cyrilzakka/clinical-trials huggingface dataset:
Sphenopalatine Nerve Block for Headache Tx360

The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.


Eligibility Criteria:
Inclusion Criteria:

* are 18 - 65 years of age
* present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region)
* have a normal neurological exams

Exclusion Criteria:

* are less than 18 years old or greater than 65
* have any focal neurological dysfunction signs or symptoms
* have a posterior/occipital/cervicogenic source predominance of headache
* are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches
* have self treated with pain medication or anti-emetic 4 hours prior to arrival
* have a history of peripheral vascular disease, cancer, or HIV infection
* are known to be pregnant
Effectiveness of Telerehabilitation for Work-Related Musculoskeletal Disorders in Cardiac Sonographers

Work-related musculoskeletal disorders(WRMDs) are common among cardiac sonographers due to their nature of work. This study aims to find out the effectiveness of the telerehabilitation method in the management of WRMDs among cardiac sonographers. 38 cardiac sonographers diagnosed with WRMDs will be randomly allocated into experimental and control groups with an allocation ratio1:1. The Experimental group will be receiving the telerehabilitation program along with an ergonomic awareness education program for 6 weeks, and the control group will receive an ergonomic awareness education alone. Pain, quality of life and work satisfaction are the outcome measures which will be measured at the baseline and after 6 weeks of the program


Eligibility Criteria:
Inclusion Criteria:

* Cardiac sonographers with work-related musculoskeletal pain.
* Cardiac sonographers practicing adult echocardiography predominantly working in public hospitals, private hospitals or/and private outpatient clinics in Saudi Arabia.

Exclusion Criteria:

* Systematic diseases as reported by the participants such as Diabetes Miletus and Fibromyalgia.
* Using cardiac medications or the pain killer as reported by the participants.
* Any biomechanical abnormalities based on the evaluation of a qualified physical therapist.
* Any other musculoskeletal disorders or injuries which is not related to WRMDs.
* Any recent surgery which may affect the ability to participate in the exercise program.
* Any other contraindications to participate in the exercise program.
* Pregnancy in female participants.
Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. As a secondary purpose, the study will evaluate the effect of a prophylactic administration of ciprofloxacin on LBP, cytokines and infections in the same patients.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis
* Ascites
* No history of spontaneous bacterial peritonitis and/or \< 1 g of protein in ascites
* No antibiotic use in previous 6 weeks
* Absence of infection (documented by clinical history, blood cytology, urinalysis and urine culture, thorax x-ray and paracentesis)
* Absence of GI bleeding or encephalopathy
* Signature of informed consent

Exclusion Criteria:

* Ciprofloxacin contraindication
* Autoimmune hepatitis, sclerosing cholangitis or other autoimmune disease
* \> 13 Child-Pugh points
* Inability to attend to regular visits
* Current alcohol intake
* Terminal disease with \< 24 week expected survival
Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma

This study will assess the safety, efficacy and pharmacokinetics of oral LBH589 in Japanese adult patients with refractory cutaneous T-Cell Lymphoma and adult T-cell leukemia/lymphoma. LBH589 is administered orally once a day for three days per week.


Eligibility Criteria:
Inclusion criteria:

* CTCL: Biopsy-confirmed MF or SS stages IB-IVA2.
* Patients who have SS with bone marrow involvement are also eligible.
* Patients with transformed CTCL are eligible.
* ATL: Patient with cytologically or histopathologically confirmed lymphoma.
* Lymphoma should be identified as tumors derived peripheral T-cells by cell surface marker.
* ATL: Patients with positivity for anti-HTLV-1 antibody
* Patients must have received at least two systemic therapy regimens.
* Patients must have had disease progression on or following their most recent treatment regimen.
* Age ≥ 20 years
* ECOG Performance Status of ≤ 2
* Written informed consent obtained prior to any study specific screening procedures

Exclusion criteria:

* Patients with a history of primary CNS tumors
* Any history or presence of brain metastases
* Patients with any peripheral neuropathy ≥ CTCAE grade 2
* Patients with unresolved diarrhea \> CTCAE grade 1
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
* Patients with concurrent severe and/or uncontrolled liver or renal disease
* Patients using sodium valproate ≤5 days prior to starting study drug
* Patients with an active bleeding diathesis or on any treatment with therapeutic doses of sodium warfarin or other antivitamin K drugs
* Patients who have received any investigational drug or chemotherapy or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
* Patients who have received biologic therapy, target therapy (e.g. denileukin diftitix ), vaccine, systemic steroids or immunotherapy ≤ 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy
* Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
The Impact of Rideshare Transportation Services on Appointment Adherence

This study is a prospective clinical trial designed to primarily test the impact of rideshare-based transportation services from a digital transportation network, Lyft, on reducing primary care clinic missed appointments--a composite outcome of no-shows and same day cancellations--for Medicaid patients. The study population consists of West Philadelphia residents who are established patients at two of the Penn Medicine Primary Care Practices within the University of Pennsylvania Health System. The study subjects are allocated into the intervention or control arm using a pseudorandomization approach - those receiving an appointment reminder on an even calendar day are in the intervention arm and odd calendar day calls are in the control arm.

Secondary outcomes include the time of arrival to the clinics relative to actual appointment time (both arms), prospective utilization of acute care settings (both arms), prospective utilization of primary care (both arms), and description of programmatic metrics in the intervention arm (travel time, misuse, and costs). The investigators will assess the patient experience after each ride using a telephone-based survey and in-depth interviews. All adults with established primary care at the Penn Medicine Clinics, who have Medicaid, and do not require wheelchair accessible rides will be eligible for the rideshare service. The investigators hypothesize that individuals offered a rideshare-based transportation service will have a decreased proportion of missed appointments and same day cancellations as those not offered the service.


Eligibility Criteria:
Inclusion Criteria:

* Patients insured by Medicaid
* Established primary care patient at the Penn Medicine Clinics
* Address in West Philadelphia zip code

Exclusion Criteria:

* Requiring wheelchair accessible transportation. We are unable to guarantee vehicles that will be able to accommodate these patients' physical needs.
Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia

Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for lamellar resection (ReLEx smile) in the reduction of myopia.

Quality control study of patients treated with ReLEx smile for myopia at the Department of Ophthalmology, Aarhus University Hospital.

The patients will be followed with standard clinical techniques (slit-lamp examination, refraction, topography) during their normal follow-up up to 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Indication for keratorefractive correction of myopia
* Patient consent to undergo keratorefractive correction of myopia

Exclusion Criteria:

* Pregnant or lactating women
Thalidomide in Treating Patients With Gynecologic Sarcomas

RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.

OBJECTIVES:

* Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.
* Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.
* Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.

OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed sarcoma or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin not amenable to resection or radiotherapy
* Measurable disease

  * Lesions accurately measured in at least 1 dimension of at least 20 mm in longest diameter with conventional techniques or at least 10 mm with helical CT scan
  * Histologically or cytologically confirmed neoplastic nature if solitary lesion
  * No nonmeasurable disease, defined as:

    * Bone lesions
    * Leptomeningeal disease
    * Ascites
    * Pleural/pericardial effusion
    * Inflammatory breast disease
    * Lymphangitis cutis/pulmonis
    * Unconfirmed abdominal masses not followed by imaging techniques
    * Cystic lesions
* Documented recurrence or persistence following appropriate surgery, radiotherapy, and/or chemotherapy
* Postmenopausal or status post hysterectomy

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* ECOG 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Granulocyte count at least 1,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* Bilirubin normal
* Transaminases less than 2.5 times upper limit of normal

Renal:

* Creatinine less than 1.5 mg/dL

Other:

* No grade 2 or greater peripheral neuropathy
* No medical or social factors that would preclude study, including inability to take oral medication
* No other serious illness requiring immediate therapy
* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics

Other:

* At least 30 days since any prior noncytotoxic experimental antiemetic or antifungal investigational drug
The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation

Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these procedures is the papillary muscles approximation. However, the safety and the positive impact of this method are still in doubt.

Ischemic mitral regurgitation develops in 10-50% of patients after myocardial infarction. Among several surgical procedures, mitral ring annuloplasty has been the method of choice for a considerable period. However, mitral regurgitation recurrence after surgery has a reported occurrence that ranges from 5% to 58%. Careful consideration of the mechanisms underlying recurrence of mitral regurgitation after annuloplasty might explain the unsatisfactory outcomes. The pathophysiology of IMR is complex and results from the imbalance between closing and tethering forces acting on the mitral valve. Enlargement of the left ventricular chamber, and displacement of papillary muscles in apical and lateral direction increase the tethering forces. Left ventricular and papillary muscle dyssynchrony, reduced myocardial contractility decrease closing forces, which lead to impaired leaflet coaptation and appearance of mitral regurgitation. Thus, treatment of mitral insufficiency requires an integrated approach affecting all units of the pathogenesis of MR recurrence.

Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these procedures is the papillary muscles approximation. However, the safety and the positive impact of this method are still in doubt. This study is conducted to identify the positive qualities and safety of this technique.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic cardiomyopathy,
* Ischemic mitral regurgitation.

Exclusion Criteria:

* Degenerative mitral valve disease,
* Unstable angina,
* Recent myocardial infarction (\< 6 months),
* Papillary muscles rupture,
* Severe right ventricular dysfunction,
* Multiple organ failures,
* Concomitant left ventricular reconstruction,
* Aortic valve procedures.
The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning

To correlate the data obtained by Electrical impedance tomography (EIT) during the spontaneous breathing trials (SBT) on a T-piece, in children, with failure in the trial and Extubation failure.

Observe if the EIT monitoring will be able to detect the children that will fail earlier than the SBT performed alone.

Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning.

Early and successful Extubation is sometimes a difficult combination in children, since the criteria for suggesting it are often subjective and poorly defined. Electrical impedance tomography (EIT) has been developed and used clinically for more than 30 years. Interest in this technology arose from the need to monitor ventilation and pulmonary perfusion at the bedside. Because it is a non-invasive and non-radiation technology, EIT is very promising in the pediatric population. Objectives: To correlate the data obtained by the EIT during the spontaneous breathing trials (SBT) on a T-piece with failure in the trial and Extubation failure and to observe if the EIT is able to detect the children that will fail earlier than the SBT performed alone. Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning. Qualitative characteristics will be described using absolute and relative frequencies and the quantitative characteristics will be described using summary measures (mean, standard deviation, median, minimum and maximum). Bivariate and later multiple logistic regression analyzes will be performed to evaluate the influence of characteristics assessed on weaning failure, mainly the reduction in functional residual capacity during and after the weaning trial. For the analysis will be used the software IBM-SPSS for Windows version 20.0 and tabulation of the data will be used Microsoft Excel 2010 software. The tests will be performed with significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

Children who are on mechanical ventilation for a period of more than 24 hours, between 28 days of age and 15 years, who are admitted to the pediatric intensive care unit (ICU) of the Children's Institute in Brazil

Exclusion Criteria:

* Upper Airway Obstruction
* Diaphragmatic hernia or diaphragmatic paralysis
* Chronic use of mechanical ventilation
* Cyanogenic congenital heart disease
* Primary pulmonary hypertension
* Neuromuscular disease
* Tracheostomy
Micro-hematology Analyzer for Viral/Bacterial Description

The purpose of the study is to evaluate the reliability and accuracy of a newly developed point-of-care analyzer, theCytoTracker, to measure complete blood count (CBC) parameters and discriminate between viral and bacterial infections.

The purpose of the study is to evaluate the reliability and accuracy of a newly developed point-of-care analyzer, the CytoTracker, to measure complete blood count (CBC) parameters. The CytoTracker results will be compared to those from a standard benchtop analyzer (Horiba Point of Care Hematology Analyzer, ABX Micros ES 60). If successful, the data from this study would be used to support a pre-submission meeting to the FDA for the CytoTracker. In addition to validating the CytoTracker, the project will study the use of CBC parameters to distinguish between observed bacterial or viral infections in adults. Hospitalized adult subjects with suspected or confirmed viral or bacterial infections will be enrolled in the study. After enrollment a venous blood sample (baseline sample) will be collected and the CytoTracker will be used to measure CBC parameters (cell counts and population distribution). Clinical data will be abstracted from the medical record and used with the CBC parameters to develop an algorithm to distinguish between bacterial and viral infections.

Eligibility Criteria:
Inclusion Criteria:

-COVID positive or suspected/confirmed bacterial infection (lower UTI, pneumonia, septecemia, etc). -Adults 18 years of age and older. -Meet SIRS criteria anytime during the ED presentation.

Exclusion Criteria:

* Subjects who are unable to give informed consent will be excluded
* Subjects with the following conditions will also be excluded: Known white blood cell, neutrophil, and lymphocyte disorders Active cancer patients; For solid tumors, subject will be excluded if he/she has received chemotherapy in the last 3 months.
* Subjects who are pregnant
Study to Determine if Fibrin Affects the Ability of a Wound to Heal

The objective of this study is to evaluate the potential inhibitory effects of HP802-247 Vehicle on wound closure (healing), by comparing mean days to closure of superficial (partial-thickness) thermal wounds against similar wounds treated with white petrolatum.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
* Are male or female, ≥ 18 years of age, of any race.
* Are willing to attend all required study visits, and to comply with study procedures.
* Meet none of the exclusion criteria (any single exclusion criterion which is met by a potential subject will disqualify that subject from participation in this study.

Exclusion Criteria:

* Have a history of dermatomyositis, systemic sclerosis, scleroderma, Sjögren's syndrome, systemic lupus erythematosus, discoid lupus, Ehler Danlos disease, icthyosis vulgaris, vasculitis, or bleeding disorders (coagulopathies).
* Have any dermatologic disease which may be aggravated or provoked by the wounding procedure, such as Lichen Planus, Psoriasis, or Vitiligo.
* Have Fitzpatrick scale skin type 6 (never sunburns, deeply pigmented).
* Are at risk of keloid or hypertrophic scar formation, based on personal history, family history, or brief skin exam (conducted at the screening visit to look for keloids or hypertrophic scars).
* Have been treated within the last three months for uncontrolled diabetes mellitus, peripheral vascular disease, vitamin C deficiency, connective tissue disorders, or any other disease process that impedes wound healing.
* Are taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs.
* Are using topical glycolic acid products, alpha-hydroxy acid products, retinoids, or chemical peel agents in the treatment areas.
* Are using systemic steroids or immunosuppressant agents, or have used these drugs within the past three months.
* The Principal Investigator may declare any subject ineligible for a valid medical reason.
Kinase Genotyping of Gastro Intestinal Stomach Tumors (GISTs) From Patients Enrolled in Pfizer A6181112 Phase IIIb Trial

The purpose of this study is to determine the genetic makeup of gastro intestinal stomach tumors (GISTs) from patients enrolled in the A6181112 phase IIIb trial. Tumor samples will be screened for mutations and this information will be used to determine whether the progression-free survival of patients being treated with the cancer medication sunitinib is related to the underlying genotype of their GIST.

In this companion study, we will analyze the genomic DNA from the GIST tumor specimens of patients enrolled in the in the A6181112 phase IIIb trial at participating U.S. and ex-U.S. medical centers. Specifically, GIST samples will be screened for mutations in KIT gene exons 9, 11, 13 and 17, and PDGFRA gene exons 12, 14 and 18, to determine the primary kinase genotype. Subset analyses will be performed and compared with the overall PFS rates observed in patients with primary and secondary imatinib resistance. Based on data from a previous phase I/II trial, our hypothesis is that patients with either primary or secondary imatinib resistance having a KIT exon 9-mutant or WT GIST will have a longer PFS when treated with sunitinib than patients with exon 11-mutant GIST. We further hypothesize that this difference will be observed among patients treated with high-dose imatinib.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in Pfizer A6181112

Exclusion Criteria:

* Patients who do not consent for analysis of their tumor in this companion study
Telo Genomics Technology to Detect & Profile Multiple Myeloma MRD

The purpose :

Detect and profile Multiple myeloma Measurable Residual Disease(MRD) prognostics for monitoring post-transplant Multiple Myeloma (MM) Patients receiving maintenance therapy.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed MM diagnosis
* Transplant eligible patients in a first remission
* Known MRD level detected by ClonoSeq (other IMWG recognized methodologies can be also employed)
* Availability of deidentified patient's demographic and clinical follow up data
* Receiving standard of care treatment
* Able to provide informed consent

Exclusion Criteria:

* Failure to meet inclusion criteria