Kornimate/medical-research-clean huggingface dataset:
safety, efficacy, and survival outcomes of neoadjuvant/induction immunotherapy in surgical and radiotherapeutic management of non-small cell lung cancer

Conditions: Lung Cancer (NSCLC); Neoadjuvant Immunotherapy; Radiotherapy; Lung Surgery

Summary: this multicenter retrospective real-world study aims to evaluate the safety, efficacy and survival outcomes of neoadjuvant/induction immunotherapy in patients with non-small cell lung cancer (nsclc). the study covers diverse treatment pathways, including surgery, definitive radiotherapy, and non-surgical strategies. it addresses gaps in existing trials by establishing a comprehensive cohort spanning neoadjuvant/induction therapy, perioperative management, and follow-up, providing real-world evidence to support treatment decisions in both operable and inoperable cases.

lung cancer is the leading cause of cancer-related deaths in both china and the world. in recent years, neoadjuvant immunotherapy has achieved breakthrough advancements in the treatment of non-small cell lung cancer (nsclc). evidence from multiple phase iii randomized controlled trials (rcts), such as checkmate 816, keynote-671, and aegean, has demonstrated clear benefits of this therapy in improving survival. however, these studies exhibited several limitations: first, stringent selection criteria resulting in limited heterogeneity among participants challenge the generalizability of their conclusions; second, some studies and clinical observations have preliminarily suggested that neoadjuvant immunotherapy may increase technical surgical difficulty; however, large-sample, real-world data on its perioperative safety remain limited; third, clinical practice involves numerous borderline resectable and unresectable cases, leading to highly complex treatment decisions (such as timing of surgical intervention after conversion therapy, radiotherapy strategies, etc.), with none of the existing guidelines reach clear consensus. this study employs a multicenter real-world design, establishing a retrospective cohort covering from neoadjuvant/induction therapy period to the surveillance period. it evaluates the safety, efficacy, and survival outcomes of neoadjuvant/induction immunotherapy across diverse treatment strategies including both surgery and radiotherapy, providing real-world evidence to inform clinical decision-making.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed non-small cell lung cancer (nsclc), regardless of the presence of egfr or alk sensitive driver gene mutations; 2. clinical staging of ia-iiic according to the ajcc 8th edition before neoadjuvant treatment; 3. received at least one cycle of neoadjuvant immunotherapy (with or without chemotherapy); 4. assessed as resectable or potentially resectable by surgical experts prior to treatment. exclusion criteria: 1. confirmed m1 disease; 2. history of previous lung malignancy or other metastatic malignant tumors; 3. participation in other randomized controlled trials involving neoadjuvant treatment; 4. significant missing clinical data.

Keywords: lung cancer neoadjuvant immunotherapy real-world study radiotherapy thoracic surgery
trial to assess parkinson's disease (pd) symptom control to four doses of rotigotine in a transdermal patch

Conditions: Parkinson's Disease

Summary: the purpose of this study is to show rotigotine dose response at four doses of rotigotine used with l-dopa in treating advanced stage parkinson's disease.

to maintain treatment blind, two different active patch sizes were used (10 cm\^2 \& 20 cm\^2). placebo patches matched according to size and appearance. during the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose.

Eligibility criteria:
inclusion criteria: * pd greater than 3 years * stable dose l-dopa but symptoms not adequately controlled and have "off" time * able and willing to complete diary on specific days exclusion criteria: * previous use of rotigotine or neupro * atypical parkinson's syndrome * pallidotomy * thalamotomy * deep brain stimulation * fetal tissue transplant * dementia * psychosis * hallucinations * epilepsy * renal or hepatic dysfunction * clinically relevant cardiac dysfunction * symptomatic orthostatic hypotension * skin sensitivity to adhesives or unresolved contact dermatitis * history of chronic alcohol or drug abuse * pregnant or of child-bearing potential * impulse control disorder

Keywords: parkinson's disease rotigotine patch transdermal dopamine agonist off time neupro
effect of wound infiltration by ketamine versus dexmedetomidine added to bupivacaine on surgical stress

Conditions: Abdominal Cancer

Summary: this study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on stress response and postoperative pain in lower abdominal cancer surgery.

patients will be randomly assigned using an online research randomizer into three groups, 30 patients in each group: group c: 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision( control group). group k: 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline +1 mg /kg ketamine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision. group d: 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline + 1µg/kg dexmedetomidine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) class i-ii body weight of 50 - 90 kg exclusion criteria: * history of bleeding diathesis * relevant drug allergy, opioid dependence * morbid obesity, sepsis
low-dose aspirin therapy for esophageal cancer

Conditions: Esophageal Cancer

Summary: the aim of this study is to evaluate the survival benefit of low-dose aspirin use for stage ii-iii esophageal cancer patients.

the investigators aimed to evaluate the hypothesis that low-dose aspirin can improve survival in stage ii-iii esophageal cancer patients, and to evaluate whether this effect is influenced by pik3ca, kras, braf mutation and cox-2 expression. eligible participants will be randomized to either aspirin treatment arm (100 mg aspirin od for 3 years), or non-aspirin user arm in 1:1 ratio. after randomization, participants will receive 3 monthly assessments during treatment and follow-up.

Eligibility criteria:
inclusion criteria: 1. male or female subjects with an age of 18 years or older. 2. subjects with stage ii-iii histological proven esophageal cancer. 3. subjects with performance status (ps) of 0-1 or ecog performance status 0-2. 4. subjects must have signed an approved informed consent prior to any study procedures. 5. subjects with adequate bone marrow, hepatic and renal functions, with a) neutrophils ≥ 1.5x109/ l; platelets ≥ 100x109/l; hemoglobin ≥ 9g/dl; b) total bilirubin ≤ 2.0 x the upper limit normal; alt and ast ≤ 2.5 x uln (≤ 5 x uln in case of liver metastasis); c) creatinine clearance \> 50 ml/min; 6. subjects undergone complete resection of primary tumor; 7. subjects with life expectancy ≥ 3 months. 8. completed standard therapy ( at least 3 months of chemotherapy ± radiotherapy ) 9. within 120 days of completion of standard therapy (surgery, chemotherapy ± radiotherapy) exclusion criteria: 1. subjects with haemorrhagic diathesis (i.e. haemophilia). 2. subjects with prior malignant tumors except for esophageal cancers in the past 5 years. 3. subjects with documented or suspected central nervous system metastases. 4. subjects with serious, nonhealing wound, ulcer, or bone fracture. 5. subjects with a history of stroke, coronary arterial disease, angina, or vascular disease. 6. subjects who are pregnant, lactating, or not using adequate contraception. 7. subjects who have known allergy to nsaid or aspirin. 8. subjects receiving other antiplatelet agents (i.e. clopidogrel, ticlopidine) or anticoagulants (i.e. warfarin, low molecular weight heparins). 9. subjects receiving current long term treatment (≥ 1 month) with aspirin or other nsaids. 10. subject unwilling or unable to comply with study requirements.

Keywords: esophageal cancer aspirin survival
a study to evaluate the pharmacokinetics of the hydrocodone extended-release tablet (cep-33237) in subjects with normal hepatic function and subjects with moderate hepatic impairment

Conditions: Hepatic Impairment

Summary: the purpose of this study is: 1. to assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function. 2. to assess the safety and tolerability of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.


Eligibility criteria:
inclusion criteria: 1. all subjects: * written informed consent is obtained 2. subjects with normal hepatic function: * the subject is in generally good health (age-appropriate) as determined by medical and psychiatric history, physical examination, ecg, serum chemistry, hematology, coagulation, urinalysis, and serology. 3. subjects with hepatic impairment: * the subject's health is otherwise clinically stable as determined by medical history, physical examination, ecg, serum chemistry, hematology, coagulation parameters (pt, activated partial thromboplastin time \[aptt\], and international normalized ratio \[inr\]), urinalysis, and serology except for those signs and symptoms attributable to liver disease. * the subject has case record notes demonstrating physical signs consistent with 1 or more of the following characteristic clinical manifestations of liver cirrhosis: liver firmness to palpation, splenic enlargement, spider angiomas, palmar erythema, parotid hypertrophy, testicular atrophy, ascites (accumulation of fluid in the abdominal cavity), or gynecomastia. * the subject has a child-pugh classification score of 7-9 points (moderate). exclusion criteria: 1. all subjects: * the subject has any clinically significant, uncontrolled medical condition. * the subject is a poor metabolizer of cyp2d6 substrates based on genotyping performed at screening. * the subject has previously participated in a study with cep-33237. * the subject has a known sensitivity or idiosyncratic reaction to hydrocodone or hydromorphone, related compounds, or to any metabolites, or any compound listed as being present in a study formulation. 2. subjects with normal hepatic function: * the subject has a positive test result for hbsag or antibodies to hepatitis c. * the subject has a history of alcohol, narcotic, or any other substance abuse. 3. subjects with hepatic impairment: * the subject has severe ascites. * the subject has an acute exacerbation of liver disease as indicated by worsening clinical signs of hepatic impairment.

Keywords: pharmacokinetics hydrocodone extended release hepatic impairment
comparison of two methods for treatment of colles´s fracture

Conditions: Distal Radius Fracture; Colle´s Fracture

Summary: the purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures). we are comparing an external fixation (hoffmann-ii-non-bridging) vs. an internal fixation(micronail). primary endpoint is patient satisfaction as scored by the dash-questionnaire.secondary followup is x-rays, strength, prwe-questionnaire.


Eligibility criteria:
inclusion criteria: * fracture older type 2. * fracture older type 3. exclusion criteria: * fractures older than 3 weeks. * pregnancy. * seq. after previous fracture. * distal fragments volar cortex \< 10 mm. * open fracture larger than gustillo 1. * disability due to other illness. * congenital abnormity or injury/disease in the affected extremity. * not capable of mentally/physically to cooperate. * not able to go to followup on the operating hospital.

Keywords: distal radius fracture colle´s fracture internal fixation external fixation dash prwe
baduanjin versus brisk walking for cognition in schizophrenia

Conditions: Schizophrenia; Exercise; Condition

Summary: the current study intends to recruit participants with schizophrenia for the practice of baduanjin, brisk walking, and health education after enrollment. the study also including a maintenance program. cognitive and physical function assessments will be conducted before, after, and during follow-up tests. the research hypothesis posits that both baduanjin and brisk walking will confer beneficial effects on various aspects of cognitive and physical functions.

cognitive function deficits are core features in patients with schizophrenia. these deficits need active intervention to prevent functional decline. baduanjin and brisk walking show promise as interventions in patients with schizophrenia. this study investigated the effects of baduanjin exercise versus brisk walking in patients with schizophrenia. this study will be a single-blind, 3-arm, parallel, randomized controlled trial. a total of 120 patients with schizophrenia will be enrolled and randomly assigned to the baduanjin group, brisk walking group or control group. the intervention group will practice badunjin exercise. while participants in brisk walking group will receive brisk walking at the same duration. the controls will watch videos that are not aimed at improving physical exertion. maintenance programs will also be conducted for participants to encourage practicing in exercise after intervention. all group will undergo evaluation at three time points: baseline, immediately after intervention and 4-week follow up after intervention. the primary outcome will be cognitive function and physical function. secondary outcomes will include mood, sleep quality, and quality of live.

Eligibility criteria:
inclusion criteria: 1. having a diagnosis of schizophrenia according to the dsm-5. 2. who will be above 20-65 years of age . 3. having a stable mental status without shift in medication and keep in same dose for at least one month. 4. being able to walk independently for 50 meters. exclusion criteria: 1. serious physical conditions that will impede participation, such as cardiovascular disease, musculoskeletal disease or pulmonary system disease. 2. visual or auditory impairment that precludes completion of assessment. 3. acute psychosis requiring hospitalization. 4. presence of severe withdrawal or profound cognitive disability that cause difficulties in following instructions.

Keywords: schizophrenia, mindful exercise, exercise, cognition
calcium and phosphorus whole-body balance and kinetics in patients with moderate chronic kidney disease

Conditions: Phosphorus and Calcium Disorders; Chronic Kidney Disease Mineral and Bone Disorder; Chronic Kidney Diseases

Summary: this pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease.

the goal of this project is to produce preliminary data on the effects of the commonly prescribed dietary phosphorus restriction on whole-body calcium (ca) and phosphorus (p) balance and kinetics patients with ckd, to support a larger future clinical study. the specific aims are to determine intestinal ca and p fractional absorption and 2) ca and p balance and full kinetics, effect sizes variance estimates in patients with ckd on a low ca diet with high p diet versus dietary p restriction. the hypothesis is that a high p diet, in the context of a typical low ca diet, leads to p retention negative ca balance, and that dietary p restriction modestly reduces p retention but does not negative ca balance. the study design is a randomized 2-period cross-over study. all outpatient and inpatient visits place at the indiana ctsi clinical research center located in iu health university hospital in indianapolis, in. subjects will be randomly assigned to controlled diets of either low ca/high p (lca/hp) or low (lca/lp) for a 1-week, outpatient diet equilibration period, followed by 1-week inpatient full balance that includes a 48-hour ca and p absorption testing protocol. after a 1-3 week washout subjects will crossover to the other diet regimen

Eligibility criteria:
inclusion criteria: * men or women, ages 30-75 years old, any race or ethnicity * moderate chronic kidney disease * female subjects must be postmenopausal (\>12 months since last menstrual period), surgically sterile, or confirmed not pregnant by pregnancy test * must be on stable doses of medications (except those noted in exclusion criteria) for at least 4 weeks prior to the study * willing to discontinue nutritional supplements (e.g. vitamin d, calcium, multivitamin/minerals, or others) upon enrollment until completion of the study * adequate vitamin d status defined as serum 25d \> 20 ng/ml exclusion criteria: * plans to initiate dialysis within 6 months * hypercalcemia defined as serum calcium \>10.5 mg/dl within past 3 months * hyperkalemia defined as serum potassium \>5.5 mg/dl within past 3 months * hyperphosphatemia defined as serum phosphate \>5.5 mg/dl within past 3 months * intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, or bariatric surgery * serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension * pregnant or breastfeeding * prescribed a phosphate binder medication, calcitriol, vitamin d analogs, calcimimetics, parathyroid hormone analogues, and other medications that may alter ca and p metabolism within past 30 days

Keywords: whole-body balance kinetic modeling intestinal absorption
effect of flavonoids on gut permeability in cyclists

Conditions: Gut Permeability, Gut Inflammation

Summary: the purpose of this investigation is to test the hypothesis that chronic supplementation with a dairy-based beverage containing a mixture of blueberry, green tea, and cocoa flavonoids (non-nutritive natural plant compounds) will ameliorate exercise-related changes in gut permeability and inflammation. in a previous feeding study in humans, (nct02728570) a high flavonoid diet (flavonoids at 340 mg/1000kcal) was effective in mitigating gut permeability and inflammation in overweight and obese adults compared to a low flavonoid diet (10mg/1000 kcal). to test this hypothesis, 20 trained cyclists will complete a randomized crossover study with supplementation for 2 weeks with a dairy-based sports beverage containing either a high flavonoid (approximately 620 mg) or low flavonoid (approximately 5mg) beverage. after the two week intervention, cyclists will complete a 1 hour cycling trial (45 min at 65% vo2 max then 15 minute time trial). the primary endpoints will be gut permeability as measured by plasma intestinal fatty acid binding protein (i-fabp) and the differential sugar test. secondary endpoints will include gut inflammation (measured via fecal calprotectin), plasma cytokines (il-6, il-10 and tnfα) and plasma lps. in addition, the distance completed in the time trial is a secondary endpoint.


Eligibility criteria:
inclusion criteria: * male or female of any race or ethnicity between 18 to 49 years of age * competed in a road race or triathlon in past 12 months * free of chronic disease and gi conditions * train at least 3 times per week, 1 hour at a time on average * willing to prepare and consume provided pre-workout beverage daily * maintain weight (no more/less than 5 kg change) * willing to avoid consumption of high flavonoid foods/supplements, large dose vitamin and mineral supplements, and nsaids or other medications known to affect inflammation during study period * willing to provide urine, stool, and blood samples exclusion criteria: * age \ 50 years * medical history of heart disease, hypertension, diabetes, crohn's disease, ibs, colitis, celiac disease, inflammatory or autoimmune disease, and lactose intolerance * uncontrolled hypertension: diastolic blood pressure \>95 mm hg or systolic blood pressure \>160 mm hg * for women: pregnancy, breast feeding or postpartum \<6 months * food allergies or restrictions to treatment/placebo beverages * chronic use of nsaids * consumption of flavonoid supplements \<1 month prior to study start * antibiotic use \<3 months prior to study start * other conditions (medical, psychiatric, or behavioral) that may present a safety hazard to the participant or interfere with study participation, as determined by the principal investigators
impact of boostrix™ maternal vaccination on morbidity and mortality of pertussis disease in infants ≤6 weeks of age, in bogota, colombia.

Conditions: Diphtheria; Acellular Pertussis; Tetanus; Aspergillosis, Allergic Bronchopulmonary; Diphtheria-Tetanus-acellular Pertussis Vaccines

Summary: this study is being conducted to assess impact of maternal immunisation against pertussis in infants ≤12 months of age before and after introduction of pertussis maternal immunisation in bogota, colombia from january 2005-december 2014.

an observational, retrospective, ecological database study which involves systematic screening of the national databases of bogota, to study pertussis related morbidity and mortality in infants ≤ 12 months of age before and after introduction of pertussis maternal immunisation in bogota, colombia from january 2005-december 2014.

Eligibility criteria:
inclusion criteria: • not applicable as since this retrospective database study will include all the available aggregated data of pertussis cases, pertussis related hospitalisations and deaths, alrti cases, primary pertussis vaccination coverage and boostrix vaccination coverage. exclusion criteria: • not applicable as since this retrospective database study will include all the available aggregated data of pertussis cases, pertussis related hospitalisations and deaths, alrti cases, primary pertussis vaccination coverage and boostrix vaccination coverage.

Keywords: boostrix™ bagota maternal vaccination pertussis mortality morbidity
the feasibility and safety of a three-port laparoscopic cholecystectomy using a 2-mm mini-instrument

Conditions: Gallbladder Disease

Summary: the aim of this study was to show that this technique is feasible, safe and easily reproducible and to evaluate the selection criteria for a three-port laparoscopic cholecystectomy using a 2-mm mini-port.

since the first four-port laparoscopic cholecystectomy (lc) was reported in 1987, various surgical options for lc have been developed. recently, single port lc (splc) has been increasingly performed to minimize tissue trauma, improve cosmesis and decrease postoperative pain for patients. some surgeons suggest that the four- or three-port lc using mini-ports could be as safe, effective, economical and cosmetic as splc. for this reason, the investigators started m-lc for patients with benign gallbladder disease in april 2010. prospectively collected data from 133 patients who underwent lc for benign gallbladder disease between april 2010 and april 2011 were retrospectively reviewed. the patient's selection for m-lc was determined by surgeon's judgment based on 'laparoscopic surgical view' after inserting the laparoscope in the operating room.

Eligibility criteria:
inclusion criteria: * all patients required laparoscopic cholecystectomy for benign gallbladder diseases. exclusion criteria: * open cholecystectomy

Keywords: laparoscopic cholecystectomy mini-instrument