Kornimate/medical-research-clean huggingface dataset:
prospective prostate biomarker study

Conditions: Indication for Prostate Biopsy Due to Suspected Prostate Cancer

Summary: • correlation of a glycoprotein panel with prostate biopsy outcome and pca aggressiveness

the main objective of this study is to correlate a glycoprotein panel with prostate biopsy outcome, i.e. distinguishing pca from benign prostatic conditions as well as high-grade cancer. the quantities of the two protein analytes cathepsin d (ctsd) and thrombospondin 1 (thbs1) are measured in human serum samples. in combination with percent free psa (%fpsa), the results are correlated with prostate biopsy outcome. the potential future benefit of using this glycoprotein panel is to validate positive tpsa tests in men with negative digital rectal examination (dre) and enlarged prostates to reduce the need for undergoing a biopsy, thereby reducing unnecessary biopsies and potentially predicting high-grade disease.

Eligibility criteria:
inclusion criteria: * male patient between 45 and 80 years old. * tpsa between 2 and 10 ng/ml * prostate volume \>=35 ml * non-suspicious dre for prostate cancer * scheduled for prostate biopsy * patient must give written informed consent exclusion criteria: * patient not undergoing biopsy of the prostate * prior prostate biopsy within the last 12 months * transurethral resection of the prostate (turp) in the last 5 years * patients with known acute or chronic prostatitis/cystitis or other known prostate abnormalities * patient taking 5-alpha-reductase inhibitor * any other prior treatment of the prostate (cryoablation, hifu, ire, radiation therapy, alcohol instillation, etc.)
study of daclatasvir (bms-790052) add-on to standard of care in treatment- naïve patients

Conditions: Hepatitis C Virus

Summary: to establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.


Eligibility criteria:
inclusion criteria: * patients chronically infected with hepatitis c virus (hcv) genotype 1 or 4 * hcv rna viral load of ≥100,000 iu/ml * no previous exposure to interferon, pegifnα, or rbv * results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. compensated cirrhotics with hepatitis c virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization) * findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma * body mass index of 18 to 35 kg/m\^2 exclusion criteria: * positive for hepatitis b or hiv-1/hiv-2 antibody at screening * evidence of a medical condition associated with chronic liver disease other than hcv * evidence of decompensated cirrhosis based on radiologic criteria or biopsy
etoricoxib in the treatment of osteoarthritis (mk-0663-007)

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * at least 40 years of age with a clinical diagnosis of osteoarthritis (oa)of the knee for 6 months prior to study entry (ara class i, ii, or iii). * positive therapeutic effect from prior nsaid therapy. * worsening of symptoms upon withdrawal of prior treatment. * with the exception of oa, in otherwise good health exclusion criteria: * weight no more than 280 pounds (male or female). * recent, sustained use of gastroprotective agents. * history of arthroscopy of the affected knee within 6 months prior to study entry. * history of acute ligamentous or meniscal injury of the study joint within the previous 2 years.

Keywords: arcoxia
the role of ivabradine in causing af in patients with chronic coronary syndrome

Conditions: AF - Atrial Fibrillation

Summary: this study is aiming to detect the possibility of ivabradine's role in the development of atrial fibrillation in chronic coronary syndrome patients with no structural heart disease.

ivabradine is a heart rate-lowering agent best characterized by its negative chronotropic effect on the sinoatrial node. its unique mechanism selectively blocks the pacemaker funny channels, which are responsible for spontaneous depolarization in the sinoatrial node that regulates heart rate during sinus rhythm. it has been well established that controlling the heart rate is the main target when treating coronary artery disease and heart failure and is associated with a beneficial effect on mortality and morbidity. according to the european society of cardiology guidelines for chronic coronary syndrome, ivabradine should be considered as an anti-anginal agent in patients with sinus rhythm and heart rate of ≥70 bpm in combination with beta-blockers or when beta-blockers are not tolerated. the if current, which is affected by ivabradine, was found to be present in the pulmonary vein myocardial sleeves, the well-recognized triggers for af. this may explain the risk of af in patients receiving this drug. however, af is commonly associated with hf and ischemic heart disease, the current two clinical indications for the use of ivabradine, hence af in this patient population may be an association rather than a drug-induced effect. previously, ivabradine's heart rate reduction was thought to be exclusively due to inhibition of if channels in the sinoatrial node. however, emerging data have shown channels that maintain the if current in the free wall of both atria. these findings support the idea that the if current plays a role in the pathophysiological procedure that initiates and maintains af.

Eligibility criteria:
inclusion criteria: * age range from 18 to 70 years. * diagnosed with chronic coronary syndrome according to european association guidelines of 2019. * normal structural heart disease (as evident by 2d transthoracic echocardiography). * in sinus rhythm. exclusion criteria: * patient with heart rate below 70 bpm at the start of treatment. * smokers. * hyperthyroidism. * hypertensive patients * patient with bradycardia arrhythmia (sinus bradycardia, advanced degree of heart block). * history of atrial fibrillation. * history of myocardial infarction, previous pci, or cabg. * patient with valvular heart disease.
the canadian e-paradigm (exercise physical activity and diabetes glucose monitoring) protocol

Conditions: Walking; Seated Control

Summary: walking is encouraged for people with type 2 diabetes but there is little evidence that performing a bout of walking can improve glucose control. furthermore, it is unknown how participant characteristics (e.g., age, sex, medications) impact the acute glucose responses to walking in people with type 2 diabetes. the primary purpose of this study is to examine how a standardized bout of walking impacts glucose control assessed over 24 hours using continuous glucose monitoring. a secondary purpose is to determine whether responses are influenced by age, sex, and medication use.


Eligibility criteria:
inclusion criteria: * diagnosed with t2d for more than 6 months * 30-90 years of age * no contra-indications to exercise (par-q+, rose angina questionnaire, limited ability to walk for 50 min). * no previous myocardial infarction, stroke or diagnosed coronary artery disease * no changes in diabetes medication in last 3 months * not treated by insulin or corticosteroids * no significant change in body weight (\>5%) in last 3 months * blood pressure \<160/100 mmhg; resting hr\<100 * able to understand english or french and comply with study requirements (e.g., attend visits during the day) * hemoglobin a1c \<9.0% * no prior history of hypoglycaemia during activity or sleep exclusion criteria: * chest pain during physical activity. * chest pain while resting (no physical activity) in the past month. * loss of balance or consciousness because of dizziness in past 12 months * bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity. * currently pregnant or planning on becoming pregnant in the next 3 months * currently taking exogenous insulin * previous heart attack or stroke * any other reason that prevents ability to walk on a treadmill for 50 minutes
influence of standardized perioperative anesthetic, analgesic care on outcome of patients undergoing hip fracture surgeries

Conditions: Fractures, Hip; Local Anesthesia; Geriatric; Nerve Block

Summary: the purpose of this voluntary research study is to clarify whether or not a single injection nerve block done before surgery and after surgery nerve block catheter can effectively enhance recovery in elderly hip fracture patients in terms of reduced delirium, reduced length of stay and improved surgical and anesthesia outcomes. delirium is a serious change in mental abilities. it results in confused thinking and a lack of awareness of someone's surroundings. the disorder usually comes on fast - within hours or a few days. prolonged hospital stay is one of the risk factors for onset of delirium.


Eligibility criteria:
inclusion criteria: 1. undergoing anesthesia for hip fracture surgery. 2. patients with fracture neck of femur fractures. 3. geriatric patients. (65 years and older) exclusion criteria: 1. non-fracture hip patients 2. non-geriatric patients. (below 65 years old) 3. patients not able to consent themselves 4. non- english-speaking patients

Keywords: hip fracture nerve blocks geriatric local anesthesia post operative outcomes
role of metabolites in nicotine dependence (3) - 6

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.

previous studies have shown that cotinine, a metabolite of nicotine, antagonizes the beneficial effects of the nicotine patch in redugin withdrawal symptoms. studies have also shown that cotinine enhances serotonin levels. this study examined the effects of several doses of a 5ht3 antagonist, ondanstron, in combination with the nicotine patch. this medication has been observed to reduce nicotine withdrawal symptoms in rats. these effects were compared to the nicotine patch alone. the results of this study produced some modest effects showing that the 8mg dose of ondansetron suppressed tobacco withdrawal symptoms to a greater extent than the nicotine patch alone.

Eligibility criteria:
inclusion criteria: male/female subjects ages 21-45 years inclusive, with a smoking history of at least 15 cigarettes daily (greater than or equal to 50) for at least 1 yr. subject is in good health as verified by medical history, screening examination, and screening laboratory tests as outlined above. subject has provided written informed consent to participate in the study and is motivated to stop smoking. subject has experienced at least 4 withdrawal symptoms upon abstinence. exclusion criteria: history of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, current peptic ulcer disease or any other medical condition which the physician investigator deems inappropriate for subject participation. insulin-dependent diabetes. pregnant or lactating, or not using adequate birth control methods. requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (less than 1yr). chronic use of systemic steroids or antihistamines. abuse of alcohol or any other recreational or prescription drug (more than 3 drinks per day or 21 drinks per wk). use of any other nicotine products, including smokeless tobacco, cigars and nicotine replacement products. inability to fulfill all scheduled visits and examination procedures throughout the study period. history of schizophrenia or manic depressive disorder. recent history of other psychiatric illness (less than 1yr since last episode of major depressive episode).
endovascular treatment key technique and emergency work flow improvement of acute ischemic stroke (angel-act): phase two

Conditions: Intracranial Artery Occlusion With Infarction (Disorder)

Summary: the study is the second phase of endovascular treatment key technique and emergency work flow improvement of acute ischemic stroke (angel-act). during the first phase of the angel-act (nct03370939, a prospective multi-center registry study), problems and difficulties in the emergency work flow of acute ischemic stroke care in china have been identified, such as inadequate pre-hospital notification, delay of in-hospital diagnosis and treatment, difficulty in treatment consent, lack of professional training of endovascular treatment,etc., especially in the delay of in-hospital diagnosis and treatment. angel-act ii is a cluster randomized, parallel controlled study. the aim of this study was to evaluate the effectiveness of multi-modal medical quality improvement measures on the delay of hospital-level emergency work flow of acute ischemic stroke management as well as its impact on patient prognosis. the interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis.

this is a prospective, multi-centre, cluster randomized, open label, parallel controlled study that enrolled patients with acute ischemic stroke who underwent endovascular treatment in about 34 hospitals in china. the ratio interventional arm control arm is 1:1, which means 17 hospitals and 332 participants in each arm.

Eligibility criteria:
investigational sites inclusion criteria: * participated in the angel-act registry study * secondary or tertiary hospitals * available of emergency department and neurology ward for stroke patients * must have 24 hours × 7 days emergency department for stroke * capable of rt-pa thrombolysis and endovascular treatment investigational sites exclusion criteria * endovascular treatment volume \< 20 per year * unwillingness to participate angel-act ii and follow the protocol * currently participating other stroke treatment improving program/project or similar clinical studies participant inclusion criteria * age ≥ 18 years old * admitted from emergency or outpatient department; * acue ischemic stroke with large artery occlusion * within 24 hours after the onset, and eligible for endovascular treatment. * the patient or legal representative give written informed consent participant exclusion criteria: * unsuitable for this study investigators' discretion * progressive stroke or in-hospital stroke
evaluation of the safety and immunogenicity of the influenza vaccine gsk2186877a in the elderly

Conditions: Influenza

Summary: the purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of glaxosmithkline biologicals' influenza vaccine gsk2186877a in the elderly. subjects were previously vaccinated (nct00529516).


Eligibility criteria:
inclusion criteria: * a male or female subject previously enrolled in study 109821 (nct 00529516) in the \>= 65 years and 18-41 years of age groups and having received the study vaccine. * subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse. * written informed consent obtained from the subject. * free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study * if the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. exclusion criteria: * administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. * planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination. * planned administration of an influenza vaccine other than the study vaccines during the entire study period. * any vaccination against influenza since january 2008 with any seasonal influenza vaccine. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of hypersensitivity to a previous dose of influenza vaccine. * history of allergy or reactions likely to be exacerbated by any component of the vaccines. * acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period. * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period. * any medical conditions in which intramuscular injections are contraindicated. * pregnant or lactating females. * female planning to become pregnant or planning to discontinue contraceptive precautions.

Keywords: elderly vaccine influenza
investigation of the relationship between digital game addiction and musculoskeletal system disorders

Conditions: Game Addiction, Video

Summary: the aim of this study is to examine the effects of digital game addiction on the musculoskeletal system and the reflections of these effects on the quality of life of adults.

this study will be conducted with a cross-sectional design in order to examine the relationship between digital game addiction and musculoskeletal disorders. the methods to be used in the research are as follows: participant information: the study will include adults aged 18-39 who play digital games in internet cafes for at least 3 hours a day, 4-5 days a week. participants will be asked to fill out a form to collect demographic information. this form will include information such as age, gender, weekly game playing frequency (by hour and day), and physical activity levels. scales to be used: the following measurement tools will be used in the study to evaluate the effects of digital game addiction on the musculoskeletal system. digital game addiction scale, arm, shoulder and hand problems questionnaire, pittsburgh sleep quality, cornell musculoskeletal disorder questionnaire.

Eligibility criteria:
inclusion criteria: * adults aged 18-39. * individuals who play digital games at least 4-5 days a week, at least 3 hours a day. * individuals who voluntarily participate in the study and sign the ethical consent form. exclusion criteria: * individuals with existing serious health problems related to the musculoskeletal system or sleep patterns. * individuals who suffered trauma or serious injuries related to the musculoskeletal system during the study period. * individuals with psychological disorders such as depression or anxiety disorder.
evaluation of safety and efficacy of avacopan in subjects with moderate to severe hidradenitis suppurativa (aurora)

Conditions: Hidradenitis Suppurativa; Acne Inversa

Summary: phase 2 study of avacopan in subjects with moderate to severe hidradenitis suppurativa

a randomized, double-blind, placebo-controlled, parallel group, phase 2 study in subjects with moderate to severe hidradenitis suppurativa. the study is multicenter and will consist of three subject groups. subjects will be randomized 1:1:1 to a treatment of 10mg avacopan twice daily, 30 mg avacopan twice daily or placebo twice daily for 12 weeks. following the 12 weeks double-blind treatment period, subjects on placebo will be re-randomized 1:1 to receive 10 mg or 30 mg avacopan twice daily for additional 24 weeks. subjects treated with avacopan will continue to receive the same dose (either 10 mg or 30 mg twice daily) for additional 24 weeks. subjects will be on study treatment for 36 weeks and will be followed for 44 weeks for assessment of safety and efficacy. study acquired by amgen and all disclosures were done by previous sponsor chemocentryx. primary efficacy analysis will be at 12 weeks.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * clinical diagnosis of hs (hurley stage ii or iii), confirmed by a dermatologist, for at least 6 months prior to screening * hs lesions are present in at least 2 distinct anatomic areas * inadequate or loss of response to a systemic course of antibiotics typically of at least 90 days * must have at least 5 inflammatory nodules or abscesses at screening * use adequate birth control for subject and partners of child bearing potential * willing and able to give written informed consent exclusion criteria: * pregnant or breast-feeding * any other skin disease that may interfere with the assessment of hs * rapidly progressive, expanding hs within 30 days prior to screening * more than 20 draining fistulae at screening * any anti-tnf-α treatment for hs or for other conditions prior to day 1 visit will be prohibited. exception: subjects who were previously treated with an anti-tnf-α drug and discontinued treatment \>12 weeks prior to day 1 visit are allowed for enrollment * systemic antibiotics are generally excluded * topical antibiotics use within 14 days prior to day 1 is excluded * have started a topical prescription medicine for hs within 14 days prior to screening * a systemic medicine for hs, including biologics and other systemic therapies * have received within 14 days prior to day 1 visit or is expected to require oral or transdermal opioid analgesics (except for tramadol) for any reason

Keywords: avacopan chemocentryx skin disease inflammatory nodule abscess sinus formation fistula formation