cyrilzakka/clinical-trials huggingface dataset:
Short Term Topical Tetracaine is Safe and Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions

The objective of this study was to show that patients with corneal abrasions would experience more pain relief with short term topical tetracaine than placebo, have similar complication rates, and take less hydrocodone for breakthrough pain.

Corneal abrasions are among the most common eye-related injuries seen in the emergency department (ED). Topical anesthetic drops are routinely used prior to slit-lamp examination for diagnosis of corneal abrasions and often provide immediate pain relief. Patients are then sent home with oral analgesics and topical antibiotics. The use of topical anesthetics for outpatient treatment of corneal abrasions is discouraged by most emergency medicine textbooks due to concerns over safety. Case reports of abuse and misuse as well as animal studies have suggested that long term use of topical anesthetics may lead to rare complications. Two clinical trials showed no delayed healing after a short course of topical anesthetics following PRK surgery. Whether this could be applied to nonsurgical patients in the ED was investigated by two small clinical trials that showed similar efficacy and safety but were underpowered to prove a statistical difference. In 2014, a larger randomized trial demonstrated the safety of tetracaine for ED patients with corneal abrasions but failed to show a significant difference in patient visual analogue scale (VAS) pain ratings over time. More recently, a retrospective cohort study of 444 ED patients given tetracaine for 24 hours reported no serious complications or uncommon adverse events. If topical anesthetics could be safely prescribed for short term use in the management of corneal abrasions, it is possible that this would decrease use of systemic opioids for this purpose. The aim of this randomized, double-blind trial was to compare the effectiveness of topical tetracaine versus placebo in ED patients with corneal abrasions as measured by a reduction in the VAS score.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years to 80 years old presenting to the ED with suspected acute corneal abrasion from mechanical trauma or removal of a foreign body by the physician were included

Exclusion Criteria:

* Patients were excluded if they wore contact lenses, had previous corneal surgery or transplant in the affected eye, presented more than 36 hours after their injury, had a grossly contaminated foreign body or coexisting ocular infection. Additional exclusion criteria were pregnancy, retained foreign body, penetrating eye injury, immunosuppression, allergy to study medication, inability to attend follow up, inability to fluently read and speak English or Spanish, or any injury requiring urgent ophthalmologic evaluation (large or complicated abrasions with significant vision loss, corneal ulcers, corneal lacerations).
Autogenic Inhibition Versus Reciprocal Inhibition Muscle Energy Techniques in Iliotibial Band Syndrome

Comparison of effects of autogenic inhibition and reciprocal inhibition muscle energy techniques on iliotibial band syndrome

A single-blinded randomized control trial will be conducted over a period of one year in Foundation University Islamabad. Forty participants will be assigned to two groups: Group A (AI) and Group B (RI), with 20 participants each. The AI technique will involve a maximal isometric contraction of the target muscle followed by a stretch, while the RI technique will involve a maximal isometric contraction of the antagonist muscle followed by a similar stretching protocol. Both groups will perform the exercises 3 times per week for 2 weeks. Pain, Hip range of motion (ROM) and lower extremity function will be assessed using Numeric Pain Rating Scale (NPRS), goniometer and Lower Extremity Functional Scale (LEFS) respectively.

The outcomes will be measured in terms of improvements in pain score (NPRS), hip range of motion (ROM), and overall lower extremity function.

Eligibility Criteria:
Inclusion Criteria

* Both male and female participants
* Age : 19-45years (8)
* Lateral knee pain (\>3 months)
* Tenderness over lateral femoral condyle
* Positive Flexibility Tests
* Modified Ober's test (9)
* Length assessment of Tensor Fasciae Latae and Iliotibial Band (10)
* Positive Pain Provocation Tests
* Renne's test
* Noble's Compression test (11) \*(individuals with 3 positive tests out of above mentioned 4 tests will be included)

Exclusion Criteria

* Recent lower limb or pelvic girdle surgery within the past 3 months
* Lower limb fractures or trauma within the past year.
* Multiple lower limb surgeries (\>2)
* Presence of any structural or postural disorders (kyphosis or severe scoliosis)
* Neurological disorders
* Hip and knee Osteoarthritis
* Rheumatoid Arthritis
* Pregnancy
The Effects of Sedatives on Tobacco Use Disorder Version 2

Double-blind, placebo-controlled, randomized mechanistic clinical trial to test an intravenous dose of either ketamine, midazolam, dexmedetomidine, or a placebo (saline) on cigarette smoking behavior, craving, and neural effects.

This double-blind, placebo-controlled, randomized mechanistic clinical trial will test non-treatment seeking smokers with an intravenous infusion of ketamine (0.71 mg/kg), midazolam (0.025 mg/kg), dexmedetomidine (0.025 mg/kg), or placebo, at least 2 weeks apart. Participants will complete 7-day ecological momentary assessment (EMA) of daily craving, withdrawal, and smoking behavior before and after each infusion. They will be asked to abstain from tobacco/nicotine for twenty-four hours post-infusion to induce withdrawal symptoms and return to the lab the following day to complete measures of craving, withdrawal, an MRI scan, and smoking latency. After this study visit, participants will be allowed to smoke as usual for the rest of the EMA diary period. Physical and subjective effects and adverse effects will be closely monitored throughout.

Eligibility Criteria:
Inclusion Criteria:

* Smokes cigarettes daily for at least 2 years
* Afternoon expired breath carbon monoxide at least 5 ppm or morning urinary cotinine at least 100 ng/ml
* Negative urine drug screen for psychoactive drugs and negative breath alcohol

Exclusion Criteria:

* Have an unstable medical condition or stable medical condition that would interact with study drug or participation, including chronic pulmonary disease, coronary artery disease, current brain tumor, current increased intracranial pressure or impaired consciousness
* History of serious head trauma or neurological disorder (e.g., seizure disorder)
* Have any of the following: hypertension (i.e., systolic \>140 mm Hg and/or diastolic \>90 mm Hg on three separate measures; systolic \>170 or diastolic \> 110 on any occasion), pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).
* Use of drugs that would interact with study drug or increase risk of adverse events
* Among women, pregnancy or lactation
Acupuncture for Hot Flushes in Menopause

In a pragmatic study investigate whether Traditional Chinese Medicine acupuncture-care decreases the frequency of hot flushes and increases health related quality of life among postmenopausal women. The intervention group will receive 10 sessions of acupuncture, the control group will engage in self care only. The study period lasts for 12 weeks.

The study objective is to determine whether Traditional Chinese Medicine (TCM) acupuncture-care together with self-care is more effective than self-care alone, to relieve climacteric complaints among women who seek alternatives to hormonal replacement therapy (HRT). Study design is a pragmatic randomised controlled trial with two parallel arms. Study participants are postmenopausal women who document a mean value of 7 flushes/24 hours and who are not using HRT or other prescribed medication that may influence climacteric complaints. The treatment group will receive 10 sessions of TCM acupuncture-care and self-care; the control group will engage in self-care only.

The duration of intervention period is 12 weeks with evaluations at baseline, 4, 8, 12 weeks, and follow up at 6 and 12 months after baseline. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life. N in each treatment group: 143 (286 altogether).

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (at least one year past the last menstrual period) who are willing to receive acupuncture and who during two weeks of self-completed diaries10 document a mean value of 7 flushes/24 hours or more (or 50 flushes or more over a period of seven consecutive days), will be randomized after a baseline evaluation.
* Current users prescribed medications that influence hot flush rate (e. g. HRT, SSRI's) can be included after a washout period. The washout-periods are eight weeks for SSRI's and systemic (including transdermal) HRT and four weeks for local estradiol preparations

Exclusion Criteria:

* Surgical menopause
* History of cancer within the past five years
* Use of anticoagulant drugs
* Heart valve disease
* Poorly controlled hypertension
* Hypothyroidism
* Hyperthyroidism or diabetes mellitus
* Organ transplant
* Mental disease
* Overt drug or alcohol dependency
* Inability to complete study forms
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age

A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 65 years old who are healthy or have co-morbidities
2. Individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Ability to attend all scheduled visits and to comply with study procedures

Exclusion Criteria:

1. Hypersensitivity, including allergy to any component of vaccines foreseen in this study
2. Abnormal function of the immune system.
3. Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study.
4. Additional eligibility criteria may be discussed by contacting the site
Efficacy of Average Volume Assured Pressure Support With Bi-Level Pressure Support Nocturnal Ventilation

Patients with chronic hypercapnic respiratory failure can be successfully treated with home nocturnal non-invasive ventilation. Bi-level pressure support ventilators are at present the most frequently used ventilators for long term home ventilation. A recently commercialized bi-level ventilator offers the feature of automatically adjusting pressure support on the basis of a pre-determined ideal effective ventilation. Because this option may induce important swings in pressure support, and thus patient discomfort, and maybe increase leaks, we chose to analyse the impact of average volume assured pressure support (AVAPS) on patient comfort, subjective and objective quality of sleep and efficacy of ventilatory support.

This study aims to compare, in a randomized order, two consecutive nights with a bi-level positive pressure ventilator (Synchrony, Respironics, USA), with and without average volume assured pressure support (AVAPS), in patients with chronic respiratory failure, treated on a long term basis by home nocturnal non-invasive ventilation.

Specific endpoints are :

* quality of sleep assessed by polysomnography scored by an independent investigator (sleep efficiency, distribution of sleep stages, arousals and sleep stage changes) and subjective scores (St Mary's questionnaire),
* perception of comfort of ventilation (clinical score),
* efficacy of ventilation (pulsoximetry, transcutaneous capnography (Tina TCM4 Radiometer, Copenhagen), effective ventilation and tidal volumes, leaks as measured by ventilator, Stardust software, Respironics).

Patients: Fourteen patients with obesity-hypoventilation and/or COPD, treated and stable for at least 3 months, will be included and undergo complete sleep studies in Geneva University Hospital's Sleep Laboratory. Patients included must be compliant to treatment (at least 4 hours of use of ventilator/night).

Methods: Patients are blinded as to whether or not AVAPS is implemented. Target tidal volume is set at 7-8 ml/kg. EPAP (Expiratory positive airway pressure) level is unchanged. Minimal IPAP (Inspiratory positive airway pressure) level is set at usual IPAP - 3 cm H2O. Maximal IPAP is set between 25 and 30 cm H2O. Back up frequency is unchanged.

All patients must provide written informed consent. Protocol has been accepted by the ethics committee on clinical research of Geneva University Hospital.

Results of scores, and relevant parameters of polysomnography, oxymetry, and capnography, will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for chronic hypercapnic respiratory failure by home bi-level positive pressure non-invasive ventilation for at least 3 months, in a stable clinical condition

Exclusion Criteria:

* Poor compliance (\< 4 hours/day) to home ventilation or recent episode ( \< 3 months) of cardiac or respiratory failure necessitating hospitalization
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care

The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of the following within 2 weeks of the screening/baseline visit: a) HIV Rapid Antibody positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1 ribonucleic acid (RNA) viral load greater than or equal to (\>=) 5,000 copies per milliliter (copies/ mL); or d) Non-reactive HIV-1 antibody/antigen assays and HIV-1 RNA viral load (\>=) 5,000 copies/mL. HIV-1 RNA viral load must be confirmed once within 1 week of initial HIV-1 RNA viral load test
* Antiretroviral treatment-naïve, except for the use of TRUVADA® for pre-exposure prophylaxis (PrEP)
* Must be able to swallow whole tablets
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study drug
* A woman of childbearing potential must have a negative urine pregnancy test at screening

Exclusion Criteria:

* Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium tuberculosis infection, or another acquired immunodeficiency syndrome (AIDS) -defining condition that in the judgement of the investigator would increase the risk of morbidity or mortality
* Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgement is not compatible with Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF FDC)
* Known history of cirrhosis as diagnosed based on local practices
* Known history of chronic (\[\>=\] 3 months) renal insufficiency, defined as having an estimated glomerular filtration rate (eGFR) less than (\<) 50 milliliter per minute (mL/min) according to the Modification of Diet in Renal Disease (MDRD) formula
* Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study treatment
Diagnosis of Graft Pathology by TruGraf

The goal of this observational study is to to identify different causes of liver diseases or damage in liver transplant patients and develop a machine learning algorithm as a non-invasive tool leveraging gene expression and patient clinical information to classify transplant liver diseases We will collect blood samples of the participants who had undergone or will undergo the liver biopsy as part of standard of care, and use this blood in TruGarf. TruGraf is a non-invasive test that measures differentially expressed genes in the blood of transplant recipients to rule out liver damage. Researcher will collect the biopsy result from the medical record and this will be compared with the TruGarf results.

Given the significant investment of healthcare resources into transplantation, it is critical to identify recipients with graft pathologies such as Acute Cellular Rejection (ACR), NASH, cholestasis, etc. at an earlier stage to implement the appropriate intervention, rather than initiating empiric treatment that could be unsafe. This project will develop a practical Machine learning-based tool based on the results of the TruGraf assay alongside clinical and laboratory data for non-invasive diagnosis of graft pathology. TruGraf is a non-invasive test that measures differentially expressed genes in the blood of transplant recipients to identify patients who are likely to be adequately immunosuppressed and, in doing so, rule out graft damage. TruGraf measures the difference in gene expression for a precise panel of specific genes that have been empirically determined to discriminate between allografts that are truly healthy (Non-ACR), and those in transplant patients that have acute rejection on biopsy (AR). Nevertheless, the exact etiology of graft damage may be difficult to discern for the transplant clinician. The clinical characteristics and history of the liver transplant recipient as well as liver enzyme patterns can provide a pre-test probability of one diagnosis being more likely than the other (Acute cellular rejection, NASH, biliary or viral disease). The proposed tool will leverage our expertise in Machine Learning tools applied to clinical and molecular data (TruGraf assay results) to enable effective clinical implementation of the TruGraf assay.

Eligibility Criteria:
Inclusion Criteria:

1. . Single-organ Liver transplant recipients
2. Male or female, age \> 18 years at the time of signing informed consent.
3. Willing and able to provide informed consent.
4. Patients will be undergoing liver graft biopsy (for any reason), or have had a liver biopsy within 48 hours of consent.

Exclusion Criteria:

1. Repeat transplant
2. Recipient of multi organ transplantation
3. Any treatment for graft rejection such as IV steroids has been given before biopsy.
4. Targeted biopsies for diagnosis of malignancy.
Computed Tomography Scanning in ICU

Patients admitted to the intensive care unit often require CT imaging. Performing this diagnostic test on a critically ill patient involves risks, such as those associated with transferring a ventilated and unstable patient and those associated with the injection of intravenous contrast material. Also, multiple CT examinations may create a burden on the X-ray institute and the medical staff, result in the postponement of CT examinations for other patients, as well as increase hospitalization costs.

In this work, we would like to check the rate of complications involved in performing a CT scan in patients hospitalized in the general intensive care unit of our institution, while analyzing the differences between the times the test is performed (morning, night shift), as well as examine in what percentage of the CT scans the test performed contributed to a significant progress in the diagnosis or a significant change in the treatment plan of the patient, while referring to subgroups (sepsis, trauma, respiratory failure, with an emphasis on covid patients, patients with scoliosis, patients with intracranial pathology).


Eligibility Criteria:
Inclusion Criteria:All patients who underwent CT examinations during hospitalization in the intensive care unit for any etiology, from January 2020 to January 2023.

-

Exclusion Criteria:Patients who did not meet the above criteria or for whom data were missing.

-
89Zr-DFO-REGN3767 in PET Scans in People With Diffuse Large B Cell Lymphoma (DLBCL)

The main purposes of this study include:

Looking at the way the body absorbs, distributes, and gets rid of 89Zr-DFO-REGN3767

Finding the best dose amount of 89Zr-DFO-REGN3767

Finding the best time for PET scanning after injection of 89Zr-DFO-REGN3767


Eligibility Criteria:
Inclusion Criteria:

A patient must be eligible for DLBCL expansion cohort 9 in study 17-421 and, in addition, meet the following criteria to be eligible for inclusion in the study:

* Measurable disease by Lugano criteria, with at least one lesion outside of the liver
* Patients must have eGFR \>50 mL/min/1.73m2.

Exclusion Criteria:

A patient must be eligible for DLBCL expansion cohort 9 in study 17-421 and, in addition, a patient who meets any of the following criteria will be excluded from the study:

* Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.
* Has not yet recovered (i.e. ≤ Grade 1 or baseline) from any acute toxicities from prior anticancer therapy except for laboratory changes as described in inclusion criteria in study 17-421, except as noted. NOTE: Patients with chronic or stable toxicity following approved therapy, such as mild persistent neuropathy, are allowed.
* Has received radiation therapy within 14 days of first administration of study drug or has not recovered (i.e. ≤ Grade 1 or baseline) from adverse events, except for laboratory changes as described in inclusion criteria, except as noted. NOTE: Patients with chronic or stable toxicity, such as mild persistent neuropathy, are allowed.
* Women who are pregnant, breastfeeding \*Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation. Pregnancy testing and screening will be performed per MSK and Department of Radiology standard pregnancy screening guidelines.