cyrilzakka/clinical-trials huggingface dataset:
A Study of Laropiprant (MK-0524) in Participants With Moderate to Severe Erythematotelangiectatic Rosacea (MK-0524-155)

This study will assess the effect of MK-0524 relative to placebo, on signs and symptoms of rosacea and to determine the safety and tolerability profile of MK-0524 in participants with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe erythematotelangiectatic rosacea with moderate to severe erythema of facial lesion
* Generally healthy excluding rosacea
* Presence of telangiectasia
* Five or less facial inflammatory lesions
* Able to restrict diet in order to avoid foods/drinks (including alcohol) that are known to exacerbate the signs/symptoms of rosacea
* Females of childbearing potential must have negative serum pregnancy test and agree to use one form of contraception

Exclusion Criteria:

* Diagnosis of skin disorders, including psoriasis, acne vulgaris, perioral dermatitis or atopic dermatitis that would interfere with the clinical evaluations of rosacea
* Using and unable to discontinue use of phosphodiesterase (PDE) 4 inhibitors, theophylline, niacin greater than 500 mg/day
* Known or suspected excessive alcohol intake
* Sensitivity to tetracyclines
* Ocular rosacea and/or blepharitis/meibomianitis
* Pregnant or breastfeeding
* Perimenopausal and has symptoms that cause flushing that may affect rosacea
* Initiated hormonal method of birth contraception within 4 months of baseline, discontinues use during the course of the study, or changes hormonal method within 4 months
* Active mycobacterial infection of any species within 3 years
* History of mycobacterium tuberculosis infection
* History of recurrent bacterial infection
* Congenital or acquired immunodeficiency common variable immunodeficiency (CVID), Hepatitis B surface antigen positive or Hepatitis B core antibody positive
* Human immunodeficiency virus (HIV) infection
* Positive for hepatitis C antibodies
* Malignancy or has had a history of malignancy greater than 3 years prior
* Will continue to use any of the following treatments during the study: Systemic retinoids, therapeutic vitamin A supplements of greater than 10,000 units/day, systemic steroids, systemic antibiotics known to have an impact on the severity of facial rosacea, systemic treatment for acne, topical steroids, topical retinoids, topical acne treatments including prescription and over-the-counter (OTC) preparations, topical anti-inflammatory agents, topical antibiotics, topical imidazole antimycotics, cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, X-ray therapy, pulse-dye laser, intense pulse light, astringents, abrasives, benzoyl peroxide products, sulfur containing washes, eye washes, Beta blockers, vasodilators, vasoconstrictors and/or chronic use (\>14 days) of topical or systemic anti-inflammatory agents
Effectiveness of DIMS Spectacle as a Function of the Age

Purpose: To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.

Methods: This was a non-randomized experimenter-masked retrospective controlled observational study of European individuals aged 6 -16 years with progressive myopia but no ocular pathology. The charts of the participants allocated to receive DIMS spectacles (Hoya® MiyoSmart®) or single vision spectacle lenses (control group) were retrospectively reviewed. The key outcome variables, cycloplegic spherical equivalent (SE) and axial length (AL), were measured at baseline and at 36 month follow up. The results were stratified by age into four groups: patients that wore DIMS spectacles oldest or youngest than 10 years (respectively, group A, 20 patients mean age 13.6±2.2 and group C, 20 patients mean age 9.0±1.2) and age matched control groups (group B, 18 patients mean age 13.2±2.5 and group D, mean age 8.5±0.9).

Participants were allocated to the study groups, receiving DIMS spectacles, or to the control groups, wearing single vision spectacle lenses.

Eligibility Criteria:
Inclusion Criteria:

* patient age between 6-16 years
* progressive myopia with cycloplegic spherical equivalent (SE) from -0.50 to -4.00 diopters (D)
* astigmatism less than 2.50D, anisometropia under 1.25D

Exclusion Criteria:

* genetic syndromes suspected (e.g., Stickler, Marfan, etc.)
* systemic diseases
* eye diseases (such as glaucoma, juvenile cataracts, retinal abnormalities, any form of strabismus)
A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia

This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample size is 50-100 patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>/=18 years of age
* Chronic renal anaemia
* Haemoglobin concentration between 10 and 12 g/dL at screening
* Adequate iron status
* Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
* Regular long-term haemodialysis therapy for at least 12 weeks prior to screening

Exclusion Criteria:

* Change in haemoglobin concentration \>/=2 g/dL during screening
* Transfusion of red blood cells less than 8 weeks prior to screening
* Poorly controlled hypertension
* Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
* Active malignant disease
* Haemolysis
* Haemoglobinopathies
The Interest of Cancer Patients and Caregivers in Acupuncture: a Survey

Cancer and cancer treatments are accompanied by several possible side effects, such as nausea, hot flashes, fatigue, drowsiness, etc. Complementary and integrative therapies, such as acupuncture, could be used to manage these symptoms. The aim of this study for our research team is to have an idea of the interest of cancer patients and caregivers in acupuncture. This is a prospective, interventional study. Cancer patients and caregivers will be approached at the day care clinic by a health care worker to participate in this study. They will be asked to complete a questionnaire about their interest in acupuncture and their motivation, what symptoms they would need it for, where they would like this acupuncture to take place, whether they are willing to pay for it, and whether they would be interested in an information session about acupuncture.


Eligibility Criteria:
Inclusion Criteria:

* Dutch speaking patients and caregivers
* Patients and caregivers presenting at the outpatient clinic, including the day-care clinic and follow up visits
Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting

In resource-limited setting, concerns remain regarding the emergence of virologic failure and high-level drug resistance mutations (DRM) during WHO recommended first-line antiretroviral therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens for Human immunodeficiency virus 1 (HIV1) infected patients. The study hypothesis is that a boosted-protease inhibitor regimen has a better outcome than a NNRTI-based regimen with a low genetic barrier to resistance.

The study is a randomized, multicenter, factorial trial (conducted in Congo), in treatment- naïve adults receiving for 96 weeks ritonavir- boosted lopinavir(LPV/r) or nevirapine (NVP) each in combination with tenofovir (TDF) /emtricitabine (FTC) or zidovudine (ZDV)/lamivudine (3TC). The primary end point is the incidence of therapeutic (clinical and/or virologic)failure by study week 24.


Eligibility Criteria:
Inclusion Criteria:

* Antiretroviral-therapy naïve HIV-1 infected Adults
* WHO clinical stage 3 and CD4 \<350/mm3 or
* WHO clinical stage 4 or
* CD4 cell count \< 200/mm3
* Negative pregnancy test

Exclusion Criteria:

* Hemoglobin \< 8.5 g/dL (female) or 9.0 g/dL (male)
* Estimated Glomerular Filtration Rate \< 50 ml/ minute (Cockcroft-Gault equation)
* Hepatic transaminases (AST and ALT)\> 3 x upper limit of normal
* Active tuberculosis
* Pregnancy
* Females who are breastfeeding
The Effect of Exercise Given to Cashiers Along With Ergonomics Training on Pain and Work Performance

The aim of the study is to examine the effectiveness of the exercises given to cashiers through ergonomics training.

The work will be done with 60 cashiers. These cashiers will be selected on the condition that they work at least 40 hours a week. 60 employees will be randomly divided into two groups of 30 people each. All participants will be given ergonomics training. In addition, participants in the exercise group will be given a 12-week exercise program. These two groups will be randomly divided into control and exercise groups. Each group will be evaluated twice, at the beginning and at the end of the study.

Eligibility Criteria:
inclusion criteria

* Those who have been working as cashiers in the market for at least 2 years
* Employees who have no obstacle to exercise
* Women and men aged 18-45
* Cashiers working 40 hours or more per week

exclusion criteria

* Being diagnosed with a serious psychological illness.
* Malignancy
* Advanced osteoporosis
* Being under 25 years of age.
Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries

The purpose of this study is to determine whether using hyperbaric oxygen (HBO) improves wound healing for patients who have a crush injury. The comparison of the prospective intervention group to the retrospective matched cohort aims to show that HBO can improve wound healing and decrease poor outcomes for patients with crush injuries. The information gained from this small study will serve as a basis for a follow-up prospective, randomized control trial to further delineate the role of HBO in a larger patient population.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to NYU Winthrop Hospital with a crush injury of the extremity, including appendages, up to 14 days post injury.
* No contraindication to hyperbaric oxygen therapy.
* Able and willing to sign informed consent.

Exclusion Criteria:

* Critically-ill patient requiring intubation or pressor support.
* Crush injury isolated to the distal phalanx (Tuft fracture).
* Absolute contraindication to hyperbaric oxygen therapy (untreated pneumothorax). Relative contraindications (uncontrolled congestive heart failure, uncontrolled seizure disorder, pulmonary disease, claustrophobia) will be assessed by the treating physician.
* Unable or unwilling to sign informed consent.
DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients respond to treatment.

PURPOSE: This laboratory study is looking at tissue samples from patients with acute myeloid leukemia.

OBJECTIVES:

Primary

* Determine gene expression, genome integrity, cytosine methylation, and chromatin structure in patients with normal cytogenetics leukemia (NCL) acute myeloid leukemia.
* Determine whether NCL can be deconstructed into specific disease entities by analysis of the integrated genomic and epigenomic datasets using supervised and unsupervised methods in these patients.
* Identify the gene pathways that define NCL subtypes and molecular targets for validation in preclinical and clinical trials for these patients.
* Determine whether integrated analysis provides markers of prognostic and therapeutic response that accurately predicts clinical outcome and can be used to select patients for risk-stratified therapeutic trials.

OUTLINE: This is a pilot, multicenter study.

Samples are analyzed to assess array comparative genomic hybridization using polymerase chain reaction (PCR) and fluorescent in situ hybridization; chromatin immunoprecipitations (chip) using PCR; Hpa II tiny fragment enrichment by ligation-mediated PCR (HELP) using DNA methylation analysis; and gene expression profiling.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Enrolled on clinical trial ECOG-E1900

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Ezetimibe in Patients Hypo-responsive to Statins

Response to statin therapy for elevated low density lipoprotein is variable and may be influenced by cholesterol absorption. This study will evaluate whether combination therapy with atorvastatin/ezetimibe will be superior to atorvastatin alone in subjects who have less than 25% LDL reduction on starting dose statin (eg, atorvastatin 10 mg daily or simvastatin 20 mg daily).

Specific Aim 1 To identify a patient population seen in the University of California, San Diego general internal medicine and cardiology subspecialty clinics as well as referrals from community physicians who are hyporesponsive to statin therapy (defined as an initial LDL reduction of \<25% in response to 10mg of atorvastatin or 20mg of simvastatin- expected mean reduction is 35% -37% for starting dose simvastatin and atorvastatin).

Specific Aim 2 To test the hypothesis, with a prospective study, that a hyporesponse to statin therapy may be related to increased cholesterol absorption, and that this hyporesponse may be overcome by the addition of ezetimibe, a specific cholesterol absorption inhibitor.

Specific Aim 3 To evaluate whether patients with less than 25% LDL reduction on 10 mg of atorvastatin (or 20 mg of simvastatin) would achieve significantly greater LDL reduction with combination therapy (atorvastatin/ezetimibe) than with statin dose titration (using atorvastatin).

Eligibility Criteria:
Inclusion Criteria:

* Patients will need to have an LDL-C level of 130 mg/dl or greater without treatment.
* They must have demonstrated an initial LDL-C reduction of less than 25% on 10 mg of atorvastatin or 20 mg of simvastatin.
* Eligible patients will be those deemed by their physicians to be eligible for lipid lowering therapy with a statin and to have stable CAD, CAD equivalent per NCEP guidelines, or Framingham risk of 10-20%.

Exclusion Criteria:

* Recent (\<3 months) diagnosis of Acute Coronary Syndromes due to ethical considerations \[10\].
* Pregnant patients, those planning to become pregnant, or those who are breast feeding, those with liver disease, history allergic reaction to any agent used in the trial, history of myositis, myopathy, pancreatitis, hypertriglyceridemia (TG \> 400 mg/dL), history of significant alcohol or drug abuse, history of organ transplantation, or patient refusal.
Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

1. To investigate the safety and tolerability of Xerecept during and following a 24-hour intravenous administration to healthy Japanese to healthy Japanese and Caucasian subjects
2. To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects

none needed

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female Japanese subjects who are citizens of Japan
* Healthy male and female Caucasian subjects
* Age range 20-45 years
* BMI \>19 and \<27 kg/m squared

Exclusion Criteria:

* Female subjects must not be pregnant at the time of study and use adequate birth control methods before,during and 4 weeks after the study
* Subjects must be negative for HCV and HIV
* Subjects must have negative urine tests for drugs of abuse and alcohol at screening
* Subjects must not have any clinically significant medical conditions
Management of Open Fracture Tibia in Teenagers

The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes

Tibial fractures are the third most common long bone fracture after the femur and forearm, representing 15% of all pediatric fractures Tibial fracture is a common injury in children, and it usually involves the diaphysis and distal metaphyseal region Open fracture tibia must be considered orthopedic emergencies due to the high risk of contamination, osteomyelitis, malformation, nonunion, and disability The anteromedial aspect of the tibia is subcutaneous with no overlying musculature for protection and the middle/distal tibia has no muscular origins, which can delay union in these areas The biology of the repair of fractures in children differs from that in adults in several ways. The soft tissues have excellent healing capacity, uncontaminated devitalised bone is salvageable and periosteum in children can regenerate bone in the presence of bone loss. Union is faster. Modalities of treatment of open fracture tibia in teenagers Including Closed reduction followed by a well- molded casting ,debridement followed by casting , utilization of external fixator (EF) remains a popular choice for open injuries, Severely comminuted and unstable fractures and those with significant soft tissue or vascular injury require external fixation However, pin tract infection (PTI) and refracture are common complications during the application of EF . Elastic Nail has also been reported with an acceptable for the treatment of open tibial fractures

, open reduction and internal fixation (ORIF) was reserved for situations in which an adequate reduction could not be obtained or maintained by conservative, Also Closed reduction and intramedullary nail fixation appropriate for the treatment of extraarticular distal tibial fractures .

Eligibility Criteria:
Inclusion Criteria :

• All patients presenting with isolated open fracture tibia in teenagers (aged 10 to 19 Years old )

Exclusion Criteria:

* Patient who refuse to participate in the study
* Patient less than 10 or more than 19 years old
* Pathologic fractures
* Open Fracture tibia with other bony or organ injury
* Open fracture tibia with soft tissue loss or vascular injury
Different Wiping Motions in Phlebotomy

This study was conducted with 90 patients. The phlebotomy site was wiped with circular motion in the group-I, vertical movement in the group-II, and first vertical and then circular motion in the group-III.

Aim: This study was conducted to evaluate the effects of different wiping motions used in phlebotomy on vein visibility, procedural success, and phlebotomy-related complications.

Background: In phlebotomy practice, many application guidelines or textbooks are used. In these references, it is seen that phlebotomy site is wiped with different motions.

Methods: This study was conducted with 90 patients. The phlebotomy site was wiped with circular motion in the group-I, vertical movement in the group-II, and first vertical and then circular motion in the group-III.

Eligibility Criteria:
Inclusion Criteria:

* who are over 18 years old,
* without any psychiatric diseases,
* without vision or hearing problems,
* hospitalized in the internal medicine clinic,
* with platelet counts of 200 000 / mm³ and above,
* 8 cc of blood is ordered for lab test and
* individuals who volunteered to participate in the study

Exclusion Criteria:

* having a local or systemic infection,
* having vascular disease,
* having an immunopathological problem,
* scarring, psoriasis, active dermatitis in the phlebotomy site,
* having peripheral nerve disease,
* having peripheral neuropathy,
* patients with coagulation disorder,
* individuals who don't volunteered to participate in the study
Serotonin and Amyloidopathy

The purpose of this study is to determine if changes in brain serotonin affects the accumulation of amyloid in the brain. The investigators will use brain imaging methods to measure the amount of serotonin and amyloid in the brain of individuals with Parkinson's Disease (PD) and otherwise healthy older people. PD participants will undergo repeat brain imaging to assess amyloid accumulation two years after their first brain imaging session. All participants will undergo examinations to assess their motor function, and asked questions to assess their mood and thinking.

Parkinson's disease (PD) is a common problem of older people often causing significant problems with thinking and memory. Abnormal accumulation within in the brain of a protein called amyloid is felt to contribute to impaired thinking and memory in PD. Excessive accumulation of this protein is also involved in Alzheimer disease (AD) and may influence thinking and memory in otherwise healthy older people. Recent evidence suggests that changes in the amount of another brain chemical, serotonin, influences the amount of amyloid accumulating in the brains of people with PD and otherwise healthy older people. The purpose of this study is to determine if changes in brain serotonin affects the accumulation of amyloid in the brain. The investigators use brain imaging methods to measure the amount of serotonin and amyloid in the brain of individuals with PD and otherwise healthy older people. PD participants will undergo repeat brain imaging to assess amyloid accumulation 2 years after their first brain imaging session. All participants will undergo examinations to assess their motor function, and asked questions to assess their mood and thinking.

Eligibility Criteria:
Inclusion Criteria:

* Persons who have been diagnosed with Parkinson disease age 45 years and older are eligible to participate in this study.
* Healthy older individuals (ages 60-80) without neurologic problems are eligible to participate.

Exclusion Criteria:

* Individuals using some drugs cannot participate. These include anti-depressant medications, buproprion, or St. John's Wort, as well as dopamine antagonist medications.
* Women of childbearing age may not participate.
* Individuals unable to have MRI scans because of a pacemaker or metal fragments may not participate.
* Individuals with a history of stroke may not participate. People with any contraindication of PET imaging such as previous participation in research procedures involving ionizing radiation may not be eligible to participate in this study.
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection

The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.

A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naive, noncirrhotic participants with chronic hepatitis C virus genotype 1a (HCV GT1a) infection.

Eligibility Criteria:
Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
* Subject has never received antiviral treatment for hepatitis C infection
* No evidence of liver cirrhosis

Exclusion Criteria:

* Significant liver disease with any cause other than HCV as the primary cause
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Positive screen for drugs or alcohol
* Significant sensitivity to any drug
* Use of contraindicated medications within 2 weeks of dosing
* Abnormal laboratory tests