Kornimate/medical-research-clean huggingface dataset:
a smoking, alcohol, and depression intervention for head and neck cancer

Conditions: Cancer

Summary: data from the surveillance, epidemiology and end results (seer) cancer registry indicates that head and neck cancers (hn ca) are nearly twice as common in veterans as non-veterans. hn ca patients are at an increased risk for smoking, alcohol consumption and depression, all of which contribute to a further decline in their quality of life (qol). in the hn ca population, diagnosis and treatment of smoking, alcohol intake and depression are sub-optimal, thereby affecting qol and survival. numerous studies have documented that smoking, alcohol and depression are interrelated and research on multi-modal interventions has been suggested.

background: data from the surveillance, epidemiology and end results (seer) cancer registry indicates that head and neck cancers (hn ca) are nearly twice as common in veterans as non-veterans. hn ca patients are at an increased risk for smoking, alcohol consumption and depression, all of which contribute to a further decline in their quality of life (qol). in the hn ca population, diagnosis and treatment of smoking, alcohol intake and depression are sub-optimal, thereby affecting qol and survival. numerous studies have documented that smoking, alcohol and depression are interrelated and research on multi-modal interventions has been suggested. objectives: to determine whether a combined intervention for smoking, alcohol intake, and depression improves the qol of veterans with hn ca. methods: patients from three va medical centers (ann arbor, mi; dallas, tx; gainesville, fl) who have at least one of the three disorders of smoking, drinking and depression were randomized to either usual care or the combined intervention. data was collected on smoking, alcohol consumption, depression and qol at baseline, 6- and 12- months after the intervention (or non-intervention). the main analyses consisted of analysis of covariance (ancova) to compare the scores on the sf-36 mental health scores and on the emotional domain of head and neck quality of life questionnaire between the experimental and control group at 6- and 12- month follow up. additional analyses examineded smoking, alcohol intake, and depression scores at these same time points. status: completed.

Eligibility criteria:
inclusion criteria: head and neck cancer patients who: 1) screen positive for at least one of the three health problems of smoking, alcohol and depression; 2) are not pregnant; 3) are greater than 18 years of age; and 4) speak english. exclusion criteria include patients who: 1) have metastatic disease (terminal); or 2) have unstable psychiatric/mental conditions such as suicidal ideation, acute psychosis, severe alcohol dependence or dementia. exclusion criteria:
a phase ii study of oxaliplatin capecitabine and pre-operative radiotherapy for patients with locally advanced and inoperable rectal cancer

Conditions: Rectal Cancer

Summary: to assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the treatment of patients with locally advanced or inoperable rectal cancer.


Eligibility criteria:
inclusion criteria: * age over 18. * histological diagnosis of adenocarcinoma of rectum. * locally advanced/ poor prognosis primary rectal cancer defined by mri criteria of any of the categories below; * tumour within 2 mm of mesorectal fascia ie circumferential resection margin threatened * any t3 tumour at/below levatores * t3c tumour at any other level ie tumour extends \>5 mm into peri-rectal fat * t4 tumour * any t stage with 4 or more involved lymph nodes * who performance status 0, 1 or 2. * no evidence of metastatic disease as determined by ct scan of chest, abdomen, pelvis or other investigations such as pet scan or biopsy if required. * adequate bone marrow function with platelets \> 100 x 109/l; wbc \> 3 x 109/l; neutrophils \> 1.5 x 109/l * normal renal function, with serum creatinine within the normal range or calculated creatinine clearance \>50 ml/min. * adequate hepatic function with serum total bilirubin \< 1.5 x upper limit of normal range. * no concurrent uncontrolled medical conditions * no previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix * adequate contraceptive precautions if relevant * informed written consent exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent * presence of metastatic disease or recurrent rectal tumour * renal impairment (creatinine clearance\<30 ml/min) * pregnancy or breast feeding * patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes * participation in any investigational drug study within the previous 4 weeks. * clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months) * patients with any symptoms or history of peripheral neuropathy. * prior pelvic radiotherapy
ai-based physiotherapy for oral cancer patients

Conditions: Oral Cancer

Summary: this study examines the effects of ai-based physiotherapy on oral function, shoulder function, whole-body physical function, and quality of life in oral cancer patients. one hundred patients will be recruited before surgery, chemotherapy, or radiotherapy and randomly assigned to an experimental group receiving 12 weeks of ai-guided physiotherapy or a control group receiving usual care. both groups will perform jaw, neck, and shoulder exercises, with the experimental group using a mobile app to monitor progress. assessments at baseline, pre-intervention, and 3 months post-intervention will measure maximal in the maximum interincisal opening (mio), joint range of motion (rom), pain, endurance (e.g., 6-minute walk test), upper extremity function, and quality of life.

this study examines the effects of ai-based physiotherapy on oral function (e.g., mouth opening), shoulder function (e.g., shoulder joint range of motion and upper extremity function), whole-body physical function (e.g., 6-minute walk test), and health-related quality of life. 100 newly diagnosed oral cancer patients will be recruited before surgery, chemotherapy, or radiotherapy and randomly assigned to two groups. the experimental group will receive ai-based physiotherapy for 12 weeks, including postural correction exercises guided by ai technology, while the control group will receive usual care. both groups will perform jaw, neck, and shoulder exercises, with the experimental group using a mobile app to monitor progress and record their exercise diaries. assessments at baseline, pre-intervention, and 3 months post-intervention will measure the maximum interincisal opening (mio), joint range of motion (rom), pain, endurance, and upper extremity function using the disabilities of the arm, shoulder, and hand (dash) scores, and quality of life using the european organization for research and treatment of cancer core quality of life questionnaire (eortc qlq-c30).

Eligibility criteria:
inclusion criteria: * newly diagnosed oral cancer patients who are scheduled to receive cancer-related treatments (e.g., oral cancer surgery, radiotherapy, chemotherapy, or chemoradiotherapy). * age between 20 and 65 years. exclusion criteria: * could not communicate. * had any disorder that could influence movement performance.

Keywords: artificial intelligence oral cancer maximum interincisal opening physical function prehabilitation physiotherapy
braini-2 elderly mild tbi european study

Conditions: Mild Traumatic Brain Injury

Summary: mild traumatic brain injury (mtbi) is one of the most frequent emergencies in the elderly population. despite most mtbi are managed with cranial computed tomography (ct), only 10% of cts show lesions, determining ct overuse. the use of serum glial fibrillary acidic protein (gfap) and ubiquitin c-terminal hydrolase-l1 (uch-l1) have shown potential for ruling out the need for cranial ct. however evidence on biomarker use in mild tbi were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. this is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild tbi and in a reference population, including patients and participants with and without comorbidities.


Eligibility criteria:
inclusion criteria: * braini2-elderly diagnostic \& prognostic: * patients ≥65 years of age * mild tbi (gcs 13-15 on admission) with indication of brain ct scan in the 12 hours after injury ; * blood sample obtained ≤12 h after injury and ct scan preferably ≤6h from blood sample. * braini2-elderly reference: * non tbi patients ≥65 years of age exclusion criteria: * braini2-elderly diagnostic \& prognostic: * age below 65 years. * gcs 3-12 on admission * time of injury unknown * time to injury exceeding 12 hours * primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma) * penetrating head trauma * patient with mechanical ventilation from the trauma scene or prehospital management. * venipuncture not feasible * no realization of brain ct-scan * subject under judiciary control * subject in inclusion period of a drug interventional study * braini2-elderly reference: * subject in inclusion period of another drug interventional study * patients harboring a brain tumor * patients that have had a stroke or neurosurgical operation 1 month prior to the inclusion in the study.
effects of manual therapy on autonomic nervous system's balance, pain and well-being in patients with fibromyalgia.

Conditions: Fibromyalgia, Manual Therapy

Summary: scientific literature dealing with patients with fibromyalgia conveys they suffer from an abnormal response of the autonomic nervous sýstem, where a marked sympathetic hyperactivity and a decrease in heart rate variability are emphasized. it is important to know what manual therapy techniques may manage to decrease the sympathetic activity and balance the sympathetic-vagal tone, therefore improving pain and life quality. this study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the ryff scale) and pain in patients with fibromyalgia.

scientific literature dealing with patients with fibromyalgia conveys they suffer from an abnormal response of the autonomic nervous sýstem, where a marked sympathetic hyperactivity and a decrease in heart rate variability are emphasized. it is important to know what manual therapy techniques may manage to decrease the sympathetic activity and balance the sympathetic-vagal tone, therefore improving pain and life quality. this study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the ryff scale) and pain in patients with fibromyalgia. the authors expect a stronger decrease in the sympathetic nervous system activation; a greater reduction in pain, and a bigger improvement in well-being and anxiety in those patients treated with active mobilization of soft tissues than passive mobilization group.

Eligibility criteria:
inclusion criteria: * rheumatologic diagnosis of fibromyalgia, chronic fatigue labels, sleep disorders, recurrent cervical pain associated with fibromyalgia exclusion criteria: * smokers, blood pressure superior to 160/100 mm/hg, coronary artery disease, peripheral vascular disease, presence of diabetes i or ii, being pregnant, psychiatric disorder established, any trauma suffered in the last 6 months, diagnosis of osteoarthritis, consumption of caffeine, alcohol or other stimulating substance at least 24 hours before the experimental intervention, performing moderate-intense physical activity 2 hours before the experimental intervention.

Keywords: fibromyalgia, manual therapy, autonomic nervous system, pain, psychological well-being
neuroelectrical biomarkers for alzheimer's disease stages

Conditions: Alzheimer Disease

Summary: recent diagnostic criteria for alzheimer's disease (ad) recognize an extended spectrum of ad stages as part of the disease, including a preclinical stage. this underscores the importance of early prognosis of ad when it is still possible to influence the course of the disorder. the investigators propose a comprehensive project which will target the data-driven modeling of the disease development. this goal will be achieved by creating and validating a battery of new sensitive biomarkers for clinical evaluation and prediction of ad in individuals. the ad-related brain changes will be assessed by noninvasive functional eeg measured during an episodic memory task in subjects at different stages of ad, as well as in healthy controls. the novel functional biomarkers will be extracted using a rigorous multistage selection procedure involving advanced methods for feature extraction, as well as statistics and classification for optimal selection. the estimate project will serve as a first step in an extensive array of research procedures which will enable the early clinical identification of alzheimer's disease in elderly individuals who could then take advantage of preventive pharmaceutical therapies.


Eligibility criteria:
inclusion criteria: * age: 70-85 years old * presence of memory impairment * completed educational level: middle school * visual and auditory acuity: normal or corrected-to-normal exclusion criteria: * monogenic ad * presence of a neurological disorder * stroke that has occurred in the last three months * prohibited medications * residence in skilled nursing facility * illiteracy, is unable to count or to read * claustrophobia

Keywords: alzheimer's disease dementia prodromal eeg erp biomarkers
does early re-administration of aspirin/clopidogrel increase the risk of bleeding from artificial ulcer after emr or esd?

Conditions: Early Gastric Cancer; Gastric Dysplasia

Summary: aspirin and/or clopidogrel users are increasing due to increased prevalence of cardiovascular or cerebrovascular disease with an aging society in korea. also, the patients having endoscopic mucosal resection (emr) or endoscopic submucosal dissection (esd) for early gastric cancer or gastric premalignant lesions including adenoma and dysplasia are increasing among aspirin and/or clopidogrel users. practically, aspirin or clopidogrel is recommended to be stopped for 5\~14 days before emr or esd because bleeding risk during or after procedure. and it is recommended to restart of aspirin and/or clopidogrel as soon as possible if immediate bleeding during or after the procedure is not occurred in consideration of thromboembolic risk. however, early restarting of aspirin and/or clopidogrel raise the risk of delayed bleeding and the risk of complications associated with delayed ulcer healing. although it is important to determine the timing of restarting aspirin and/or clopidogrel in consideration of complications of post-emr/esd ulcer and thromboembolic risk, there is no definite guideline about the timing of restarting aspirin and/or clopidogrel. this study is aimed to determine the timing of restarting aspirin and/or clopidogrel for the patients having emr or esd among aspirin and/or clopidogrel users. the investigators planned to compare the delayed bleeding rate and ulcer healing rate in patients with post-emr/esd ulcer when take proton pump inhibitor (pantoprazole 40 mg per day) between the patients restarting aspirin and/or clopidogrel within 3\~4 days after the procedure and the patients restarting aspirin and/or clopidogrel 2 weeks after the procedure during 4 weeks. the primary endpoint is delayed ulcer bleeding rate at 4 weeks after emr/esd. the secondary end point is ulcer healing rate within 4 weeks.


Eligibility criteria:
inclusion criteria: * patients who have taken aspirin and/or clopidogrel for cardiovascular and/or cerebrovascular disease and are found to have early gastric cancer or premalignant lesions including adenoma and dysplasia by upper endoscopy. exclusion criteria: * patients with known coagulopathy or abnormal coagulation tests (prothrombin time, partial thromboplastin time and platelet count) * patients receiving other antithrombotic, anticoagulant drugs * patients needing continuation of nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 (cox-2) inhibitors, or steroid after emr/esd * patient with recent percutaneous coronary intervention (placement of drug eluting coronary artery stent within 12 months, bare metal coronary artery stents within 1 month) * patient's age \> 80 year-old or \< 18 year-old * patient with severe cardiovascular, pulmonary, hepatic, or renal disease
a study on how vedolizumab is given and the outcomes for adults with inflammatory bowel disease (variety-belgium)

Conditions: Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohns Disease

Summary: ibd consists of either ulcerative colitis or crohn's disease. the main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or crohn's disease when treated with vedolizumab. this will include how vedolizumab is given, which can either be an infusion through a vein (intravenous or iv), or an injection just under the skin (subcutaneous injection, or sc).

this is a non-interventional, prospective study of participants with moderately to severely active ibd (uc or cd) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab according to the current smpc in the real world setting. the study will enroll approximately 200 participants. the data will be collected prospectively and will be recorded into electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: • participants with ibd this multi-center study will be conducted in belgium at specialized gastroenterology centers.

Eligibility criteria:
inclusion criteria: 1. has moderately to severely active ibd (uc or cd), initiating or ongoing iv induction treatment with vedolizumab in accordance with the current smpc at baseline or ibd participants receiving ongoing/maintenance iv vedolizumab treatment, with the option to switch to sc vedolizumab maintenance treatment. exclusion criteria: 1. prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy) to vedolizumab therapy as defined in the current smpc. 2. current or planned participation in an interventional clinical trial for cd or uc. 3. cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Keywords: drug therapy
the efficacy of wvi in patients with localized basal ganglia intracranial germ cell tumors

Conditions: Intracranial Germ Cell CNS Tumor, Childhood

Summary: primary endpoint 1. three-year disease-free survival of patients with localized basal ganglia germ cell tumors receiving whole-ventricle irradiation 2. health-related quality of life measured by pedsql 4.0 and sf-36 second endpoint 1. three-year overall survival of patients with localized basal ganglia germ cell tumors receiving whole-ventricle irradiation 2. adverse effects of chemoradiotherapy measured by nci ctcae 5.0

intracranial germ cell tumors originating from the basal ganglia area are rare, accounting for less than 20% of patients. radiotherapy played a vital role in the treatment of this malignancy. however, the optimal target volume is still undetermined. our study regarding relapse patterns of different radiation volumes showed that the ventricular system and ipsilateral frontal lobe were at risk of relapse after focal radiotherapy. although craniospinal irradiation (csi) and whole-brain irradiation (wbi) could significantly reduce the relapse in the above areas, the adverse effect on the quality of life is still a concern. as a result, the investigators proposed whole-ventricular irradiation (wvi) in patients with localized basal ganglia germ cell tumors. in order to evaluate its efficacy and safety, the investigators designed this phase ii study.

Eligibility criteria:
stratum i: germinoma inclusion criteria: * 3 years ≤ age ≤ 30 years * newly diagnosed * unilateral basal ganglia/thalamus lesion * germinoma：histologically confirmed; and/or serum and/or csf beta-hcg elevation (≤50iu/l); afp negative * no radiological evidence of additional lesions in the cns * negative csf cytology test * adequate organ function * written informed consent exclusion criteria: * bilateral basal ganglia/ thalamus lesions * synchronous pineal or sellar/suprasellar lesion * diabetes insipidus * with extracranial lesion(s) * serum/csf β-hcg \>50iu/l without histology * mature teratoma with normal tumor markers * inadequate organ function * poor compliance stratum ii: non-germinomatous germ cell tumors inclusion criteria: * 3 years ≤ age ≤ 30 years * newly diagnosed * unilateral basal ganglia/thalamus lesion * nggcts: histologically confirmed; and/or serum and/or csf afp elevation; beta-hcg≥500iu/l * no radiological evidence of additional lesions in the cns * negative csf cytology test * adequate organ function * written informed consent exclusion criteria: * bilateral basal ganglia/ thalamus lesions * synchronous pineal or sellar/suprasellar lesion * diabetes insipitus * with extracranial lesion(s) * 50iu/l\<serum/csf β-hcg \<500iu/l without histology * mature teratoma with normal afp and β-hcg \<500iu/l * inadequate organ function * poor compliance

Keywords: intracranial germ cell tumors basal ganglia radiotherapy target volume quality of life
zk-epo given with carboplatin in patients with recurrent ovarian cancer

Conditions: Ovarian Neoplasms

Summary: the purpose of this study is to evaluate whether treatment with a new drug called zk-epothilone (zk-epo) given with carboplatin in patients with recurrent ovarian cancer, who previously have had a good response with cisplatin or carboplatin, is safe and helps to decrease or stop tumor growth.

this study has previously been registered by berlex, inc. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc.bayer healthcare pharmaceuticals, inc. is sponsoring this trial.

Eligibility criteria:
inclusion criteria:- must have evidence of ovarian cancer measurable by computed tomography (ct) scan or by ca125 blood levels- no radiation therapy in last 4 weeks- no chemotherapy in last 24 weeks - no immunotherapy in last 4 weeks- good response after previous treatment with carboplatin or cisplatin and then the ovarian cancer got worse again after at least 6 months- additional criteria determined at screening visit exclusion criteria:- having had more than one treatment regimen with carboplatin or cisplatin- prior treatment with other epothilones (e.g. ixabepilone)- use of any investigational drug in the last 4 weeks- previous radiation to the whole pelvis- symptomatic brain tumors requiring radiation to the brain - active infection- pregnant or breast feeding- additional criteria determined at screening visit

Keywords: ovarian cancer ovarian neoplasms, epithelium