reference mortality risks between countries, due to the scarce availability of nationwide coronary heart disease data. The demographics and medical expenditure percentage are comparable in the United Kingdom and Sweden; however, the in-hospital case-fatality rates within 30 days after admission for acute myocardial infarction was greater in the UK than Sweden (6.3% versus 2.9%)(OECD, 2009). To investigate the discrepancy, the current study aims to compare the mortality risk differences and associated explanatory factors between the two countries. Results of the study can contribute to myocardial infarction care implementation in the UK and Sweden.

The UK Myocardial Ischaemia National Audit Project (MINAP)and Register of Information and Knowledge about Swedish Heart Intensive care Admissions (RIKS-HIA) are few quality national registries currently available for acute coronary syndrome. Using data from the MINAP and RIKS-HIA, we propose to investigate (1)the survival trajectories for a reference patient with myocardial infarction and (2) hospital variability in myocardial infarction mortality rate in the UK and Sweden, adjusted for important patient-level and hospital-level covariates.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged above 30 years old who had hospital admission for acute myocardial infarction.
* Admission period ranged from 1st January, 2004 to 31th December, 2008.

Exclusion Criteria:

* Patients with missing data in the admission time and/or primary outcomes.
Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

Sepsis and septic shock are public health problems worldwide that represents an excessive cost for health systems. Despite the great technological and research advances, mortality can reach up to 80% in patients with multiple organ failure (FOM). Therapeutic studies focused on evaluating the usefulness of the use of antioxidants have shown different outcomes and results. This randomized clinical trial in patients with septic shock at two general intensive care units try to evaluate the usefulness of four different antioxidant therapies added to the conventional treatment, which includes: n-acetyl cysteine, vitamin C, vitamin E and melatonin. Measurement of parameters before and after treatment of oxidative stress includes nitrates and nitrites, lipid peroxidation, glutathione peroxidase, glutathione s transferase, extracellular activity of SOD, GSH concentration and evaluation of total antioxidant capacity. The investigators will also evaluate the clinical impact of antioxidant therapy with the SOFA score.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of septic shock in the last 24 hours characterized by refractory hypotension and vasopressor requirement despite sufficient fluid resuscitation (20 mL/kg of colloids or 40 mL/kg of crystalloids) to maintain a blood pressure ≥ 65 mmHg with a lactate\> 2 mmol/L.
* Admitted to the ICU of the ABC Medical Center.
* Give informed consent.

Exclusion Criteria:

* Patients who refuse to be included.
* Chronic or recent use of steroids.
* Use of statins.
* Patients receiving some type of antioxidant treatment.
* Any contraindication to the use of vitamin C, vitamin E, n-acetylcysteine or melatonin.
* Pregnant women.
Intracranial Pressure Waves Via Lumbar Puncture

Patients are subjected to simultaneous intracranial and lumbar puncture pressure measurements. This study focus on intracranial pulse amplitude. Hypothesis: Intracranial pressure amplitude is reflected by lumbar puncture pressure amplitude.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Idiopathic Normal Pressure Hydrocephalus

Exclusion Criteria:

* Known cause of hydrocephalus
HCV-Smoking Cessation Study

A 12-week study for patients who are being treated for Hepatitis C and would like to quit smoking. During the 12 weeks of Hepatitis C treatment, the research team will have counseling sessions with the participants to discuss challenges related to Hepatitis C and smoking.

A 12-week smoking cessation intervention addressing concurrently HCV and smoking cessation The Standard of care for HCV is 12 weeks of oral medication with 3 in-person provider/laboratory visits throughout. This study utilizes both in-person and phone counseling and health education sessions. Each session will address a different topic related to HCV, smoking, and how both smoking and HCV affect health and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old)
* Current HCV infection (HCV RNA+)
* Current cigarette smoking
* Patients in contemplation / preparation stage of change

Exclusion Criteria:

* Inability to speak/read English, as materials will be provided in English
* Current suicidal ideation as determined by the PHQ-9, requiring a greater level of clinical care
* Severe medical or psychiatric disability that prevents participant from ability to comprehend or consent to study
Myocilin Variations and Familial Glaucoma in Taxiarchis

Taxiarchis, a small village in Northern Greece with 1060 inhabitants, was considered to have a surprisingly high incidence of glaucoma. This isolated population located on Mount Holomondas appeared to be enriched for familial glaucoma. Based upon the high reported incidence of glaucoma in Taxiarchis and previous findings of the Thr377Met myocilin mutation in the Greek population,the investigators undertook a community-based study to determine if this variant was present in this village.


Eligibility Criteria:
Inclusion Criteria:

* Individuals born in Taxiarchis

Exclusion Criteria:

* Individuals that have not been born in Taxiarchis