Kornimate/medical-research-clean huggingface dataset:
study on the use of micropulse laser to treat central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: the investigators hypothesis is that using the micropulse laser in patient with central serous chorioretinopathy (csc) will prompt resolution of csc and will be effective in significantly minimizing visual recovery time from this disease as well as potentially preventing recurrences.

the investigators hypothesize that application of 577nm micropulse laser in patients with csc will prompt resolution of csc as measured by ocular coherence tomography and best corrected visual acuity. this will be a pilot study to establish sound methods and provide some insights to the safety and efficacy of csc treatment.

Eligibility criteria:
inclusion criteria: * patients with new diagnosis of csc and no other comorbidities or prior retinal treatment * patients ranging from 30 to 60 years of age exclusion criteria: * patients with no case of csc * patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration * patients with prior retinal treatment

Keywords: csc edema retinopathy
sepantronium bromide for the treatment of high-grade b-cell lymphoma

Conditions: High-grade B-cell Lymphoma; Burkitt Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphatic Diseases; Lymphoma, High-Grade; C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma; C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma; C-Myc Gene Rearrangement

Summary: this is a multi-center phase 2 study to determine the safety and efficacy of sepantronium bromide (sepb) in adult patients with relapsed or refractory high-grade b-cell lymphoma

this is a multi-center, open label, dose-ranging phase 2 study evaluating the safety and efficacy of sepb in patients with relapsed/refractory c-myc rearranged hgbcl. cohorts of three patients will be enrolled at each dose level for sepb with expansion to six patients, if necessary, to assess toxicity. following the completion of 2 cycles of treatment of each cohort, an independent data monitoring committee (dmc) will review the safety data to assess study drug related toxicities from the current cohort. following this review, a decision will be made to continue dose escalation to the next dose level, to declare that a given dose level is the level of dose-limiting toxicity (dlt) or to further explore toxicity at the dose level in question by enrolling additional subjects to a maximum of six subjects at that level. an additional 6 patients will be enrolled at the recommended phase 2 dose (rp2d). the rp2d will be established on the basis of the maximally tolerated dose between the two specified dose levels as well as other relevant data, including clinical signals of activity, pharmacokinetic (pk) and pharmacodynamic (pd) data.

Eligibility criteria:
inclusion criteria: * confirmed histologic diagnosis of c-myc rearranged high-grade b-cell lymphoma * relapse or refractory disease after at least one previous line of therapy * measurable disease as defined by 2014 lugano classification * ecog performance status of 0-2 * acceptable coagulation parameters exclusion criteria: * allogeneic transplant within 3 months * autologous transplant without resolution of post-transplant cytopenias * known cns involvement * average qt/qtc interval duration \> 450 msec * inadequate marrow, hepatic or renal function * unresolved grade 2 or greater toxicities from prior anticancer therapy * radiotherapy within prior 4 weeks * requires systemic immunosuppressive therapy * positive for hepatis b or hepatis c * seropositive for hiv

Keywords: relapsed/refractory
evaluation of effectiveness of the treatment after repeated administration of klacid®sr

Conditions: Tracheitis; Tracheobronchitis; Bronchitis; Chronic Bronchitis; Community-Acquired Pneumonia (CAP)

Summary: this post-marketing observational study (pmos) will be conducted in a prospective, single-arm, single-country, multicenter format. the investigational sites will be consulting rooms of gps (general practitioner), pneumologists and centers with experience in the treatment of patients with acute infections of trachea, bronchi, aecb (acute exacerbation of chronic bronchitis) and cap (mild community-acquired pneumonia). since this will be a post-marketing observational study, klacid sr will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. objective: to describe the effectiveness of the treatment with repeated administration of klacid sr in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic bronchitis (aecb) or mild community-acquired pneumonia (cap) who received klacid sr treatment 6 weeks to 24 months prior to the klacid sr dose administered within this study.

follow-up of participants should enable three visits during this period. at the screening visit the decision for klacid sr therapy in a dose of 500 -1000 mg once daily will be made. the second visit will occur 8 - 16 days after study initiation. the last visit will be a phone call to the participant after 30 days from the initiation of the treatment. study visits will be defined as "v1" = screening visit, "v2" = visit in which klacid sr therapy will be terminated and "v3" = phone call 30 days after initiation of klacid sr therapy.

Eligibility criteria:
inclusion criteria: * men, women at least 18 years old. * patients treated with klacid®sr between 6 weeks and 24 months prior to start of the pmos. * patients: * with acute tracheitis, * acute tracheobronchitis, * acute bronchitis, * mild community-acquired pneumonia or * acute exacerbation of chronic bronchitis exclusion criteria: * patients without previous administration of klacid®sr and patients who used klacid®sr less than 6 weeks ago or more than 24 months ago. the information about previous administration of klacid®sr will be based on physician records or patients anamnesis. * patients with known hypersensitivity to macrolide antibiotics * patients with documented renal impairment (creatinine clearance under 30 ml/min). * patients with documented liver parenchyma impairment (ast, alt and gmt \> 3x higher level in comparison with the norm) * concomitant therapy with the following drugs: astemizole, cisapride, colchicine, pimozide, terfenadine and ergotamine or dihydroergotamine * pregnancy * breast feeding

Keywords: acute tracheitis acute tracheobronchitis or acute bronchitis acute exacerbation of chronic bronchitis mild community-acquired pneumonia
mind over cervix: using virtual reality to reduce colposcopy anxiety

Conditions: Anxiety; Colposcopy

Summary: colposcopy is an extremely important part of womens healthcare in the prevention of cervical cancer. women report feeling extremely anxious attending colposcopy, due to the association with cancer and the intimate nature of the examination. the goal of this clinical trial is to investigate where the use of virtual reality headsets during outpatient colposcopy appointments has any effect on womens' experience. the main question\[s\] it aims to answer are: * does the use of virtual reality headsets reduce anxiety in patients attending colposcopy * does the use of virtual reality headsets reduce pain in patients attending colposcopy patients will offered to enroll in the trial when they attend for their colposcopy appointment. participants will fill out a questionnaire to measure their anxiety beforehand and collect patient demographics. they will be randomly allocated into the intervention arm or the control arm. this means they will either use virtual reality headset in addition to the standard care, or have standard colposcopy care only after their colposcopy, they will then be asked to to fill out another questionnaire to measure anxiety and pain levels. if there is a comparison group: researchers will compare the results from the women who had colposcopy while using the virtual reality headsets to women to see if there is any meaningful difference in anxiety while using the virtual reality headsets.


Eligibility criteria:
inclusion criteria: * patients * women over 18 years of age who attend for outpatient colposcopy and provide informed written consent * staff * have completed colposcopy training and be a registered member of the british society of colposcopy and cervical pathology (bsccp) * informed written consent to take part in the trial. exclusion criteria: * patients : * significant hearing or visual impairments that may effect communication * any known characteristics that may make the office procedure more difficult (eg. previous lletz, previous cervical conisation, uterine didelphis) * inability to provide consent. * denial or withdrawal of informed consent orally staff : * the denial or withdrawal of informed consent. * trainee colposcopist performing clinic.

Keywords: colposcopy anxiety reduction cervical screening virtual reality pain reduction
efficacy of radiofrequency nucleoplasty and targeted disc decompression in lumbar radiculopathy

Conditions: Visual Analogue Pain Scale; Pain Measurement

Summary: the aim of this study is to compare early and long term efficacy of lumbar radiofrequency nucleoplasty and targeted disc decompression in patients with lumbar radiculopathy who failed previous conventional therapy. medical records of 37 patients undergoing targeted disc decompression, 36 patients undergoing lumbar radiofrequency nucleoplasty were retrospectively examined.visual analogue scale (vas), numerical rating scale (nrs), functional rating index, backache index, oswestry lumbar back pain disability index, rolland-morris lumbar back pain questionnaire scales were used before treatment and 1,6,12 months after the procedure. north american spine society satisfaction scale was used at 12th month after the procedure.


Eligibility criteria:
inclusion criteria: * patients having radicular pain with or without low back pain for at least 6 weeks inspite of conservative treatment who have unsequestrated, bulging, protruded or extruded hernia confirmed with mri. exclusion criteria: * patients having a more than 50% loss in disc area, sequestrated disc, the presence of vertebra fracture or tumor, the patients having spinal stenosis or spondylolisthesis

Keywords: intervertebral disc disease radiculopathy chronic pain thermocoagulation
a study of ly3537982 in chinese participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is an open-label, single-arm, multicenter, phase 1 study of ly3537982 as monotherapy in chinese participants with kras g12c-mutant advanced solid tumors. the main purpose of this study is to determine how much of ly3537982 gets into the bloodstream and how long it takes the body to eliminate it in chinese participants. the safety, tolerability and preliminary efficacy of ly3537982 will also be evaluated. approximately 12 patients will be enrolled in this study.


Eligibility criteria:
inclusion criteria: * - native chinese participants must be of an acceptable age to provide informed consent. * have measurable disease per response evaluation criteria in solid tumors version 1.1 (recist version 1.1). * have disease with evidence of kras g12c mutation * have a histologically or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and must be appropriate candidates for study treatment. * have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * have adequate laboratory parameters. * must be able to swallow capsules or tablets. * estimated life expectancy ≥12 weeks exclusion criteria: * have disease suitable for local therapy administered with curative intent. * have an active fungal, bacterial, and/or active untreated viral infection, * have a serious pre-existing medical condition(s) that would preclude participation in this study. * have a serious cardiac condition. * have untreated active symptomatic central neural system (cns) malignancy or metastasis and/or carcinomatous meningitis. * have received prior treatment with any kras g12c small molecule inhibitor. * females who are pregnant or lactating. * have a known allergic reaction against any of the components of the study drug

Keywords: pharmacokinetics safety and tolerability chinese
mothers avoiding depression through empowerment intervention trial

Conditions: Postpartum Depression

Summary: postpartum depressive symptoms are a major health problem that affects hundreds of women annually. the investgators propose to test an intervention to reduce postpartum depressive symptoms and prevent elevated levels of depressive symptoms in postpartum mothers by preparing and educating women about specific situational triggers of depressive symptoms, by bolstering personal and social resources, by enhancing self-management skills to buffer postpartum demands, and by increasing access to existing healthcare and community resources available to postpartum mothers.

postpartum depression (ppd) is a disorder affecting many women after delivery of a child. up to 50% of mothers may experience some depressive symptoms after giving birth, and up to 25% of them will develop major depressive disorder. some situational factors that place mothers at risk of ppd may be changed or minimized, including social support, the mother's efficiency in handling situational stress, and distress from physical symptoms. preparing mothers to identify potential situational triggers of depressive symptoms, enhancing their postpartum self-management skills , and providing them access to the proper social and healthcare resources may prevent them from developing major depression. this study will test the efficacy of a brief intervention that aims to prevent ppd by preparing mothers to deal with stressful triggers and depressive symptoms. this study will last 6 months. participants will be randomly assigned to receive either treatment as usual or the behavioral education intervention. the intervention will involve two parts. first, after giving birth and while still in the hospital, participants will complete an education session with a social worker and receive written materials about ppd. then, 2 weeks after discharge from the hospital, participants will receive a call from the social worker, who will conduct a needs assessment that addresses participants' physical and emotional health. if a participant is experiencing distress, the social worker will refer her to appropriate resources and will reinforce self-management skills. all participants will receive a list of community and hospital resources by mail. study assessments will take place at 3 weeks, 3 months, and 6 months after study entry. at these points, participants will complete a 20-minute survey with a research assistant about their health, mood, and basic demographic information.

Eligibility criteria:
inclusion criteria: * patient in the maternity unit at mount sinai hospital * infant has a birth weight greater than or equal to 2,500 grams * infant has a 5-minute apgar score greater than or equal to 7 * self-identifies as black/african american or hispanic/latina; white or minority other than black/african american or hispanic/latina will be referred to a parallel study with the same protocol at mount sinai hospital * speaks english or spanish * has a working telephone
longitudinal follow-up of high school athletes

Conditions: Elite Athlete; Healthy

Summary: in this study the investigators will study the lung function and airway inflammation in elite athletes starting at the elite sport school (age: 12-13 year) and the change in lung function parameters and airway inflammation after 1 and 2 years at the elite sport school in comparison to age-matched controls (exercising at a recreational level, \<4 hours/week).

a group of elite athletes (from the elite sport school in leuven (n=35) in cooperation with 'sportmedisch advies centrum' (smac) uz leuven) and the future team of the flemish swimming federation (n=15) will be recruited at the start of their career (first level) as an elite athlete. a group of healthy subjects (n=20) will be recruited to serve as a control. the investigators will compare lung function parameters and airway inflammation at the first visit in the autumn of 2011 and the second and third visit (one and two years later, respectively). lung function will be assessed by spirometry. sputum will be induced with an aerosol of inhaled hypertonic saline in concentrations of 3%, 4% and 5% for 7 minutes generated by a de vilbiss nebuliser (ultra-neb 2000 model 200hi) after pretreatment with 400 mg inhaled salbutamol. sputum will be processed as previously described and the obtained cell suspensions will be used for differential cell counts and cytokine mrna analysis. the supernatant will be used to measure cytokine and chemokine levels. eia diagnosis (visit 1,2 and 3) will be assessed by a diagnostic test for asthma (positive reversibility test with salbutamol) and a positive eib-test. eucapnic voluntary hyperventilation test will be used as a test for eib (gold standard of ioc-mc). dynamic lung function parameters will be assessed before and immediately after, 5' after, 10' after and 15' after eucapnic hyperventilation. patients were asked to breath at 85% of the maximal ventilation (predefined as maximal voluntary volume) for 6 minutes through a mouthpiece connected to a reservoir. the reservoir is be filled with a gas mixture of 21% 02, 5% co2 and 74% n2. the test is considered positive when a drop in fev1 of \>10% occurred at one of the time points after eucapnic hyperventilation.

Eligibility criteria:
inclusion criteria: * elite athletes from the elite sport school in wilrijk and leuven * first grade of high school exclusion criteria: * performing \>4hours/week sports

Keywords: individual
yiqi wenjing prescriptions preventive efficacy of oxaliplatin-induced peripheral neuropathy clinical trial

Conditions: Chemotherapy-induced Peripheral Neuropathy; Colorectal Cancer

Summary: this study is a randomized, placebo-controlled, double-blind, multicenter phase iii clinical trial of yiqi wenjing prescriptions for preventing oxaliplatin-induced peripheral neuropathy.

this study is a randomized, placebo-controlled, double-blind, and multicenter clinical trial. three hundred sixty postoperative patients with colon cancer stage iia-iiic will be randomly assigned into treatment group i, treatment group ii and placebo-control group, taking huangqi guizhi wuwu granules, danggui sini granules and the mimetic granules of yiqi wenjing granules respectively. all subjects will receive mfolfox6 or folfox4 or xelox chemotherapy regimen along with traditional chinese medicine(tcm) or placebo treatment per day for at least three months and one year follow up. eortc qlq-cipn20 will be used to assess the degree of peripheral neuropathy as the primary outcome measure. grades of oipn evaluated by nci-ctcae 5.0, quality of life evaluated by eortc qlq-c30, chemotherapeutic efficacy evaluated by resist 1.1, and the number of completed chemotherapy cycles are selected as the secondary outcome measures.

Eligibility criteria:
inclusion criteria: * subject diagnosed with colorectal cancer stages iia-iiic, confirmed by histopathological examination, according to csco guidelines for diagnosis and treatment of colorectal cancer. * subject suitable for receiving folfox4 or mfolfox6 as adjuvant chemotherapy after radical resection of colorectal cancer, receiving each dose and cumulative dose of oxaliplatin are 85mg/m2 and ≥540 mg/m2 respectively. * subject with karnofsky performance status scale (schag et al.1984) index ≥60 points and an expected survival time ≥6 months. * subject over 18 years of age, men or women. * subject without severe damage of the heart, liver, kidney or hematopoietic system. exclusion criteria: * subject with any grade of peripheral neuropathy. * subject who has ever received treatment of neurotoxic chemotherapeutics, such as oxaliplatin, cisplatin, taxanes, or vinca alkaloids. * subject who is receiving agents with potential preventive or therapeutic effects to neuropathy, such as duloxedine, carbamazepine, venlafaxine, gabapentin, pregabalin, phenytoin, valproate, milnacipran, or tricyclic antidepressant. * subject who is participating or have participated in other clinical trials. * subject with a family history of hereditary/familial neuropathy. * subject who cannot take drugs orally. * subject with mental illness who cannot cooperate. * pregnant or lactation period women.

Keywords: clinical trial yiqi wenjing prescriptions oxaliplatin-induced peripheral neuropathy randomized placebo-controlled
trial of nebulized heparin versus placebo for inhalation trauma

Conditions: Inhalation Injury; Burn Injury

Summary: the purpose of this international multi-center double-blind randomized placebo-controlled trial is to determine the effect of nebulized heparin, compared to placebo, on the number of ventilator-free days at day 28, in burn patients with confirmed inhalation trauma requiring mechanical ventilation.


Eligibility criteria:
inclusion criteria: * informed consent * age \> 18 years * need for invasive mechanical ventilation * confirmed inhalation trauma (bronchoscopically) exclusion criteria: * \> 36 hours after trauma * receiving invasive ventilation \> 24 hours * expected duration of mechanical ventilation \< 24 hours * chronic obstructive pulmonary disease gold stage iii and iv * any history of pulmonary hemorrhage in the past 3 months * any history of significant bleeding disorder * known allergy to heparin, including heparin-induced thrombocytopenia * pregnancy or breast feeding * unlikely to survive for \> 72 hours * total body surface area (tbsa) \> 60% * witnessed or proven aspiration (i.e., confirmed by bronchoscopy)

Keywords: inhalation trauma pulmonary coagulopathy heparin nebulization mechanical ventilation
hip-fracture surgery on patients in clopidogrel therapy

Conditions: Hip Fracture

Summary: patients in clopidogrel therapy alone or in combination with acetylsalicylic acid (dual antiplatelet therapy (dapt) presenting with a hip-fracture represent the surgeon with the dilemma of putting the patient at risk of a major blood loss during and after surgery, or putting the patient at risk of a thromboembolic event after surgery. the investigators hypothesize that the risk of a major blood loss in patients that are still under the effect of clopidogrel or dapt during or after hip-fracture surgery is relatively low. the investigators have conducted a retrospective observational study on hip-fracture patients to test this hypothesis.


Eligibility criteria:
inclusion criteria: * all patients operated with short intramedullary nail for hip-fractures, in the study period. (1st of jan. 2011-31st of dec. 2013) exclusion criteria: * patients operated \>24 hours after admission, patients in other forms of anticoagulation medication except acetylsalicylic acid (including vitamin k antagonists, dipyridamole, dabigatran, apixaban and rivaroxaban), missing data on blood loss in patient chart, missing blood samples in the first 4 days and extra-national patients (follow up not possible). patients operated on both sides during the inclusion period were only included with data on their latest operation.

Keywords: clopidogrel therapy platelet aggregation inhibitor adverse event