Kornimate/medical-research-clean huggingface dataset:
a study using radiation therapy and temozolomide to treat glioblastoma in patients over 70

Conditions: Glioblastoma

Summary: in this study we propose to determine outcomes of patients age 70 or older treated with radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease progresses.


Eligibility criteria:
inclusion criteria: 1. participants must have histologically confirmed glioblastoma/gliosarcoma. 2. tumor o6-methylguanine-dna-methyltransferase promoter methylation status must be determined 3. participants must not have had any prior therapy for glioblastoma multiforme including radiation or chemotherapy. 4. participants must be \> 70 years of age. 5. participants must have life expectancy greater than 6 months. 6. karnofsky performance status \> 60 (ecog \< 2). 7. patients must have normal organ and marrow function * leukocytes \> 3,000/microliter * absolute neutrophil count \> 1,500/microliter * platelets \> 100,000/microliter * total bilirubin within normal institutional limits 12 * aspartate aminotransferase test(sgot)/alanine aminotransferase test(sgpt) \< 2.5 x institutional upper limit of normal * creatinine within normal institutional limits or creatinine clearance \> 60 ml/min/1.73 m2 for subjects with creatinine levels about institutional normal 8. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. participants may not be receiving any other study agents. 2. participants may not have had chemotherapy wafer placement at surgery. 3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide. 4. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 5. individuals with a history of a different malignancy are ineligible except for the following circumstances. individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. 6. hiv-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with temozolomide. in addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
short-course benznidazole treatment to reduce trypanosoma cruzi parasitic load in women of reproductive age

Conditions: Chagas Disease

Summary: the investigators are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short 30-day treatment with bzn 150mg/day (30d/150mg) vs. a 60-day treatment with bzn 300 mg/day (60d/300mg). the investigators will recruit not previously treated t. cruzi seropositive women with a live birth during the postpartum period in argentina, randomize them at six months postpartum, and follow them up with the following specific aims: specific aim 1: to measure the effect of bzn 30d/150mg compared to 60d/300mg preconceptional treatment on parasitic load measured by the frequency of positive pcr (primary outcome) and by real-time quantitative pcr (qpcr), immediately (specific aim 1a) and 10 months (specific aim 1b) after treatment. hypothesis 1a: the frequency of positive pcr and the parasitic load measured by qpcr immediately after bzn 30d/150mg will be non-inferior (non inferiority \[ni\] margin for pcr: 10% absolute difference) to bzn 60d/300mg. hypothesis 1b: the frequency of positive pcr and the parasitic load measured by qpcr 10 months after bzn 30d/150mg will be non-inferior (ni margin for pcr: 9% absolute difference) to bzn 60d/300mg. specific aim 2: to measure the frequency of serious adverse events leading to treatment interruption of bzn 30d/150mg compared to 60d/300mg. hypothesis 2: the frequency of serious adverse events leading to treatment interruption will be 50% lower with bzn 30d/150mg than with bzn 60d/300mg. a 24-month recruitment period is planned in four hospitals with 23,436 deliveries in 2015 and frequencies of t. cruzi seropositive women varying from 1.5% to 4.8%. the investigators are planning to enroll 600 t. cruzi seropositive women.


Eligibility criteria:
inclusion criteria: * written informed consent from the mother. * t. cruzi seropositivity confirmed by at least two positive tests. * live birth. exclusion criteria: * women residing outside of the provinces of chaco, santiago del estero, or tucumán. * previous trypanocide treatment (bzn or nifurtimox). * female sterilization; no intention to use modern contraception methods during treatment. * positive pregnancy test. * history of severe alcohol abuse within two years; renal insufficiency.

Keywords: congenital transmission trypanosoma cruzi benznidazole
the evlw for set the positive end expiratory pressure (peep) in the acute respiratory distress syndrome (ards)

Conditions: Acute Respiratory Distress Syndrome

Summary: * ards is a severe pathology with high mortality and morbidity.actual ventilatory management is clear for the set of the tidal volume and for the survey of the plateau pressure for the patients who require mechanical ventilation. * the set of the peep (low or high levels) remains unclear : it seems that some patients need low levels of peep whereas anther need high levels; but there is no validated data that can discriminate them. * we hypothesized that patients with low levels of evlw ( measured with the picco® system ) need low level of peep to ameliorate their oxygenation ( measured with the pao2/fio2 ratio ) whereas patients with high levels of evlw) need high levels of peep.


Eligibility criteria:
inclusion criteria: * age\>18; * ards criteria. exclusion criteria: * severe pulmonary hypertension; * chronic right ventricular failure; * pulmonary embolism; * tricuspidian valvulopathy; * history of spontaneous pneumothorax; * severe emphysema; * bronchomalacia; * recent pulmonary surgery; * bmi\>40; * interstitial pulmonary fibrosis; * end of life; * chronic neuromyopathie; * recent neurosurgery or intracranian hypertension; * pregnancy.

Keywords: ards mechanical ventilation peep with low level peep with high level evlw picco® system pao2/fio2 ratio
the role of induction gemcitabine and cisplatin in locoregionally advanced nasopharyngeal carcinoma in the era of imrt

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to verify that induction gemcitabine and cisplatin plus intensity-modulated radiotherapy (imrt) is non-inferior to concurrent weekly cisplatin plus imrt for patients with locoregionally advanced nasopharyngeal carcinoma (npc).

patients with non-keratinizing npc t1-4n2-3或t3-4n0-1m0 (uicc/ajcc 7th edition) are randomly assigned to receive induction chemotherapy or ccrt alone. patients in experimental group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before intensity-modulated radiotherapy (imrt). patients in control group receive imrt concurrently with weekly cisplatin 40 mg/m² up to 7cycles. imrt is given as 2.0-2.33 gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 gy or greater to the primary tumor. our primary endpoint is failure-free survival (ffs). secondary end points include overall survival (os), locoregional failure-free survival (lr-ffs), distant failure-free survival (d-ffs) rates and toxic effects. all efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility criteria:
inclusion criteria: * patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma (including who ii or iii). * tumor staged as t1-4n2-3或t3-4n0-1m0 (according to the 7th ajcc edition). * satisfactory performance status: karnofsky scale (kps) ≥ 70. * adequate marrow: leucocyte count ≥ 4000/μl, hemoglobin ≥ 90g/l and platelet count ≥ 100000/μl. * adequate liver function: alanine aminotransferase (alt), aspartate aminotransferase (ast) \< 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤ 2.5×uln, and bilirubin ≤1.5×uln. * adequate renal function: creatinine clearance ≥ 60 ml/min. * patients must be informed of the investigational nature of this study and give written informed consent. exclusion criteria: * who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. * treatment with palliative intent. * prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume). * prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×uln), and emotional disturbance.

Keywords: nasopharyngeal carcinoma induction chemotherapy
dermal penetration of the titanium dioxide in anthelios sx spf40 cream

Conditions: Sunburn

Summary: to determine the penetration of micronized and pigmentary tio2 in formulas 283419 2 and 760.001 into the stratum corneum of compromised (induced sunburn) human skin via skin stripping of human subjects.


Eligibility criteria:
inclusion criteria: * all subjects must: 1. be between the ages of 18 and 65. 2. agree to not participate in any other product evaluations or clinical evaluations during the course of this study. 3. have read, understood and signed an informed consent form. 4. have intact skin in the treatment area. 5. have fair skin - skin types i, or ii - as defined in appendix ii. 6. be able to understand and willing to follow all study procedures and restrictions. exclusion criteria: subjects will be excluded from participating in the study if they: 1. are female and are pregnant or lactating \[must be using an acceptable method of birth control if of child bearing potential\].\* 2. exhibit any visible symptoms of skin disease, such as psoriasis or eczema, or skin abnormality (including active dermal lesions, uneven skin tone or scars) which might interfere with interpretation of the study results. the presence of nevi, blemishes, or moles will be acceptable if, in the investigator's judgement, they will not interfere with the study results or skin stripping procedures. 3. have a history of allergic responses to sunscreens or other products similar to those included in this study. 4. have very dry or scaly skin on the test site. 5. have diabetes. 6. have a history of abnormal responses to sunlight, such as a phototoxic or photoallergic response. 7. have an existing sunburn or suntan, or been to a tanning booth which would interfere with interpretation of the study results. 8. have used self tanners within the past two weeks. 9. have excessive hair at the test site area which could, in the opinion of the investigator, interfere with the interpretation of the results. 10. have participated in a research drug trial or patch test within six weeks of beginning this study. 11. have a known sensitivity to scotch 600 transparent tape. 12. are currently receiving, or within the past two weeks received, topical or systemic medication which could, in the opinion of the investigator, interfere with the interpretation of the results, affect the safety of the subject, or which may change the body's response to ultraviolet light. 13. are currently taking any of the drugs listed on the next page. in addition, the use of st. john's wort or other similar dietary supplements, aspirin or otc ibuprofen is contraindicated for the duration of the study. low dose daily aspirin use, 81 mgs, taken for heart attack prevention is excluded. * acceptable methods of birth control that can be used during the course of the study are: oral contraceptive pill, intrauterine device, patch, injection, condom with spermicide, partner vasectomy, bilateral tubal ligation, abstinence or evidence of non childbearing potential (i.e., post-menopausal \[one year without menstrual period\], hysterectomy or bilateral ovariectomy).

Keywords: sun protection
the effect of free weight resistance training and body composition on cognition

Conditions: Cognitive Performance

Summary: this study, titled the effect of free weight resistance training (fwrt) on cognitive function explored through eye tracking, will be a randomized double-blind clinical trial aimed at evaluating how fwrt influences cognitive processing in healthy young adults. eye-tracking technology will be used to measure reading metrics and dxa scans will be used to measure body composition before and after a 10-week fwrt intervention. participants will be randomly assigned to either an experimental group, which will undergo a 10-week fwrt program, or a control group. this study will provide insights into the potential benefits of free weight resistance training on the cognitive performance of text processing tasks.


Eligibility criteria:
inclusion criteria: * university students between the ages of 18 and 30. * healthy individuals with no recent participation (last six months) in physical training programs. * normal or corrected-to-normal vision. exclusion criteria: * physical or health limitations that prevent participation in a resistance training program. * current involvement in other physical training programs. * visual impairments that cannot be corrected with glasses or contact lenses.
rossetti: registry of combined vs single thrombectomy techniques

Conditions: Thrombectomy; Stroke; Ischemic

Summary: the rossetti registry is an ongoing investigator-initiated prospective study recruiting deidentified demographic, clinical presentation, site-adjudicated angiographic, procedural, and outcome data in acute ischemic stroke (ais) consecutive patients treated with mechanical thrombectomy (mt) across 10 comprehensive stroke centers in spain. the registry started in june 2019 and therefore incorporates the more recent device technology

the study inclusion criteria are the following: age ≥18 years; confirmed large vessel occlusion (lvo) in the anterior circulation (intracranial internal carotid artery m1, proximal m2 segments, time from last seen well to treatment (tlswt) \<24 hours, baseline national institutes of health stroke scale (nihss) score ≥2, and premorbid modified rankin scale (mrs) score ≤2. all participating centers received institutional review board approval from their respective institutions and patients or representatives signed informed consent. the study data are collected prospectively through an online questionnaire. type of stent-retriever , as long as european community approved, is at the discretion of the operator. the primary clinical outcome is the rate of excellent clinical outcome, defined as mrs score 0-1 at 90 days (no or minor symptoms but no functional limitations).\[28\] the primary technical outcome is the rate of first pass effect (fpe) defined as achieving near-complete/complete revascularization \[modified thrombolysis in cerebral infarction (mtici 2c-3)\] after single-device and single-pass approach

Eligibility criteria:
inclusion criteria: * age ≥18 years; * confirmed large vessel occlusion in the anterior circulation (intracranial internal carotid artery, m1segment of middle cerebral artery, proximal m2 segment of middle cerebral artery * time from last seen well to treatment (tlswt) \<24 hours, * baseline national institutes of health stroke scale (nihss) score ≥2, * premorbid modified rankin scale (mrs) score ≤2. exclusion criteria: * no evidence vessel occlusion. * extra and intracranial occlusion or severe stenosis. * low platelets (100 x 10000) or impaired function, * contraindication of computed tomography or magnetic resonance * allergy to iodinated contrast non treatable medically, * pregnant or breast feeding patient, * hemorrhagic stroke on computed tomography or magnetic resonance

Keywords: mechanical thrombectomy stroke
electrical stimulation after botulinum toxin injections to the upper extremity

Conditions: Stroke

Summary: the purpose of this study is to investigate the effectiveness of using electrical stimulation to improve upper extremity function in stroke survivors who receive botulinum toxin injections for spasticity. we hypothesize that individuals who receive the electrical stimulation could demonstrate improved benefit of the botulinum toxin injections and improved functional use of their weaker upper extremity.

this is a pragmatic investigation that will utilize a two group comparison to compare electrical stimulation to a sham stimulation in individuals who are scheduled to receive botulinum toxin injections to their upper extremity for spasticity management. the electrical stimulation will be to the antagonist muscles of the injected muscles of the upper extremity and will be administered for 4 weeks post injections.

Eligibility criteria:
inclusion criteria: * diagnosis of stroke, within first 6 months post stroke, have not previously received botulinum toxin injections for upper extremity spasticity, hemiplegic upper extremtity, able to communicate in english. exclusion criteria: * contraindication for electrical stimulation (presence of implanted cardiac or other medical device, open wound on the wrist or hand, malignancy), fixed contracture of the elbow, wrist or hand, inability to follow simple directions, pregnancy.

Keywords: botulinum toxins spasticity upper extremity electrical stimulation
to compare sweeping of membranes versus expectant management for spontaneous onset of labor and vaginal delivery.

Conditions: Post-Term Pregnancy

Summary: the study is planned to fill the gaps regarding the effectiveness of sweeping of membranes versus expectant management in terms of spontaneous onset of labor and vaginal delivery in post-date primigravida.

this study is important as it provides localized data on the effectiveness and practicality of membrane sweeping in a low-resource setting, which is underrepresented in current literature. potential benefits of this research may include reduced need for formal labor induction, lower healthcare costs, and improved maternal and neonatal outcomes. the findings may enhance clinical practices by offering an evidence-based, patient-friendly approach to managing postdate pregnancies, particularly in resource-limited settings where induction facilities are constrained.

Eligibility criteria:
inclusion criteria: * primigravid women * aged between 18 and 40 years * gestational age ≥40 weeks, confirmed by ultrasound or early dating scan * singleton pregnancies * cephalic presentation exclusion criteria: * multiple gestations * fetal distress or anomalies detected on ultrasound * contraindications to vaginal delivery (e.g., placenta previa, previous uterine surgery) * previous uterine scar
the role of postoperative immobilization after arthroscopic rotator cuff repair

Conditions: Rotator Cuff Rupture

Summary: the study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.

rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. the study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. our aim is also to establish guidelines for timing of return to work. the major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. the information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.

Eligibility criteria:
inclusion criteria: repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon - exclusion criteria: irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon. large/massive rotator cuff tear. diabetes mellitus. systemic inflammatory disorder. fatty muscle infiltration \>grade 2 (goutallier). subscapularis tendon tear. adhesive capsulitis. concomitant labral repair. revision repair. -

Keywords: rotator cuff rehabilitation
cardiac positioning system in peripheral angioplasty procedure.

Conditions: Peripheral Arterial Disease

Summary: this clinical investigation is intended to evaluate the ability of a magnetic cardiac positioning system to decrease medical radiation exposure on a peripheral angioplasty procedure in patients with a peripheral artery stenosis.

the present study aims at addressing the fluoroscopy exposure time concern among physicians by proposing a new methodology that capitalizes on the cardiac positioning system (cps) to reach near-zero fluoroscopy time for interventional cardiologists. intracoronary navigation of balloon catheter toward an anatomical landmark will be done with two navigation method: 1. fluoroscopy alone 2. fluoroscopy + cps combination. the order of the navigation method (method 1 then method 2 or vice versa) will be determine arbitrarily determined for each subject.

Eligibility criteria:
inclusion criteria: * at least 18 years of age; * scheduled for clinically indicated or contemplated percutaneous transluminal angioplasty or stenting of an peripheral artery; * able to provide informed consent for study participation and willing and able to comply with the clinical investigational plan described evaluation. exclusion criteria: * pregnant women or women planning to be pregnant during the study. * patients currently participating in another clinical study * patients with a thrombophilia * patients with critical limb ischemia * patients with unstable clinical condition or conditions limiting life expectancy that, in the opinion of the study investigator, excludes the participation.