Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of biib100 administered orally to adults with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the primary objective of this study is to evaluate the safety, tolerability of single-ascending doses of biib100 in adults with amyotrophic lateral sclerosis (als). the secondary objective of the study is to characterize the pharmacokinetic profile of biib100.


Eligibility criteria:
key inclusion criteria: * must meet the laboratory-supported probable, probable, or definite criteria for diagnosing als according to the world federation of neurology el escorial criteria. * participants taking concomitant riluzole at study entry must be on a stable dose for greater than or equals to (\>=) 30 days prior to the first dose of study treatment (day 1). participants taking concomitant riluzole must be willing to continue with the same dose regimen throughout the study, unless the investigator determines that riluzole should be discontinued for medical reasons, in which case it may not be restarted during the study. * participants taking concomitant edaravone at study entry must be on a stable dose for \>= 60 days prior to the first dose of study treatment (day 1). * adequate respiratory function as indicated by slow vital capacity (svc) \>= 65% of predicted value as adjusted for sex, age, and height (from the sitting position). key exclusion criteria: * ongoing medical condition (e.g., wasting or cachexia, severe anemia) that would, in the opinion of the investigator, interfere with the conduct or assessments of the study. * significant cognitive impairment or unstable psychiatric illness, including psychosis, suicidal ideation, suicide attempt, or untreated major depression less than or equals to (\<=) 90 days of screening, which in the opinion of the investigator would interfere with the study procedures. * treatment with drugs that are transported by breast cancer resistance protein (bcrp) and p-glycoprotein (p-gp) including, but not limited to, rosuvastatin, sulfasalazine, dabigatran, digoxin and fexofenadine. * current enrollment or plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 30 days or 5 half-lives of the agent, whichever is longer, prior to the baseline visit (pre-dose on day 1). participation in a noninterventional study focused on als natural history may be allowed at the discretion of the investigator and after consultation with the sponsor. note: other protocol defined inclusion/exclusion criteria may apply.
a trial comparing the efficacy and safety of gzr4 injection versus insulin degludec in subjects with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this study compares the efficacy, safety, and tolerability of once-weekly gzr4 injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antidiabetic drug (oad) therapy or oad therapy in combination with basal insulin.


Eligibility criteria:
inclusion criteria: 1. aged 18-75 years (both inclusive) at the time of signing informed consent form (icf) 2. body mass index between 18.5 and 35.0 kg/m2 (both inclusive) 3. diagnosed with type 2 diabetes mellitus above or equal to 6 months 4. 7.5% ≤ hba1c ≤ 10.0% at screening. exclusion criteria: 1. female who is pregnant, breast-feeding. 2. presence or history of malignant neoplasm prior to screening. 3. diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolar syndrome within 6 months prior to screening. 4. known or suspected hypersensitivity to investigational medical product(s) or related products. 5. severe hypoglycemia (level 3 hypoglycemia) within 6 months prior to screening 6. history of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening. 7. participation in a clinical study of another study drug within 3 month prior to randomization.
elvr in ph patients with severe emphysema

Conditions: COPD; Pulmonary Emphysema

Summary: the purpose of this study is to investigate the effect of endoscopic valve implantation in patients with copd and ph on hemodynamics, symptoms, exercise tolerance and quality of life in 10 patients in a prospective study. an improvement of objective parameters may also have a prognostic significance

so far there is no treatment of copd in addition to the established treatment of concomitant ph. administration of ph-specific medication outside of clinical trials is not recommended in new guidelines for ph of the ers/esc. the influence of endobronchial valve implantation on the ph has not been studied in detail. the purpose of this study is to investigate the effect of endoscopic valve implantation in patients with copd and ph on hemodynamics, symptoms, exercise tolerance and quality of life in 10 patients in a prospective study. an improvement of objective parameters may also have a prognostic significance

Eligibility criteria:
inclusion criteria: * signed patient consent form * men and women \>30 years * clinically indicated endoscopic lung volume reduction * pulmonary hypertension according to group 3.1 of the dana point classification * severe pulmonary emphysema * fev1 \<45% * rv\> 150% * tlc\> 100% * maximum of medical therapy according to gold * heterogeneous emphysema * detected in the hr-ct * confirmation of the heterogeneity of emphysema by computer-assisted quantification (yacta ®) * stable copd * no exacerbation in the last 8 weeks * cortisone dose \<20 mg prednisolone equivalent * non-or ex-smoker * nicotine abstinence\> 4 months * actual cohb \<2.5% * diagnosis of pulmonary hypertension (ph), invasively diagnosed by right heart catheterization: * mean pulmonary arterial pressure (mpap)\> 25 mmhg * pulmonary capillary wedge pressure (pcwp) \<15 mmhg * pulmonary vascular resistance (pvr)\> 320 dyne \* sec \* cm-5 exclusion criteria: * ph of group 1, 2, 4, 5 of the dana point classification * previous operations * s/p lung resection (lobectomy / pneumonectomy) * s/p endoscopic lung volume resection * significant bronchiectasis * sputum volume\> 4 tablespoons / day * severe cardiac comorbidities: * s/p myocardial infarction in the last 6 weeks * congestive heart failure * cardiomyopathy with highly impaired lvf * clopidogrel in long-term medication * respiratory insufficiency: paco2 mmhg at rest\> 55 * current pregnancy
the cascade hf soft launch and calibration phase i and ii

Conditions: Heart Failure

Summary: invasive telemonitoring has shown promising results in reducing readmissions and health service utilization, and improving patient outcomes; however, such evidence is lacking for non-invasive telemonitoring. our proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, specialists, and surgeons, and has the potential to transform care management in the post-discharge period, where patients are the most vulnerable for readmission.


Eligibility criteria:
inclusion criteria: * patient is an inpatient at northshore university healthsystem * patient is on the heart failure consult list * patient has a history of heart failure * patient received at least one dose of iv diuretics at index hospitalization * patient is discharging with northshore home health services * symptoms corresponding to new york heart association function class ii-iv * patient has heart failure with reduced left ventricular ejection fraction (lvef)\<40%, or hf with mid-ranged ejection fraction (lvef 40-50%), or hf with preserved ejection fraction (lvef≥50%) * patient is in the top 50% risk of readmission across northshore university healthsystem's cape 30-day readmission model * patient is at least 18 years of age * patient is fluent in english * patient agrees to protocol-required procedures exclusion criteria: * patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to maintain patch, phone * patient has allergy to hydrocolloid adhesives * patient has present skin damage preventing them from wearing a study device * patient has renal dysfunction requiring dialysis * pregnancy
comparison of pre-exercise beta-hydroxy-beta-methylbutyrate free acid (hmb-fa) and cold water therapy for the attenuation of muscle damage and soreness

Conditions: Muscle Damage

Summary: study objectives 1. compare beta-hydroxy-beta-methylbutyrate free acid (hmb-fa) to cold water immersion on performance recovery from an acute bout of high intensity resistance exercise. 2. compare hmb-fa + cold water immersion to hmb-fa or cold water immersion. 3. examine the effect of these recovery modalities on markers of muscle damage, inflammation and immune function. subjects subjects (men and women, 18 - 35 y) with at least one year of resistance training experience will be recruited. subjects will be randomly divided into one of four groups: a cold water immersion group (cw), hmb-fa, cw+hmb-fa and a control group (ct). study protocol subjects will report to the human performance laboratory (hpl) on four separate occasions. on the first visit (t1) subjects will be tested for maximal strength \[one repetition-maximum (1-rm)\] on the squat, dead lift and barbell lunge exercises.\] on their second visit (t2) subjects will perform a lower body resistance exercise session consisting of four sets of the squat, dead lift and barbell lunge exercises. all subjects will then report back to the hpl at 24- (t3) and 48-hours (t4) post-exercise. during t3 and t4, subjects will perform four sets of the squat exercise only using the same loading pattern and rest interval length as t2. following the t2 and t3 workouts subjects in ct will undergo no treatment; subjects in cw will be required to sit in a whirlpool tub for 10-min up to their umbilicus in water at 50° f - 54° f (10° c - 12° c); subjects in hmb-fa will be provided the supplement 30 min prior each workout and cw+hmb-fa will be administered together at time points describe above. statistical analysis statistical evaluation of performance and biochemical changes will be accomplished using a repeated measures analysis of variance (anova).


Eligibility criteria:
inclusion criteria: * at least one-year of resistance training experience * free of any physical limitations (determined by health and activity questionnaire). * between the ages of 18 and 35 exclusion criteria: * inability to perform physical exercise (determined by health and activity questionnaire) * taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire). * any chronic illness that causes continuous medical care * taking any type of prescription or over-the-counter medication, having any chronic illness causing you to seek medical care, pregnancy
nicotine lozenges for treatment of smokeless tobacco addiction

Conditions: Smokeless Tobacco Use

Summary: this study will be a randomized, blinded, placebo-controlled two-group clinical trial. the independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and st abstinence at 3 and 6 months. st users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

smokeless tobacco (st) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. both groups will receive a behavioral intervention. the two sites for this clinical trial will be the mayo clinic in rochester, minnesota (central coordinating site) and the oregon research institute (ori) in eugene, or. a total of 270 st users will be recruited into this clinical trail. all subjects will be randomized to 4 mg nicotine lozenges (taken ad lib) or matching placebo. they will be on study medication for 12 weeks and followed up for 6 months from study enrollment

Eligibility criteria:
inclusion criteria: * are at least 18 years of age; * report smokeless tobacco (st) as their primary tobacco of use; * have used st daily for the past 6 months; * are in general good health (determined by medical history and screening physical examination); * have been provided with, understand, and have signed the informed consent.

Keywords: tobacco use disorder tobacco cessation
controlled study of the occurrence of actinic keratosis on the face after cryotherapy + aminolevulinic acid (ala) photodynamic therapy

Conditions: Actinic Keratosis

Summary: the purpose of this study is to determine if levulan photodynamic therapy (pdt) is safe and effective in the treatment of actinic keratoses (ak) on the face, following treatment with liquid nitrogen cryotherapy.


Eligibility criteria:
inclusion criteria: * four to fifteen aks on the face * histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to aks * at least one previously treated nonmelanoma skin cancer (nmsc) on the head and/or neck area within the past five years exclusion criteria: * pregnancy * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the treatment area * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * subject is immunosuppressed * unsuccessful outcome from previous ala-pdt therapy * currently enrolled in an investigational drug or device study * has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment * known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) * has an active herpes simplex infection or a history of 2 or more outbreaks within the past 12 months, on the face * use of the following topical preparations on the extremity to be treated: * keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days * retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks * microdermabrasion, laser ablative treatments, ala-pdt, chemical peels, 5-fluorouracil (5-fu), diclofenac, ingenol mebutate, imiquimod or other topical treatments for ak within 8 weeks * use of systemic retinoid therapy within 6 months

Keywords: actinic keratosis
effect of n-3 pufa from fish in enteral nutrition of major burn patients

Conditions: Burn Injury

Summary: studies have shown that burn patients may benefit from low fat diets, but there is still no strong data regarding the impact of fatty acid composition used for feeding. the trial test the hypothesis that the inclusion of omega-3 pufa in a low fat diet may improve outcome. prospective randomised controlled trial in adult patients admitted for burns \> 15% body surface area (bsa), and inhalation injury requiring mechanical ventilation and enteral nutrition. on admission randomization to receive a low-fat (18% energy as fat) modular enteral diet (lf-en) and identical with the half of fat provided by fish oil (fo-en). study endpoints: mechanical ventilation time, inflammation (crp), infectious and other complications, mortality until discharge. the study is planed as 2 parts: 1) preliminary study testing the feasibility of the study, 2) the study completed with information from the preliminary phase, both phases being randomised and controlled.

randomisation within the first 24 hours of admission to 2 types of enteral feeds: 1) ω 3 pufa (fo-en) or 2) control solution which is the hospitals standard low 18% fat containing solution. the patients are fed as long as clinically required with the initial solution.

Eligibility criteria:
inclusion criteria: - adult \>16 years, burns \> 15% bsa, mechanical ventilation, next of kin consent exclusion criteria: * absence of the above, absence of commitment to full treatment * comorbidities (cancer, copd, diabetes, liver failure (child pugh b and c) * pregnancy

Keywords: infections, enteral nutrition, sirs, critically ill
incidence of hypoglycemia during ramadan in patients with type1 diabetes on insulin pump versus multi dose injection

Conditions: Type 1 Diabetes

Summary: managing patients with type1 diabetes when fasting ramadan is very challenging. insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (mdi). however, there are extremely limited studies on the difference between insulin pump compared to mdi on the incidence of hypoglycemia and other acute complications during fasting ramadan the investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting ramadan compared to mdi without deterioration in glycemic control. results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1dm during ramadan.


Eligibility criteria:
inclusion criteria: 1. dm type 1 2. age ≥14 years 3. patients on insulin pump (more than 3 months) 4. patients on mdi (glargine or detemir combined with aspart or lispro) regimen 5. diagnosis of type 1 dm of more than 6 months. 6. willing to do self monitoring blood sugar (smbg) 7. have no other contraindication to fast exclusion criteria: 1. patient with renal or hepatic impairment 2. patient with diagnosed adrenal insufficiency 3. pregnancy 4. alcoholism 5. any diagnosed psychiatric disease 6. can not do smbg

Keywords: ramadan fasting diabetes type1 insulin pump
effects of a dipeptidyl peptidase-4 inhibitor sitagliptininsulin on the progression of coronary atherosclerosis in patients with type 2 diabetes

Conditions: Atherosclerosis Type 2 Diabetes Mellitus Dipeptidyl Peptidase-4 Inhibitor GLP-1

Summary: this study was to investigate the effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on progression of coronary atherosclerosis in patients with type 2 diabetes.

this study was to investigate the effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on progression of coronary atherosclerosis in patients with type 2 diabetes.

Eligibility criteria:
inclusion criteria: * patients \> 18, \< 80 years old, with type 2 diabetes mellitus and coronary heart disease. exclusion criteria: * allergy or hypersensitivity to any of the drug's components. severe liver failure, moderate or severe kidney failure malignant disease. active infectious disease. pregnancy or breastfeeding.
the halland obesity municipal effort for children

Conditions: Childhood Obesity; Physical Inactivity; Physical Activity; BMI; Neurodevelopmental Disorders; Hypertension

Summary: a retrospective study to investigate the method called the halland obesity municipal effort for children. all children participating in the intervention since the start of this specific method will be eligible for inclusion. the aims are to describe participants and the method-specific activities they are participating in, as well as the effect on their health and school grades.

this method involves the entire municipal community in laholm and kungsbacka (two cities in sweden): pediatric care unit, child psychiatry, social services, school healthcare, private companies, and local sports clubs. the model includes group activities and individual activities and offer 15 different health promoting and free activities per week. all activities are modified and take place in a safe environment. the activities range from golf, riding, gym training, swimming, fishing, art classes, karate, dance classes, and the possibility for the child to get a grade in physical education through a specific collaboration with the local schools in the municipality. the children are given a fruit at each activity and cooking classes are frequently given. the municipal activity coordinator who is responsible uses different methods such as kasam, health action model and empowerment to help each child develop skills in self-monitoring, goal setting, problem solving, contingent reward systems, and stimulus control. parents are given a specific support program called cope, community parent education. some activities include the whole family. in addition to the weekly activities, the activities are also always given on school holidays and weekends when children are known to be less active. this study will investigate this method by focusing on bmi, metabolic control, blood pressure, level of physical activity, age, sex, the existence of comorbidities, presence of neurodevelopmental disorders, school related issues, involvement of social services, need of grades in physical education and help to learn how to swim, which activities the children were undertaking as well as the frequency of participation. the proportion of children achieving full 12 years of education will also be investigated.

Eligibility criteria:
inclusion criteria: * patients involved in the home project since the start. children that have been offered this intense intervention. exclusion criteria: those who are not willing to participate. -
treatment of vascular lesions with a tandem 532/1064 nm laser

Conditions: Vascular Lesion

Summary: dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation. it has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal. the tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple 532/1064 nm laser pulses.this mode may reduce malformed blood vessels with a low incidence of long-term side effects.

the researcher can determine the blanching of vascular lesions after tandem laser with multiple 532/1064 nm laser pulses treatment. the researcher will select one to four test sites spots for laser treatment. will be different laser parameters can be used for each test site. the research will evaluate of the test sites at 6-12 weeks for bruising and blanching. parameters of the test area with the greatest degree of blanching without adverse effects will be utilized for further treatment. if no test area is determined to have blanching without adverse effects, further test sites may be performed.

Eligibility criteria:
inclusion criteria: * adult age 18 years and older * diagnosis of vascular lesion exclusion criteria: * age \<18 * pregnancy * history of cutaneous photosensitivity * any therapy to the proposed treatment sites within the previous two months * current participation in any other investigational drug or device evaluation

Keywords: facial telangiectasia, leg vein telangiectasia port wine stain birthmarks