Kornimate/medical-research-clean huggingface dataset:
simplifying hepatitis c antiviral therapy in rwanda for elsewhere in the developing world

Conditions: Chronic Hepatitis C

Summary: the main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (ldv/sof), used to treat individuals with chronic hepatitis c virus (hcv) in rwandan adults. a sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.

this is an open-label single arm study that will evaluate the antiviral efficacy, safety and tolerability of ledipasvir/sofosbuvir fixed dose combination administered for 12 weeks in hcv treatment-naive and treatment-experienced participants with chronic genotype 1 or 4 hcv infection. approximately 240 participants will be enrolled and treated with sofosbuvir (sof) 400 mg/ldv 90 mg fixed dose combination (fdc) one tablet once daily for 12 weeks in the shared 1 study. sixty additional participants will be enrolled in the shared 2 sub-cohort with laboratory monitoring blinded to study clinicians.

Eligibility criteria:
inclusion criteria: * patients that are willing and able to provide written informed consent * age ≥ 18 years * hcv rna ≥ 103 iu/ml * hcv genotype 1 or 4 * screening ultrasound excluding hepatocellular carcinoma (hcc) * acceptable laboratory values (hemoglobin ≥8.0 g/dl, platelet count ≥40,000/mm3; ast, alt, and alkaline phosphatase ≤10 × uln; creatinine clearance ≥30 ml/min) * general good health * ability to comply with study procedures * hiv-infected patients must have completed at least 6 months of any approved hiv antiretroviral therapy (art) per rwanda national guidelines 2013, have been taking for at least 2 weeks prior to screening art compatible with sof/ldv (efavirenz, rilpivirine, raltegravir, dolutegravir, emtricitabine, lamivudine, zidovudine, tenofovir), have screening hiv rna \< 200 copies/ml, and have screening cd4 t-cell count of ≥100 cells/µl exclusion criteria: * current or history of clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage) * active tuberculosis * other clinically-significant illness (except hcv and/or hiv) or any other major medical disorder * active hepatitis b infection * difficulty with blood collection and/or poor venous access for the purposes of phlebotomy * any ifn-containing regimen within 8 weeks prior to screening or any prior exposure to hcv-specific direct-acting antiviral agent (other than a ns3/4a protease inhibitor and sof), current pregnancy or breastfeeding, and active drug or alcohol use or dependence

Keywords: hepatitis c virus sofosbuvir/ledipasvir efficacy
location of lower limb cutaneous melanomas as a prognostic factor.

Conditions: Cutaneous Melanoma; Anatomical Pathological Condition

Summary: observational study to know the relevance of specific anatomical location of cutaneous melanoma on lower limbs.

ambispective (retrospective and prospective) observational register of patients with cutaneous melanoma on lower limbs are grouped in 1) proximal (thigh), 2) medium (leg), and 3) distal (ankle and foot) location. analysis of melanoma-specific overall and disease-free survival will be made, as well as multivariant analysis for prognostic variables including anatomical location.

Eligibility criteria:
inclusion criteria: * cutaneous melanoma on the lower limb exclusion criteria: * incomplete staging

Keywords: cutaneous melanoma lower limb prognostic
a phase 1-2 study of prt-201 administered in chronic kidney disease (ckd) patients

Conditions: Chronic Kidney Disease

Summary: prt-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. the purpose of this study is to determine if prt-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (avf), is safe, dilates the blood vessel, and increases blood flow through the avf.


Eligibility criteria:
inclusion criteria: * age of at least 18 years. * chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence. * planned creation of a new avf. exclusion criteria: * patients for whom this is the only potential site for an avf. * by physical examination, absence of radial or ulnar artery flow or non-patent palmer arch. * treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent. * pregnancy, lactation or plans to become pregnant during the course of the study.

Keywords: arteriovenous fistula avf hemodialysis vascular access prt 201 dose escalation dialysis fistula access vonapanitase kidney renal
relapse-free survival with adjuvant dabrafenib/trametinib therapy in patients with braf v600-mutated stage iii/iv melanoma

Conditions: BRAF V600 Mutated-Stage III/IV Melanoma

Summary: this was a retrospective chart review study of all proto-oncogene b-raf (braf) v600-mutated patients who received adjuvant checkpoint inhibitor (cpi) therapy, relapsed locoregionally or distantly, and were again resected to no evidence of disease (ned) and treated with adjuvant dabrafenib and trametinib (dab/tram) combination therapy.


Eligibility criteria:
inclusion criteria: * any patient at least 18 years of age at the time of diagnosis of stage iii/iv melanoma. * received surgical resection with no residual disease following initial stage iii/iv melanoma diagnosis. * documented local or central assay-positive for tumor braf v600e/k mutation. * received adjuvant cpi alone or in combination with any other immune treatment as their first adjuvant therapy. * following adjuvant cpi, relapsed (locoregionally or distantly) on or off treatment and was again rendered free of disease after subsequent surgical resection. * received additional adjuvant dab/tram combination therapy after failing adjuvant cpi and being subsequently resected to ned. exclusion criteria: * previous administration of any braf- or mitogen-activated protein kinase (mek)-targeted therapies. * more than 120 days duration between surgery to render the patient ned after relapsing during or after adjuvant cpi therapy and initiation of dab/tram adjuvant therapy. * administration of any intervening antitumor medical and/or radiation therapy between failing adjuvant cpi and initiation of adjuvant dab/tram.
study of ath434 in participants with multiple system atrophy

Conditions: Multiple System Atrophy

Summary: this study will assess the safety and efficacy of ath434 in participants with multiple system atrophy


Eligibility criteria:
inclusion criteria: 1. participant has clinical features of parkinsonism. 2. participant has evidence of orthostatic hypotension and/or bladder dysfunction. 3. participant has ataxia and/or pyramidal signs on neurological examination. 4. participant is ambulatory. 5. participant has biomarker evidence of msa in biologic fluid and on mri. exclusion criteria: 1. participant has motor symptoms for \> 4 years. 2. participant has advanced disease, as indicated by frequent falls or choking. 3. participant has structural brain abnormality on mri. 4. participant has any significant neurological disorder other than msa. 5. participant has an unstable medical or psychiatric illness. 6. participant has a contraindication to, or is unable to tolerate, mri or lumbar puncture.

Keywords: multiple system atrophy ath434 neurodegenerative disease shy-drager syndrome movement disorders autonomic dysfunction synucleinopathies atypical parkinsonism
efficiency and usability of the iontophoretic patch feeligreen diclofenac in treating acute osteoarthritic knee pain

Conditions: Osteoarthritis

Summary: the aim of the study is to evaluate the antalgic efficacity of feeligreen® patch on osteoarthritic knee pain acute. this patch work by diffusion controlled by iontophoresis allowing an improvement of transdermal diffusion of active (diclofenac).


Eligibility criteria:
inclusion criteria: * patients with age above 70 years, * having a knee arthritis (unilateral or bilateral) for at least 6 months, * pain intensity ≥ 40 mm on a visual analog scale (vas) * lack of analgesic treatment or analgesic, exclusion criteria: * cognitive disorders : moderate to severe stage or not allowing an understanding of the vas (as determined by the clinician) * a history of chronic inflammatory rheumatic disease, * diagnosis of osteoarthritis of secondary origin, * non-steroidal anti-inflammatory medication within 7 days prior to inclusion, * diagnosis of severe hepatic and renal insufficiency, gastrointestinal bleeding, severe heart failure, * allergy to diclofenac or similar activity substances such as other nsaids, aspirin, excipients, * damaged skin
a study in patients who will undergo surgical removal of non-small cell lung cancer to evaluate molecular changes that occur in tumor tissue after short term exposure to pf-00299804

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Summary: this study will enroll patients who are planned to undergo surgical removal of their tumor. the goal of the study is to evaluate the changes that occur in the tumor after brief (about 8 days) exposure to the study drug.

the a7471031 study was terminated on may 2, 2012. the decision for unplanned study termination was triggered by feasibility of further conduct of this trial as only 22 of the protocol-specified 75 patients were enrolled since the study initiated in february 2010. based on this low accrual rate it was determined that the study was highly unlikely to complete accrual and provide meaningful data. the discontinuation of the study is not due to any safety issue.

Eligibility criteria:
inclusion criteria: * radiographs consistent with lung cancer for which resection is indicated upon histologic confirmation of non-small cell lung cancer. * patient willing to take pf-00299804 for 5 to 11 days and provide blood and tissue specimens as required in the study. exclusion criteria: * prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy) less than one year from time of consent. * prior or concurrent radiation therapy to tumor at site of planned resection. * congestive heart failure (lvef \< 50%), uncontrolled hypertension, significant ventricular arrythmia. * drugs that are highly dependent on cyp2d6 for metabolism, or are generally accepted to have a risk of causing torsades de pointes. * prior or concurrent radiation therapy to tumor at site of planned resection.

Keywords: stage i - iii surgical resection molecular change brief pre-operative exposure
homecoming line: telephone support for veterans

Conditions: Stress Disorders, Post-Traumatic

Summary: this study will determine whether telephone support improves clinical outcomes of veterans who begin outpatient treatment for posttraumatic stress disorder. participants will be randomly assigned to receive either usual care or usual care supplemented by biweekly monitoring and support by telephone during the first 3 months of treatment. patients in both conditions will be compared on ptsd symptoms, engagement in treatment, violence and drinking at 4 months and 12 months after entering treatment.

this multisite randomized controlled trial will test whether a 3-month period of providing telephone monitoring to ptsd patients as a supplement to usual specialty mental health care improves 12-month clinical outcomes (a reduction in ptsd symptoms, violence, and substance use). secondarily, this study will determine whether telephone monitoring promotes better engagement in outpatient treatment (number of mental health and psychotherapy visits during the 3-month intervention period). demand for va ptsd treatment is increasing as troops return from combat deployments in afghanistan and iraq. telemedicine is likely to be an important component in developing more effective and efficient models of ptsd care that improves patient functioning and treatment utilization. it is hoped that using telephone case monitoring as an inexpensive adjunct to standard care may improve clinical outcomes and reduce hospitalization among veterans with ptsd.

Eligibility criteria:
inclusion criteria: * va patients newly entering outpatient treatment mental health treatment for ptsd starting a new phase of outpatient ptsd treatment (e.g., transitioning from a psycho-education group to active psychotherapy) at one of the study sites. exclusion criteria: * active duty personnel * cognitive impairment which precludes giving informed consent * initiating residential or inpatient treatment rather than outpatient treatment

Keywords: stress disorders, post-traumatic ambulatory care telemedicine remote consultation health services accessibility
sisomicin cream vs nadifloxacin cream in primary pyodermas (study p04460)

Conditions: Pyoderma

Summary: this open-label, randomized, parallel-group clinical study is designed to compare the efficacy and safety of the topical antibiotic, sisomicin cream, with that of another topical antibiotic cream, nadifloxacin cream, in the treatment of indian patients with primary pyodermas.


Eligibility criteria:
inclusion criteria: * patients of either sex and suffering from primary pyodermas requiring topical antibiotic therapy without occlusive dressings. * \>=6 years of age. * written informed consent. exclusion criteria: * patients must not take any other antibiotics. * patients should not be hypersensitive to any of the test drugs. * patients are not to have any other investigational drug within one month of starting this study. * patients cannot be enrolled more than once in the study. * patients must not have any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment. * pregnant women and nursing mothers are to be excluded.

Keywords: pyoderma sisomicin nadifloxacin
efficacy of vr and buzzy on pain and anxiety

Conditions: Procedural Pain; Procedural Anxiety; Pain; Children, Only

Summary: the study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using external cold and vibration-buzzy and vr on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy injection.

in the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. in light of this information, this study aimed to compare the effect of distraction by using buzzy and vr on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy. this study is a prospective, randomized and controlled trial. children aged 7 to 12 years who required phlebotomy were divided into three groups; buzzy, virtual reality, and controls. data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. the children's pain levels were assessed and reported by the parents and observers and the children themselves who self-reported using wong-baker faces. the children's anxiety levels were also assessed using the children's fear scale. the study population consisted of children aged 7 to 12 years who presented to the children's phlebotomy room of the hospital. sample of the study consisted of a total of 120 children who met the sample selection criteria and were selected via randomization method. children were randomized into three groups: buzzy (n= 40), vr group (n= 40), and the control group (n= 40). data were collected using the information form, wong-baker faces pain rating scale, children's fear scale.

Eligibility criteria:
inclusion criterial: the sample selection criteria of the study were as follows: the children who * were in the age group of 7-12 years, * due to undergo phlebotomy for blood testing, exclusion criteria: * had chronic diseases, * had neuro-developmentally delayed, * had visual, audio, or speech impairments, * were hospital stay for treatment, * had a history of sedative, analgesic or narcotic use within 24 hours before admission

Keywords: child child nursing non-pharmacological method pain relief
stereotactic radiotherapy for oligometastatic prostate cancer

Conditions: Prostatic Neoplasms

Summary: this is a study that assesses the safety and efficacy of using stereotactic radiotherapy in conjunction with hormone therapy for patients with metastatic prostate cancer where there are a limited number of metastatic tumours.

patients will receive androgen deprivation therapy (adt) for a minimum of 1 year. after this, an intermittent hormone therapy approach will be taken, where adt will not be restarted until the prostate specific antigen (psa) reaches a minimum of 10-15 ng/ml. lupron 30 mg im will be delivered every 4 months when on adt. the prostate (if not previously treated) will be treated to a dose of 35-40 gy in 5 fractions. all visible nodal metastases will be treated to a dose of 30-35 gy in 5 fractions. it is very likely that nodal metastases will shrink significantly (often completely) with adt. in this scenario, the involved nodal regions will be treated to a more modest dose of 25 gy in 5 fractions (roughly equivalent to a dose of 46 gy in 23 fractions assuming an α/β value of 1.4). non-spine bone metastases will be treated to a dose of 30-40 gy in 5 fractions. metastases in the brain, spine, lung, liver, and adrenal will be treated according to established stereotactic radiotherapy (srt) policies at sunnybrook odette cancer centre. comprehensive srt should be delivered within 3 months of starting adt. during any "off" period of adt (before the psa rises above 10-15 ng/ml), comprehensive srt can be repeated if there are new oligometastases that become visible. one month after initiation comprehensive srt, patients will be contacted to assess for acute toxicities. after completion of radiotherapy to all disease sites, patients will be followed every 3-4 months with psa testing until the development of castrate resistant prostate cancer. at the same time points, late toxicity and quality of life will be collected for a minimum of 2 years. computed tomography (ct) of the chest/abdo/pelvis +/- magnetic resonance imaging (mri) of previously irradiated body sites and bone scan will be performed whenever the psa reaches ≥ 10 ng/ml (prior to re-starting androgen deprivation therapy during intermittent hormone therapy approach), or at a minimum frequency of once per year.

Eligibility criteria:
inclusion criteria: * able to provide informed consent. * ecog performance status 0-1. * histologic confirmation of prostate adenocarcinoma. * stage iv disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes. * ≤ 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases). * all sites of disease are amenable to stereotactic radiotherapy. exclusion criteria: * castrate resistant prostate cancer. * evidence of spinal cord compression. * previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy). * inability to safely treat all sites of visible disease. * prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.
efficacy of xp20b following bunionectomy surgery

Conditions: Acute Pain

Summary: the purpose of this study is to determine if xp20b is an effective treatment for the relief of pain following bunionectomy surgery.


Eligibility criteria:
inclusion criteria: * having undergone bunionectomy surgery * having achieved the requisite level of pain exclusion criteria: * pregnant or lactating * history of substance abuse * clinically significant condition or lab abnormality * taken any prohibited medications * gastrointestinal bleeding or history of

Keywords: pain
gnrha combined with hcg and hmg for treatment of patients with non-obstructive azoospermia

Conditions: Azoospermia

Summary: preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with noa. it was generally believed that gonadotrophin treatment would be ineffective in the presence of high plasma levels of endogenous gonadotrophin.the purpose of this study is to determine whether gnrha(gonadotropin-releasing hormone agonist) combined with hcg(human chorionic gonadotropin) and hmg(human menopausal gonadotropin) are effective in the treatment of non-obstructive azoospermia.


Eligibility criteria:
inclusion criteria: * male subjects aged 18-45 with clinical diagnosis of non-obstructive azoospermia. * at least testicular volume more than 8.0ml on one side . * fsh more than 5.5 iu/l. exclusion criteria: * subjects with anatomical abnormalities of the genital tract. * allergy to the drugs used for treatment. * y chromosome deletions or abnormal karyotypes. * subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease

Keywords: azoospermia nonobstructive male infertility
comparative study of intermittent catheters and occurrence of urinary tract infections

Conditions: Urinary Tract Infections

Summary: the purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. patients will use either a coated catheter or an uncoated catheter with gel.

introduction: spinal cord injured (sci) constitutes a large group of patients suffering from neurogenic bladder dysfunction, which is often managed by intermittent catheterization (ic). intermittent catheterization is accepted as a safe and effective method for maintaining bladder and renal health in individuals with neurogenic bladder dysfunction. however, ic several times a day places an individual at risk for urethral trauma, hematuria, and particularly symptomatic urinary tract infections (uti). attempts to control uti with prophylactic antibiotics or sterile technique have not been overly successful but more recent advances in catheter technology, such as the hydrophilic-coated catheter, offer potential benefit. the hydrophilic-coated catheter has a slippery, pre-lubricated surface (along the entire length of the catheter) when soaked in water, allowing smooth insertion without the need for additional water soluble lubricant. two proposed advantages over uncoated catheters are 1) reduced incidence of symptomatic uti, and 2) reduction of urethral irritation or urethral trauma, and lowered risk of urethral strictures. currently, while there are trends in favour of hydrophilic-coated catheters with respect to uti overall evidence remains inadequate for clinical decision-making for choice of catheter type. randomised trials to date have been limited by short follow up, heterogeneity, attrition, imprecise outcome measures, and varying definitions of uti5. conclusions of the cochrane group in 20076 were echoed in a recent comprehensive re-view of all studies on hydrophilic-coated catheters - there is modest evidence favouring hydrophilic-coated catheter in reduction of uti, but further robust research is required.

Eligibility criteria:
inclusion criteria: * traumatic spinal cord injury within 3 months prior to inclusion * neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily exclusion criteria: * has symptoms of uti at inclusion * treated with prophylactic antibiotics to prevent utis * has a history of unresolved bladder-ureteral reflux and/or stones in the urinary tract * has used intermittent catheterization for more than 10 days prior to inclusion