Kornimate/medical-research-clean huggingface dataset:
use of cold and compression therapy with total knee replacement patients

Conditions: Osteoarthritis; Total Knee Arthroplasty

Summary: the purpose of the study is to evaluate the effectiveness of a device that delivers cold and intermittent compression as compared to ice and compressive wraps on patients who have undergone knee replacement.

the use of cryotherapy with compression for orthopedic postoperative recovery has not been fully investigated. a new device has been developed that combines cold and intermittent pneumatic compression in a single system. a well-controlled clinical study evaluating the clinical effectiveness of cryotherapy with compression in an orthopedic postoperative application is the subject of this protocol. patients diagnosed with osteoarthritis of the knee and scheduled for primary total knee arthroplasty procedure will be invited to participate in this study.

Eligibility criteria:
inclusion criteria: * at least 18 but no more than 85 years of age * body mass index not greater than 40 * diagnosis of osteoarthritis of the knee * medically cleared for total knee replacement surgery * physically and mentally able and willing to participate in and follow the study protocol and schedule * able and willing to have all postoperative physical therapy visits in a physical therapy clinic associated with the research site * signed informed consent document for the study exclusion criteria: * rheumatoid arthritis * severe pitting edema in the ipsilateral limb * history of thrombophlebitis in lower extremities * an active systemic disease such as aids, hiv, hepatitis, etc. * is immunologically suppressed or has received or is receiving steroids at any dose daily for more than one month within the last 12 months * is pregnant or planning to become pregnant during the study period * any condition that would contraindicate using the game ready * currently enrolled in another clinical trial that could affect outcome of this study * previously enrolled in this study

Keywords: osteoarthritis total knee arthroplasty cryotherapy
protect ii, a prospective, multicenter randomized controlled trial

Conditions: Coronary Artery Disease

Summary: the impella® 2.5 system will be superior to intra aortic balloon pump in preventing the composite rate of major adverse events during and after the pci procedure.


Eligibility criteria:
inclusion criteria: * informed consent * subject is indicated for a non emergent percutaneous treatment of at least on de novo or restenotic lesion in a native coronary vessel or bypass graft. * patient presents with: * a compromised ejection fraction * intervention on the last patent coronary conduit * intervention on an unprotected left main artery or * patient presenting with triple vessel disease. exclusion criteria: * st elevation m.i. * pre procedure cardiac arrest within 24 hours. * subject in cardiogenic shock

Keywords: patient undergoing scheduled pci
transhepatic versus subcostal views to assess inferior vena cava variation in pediatric patients

Conditions: Inferior Vena Cava Abnormality

Summary: currently, in order to visualize the inferior vena cava (ivc) of the heart using ultrasound, physicians traditionally place the ultrasound probe onto the "subcostal" area which is located below the chest in the upper abdomen area. in this location, the pressure from the ultrasound probe is often uncomfortable for adults, and even more so for pediatric patients. previous research and physician experience have demonstrated that it is possible to visualize the heart in the "transhepatic" area which is located under the arm on the side of the chest. by placing the ultrasound probe in this location, it is more comfortable for the patient when applying pressure, and this study aims to prove the effectiveness of visualizing the heart through this new location.


Eligibility criteria:
inclusion criteria: 1. be between ages of 2-18 years of age 2. have parental consent 3. located at an inpatient/outpatient facility at lpch 4. be hemodynamically stable exclusion criteria: 1. emergent surgical procedures 2. bmi greater than 24
efficacy and safety of metoprolol succinate prolonged-release tablet in patients with mild to moderate hypertension

Conditions: Hypertension

Summary: this is an open-label, non-comparative, multi-centre clinical study to evaluate the efficacy and safety of metoprolol succinate prolonged-release tablet (betaloc zok) in patients with mild to moderate essential hypertension.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * newly diagnosed essential hypertension who have not received anti- hypertensive treatment, or patients without antihypertensive medication in two weeks before screening, 90mmhg\<sidbp \<110mmhg and sisbp \<180mmhg. exclusion criteria: * known or suspected secondary hypertension * resting hr is \< 55bpm. * sick sinus syndrome * atrioventricular block of first degree (with p-r\>0.24seconds), or second or third degree

Keywords: post marketing study
comparison of nsaid patch given in monotherapy and nsaid patch in combination with transcutaneous electric nerve stimulation, heating pad, or topical capsaicin in the treatment of patients with myofascial pain syndrome of the upper trapezius: a pilot study

Conditions: Myofascial Pain Syndrome of the Upper Trapezius

Summary: myofascial pain syndrome (mps) is a common clinical problem of musculoskeletal pain and various treatment modalities have been introduced. if self-applicable physical modalities and medications that are used for treatment of mps patients are combined, they may open up new possibilities for effective and practical self-care. the aim of this study is to compared the therapeutic effect of non-steroidal anti-inflammatory drug (nsaid) patch given in monotherapy and nsaid patch in combination with transcutaneous electric nerve stimulation, heating pad, or topical capsaicin in the treatment of patients with mps of the upper trapezius.


Eligibility criteria:
inclusion criteria: 1. patients over 20 years of age with diagnosis of myofascial pain syndrome of the upper trapezius. 2. visual analogue scale (vas, 0 = no pain, 10 = worst pain) greater than exclusion criteria: 1. pregnant or breast feeding women, patients who have taken opioids within seven days, patients with severe disease (heart disease, liver disease, etc) that might affect the results of the study, patients who have participated in another clinical study within 30 days.

Keywords: capsaicin myofascial pain syndrome non-steroidal anti-inflammatory agents transcutaneous electric nerve stimulation
neonatal neurological examination to detect infants at risk

Conditions: Neonatal Encephalopathy

Summary: the study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.

the study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies. infants at risk of neurological abnormlaiyies, such as very pèretrm infants and infants with asphyxia or with overt neyurologocal abnormla signs suh as convilsions will be assessed with a structured neurological examination and followed over time.

Eligibility criteria:
inclusion criteria: all newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions exclusion criteria: families unwilling to sign consent
a long-term study of nemolizumab (cd14152) in participants with prurigo nodularis (pn)

Conditions: Prurigo Nodularis

Summary: the primary purpose of this study is to assess the long-term safety of nemolizumab (cd14152) in participants with prurigo nodularis (pn).


Eligibility criteria:
inclusion criteria: * participants who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for pn including: (a). participants who completed the treatment period in a phase 3 pivotal study (nct04501666 or nct04501679) and enroll within 56 days or (b). participants who were previously randomized in the nemolizumab phase 2a pn study (nct03181503) or (c). participants who completed through week 24 of the phase 3b durability study (nct05052983) or who exit the study due to relapse may be eligible to re-enter in the lte study within 28 days of exiting the durability study (selected countries/ selected sites) * female participants of childbearing potential (that is, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection * participant willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the participant using an electronic handheld device provided for this study * understand and sign an informed consent form (icf) before any investigational procedure(s) are performed exclusion criteria: * participants who, during their participation in a prior nemolizumab study, experienced an adverse event (ae) which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant * body weight \< 30 kg * pregnant women (positive pregnancy test result at screening or baseline visit or re-entry week r0 visit), breastfeeding women, or women planning a pregnancy during the clinical study * any medical or psychological condition that may put the participant at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (example, poor venous access or needle-phobia) * planning or expected to have a major surgical procedure during the clinical study * participants unwilling to refrain from using prohibited medications during the clinical study * history of alcohol or substance abuse within 6 months prior to the screening visit or re-entry week r0 visit
a clinical comparison of three bronchial blockers for one-lung ventilation in thoracic surgery

Conditions: Thoracic Surgery

Summary: this is a clinical trial comparing surgical conditions during one-lung ventilation with three different bronchial blockers or with double-lumen endobronchial tubes.


Eligibility criteria:
inclusion criteria: * left thoracotomy exclusion criteria: * contraindication to lung isolation

Keywords: bronchial blockers lung isolation thoracic anesthesia
a safety and effectiveness study of cnto 1275 in patients with moderate to severe plaque-type psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of cnto 1275 in the treatment of patients with moderate to severe plaque psoriasis.

this is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of cnto 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). the dose of cnto 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses. patients who inadequately respond to their treatment may receive one additional dose. patients will be monitored for the safety throughout the study.

Eligibility criteria:
inclusion criteria: * have had a diagnosis of plaque-type psoriasis at least 6 months * plaque-type psoriasis covering at least 10% of total body surface areas * psoriasis area-and-severity index score of 12 or greater * considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis * women of childbearing potential and all men must agree to use adequate birth control measures * have no history of latent or active tuberculosis exclusion criteria: * currently have nonplaque forms of psoriasis or drug-induced psoriasis * women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study * patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months * patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection * patients known to be infected with human immunodeficiency virus, hepatitis b, or hepatitis c * patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease * have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence)

Keywords: psoriasis cnto 1275 ustekinumab stelara interleukin-12 il-12 interleukin-23 il-23
irinotecan liposome combined with oxaliplatin and tegafur as adjuvant therapy for pancreatic cancer

Conditions: Pancreatic Cancer; Adjuvant Therapy

Summary: the purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (nasox) for postoperative adjuvant chemotherapy for pancreatic cancer.


Eligibility criteria:
inclusion criteria: 1. ecog performance status 0 or 1. 2. histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (r0 and r1). 3. ecog performance status 0 or 1. 4. life expectancy of greater than or equal to 6 months. 5. able and willing to provide a written informed consent. exclusion criteria: 1. patients who cannot eat orally and have gastric emptying disorder after surgery; 2. patients with moderate diarrhea: diarrhea ≥4 times per day; the moderate and severe effluents from stoma increased; or diarrhea that limits activities of daily living; 3. patients who cannot eat orally and have gastric emptying disorder after surgery; 4. patients who cannot eat orally and have gastric emptying disorder after surgery;
graduated recovery intervention program for enhancing treatment for first-episode psychosis

Conditions: Psychotic Disorders; Schizophrenia

Summary: this study will determine the effectiveness of the graduated recovery intervention program, a manual-based individual therapy program, in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.

several mental disorders can be classified as psychotic disorders, such as schizophrenia and manic depression. psychosis is a defining feature of psychotic disorders, and is characterized by delusions and hallucinations that result in extreme impairment of a person's ability to think clearly. first-episode psychosis refers to the first time someone experiences psychotic symptoms or a psychotic episode. the symptoms can be disturbing and unfamiliar to those who have not previously experienced them. the person experiencing first-episode psychosis may not understand what is happening, and may become confused and distressed. psychosis is treatable, however, and most people recover. standard treatment for psychosis entails a combination of behavioral therapy and drug therapy. grip is a comprehensive psychosocial intervention for people recovering from an initial episode of non-affective psychosis. the purpose of grip is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. this study will determine the effectiveness of grip in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis. participants in this study will be randomly assigned to receive either treatment as usual (tau) or tau plus grip. participants receiving tau will meet with their case-manager and health care providers on an as-needed basis. participants assigned to receive tau plus grip will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. grip includes four phases, each of which focuses on one of the following topics: engagement and wellness management; substance use; persistent symptoms; and functional recovery. assessments of social functioning, psychotic symptoms, attitudes toward treatment, substance use, and hospital readmission rate will be assessed at baseline, mid-treatment, post-treatment, and at the follow-up visit 3 months post-treatment.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder * has been in treatment for psychosis for less than 3 years * clinically stable (based on clinician judgement) * iq score greater than 70 * currently receiving keyworker services at unc hospital's oasis program exclusion criteria: * organic brain disorder * substance-induced psychotic disorder * mental retardation

Keywords: first episode psychosis early psychosis psychosocial intervention
comparison of core muscle asymmetry using spine balance 3d in patients with arthroscopic shoulder surgery

Conditions: Muscle Disorder; Postoperative Pain; Shoulder Injuries; Immobilization; Asymmetric Limb Muscle Stiffness

Summary: this study is an observational cross-sectional study. post-operative patients need an immobilization period for a certain period of time after surgery. kinetic chain changes due to immobilization can affect the symmetry of the core muscle. therefore, in this study, core muscle asymmetry (cma) is measured using a whole body tilt device for inpatients who have undergone arthroscopic shoulder surgery. we would like to make a clinical suggestion for post-operative rehabilitation by identifying the characteristics of cma according to the left or right site.


Eligibility criteria:
inclusion criteria: * arthroscopic shoulder surgery * limit of motion due to shoulder pain exclusion criteria: * orthopedic surgery or other medical history in the lower extremities * neurological history or are taking related medications * chronic headache or disease related to the inner ear * cardiovascular disease that may affect balance ability or take related medications * acute dizziness * when performing other balance training
a study of jzp150 in adults with posttraumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: this is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of jzp150 in the treatment of adult participants with post-traumatic stress disorder (ptsd).

jzp150 is an oral, highly selective inhibitor of fatty acid amide hydrolase (faah). in this phase 2 study, participants with ptsd will receive either placebo or 1 of 2 doses of jzp150. the primary objective of the study will assess the change in ptsd symptoms from baseline to week 12 using the clinician administered ptsd scale (caps-5).

Eligibility criteria:
inclusion criteria: * participants aged 18 to 70 years * participants must be outpatients with a primary diagnosis of diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) defined ptsd confirmed by the clinical interview * ptsd is primary diagnosis exclusion criteria: * acute or unstable medical condition, behavioral or psychiatric disorder (other than ptsd) * suicidal behavior in the past 2 years or active suicidal ideation in the past 6 months * ongoing traumatic event or exposure to a traumatic event \<3 months prior to screening * index event \> 12 years * index event is combat trauma

Keywords: post traumatic stress disorder jzp150
nicotine pharmacodynamics with a new oral nicotine replacement therapy and nicotine gum

Conditions: Tobacco Dependence

Summary: a comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.

this study will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. treatments comprise single doses of an experimental nicotine replacement therapy (nrt) and nicorette freshfruit gum 4 mg, which are chewed during 30 minutes. all subjects will be given both treatments in a crossover setting. the length of the time interval separating treatment visits, and during which no nrt must be used, will be at least 36 hours. the subjects will abstain from smoking from 8 pm the evening before until the end of each visit. the subjects will take the gums according to instructions from the study personnel. after chewing, used gums will be collected for nicotine analysis. electronic diaries will be used to collect data. urges to smoke will be scored on a 100 mm visual analogue scale (vas) before the start of treatment and during 5 hours thereafter. subjects will also be monitored to capture any adverse events that may occur.

Eligibility criteria:
inclusion criteria: * healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion. * body mass index (bmi) between 17.5 and 32.0 kg/m2 and a total body weight of at least 55.0 kg. * female participants of child-bearing potential are required to use a medically acceptable means of birth control. * a personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: * pregnancy, lactation or intended pregnancy. * treatment with an investigational product within one month preceding the first dose of study medication.

Keywords: smoking cessation nicotine pharmacodynamics