Kornimate/medical-research-clean huggingface dataset:
a proof-of-concept study to correlate retinal nerve fiber layer changes in patients with multiple sclerosis treated with natalizumab or interferon beta 1-a

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: phase iv, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of natalizumab (tysabriâ®) or interferon beta-1a (avonexâ®) treatments initiated at the time of acute optic neuritis (aon) as measured by rnfl thickness from optical coherence tomography in patients with relapsing remitting multiple sclerosis (rrms).


Eligibility criteria:
inclusion criteria: * diagnosis of rrms. * patients with unilateral aon consistent with multiple sclerosis (ms). * treatment with intravenous methylprednisolone (ivmp) at 1gm daily for three days after the onset of aon, without a taper, and completed within 14 days of the aon symptom onset. * age 18-55 years. * expanded disability status scale (edss) 0 to 5.0. * understand and sign informed consent. exclusion criteria: * history or presence of progressive multifocal leukoencephalopathy (pml). * diagnosis of primary progressive multiple sclerosis (ppms) or secondary progressive multiple sclerosis (spms). * immune-compromised in the judgment of the investigator. * history of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or sponsor, would preclude participation in the study. * concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc). * previous history of severe disc edema, hemorrhage, or \> 1 confirmed optic neuritis (on) with the most recent on symptom onset being less than 12 months ago. * previous treatment with \> 1 disease modifying therapy (dmt). * previous treatment with investigational products for ms, immunosuppressant or cytotoxic therapy. * previous treatment with tysabri® * women who are not postmenopausal, surgically sterile, or willing to practice contraception. * women pregnant, breast feeding, or planning to become pregnant. * involved with other study protocol simultaneously without prior approval. * determined not suitable for study participation by investigator and/or sponsor.
quality of life after transanal endoscopic microsurgery (tem)

Conditions: Transanal Endoscopic Microsurgery (TEM)

Summary: this is a observational cohort study to determine the influence of transanal endoscopic microsurgery (tem) on patients quality of life

patients who planning transanal endoscopic microsurgery (tem) for rectal neoplasms should undergoing fecal incontinence quality of life scale and wexner score before and after surgery for measurement their quality of life. for objectification data sphinctrometry will be perform.

Eligibility criteria:
inclusion criteria: * have a planned of transanal endoscopic microsurgery (tem) * have signed approved informed consent form for the study exclusion criteria: * non epithelial malignancy * recurrent neoplasm * stoma formation

Keywords: transanal endoscopic microsurgery tem qol quality of life rectal cancer rectal surgery rectal neoplasm
crucial areas on af termination

Conditions: Atrial Fibrilation Termination Endpoint

Summary: recent data has demonstrated that focal sources are determinant in human atrial fibrillation (af) perpetuation. the investigators sought to identify crucial areas for af perpetuation during our routine electrogram (egm)-based substrate ablation.


Eligibility criteria:
inclusion criteria: * atrial fibrilation * undergoing egm-based substrate ablation exclusion criteria: * age \< 18
efficacy and safety of volinanserin on sleep maintenance insomnia - polysomnographic study

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. the patients suffering from that condition frequently wake up during the night, their sleep is non restorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.


Eligibility criteria:
inclusion criteria: * diagnosis of primary insomnia based on diagnostic and statistical manual of mental disorders (fourth edition) criteria * disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month * specific criteria based on the npsg recordings during the screening nights exclusion criteria: * females who are lactating or who are pregnant * night shift workers, and individuals who nap 3 or more times per week over the preceding month * consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day * participation in another trial having received study medication within 1 month before the screening visit * body mass index ≥ 33 * use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, st. john's wort, alluna or prescription sleep medication * use of any substance with psychotropic effects or properties know to affect sleep/wake * history of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia * clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder * positive qualitative urine drug screen (opiates, cocaine, amphetamine...) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: sleep problems insomnia sleeplessness polysomnographic
exhaled no as a biomarker of gestational osa and persistence postpartum

Conditions: Pregnancy; OSA

Summary: this study will evaluate the presence or absence of obstructive sleep apnea (osa) in the third trimester of pregnancy and again postpartum.

this is a prospective cohort study to evaluate the presence or absence of osa in the third trimester of pregnancy and again postpartum. the investigators will use the watch-pat200® device as their accepted standard for diagnosis of obstructive sleep apnea. when enrolled, women will be taught how to use the watch-pat200® via a company produced video that will be shown in the clinic and will be available via youtube for review later if needed. they will also complete the berlin questionnaire. the patient will then use the watch-pat200® device overnight to evaluate for obstructive sleep apnea. this will be performed between 32-36 weeks gestation. apnea-hypopnea indices (ahi) will be calculated and an ahi\>5 will be considered diagnostic for osa. the next morning when the patient returns the watch-pat200® device they will exhale into the niox mino® to assess their exhaled nitric oxide levels. this will be performed between 800-1000 am by one of the study personnel. the patient will also wear the watch-pat200® device the first postpartum night. the entire process will be repeated between 6-8 weeks postpartum.

Eligibility criteria:
inclusion criteria: * female (\> or equal 18 year of age) * pregnant between 32 0/7 prior to 35 6/7 weeks gestation * anticipated delivery at forsyth medical center: winston salem, north carolina exclusion criteria: * illicit drug/alcohol abuse * current treatment for obstructive sleep apnea * age \<18 years * inability to speak/read english proficiently enough to give informed consent * usage of alpha blockers or short acting nitrates * permanent pacemaker * sustained non-sinus cardiac arrhythmias

Keywords: obstructive sleep apnea
pharmacological treatment in osteoarthritis

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine the efficacy of hydroxychloroquine in hand osteoarthritis.

osteoarthritis is the most common joint disease, most frequently involving the hands, resulting in pain, stiffness and loss of hand function. at present, there is no option to prevent the onset or the progression of hand osteoarthritis (oa). it is believed that inflammation plays an important role in the pathogenesis of oa and that anti-inflammatory drugs might be an effective treatment for oa. anti-malarial agents like chloroquine and hydroxychloroquine are potential anti-inflammatory drugs and hydroxychloroquine has already proven to be an effective suppressor of inflammation in rheumatoid arthritis. several previous studies with hydroxychloroquine in hand oa also showed a possible effect on pain and inflammation, but these studies were mostly retrospective with a small number of patients. this is the first prospective, randomised, placebo-controlled study to determine the effect of hydroxychloroquine in hand osteoarthritis.

Eligibility criteria:
inclusion criteria: * age ≥ 40 years * primary hand oa according to the acr classification * heberden or bouchard nodule or kellgren-lawrence grade 1, 2 or 3 changes in ≥ 2 symptomatic joints * pain in the dominant hand ≥ 12 months * use of an nsaid for ≥ 1 episode of pain * written informed consent exclusion criteria: * secondary hand oa, e.g. haemochromatoses, rheumatoid arthritis, posttraumatic * kellgren-lawrence grade 4 oa * use of hydroxychloroquine within 3 months before entering the study * use of nsaids or corticosteroids within 7 days before entering the study * retinopathy * myasthenia gravis * known allergy or hypersensitivity for hydroxychloroquine
the effects of nutritional supplementation on occupational performance in firefighters

Conditions: Fatigue

Summary: the purpose of this study was to assess the usefulness of protein and carbohydrate supplementation, with and without creatine, on occupational performance in firefighters. research has examined the effects of adding creatine to whey protein and carbohydrates on training adaptations in resistance-trained individuals with mixed finding. furthermore, the ergogenic benefit of protein and carbohydrate supplementation, with or without creatine, in firefighters is largely unknown. therefore, the primary aim of the current study was to examine the effects of protein and carbohydrate supplementation, with or without creatine, on occupational performance in firefighters.


Eligibility criteria:
inclusion criteria: * being a firefighter between the ages of 18-55 years of age, and medically cleared for field duty. exclusion criteria: * any current musculoskeletal or neurological condition that would prohibit the completion of performance testing.

Keywords: creatine
the effects of hormones in growth hormone-treated girls with turner syndrome

Conditions: Dwarfism; Turner's Syndrome

Summary: turners syndrome is a genetic condition in females that is a result of abnormal chromosomes. patients with turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. in addition, some patients with turner syndrome have low bone density (osteoporosis) and differences in learning abilities. this study will research the effects of steroid hormones on patients with turner syndrome. it will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. in addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination. all patients asked to participate in this study will receive growth hormone injections. however, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. the other half of the patients will receive a placebo or "sugar pill". this will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone. the study will last approximately 2 years. after 2 years of research the patients may qualify for an additional 2 years of treatment. patients may benefit directly from this research with increased growth and improved ability to learn.

turner syndrome is associated with short stature, multiple physical stigmata, and absent pubertal development. we propose to: (1) examine the effects of sex steroids (androgen) on multiple variables (growth rate, gh binding protein, igf-i, and cognitive function), in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination on the above variables.

Eligibility criteria:
* inclusion criteria: girls with turner syndrome will qualify to participate in this study if they meet the following criteria: karyotype diagnosis compatible with turner syndrome. no treatment with estrogen, androgen or growth hormone exceeding twelve months, and no treatment with either of these agents in the preceding 3 months. chronological age of 10.0 to 14.9 years. bone age less than or equal to 12 years. exclusion criteria: prior treatment with estrogen, androgen, or growth hormone for more than twelve months. y component in peripheral karyotype.

Keywords: turner's syndrome short stature cognitive function sex steroids turner syndrome ts
mometasone furoate 0.1% versus eucerin on moderate to severe skin toxicities in breast cancer patients receiving postmastectomy radiation

Conditions: Invasive Breast Cancer

Summary: the purpose of this study is to find out if the effect of mometasone furoate is any different from eucerin in decreasing the severity of redness of the skin during irradiation, preventing the skin from peeling, or reducing the amount of irritation the patient reports during treatment.


Eligibility criteria:
inclusion criteria: * age ≥18 years * stage 1-4 invasive breast cancer that is histologically confirmed at mskcc * status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive pmrt * ecog performance status of 0 or 1 exclusion criteria: * male * patients with clinical evidence of gross disease * patients who are pregnant or breastfeeding * prior radiation therapy to the ipsilateral chest wall or thorax * patients requiring a chest wall boost * concurrent chemotherapy (biologic agents are allowed) * psychiatric illness that would prevent the patient from giving informed consent * inability or unwillingness to comply with skin care instructions and follow-up * allergy to either eucerin or mf * residual grade \>1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of rt * medical condition such as uncontrolled infection (including hiv), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) * treatment with palliative or pre-operative radiation

Keywords: breast cancer status post mastectomy plan to receive pmrt topical steroid cream emollient skin care eucerin mometasone furoate 0.1%
effective treatment of hepatitis c in substance users

Conditions: Hepatitis C; Opiate Dependence

Summary: we hypothesize that integrating hepatitis c into methadone and buprenorphine treatment will improve hepatitis c outcomes as well as drug treatment outcomes in patients who are addicted to opiates. we will test this hypothesis by randomly assigning patients to receive integrated or separated care. the first group will receive hepatitis c treatment and substance abuse treatment contemporaneously at the south central rehabilitation center (scrc). they will take both methadone or buprenorphine and hepatitis c medications under the daily (methadone) or weekly (buprenorphine) observation of a health care provider. the second group will receive substance abuse treatment at scrc, and go to another facility to receive hepatitis c treatment services. these participants will take their medications on their own (without observation). we will look at outcomes such as hepatitis c viral loads, adherence to medications, and drug treatment outcomes such as receipt of buprenorphine and methadone and urine toxicology testing.


Eligibility criteria:
inclusion criteria: * subjects with a dsm iv diagnosis of opioid dependence who are currently enrolled in methadone or buprenorphine maintenance at south central rehabilitation center in good standing (opiate free urine with positive methadone or buprenorphine, respectively) for at least 30 days. * hepatitis c infection as evidenced by a positive hcv antibody and a detectable hcv rna. exclusion criteria: * suicidal or homicidal ideation * psychiatric condition that is not stable * pregnancy (rbv is a class c drug during pregnancy) * pending court case or warrant which would interrupt treatment * decompensated cirrhosis (child's class b or c) or presence of hepatocellular carcinoma * hiv+ with cd4\ 200 and vl\>5,000 copies/ml * platelet count \< 75,000 /ml * hemoglobin \< 10 mg/dl * absolute neutrophil count \<1500 cells/ml
single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bms-986141 in healthy subjects

Conditions: Thrombosis

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of a single and multiple oral doses of bms-986141 in healthy subjects.

maximum age: part a sad 65 years part b mad 75 years part c mad japanese 75 years

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: 1. healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations 2. body mass index (bmi) of 18 to 32 kg/m2, inclusive. bmi=weight (kg)/\[height(m)\]2 3. women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive exclusion criteria: 1. concurrent or use within 2 weeks of study drug administration, of marketed or investigational, drugs as specified in protocol 2. other protocol-defined exclusion criteria could apply
lva on serum profiling in patients with lymphedema

Conditions: Lymphedema

Summary: the correlation between oxidative stress and increased lymphedematous limb volume lacks supporting evidence. lymphedema patients are prone to cellulitis. this study aims to investigate the link between oxidative stress, limb volume, and cellulitis after supermicrosurgical lymphaticovenous anastomosis (lva).

in this study, we focused on the changes in serum antioxidant biomarkers before and after lva, detected by isobaric tags for relative and absolute quantitation (itraq)-based quantitative proteomic analysis, enzyme-linked immunosorbent assay (elisa), and oxidative stress panel kit. for clinical correlation, magnetic resonance (mr) volumetry was implemented for precise lymphedematous limb volume measurements. correlations were made between changes in oxidative stress, limb volume, and cellulitis before and after lva.

Eligibility criteria:
inclusion criteria: * patients with lower limb lymphedema confirmed with lymphoscintigraphy * unilateral lower limb lymphedema * lymphedema duration \> 2 years * no active infection * no prophylactic antibiotic use for at least one month before lva * no tumor recurrence or metastasis * no consumption of antioxidants, such as vitamin e or ascorbic acid exclusion criteria: * patients with upper limb and bilateral lower limb lymphedema
itp registry and accompanying biospecimen collection

Conditions: Immune Thrombocytopenia

Summary: the objective of this itp registry is to collect clinical information, including biosampling, from consenting patients with a variety of itps at different points in the course of their disease.

immune thrombocytopenia (itp) is a rare hematologic disorder that can lead to a greater risk of bleeding or a prolonged bleeding time due to an autoimmune-mediated deficiency of platelets. in recent years, new treatment options for patients with immune thrombocytopenia have emerged. the results of published clinical studies on itp can only be used for broad patient care to a limited extent, as they are designed for a patient population with clearly defined inclusion and exclusion criteria. real world data collected from this registry will help to better understand the diagnosis and therapy of itp patients in everyday treatment and to more effectively direct individual patients to optimal therapy, thus improving their outcomes. by collecting biospecimens, this project will contribute new knowledge to the study of itp through standardized, systematic, and high-quality collection and storage of patient samples and associated data. the registry collects clinical data from patients diagnosed with itp at defined points in the course of the disease. the data collection includes a range of clinical measures, disease-related factors, treatment/treatment course and outcomes, complications during treatment and qol, fatigue scoring and survival data (up to 5 years). the data are collected prospectively. in addition, patients can be included retrospectively up to 12 months after the initial diagnosis if continuous documentation can be provided at the treatment centre. in both cases, a written declaration of consent is obligatory.

Eligibility criteria:
inclusion criteria: * primary or secondary immune thrombocytopenia (itp) * age ≥18 years * signed declaration of consent exclusion criteria: * diagnoses that cannot be reconciled with the diagnosis of itp (esp. heparin-induced thrombocytopenia, pregnancy-associated thrombocytopenia, pseudothrombocytopenia) * no informed consent possible (this covers patients who are unable to understand the nature and scope of participation)