Kornimate/medical-research-clean huggingface dataset:
comparing preoperative short-course radiotherapy with or without local boost for rectal cancer

Conditions: Rectal Cancer

Summary: a randomized trial comparing weather preoperative short-course radiotherapy with local boost is better than conventional preoperative short-course radiotherapy for local advanced rectal cancer.

the study plans to recruit 100 patients,randomized into study group and control group,patients in study group are given the dose of ptv(planned target volume)-ctv(clinical target volume) 25gy/5f with a local boost of ptv-gtv(gross tumour volume) 30gy/5f；patients in control group are given the dose of ptv-ctv 25gy/5f without a local boost. the other inventions are the same during the whole treatment,after the radiotherapy,they will receive a surgery under tme((total mesorectal excision) principal.comparing the toxicity of radiotherapy, r0 resection rate,pathological complete remission rate, complications of operation and sphincter retention rate of these two groups to find out weather local boost bringing benefits to patients with local advanced rectal cancer.

Eligibility criteria:
inclusion criteria: * local advanced rectal cancer (tnm stage ：t3-4nxm0 )diagnosed by biopsy and mri or endoscopic ultrasonography . * distance between tumour and anal edge ≤12cm. * ps（(performance status） score 0-2 or karnofsky score≥70. * liver and kidney functions are normal. * without any treatment before inclusion. exclusion criteria: * metastasis * combined with other severe diseases，such as other kind of cancer ,copd,myocardial infarction,ect. * include in other clinical trails.
nicotine tms eft smoking pilot study

Conditions: Smoking; Nicotine Dependence; Addiction; Smoking, Cigarette

Summary: prior and recent evidence suggests a role of medial prefrontal cortex (mpfc) in cigarette smoking. episodic future thinking (eft) has also been shown to be associated with increased delayed discounting and reduced cigarette self administration. in the present study, we will examine whether a single administration of theta-burst transcranial magnetic stimulation (tbtms) can increase episodic future thinking and delayed discounting while reducing craving for nicotine.

the purpose of this study is to develop theta burst transcranial magnetic stimulation (tbtms) as a potential treatment for nicotine addiction. theta burst tms is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). this study will test whether tbtms over the forehead can produce a reduction in things that may prompt individuals to want to smoke cigarettes. tms has been approved by the food and drug administration as an investigational tool as well as a therapy for depression. however, tms is not approved by the food and drug administration as a treatment for nicotine cravings and other addictions. this study consists of one consent session and one tms session. participants will be asked to complete a series of questionnaires and computer assessments about nicotine both before and after a single tbtms session.

Eligibility criteria:
inclusion criteria: 1. 18-65 years of age 2. smoke at least 10 cigarettes a day (on average) 3. not be pregnant 4. meet all criteria on a standardized tms safety screen (including to but not limited to implanted electronic devices, bullets or metallic fragments above the neck, hair clips that cannot be removed) 5. no barriers to making contact between the tms coil and the skin (e.g. cornrows that cannot be removed, glasses that the participant is unwilling to remove) exclusion criteria: 1. report comorbid mental or physical illness (managed or unmanaged) 2. currently using prescription medication that might affect smoking or nicotine metabolism 3. using smokeless tobacco or alternative nicotine products 4. history of epilepsy or seizures (other than childhood febrile seizures) 5. history of chronic migraines

Keywords: brain stimulation
infectious disease (id) testing outreach in carceral hubs

Conditions: HIV Infections; Opioid Use Disorder

Summary: this pilot feasibility study represents part 3 of a larger r61 study, where the investigators will follow a cohort about their experiences with human immunodeficiency virus (hiv) testing. this project aims to assess the effectiveness of an intervention at two jail sites in the boston area: south bay house of corrections and nashua street jail implemented in january of 2025 that is aimed at improving hiv testing practices and hiv treatment in those carceral facilities. this implementation was developed independently of the investigators' study activities. the jails worked to develop changes in their electronic health record to offer hiv testing at various points in their intake and physical exam process. hiv care was not well-integrated with the jails' existing intake and healthcare administration systems and medications for opioid use disorder (moud) program. the investigators will evaluate the intervention the jails developed to address these issues. the outcomes of interest are more implementation than effectiveness outcomes. the primary goal of this study is to identify existing barriers in the carceral healthcare setting that prevent the improvement of hiv testing and treatment.


Eligibility criteria:
inclusion criteria: * incarcerated at south bay house of corrections or nashua street jail * participant report that they will be leaving jail within 1 month. * participant must be comfortable speaking in the english language * has opioid use disorder (oud) indicated by participation in medications for opioid use disorder (moud) program and/or self-report exclusion criteria: * cognitive ability that prevents obtained consent or completion of study activities (defined through research assistant (ra) determination)

Keywords: carceral system hiv testing pre-exposure prophylaxis (prep) justice community opioid innovation network (jcoin) end hiv epidemic (ehe) hiv services
an efficacy and safety study of acetaminophen plus tramadol hydrochloride (jns013) in participants with chronic pain

Conditions: Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (jns013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (nsaids).

this is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group comparison study. the total duration of the study will be 11 weeks and consists of 4 periods; a pre-observation period (4 weeks), open-label period (2 weeks), double-blind period (4 weeks) and follow-up period (1 week). participants will receive tramadol hydrochloride plus acetaminophen tablets orally 4 times daily for 2 weeks with no less than 4-hour intervals (up to 8 tablets per day) during the open-label period and the dose will be fixed for each participant in the latter 1 week. during the double-period participants will receive tramadol hydrochloride plus acetaminophen tablets or placebo at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. efficacy will be primarily evaluated by number of participants with insufficient pain relief after the start of double-blind period. participant's safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants with sustention of chronic pain associated with oa or lbp for at least 3 months * participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral nsaids at a usual maximum dose during 3 months prior to this study * outpatients * ambulatory participants without need for any supportive device or assistance during daily life exclusion criteria: * participants with conditions for which opioids are contraindicated * participants with conditions for which acetaminophen is contraindicated * participants with history of convulsion or the possibility of convulsive seizure * participants with concurrent, previous, or possible alcohol dependence, drug dependence, or narcotic addiction * pregnant participants or those who may be pregnant, lactating mothers, and participants who wish pregnancy during the study period

Keywords: chronic pain acetoaminophen tramadol osteoarthritis of the knee low back pain
practice of sedation and analgesia in patients with severe brain injury in china

Conditions: Intensive Care Unit

Summary: sedation and analgesia is necessary management for patients in the intensive care units. the high-level studies of sedation and analgesia in china are still deficient, especially in patients with brain injuries who even have been excluded from the relevant studies.

sedation and analgesia is necessary management for patients in the intensive care units. the high-level studies of sedation and analgesia in china are still deficient, especially in patients with brain injuries who even have been excluded from the relevant studies. in the present study, a multicenter, 1-day point cross-sectional study about the sedation and analgesia among patients in china, particularly brain-injured will be investigated. the objectives are to investigate sedation and analgesia among patients in china and to compare sedation and analgesia between brain injuries and other patients.

Eligibility criteria:
inclusion criteria: * all adult patients admitted to the participating icus on the investigation day exclusion criteria: * age under 18 years * less than 24 hours of icu stay before screening * taking part in other studies

Keywords: severe brain injuries sedation and analgesia intensive care unit survey
the effectiveness and safety of pharmacopuncture on inpatients with acute knee pain caused by traffic accidents

Conditions: Pharmacologic Action

Summary: the purpose of this study is to reveal the effectiveness and safety of knee herbal acupuncture for patients with acute knee joint pain caused by a traffic accident. it is a practical clinical study to confirm the comparative effectiveness by comparing the strategy of treating knee herbal acupuncture in parallel with the strategy of treating it with integrated oriental medicine treatment, which is an existing treatment method.


Eligibility criteria:
inclusion criteria: * when the nrs (numeric rating scale) of knee pain caused by a traffic accident is 5 or higher. * patients hospitalized for traffic accident treatment. * patients with acute pain within 14 days of experiencing knee pain due to a traffic accident. * patients aged between 19 and 70 years old. * participants who agree to participate in clinical research and provide written test subject consent. exclusion criteria: * for patients diagnosed with a specific serious disease that may cause knee pain (acute fracture, dislocation, complete rupture of ligaments, etc.) * if the cause of the pain is caused by a disease other than the knee (tumor, fibromyalgia, rheumatoid arthritis, gout, lumbar disc herniation, etc.) * cases where surgical intervention is required due to suspected acute fracture, dislocation, or ligament and cartilage damage * if there is another acute disease (stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with the treatment effect or interpretation of results * patients currently taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect their findings * inadequate or unsafe medication: hemorrhagic disease, anticoagulant therapy, severe diabetic patients with risk of infection * patients who have taken drugs that may affect pain, such as non-steroidal anti-inflammatory drugs (nsaids), or have received herbal acupuncture or physical therapy within the past week * in the case of pregnant women and in the case of planning to become pregnant or nursing * patients within 3 months after knee surgery or if knee replacement surgery was performed * if it has been less than 1 month since participants finished participating in another clinical study, or if participants are planning to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection * if it is difficult to fill out the consent form for research participation * in cases where it is difficult for other researchers to participate in clinical research
medi4736 alone and in combination with tremelimumab or azd9150 in adult subjects with relapsed/refractory dlbcl (d4190c00023)

Conditions: Diffuse Large B-Cell Lymphoma

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy of medi4736 (durvalumab) alone and in combination with either tremelimumab or azd9150 in adult subjects with relapsed or refractory diffuse large b-cell lymphoma.

this is a multicenter, open-label, dose-escalation and dose-expansion study of medi4736 (durvalumab) as monotherapy or in combination with either tremelimumab or azd9150. the objectives are to describe any dose-limiting toxicities, determine the maximum tolerated dose, and evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of medi4736 as monotherapy or in combination with either tremelimumab or azd9150 in adult subjects with relapsed or refractory diffuse large b-cell lymphoma.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. subjects with histologically confirmed relapsed or refractory dlbcl who have received at least 1 prior rituximab containing chemotherapy regimen but no more than 5 prior lines of therapy 3. eastern cooperative group (ecog) performance status of 0 or 1 4. measurable disease by international working group (iwg) response criteria for lymphoma 5. adequate organ and marrow function exclusion criteria: 1. previous immune-mediated therapy 2. subjects with prior asct or allogenic hct. subjects ineligible for available curative options after failing asct and have met the hematologic criteria are eligible to participate in this study. subjects with prior allogenic hct will be excluded. 3. documented current central nervous system involvement 3. active or prior documented autoimmune or inflammatory disease within 3 years, with some exceptions 4. concurrent or prior conventional or investigational anticancer therapy, within 28 days prior to the first dose of study medication(s)

Keywords: dlbcl medi4736 durvalumab tremelimumab azd9150 anti-pd-l1 anti-ctla-4 immunotherapy imtc stat3
32 week, open, randomized, 2 way cross over multicentre trial to compare safety & efficacy of combination of hoe901 insulin analogue once daily at bedtime + lispro insulin before meals vs nph insulin (twice a day) + regular in type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: to compare the efficacy (in terms of metabolic control evaluated through hba1c levels) of treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as mealtime insulin with a regimen of insulin nph as basal insulin with regular insulin, as mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety of both treatments, evaluated through hypoglycemic rates.

multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment phases of 16 weeks each in two treatment groups: * study arm with insulin glargine + insulin lispro (phase 1) and insulin nph + regular insulin (phase 2) * insulin nph + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)

Eligibility criteria:
inclusion criteria: * subjects with type 1 diabetes mellitus * 18-65 years of age * c-peptide negative * treated at least for 6 months with multiple daily doses of insulin and with hba1c greater than or equal to 7.0% and less than or equal to 9.5% and a bmi less than or equal to 35 kg/m². * women of childbearing potential must have a negative pregnancy test in visit 1 and must use an effective contraceptive method during the study.
efficacy of light therapy in treatment of chronic cluster headache

Conditions: Cluster Headache

Summary: cluster headache is a primary headache. the chronic form of the disease is often difficult to treat. it is now considered a chronobiological disease. this chronobiological character is based on clinical, biological and radiological arguments. this study focuses on the use of light therapy in cluster headache. light therapy has already been used in the treatment of other chronobiological diseases, such as seasonal depression, but also recently in the therapy of other primary headaches (such as migraine). its aim is to re-adjust chronobiological rhythms, and it therefore seems worth testing in the chronic form of cluster headache. light therapy is delivered to the patient using a consumer electronics device.the main objective is to evaluate the prophylactic efficacy of light therapy in patients with chronic cluster headache.


Eligibility criteria:
inclusion criteria: * male or female, of 18 years years old or more; * diagnosis of chronic cluster headache according to ichd-3 criteria; * number of seizures during baseline equal to at least 24; * stability of prophylactic treatment for at least 1 month and commitment not to change it for the duration of the study; * patient affiliated to the french social security system. * patient who understands and speaks french correctly; * patient who has given free and informed written consent. exclusion criteria: * contraindication to the use of light therapy: use of a photosensitizing treatment; * ophthalmological history: cataract, macular degeneration, glaucoma, retinitis pigmentosa; * patients who work at night; * other neurological, psychiatric or developmental pathologies considered incompatible with the study; * background treatment of cluster headache with melatonin; * persons protected by articles l1121-5, l1121-6 and l1121-8 of the french public health code (pregnant or breast-feeding women, persons deprived of their liberty by judicial decision, socially vulnerable persons, adults incapable or unable to express their consent).
acute myocarditis registry with prognostic, histologic, immunologic, biological, imaging and clinical assessment

Conditions: Myocarditis

Summary: the amphibia study is an observational ambispective and prospective cohort that aim to describe the histologic, immunologic, biological, imaging, genetic and clinical characteristics of the patients hospitalized for an acute myocarditis and to evaluate their association with prognosis.

acute myocarditis is an inflammatory disease of the heart muscle. its clinical presentation and its etiologies are multiple and make it a complex disease to treat. its course also varies, ranging from complete clinical recovery to recurrence of ventricular arrhythmia or progression to chronic dilated heart disease, while being difficult to predict. the long-term prognosis is poorly understood. consecutive patients hospitalized in a tertiary university referral center cohort from 2006 to 2041 for an acute myocarditis will be ambispectively or prospectively analyzed. this project will establish a registry including up to 400 patients in the ambispective analysis cohort from 2006 to 2021 and 1000 patients in the prospective analysis cohort during a 20 years inclusion period. the aim of the study is to describe the characteristics of patients hospitalized for an acute myocarditis and to evaluate their association wih the long term (until 20 years) prognosis. features of interest will include : * clinical * biological * etiological * echocardiographic * cardiac magnetic resonance imaging * genetics (for the prospective cohort) * anatomopathological the collection of clinical, biological and radiological data will represent an unique source allowing research teams in the coming years to access the data necessary to answer various specific questions (pathophysiological, diagnostic, prognostic) relevant to the state of knowledge on this pathology.

Eligibility criteria:
inclusion criteria: * acute myocarditis confirmed by cardiac magnetic resonance according to lake louise modified criteria or by endomyocardial biopsy according to histologic, immunologic and immunohistochemic criteria. * affiliation to the french health care system "sécurité sociale" exclusion criteria: * severe valvulopathy * complex congenital cardiopathy * previous heart transplant * known significative coronary disease

Keywords: cardiomyopathies inflammatory heart disease magnetic resonance imaging viral
equivalency of penicilloate skin test reactivity prepared by a modified alkaline hydrolysis technique

Conditions: Penicillin Allergy

Summary: the primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation. the secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.

the primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation. the secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity. five (5) adult subjects without a history of penicillin allergy and fifteen (15) adult subjects with a history of penicillin allergy and previous positive penicillin skin test to the minor determinant (penicilloate) and/or major determinant (penicilloyl) will be enrolled into the study. each subject will be skin tested with our current penicillin skin test which includes penicilloate conducted in the division of allergic diseases will be compared the skin test of our penicilloate prepared by our newer method along with the different diastereoisomers of penicilloic acid on the same day and time. the adult subjects without a history of penicillin allergy will serve as our control.

Eligibility criteria:
inclusion criteria: 1. history of penicillin allergy 2. previous or current positive skin test to penicilloate 3. greater than or equal to 18 years of age exclusion criteria: 1. uncontrolled asthma by symptoms 2. patients who have received penicillin and had no adverse drug reaction 3. previous adverse reaction to penicillin skin test 4. dermatological conditions that may interfere with skin testing i.e. atopic dermatitis and dermatographism 5. medication that may interfere with skin testing i.e. antidepressants, antihistamines, and sedatives.

Keywords: penicillin allergy, penicillin skin test