Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of low dose ticagrelor in patients with unstable angina pectoris after coronary stent implantation

Conditions: Unstable Angina Pectoris; Coronary Stent Implantation

Summary: the study is to evaluate efficacy and safety of low dose of ticagrelor therapy for chinese unstable angina patients treated with non-urgent coronary stent implantation, to examine whether lower dose ticagrelor (45 mg twice-daily) is not inferior to standard dose (90 mg twice-daily) for the prevention of major adverse cardiovascular and cerebrovascular events, as well as will reduce the incidence of bleeding during long-term treatment.

this is a prospective, single center, randomized, parallel-group trial designed to evaluate the efficacy and safety of low dose ticagrelor on a background of aspirin for patients treated with non-urgent coronary stent implantation. 2036 subjects will be enrolled. all patients will receive treatment with aspirin and a p2y12 inhibitor for 3 months after the index procedure. at 3 months, eligible patients were then randomly assigned in a 1:1 ratio to receive a standard dose ticagrelor 90 mg bid or a lower dose ticagrelor 45 mg bid in addition to aspirin 100mg. the primary efficacy end points are the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke at 24 months. the primary safety end point is the incidence of plato major bleeding at 24 months.

Eligibility criteria:
inclusion criteria: * patients admission for coronary artery disease treatment with non-emergency percutaneous intervention with stent deployment * 18 years≤age≤80 years * patients understands the study requirements and the treatment procedures and provided informed consent before the procedure exclusion criteria: * allergy or intolerance to ticagrelor or aspirin * need for oral anticoagulation therapy * concomitant oral or intravenous therapy with strong inhibitors of cytochrome p450, family 3, subfamily a (cyp3a), substrates of cyp3a with narrow therapeutic indices or strong inducers of cyp3a * active bleeding, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days * high risk of bradyarrhythmias * severe liver dysfunction and abnormal renal function * patient is a woman who is pregnant or nursing * unable or unwilling to give written informed consent

Keywords: unstable angina stent ticagrelor platelet aggregation percutaneous coronary intervention coronary artery disease major adverse cardiovascular and cerebrovascular events bleeding events
a controlled clinical study to determine the gingivitis benefit of flossing

Conditions: Gingivitis

Summary: this is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing gingivitis.


Eligibility criteria:
inclusion criteria: in order to be included in the study, each subject must: * be at least 18 years of age; * be physically able to floss their teeth; * have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included); * have refrained from performing oral hygiene the morning of the baseline visit; * be in good general health; * have interproximal mgi (modified gingival index) score of \>2.8. exclusion criteria: subjects are excluded from study participation where there is evidence of: * severe periodontal disease; * discoloration or pigmentation in the gingival tissue; * meaningful misalignment of front teeth; * fixed facial orthodontic appliances; * use of antibiotics within two weeks of the baseline visit and at any time during the study; * any diseases or conditions that could be expected to interfere with the subject safely completing the study.
a first time in human study to assess the compound gsk615915

Conditions: Bronchospasm

Summary: gsk615915a is being developed as a novel surfactant for use in the formulation of gsk's future generation of metered dose inhalers (mdis). a surfactant in a mdi would provide a more stable drug suspension, this in turn will produce a consistent dose of drug being delivered with each puff.


Eligibility criteria:
inclusion criteria: * women of non-child bearing potential. * body weight = 50 kg (110 lbs) for men and = 45 kg for women and body mass index (bmi) within the range 19.0-30.0 kg/m² * the subject is a current non-smoker who has not used any tobacco products in the last 12 months with a pack history of = 10 pack years. * the subject has demonstrated the ability to correctly use a metered dose inhaler device. * if asthmatic: the subject must be clinically stable the subject has a baseline fev1 = 80% of predicted. exclusion criteria: * as a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study. * the subject has a history of allergy to excipients, mdi propellants, or a history of drug or other allergy that, in the opinion of the physician responsible makes the volunteer unfit to participate. * the subject has recently participated in another clinical trial. * the subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including st johnâ€™s wort) within 7 or 14 days. * the subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female, or an average daily intake of greater than 3 units regularly, where 1 unit is equivalent to a half-pint (220ml) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine. * any history of breathing problems (e.g. history of asthmatic symptoms). * the subject is infected with the hepatitis b, hepatitis c, or hiv virus. * the subject is has a positive drugs of abuse test. * the subject has had a respiratory tract infection within 4 weeks of the start of the study. * the subject has a past or present disease, which as judged by the doctor, may affect the outcome of this study. * the subject has a history of life-threatening asthma. * the subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study. * the subject has taken long acting inhaled beta 2 agonists within 96 hours before the screening visit. * the subject has taken short acting inhaled beta 2 agonists within 8 hours before the screening visit. * the subject is unable to abstain from other drugs that may interfere with the conduct of the study or its interpretation. * the subject has ongoing rhinitis that requires treatment.

Keywords: gsk615915 asthma surfactant mdi
study on the development of arthroscopic treatment of refractory tennis elbow

Conditions: Tennis Elbow

Summary: the aim of this study was to investigate the exploration history, key theories, methods, and techniques involved in the evolution from the intracapsular method to the extracapsular method for arthroscopic treatment of tennis elbow, and explore the effectiveness and safety of extracapsular method on the basis of retrospective analysis of 43 cases.

background: arthroscopic surgery is widely used in the treatment of refractory tennis elbow due to its advantages of minimally invasive, safe and direct vision. intra-capsular arthroscopy(intracapsular method), which is performed via natural cavity, is the mainstream arthroscopic procedure. however, intracapsular method requires the damage of joint capsule and may cause intraoperative neurovascular injury and other complications. in view of the defects of intracapsular method, the surgical scheme of the extracapsular arthroscopy (referred to as "extracapsular method") has emerged. the aim of this study was to investigate the exploration history, key theories, methods, and techniques involved in the evolution from the intracapsular method to the extracapsular method for arthroscopic treatment of tennis elbow, and explore the effectiveness and safety of extracapsular method. methods: qualitative data were collected via focus group interview. 7 surgeons who were selected through purposive sampling discussed on the theories, methods, and technical specifications of the transition from intracapsular method to extracapsular method. qualitative data were analysed using nvivo11. quantitative data of consecutive 43 patients were analysed to evaluate the effectiveness and safety of the extracapsular method. descriptive analysis was conducted to analyse the demographic characteristics and clinical outcomes after surgery.

Eligibility criteria:
inclusion criteria: 1. diagnosis was refractory tennis elbow; 2. standard extracapsular method was used for surgery. exclusion criteria: 1. patient had past history of joint infection, joint tuberculosis, or osteomyelitis, or the upper limb had undergone surgery within the past 6 months; 2. diagnosis was combined with severe heart, brain, kidney, or another organ dysfunction; 3. case was complicated with other serious elbow joint diseases or injuries; 4. patient did not sign the informed consent form.

Keywords: qualitative quantitative tennis elbow arthroscopy surgical techniques
rtms on diabetic peripheral neuropathic pain

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: background: approximately half of the patients with long-standing diabetes are known to have diabetic peripheral neuropathy (dpn). pain from dpn deteriorates the quality of life and hinders daily life activities. objectives: this study aimed to evaluate the effect of high-frequency (10 hz) repetitive transcranial magnetic stimulation (rtms) on the left primary motor cortex (m1) for neuropathic pain in the lower extremities due to dpn. methods: in this randomized trial, 22 patients with dpn will randomly assign to the rtms group (10 hz stimulation, five sessions) or the sham group. a numeric rating scale (nrs) will use to measure pain intensity before treatment and after 1 day and 1 week of the treatment. physical and mental health status will evaluate using the short form 36-item health survey (sf-36), comprising two subscales (physical and mental component scores \[pcss and mcss\]), at 1-week post-treatment.


Eligibility criteria:
inclusion criteria: * diabetes * neuropathic pain (stocking glove distribution) of a numeric rating scale (nrs) score of ≥3 (where 0 indicates no pain and 10 indicates the most intense pain imaginable) in the lower extremities * pain duration of ≥3 months * age between 21 and 80 years exclusion criteria: * presence of contraindications for tms, such as a history of epileptic seizure, presence of metal in the skull, and presence of a cardiac pacemaker.

Keywords: diabetic peripheral neuropathy diabetes repetitive transcranial magnetic stimulation pain quality of life
hemicraniectomy in patients with malign middle cerebral artery infarction

Conditions: Cerebral Herniation

Summary: this trial is a prospective, randomized, controlled, clinical trial based on a stroke center. we randomly assigned 151 patients 41 years of age or older (median, 65 years; range, 41 to 83) with malignant middle cerebral artery infarction to either conservative medical treatment or hemicraniectomy; assignments were made within 12 to 38 hours after the onset of symptoms. the primary end point was survival with slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified rankin scale, which ranges from 0 \[no symptoms\] to 6 \[death\]). secondary outcome included death, barthel index, national institute of health stroke scale, and stroke impact scale 2.0 (sis) 6 months and 1 year after randomization. variables for subgroup analyses were age, sex, presence of aphasia or neglect, stroke severity and time to randomization. the study was performed according to consolidated standards of reporting trials (consort).

patients between 40 to 80 years of age were included within 12 to 38 hours of a malignant middle cerebral artery infarction defined by the association of 3 criteria: a national institutes of health stroke scale score ≥16, including a score ≥1 for item 1a (level of consciousness); brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory; and a diffusion-weighted imaging (dwi) infarct volume \>150cm3. the first patient was enrolled in january 2003 and the last patient in december 2007. an independent data safety monitoring committee monitored the safety, progress, and ethics of the trial. patients were randomized to either surgical plus medical treatment or to conservative medical treatment alone.

Eligibility criteria:
inclusion criteria: * a national institutes of health stroke scale score ≥16 * a score ≥1 for item 1a (level of consciousness) * brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory * diffusion-weighted imaging infarct volume \>150cm3 exclusion criteria: * prestroke modified rankin score score ≥2 * prestroke score on the barthel index \<95 * score on the glasgow coma scale \<6 * both pupils fixed and dilated * any other coincidental brain lesion that might affect outcome * plasminogen activator in the 12 h before randomisation * space-occupying hemorrhagic transformation of the infarct * pregnancy * life expectancy \<3 years * other serious illness that might affect outcome * known coagulopathy or systemic bleeding disorder * contraindication for anesthesia

Keywords: infarction, hemicraniectomy
a minimally invasive surgery for axillary osmidrosis: combined liposuction with subcutaneous pruning

Conditions: Sweat Gland Diseases

Summary: patients with axillary osmidrosis are treated with minimally invasive procedure combined tumescent liposuction with subcutaneous pruning. effectiveness of this modified method in reducing odor is to be determined.

patients with excessive malodor are recruited. they are surgically treated with minimally invasive procedure combined tumescent liposuction with subcutaneous pruning and followed up for 6-24 months to evaluate effectiveness sand side effect.

Eligibility criteria:
inclusion criteria: * 18 years or older * unpleasant odor from the axillae * willing and able to appear for all scheduled, post-operative visits exclusion criteria: * under the age of 18 * have undergone a prior surgical intervention * inappropriate candidates for surgery due to medical or mental health reasons * elect not to participate in the study

Keywords: axillary osmidrosis liposuction minimally invasive surgery
modified atkins diet versus topiramate in children with epileptic spasms refractory to hormonal treatment: a randomized open-label study

Conditions: Epileptic Spasms, Failed Hormonal Therapy

Summary: this study has been planned to compare the efficacy and tolerability of topiramate, a commonly used second line agent, with modified atkins diet in children with epileptic spasms refractory to hormonal treatment, in a randomized open label study.

infantile epileptic spasms syndrome, formerly known as west syndrome is a severe and difficult to treat epilepsy syndrome in infants and young children. the first-line options of this condition include hormonal therapy, i.e., adrenocorticotropic hormone (acth) or oral corticosteroids, and/or vigabatrin. these are effective in 45%-55% of the patients. these are however associated with significant side effects, and high relapse rates. newer drugs such as topiramate, zonisamide, and levetiracetam have also been evaluated; but there have been no randomized trials to evaluate the efficacy of these agents. topiramate is one of the most commonly used second line agents used for the treatment of epileptic spasms. the ketogenic diet (kd), a high-fat, low-carbohydrate, adequate-protein diet is an established, effective non-pharmacologic treatment for children with intractable epilepsy. despite being highly efficacious, ketogenic diet has practical constraints in implementation leading to need for alternative approaches. the modified atkins diet is a less restrictive variation of the ketogenic diet. this diet is more palatable and acceptable in comparison to ketogenic diet. the modified atkins diet has shown to be effective in children with epileptic spasms refractory to first line treatment in a recent randomized controlled trial, comparing add-on diet versus continuing the on-going anti-seizure medications alone. at the end of 4 weeks, 11 children in the diet group were spasm free compared with none in the control group (p ≤ .001). this study has been planned to compare the efficacy and tolerability of topiramate, a commonly used second line agent, with modified atkins diet in children with epileptic spasms refractory to hormonal treatment, in a randomized open label study. the results will guide clinicians as to the best options in children with epileptic spasms refractory to hormonal treatment.

Eligibility criteria:
inclusion criteria: 1) age: 9 months to 3 years 2) diagnosis of infantile epileptic spasms syndrome as per the ilae 2022 diagnostic criteria 3) failure of hormonal therapy, i.e. oral prednisolone or acth - exclusion criteria: 1) known or suspected inborn error of metabolism 2) prior use of the ketogenic or modified atkins diet or topiramate 3) systemic illness- chronic hepatic, renal or pulmonary disease 4) diagnosed renal stones -
efficacy and safety of oral amn107 in adults with chronic myelogenous leukemia resistant and/or intolerant to imatinib mesylate therapy

Conditions: Leukemia, Myeloid, Chronic

Summary: this open-label, multicenter trial will evaluate the efficacy and safety of treatment with amn107 in chronic myelogenous leukemia (cml) patients that are resistant and/or intolerant to imatinib mesylate therapy.


Eligibility criteria:
inclusion criteria: * imatinib - resistant or - intolerant philadelphia chromosome-positive cml in blast crisis, accelerated or chronic phase * males or females ≥ 18 years of age exclusion criteria: * impaired cardiac function * acute or chronic liver or renal disease * use of therapeutic coumadin * central nervous system (cns) infiltration additional protocol-defined inclusion/exclusion criteria may apply.

Keywords: amn107 cml bcr abl cytogenetic response chronic myelogenous leukemia (cml) imatinib mesylate
study of ryz101 in combination with soc in subjects with sstr+ es-sclc

Conditions: SCLC,Extensive Stage

Summary: this study aims to determine the safety, preliminary antitumor activity, and pharmacokinetics (pk) of ryz101 in combination with standard of care (soc) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (sstr+) es-sclc.


Eligibility criteria:
inclusion criteria * age of at least 18 years at the time of signing the informed consent. * cytologically or histologically confirmed es-sclc (american joint committee on cancer \[ajcc\] 8th edition) and is untreated or received ≤1 cycle of platinum-etoposide and pd-l1 inhibitor therapy. it is acceptable to omit the first dose of pd-l1 inhibitor therapy due to logistical reasons if receiving soc during or prior to the start of the screening period. * subject is a candidate for therapy with soc which includes: * carboplatin for a maximum of 4 cycles * etoposide for a maximum of 4 cycles * atezolizumab * at least 1sstr-pet imaging-positive measurable site of disease (according to recist v1.1) and ≥50% of recist v1.1 measurable metastatic lesions must be sstr-imaging positive. * adequate hematologic, renal and hepatic function exclusion criteria * prior exposure to immune-mediated therapy, * known active or suspected autoimmune disease or any condition requiring systemic treatment with immunosuppressive medications within 14 days prior to first dose of study drug * history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. note: history of radiation pneumonitis is permitted. * severe infection within 4 weeks and/or treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to initiation of study treatment. * prior allogeneic stem cell or solid organ transplantation. * treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab. * radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy. radiation therapy outside of the chest for palliative care is allowed but must be completed \>2 weeks prior to first dose of study drug. * significant cardiovascular disease and/or resistant hypertension * subjects with previously treated central nervous system (cns) metastases who have not recovered from acute side effects of radiotherapy.

Keywords: actinium alpha-emitter sstr+ es-sclc sclc es-sclc ryz101 225ac 225ac-dotatate targeted radiotherapy atezolizumab carboplatin etoposide radiopharmaceutical
identification of celiac ganglia

Conditions: Celiac Ganglia

Summary: computer-aided image recognition will improve the technique of endoscopic ultrasound-celiac plexus block/celiac plexus neurolysis (eus-cpb/cpn) and improved pain relief.

all subjects who are undergoing eus will be eligible. consecutive patients undergoing eus will be invited to participate in this study. subjects must be 18 years old or above at the time of the procedure.

Eligibility criteria:
inclusion criteria: * all eus patients exclusion criteria: * under 18 yrs

Keywords: celiac ganglia
the effects of n-3 lcpufas in patients with colorectal cancer

Conditions: Cancer Cachexia; Side Effects; Quality of Life

Summary: the aim of this study is to determine the effects of n-3 pufas on weight, physical funktion and quality of life in patients with colorectal cancer.

primary outcomes: * weight * physical function * hand-grip strength secondary outcomes: * quality of life * mid-upperarm circumference * incorporation of n-3 pufas into cell membranes

Eligibility criteria:
inclusion criteria: * ≥18 years * patients with diagnosed colorectal cancer with metastases treated with chemotherapy on rigshospitalet, copenhagen exclusion criteria: * \< 18 years * patients in palliative care * patients with haemophilia * patiens in treatment of anti-coagulation * patients with genetic hyperkolesterolemia * pre-dialytic patients (gfr\<15ml/min/1,73m2 eller kreatinin ≥500 mmol/l)

Keywords: cancer nutrition fish oil