Kornimate/medical-research-clean huggingface dataset:
clinical performance and safety of the unicompartmental univation® xf pro implant

Conditions: Gonarthritis; Degenerative Disease

Summary: the study is designed as a prospective, observational, mid-term, multi-center follow-up study. it is planned to include 150 patients from 4 different study centres in germany. the product under investigation is used in routine clinical practice and according to the authorized instructions for use (ifu). the data that is obtained in routine clinical use will be documented in an electronical case report form (ecrf). the study's main purpose is the collection of clinical data on the safety and performance of the redesigned univation® xf pro implant.


Eligibility criteria:
inclusion criteria: * indication for a primary medial unicompartmental knee endoprosthesis acc. to instructions for use: * both cruciate ligaments intact * lateral ligaments intact * leg axis amenable to passive correction * varus deformity under 15° * bending capability of at least 90° * extension deficit no greater than 5-10° * written informed consent of patient * kellgran \& lawrence score \> ii (only straight or varus * patients with moderate radiological symptoms * patients without clinical symptoms exclusion criteria: * pregnancy * patient age \ 75 years * bmi ≥ 40 * high risk patients asa \> iii

Keywords: degenerative medial unicompartmental gonarthrosis unicompartmental knee arthroplasty safety and performance
coordinated endoscopic colorectal cancer screening

Conditions: Preventive Health Services

Summary: the investigators aim to use a randomized design to test the effects of 1) tailored physician recommendations, relative to non-specific recommendations, and 2) coordinated physician office management systems on patient adherence to colorectal cancer screening recommendations.

the investigators aim to use a randomized design to test the effects of 1) tailored physician recommendations, relative to non-specific recommendations, and 2) coordinated physician office management systems on patient adherence to colorectal cancer screening recommendations. to accomplish these aims, the investigators propose 1) to use existing physician practice-based computerized patient registration systems to define populations of 50 to 79 year-old pri-mary care patients, 2) to use mailed questionnaires to determine colorectal cancer risk factor status and prior colorectal cancer screening history, 3) to use responses from mailed questionnaires to identify persons not adhering to colorectal cancer screening guidelines, 4) to use computer driven algorithms to help physicians prepare and deliver individually tailored and written colorectal cancer screening recommendations, and 5) to develop, implement, and evaluate a centralized service for delivering high quality screening flexible sigmoidoscopy.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * history of colorectal cancer or polyps * flexible sigmoidoscopy within five years of enrollment * barium enema within five years of enrollment * colonoscopy within five years of enrollment

Keywords: colorectal cancer screening sigmoidoscopy colonoscopy
taco crossover trial

Conditions: Transfusion-associated Circulatory Overload; Blood Transfusion Reaction

Summary: this is an open-label, prospective crossover randomized controlled trial to investigate wether taco is solely hydrostatic pressure overload or arises from a combination of hydrostatic pressure overload and capillary leakage, by investigating the difference in change in static pressure parameters (pcwp), dynamic volume parameters (picco) as indirect measurements of volume status and capillary leakage after autologous transfusion or saline infusion. the investigators will estimate effective circulating volume following autologous transfusion or saline infusion. furthermore, the investigators will investigate the effect of fluid loading on the microcirculation.

coronary arterial bypass grafting surgery patients with reduced left ventricular function will be allocated to either infusion of 300ml saline with a subsequent autologous rbc (cell saver) transfusion of 300 ml at a rate of 10ml/min, or the same in the reversed order. prior to start of the intervention, 15 minutes following start of infusion and a the end of infusion, the investigators will measure right-ventricular pressure and wedge pressure (pcwp), as well as extravascular lung water index (evlwi) and co estimation through picco® and pulmonary artery catheter. the investigators will identify fluid responsiveness by performing a passive leg raise test (plr). the investigators aim to measure total vessel density (tvd), perfused vessel density (pvd), proportion of perfused vessels (ppv), microvascular flow index (mfi), and blood vessel diameters (øbv) from the oral microcirculation by cytocam microscope system. the investigators will estimate the effective circulating blood and plasma volume through dilutional infusion of indocyanine green prior to initial infusion, between and at the end of subsequent infusion.

Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. elective (non-redo) coronary arterial bypass grafting surgery 3. reduced left ventricular ejection fraction (\<55%) 4. transfusion of autologous blood (cell saver blood, 300ml, hct60%, 30min) 5. informed consent exclusion criteria: 1. patients with no indication for autologous rbc transfusion 2. patients with pulmonary hypertension, congenital heart disease, mitral or tricuspid valve disease. 3. contraindications for pac placement; coagulopathy, bundle branch block, defibrillator or pacemaker (risk of displacement). external pacemaker placed during surgery is no exclusion criterium. 4. patients for acute, non-elective surgery 5. chronic kidney disease stage 4 or higher (egfr \< 30) 6. massive transfusion 7. previous randomization in the current trial 8. postoperative ongoing bleeding 9. bypass duration \> 2 hours 10. infusion of high dose corticosteroids 11. hemodynamic instability with a mean arterial pressure (map) \ 20 mmhg or dependence on high dosages of inotropic drugs after admittance to the icu 12. severe arrhythmias 13. development of severe pulmonary edema during infusion of autologous blood or saline. 14. elevated liver enzymes 15. iodine allergy
randomized, placebo/active crossover dose-ranging study for safety and efficacy in asthma patients.

Conditions: Asthma

Summary: the main objective of this study is to evaluate the efficacy and safety of the armstrong's epinephrine hfa-mdi (e004) formulation, in comparison to the placebo (placebo-hfa) and an active control (epinephrine cfc-mdi), and to identify the optimum e004 dose strength(s) for the ensuing pivotal clinical trials. the study will be conducted in adult patients who have intermittent, or mild-to-moderate persistent, asthma, but are otherwise healthy. the bronchodilatory efficacy of e004, is evaluated in terms of post-dose area under the curves (auc) of fev1 changes (% and volumes), from the pre-dose baseline values, in comparison to the placebo control and the active control.


Eligibility criteria:
inclusion criteria: 1. generally healthy, male and female adults aged 18 to 55 years at screening. 2. clinical diagnosis of intermittent, or mild-to-moderate persistent, asthma for at least 6 months before screening, and having used inhaled epinephrine or β-agonist(s) for asthma control; 3. demonstrating a baseline forced expiratory volume in 1 second (fev1) at 50-90 percent of predicted normal at screening; 4. demonstrating a 12.0 percent or greater airway reversibility in fev1 within 30 min after inhaling 2 actuations of epinephrine cfc-mdi (440 mcg epinephrine base) at screening; 5. females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control; 6. demonstration of proficiency in the use of a mdi inhaler after training; 7. having properly consented to participate in the trial. exclusion criteria: 1. a smoking history of 10 or more pack-years, or having smoked within 6 months prior to screening; 2. upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to screening; 3. asthma exacerbations that required emergency care or hospitalized treatment, within 4 wk prior to screening; 4. any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma; 5. concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine (including diabetes), psychiatric, neoplastic or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study; 6. known intolerance or hypersensitivity to any of the study mdi ingredients (i.e., epinephrine, hfa-134a, cfc-12, cfc-114, polysorbate-80, ethanol, thymol, nitric acid and ascorbic acid); 7. use of prohibited drugs or failure to observe the drug washout restrictions; 8. having been on other investigational drug/device studies in the last 30 days prior to screening.

Keywords: mild to moderate asthma dyspnea wheezing status asthmaticus
immediate implant placement in the molar regions

Conditions: Periodontitis; Dental Caries; Periapical Periodontitis

Summary: the purpose of this study is to look at the bonehealing when a molar has been extracted and immediately replaced by an implant leaving some defects around the implant. the defects are being treated in three different with the hypothesis that the three ways of treatment result in equal bonehealing.

this study is a randomized clinically controlled study with three group of each thirty patients, where the bonehealing after immediate implantplacement in molarregions is being investigated. totally 90 patients are going to get a molar tooth extracted and immediately replaced with an implant (brånemark system, wide platform). the molar tooth should be in such a condition that is has to be extracted. extracting a molar leaves a defect which cannot completely be filled out by an implant. the 90 patients are therefore randomised into 3 groups according to how the perimarginal bonedefects around the placed implants are being treated: 1. bonechips 2. membrane 3. bonechips+membrane. the bonehealing of the defects around the implants are then compared the groups in between. the amount of newly formed bone is being estimated too by digital radiography and subtractionradiography. furthermore the prognosis for immediate placed implants in molar regions in relation to the method of defectreconstruction one year after crown delivery is also being investigated. all the investigations are conducted with the ho-hypothesis that there is no difference in the bonehealing the three groups in between.

Eligibility criteria:
inclusion criteria: * a molar tooth which has to be extracted * healthy persons with only mild systemic disease with no functional limitation exclusion criteria: * pregnant * any disease that is influencing the turnover of bone or oral mucosa

Keywords: implant immediate placement molar tooth
weight reduction in clbp

Conditions: Chronic Low-back Pain; Overweight or Obesity

Summary: we will recruit overweight/ obese participants between the age of 18 and 65 with chronic nonspecific low back pain . the participants will be randomly assigned to one of two interventions (each lasting 10 weeks). all interventions will be delivered in a blended format and will be a combination of online education material and face-to-face sessions with a physical therapist. the first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. allocation to the groups will be at random. participants and assessors will be blinded for group allocation. the primary outcomes is pain intensity. secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.


Eligibility criteria:
inclusion criteria: * overweight (bmi ≥ 25 kg/m2) or obese (bmi ≥ 30 kg/m2) with chronic low back pain * non-specific low back pain for at least 3 months' duration * currently seeking care for low back pain * native dutch speaker * access to internet and computer/tablet/smartphone exclusion criteria: * leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale * evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy) * evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases) * bmi ≥ 40 kg/m2 * being pregnant or given birth in the preceding year * currently receiving dietary or exercise interventions

Keywords: chronic low back pain chronic pain physiotherapy physical therapy weight reduction pain management
prevalence of muscle and nerve and joint pain

Conditions: Muscle Pain; Joint Pain; Nerve Pain

Summary: the purpose of the study is to provide adequate information about the percentage of the main tissue that causing pain in most common spinal disorders either it is muscular, nerve or joint in each spinal parts, that will provide the physical therapist with large data that can be helpful in differential diagnosis.


Eligibility criteria:
inclusion criteria: 1. - patients from 18 to 60years 2. - both gender and any condition diagnosed by orthopedic physician with spinal disorders 3. - pre and post operative patient may be included. exclusion criteria: 1. viscerogenic pain 2. cancer 3. psychogenic pain or psychogenic disorder 4. rheumatoid arthritis 5. fibromyalgia.
anxiety of patient and his partner during admission to emergency department

Conditions: Anxiety; Emergencies

Summary: evaluate and compare the impact of partner's stress in the pain of the patient admitted in the emergency department

admission to an emergency department is a major source of anxiety for the patient. anxiety plays not only a role in its emotional state but can also have consequences on the taking care of the patient and especially on the analgesic procedure. since pain is one of the first causes of emergency admission, patient anxiety should not be overlooked. in the emergency department, patient consults frequently, with his partner . anxiety can also affect the partner, which may affect the patient. no studies have yet demonstrated this correlation. this study will evaluate, the anxiety of both parties and show the presence or not of an influence of the partner's anxiety on the patient using a standardized questionnaire, the state-trait anxiety inventory- form y (stai-y).

Eligibility criteria:
inclusion criteria: * admission to emergency department accompanied by his partner (lives in concubinage with the patient) * nurse patient's classification score up or equal to 3, 4 or 5 * oral consent given to the inclusion by the patient and the partner * patient and partner francophone or with a good understanding of french exclusion criteria: * patient under a system of legal protection * non-communicating patient and partner * patient and partner unable to write * refusal of patient or partner * admission of the patient with shock treatment corresponding to the nurse patient's classification score 1 and 2
effect of thrombus aspiration in patients with myocardial infarction presenting late after symptom onset

Conditions: Myocardial Infarction

Summary: the purpose of this study is to examine the benefit of thrombus aspiration in patients with st-elevation myocardial infarction presenting late after symptom onset.


Eligibility criteria:
inclusion criteria: * st-elevation myocardial infarction \>12 and \<48 hours after symptom onset * age 18 to 90 years * informed consent exclusion criteria: * prior fibrinolysis * severe comorbidities with limited life expectancy * pregnancy * patient unable to give informed consent * participation in another trial * contraindications for heparin, aspirin or thienopyridines * contraindications for cardiac magnetic resonance examination
sleep treatment education program for cancer survivors: step-together

Conditions: Insomnia; Insomnia Chronic; Survivorship

Summary: this single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the sleep treatment education program together (step-together) intervention which is delivered as a synchronous group session by videoconference.

this single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the sleep treatment education program together (step-together) intervention which is delivered as a virtual group session. the research study procedures including screening for eligibility and questionnaires. participation in this research study is expected to last about 16 weeks. it is expected about 90 people will participate in this research study.

Eligibility criteria:
inclusion criteria: * age 18-89 * history of a cancer diagnosis (except non-melanoma skin cancer) ≥ 6 months prior * no active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned. * significant insomnia as evidenced by an insomnia severity index score ≥ 8 * regular access to the internet * able to read and write in english exclusion criteria: * usual bedtime does not fall between 5:00 pm and 5:00 am. * employment in a position where falling asleep at work could impact public safety (such as air traffic-controller, operating heavy machinery). * ever diagnosed with bipolar disorder or with seizure disorder, currently taking medications to prevent a seizure, or have experienced a seizure in the prior 12 months. * any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.

Keywords: insomnia chronic insomnia cancer survivorship
trial of imo-3100 in patients with moderate to severe plaque psoriasis

Conditions: Actively Extending Plaque Psoriasis; Moderate to Severe Plaque Psoriasis

Summary: the purpose of this study is to evaluate different dose levels of imo-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.

to evaluate the safety, tolerability and treatment effect of different dose levels of imo-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.

Eligibility criteria:
inclusion criteria: * is age 18 to 70 years, inclusive; * completes the informed consent procedure (see section 15.3), including signing and dating the informed consent form; * has moderate to severe plaque psoriasis meeting the criteria specified above; * female subjects must have a negative pregnancy test at screening and on day 1 prior to start of treatment; * female subjects of childbearing potential (see section 8.4.1) and male subjects who have partners of childbearing potential must agree to use effective birth control (contraception; see section 8.4.1) from screening through the treatment period and for four (4) weeks after the last injection of study drug. exclusion criteria: * has known hypersensitivity to any oligodeoxynucleotide; * is nursing; * has body weight \< 50 kg; * has bmi \> 34.9 kg/m2; * regularly consumes \> 3 drinks of alcoholic beverages (beer, wine, or distilled spirits) per day; * has a positive test for antibody to human immunodeficiency virus (hiv-1 or -2) or hepatitis c virus; * has a positive test for hepatitis b surface antigen (hbsag); * has at screening safety laboratory tests meeting one or more of the following criteria: * hemoglobin \< 10.5 g/dl * white blood cell count \< 4,000 cells/mm3 * absolute neutrophil count (anc) \< 1500/mm3 * platelet count \< 100,000/mm3 * alanine transaminase (alt; sgpt) \> 1.5x uln * aspartate transaminase (ast; sgot) \> 1.5x uln * serum total bilirubin \> 1.4x uln * serum creatinine \> 1.3x uln; * has a history of allogeneic organ transplant (including bone marrow or stem cells); * has, within the past 10 years, had evidence of or required treatment for cancer (except treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ); * has had within the past three months or is expected to have during the study period any of the following treatments: * surgery requiring general anesthesia * hematopoietic stimulating agents (e.g., erythropoietin, g-csf, gm-csf) * another investigational drug; * has other significant medical disease (chronic or active within the past 6 months), including, but not limited to: cardiac disease (e.g., unstable angina, myocardial infarction, congestive heart failure, ventricular arrhythmia); uncontrolled seizure disorder; liver disease; chronic infection (e.g., tuberculosis); uncontrolled diabetes; * has any other condition that would, in the opinion of the investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.

Keywords: psoriasis plaque psoriasis
use of oral itraconazole in patients with locally limited basocellular carcinoma of skin.

Conditions: Basal Cell Carcinoma; Hedgehog Pathway

Summary: patients with localized basocellular carcinoma of the skin, will receive oral itraconazole, 200 mg twice daily, for 60 days, prior to curative intent surgery.

patients with localized basocellular carcinoma of the skin, will receive oral itraconazole, 200 mg once daily, for 60 days, before surgery with curative intent. tumor area regression will be measured through dermatologic evaluation and photographic documentation on baseline and at the end of the 60 day treatment period. the activity of the hedgehog pathway will be measured on tissue samples obtained at the time of diagnosis and at the time of curative intent surgery, through the measuring of the ki67 index.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of basocellular carcinoma (bcc) of the skin, histologically confirmed. * at least one bcc lesion with 10 mm in the longest diameter * disease amenable to surgical intervention with curable intent. * signed informed consent * ps ecog 0 to 3 exclusion criteria: * chronic renal disease, with a glomerular filtration rate of less than 30 ml/min * acute or chronic liver disease, as measured by: total bilirubin \> than 1.5 x uln and ast and alt \> than 5 x uln. * symptomatic cardiac insufficiency or an ejection fraction lower than 50% measured through echocardiography, * other active malignancies in the last year. * uncontrolled systemic hypertension, * any chronic infections such as tuberculosis, viral hepatitis and hiv. * pregnancy, suspected or confirmed. * known intolerance to the use of itraconazole.

Keywords: itraconazole