cyrilzakka/clinical-trials huggingface dataset:
A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects with COPD

A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW642444H (100 administered once daily in the morning via DISKUS™ dry-powder inhaler) compared with SEREVENT (salmeterol) (50mcg administered twice daily via DISKUS dry-powder inhaler) and placebo in subjects with moderate COPD.

Eligibility Criteria:
Inclusion criteria:

* females must be of non-childbearing potential
* moderately severe COPD

Exclusion criteria:

* Subjects with a main diagnosis of asthma
* subjects with poorly controlled COPD
* subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological disease.
Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients

To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in de novo renal transplant recipients by assessing rejection rate everolimus trough levels, other safety laboratory variables and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged above 18 years.
* Patients having received their first or second single renal transplant from deceased or living donor
* Patient willing and capable of giving written informed consent for study participation
* Patients treated with as induction therapy at the time of transplantation
* Patients maintained on a triple immunosuppressive regime consisting of cyclosporine (C-0 h between 100-250 ng/ml or a C-2 h between 900-1100 ng/ml), Enteric coated mycophenolate sodium (EC-MPS), minimum dose 1080 mg and corticosteroids, minimum dose 10 mg
* Patients without any biopsy proven acute rejection episode or treatment for any acute rejection since the transplant
* Females capable of becoming pregnant must have a negative pregnancy test prior to the switch to everolimus and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility.

Exclusion Criteria:

* Recipient of multi-organ transplants, and or previously transplanted with any other organ different from a kidney transplant
* Patients with antibodies towards the donor kidney above 30%
* Patients receiving a renal transplant from HLA-identical sibling
* Presence of hyper sensitivity to drugs similar to everolimus ( e.g. macrolides)
* Patient with past (within the last two years) or present malignancy other than excised basal cell or squamous cell carcinoma of the skin
* Patients who are recipients of AB0 incompatible transplants
* Patients with unsuitable laboratory values
* Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator
* Patient with a current severe major local or systemic infection
* Patients requiring dialysis and/or having a calculated glomerular filtration rate (Cockcroft-Gault) \< 20 ml/min
* Presence of intractable immunosuppressant complications or side effects (e.g., severe gastrointestinal adverse events) at the time of the switch
* Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded.
* Evidence of severe liver disease

Other protocol-defined inclusion/exclusion criteria may apply.
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms

Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.


Eligibility Criteria:
Inclusion Criteria:

* Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours
* Presence of lesions with some degree of symmetry to allow comparison between both pharmaceutical formulations
* Compliance of the subject to the treatment protocol
* Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old

Exclusion Criteria:

* Pregnancy or risk of pregnancy
* Lactation
* Signs of solar erythema of severe intensity
* Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
* History of atopy or allergic diseases
* History of allergy to any component of the formulations
* Other conditions considered by the investigator as reasonable for non-eligibility
TELAXMAN - Laser Lithotripsy With Automatic Real-time Stone Recognition

Urolithiasis is an extremely common disease affecting about 12% of the world population with increasing tendency. Urinary stones are sediments that form in the kidney from crystals, such as calcium oxalate.

Currently, urological endoscopy with laser lithotripsy represents the leading and most frequently used method for the treatment of urinary stones of different localization, size and composition.

Surgical urology, including interventional stone treatment, is highly inﬂuenced by technology. With regard to fragmentation properties and effectiveness for all stone types Holmium:yttrium-aluminium-garnet (Ho:YAG) laser lithotripsy has become the standard technology to disintegrate urinary calculi.

In addition, other kinds of lasers are emerging, such as the thulium fiber laser (TFL); a new solid-state, diode-pumped laser that may provide urologists with increased options for stone treatment.

While urolithiasis treatment in general and laser lithotripsy in specific rarely goes along with major complications, recent studies have shown that there are possible indirect risks to the treatment with lasers, such as thermal damages to the urinary tract even at low-power settings if inadequate irrigation is applied. Sufficient irrigation is mandatory to perform safe Ho:YAG laser lithotripsy.

The RevoLix HTL+ automatic real-time stone detection module was developed to overcome these limitations and improve the safety of the patient with regard to potential thermal damages.

The objective of this clinical investigation is to assess the feasibility of stone recognition and disintegration with the RevoLix HTL+ in clinical conditions and to identify hypotheses to be used in future clinical investigations.


Eligibility Criteria:
Inclusion Criteria:

* Subject scheduled for laser lithotripsy
* Subject aged 18 or older
* Subject able to give consent
* Informed consent documented by signature

Exclusion Criteria:

* Subject pregnant or nursing
* Subject requiring emergency lithotripsy
* Contraindication for the surgical procedure:

  * Positive urine culture,
  * Unfit for general anesthesia,
  * Therapeutic anticoagulation, or systemic infection
Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections

In this pilot study, the objective is to determine the prevalence of asymptomatic carriage of S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with either linezolid or clindamycin at 40 days after the completion of therapy. Secondarily, the investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy of ABSSSIs and minor cutaneous abscesses, as well as the genotypic spectrum of S. aureus isolates causing ABSSSIs or minor cutaneous abscesses and colonization in the target patient population before and after therapy. Given the results of a recent study on linezolid and vancomycin and the investigator's own experience, it is hypothesized that persistent MRSA carriage will be less common after therapy with linezolid for ABSSSIs and minor cutaneous abscesses than it is with oral clindamycin.


Eligibility Criteria:
Inclusion Criteria:

* having an ABSSSI or a minor cutaneous abscess treated in the ED
* age 18 years or older
* any one or more of the following co-morbidities:

  * diagnosis of diabetes mellitus
  * obesity with a BMI \>35
  * chronic kidney disease
  * coronary artery disease
  * peripheral vascular disease

Exclusion Criteria:

* known history of or current thrombocytopenia
* Currently taking anti-depression medication
* Current or recent hospitalization
* Known current alcohol or drug abuse
* Known or suspected hypersensitivity to any ingredient of the study drugs
* Irregular heart rate and blood pressure measurements
* Fevers or low body temperature
* Known psychiatric condition
* Superficial skin infection
* Skin infection caused from an animal bite
* Recent treatment with antibacterials
* Pregnancy

Other protocol related inclusion/exclusion criteria may apply.
Prospective Validation of Liver Cancer Risk Computation (LIRIC) Models

The goal of this prospective observational cohort study is to validate previously developed Hepatocellular Carcinoma (HCC) risk prediction algorithms, the Liver Risk Computation (LIRIC) models, which are based on electronic health records.

The main questions it aims to answer are:

* Will our retrospectively developed general population LIRIC models, developed on routine EHR data, perform similarly when prospectively validated, and reliably and accurately predict HCC in real-time?
* What is the average time from model deployment and risk prediction, to the date of HCC development and what is the stage of HCC at diagnosis?

The risk model will be deployed on data from individuals eligible for the study. Each individual will be assigned a risk score and tracked over time to assess the model's discriminatory performance and calibration.

The investigators will conduct a prospective observational cohort study, separately deploying three separate LIRIC models (the general population, cirrhosis, and no_cirrhosis models) on retrospective de-identified EHR data of 44 HCOs in the USA, using the TriNetX federated network platform. LIRIC will generate a risk score for each individual. All risk-stratified individuals will be prospectively, electronically followed for up to 3-years to assess the primary end-point of HCC development. At the end of this period, model discrimination will be assessed, using the following metrics: AUROC, sensitivity, specificity, PPV/NPV. Risk scores generated by the model will be divided into quantiles. For each quantile, the investigators will evaluate the following: number of individuals in each quantile, number of HCC cases, PPV, NNS, SIR. Model calibration will be used for assessing the accuracy of estimates, based on the estimated to observed number of events. The model will dynamically re-evaluate all individual data every 6 months, re-classifying individuals (as needed).

Eligibility Criteria:
The investigators will utilize the following criteria for all 3 models:

Inclusion criteria:

* Male and females age ≥40 years from all US HCOs available on the platform
* at least at least 2 clinical encounters to the HCO, within the last year, before the study start date

Exclusion Criteria:

* Personal history of HCC or current HCC (ICD-9: 155.0; ICD-10: C22.0)
* Age below 40. The same dataset will be utilized for the non-cirrhosis validation, with exclusion of all cases with cirrhosis (ICD-9: 571.2, 571.5; ICD-10: K70, K70.3, K70.30, K70.31, K74, K74.0, K74.6, K74.60, K74.69). For the cirrhosis validation, the investigators will include only patients with the above cirrhosis codes.
Study of Stereotactic Ablative Radiotherapy (SABR) in Elderly Stage I NSCLC

This study aims to prospectively investigate the efficacy, toxicity and quality of life (QOF) of stereotactic ablative radiotherapy (SABR) using a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy) in a single arm of elderly ( ≥ 70) patients with stage I (2009 UICC) non-small cell lung cancer (NSCLC).

This study aims to prospectively investigate the local regional control, overall survival, treatment related toxicities and quality of life (QOF) of elderly stage I NSCLC patients receiving stereotactic ablative radiotherapy (SABR) with a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy). Patients' general characteristics, treatment modality, dose-volume histogram (DVH) parameters, toxicity profiling, quality of life, pattern of failure as well as survival time will be prospective recorded for the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70
* Pathologically or cytologically confirmed NSCLC
* Stage T1- 2 N0M0 based on adequate workup
* Peripheral tumor
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Inoperable NSCLC

Exclusion Criteria:

* Pathologically or cytologically confirmed SCLC
* Direct evidence of regional or distant metastasis
* Central tumor
* Past history of malignancy
* Past history of thoracic irradiation
* Past history of chemotherapy
* Past history of thoracic surgery
* Pure Bronchioalveolar adenocarcinoma
* Active systemic, pulmonary or pleural lung diseases
* Pulmonary infection
Intravenous Fluids in Pediatric Migraine

The goal of this clinical trial is to compare intravenous (IV) fluids in pediatric patients with migraine. The main questions it aims to answer are:

* Does a large amount of fluids (bolus) improve pain
* Does a large amount of fluids (bolus) reduce admissions to the hospital for migraine Participants will be asked to report their pain and have vital signs checked every 30 minutes for two hours.

Researchers will compare a large amount of fluids (bolus) to a small amount (half maintenance) to see if there is a difference in pain improvement.

Patients will be randomized to one of two treatment groups. The intervention group will receive a 20 mL/kg bolus of normal saline (with a maximum of 1L), given over one hour.

The control group will receive normal saline at half maintenance (with a maximum of 50mL/hr) over one hour.

Both groups will receive:

* ketoralac (Toradol), 0.5mg/kg, with a maximum of 30mg
* diphenhydramine(Benadryl), 0.5mg/kg, with a maximum of 25mg
* prochlorperazine(Compazine), 0.15mg/kg, with a maximum of 10mg

Pain score, heart rate, and blood pressure will be monitored every 30 minutes from the start of the medications/fluids being started, for a period of two hours. Pain will be recorded using a 100mm visual analog scale.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 prior headache
* Minimum pain score of 10mm
* Headache lasting 2-72 hours
* At least two of the following four: 1 Bifrontal/bitemporal or unilateral location, 2 Pulsating quality, 3 Moderate or severe pain intensity, 4 Aggravation by or causing avoidance of routine physical activity
* At least one of the following: 1 Nausea and/or vomiting, 2Photophobia and phonophobia, 3 Not better accounted for by another ICHD-3 diagnosis

Exclusion Criteria:

* Shunted hydrocephalus
* Temperature equal to or greater than 38.5C
* Clinical suspicion of meningitis
* Known or suspected intracranial lesion
* Clinical evidence of significant dehydration (or signs of shock, or attending discretion)
* Head trauma in previous 7 days
* Pregnancy or breastfeeding
* Initial pain score less than 10mm
* Allergy to study medications
* Patients previously participating in the study
Penn SICCA Follow-up Study

This study will involve the collection of follow-up data for patients who previously participated in the Sjogren's International Clinical Collaborative Alliance (SICCA) study at the University of Pennsylvania. Clinical data and specimens will be collected from subjects with objective evidence of dry eye who were or were not diagnosed with Sjogren's syndrome at the time of their initial participation in the SICCA study. Specimens will be collected from participants which will include tears, saliva, whole blood, serum, DNA and possible labial minor salivary gland biopsies when indicated. All individuals will participate in a standard evaluation protocol including an oral, ocular and physical examination, objective tests for dry eyes and dry mouth and, whenever necessary, a labial minor salivary gland biopsy. The biopsy requirement is waived for those who have already had positive lip biopsies in the past.

General study design: This is a single center study that involves follow-up of patients who previously participated in the Sjogren's International Collaborative Clinical Alliance (SICCA) at the University of Pennsylvania. Objective evaluation of salivary function will be done by collecting unstimulated whole and stimulated parotid saliva. Objective evaluation of lacrimal function will be performed using the Schirmer test I, Lissamine Green staining, and determining tear break-up time. In a subset of patients, when indicated an objective evaluation of lymphocytic infiltration of the minor salivary glands will be performed by histologic analysis of labial salivary gland biopsies. Serum autoantibody profiles will be determined. In addition, specimens such as biopsies, saliva, sera, conjunctival cells, and tears will be collected. Standardized questionnaires will be used to gain health information.

Eligibility Criteria:
Inclusion Criteria:

1. Previously participated in the SICCA study at Penn
2. Be 18 years or older

4. Have signed an IRB consent form agreeing to the terms of the study

Exclusion Criteria:

1. Did not previously participate in SICCA study at Penn
2. Under the age of 18 years
Enhanced Community-Based Asthma Monitoring Through Novel Technology

The goal of this pilot interventional study is to learn about the implementation of a home monitoring program (using remote study visits and lung function testing) in children with asthma.

The main questions to answer are:

1. Do participants find the program to be feasibile, acceptable and accessible?
2. What factors are associated with completion of the program?
3. Does the program have an effect on asthma control and daytime sleepiness?

The primary objective of the proposed study is to pilot test implementation of a protocol for enhanced asthma monitoring using novel technology, including mobile spirometry and remote study visits, for rural and medically underserved children with persistent asthma in Delaware and to determine its feasibility, acceptability, and accessibility.

Additionally, the proposed study aims to explore patient and family demographic characteristics and social factors associated with successful completion of the program and to explore the preliminary effect of the enhanced asthma monitoring program on asthma control and sleepiness as a measure of daytime functioning.

Eligibility Criteria:
Inclusion Criteria:

* Followed by a Primary Care Practice meeting HRSA rural or medically underserved designation status
* Diagnosis of persistent asthma: on at least 1 controller/ preventative medication for asthma
* Ability to follow directions and perform study measures, including in-office spirometry at initial visit
* Access to mobile device with internet connectivity to connect to telehealth visit and mobile spirometer application

Exclusion Criteria:

* Significant cardiopulmonary disease other than asthma (Examples: Cystic Fibrosis, complex congenital heart disease)
* Non-English Speaking
Affect Management Intervention for Early Adolescents Wtih Mental Health Problems

Adolescents are at risk for HIV because of sexual and drug use behavior initiated during early adolescence, and those with mental health problems appear to be particularly susceptible. Problems with managing emotions may make it difficult for early adolescents to make good decisions about sexual and substance use behaviors. This project will develop and evaluate interventions for early adolescents with mental health issues. An intervention focused on teaching affect management skills will be compared to an intervention addressing a variety of health topics to determine which intervention best reduces risk behavior among this at-risk population.


Eligibility Criteria:
Inclusion Criteria:

* Seventh graders identified by counselors at participating public school

Exclusion Criteria:

* Adolescent is HIV positive
* Adolescent is developmentally delayed
* Adolescent in pregnant
* Adolescent has a history of sexual crime
US Ovulation Inhibition Study in Obese Women

Birth Control Patch Study


Eligibility Criteria:
Inclusion Criteria:

* Female subject requesting contraception
* Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
* Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
* History of regular cyclic menstrual periods
* Willingness to use non-hormonal methods of contraception during the entire study.

Exclusion Criteria:

* Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
* Hypersensitivity to any ingredient of the study drug
* Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
* Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis)
* Any disease or condition that may worsen under hormonal treatment.
Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants

This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100 mg once daily (QD), in healthy participants with functional CYP2C19 alleles. The study also reviews the effects of atazanavir/ritonavir, 300/100 mg QD, on the pharmacokinetics of voriconazole, 200 mg, BID in healthy participants with functional CYP2C19 alleles.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants as determined by no clinically significant deviation from normal
* Body Mass Index (BMI) of 18 to 32 kg/m\^2, inclusive. BMI=weight(kg)/height (m)\^2
* Women who are not of childbearing potential (WOCBP)(ie, who are postmenopausal or surgically sterile) and men, ages 18 to 45 years, inclusive

Exclusion Criteria:

* WOCBP
* Sexually active fertile men not using effective birth control if their partners are WOCBP
* Proven or suspected acute hepatitis (within 12 months prior to the 1st dose)
* Any significant acute or chronic medical illness
* Any gastrointestinal surgery that could impact on the absorption of study drug
* Smoking more than 5 cigarettes per day
* History of any hemolytic disorders (including drug-induced hemolysis)
* History of acute or chronic pancreatitis
* History of hypochlorhydria or achlorhydria
* Men and women weighing \<40 kg
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 or HIV-2 antibody
* Patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption