Kornimate/medical-research-clean huggingface dataset:
study comparing radiation therapy and chemotherapy with or without nimotuzumab

Conditions: Carcinoma; Head and Neck Cancer

Summary: primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups. secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.

this is a phase iii, superiority, national, open-label, randomized, and two-arm study. patients' enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months. all patients taking part in the study must sign an informed consent. the patients will have stage iii or iv, unresectable head and neck scc, performance status 0 or 1. randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage, 1:1

Eligibility criteria:
inclusion criteria * aged 18 to 75 years old; * histological or cytological confirmation of scc in oral cavity, oropharynx, hypopharynx, or larynx; * stages iii or iv disease * unresectability according to responsible surgeon or medical staff's opinion; * performance status 0 or 1 * present indication for radiation therapy and chemotherapy treatment with cisplatin; * adequate hepatic, renal and medullar functions, indicated by: * life expectancy above 6 months. exclusion criteria * presence of nasopharyngeal, paranasal sinuses, or salivary glands carcinoma; * presence of known distant metastasis; * presence of any other active neoplasm or history of any tumor diagnosed in the last 5 years * patients with inability to eat normally, in whom a gastric or enteral tubing was not possible at least 2 weeks before their enrollment in the study; * previous treatment with chemotherapy, radiation therapy, or egfr inhibitors of any pharmacological class; * presence of serious comorbidity that, in the investigator's opinion, will put the patient at risk or will jeopardize protocol compliance; * active known seropositivity for hiv, hepatitis b or c * presence of a significant neurological or psychiatric disease, as per the investigator's judgment; * hypersensitivity or allergy to any of the study treatments; * presence of uncontrolled hypercalcemia; * pregnancy or breastfeeding; * female patients of childbearing potential who wish to become pregnant or are unwilling, as well as their partners, to use an appropriate contraceptive method throughout the study period; * participation in any clinical trial in the last 12 months.
osimertinib with chemotherapy as first-line therapy for egfr mutation-positive nsclc

Conditions: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Summary: to estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported pfs and os.

the objectives of this study are to assess the effectiveness and safety of osimertinib combined with chemotherapy in a real-world setting in patients with locally advanced or metastatic, egfr mutation-positive nsclc.

Eligibility criteria:
inclusion criteria: * age ≥18 years * histologically or cytologically documented nonsquamous nsclc. nsclc of mixed histology is allowed. * stage iiib or iiic or stage iv metastatic nsclc or recurrent nsclc (based on the american joint committee on cancer edition 8) not amenable to curative surgery or definitive chemoradiation. * egfr sensitive mutation-positive (ex19del and/or 21 l858r) * who performance status of 0 to 2 at screening with no clinically significant deterioration in the previous 2 weeks. * patients who receive osimertinib plus chemotherapy as first-line treatment based on physician's medical assessment are eligible (for patients who received prior chemotherapy alone/osimertinib monotherapy/osimertinib plus chemotherapy as first-line therapy ahead of enrolment, they are diseases progression-free at the time of enrolment and the duration of prior therapy ≤3 months). * patients with asymptomatic cns metastases or patients who have completed definitive therapy, are not on steroids and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids are allowed. * prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease. exclusion criteria: * spinal cord compression and symptomatic brain metastases * past medical history of ild, drug-induced ild, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ild * any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, etc * any banned substance in label

Keywords: osimertinib epidermal growth factor receptor nsclc non-small cell lung cancer observational
ovarian cyst's enucleation spillage score

Conditions: Ovarian Cysts; Spillage

Summary: cystic enucleation is one of the most common conservative surgeries in gynecology; it is commonly performed by a minimally invasive approach such as laparoscopy. a high percentage of these surgeries (6-88 % of cases) are complicated by the cystic rupture with intra-abdominal spillage of its contents (spillage). this occurrence affects the surgical and prognostic outcome by lengthening the time of surgery, increasing the risk of postoperative infection or granulomatous peritonitis, of possible second manifestation of the pathology (example: endometriosis), and in the case of neoformation of a carcinomatous nature by leading to an increase in the stage of disease, exposing patients to a prognostic disadvantage and the need for adjuvant treatments also avoidable. in addition, the previous spillage may be associated with the adherent syndrome with repercussions on patients' morbidity and fertility. for these reasons, it is crucial to optimize the selection of patients who are candidates for cystic enucleation. the present study aims to evaluate a series of ultrasound, medical history, and surgical-preoperative parameters to develop a predictive score for the risk of spillage during laparoscopic surgery. prospective observational study. the study aims to enroll 156 patients.


Eligibility criteria:
inclusion criteria: * patients \>18 years of age * patients undergoing laparoscopic cystic enucleation * patients who underwent pelvic ultrasound examination within 30 days prior to surgery * patients who signed informed consent for the study * ecog performance status \< 2 exclusion criteria: * pregnancy status * patients with cardiological, neurological, or metabolic disorders not treated pharmacologically * asa iii * patients undergoing laparotomy conversion prior to enucleation

Keywords: ovarian cysts laparoscopy cyst enucleation spillage
cranberry juice and cardiovascular disease

Conditions: Cardiovascular Disease

Summary: previous studies have shown that consumption of a low calorie cranberry beverage imparts a favorable impact on hdl cholesterol, ldl oxidation, and cell adhesion molecules in men. however, these studies were not well controlled. thus, it is important to confirm these effects in a blinded, placebo-controlled feeding study. the investigators goal is to verify the cardioprotective effects of cranberries by conducting a dietary intervention trial with healthy subjects in a controlled environment.


Eligibility criteria:
inclusion criteria: * 25 to 65 years of age * bmi 20 to 38 kg/m2 exclusion criteria: * history of bariatric or certain other surgeries related to weight control * kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes * type 2 diabetes or use of glucose-lowering medication * have a fasting blood sugar greater than 126 mg/dl * ldl-cholesterol less than 130 mg/dl * fasting triglycerides greater than 300 mg/dl * use of cholesterol-lowering medication or supplements * use of blood pressure-lowering medication * smoking or use of other tobacco products (within 6 months prior to the start of the study) * unwillingness to abstain from vitamin, mineral, and herbal supplements for 2 weeks prior to the study and during the study * use antibiotics during the study,or for 3 weeks prior to starting the study. * history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets) * weight loss of \>/= 10% of your body weight within the last 12 months or plan to initiate a weight loss program during the next 10 months * inability to eat cranberries * inability or unwillingness to give informed consent or communicate with study staff * self-reported history of alcohol or substance abuse within the past 12 months and/or are currently in treatment or rehabilitation program for these problems (long-term participation in alcoholics anonymous is not an exclusion) * other medical, psychiatric, or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol

Keywords: cranberry cardiovascular adhesion polyphenol
tranexamic acid in chinese elderly patients with intertrochanteric fracture rct

Conditions: Fracture of Femur

Summary: hip fracture posed a major challenge to the health care system, with the one-year mortality of hip fracture reported as being approximately 20%. perioperative haemoglobin level was associated with functional level of the patient and even mortality. different methods for administration of tranexamic acid had been described. it was well established that systemic administration of tranexamic acid could reduce perioperative blood loss and transfusion rate. topical administration had been shown to decrease blood loss and transfusion rate. the objective of our study is to investigate the hypothesis that tranexamic acid will reduce blood loss and transfusion rate in elderly patients undergoing hip fracture surgery.

the incidence of geriatric hip fractures is projected to increase by more than 250% in the next twenty-five years as the world population ages. hip fracture in elderly patients are associated with significant morbidity and mortality. one of the significant morbidity is blood loss, which has been reported as high as 1500ml. blood loss may lead subsequent blood transfusion. the rate of blood transfusion has been reported between 20 to 60%. blood loss and subsequent blood transfusion could lengthen the overall hospital length of stay and delay the rehabilitation. tranexamic acid, one of antifibrinolytic agents, is a synthetic derivative of the amino acid lysine and acts as a competitive inhibitor in the activation of plasminogen to plasmin, therefore preventing the degradation of fibrin. shakur et al. reported that the use could reduce mortality in trauma patients. tranexamic acid has been widely used in elective orthopaedic surgery such as total joint replacement and spine surgery. several authors reported that tranexamic acid could decreases the blood loss, transfusion rate and cost.

Eligibility criteria:
inclusion criteria: * adults over the age of 60 * acute isolated intertrochanteric fracture and sub trochanteric fracture treated with short proximal femoral nailing exclusion criteria: * use of any anticoagulant at the time of admission * documented allergy to tranexamic acid * history of pulmonary embolism or deep vein thrombosis * hepatic failure * severe renal insufficiency * active coronary artery disease in the past 12 months * history of cerebrovascular accident in the past 12 months * presence of a drug-eluting stent * active oncological diseases * coagulopathy (international normalised ratio (inr)\>1.4) * pathological fractures * periprosthetic fractures * operation \>2 days from admission

Keywords: elderly intertrochanteric fracture
rasagiline as add on to dopamine agonists in the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: to assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early parkinson disease (pd) patients, , not optimally controlled on dopamine agonists as compared to placebo.


Eligibility criteria:
inclusion criteria: * receiving stable dose of oral ropinirole or pramipexole whose symptoms are not optimally controlled or whose oral dopamine agonist titration regimen was truncated due to intolerability: * 1) minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole * 2) stable dopamine agonist treatment must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline * males and females. women of childbearing potential must agree to practice an acceptable method of birth control. * idiopathic parkinson disease confirmed at baseline by presence of at least 2 cardinal signs (resting tremor, bradykinesia, rigidity), w/o other known or suspected cause of parkinsonism * hoehn \& yahr \> 1 (symptoms on only one side of the body) with treatment and \< 3 (mild to moderate bilateral disease; some postural instability; physically independent). * dopamine agonist dose must be stable for ≥30 days preceding the baseline visit. * for patients who are receiving amantadine or anticholinergics, the dose must have been stable for ≥30 days prior to screening. * medically stable outpatients (investigator's judgment). exclusion criteria: * receive rasagiline or other monoamine oxidase (mao) inhibitors 60 days preceding baseline * receive levodopa \> 21 consecutive days within 90 days prior baseline * moderate to severe motor fluctuations * hepatic impairment * investigational medications 30 days preceding baseline * dopamine agonist use \> 5 years prior to baseline * major depression as defined by beck depression inventory (bdi) short form score greater than 14 * significant cognitive impairment as defined by mini-mental state exam (mmse) score less than 26. * impulse control disorder (icd) based on the questionnaire for impulsive-compulsive disorders in parkinson's disease form (quip). * pregnant or lactating or planning on becoming pregnant in the next 18 weeks * uncontrolled hypertension. patients whose hypertension is controlled with medications are eligible. * concomitant monoamine oxidase (mao) inhibitors or medicines contraindicated w/ mao inhibitors not allowed

Keywords: parkinson's disease updrs clinical global evaluation illness severity score clinical global evaluation improvement b-sit scopa - sleep daytime sleepiness pdq -39 scopa - cognition levodopa rasagiline dopamine agonist therapy monoamine oxidase type b inhibitor
comparative study of lubiprostone and peg preparation versus conventional peg preparation for colonoscopy

Conditions: Colorectal Carcinoma

Summary: lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel preparation can be improved for a good colonoscopic examination without missing lesions and complications.

objectives: 1. primary: * same day low volume peg with placebo (arm 1) versus same day low volume peg with lubiprostone (arm 2) * waiting time for colonoscopic procedure and quality of bowel preparation 2. secondary: * quality of bowel preparation without dietary restriction (modified bowel preparation regime without fiber diet restrictions)

Eligibility criteria:
inclusion criteria: 1. all adult patient referred for colonoscopy to aig 2. age 18 - 75 years old exclusion criteria: 1. acute gi bleeding. 2. patient of bowel preparation regime other than excepted for the study. 3. renal insufficiency. 4. dementia. 5. symptomatic heart failure. 6. recent myocardial infarction. 7. patients with ileus. 8. suspected bowel obstruction. 9. prior alimentary tract surgery. 10. significant gastroparesis. 11. gastric outlet obstruction. 12. toxic colitis or megacolon. 13. pregnant or lactating patients.

Keywords: lubiprostone bowel preparation regime
post-marketing observational study in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

this was a multicenter, uncontrolled, 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis (ra) who had received adalimumab for at least 3 months in nct00448383 (study m02-497), an interventional study that ended when adalimumab became commercially available for the treatment of ra. participants had to have been receiving ongoing adalimumab treatment at the time nct00448383 (study m02-497) ended and been prescribed commercial adalimumab, and could have received commercial adalimumab for up to 1 year afterward prior to enrollment in nct00234884 (study m03-634). physician investigators were encouraged to treat participants as they would any other patient with ra in their routine clinical practice, and were free to determine the appropriate therapy for each patient. concomitant treatment with disease-modifying antirheumatic drugs (dmards), including methotrexate, could be continued while receiving adalimumab. if treatment with adalimumab was permanently discontinued for any reason, participants were discontinued from the study and the reason was recorded. investigators were asked to record adverse events up to 3 months after last administration of adalimumab.

Eligibility criteria:
inclusion criteria: * participants with ongoing adalimumab treatment who completed at least month 3 (visit 5) of nct00448383 (study m02-497) and who had subsequently been prescribed adalimumab according to the summary of product characteristics (smpc). * participants must have been willing to consent to data being collected and provided to abbott. exclusion criteria: · participants with contraindications according to the smpc.

Keywords: rheumatoid arthritis adalimumab
postoperative pain evaluation after obturation with different sealers

Conditions: Periapical Periodontitis; Pulpitis; Necorsis

Summary: this study aims to evaluate the incidence and intensity of postoperative pain in patients undergoing root canal treatment on teeth diagnosed with pulpitis, pulp necrosis, or with previous endodontic treatment. teeth will be obturated using either bioceramic or resin-based sealers. the primary objective is to determine whether the type of sealer significantly influences the level of postoperative pain as reported by patients. pain intensity will be assessed using the visual analogue scale (vas) at three time points: immediately after treatment, 24 hours, and 72 hours postoperatively. the findings are expected to provide clinical insight into which obturation material may be more effective in minimizing postoperative discomfort.


Eligibility criteria:
inclusion criteria: patients aged 18 years and older. teeth with a diagnosis of pulpal necrosis or irreversible pulpitis. informed consent provided for data usage. exclusion criteria: * patients with systemic conditions that may impair healing (e.g., uncontrolled diabetes, immunosuppression). * asymptomatic presentation * teeth with root fractures, resorption, or open apices. * incomplete clinical or radiographic records. * cases with poor-quality radiographs or lack of standardization for evaluation

Keywords: bioceramic sealers resin-based sealers endodontics
determinants of acquired endocrine resistance in metastatic breast cancer: a pilot study

Conditions: Metastatic Breast Cancer

Summary: this is a single-center prospective study involving analysis of circulating tumor dna (ctdna) and the gut microbiome in patients with metastatic breast cancer on standard of care endocrine therapy with an aromatase inhibitor in combination with an inhibitor of the cyclin-dependent kinases 4 and 6 (cdk 4/6). up to 20 patients with estrogen receptor positive (er+), human epidermal growth factor receptor 2 negative (her2-) metastatic breast cancer and eastern cooperative oncology group (ecog) performance status 0-1 will be enrolled. this study involves the collection and analysis of patient samples and does not involve therapeutic intervention.

endocrine therapies have been associated with an overall survival benefit in breast cancer and are the preferred initial treatment approach in patients with er+, her2- metastatic breast cancer. unfortunately, resistance to endocrine therapies eventually develops in the metastatic setting and metastatic breast cancer remains an incurable disease. endocrine resistance may develop as a result of alterations in estrogen signaling and metabolism pathways, which may be modulated by gut bacteria. in addition, genomic profiling of archival tissues and circulating tumor dna (ctdna) in er+ breast cancer has identified multiple somatic molecular alterations that may mediate response to endocrine therapies. this study is designed to identify markers of endocrine resistance in ctdna and the gut microbiome in patients with er+ her2- metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * sign written and voluntary informed consent * histological confirmation of advanced er positive and her2 negative breast cancer. * adult patients at least 18 years of age * ecog performance status equal to 0 or 1 * able to provide written informed consent * must be willing to provide blood for ctdna analysis on study enrollment and at specified study time points * must be willing and able to perform stool sample collection * patients must be suitable, as per their treating physician, for initiation of first line endocrine therapy with an aromatase inhibitor and a cdk 4/6 inhibitor for metastatic disease exclusion criteria: * prior treatment with cdk 4/6 inhibitors in the neoadjuvant or adjuvant setting * use of targeted therapies other than endocrine therapies alone in the neoadjuvant or adjuvant setting * relapse on prior endocrine therapy or within 6 months of discontinuation of prior adjuvant endocrine therapy * history of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator * use of immunosuppressants including steroids within the previous 4 weeks of planned cycle 1 day 1 treatment

Keywords: cdk4/6 inhibitors endocrine resistance gut microbiome
piloting treatment with intranasal oxytocin in phelan-mcdermid syndrome

Conditions: Phelan-McDermid Syndrome

Summary: this is a pilot study examining the efficacy, safety and tolerability of intranasal oxytocin as a novel treatment in phelan-mcdermid syndrome (pms). this study will utilize a randomized, placebo-controlled design for 12 weeks (phase 1), followed by an open-label extension for 12 weeks (phase 2). the purpose is to evaluate the effect of intranasal oxytocin on impairments in attention, social memory, socialization, language, and repetitive behaviors.


Eligibility criteria:
inclusion criteria: * have a diagnosis of phelan-mcdermid syndrome defined by pathogenic deletion or mutation of the shank3 gene and confirmed by chromosomal microarray or sequencing. * must be between the ages of 5 and 17 * must be on stable medication and psychosocial therapy regimens for at least three months prior to enrollment exclusion criteria: * allergy to oxytocin * active cardiovascular disease, epilepsy, or renal disease that is not controlled by medication * pregnant, lactating or refuse to practice contraception if sexually active * have caretakers who are unable to speak english, be consistently present at visits to report on symptoms, or are otherwise judged unable to comply with the protocol by the study team * comorbid conditions such that the patient is too medically compromised to participate