Kornimate/medical-research-clean huggingface dataset:
effectiveness of an anger and stress management program on reducing blood pressure levels in youth

Conditions: Cardiovascular Diseases; Hypertension

Summary: high blood pressure can often be caused by stress or anxiety. this study will evaluate a school-based stress and anger management program that aims to lower blood pressure and anger levels among high school students.

high blood pressure can be caused by many factors, including stress, anxiety, diabetes, kidney disease, or obesity. in many people, there is no identifiable cause for their high blood pressure; this is known as essential hypertension (eh). increasingly, children are being diagnosed with high blood pressure, which may lead to an increased risk of developing eh as adults. therefore, the need exists for an effective blood pressure reduction program targeted toward youth. research has shown that improving people's abilities to manage stress and anger reduces their risk of developing high blood pressure and heart disease. the williams lifeskills (wls) workshop is a program that teaches people to cope with stressful situations. it has been shown to improve heart health, including blood pressure levels, in adults with cardiovascular disease. however, the effect of stress and anger management programs on blood pressure levels in youth has not been widely studied. study researchers have developed and preliminarily tested a school-based anger and stress management wls program. this study will evaluate the effectiveness of the school-based wls program at reducing blood pressure and anger levels in high school students. if successful, this program could be implemented in schools across the country. this study will enroll high school students. participants will be randomly assigned to either a 12 lesson wls program or a control group. participants in the control group will attend regular high school classes. participants in the wls program will attend 12 sessions that will focus on coping skills to help manage stress and anger levels. at baseline, the end of the 12 lesson program, and follow-up visits 3 and 6 months later, participants will complete questionnaires on anger levels; life skills; hostility; stress; self-esteem; and attitudes toward school, teachers, and parents. they will also wear a blood pressure monitor for a 24-hour period.

Eligibility criteria:
inclusion criteria: * high school student exclusion criteria: * history of any chronic illness or any chronic health problem requiring pharmacological treatment (e.g., asthma, sickle cell disease, epilepsy) * adolescents with ambulatory systolic blood pressure greater than the 95th percentile based on age, sex, and height at screening will be allowed to participate in the workshop but may be excluded from testing * unwilling to be assigned into a specific treatment group

Keywords: blood pressure systolic blood pressure diastolic blood pressure ambulatory blood pressure monitoring relaxation meditation coping skills adolescents
further studies of attention deficit disorder - residual type (rt)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the first phase was a double-blind crossover design of methylphenidate in the treatment of adult adhd. the second phase consisted of an open-label extension trial of methylphenidate in adult adhd. it was hypothesized that methylphenidate would prove more effective than placebo in treating adhd symptoms during the first phase. it was also hypothesized that methylphenidate responders from the double-blind trial would continue to benefit from treatment in the second phase. improvement would include both adhd symptoms and social adjustment.

all patients received a single-blind week on placebo, followed by a double-blind random assignment crossover trial of methylphenidate and placebo, with each double-blind phase lasting two weeks. subjects who experienced moderate or marked improvement on methylphenidate would be allowed to enter a long-term, open-label trial. adhd symptom severity was measured monthly by a structured interview, the wender-reimherr adult attention deficit disorder scale (wraadds), clinical global impression - improvement (cgi-i) and global assessment of functioning (gaf). social functioning was assessed by the clinician administered version of the weissman social adjustment scale (wsas). dosing was determined by clinical judgement, symptom improvement and aes.

Eligibility criteria:
inclusion criteria: * ages 21-55 years; male and female; met "utah criteria" for adult adhd; 95th or higher percentile on the parent rating scale and/or the wender utah rating scale; exclusion criteria: * patients with other axis-i and axis-ii diagnoses were excluded as were patients with significant medical problems.

Keywords: adhd adult crossover randomized long-term open-label methylphenidate social adjustment
the watch the spot trial

Conditions: Solitary Pulmonary Nodule; Coin Lesion, Pulmonary; Lung Neoplasms; Carcinoma, Non-small-cell Lung

Summary: this study will compare two clinically accepted protocols for surveillance imaging in individuals who are found to have a small pulmonary nodule on chest computed tomography (ct) scans.

the investigators will conduct an unblinded, prospective, pragmatic, cluster-randomized, comparative effectiveness trial of more intensive versus less intensive ct surveillance of patients found to have small pulmonary nodules in diverse health care settings. the goal of this pragmatic clinical trial is to identify the surveillance strategy that will maximize early diagnosis for individuals with cancerous nodules, while minimizing unnecessary surveillance of patients without cancer that can result in emotional stress, exposure to harmful ionizing radiation, and the discovery of incidental findings that may lead to unnecessary treatment.

Eligibility criteria:
inclusion criteria: the target population includes adults with small lung nodules that may represent a new diagnosis of lung cancer, who typically would be managed by ct surveillance in usual clinical practice. thus, we will enroll all patients: * aged ≥35 years * at least one nodule measuring ≤15 mm in average diameter on chest ct. exclusion criteria: * pregnant women * age \<35 years * known diagnosis of cancer (except non-melanoma skin cancer) within 5 years
study of heat shock proteins as prognostic factor of acute renal failure in children (hsp-study)

Conditions: Kidney Failure, Acute

Summary: the purpose of the investigators' study is to determine whether the production of heat shock proteins has an effect on the development and the outcome of acute renal failure in children.

a prognostic factor for the development of acute renal failure (anr) in children would be very valuable for therapy regulation. so-called chaperones out of the family of heat shock proteins (hsp) are promising candidates which are involved in the development of anr as well. this could be a starting point for the development of new therapeutic approaches. anr occurs in up to 50 percent of all critical ill patients and has a high rate of morbidity and mortality despite advances in symptomatic therapy. following severe sepsis, septic shock or other shocks, combined with multiple organ failure, the anr is an autonomous prognosis worsening factor. should the results of our study show a correlation between the production of hsp and the outcome of children with anr, further studies would be required, to examine the pathophysiological relevance of hsp in anr. we would then be able to determine a high risk population for anr. a modulation of anr therapy might be a result of further studies.

Eligibility criteria:
inclusion criteria: * between 0 and 18 years of age. * either severe sepsis, shock of any origin or asphyxia. * operated patients with operative or post-operative transfusion requirement of at least 0.5 x 80 ml/kg body weight of erythrocyte concentrate. exclusion criteria: * existing affection of the kidney. * kidney transplantation. * missing written consent of the parents or guardian (if applicable).

Keywords: kidney failure, acute acute renal failure kidney failure heat-shock proteins children
prevalence of carbohydrate intolerance in lean and obese children

Conditions: Obesity; Glucose Intolerance; Diabetes; Acanthosis Nigricans

Summary: the prevalence of obesity in children is reaching epidemic proportions. excess adiposity is more than just a cosmetic problem, having substantial metabolic consequences. insulin resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen in obese children. in this study the prevalence of impaired glucose (carbohydrate) tolerance in lean children with a family history of diabetes and obese children with acanthosis nigricans with or without a family history of diabetes mellitus will be studied.


Eligibility criteria:
inclusion criteria: * obesity: bm +/- 95% for age general good health
study of mb07811 in subjects with hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: a phase 2 randomized, placebo controlled study assessing the efficacy, safety, and tolerability of mb07811 given orally to subjects with primary hypercholesterolemia for 12 weeks followed by a 6-week off drug phase.

this is an outpatient, phase 2, multicenter, double-blind, placebo-controlled, randomized, parallel-group study assessing the efficacy, safety, and tolerability of mb07811 given orally to subjects with primary hypercholesterolemia for 12 weeks. there will be a 3- to 6-week screening/run-in period, including washout of any lipid-modifying therapies (as needed) prior to randomization. eligible subjects will be randomized (1:1:1:1) to placebo, or 3 different doses of mb07811 for 12 weeks. after the double-blind treatment phase, all randomized subjects will proceed into a 6-week off-drug phase. assessments include: laboratory tests, adverse events (aes), electrocardiograms (ecgs), vitals, and pk samples.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) 18.50 - 40 kg/m2 inclusive at screening; * fasting serum ldl-c ≥145 mg/dl at both q2 and q3 visits; * fasting mean serum ldl-c \<220 mg/dl from q2 and q3; exclusion criteria: * history of clinically significant cardiovascular disease * uncontrolled hypertension * significant sinus bradycardia defined as \<40 beats per minute (bpm); * personal or family history of clinically significant unexplained syncope, near-syncope or unexplained sudden death or qt syndrome; * holter monitor report demonstrating any abnormality that is clinically significant, including but not limited to pvc frequency \> 1 per minute, any alert criteria or any other condition that requires further evaluation; * history of clinical significant arrhythmia; * resting 12-lead ecg showing qtc \>450 msec or \<360 msec (males or females), any tachyarrhythmia or morphology change, or any other clinically significant abnormality; * any other cardiovascular event requiring hospitalization; * history or presence of thyroid disorder or other metabolic/endocrine disorder that affects lipids or glucose; exceptions: polycystic ovarian syndrome (pcos) and impaired glucose tolerance (igt) are allowed. * liver disease, gallbladder disease, gilbert's syndrome, biopsy-proven nonalcoholic steatohepatitis (nash), positive serology for hepatitis b surface antigen (hbsag) or hepatitis c antibodies; exceptions: gallbladder disease treated with cholecystectomy * history of human immunodeficiency virus (hiv); * subjects with a prior history of malignancy in past 5 years;exceptions: subjects with previous history of basal or squamous cell carcinoma of the skin, or cervical cancer in situ are allowed if successfully treated; * history of myopathy, including any history of statin-induced myopathy; * history of intolerance to statins (e.g., myalgias, elevated liver tests); * history of clinically significant psychiatric disorders, including but not limited to bipolar disorder, major depressive disorder, psychosis; * renal dysfunction; * alcohol and/or drug abuse within 12 months prior to screening;

Keywords: hyperlipidemia
the long covid-19 wearable device study

Conditions: Long COVID; Postural Orthostatic Tachycardia Syndrome; Dysautonomia; Myalgic Encephalomyelitis; Chronic Fatigue Syndrome; Long Covid19

Summary: to further characterize long covid-19 by collecting data from individuals who already own wearable devices or are provided with a wearable device along with basic and enhanced educational materials to determine if both can improve long covid-19 symptom management and post-exertional malaise.

this study will have two components: one study group will consist of up to 100,000 individuals who own wearable devices and are willing to share their data. these participants will be randomized and will receive educational materials. the investigators will study these dynamic wearable data along with participant survey responses that focus on diagnoses, symptoms, and quality of life to improve disease characterization and understanding of differences within and between individuals. the other group in the randomized trial will participants who do not already own a wearable device. the study will distribute wearable devices and pacing educational materials to 500 individuals who do not already own them and experience post-exertional malaise, or the worsening of symptoms following exertion. the investigators hypothesize that access to personalized information from a wearable device will enable participants to reduce post-exertional malaise. the investigators will include up to 25% individuals whose post-exertional malaise is caused by a condition other than long covid-19.

Eligibility criteria:
inclusion criteria: * is at least 18 years old. * has a self/and or physician diagnosis of: * long covid (based on the who working definition), * me/cfs (myalgic encephalomyelitis / chronic fatigue syndrome, self-diagnosis based on iom criteria), and/or * pots (postural orthostatic tachycardia syndrome). * is interested in tools to manage me/cfs, pots, and/or long covid symptoms. * owns a wearable device they are willing to use for this study or does not own a device and agrees to utilize a study-provided one. * agrees to wear the device throughout the study period, share the data with the study, and sync data at least weekly. * has access to a smartphone or tablet to enable syncing wearable data and viewing device feedback. * agrees to disclose involvement in other me/cfs, pots, and/or long covid interventions such as medical treatment, self-management, and other interventional studies. * agrees to complete at least 75% of the study surveys. exclusion criteria: * as long as they meet inclusion there is no exclusion
multimodal vasopressor strategy in septic shock

Conditions: Shock, Septic

Summary: the goal of this prospective randomized controlled trial is to compare the effects of classic stepwise vs. early balanced multimodal vasopressor strategies in septic shock.

control group(classic stepwise vasopressor administration): patients will be started on norepinephrine with increases of 0.05-0.1 mcg/kg/min up to 0.5 mcg/kg/min, followed by vasopressin (administered at a fixed dose of 0.03 ie/min). if map remains \< 65 mmhg, norepinephrine will be titrated above dose of 0.5 mcg/kg/min until map ≥ 65 mmhg. initiation of additional vasoactive drugs (epinephrine, methylene blue, dobutamine, or dopamine) as per clinical team decision. experimental group(balanced multimodal vasopressor administration): early, simultaneous start of norepinephrine, angiotensin ii and vasopressin at equivalent starting doses (equivalent to approximately 0.05 mcg/kg/min of norepinephrine). increments of 0.05 mcg/kg/min of equivalent doses of all three vasopressors every 3-5 min until map ≥ 65 mmhg is reached (vasopressin will be administered at a maximum dose of 0.03 ie/min, at ii will be administered at maximum dose of 100ng/kg/min).

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years). * sepsis (an acute change in total sequential organ failure assessment (sofa) score ≥2 points consequent to infection) with persisting hypotension requiring vasopressors to maintain map ≥65 mm hg and having a serum lactate level \>2 mmol/l despite adequate volume resuscitation (20-30ml/kg in 3 hours). * vasopressor requirement of ≥0,15 μg/kg/min equivalent of norepinephrine base. * patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 72 hours of study. * patients are required to have an urinary catheter present, and it is expected to remain present for at least the initial 72 hours of study. * patients must have cardiac index (ci) \>2.3 l/min/m2 (measured by bedside echocardiography, pulse contour cardiac output (picco) or swan-ganz catheter). exclusion criteria: * death expected \<24 hours. * pregnancy (suspected or confirmed). * surgery expected for source of infection. * inter-hospital transfer expected during first 72 hours of hospitalization. * liver failure with a model for end-stage liver disease (meld) score of ≥30. * patients with acute mesenteric ischemia or a history of mesenteric ischemic. * patients with raynaud's phenomenon, systemic sclerosis or vasospastic disease. * patients with active bleeding and an anticipated need (within 48 hours of initiation of the study) for transfusion of \>4 units of packed red blood cells. * patients with a known allergy to mannitol. * patients on veno-arterial (va) ecmo.

Keywords: vasopressor agents angiotensin ii vasopressin norepinephrine renin lactate
effectiveness of additional acupuncture therapy for lung cancer patients

Conditions: Lung Cancer

Summary: this study aims for evaluating the effectiveness, safety and feasibility of additional acupuncture therapy for lung cancer patients who are under chemotherapy in an inpatient setting. the acupuncture therapy will be administered during a resting period between cycles of chemotherapy.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * karnofsky performance status (kps) 60% or more * undergoing antineoplastic chemotherapy for lung cancer * able to provide informed consent exclusion criteria: * brain metastasis, stroke or major psychiatric diseases * active infection * severe heart disease * serious systemic diseases such as uncontrolled hypertension and diabetes mellitus * acupuncture therapy within the previous three months * communication disorder * unwillingness to participate in the trial * severe immunocompromised state (absolute neutrophils count \< 1000/cubic mm)
blood flow restriction exercise-induced hypoalgesia

Conditions: Rotator Cuff Injury; Rotator Cuff Tear; Rotator Cuff Repair

Summary: the goal of this crossover randomized clinical trial is to compare the acute effect on exercise-induced hypoalgesia (eih) between isometric exercise with blood flow restriction (bfr) and isometric exercise alone in adults undergoing arthroscopic rotator cuff repair. it is presumed that the addition of bfr to isometric exercises induces a greater effect in eih. patients who agree to participate in this research will be randomly assigned to two intervention sequences (ab or ba), where intervention a (experimental) corresponds to isometric exercises with bfr, and intervention b (control) corresponds to isometric exercises alone. for one week, each participant attended two sessions, separated by a 72-hours wash-out period. the primary variables will be the pressure pain threshold (ppt) and conditioned pain modulation (cpm). secondary variables will be the pain intensity and distribution, kinesiophobia, upper extremity disability, and quality of life. results will be measured before intervention (t1, pre-intervention), immediate after intervention (t2, post-intervention 1) and 10 minutes after intervention (t3, post-intervention 2).


Eligibility criteria:
inclusion criteria: * age between 40-65 years. * symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging. * undergoing arthroscopic rotator cuff repair * be able to read and understand spanish. exclusion criteria: * massive irreparable rc tears, concomitant fracture, labral or nerve injury. * suspicion of developing/diagnosis a frozen shoulder. * revision surgery after rc repair. * previous corticosteroid injection (\< 1 year). * recent surgery (\< 1 year) in the contralateral shoulder. * a history of deep venous thrombosis/pulmonary embolism. * peripheral vascular disease, thrombophilia or clotting disorders. * severe or uncontrolled hypertension, or any comorbid condition that prevents participants from complete the intervention.

Keywords: blood flow restriction therapy blood flow restriction training exercise-induced hypoalgesia
the effect of platelet rich plasma (prp) on post operative pain in anterior cruciate ligament reconstruction

Conditions: Post Operative Pain

Summary: the purpose of this research study is to investigate whether or not platelet rich plasma (prp) may help to improve tendon healing and decrease post operative pain in patients undergoing anterior cruciate ligament (acl) reconstructive surgery using their own patellar tendons as autografts.

there is currently a paucity of well-designed, prospective, randomized, blinded (level 1) clinical studies that carefully and comprehensively investigate the role of prp in acl surgery. specifically, acl reconstruction using bone patellar tendon bone (bptb) harvest and the role of prp in decreasing postoperative pain at the donor site. given the need for a highly powered study to demonstrate the clinical efficacy of prp in acl reconstruction, the investigators have designed a prospective, randomized, level 1, double-blinded study to evaluate the effects of prp on the specific outcomes of donor site pain and radiographic measures of graft healing and incorporation. the aim of this study is to evaluate the efficacy of intra-operatively applied autologous prp in reducing donor site morbidity and increasing radiographic healing in acl reconstruction using autologous bptb.

Eligibility criteria:
inclusion criteria: * primary acl reconstruction * outerbridge \</= 2 * minimum follow up of two years * no ligamentous secondary injury * willingness to participate in study exclusion criteria: * any previous knee injury * prior history of anterior knee pain * outerbridge classification 3 or greater * revision acl * diabetic or smoker * workers compensation patient * pregnant or nursing women * any patient with limited english proficiency

Keywords: prp bptb vas anterior knee pain