Kornimate/medical-research-clean huggingface dataset:
a phase ⅱ trial of neoadjuvant toripalimab plus platinum-doublet chemotherapy in locally advanced nsclc.

Conditions: Locally Advanced NSCLC

Summary: this is a phase 2, prospective, single-arm, open-label, single-center study that to find out (1)the effectiveness and safety of toripalimab combined with platinum-doublet chemotherapy as a preoperative neoadjuvant therapy for locally advanced (stage iib, iiia, and resectable stage iiib) nsclc, (2)the best treatment time for this combination of neoadjuvant therapy before surgery, (3)the effectiveness and safety of combination of neoadjuvant therapy as salvage neoadjuvant therapy after failure of neoadjuvant chemo-only for locally advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * sign the informed consent form before starting any trial related procedure. * 18-80 years old, male or female. * non-small cell lung cancer confirmed by cytology or histology. evaluation by the researchers to confirm resectable stage iib, iiia or resectable stage iiib (ct3-4n2m0) nsclc patients without any treatment before. * if the pathological type is adenocarcinoma, genetic testing is required. * newly treated patients or patients with failure of traditional preoperative neoadjuvant chemotherapy can be enrolled; * ecog ps 0-1. * good cardiac function, left ventricular ejection fraction \>50%; * good respiratory function, able to tolerate radical resection of lung cancer; * bone marrow hematopoietic function is good, leukocyte\> 4×10\^9/l; hemoglobin\> 10g/dl; platelet \> 100×10\^9/l; * good renal function, glomerular filtration rate\>60 ml/min. * good liver function, total bilirubin(tbil)\<1.5uln, ast\<2.5 uln, alt\<3uln; * there must be at least one evaluable focus judged according to recist1.1 standard. exclusion criteria: small cell lung cancer confirmed by cytology or histology. pathologic type was adenocarcinoma with egfr gene mutation or alk gene rearrangement. advanced lung cancer, or unresectable lung cancer a patient who had received preoperative neoadjuvant radiotherapy for nsclc. patients who have a history of active autoimmune disease or potentially recurrent autoimmune disease. patients with active hepatitis allergic to study drug (toripalimab ,cisplatin, carboplatin, paclitaxel, gemcitabine and pemetrexed) components excipients. patients were given antibiotics within 2 weeks. the investigator considered that the subject's comordities or other conditions may affect the compliance with the protocol or are not suitable for participating in this study
bioavailability of increasing pramipexole doses of oral extended release (er) tablets in healthy male volunteers

Conditions: Healthy

Summary: the objectives of the studies are: * to demonstrate similar total exposure between pramipexole er fasted and pramipexole er fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal any food effect leading to uncontrolled release * to investigate the relative bioavailability of the er-formulation of pramipexole in comparison to the ir-formulation at the highest daily dose of 4.5 mg after multiple dosing * to demonstrate dose proportionality between the dose strengths of the pramipexole er formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing


Eligibility criteria:
inclusion criteria: * all participants in the study should be healthy males * age range from 21 to 50 years * body mass index (bmi) be within 18.5 to 29.9 kg/m2 * in accordance with good clinical practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate and ecg) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * history of orthostatic hypotension, fainting spells or blackouts * chronic or relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study * use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study * participation in another trial with an investigational drug (≤ one month prior to administration or during the trial) * smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * inability to refrain from smoking on in-house trial days * alcohol abuse (\> 40 g/day) * drug abuse * blood donation (≥ 100 ml within four weeks prior to administration or during the trial) * any laboratory value outside the clinically accepted reference range * excessive physical activities within the last week before the trial or during the trial * hypersensitivity to pramipexole, or other dopamine agonists * supine blood pressure at screening of systolic \< 110 mmhg and diastolic \< 60 mmhg
syndesmosis ankle study

Conditions: Syndesmotic Disruption; Weight-bearing Status

Summary: a debate regarding ankle fracture fixation centers on time to weight bearing. recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. however, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is a syndesmotic disruption. there is very little literature on time to weight bearing, with most available series casting/immobilizing these injuries for 6 weeks after fixation. there is very little data examining post-operative weight bearing after syndesmotic stabilization, and the majority centers on screw fixation. the minimum time to weight bearing after an ankle fracture with syndesmotic fixation in the literature is 4 weeks, with most focusing on 6 to 12 weeks. based on biomechanical data regarding suture button techniques, the investigators hypothesize that patients undergoing ankle fracture fixation plus suture button fixation of their syndesmotic disruption will be able to safely bear weight early (2 weeks) after surgery. the investigator's null hypothesis is that there will be no difference between early weight bearing (2 weeks), and late weight bearing (6 weeks) in terms of outcome, hardware failure, loss of reduction, and return to work. adult patients who have an ankle fracture with suspected syndesmotic disruption, requiring a suture button fixation operative intervention will be randomized into early (2 weeks post-surgically) weight-bearing status or delayed weight-bearing status (non-weight-bearing for 6 weeks following fixation). primary objective: maintenance of ankle reduction at 1 year follow-up (measured by comparing immediate post-op ct and 1 year time-point ct). secondary objectives: pain scores, surgical experience, work productivity and activity impairment , aaos foot and ankle scores (2w, 6w, 12w, 6m, 1y), use of assistive devices, range of motion, physical therapy requirement/length of use/compliance, post-operative protocol compliance, post-operative complications (wound healing, infection, implant failure, fracture healing).


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. ankle fracture with suspected syndesmotic disruption that would likely be treated with suture button fixation operative intervention 3. ability to ambulate preoperatively exclusion criteria: 1. younger than 18 2. length unstable syndesmotic injury (i.e. maisonneuve) 3. neuropathic diabetics 4. 325 pounds or more 5. prisoner 6. pregnant or lactating 7. end stage renal disease 8. inability to follow commands (dementia, tbi, etc.) 9. polytrauma patients
self-compassion for people with multiple sclerosis: an exploratory feasibility study

Conditions: Multiple Sclerosis; Self-Compassion

Summary: the goal of this clinical trial is to develop and investigate a compassion-based intervention (mindful self-compassion course) in people with multiple sclerosis. the main objectives are: 1. explore feasibility of trial processes including recruitment, adherence, retention, and follow-up 2. explore experiences of people with multiple sclerosis with the compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement 3. determine potential effects on stress, anxiety, depression, emotion regulation, illness adjustment, and self-compassion. participants will be asked to take part in an 8-week online mindful self-compassion course and report changes in levels of stress, anxiety, depression, self-compassion, adjustment, emotion, and quality of life from pre- to post-intervention and at 3-month follow-up. additionally, participants will be asked to take part in a semi-structured interview to explore their experiences with the course, perceived effects, and suggestions for improvement.


Eligibility criteria:
inclusion criteria: 1. aged 18 years or older 2. able to understand spoken and written english 3. have a neurologist-confirmed diagnosis of multiple sclerosis 4. willing to take place in an mindful self compassion course exclusion criteria: 1. cognitive impairment (\<26 on the montreal cognitive assessment) 2. severe active mental health impairment (psychosis, suicidality)

Keywords: mindfulness
indacaterol versus tiotropium on dynamic hyperinflation in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: exercise intolerance is a major complain of patients with chronic obstructive pulmonary disease (copd). dynamic hyperinflation has been recognized as an important limiting factor responsible for the appearance of intolerable dyspnea during exercise. regular treatment with long-acting bronchodilators promotes a more sustained reduction of hyperinflation and consequent symptom relief and increase in the patient's ability to overcome physical demands of daily life. tiotropium bromide (tio) is a new generation, long-acting anticholinergic bronchodilator that significantly improves lung function, reduces symptoms and improves exercise tolerance in patients with advanced copd. indacaterol is a new ultra-long duration (\>24 h) β2-agonist, which promotes sustained dilation of the bronchi with a once-daily administration. compared to tiotropium, indacaterol provides evidence that is as effective as tiotropium for bronchodilation, as well as other clinical outcomes such as dyspnea and state of health. however, comparative effects of indacaterol versus tiotropium with regard to outcomes in tolerance, dyspnea and dynamic lung hyperinflation during exercise is scarce. we hypothesized that indacaterol and tio are not different in terms of exercise tolerance and its determinants (dynamic hyperinflation and dyspnea).


Eligibility criteria:
inclusion criteria: * men and women (neither pregnant nor nursing women) ≥40 years of age, with a history of smoking (\>20 years/pack) and copd diagnosis according to gold criteria. * post-bronchodilator fev1 \>50% and \<80%, and fev1/fvc ≤70% of predicted value. exclusion criteria: * hospital admission due to copd exacerbation or lung infection in the 6 weeks prior to screening, diagnosis of current or previous bronchial asthma, history of allergic rhinitis or other atopic diseases, or peripheral eosinophilia \>400/mm3. * inability to discontinue the usual bronchodilator therapy prior to initial screening tests, need for continuous oxygen therapy, or arterial oxygen saturation \<85% at rest, or history of adverse reactions to sympathomimetic amines or use of inhaled medication. * anemia, hypo- or hyperthyroidism, hyperadrenergic conditions, uncontrolled insulin-dependent diabetes mellitus, malignancy, or any disease or condition that limits exercise capacity other than copd. * history of drug or alcohol abuse, poor adherence to drug treatment, or treatment with any investigational drug in the month before screening. * patients with ventricular arrhythmia. * patients with \<80% oxyhemoglobin saturation during exercise testing

Keywords: copd
validation of the french version of the pain sensitivity questionnaire

Conditions: Scheduled Surgery; Healthy Volunteers

Summary: the pain sensitivity questionnaire (psq) is a tool created in 2009 by dr. r. ruscheweyh in germany. it aims at identifying the natural sensitivity to pain, through a set of 17 simple questions. these questions simulate daily life situations likely to induce pain of various intensities. the internal validity of the tool had been demonstrated both for the original version in german, and then for its english version. the external validity had also been demonstrated by correlation to real nociceptive stimulations applied to healthy volunteers (german version), and to patients before surgery (english version). a french validation of the questionnaire is needed, in order to integrate it in pain research programs in french-speaking countries.

the aim is to validate the french version of the psq in a 2-step plan : (i) validity of internal structure, convergent validity and reproducibility, in a sample of patients before scheduled surgery, and (ii) structure and convergent validity against external criterion, in healthy volunteers. a secondary objective is to study the relationship of scores of the psq with a scale assessing sensitivity to natural smells, noise and light sensitivity.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 65, currently french-speaking and able to answer questionnaires, undergoing a pre-anesthetic mandatory visit, either for scheduled surgery, or as a follow-up of pregnancy * healthy volunteers aged 18 to 60, currently french-speaking and able to answer questionnaires, bmi 19 to 30 kg/m2, free from any medication since 7 days before each study session, covered by the french welfare health system. exclusion criteria are : risk of pregnancy, any medical history or condition likely to impair participation or quality of outcome measurement, any ongoing relevant disease, any cutaneous lesion at nondominant forearm, any ocular, neurological or acoustic contra-indication to the tests, spontaneous tinnitus or disease with hyperacusia, anxiety or depression with score \>11 on had, addiction to drugs or alcohol abuse, inclusion in a concomitant trial, french legal protection exclusion criteria: -

Keywords: pain psychophysics nociception sensitivity senses phenotyping questionnaire anxiety depression catastrophizing
twice-daily sib radiotherapy versus standard radiotherapy for patients with sclc

Conditions: Small Cell Lung Cancer Limited Stage; Radiotherapy

Summary: this trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial. in order to establish whether the sib technique can improve the results of twice-daily chemo-rt for patients with ls-sclc, the investigators will primarily compare survival of patients treated with standard chemotherapy (cisplatin and etoposide) and either sib twice-daily rt or standard dose twice-daily rt.

three hundred and twenty-six patients with a histological or cytological proven diagnosis of sclc will be recruited from 35 centers in 14 areas including provinces, municipalities and autonomous region, from may 2017 to may 2020.

Eligibility criteria:
inclusion criteria: * read the patient information and sign the informed consent before enrollment * either sex, age ≥18 and ≤70 * histologically or cytologically confirmed slcl * limited stage disease(ajcc, 2009 version 7), stage i-iii(t any, n any, m0) that can be safely treated with definitive radiation doses, excludes t3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, clinical nonmalignant diagnosis by investigator when the pleural is too few to obtain cytological evidence. * measurable lesion according recist 1.1 * ps ecog 0-1 * having zero to two cycles of systemic chemotherapy with etoposide and cisplatin (cisplatin 60-80 mg/m2 at day1 or divided into two to three days, etoposide 100-120 mg/m2 at day 1 to 3, q21d, and the treatment delay between two cycles shouldn't be more than 14days). * patients especially female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception. man must also use adequate contraception * adequate haematological function: white blood cell ≥3.0×109/l , neutrophils ≥1.5×109/l, platelet ≥100×109/l, hemoglobin ≥90g/l. * adequate liver and renal function: total bilirubin ≤1.5 ×upper limit normal , alanine transaminase and aspartate aminotransferase ≤1.5 ×upper limit normal, normal serum creatinine and/or calculated creatinine clearance ≥60ml/min. exclusion criteria: * prior surgical resection of the primary tumor or prior rt for lung cancer * mixed small-cell and non-small-cell histological features * contemporaneous immunotherapy or target therapy * pregnancy or lactation * physical or mental disease that could impact treatment plan * unable to understand the trial, or could not follow the process * to refuse the sign the informed consent. * no history of previous malignancy in the past 5 years (except non-melanomatous skin or in situ servix carcinoma) * be allergic to any known protocol in this trail * be enrolled in other clinical trial in past 30days

Keywords: small cell lung cancer limited stage twice-daily radiotherapy simultaneous integrated boosting technique
effect of 12-week probiotic supplementation on bacterial and viral infections in infants aged 6 to 12 months.

Conditions: Effect of Probiotics on Infections in Infants.

Summary: the purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months.

probiotics are live bacteria that offer a health benefit to the host when administered via the diet in adequate amounts. probiotic supplementation is safe for use in infants to the elderly and has demonstrated beneficial effects for a wide variety of health conditions such as acute diarrhea, antibiotic-associated diarrhea, allergies, and inflammatory bowel disease. the immune-enhancing benefits of probiotics are attractive, particularly for infants, a group that is particularly prone to a variety of infections, e.g. respiratory tract infection, strep throat, and diarrhea. probiotic supplementation has been utilized in previous studies of childhood infections with promising results. in this study, the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months will be determined. the subjects will receive follow-on formula containing 1 million cfu/g lactobacillus rhamnosus hn001 (trademarked dr20), 1 million cfu/g bifidobacterium animalis subsp. lactis hn019 (trademarked dr10), or placebo formula for at least three feeds per day for 12 weeks.

Eligibility criteria:
inclusion criteria: * age 6 to 12 months. * known vaccination history. * ability of the participant's parent or legal guardian to comprehend the full nature and purpose of the study including possible risks and side effects. * parental or legal guardian's consent to the study and willing to comply with study procedures. exclusion criteria: * symptoms of any infection at screening. * history of ≥5 infections in the previous 2 months. * lactose intolerance or unable to drink milk. * leukopenia or leukocytosis. * immunodeficient or use of immunosuppressive drugs. * use of antibiotic and anti-inflammatory medications within the last 2 weeks. * use of products containing prebiotics or probiotics within the last 2 weeks. * use of low-lactose or lactose-free infant or follow-on formula within the last 2 weeks. * hepatitis b or c. * medications or supplements that may affect subject safety or confound study outcomes in the opinion of the investigator. * medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator. * participation in another study with any investigational product within 3 months of screening. * any other condition that, in the investigator's opinion, may preclude the subject's ability to safely complete the trial.

Keywords: probiotics for infants bacterial and viral infections in infants
a study to evaluate the efficacy and safety of karxt + karx-ec for cognitive impairment in alzheimer's disease (mindset 2)

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of karxt + karx-ec for cognitive impairment in alzheimer's disease


Eligibility criteria:
inclusion criteria * participants must have a confirmed diagnosis of alzheimer's disease (ad), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the national institute on aging and alzheimer's association (nia-aa) core clinical criteria. the diagnosis of ad pathology must be confirmed through the 2024 revised nia-aa workgroup criteria using a stepwise diagnostic approach. * participants must have an mini-mental state examination (mmse) score ranging from 12 through 22, inclusive, at the time of screening. * participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. the caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities. * participants on acetyl choline esterase inhibitors (acheis) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration. exclusion criteria * participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. this includes any grade of hepatic impairment. * participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion. * participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to karxt or are currently undergoing treatment with disease-modifying anti-amyloid therapies for ad within the past 6 months prior to screening. * participants must not have significant pathological findings on brain magnetic resonance imaging (mri) at screening that could affect safety or interfere with study procedures. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: dementia cognitive impairment kar-xt karx-ec mild alzheimer's disease moderate alzheimer's disease