cyrilzakka/clinical-trials huggingface dataset:
Ketamine Pilot Study

This is a pilot study to evaluate pain responses from two different approved medications (ketamine and fentanyl) in the treatment of pain after rattlesnake envenomation (RSE). Both medications are currently used in standard practice to treat both acute and chronic pain and are options for pain management after RSE. Multiple studies exist showing ketamine to be both safe and effective for the treatment of acute pain, and to be as good as or better than opioids for this indication. The specific comparison of ketamine to fentanyl, however, has never been studied for the treatment of acute pain after rattlesnake envenomation in the United States. The investigators plan to measure pain scores after a single dose of ketamine or fentanyl in patients shortly after being envenomated, followed by continued treatment of pain guided by the treating doctor. There will be no restrictions on additional pain medications given and no other changes to the treatment of these patients during their hospitalization. This research is important because pain after RSE can be difficult to control and may require frequent, high doses of opioids for several days. An effective non-opioid medication would be helpful both to better-control pain and to reduce exposure to opioids in this patient population. This study will compare patient-reported pain scores after receiving a single dose of ketamine or fentanyl in patients with rattlesnake bites who have been admitted to the toxicology service at Banner - University Medical Center Phoenix (BUMCP).

Multiple studies have shown ketamine to be safe and effective agent for acute pain syndromes. RSEs classically result in severe pain that can be difficult to control, despite use of opioids, non-opioid analgesics, and positioning techniques, including splinting and elevation. Furthermore, the ongoing opioid epidemic pushes clinicians to explore non-opioid agents to avoid unnecessary exposure of patients to these high-risk medications. At least one small study has shown ketamine to be safe in rattlesnake envenomated patients.

Eligibility Criteria:
Inclusion Criteria:

* Ages ≥ 18 years.
* Able to speak and understand English.
* RSE requiring IV pain medication for NRS pain score \> 5.
* No allergy to ketamine or fentanyl.
* Ability to provide informed consent.
* ≤ 24 hours from envenomation.

Exclusion Criteria:

* Pregnant or lactating.
* Prisoners.
* Refugees.
* History of schizophrenia.
* Clinically intoxicated.
* On buprenorphine therapy.
* History of uncontrolled hypertension
* Increased intracranial pressure
* Systemic envenomation
Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) - Safety

To prove the safety of the gynaecological formulation in normal conditions of use.


Eligibility Criteria:
Inclusion Criteria:

* Integral skin test in the region,
* Use of cosmetic product of the same category

Exclusion Criteria:

* Lactation or gestational risk or gestation
* Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs
* Atopic antecedent or allergic to cosmetic product
* Active cutaneous disease in the evaluation area
* Diseases which cause immunology decrease, such as diabetes and HIV
* Endocrinal pathologies
* Intense solar exposure 15 days before the evaluation
* Treatment until four months before the selection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Laryngeal Mask Insertion Conditions And Hemodynamic Effects

This interventional double-blind, randomized trial has included120 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1and 8 years of either sex, scheduled for outpatient minor surgery under general anesthesia.This study examined whether co-induction with ketamine-propofol enhance laryngeal mask airway (LMA) insertion conditions and preserve hemodynamic state in patients.

This study aims to compare two anesthesia protocols: propofol induction with or without a prior injection of ketamine, in term of LMA insertion conditions(favorable= satisfactory or unfavorable= unsatisfactory ) and hemodynamic effects (decrease of 20 % from baseline of blood pressure and heart rate).

The conditions of LMA insertion have been assessed in each study group by an experimented anesthesiologist, who was unaware of the treatment group assignment. Conditions were considered satisfactory, if the 4 following criteria were acceptable: the jaw was relaxed, there was no coughing, swallowing and no limb movement, and then the LMA was inserted. When the investigators save at least one unacceptable of these criteria, conditions were considered to be unsatisfactory and thereafter anesthesia was deepened with supplemental dose of propofol 1mg.kg-¹ and 1 minute later a reinsertion was attempted. The total number of attempts at LMA insertion was recorded. Children trachea was intubated after 3 failed attempts of LMA insertion, and then patient was excluded.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II who were scheduled to minor elective ambulatory surgery (e.g. inguinal hernia, undescended testes, umbilical hernia) performed by experienced surgeon under general anesthesia.

Exclusion Criteria:

* patients with full stomach
* A history of gastric reflux
* A history of convulsions, cardiovascular or neuromuscular disease
* Allergies to the study drugs
* obese children
* suspected difficult airway and hyper-reactive airway disease
Safety and Durability of Sirolimus for Treatment of LAM

The MIDAS study aims to follow male and female LAM patients who are currently taking, have previously failed or been intolerant of, or may (at some time in the future) take mTOR inhibitors (sirolimus or everolimus) as part of their clinical care. Adult female TSC patients may also enroll, with or without lung cysts.

Lymphangioleiomyomatosis (LAM) is an uncommon disease affecting women. It is associated with cystic lung destruction and progressive respiratory failure. The Multicenter International LAM Efficacy of Sirolimus (MILES) Trial, led by the investigators' research team, demonstrated that mTOR (mammalian target of rapamycin) inhibition with sirolimus was an effective therapy that stabilized decline in FEV1 (forced expiratory volume). However, lung function decline resumed when the drug was stopped at the one year point in MILES, suggesting that therapy is suppressive rather than remission-inducing, and may need to be lifelong. There is therefore a need to understand whether long-term therapy with sirolimus is safe and effective. To accomplish this goal, the investigators will conduct the Multicenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS). This is an observational, real world registry. The investigators propose to enroll 600 LAM patients who are on, have previously failed or been intolerant of or are considering taking sirolimus or everolimus for clinical reasons in a longitudinal observational study. This registry will follow lung function tests and adverse events that are obtained for clinical purposes over periods of at least 2 years. The decision to treat with mTOR inhibitor therapy is made by the clinician and the patient, and will be managed by the participant's clinician. This study will help us to refine treatment for patients with LAM and determine if long term suppressive therapy with sirolimus can prevent progression to later stages of disease. This research will be accomplished as part of the NIH/NCATS Rare Lung Disease Consortium, with data stored and analyzed by the Database Management Coordinating Center (DMCC) at the University of South Florida.

Eligibility Criteria:
Inclusion Criteria:

* Female or male, age 18 or over
* Diagnosis of LAM based on ATS/JRS criteria
* Signed and dated informed consent
* On chronic therapy, newly treated or may be considered for therapy with mTOR inhibitors or previously intolerant of or having failed mTOR inhibitor therapy

Exclusion Criteria:

* Inability to attend at least one RLD Clinic visit per year
* Inability to give informed consent
* Inability or unwillingness to perform pulmonary function testing
Assessment of Integration Success of an Implant System With a Novel Abutment Attachment Design in Early Loaded Cases

Integration success rates measured by resistance to countertorque testing will be higher for the experimental implant design than for the control implants.

In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by countertorque testing and cumulative success rate in cases that are loaded early

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching
Selenium and Prostate Cancer: Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression

The aim of this study is to determine whether selenium supplementation leads to changes in selenium levels and gene expression profiles in prostate tissue.

Rationale: Prostate cancer is a frequently observed malignancy in men, especially in elderly men. Besides diagnosis and treatment, also prevention of prostate cancer is an important point of interest to reduce the incidence and mortality of prostate cancer. Selenium is considered to be a promising chemopreventive agent for prostate cancer. Exact mechanisms of chemoprevention by selenium are not fully understood. However, it is expected that selenium (among other effects) directly affects gene expression in the prostate.

Objective: The aim of this study is to get insight into bioavailability of selenium in prostate tissue and changes of gene expression profiles that might be responsible for selenium-induced chemoprevention. To meet this objective, the relationship between dietary selenium intake and changes in gene expression profiles, tissue selenium levels and blood flow in prostate tissue will be examined.

Study design: The present study is designed as a double-blind, randomized and placebo-controlled intervention trial. Blood samples, toenails, questionnaires, MR images and surgical specimens will be collected to examine effects of selenium supplementation.

Study population: The study population will consist of 60 men, diagnosed with prostate cancer and scheduled for radical prostatectomy. Written informed consent will be obtained from each participant.

Intervention: Participants will receive 300 ug selenium / day or a placebo during 5 weeks prior to radical prostatectomy. Selenium will be supplemented in the form of selenized yeast tablets (SelenoPrecise, Pharma Nord).

Main study parameters: Levels of selenium in prostate tissue and changes in prostate gene expression profiles of participants supplemented with selenium or placebo, compared before and after the short intervention period, will be considered as the main parameters of the present study. Besides gene expression profiles in prostate tissue, also gene expression profiles of peripheral mononuclear cells (PBMC), levels of selenium in blood and toenails and blood flow and permeability of blood vessels of prostate tissue will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* male
* biopsy proven prostate cancer
* scheduled for radical prostatectomy

Exclusion Criteria:

* liver diseases (e.g. hepatitis)
* kidney diseases
* inflammatory bowel diseases
* use of dietary supplements containing selenium
* adjuvant therapy for prostate cancer (e.g. hormonal therapy, HIFU)
* previously or concurrent diagnosed with cancer, other than prostate cancer
The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients

The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate and different intensity warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of atrial fibrillation
2. Echocardiography confirmed a non-valvular heart disease
3. Age≥60 years

Exclusion Criteria:

1. Unable to cooperate with doctors
2. CHA2DS2-VASc\<2
3. Life expectancy of less than 1 year
4. Rheumatic heart disease or dilated cardiomyopathy
5. History of artificial valve replacement surgery
6. Infectious endocarditis
7. Stroke or transient ischemic attack(TIA) within the last 6 months
8. Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding
9. Previous intolerance/allergy to warfarin or dabigatran etexilate
10. Blood pressure greater than 180/110 mmHg
11. Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times
12. Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min
13. Patient was receiving antiplatelet or anticoagulant therapy due to other reasons
Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin for patients with unresectable, advanced gastric cancer who had no prior palliative chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase 2, which has been completed and now a total of 60 qualified patients will be enrolled in the phase 2 of this study. The treating physician will determined the maximum number of cycles of pemetrexed plus cisplatin that a patient may receive in this study.


Eligibility Criteria:
Inclusion Criteria:

* Histological proven diagnosis of adenocarcinoma of the stomach
* Stage IV disease not amenable to curative surgery.
* Disease status must be that of measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale.
* Adequate organ functions

Exclusion Criteria:

* Prior palliative chemotherapy for advanced gastric cancer.
* Pregnancy and breast feeding.
* Known or suspected brain metastasis and secondary primary malignancy
* Inability to interrupt aspirin, or other non-steroidal anti-inflammatory agents for a 5-day period.
* Inability or unwillingness to take folic acid or vitamin B12 supplementation.
* Concurrent administration of any other tumor therapy.
Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples

Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples.

Breath testing, which links specific volatile molecular biomarkers in exhaled breath to medical conditions, is becoming increasingly popular as a non-invasive and potentially inexpensive diagnostic method for various diseases. NA-NOSE performs odor detection from exhaled breath, thus producing a distinct fingerprint for each mixture of analytes.

Several studies have been published, stating the advantages of these sensors, leading to promising outcomes in several fields.

The NA-NOSE breath test would be fast (examination and results would be obtained within 5-10 min), inexpensive, eventually portable (smaller than desktop computer), non-invasive and free of any side effects.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* ≥ 18 years of age, male or female
* Left ventricular Ejection fraction less than 40% or known to suffer from heart failure with preserved ejection fraction
* In decompensated heart failure group: dyspnea with confirmation of pulmonary congestion/edema by chest x-ray

Exclusion Criteria:

* Pericardial diseases, e.g. constrictive pericarditis, tamponade
* Significant congenital heart disease, up to the investigator's opinion
* Life-threatening or uncontrolled arrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate \>110 beats per minute.
* Acute ST elevation myocardial infarction
* Pregnant women
* Patients with pulmonary embolism
* Probable alternative diagnoses that in the opinion of the investigator could account for patient's HF symptoms (i.e., dyspnea), such as:

  1. significant pulmonary disease
  2. anemia with hemoglobin \<10 g/dl
* participation in another study
An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound

Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of subclinical enthesitis in psoriasis patients. This study will be the first randomized trial of a biologic therapy versus placebo in participants with plaque psoriasis and subclinical psoriatic arthritis, using musculoskeletal ultrasound.

The primary objective of this study is to estimate the difference in effect between secukinumab 300 mg s.c. and placebo, based on change from baseline to Week 16 in the OMERACT ultrasound enthesitis score.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic plaque-type psoriasis confirmed through physical examination by a dermatologist, with at least six months of clinical history prior to the baseline visit
* Moderate to severe plaque psoriasis at baseline as defined as:
* ≥ 10 % Body Surface Area (BSA) involvement, or
* ≥ 3% to \<10% Body Surface Area with involvement of special regions (nails, scalp, or intertriginous skin), or with a history of psoriatic arthritis in a parent

Candidate for systemic therapy, defined as having psoriasis inadequately controlled by current topical and/or systemic treatment(s) (including topical corticosteroids), phototherapy, or previous systemic therapies

Presence of sonographic enthesitis at screening, in at least one enthesis, defined by the presence of at least abnormal thickening and hypoechogenicity of the tendon insertion, with or without presence of Doppler signal (Grade 0-3), or by the presence of grade ≥ 2 Doppler signal, independent of gray scale abnormalities

Exclusion Criteria:

* Diagnosis of PsA as per CASPAR confirmed by a rheumatologist (including the presence of inflammatory pain in entheses or joints), and any other known rheumatological disease affecting the assessed joints
* Exposure to any IL-17 or IL-23(p19) inhibitor for the treatment of psoriasis (approved or investigational) within twelve months prior to screening, or exposure to any inhibitors of TNF-ɑ and IL12/23 within six months prior to screening
* Previous exposure to non-biologic systemic therapy for psoriasis, including methotrexate, PDE-4 inhibitors, or systemic corticosteroids within 12 weeks or 5 half-lives (whichever is longer) prior to screening
* A degree of obesity that impedes proper ultrasound examination of entheses and joints
* Forms of diagnosed psoriasis other than chronic plaque psoriasis (e.g., erythrodermic, generalized or localized pustular psoriasis, or new onset guttate psoriasis)

Other protocol-defined inclusion/exclusion criteria may apply
Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision

Purpose:

To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.

Aims of the Research Project:

1. To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.
2. To quantify the reproducibility of the performance-based tests.
3. To gather acceptability and ease-of-use data from patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants
2. Age 20-50
3. Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.
4. Sight impairment criteria are as follows:

   * Visual acuity of 3 / 60 to 6 / 60 with a full field of vision.
   * Visual acuity of up to 6 / 24 with a moderate reduction of field of vision

Exclusion Criteria:

1. Any physical impairment that would make use of the virtual reality headset difficult or unsafe.
2. A history of vertigo or dizziness.
Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure

The primary objective of this study is to estimate the accuracy of the pre-operative VRI quantitative results versus the gold standard pre-operative perfusion scan.

The secondary objective is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (forced expiratory volume in 1 second \[FEV1\] and diffusing capacity of the lung for carbon monoxide \[DLCO\]) in patients who underwent surgical resection.

Pre lung operation candidates for procedures such as lung volume reduction surgery (LVRS), lung resection, bullectomy and lung transplant are frequently evaluated for differential lung function by a semi quantitative lung scintigraphy. VRI may offer the same differential lung function information for the physician without the risks, time and patient discomfort of lung scintigraphy in the treating physician office.

Moreover, VRI may provide a safe, quick and simple method to measure "split function" in lung cancer patients who are candidates for lung surgery. Thus eliminating the safety and complexity issue related with the current ventilation perfusion "split function" methods.

In addition the VRI may aid in achieving the goal of developing strategies to reduce risk and maximize the number of patients that can benefit from surgical therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to read, understand, and provide written informed consent;
2. Male or female in the age range of 18-80 years;
3. Patients who were referred to perform perfusion scan for pre lung surgery evaluation such as LVRS, thoracotomy, bullectomy and lobectomy.
4. Body mass index (BMI) \> 21.

Exclusion Criteria:

1. Chest wall deformation;
2. Spine deformation (including scoliosis);
3. Hirsutism;
4. Potentially contagious skin lesion on the back;
5. Skin lesion that would interfere with sensor placement; (Keloids)
6. Cardiac pacemaker or implantable defibrillator;