Kornimate/medical-research-clean huggingface dataset:
cetuximab + taxotere with low dose fractionated radiation for head and neck carcinoma

Conditions: Squamous Cell Carcinoma; Head and Neck Cancer; Recurrent Disease

Summary: whether low-dose radiation in addition to taxotere and erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.

the investigator's approach is based on the following reasons: * low dose hyper-radiation sensitivity response will be significantly enhanced in taxotere- induced g2/m cell cycle arrest. * ldfrt will render enhanced bax activation mediated mode of cell death. * erbitux will arrest the cells in g1/g0 phase leading to p21-mediated mode of cell death. * the toxicity profile is expected to be minimal. based on the above mentioned reasons, we propose this novel schema of treatment in recurrent scchn.

Eligibility criteria:
inclusion criteria: 1. patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract .patients may have experienced more than one recurrence as long as the first recurrence occurred ≥ 6 months following the end of the prior rt. 2. the recurrence must have defined bi- or uni-dimensional measurements. 3. recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence). 4. the patient must not be a candidate for surgical resection. 5. patients must be at least 6 months from completion of prior chemotherapy and radiation therapy. 6. patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease. 7. eastern cooperative oncology group (ecog) performance status 0-2. 8. granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl, creatinine \< 1.5 mg/dl within 3 weeks prior to registration. 9. liver function tests (lfts) ≤ 2 x normal (serum glutamic oxaloacetic transaminase (sgot)/serum glutamic-pyruvic transaminase (sgpt)/alkaline phosphatase). if \> 2 x normal, liver ultrasound or ct is required to exclude metastases. if negative for metastases, patients are eligible. 10. patients must sign a study-specific informed consent form prior to study entry. exclusion criteria: 1. distant metastases outside of the head and neck. 2. primary disease in the nasopharynx or the salivary gland. 3. other concurrent invasive malignancies. 4. prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are permissible). 5. intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. 6. pre-existing grade ≥ 2 peripheral sensory neuropathy 7. pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns. 8. prior history of sever hypersensitivity reaction to docetaxol, cetuximab or a drug with formulated with polysorbate 80.

Keywords: scchn head and neck cancer squamous cell carcinoma recurrent
study with mitomycin c/5-fu/fa in pretreated gastrointestinal cancer patients with metastases (>= second-line treatment)

Conditions: Gastrointestinal Neoplasms; Neoplasm Metastasis

Summary: the aim of this study was to define the maximum tolerated dose (mtd) of bolus mitomycin c (mmc) in combination with 24 h-continuous infusion of 5-fluorouracil (fu) plus folinic acid, and to assess the toxicity and activity in patients with previously treated colorectal and gastric cancer. escalating doses of mmc starting from 6 mg m(-2) in 2 mg m(-2)-steps to a maximum of 10 mg m(-2) were applied on days 1 and 22, given to fixed doses of 5-fu (2.600 mg m(-2)) as 24 h infusion and folinic acid 500 mg m(-2) prior to 5-fu weekly for 6 weeks


Eligibility criteria:
inclusion criteria: phase 1 (dose escalation) * patients with histological proven gastrointestinal neoplasms, without standard therapy option * measurable or evaluable disease * \>= second-line therapy (metastasized stage) phase 2 (efficacy) * patients with proven colorectal neoplasms * measurable disease, metastasized * previous chemotherapy with 5-fu/fa ("aio-regimen") * age between 18 and 75 years, both male and female * life expectancy \> 3 months * who-performance status \<= 2 * adequate bone marrow function: hemoglobin \>= 10 mg/dl, neutrophils \>= 2.0 \* 1000000000/l, thrombocytes \>= 150 \* 1000000000/l * adequate renal and liver function: bilirubin \<= 1.25 \* uln(\<= 1.5 uln \* by liver metastases), creatinine \<= 1.25 \* uln, asat and alat \<= 3 \* uln (\<= 5\* uln by liver metastases; ap \<= 3\* uln * written informed consent prior to inclusion into the study exclusion criteria: * pretreated with mitomycin c * contraindication concerning 5-fu (e.g. anxiety, myocardial infarction within last 6 months, significant toxicities during previous therapy with 5-fu * florid infections * ileus or subileus, morbus crohn or colitis, ulcerative * actual chronic diarrhea * other uncontrolled severe concurrent disease excluding cytotoxic intervention * second malignancy except basal cell carcinoma or cervical carcinoma in situ * known cns metastases or carcinomatous leptomeningitis * pregnancy or lactation period * no effective contraception * concomitant treatment with another antineoplastic agents * participation in another clinical trial within the last 4 weeks * patients being unwilling or unable to undergo trial specific procedures
management of the idiopathic overactive bladder with botulinum toxin: systematic review

Conditions: Urinary Bladder, Overactive

Summary: overactive bladder is defined as a syndrome composed of urgency, increased urinary frequency, and sometimes urinary incontinence; its etiology may be characterized as neurogenic or non-neurogenic (i.e., idiopathic). this illness has a great impact in quality of life and one of the available treatments is the injection of botulinum toxin. this study aims to review the efficacy and safety of type-a botulinum toxin in the management of idiopathic overactive bladder. a systematic search was performed in medline, embase, central and lilacs, and the controlled randomized clinical trials were chosen to review with the consort criteria by independent reviewers. outcomes analyzed were the efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence), adverse events to treatment, change in quality of life and urodynamic measures.


Eligibility criteria:
inclusion criteria: * controlled randomized clinical trials * adult patients diagnosed with idiopathic overactive bladder * language of the study: english exclusion criteria: * diagnosis of neurogenic overactive bladder * patients under 18 years old * use of type-b botulinum toxin as the intervention * other types of studies
nilotinib roll-over protocol for patients in novartis-sponsored nilotinib study and benefiting from nilotinib treatment

Conditions: Gastrointestinal Stromal Tumors

Summary: the purpose of this study is to collect and assess long-term safety of nilotinib in patients who are on nilotinib treatment in a novartis-sponsored, oncology clinical development \& medical affairs study and are benefiting from the treatment as judged by the investigator.

this was an open label, multi-center, phase ii study to collect and assess long-term safety of nilotinib to patients treated in novartis sponsored clinical studies (nct00785785 and nct00718562) and who were benefiting from treatment with nilotinib. there was no screening period for this study. at the enrolment visit the patient was consented to the study and eligible patients started their treatment with nilotinib.

Eligibility criteria:
inclusion criteria: * patient is currently enrolled in a novartis-sponsored, clinical study receiving nilotinib and benefiting from the treatment with nilotinib, as determined by the investigator exclusion criteria: * patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.

Keywords: gastrointestinal stromal tumors gastrointestinal, stromal, tumors, gist, amn107, nilotinib
treatment of apathy in alzheimer's disease with modafinil

Conditions: Apathy; Alzheimer's Disease

Summary: this study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (adls) and caregiver burden in individuals with alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: * diagnosis of mild to moderate stage probable alzheimer's disease * on a stable dose of a cholinesterase inhibitor medication for at least 30 days * clinically elevated levels of apathy as measured by the frontal systems behavior scale exclusion criteria: * diagnosis of major depression * focal brain lesion on neuroimaging * history of significant substance abuse * history of significant head trauma with loss if consciousness \>10 minutes

Keywords: apathy alzheimer's disease activities of daily living performance caregiver burden
initial chronic human validation study: subcutaneous implantable cardioverter defibrillator (s-icd) system

Conditions: Ventricular Tachyarrhythmias

Summary: primary objective is to evaluate the safety and performance of the implanted subcutaneous implantable cardioverter defibrillator (s-icd) system. a maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted s-icd system. additionally, patient comfort will be assessed as will cosmetic outcome.


Eligibility criteria:
inclusion criteria: * replacement of an existing transvenous implantable cardioverter defibrillator (icd) system * american college of cardiology/american heart association/heart rhythm society (acc/aha/hrs) class i or ii indications for icd implantation * age \>= 18 years * appropriate pre-operative electrocardiogram (ecg) as measured with a specially developed template exclusion criteria: * subjects unable or unwilling to provide informed consent * any condition which precludes the subject's ability to comply with the study requirements * females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study * participation in another investigational device trial at any time during the conduct of the s-icd system trial without written consent from the sponsor. * patients with a serious medical condition and life expectancy of less than one year. * patients with documented spontaneous and frequently recurring ventricular tachyarrhythmias (vt) that is reliably terminated with anti-tachycardia pacing * patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant * patients with chronic renal failure, i.e. with a creatinine level of \>2.5 mg/dl unless prescribed drug therapy known to increase creatinine levels in which case the value should be \<= 3mg/dl
multicenter observational study of psc and igg4-sc in china

Conditions: Primary Sclerosing Cholangitis; IgG4-related Sclerosing Cholangitis

Summary: the investigators aimed to collect demographic features and clinical outcomes in patients diagnosed with psc and igg4-sc by utilizing participants database from multiple medical centers across mainland china. cross-sectional studies will focus on characterizing clinical presentations and validating diagnostic and prognostic models on chinese psc and igg4-sc patients.


Eligibility criteria:
inclusion criteria: * age above 18 years old, * male or female, * patients admitted in our medical centers which met the psc criteria according to the european association for the study of the liver clinical practice guidelines "management of cholestatic liver diseases" in 2009; or patients diagnosed with igg4-sc which met initially using the japan pancreas society criteria and confirmed using hisort criteria. exclusion criteria: * female subjects who is pregnant, breastfeeding or is considering being pregnant during the study; * history of other malignancies, including hematological tumors, solid tumors except hepatobiliary system; * history of infectious diseases, including hepatis a, b, c, e and tuberculosis.
clinical study of anti-cd147 humanized meplazumab for injection to treat with 2019-ncov pneumonia

Conditions: Coronavirus Disease 2019 (COVID-19)

Summary: to evaluate the safety and efficacy of humanized meplazumab for injection in patients infected by 2019-ncoa.

according to the results of nonclinical study of humanized meplazumab for injection, a single dose will be used for the treatment. the treatment plan is first dose on the first day (0d) and second dose on the second day (1d) of the treatment period by intravenous(iv) infusion, each dose 10mg; the third dose will be given within 3-5 days after the second dose according to the patient's 2019-ncov nucleic acid load, clinical manifestations and the overall evaluation of doctors, dose is 10mg. 30 mg of methylprednisolone will be given intravenously 30 minutes before each administration. each subject will be evaluated the therapeutic effect within 28 days after the first administration, and to determine the preliminary therapeutic effect, safety and tolerability of humanized meplazumab for injection.

Eligibility criteria:
inclusion criteria: * men and women aged 18 to 75 years (inclusive) * in line with the new coronavirus infection pneumonia diagnosis and treatment plan (trial version 4) issued by the health commission, patients with new coronavirus (2019 ncov) pneumonia were clinically diagnosed; * the subjects must be able to understand the study and willing to participate in the study, and sign the informed consent (if the subjects with no behavioral ability think it is in their own interests to participate in the test, they should sign the informed consent by their legal guardian, or notify the consent by phone (recording) and explain it in the original medical record and other relevant documents). exclusion criteria: * known or expected to have allergic reactions or a history of allergy to any of the ingredients treated in this trial; * in the judgment of the investigator, there are other reasons that the patient is not suitable to participate in this study.

Keywords: covid-19, pneumonia
healthy approach to weight management and food in eating disorders (hapifed)

Conditions: Binge Eating Disorder; Bulimia Nervosa; Eating Disorder

Summary: the investigators have developed a new integrated therapy, namely a healthy approach to weight management and food in eating disorders (hapifed). hapifed is an enhanced behavioral weight loss therapy integrated with cbt for the management of eds. hapifed uses cbt to treat ed behaviors and body image distress, whilst simultaneously emphasize a healthy lifestyle, the role of food and physical activity in mood regulation, and revised but clinically meaningful goals for weight loss. the investigators propose a randomized controlled trial (rct) that will compare hapifed to cbt-e in people with obesity and either bn or bed. the two main aims will be to reduce symptoms of ed and to improve weight management. the rct will be conducted in sydney and in são paulo with a one year follow-up.

in sum, a new approach in management of the increasing numbers of obese people with bn and bed is needed. the investigators propose a rct that will compare a novel therapy hapifed with the current 'gold-standard' trans diagnostic treatment, cbt-e. hapifed has been developed by the cis and is based on recent developments in psychological approaches to obesity in general (as highlighted in casazza et al.'s (2013) paper on "myths, presumptions and facts about obesity") and in people with co-morbid obesity and bn or bed. unlike cbt-e, it allows reduced energy intake and education around specific food choices - a necessary element in weight loss.

Eligibility criteria:
inclusion criteria: * diagnosis of threshold or subthreshold for bulimia nervosa or binge eating disorder (dsm-5/icd-11) * bmi between ≥ 27 and \< 40 exclusion criteria: * diagnosis of psychosis, bipolar disorder or substance abuse dependence and/or a high level of suicide risk. * use of weight loss medication or medications that interfere with appetite. * cushing or prader-willi syndromes * history of bariatric surgery * patients who are already in treatment

Keywords: bed binge eating disorer bn bulimia nervosa obesity
dental extractions in patients under dual antiplatelet therapy

Conditions: Blood Coagulation Disorders

Summary: the purpose of this study is to compare two hemostatic agents in patients under dual antiplatelet therapy using the intraoral bleeding time after dental extractions.

postoperative hemostasis is a fundamental patient management issue in the oral and maxillofacial surgery setting. the risk of excessive bleeding prompts physicians to stop multiple antiplatelet agents before minor surgery, which puts coronary stenting patients at risk for adverse thrombotic events. adequate hemostasis must be achieved in order to make oral surgeries possible for these patients without discontinuation of the antiplatelet regimen. the hemcon dental dressing (hemcon medical technologies, inc, beaverton, or) is a novel chitosan-based hemostatic agent which may greatly improve upon the efficacy of wound healing and hemostasis both in extent and time for minor oral surgeries. dental extractions will be performed in patients under dual antiplatelet therapy without altering their medication regimen. all patients will require to have two or more surgical sites so they will have internal surgical control sites. cutaneous bleeding time and platelet aggregation tests will be obtained prior to extractions. the primary hemostasis will be evaluated by measuring the intraoral bleeding time after each extraction and further bleeding and healing outcomes will be ascertain by phone questionaires and clinical evaluations. the aim of this study is to evaluate the effectiveness of hemcon dental dressing in controlling post extraction bleeding and to ascertain its role in healing of extraction wounds compared to a standard haemostasis method.

Eligibility criteria:
inclusion criteria: * patients requiring two or more dental extraction procedures. * patients must be under dual antiplatelet therapy of any kind. * patients must be 18 years of age or older. * patients must be available for a minimum of one post operative evaluation to be scheduled at the time of the procedure approximately 7 days post surgery. * extraction sites do not require primary closure of suturing. * willingness and ability to provide informed consent exclusion criteria: * patients who are currently undertaking other anticoagulant medications (e.g., aspirin, coumadin, heparin) or have discontinued their anticoagulant medications. * history of heart attack in less than 1 week. * patients with seafood allergy. * unable of unwilling to provide informed consent.

Keywords: tooth extraction surgical hemostasis platelet aggregation inhibitors chitosan
fatigue and interleukin-1 (il-1) blockade in primary sjøgrens syndrome

Conditions: Fatigue; Primary Sjogren

Summary: fatigue is a prevalent phenomenon in primary sjøgrens syndrome (pss). observations indicate that the cytokine il-1 is of importance for this phenomenon. in this study the investigators block il-1 by giving anakinra (an il-1 receptor antagonist) to patients with pss.

a double-blind, placebo-controlled, parallel study of the effect on fatigue of daily injections of anakinra for one month.

Eligibility criteria:
inclusion criteria: * primary sjøgrens syndrome according to the european-american criteria * age 18-80 years * written informed consent exclusion criteria: * hyper- og hypothyreosis * malignant disease * parkinsons disease * multiple sclerosis * conditions or diseases where anakinra is contraindicated * mental depression (bdi \>13) * neutropenia (\<1.5\*10.9) * frequent infections * pregnancy, lactating women.
the effect of air polishing on the tooth surface

Conditions: Dental Plaque

Summary: the use of air-polishing device that operates by directing a fine slurry of pressurized air, water, and abrasive particles has become widespread in dentistry for polishing. the introduction of abrasive powders with different properties creates the need to evaluate the effects of these powders on dental hard tissues. this study was focused on the effect of sodium bicarbonate, glycine and erythritol air polishing on enamel and exposed root surface.

the aim of this study is to evaluate the effect of sodium bicarbonate, glycine and erythritol air polishing on enamel and exposed root surface. forty eight single root extracted teeth were included into the study. the teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. samples were scanned in a micro-computed tomography (micro-ct) at baseline and then after powder treatment and the defect depth, defect volume, demineralization depth and mineral density values were estimated.

Eligibility criteria:
inclusion criteria: * being older than age of 18, * willing to participate the study, * to have a single rooted tooth with gingival recession on all surfaces and need to be extracted, * the tooth has to be free of caries, defects and restorations. exclusion criteria: have history of infectious diseases like hepatitis and/or hiv (+).

Keywords: glycine erythritol sodium bicarbonate x-ray microtomography gingival recession air abrasion
ghrelin, growth hormone and cortisol interaction in growth hormone deficient patients

Conditions: Hypopituitarism

Summary: in growth hormone deficient patients: determination of endogenous circulating ghrelin levels, ghrelin effects on insulin sensitivity, appetite, energy metabolism, and signal transduction in fat and muscle.


Eligibility criteria:
inclusion criteria: * age between 18 and 60 yrs. * verified hypopituitarism * unchanged substitution treatment through 3+ months * unchanged additional medical treatment * oral and written informed consent exclusion criteria: * age below 18 or above 60 yrs. * diabetes mellitus * body mass index \> 30 * fasting hypoglycemia * convulsions * allergy to trial products