Kornimate/medical-research-clean huggingface dataset:
evaluate the safe and effective use of the avonex® single-use autoinjector in multiple sclerosis subjects

Conditions: Multiple Sclerosis

Summary: the primary objective of the study was to evaluate the safe and effective use of the single-use autoinjector for the intramuscular (im) delivery of liquid avonex® (interferon beta-1a) in participants with multiple sclerosis (ms).

the main study was a 4-week treatment period which consisted of 1 avonex manual injection using a prefilled syringe, followed by 3 avonex injections using the single-use autoinjector. the extension study was designed to provide continuation of treatment with the avonex single-use autoinjector to eligible participants who completed the main study for up to an additional 12 weeks, and to obtain additional safety and preference data for the avonex single-use autoinjector. participants were enrolled under the initial study protocol (initial subject subset); the study was subsequently suspended. changes were made to the protocol (including modifications to the autoinjector needle), and additional participants were enrolled (main subject subset).

Eligibility criteria:
inclusion criteria: 1. ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations. 2. must be 18 to 65 years old, inclusive, at the time of informed consent. 3. must currently be self-administering avonex prefilled syringes to treat ms and must have been self-administering avonex prefilled syringes for the 12 weeks prior to the screening visit. 4. in the investigator's opinion, subjects must be willing and able to self-administer all injections required by the protocol. 5. must speak english. 6. all male subjects and female subjects of child-bearing potential must practice effective contraception during the study. exclusion criteria: 1. history of seizure disorder or unexplained blackouts or history of a seizure within 3 months prior to the screening visit. 2. history of suicidal ideation within 3 months prior to day 1 or an episode of severe depression within 3 months prior to day 1. severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy. note: subjects receiving ongoing antidepressant therapy are not excluded from the study unless the dose has been increased within the 3 months prior to the screening visit. 3. clinically significant local infection (for example cellulitis, abscess) or systemic infection (pneumonia, septicemia), at the discretion of the investigator. 4. known history of human immunodeficiency virus (hiv). 5. known history of, or positive test result for hepatitis c virus (test for hepatitis c virus antibody \[hcv ab\]) or hepatitis b virus (test for hepatitis b surface antigen \[hbsag\] and/or hepatitis b core antibody \[hbcab\]).
d-serine adjuvant treatment for parkinson's disease

Conditions: Parkinson's Disease

Summary: the proposed experiment will evaluate the effects of the nmda receptor full agonist d-serine (\~2g/day) on persistent symptoms of parkinson's disease and on antiparkinsonian drugs-induced dyskinesias. d-serine will be used as add-on therapy to on-going medications received by parkinson's disease patients. the rational for this study stems from observations made in pervious clinical trials with schizophrenia patients, in which it was demonstrated that d-serine adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted effects, anhedonia) symptoms which are similar to symptoms encountered in parkinson's disease. the study will have a crossover design in accordance to which each patient will receive, in random order d-serine and placebo for a 6 weeks period each. thus, any participant will have the opportunity to receive the experimental treatment.


Eligibility criteria:
inclusion criteria: * pd diagnosis * ≥2 on updrs items 32,33 * receive treatment with l-dopa alone or in combination with other antiparkinsonian medications. exclusion criteria: * current or previous history of other neurological disorders * unstable medical conditions * renal pathology * pregnant female patients excluded
pilot study of ranibizumab with and without ketorolac eyedrops for exudative age-related macular degeneration

Conditions: Wet Macular Degeneration

Summary: the addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting vegf addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of vegf production.


Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent and comply with study assessments for the full duration of the study; 2. age \>40 years; 3. presence of treatment-naïve neovascular amd with a visual acuity between 20/25 and 20/200 on the early treatment diabetic retinopathy study (etdrs) chart. inclusion criteria for amd were neovascularisation, fluid, or haemorrhage under the fovea. exclusion criteria: 1. any previous intravitreal treatment; 2. previous laser treatment in the study eye; 3. myopia \>7 dioptres in the study eye; 4. concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma); 5. concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal; 6. known sensitivity to any component of the formulations under investigation.

Keywords: ketorolac nsaids wet macular degeneration choroidal neovascularization
assessment of safety, tolerability, systemic exposure and efficacy of gpb cream in adolescents with severe primary hyperhidrosis

Conditions: Primary Axillary Hyperhidrosis

Summary: the aim of this study is to evaluate the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% gpb in adolescents with severe primary axillary hyperhidrosis.


Eligibility criteria:
inclusion criteria: * medical diagnosis of severe primary axillary hyperhidrosis with a prhs score of ≥5 with symptoms for at least 3 months before screening * at least 50 mg of sweat production in each axilla measured gravimetrically over a period of 5 minutes at room temperature along with a humidity consistent with the normal climate in that area (patients have to acclimatize to that room for at least 30 minutes before the measurement) * adolescents of both sexes aged 12 to 17 years (until study completion) with a body mass index percentile ≥10 and ≤90 (according to kromeyer-hauschild et al 2001) * local tolerability assessment (skin reaction) score = 0 exclusion criteria: * secondary hyperhidrosis, ie, hyperhidrosis that is secondary to other underlying diseases such as (but not limited to) hyperthyroidism, lymphoma, and malaria * previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage, ultrasonic surgery, microwave treatment (miradry), or laser treatment * botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months * hypersensitivity to glycopyrrolate, or to any of the excipients of the investigational medicinal product (imp)

Keywords: excessive sweating
aromatase inhibitors plus chemotherapy vs chemotherapy as neoadjuvant treatment in postmenopausal hr(+) breast cancer

Conditions: Neoadjuvant Therapy

Summary: the investigators designed this study to investigate the effect of aromatase inhibitors (ai) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.

the endocrine therapy has been used more and more in neoadjuvant treatment of hormone receptor-positive breast cancer. but it still a question if neoadjuvant endocrine therapy can be used combined with chemotherapy. there have been several small-sample studies concerning about this item and also got some results that support the suppose that endocrine therapy combined with chemotherapy could rise the effect of neoadjuvant treatment. this study is to investigate the effect of aromatase inhibitors (ai) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.

Eligibility criteria:
inclusion criteria: * provision of informed consent * clinical stage iia\~iiic * histologically proven hr+ invasive breast cancer * women defined as postmenopausal according to nccn guideline * plan to accept the neoadjuvant (pre operational) chemotherapy treatment exclusion criteria: * clinical evidence of metastatic disease * bilateral oophorectomy; * radiation of the ovaries * patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements * patients who accepted anti-cancer treatment before * previous hormonal therapy as adjuvant treatment for non-cancer disease * patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop * previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied * treatment with a non-approved or experimental drug during 1 month before entry into the study * history of bleeding diathesis (i.e., disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin) * leukopenia and/or thrombocytopenia * history of ocular fundus diseases * history of thromboembolic diseases * history of osteoporotic fractures

Keywords: aromatase inhibitors chemotherapy neoadjuvant postmenopausal breast cancer
endoscopic band ligation vs apc in management of gave

Conditions: GAVE - Gastric Antral Vascular Ectasia

Summary: * overall aim: to compare the efficacy and safety of endoscopic band ligation and endoscopic argon plasma coagulation for the management of gastric antral vascular ectasia. * secondary aims: 1. study risk factors of gave. 2. prevalence of gave among causes of non-variceal gastrointestinal bleeding.

gastric antral vascular ectasia (gave) is a capillary-type vascular malformation characterized endoscopically by red, angiomatous lesions originating in the antrum and organized either in stripes or in a diffuse pattern. gave may cause chronic iron-deficiency anemia with or without the presence of overt gastrointestinal bleeding, manifested commonly by melena, may account for about 4% of the causes of non-variceal bleeding. gave can be isolated or associated with systemic conditions, especially in patients with liver cirrhosis, scleroderma, chronic renal failure, and after bone marrow transplantation. multiple mechanisms have been proposed as the origin of its development. these have included gastric dysmotility leading to chronic mucosal trauma and subsequent fibromuscular hyperplasia and vascular ectasia or an autoimmune reaction to gastric blood vessels among the main contributing factors. management of gave-related gastrointestinal bleeding is a clinically challenging issue. in the last two decades, many therapeutic options and modalities have been applied for gave including medical, endoscopic, and surgical management. endoscopic management including different options such as cryotherapy, argon photo coagulation (apc), neodymium-yttrium-aluminum garnet laser coagulation, radiofrequency ablation and endoscopic band ligation. the first case using endoscopic band ligation as salvage treatment for gave was reported in 2006. after two sessions of ebl with a multi-band ligature, hemoglobin became stable and serum ferritin normalized in 16 months of follow up. some studies show that management of gave with endoscopic band ligation superior to apc in bleeding cessation and fewer treatment sessions.

Eligibility criteria:
inclusion criteria: * • both sexes will be included. * age above 18 years old patients will be included. * with overt or occult bleeding from gave. * characteristic endoscopic findings of gave: gave was limited to the antrum and its appearance either watermelon stomach or diffuse pattern. exclusion criteria: * • all causes of emergence upper git bleeding other than gave. * patient with contraindication to general anesthesia
flax mucilage and apparent nutrient digestibility

Conditions: Obesity

Summary: the aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults.

a 3 times 1-wk randomised crossover dietary intervention study, where the full diet is provided to 17 young subjects along with different flaxseed mucilage preparations. during the last five days, fecal samples are collected. fasting blood samples are collected on day 1 and 8 in each period and appetite sensation is registered three times daily before the main meals.

Eligibility criteria:
inclusion criteria: * 18-40y * bmi 22-28 * healthy exclusion criteria: * smoking * medication * excess pa

Keywords: dietary fiber obesity apparent energy digestibility
creatine hcl and creatine ethyl ester supplementation in perimenopausal and menopausal women

Conditions: Menopausal; Perimenopause

Summary: the goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with creatine hcl and creatine ethyl ester supplementation on cognitive performance, multidimensional fatigue, brain metabolism, and biochemical indices in perimenopausal and menopausal women


Eligibility criteria:
inclusion criteria: * body mass index 18.5 - 29.9 kg/m2 * free of major chronic diseases or acute disorders (including ad and dementia (mmse score \> 25 points) * menopausal: no menstrual cycle for consecutive 12 months (with no other obvious causes) * perimenopausal: still menstruating (regular or irregular) but have at least one of the following symptoms: (1) hot flashes, (2) sleep disturbances, (3) mood swings, and (4) concentration difficulties * given written informed consent exclusion criteria: * history of dietary supplement use 4 weeks before the study commences * pregnancy (or planning pregnancy) * abnormal values for lab clinical chemistry (\> 2 sd) * unwillingness to return for follow-up analysis * participation in other clinical trials

Keywords: creatine brain metabolism cognition fatigue
influence of cpb temperature on cabg morbidity

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia; Neurologic Manifestations

Summary: to compare three accepted modes of myocardial preservation, warm, tepid, and cold blood cardioplegia, coinciding with normothermic (37 degrees centigrade), tepid (32 degrees centigrade) and hypothermic (8 to 10 degrees centigrade) cardiopulmonary bypass (cpb) to define differences in neurologic function in coronary artery bypass graft (cabg) patients.

background: a pilot study of warm versus cold perfusion and preservation was completed in 32 patients prior to the ongoing study. the findings of the pilot study showed 53 percent of patients had evidence of new neurologic disturbance at postoperative day four. only the neurologic dysfunction could be correlated with warm versus cold perfusion (37.5 percent warm versus 75 percent cold, p less than 0.05). the changes in neurologic function had abated or clearly improved by one month of follow-up, and the distinction in neurologic dysfunction grading was no longer apparent between the two groups. design narrative: patients were randomly assigned to cold, tepid, or warm blood cardioplegia, coinciding with normothermic, tepid, and hypothermic cardiopulmonary bypass. all patients received a standard anesthetic protocol combining narcotic and inhalational anesthesia. each patient entering the study had extensive clinical data collected prospectively incorporating most aspects of measurable determinants related to myocardial preservation. additionally, neurologic tests were performed by a blinded neurologist and rated by an objective scoring system, the mathew scale. the studies were performed preoperatively, on the third or fourth postoperative day, and at one month following surgery. hematologic data were measured for fibrinolytic potential.

Eligibility criteria:
patients, referred for elective or urgent coronary revascularization, not having ongoing angina instability, requiring three or more bypass grafts, and under 70 years of age.
physiologic pacing for symptomatic first-degree heart block

Conditions: Symptomatic First-degree Heart Block

Summary: the purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms).

the purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms). patient will undergo a comparative effectiveness study where patients with symptomatic first-degree heart block (pr interval ≥250ms) undergo left bundle pacing (3830 lead) and are randomized to ddd-50 vs managed ventricular pacing-50 (mvp-50; aai-ddd 50) and undergo a crossover at 3 months. this study will compare two standard of care options utilizing food and drug administration (fda) approved devices. patients are evaluated at baseline, 3 months, and 6 months in terms of patient symptoms, exercise capacity, arrhythmia burden, and patient activity.

Eligibility criteria:
inclusion criteria: * aged 18 or above * ventricular ejection fraction (ef) \> 50% * new york heart association (nyha) class ii-iv * pr interval ≥250ms * narrow qrs duration (≤140ms) or prolonged qrs duration with typical right bundle branch block (rbbb) morphology on 12 lead ecg and sinus rhythm exclusion criteria: * permanent atrial fibrillation (af) * patients who are unable to perform a 6 minute hall walk * other serious medical condition with life expectancy of less than 1 year * lack of capacity to consent * pregnancy * contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)
study of bms-936558 (nivolumab) compared to docetaxel in previously treated advanced or metastatic squamous cell non-small cell lung cancer (nsclc) (checkmate 017)

Conditions: Squamous Cell Non-small Cell Lung Cancer

Summary: the purpose of the study is to compare the overall survival of bms-936558 as compared with docetaxel in subjects with squamous cell non-small cell lung cancer (nsclc), after failure of prior platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: * men and women ≥18 years of age * subjects with histologically or cytologically-documented squamous cell nsclc who present with stage iiib/iv disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease) * disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease * measurable disease by computed tomography (ct)/magnetic resonance imaging (mri) per response evaluation criteria in solid tumors (recist) 1.1 criteria * eastern cooperative oncology group (ecog) performance status ≤1 * a formalin fixed, paraffin-embedded (ffpe) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. specimens must be received by the central lab prior to randomization. biopsy should be excisional, incisional or core needle. fine needle aspiration is insufficient exclusion criteria: * subjects with untreated central nervous system (cns) metastases are excluded. subjects are eligible if cns metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. in addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) * subjects with carcinomatous meningitis * subjects with active, known or suspected autoimmune disease. subjects with type i diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll * subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization * prior therapy with anti-programmed death-1 (pd-1), anti-programmed cell death ligand 1 (pd-l1), anti-programmed cell death ligand 2 (pd-l2), anti-cd137, or anti-cytotoxic t lymphocyte-associated antigen 4 (ctla-4) antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways) * prior treatment on the first line study ca184104 first line nsclc study * prior treatment with docetaxel * subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity * treatment with any investigational agent within 14 days of first administration of study treatment
efficacy and safety of afq056 in reducing l-dopa induced dyskinesias in parkinson's disease patients

Conditions: Parkinson's Disease; L-dopa Induced Dyskinesia

Summary: this study will evaluate the safety and efficacy of administration of afq056 in combination with l-dopa, in reducing the number of l-dopa related dyskinesias in parkinson's disease patients.


Eligibility criteria:
inclusion criteria: * patients with parkinson's disease * patients with l-dopa induced dyskinesia for at least 3 months * patients with l-dopa treatment for at least 3 years, stable for 1 month minimum exclusion criteria: * history of severe allergy to food or drugs * very low or high body weight. * prior surgery for parkinson's disease * smokers other protocol-defined inclusion/exclusion criteria may apply

Keywords: parkinson's l-dopa dyskinesia
atazanavir and ritonavir (atv/rtv) and an oral contraceptive in healthy females

Conditions: HIV Infections

Summary: the purpose of this study is to administer a combined oral contraceptive (ethinyl estradiol and norgestimate) with the hiv treatment of atazanavir and ritonavir to healthy females in order to assess if the concentrations of the oral contraceptive change. the safety of this treatment regimen will also be studied.


Eligibility criteria:
inclusion criteria: * women of childbearing potential with intact ovarian function who have been on a stable regimen of oral contraceptives for at least 2 months prior to beginning the study * documented acceptable pap smear within 1 year prior to dosing * body mass index (bmi) 18-32 kg/m2 exclusion criteria: * males * subjects with an abnormal menstrual cycle during the 2 months prior to the start of the study or during the lead-in period (breakthrough bleeding/spotting) * history of conditions where the use of oral contraceptives are contraindicated * known or suspected carcinoma or suspected estrogen dependent neoplasia * history of migraine with focal aura * history of uncontrolled hypertension * positive screening test for hiv-1, -2, hiv viral ribonucleic acid (rna), hepatitis b surface antigen, or hepatitis c antibody

Keywords: hiv protease inhibitor