Kornimate/medical-research-clean huggingface dataset:
study of the 4.0mm sirolimus-eluting stent in the treatment of patients with coronary artery lesions

Conditions: Coronary Artery Disease

Summary: the main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting bx velocitytm stent in reducing in-lesion late loss in patients with de novo native coronary artery lesions.


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female patients minimum 18 years of age 2. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b\&c, i-ii) or patients with documented silent ischemia; 3. target lesions treatable with 4mm stent (visual estimate); 4. target lesion is 30mm in length (visual estimate); 5. target lesion stenosis is \>50% and \<100% (visual estimate); exclusion criteria: 1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck \>2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remains above normal at the time of treatment; 2. has unstable angina classified as braunwald iii b or c, or is having a peri infarction; 3. documented left ventricular ejection fraction 25%; 4. impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
impact of educational intervention protocol on the level of knowledge, clinical control and lung function of people with asthma

Conditions: Asthma

Summary: the goal of this randomized controlled clinical trial is to evaluate the effects of a proposed educational intervention on people with asthma. the main question it aims to contribute to a better understanding of the effectiveness of educational intervention strategies in people with asthma. participants allocated to the control group will receive standard follow-up according to the clinic routine. participants allocated to the experimental group will undergo an educational intervention bundle, prepared in accordance with the recommendations of the global initiative for asthma- gina (2024).

people with asthma will participate in the study, from the pulmonary function clinic of the department of physiotherapy at federal university of paraíba - ufpb. spirometry data, knowledge about asthma and correct control over inhalation therapy, clinical control of the disease using the asthma control test (act) and c-act questionnaire, number of asthma attacks, amount of medication used, hospitalizations and visit to the emergency room in the last 4 weeks will be assessed. assessments will be carried out at the first contact (baseline) and twelve weeks after the first contact.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma * assisted by the pulmonary function clinic * ventilatory dysfunction assessed by spirometry exclusion criteria: * obesity * treatment with systemic corticosteroids * previous chest surgery * unable to perform any of the proposed assessment steps

Keywords: asthma heath education spirometry respiratory tract disease
dipole density right atrial mapping and assessment of therapy in cavotricuspid isthmus flutter

Conditions: Atrial Flutter

Summary: study to determine the feasibility of the acutus medical system in obtaining data to create dipole density maps of electrical activation in the right atrium in patients with typical atrial flutter.


Eligibility criteria:
inclusion criteria: * age 18-75 years * one documented occurrence of typical afl within the past 6 months * be able and willing to sign informed consent exclusion criteria: * contraindication to a non-emergent interventional ep procedure * require treatment in or access to left atrium * had a myocardial infarction within the prior two months * had cardiac surgery within the prior three months * intracardiac thrombus * permanent pacemaker/icd leads in/through right atrium * clinically significant tricuspid valve regurgitation or stenosis * cerebral ischemic event (including tia) in the prior six months * pregnant * currently enrolled in any other clinical investigation * any other significant uncontrolled or unstable medical condition
erectile dysfunction treatment using stem cells

Conditions: Erectile Dysfunction

Summary: a prospective clinical study to investigate the safety and efficacy of intracavernosal injections of umbilical cord stem cells (ucscs) combined with platelet-rich plasma (prp) for erectile dysfunction

umbilical cord mesenchymal stem cells (uc-mscs) combined with platelet-rich plasma (prp) will be injected into the corpora cavernosa of the penis of male patients with erectile dysfunction. the injection will be done at four points along the shaft on both sides of the penis. penile doppler ultrasonography will be performed on all patients before the initiation of the treatment. this assessment will be conducted to establish a baseline measurement of penile blood flow in both left and right sides of the penis. subsequently, after four months of treatment, penile duplex doppler ultrasonography will be repeated to compare the penile doppler before and after treatment. statistical analyses will be performed using ibm spss statistics for windows, version 26.

Eligibility criteria:
inclusion criteria: * male patient with erectile dysfunction exclusion criteria: * undergo other treatments for erectile dysfunction
acupuncture for postoperative nausea, vomiting and pain in children: the implication of parental attitudes

Conditions: Postoperative Nausea and Vomiting; Postoperative Pain

Summary: postoperative nausea and vomiting (ponv) remain a significant challenge in our practice. however, pharmaceutical prophylaxis is only partially effective and can imply unpleasant adverse effects. accordingly, the use of non-pharmacological methods in preventing ponv is appropriate. acupuncture is reported to reduce ponv and pain, and the adverse events are minimal. the objective of this multicentre, double-blinded, randomized, controlled trial is to investigate whether acupuncture can be a supplementary to the ordinary treatment in children undergoing tonsillectomy and/or adenoidectomy. in addition, the non-specific effect of parental attitudes and expectations on the outcomes will be explored. two hundred and eighty patients will be included and randomized into two groups 1. treatment group: acupuncture treatment (approximately 15 to 20 minutes) during anaesthesia and standard treatment 2. control group: standard treatment the primary endpoints in the intervention study are nausea, retching, vomiting and pain during 24 hours postoperatively. the effect of acupuncture will be studied with regard to any association with possible factors of predisposition to ponv, as well as with other factors registered during the study. adverse events from acupuncture will be registered. the objective of the self-report questionnaires is to * investigate parental attitudes and expectations to the acupuncture treatment pre- and postoperatively * compare data of the outcomes from the intervention trial with data from the questionnaires, in order to find any correlation between parental beliefs, attitudes and expectations, and the effect of the acupuncture treatment


Eligibility criteria:
inclusion criteria: * children from two to eleven years of age * children scheduled for tonsillectomy and/or adenoidectomy * informed consent from the parents exclusion criteria: * american society of anesthesiologists grade greater than or equal to iii (patient with severe systemic disease) * patients/parents in need of an interpreter * rash or local infection over an acupuncture point * emesis during the previous 24 hours * use of medication with antiemetic effect within the 24 hours before surgery * gastric or intestinal diseases

Keywords: acupuncture children postoperative nausea and vomiting postoperative pain parental attitudes parental expectations
bone histomorphometry in postmenopausal men and women with osteoarthritis undergoing total hip replacement

Conditions: Osteoporosis

Summary: the primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (thr).


Eligibility criteria:
inclusion criteria: * subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures * ambulatory postmenopausal women and men with osteoporosis * scheduled to undergo elective thr due to osteoarthritis of the hip * received at least 2 doses of denosumab 60 mg subcutaneously over 18 months * last dose of denosumab within 6 months of scheduled thr exclusion criteria: * received treatment for osteoporosis other than denosumab in one year prior to thr * subjects with current diagnosis of any of the following conditions are excluded * current, uncontrolled hypo- or hyperthyroidism (subjects who have controlled hypo- or hyperthyroidism may be eligible, provided that they have been on a stable therapy for at least 3 months \[per subject report\]) * current, hypo- or hyperparathyroidism * osteomalacia * paget's disease of bone * other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) * severe chronic kidney disease (ckd), defined as ckd stage 4 or greater * malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma) * self-reported alcohol or drug abuse within the previous 12 months * currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) * other investigational procedures while participating in this study are excluded * subject has known sensitivity to any of the products to be administered (eg, tetracycline, demeclocycline) during study * subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge * history or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

Keywords: bone biopsy tetracycline demeclocycline total hip replacement
high frequency repetitive transcranial magnetic stimulation (rtms) in the treatment of post-traumatic stress disorder (ptsd)

Conditions: Post-Traumatic Stress Disorder

Summary: this is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of high-frequency (20hz) rtms applied to the right dorsolateral prefrontal cortex for 6 weeks. the primary objective is to evaluate the change in ptsd symptoms before and after six weeks of high-frequency rtms treatment as measured by the clinician administered ptsd scale (caps) in both active and control groups.


Eligibility criteria:
inclusion criteria: * signed patient information and consent. * patients with primary post-traumatic stress disorder (as diagnosed by mini) and dsm iv tr. * patients with caps score of at least 40. * males or females between 18-65 years of age. * patients not taking ptsd pharmacotherapy for at least last 2 weeks prior to commencing in the study or if they are taking ptsd pharmacotherapy it must be stable for at least 6 weeks prior to the start and not be changed during the 6 weeks of the study treatment phase. * individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase. exclusion criteria: * current primary axis i disorder including schizophrenia, bipolar disorder type i, major depressive disorder. * other primary axis i disorders which, in the opinion of the investigator, may affect the outcome of this study. * patients with hdrs score ≥ 18. * a metallic implant in cranium (except the mouth). * patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety. * ect treatment within the last three months. * patients with a history of epilepsy. * patients with neurological disorder leading to increased intracranial pressure. * patients with severe cardiac disorder or intracardiac lines and pacemakers. * patients with current suicide risk ≥ 6 points by mini.
sympathetic activation in obesity

Conditions: Obesity; Healthy

Summary: the primary objective of this study is to determine whether sympathetic nervous system (sns) activity in white adipose tissue (wat) and brown adipose tissue (bat), skeletal muscle and brain is altered in individuals with obesity in comparison to individuals with normal weight. simultaneous multi-organ sns activation will be obtained with a radiotracer for norepinephrine transporter (net) for whole-body positron emission tomography (pet) imaging and microneurography (peroneal muscle sns activity). the secondary objectives of this study are: 1) to evaluate whether gender differences affect peripheral sns in healthy normal weight and obese men and women in adipose tissue (wat and bat) and muscle (resting/fasting); 2) to investigate the relationship between peripheral and central sns activity in obesity, by correlating sns activity in peripheral tissues (wat, bat, and muscle) and brain; and 3) to investigate net cns and peripheral sns activity before and after a high carbohydrate mixed meal in lean and obese men and women.


Eligibility criteria:
inclusion criteria:in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. age 18-45 years 4. in good general health as evidenced by medical history and lean (bmi 18.5-24.9 kg/m2) or non-diabetic obese (bmi 30-50 kg/m2) with a fasting plasma glucose (fpg) \<100 mg/dl and a hemoglobin a1c \<5.7%. exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: 1. hypertension 2. cardiac or pulmonary disease, 3. known history of type 1 or type 2 diabetes 4. hepatic disease, swallowing and gastrointestinal disorders 5. current use of anti-obesity medications, supplements and/or anti-hyperglycemic medications 6. neurological injury or illness, and psychiatric medications 7. women who are pregnant or lactating 8. subjects who suffer from claustrophobia 9. subjects who have received a diagnostic or therapeutic radiopharmaceutical within 7 days prior to participation in this study 10. radiation works or participation in other research studies involving ionizing radiation within one year of the pet scans that would cause the subject to exceed the yearly dose limits. 11. subjects with history of iv drug use which would prevent venous access for pet tracer injection 12. severe motor problems that prevent the subject from lying still for pet and mr imaging 13. subjects who complain of chronic pain 14. blood donation within 8 weeks of the study
double blind study to evaluate the efficacy of collagenase histolyticum in the treatment of lipoma

Conditions: Lipoma

Summary: the purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.

this study will evaluate the safety and efficacy of a food and drug administration (fda) approved drug (xiaflex) in the treatment of lipoma (fatty tumors). the fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). treatment of the lipoma with an injection of xiaflex (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it. each subject must have two lipomas; one lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be observed similarly throughout the trial.

Eligibility criteria:
inclusion criteria: * 18-75 years of age, of either sex or any race * clinical history of at least 2 lipomas for at least one year * lipomas diagnosed as benign * two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart, with easily definable edges * each lipoma is a single mass with easily definable edges * lipomas are 5 to 24 cm squared * women of childbearing potential must use an acceptable method of birth control exclusion criteria: * lipomas on the head, neck, hand or foot, or female breast * women who are nursing or pregnant * multi-lobular lipomas * subjects who have received an investigational drug within 30 days before receiving the first dose of study drug in this study * subjects with a known allergy to collagenase or any of the inactive ingredients in xiaflex * subjects with uncontrolled diabetes, hypertension, or thyroid disease, or any medical condition that would make the subject unsuitable for enrollment * subjects having prior treatment or trauma of the lipoma that could interfere with study assessments * subjects with a history of connective tissue diseases, rheumatological diseases * subjects taking anticoagulants or planning to receive anticoagulants (except for lo dose aspirin and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days of injection of study drug
a study of patients with relapsed/refractory mantle cell lymphoma treated with lisocabtagene maraleucel in the post-marketing setting

Conditions: Mantle Cell Lymphoma (MCL)

Summary: the purpose of this study is to understand the long-term safety and effectiveness of lisocabtagene maraleucel (liso-cel) for the treatment of mantle cell lymphoma (mcl).


Eligibility criteria:
inclusion criteria: • participants must have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel (liso-cel) used for the treatment of mantle cell lymphoma (mcl) according to the fda-approved indication and dose range (ie, per the us prescribing information) and with a product meeting the specifications for commercial release approved in the usa exclusion criteria: * participants known to be participating in investigational studies at the time of liso-cel infusion. * participants treated with non-conforming car t-cell product.

Keywords: mantle cell lymphoma (mcl)
drug abuse during the covid-19 pandemic.

Conditions: Substance Abuse; Stress, Psychological

Summary: the pandemic we live through has put various sectors of the medical system and its tributaries to the test. the accumulation of external and internal stress has been completely correlated with the predisposition to psycho-emotional problems and, in turn, to drug use as an immature response for ego protection. that is why the economic, social, and psychological evaluation can help understand the current situation about drug abuse and how to help patients afflicted by it. the added stress of personal problems, work alterations, daily life in a pandemic, economic and varied responsibilities, and the understanding of the pandemic have predisposed and amplified the use of drugs to reduce emotional distress perceived by individuals. the hypothesis of this study is that the increment of stress and a lack of preparation for the pandemic are associated with increased drug abuse.


Eligibility criteria:
inclusion criteria: * \> 18 years old * willing to participate in the study * patient currently with a paying job exclusion criteria: * patients without a paying job

Keywords: substance abuse covid-19 stress economical impact
effects of nutrition education on 3rd and 5th grade student's fruit and vegetable consumption and knowledge

Conditions: Obesity

Summary: the primary objective is to assess pre- and post-intervention nutrition education knowledge and preference. the secondary objective is to assess pre- and post-intervention fruit and vegetable consumption via a plate waste study.

background: the prevalence of overweight and obese children in the united states is at epidemic proportions, making it a recognized public health priority. overweight and obese children are more likely to remain overweight and obese as adults, which increases their risk for developing obesity-related diseases and psychological disorders. research shows that regular consumption of fruit and vegetables (f/v) may reduce the risk of obesity and obesity-related diseases yet most american school children fail to meet recommended intakes . objective: the purpose of this study was to determine if a f/v-targeted nutrition education intervention would increase f/v preference, knowledge, and consumption among elementary-school students. methods: eight 20-minute nutrition lessons, focusing on f/v consumption, were administered over an eight-week period to 3rd and 5th grade students (n=150) at a local ellensburg school district elementary school . pre/post surveys were used to examine f/v knowledge and preference. researchers observed and photographed students' lunches for 5-consecutive days pre- and post- intervention to assess possible change in consumption patterns. results: data is currently under analysis. conclusions: to be determined june 2017.

Eligibility criteria:
inclusion criteria: * participated in the national school lunch program exclusion criteria: * did not participate in the national school lunch program
erector spinae block for thoracoscopic surgery

Conditions: Postoperative Pain; Thoracic Neoplasms

Summary: this randomized clinical trial compares the effects of the erector spinae plane block with levobupivacaine and 0,9% saline on postoperative pain intensity, and opioid consumptions following thoracoscopic pulmonary surgery.

sixty patients planned for thoracoscopic pulmonary surgery are randomly assigned to an erector spinae plane block (espb) with levobupivacaine (intervention group) or 0,9% saline (control group). espb is performed under general anaesthesia before surgery. postoperative pain medication incudes acetominophen, nsaids en parenteral morphine (patient controlled analgesia). following surgery pain intensity (numeric rating scale) is registered at the recovery ward one hour after surgery. furthermore, pain intensity is registered 2,4,8, 12 hours after the operation. on the first postoperative day, pain intensity is registered at 8.00 o'cock am and 8.00 o'clock pm. opioid consumption is registered as a second parameter of postoperative pain.

Eligibility criteria:
inclusion criteria: * patients scheduled for thoracoscopic pulmonary sleeve resection or lobectomy * age 18 years or older * american society of anesthesiologists (asa) health status class i-iii * informed consent exclusion criteria: * contraindication for regional analgesia (e.g. coagulopathy, infection at injection site) * contraindication for nsaids * chronic opioid use * pregnancy

Keywords: thoracoscopy pain regional anaesthesia