Kornimate/medical-research-clean huggingface dataset:
safety and antiviral activity of clevudine in patients who have completed the l-fmau-301 or l-fmau-302 trials

Conditions: Hepatitis B

Summary: the purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period


Eligibility criteria:
inclusion criteria: 1. patient is between 18 and 60, inclusive 2. patients who have completed l-fmau-301 or l-fmau-302 clinical trial. 3. patient is hbsag positive at week 48 in l-fmau-301 or l-fmau-302. 4. patient has bilirubin levels less than 2.0 mg/dl, prothrombin time of less than 1.7 (inr), a serum albumin level of at least 3.5 g/dl at week 48 in l-fmau-301 or l-fmau-302. 5. women of childbearing potential must have a negative serum (β-hcg) pregnancy test at screening. 6. patient is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. patients with hbv dna \< 4,700 copies/ml, alt normalization and consecutive e seroconversion at week 40 and 48 in l-fmau-301 2. patients with hbv dna \< 4,700 copies/ml and alt normalization in l-fmau-302 3. patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy. 4. patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for hbv infection. 5. patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. 6. patient is coinfected with hcv, hdv or hiv. 7. patient with clinical evidence of liver mass or hepatocellular carcinoma and α-fetoprotein \> 50 ng/ml 8. patient is pregnant or breast-feeding. 9. patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. for males, condoms should be used. females must be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. iud, barrier methods with spermicide or abstinence) 10. patient has a clinically relevant history of abuse of alcohol or drugs. 11. patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic gb stone, neurological, cardiovascular, oncologic or allergic disease. the patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor. 12. patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72)(serum creatinine \[mg/dl\]) \[note: multiply estimates by 0.85 for women\] 13.patient whom investigator consider is not suitable in this study
knee arthroplasty performed with conventional and customized instrumentation

Conditions: Knee Arthritis

Summary: the main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with customized patient instrumentation (cpi) than with conventional instrumentation. each case will be recorded by video camera, in order to time the length of surgery and each surgical step. the number of surgical trays required for each case will be recorded. as an additional endpoint, the investigators will measure limb and component alignment on x-rays to determine if these two methods achieve equivalent alignment results. the thickness of bone cuts will be compared to the surgical plan and to each other. the primary hypothesis is that the use of customized patient instrumentation will reduce the operative time required for total knee arthroplasty.

patient-specific instrumentation (psi) has been developed for total knee arthroplasty (tka) with several potential advantages over traditional instrumentation (ti). shortened surgical time, fewer surgical instruments, and improved alignment are some of these proposed advantages. we sought to examine these assertions. 52 patients (26 per group) were enrolled in a prospective, randomized trial comparing ct-based psi with ti. no difference was seen in average patient age (68 years) or bmi (31) between groups (p=0.84 and p=0.89), although there were more males in the psi group (14 vs 7, p=0.002). a single surgeon and consistent staff performed the surgeries with the same knee prostheses, and all cases were videotaped to measure the length of surgery and each individual step. any additional bone cuts, size changes, or ligament releases made to achieve correct alignment and balance were documented. the number of instrument trays opened for each case was recorded. postoperative long alignment and lateral radiographs were taken to measure the coronal and sagittal plane component alignment and mechanical axis in each patient.

Eligibility criteria:
inclusion criteria: * patient requires unilateral primary total knee arthroplasty exclusion criteria: * body mass index greater than 41 * previous ipsilateral hip or ankle replacement * knee flexion contracture greater than 20 degrees

Keywords: total knee arthroplasty instrumentation
efficacy and safety study of sunpg1622

Conditions: Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis

Summary: this is a randomized, double-blind, placebo-controlled phase 2a study to evaluate the efficacy and safety of sunpg1622.


Eligibility criteria:
inclusion criteria: * subject has provided informed written consent * subject is ≥ 18 years of age at time of screening * subject must be on a stable dose of nsaid for ≥ 2 weeks prior to initiation of investigational product * subject has a negative test for tb within 4 weeks before initiating imp exclusion criteria: * subjects with known diagnosis of fibromyalgia or complex regional pain syndromes * active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening * radiographic evidence of total ankylosis of the spine * subject has a planned surgical intervention between baseline and the week 24 evaluation for a pre-treatment condition
telemedical versus conventional emergency care of hypertensive emergencies

Conditions: Hypertensive Emergency; Hypertensive Urgency

Summary: comparison of telemedical prehospital emergency care and conventional on-scene physician based care of hypertensive emergencies and urgencies. the adherence to current guidelines should be researched.

telemedically guided cases of hypertensive emergencies (april 2014 - march 2015) and urgencies are compared with a historical control group of conventional emergency medical service physician care on-scene for these scenarios. the historical control group is a time period prior to implementation of the telemedicine system and after a research project with a precursor telemedicine system. no telemedical support but only conventional on-scene ems physician care was available (november 2013 - march 2014).

Eligibility criteria:
inclusion criteria: * prehospital diagnosis of hypertensive emergency of hypertensive urgency exclusion criteria: prehospital diagnoses of: * pulmonary edema * aortic dissection * acute coronary syndrome * acute stroke * acute respiratory insufficiency
a clinical study to compare functional outcomes after surgery using a transverse or longitudinal surgical incision in the skin.

Conditions: Functional Disturbance as Result

Summary: trigger finger is a common pathology in the hand. patients suffer from pain and depending on which tasks, patients have difficulty to perform them. its treatment in initial and less serious phases includes conservative measures, but failure of these may require releasing the trigger finger with surgery. the surgical technique performed for trigger finger is the opening of the a1 pulley, the skin incisions used for this surgery are various (transverse, longitudinal, oblique). trigger finger surgery presents good results in terms of resolution, but complications may also occur. the reason for this study is to assess whether there are functional differences using the dash scale when we perform a transverse or longitudinal incision in trigger finger surgery.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * clinical diagnosis of trigger finger grade ii to iv. grade i (pre-trigger) pain, history of entrapment, but not demonstrable on physical examination, tenderness over the a1 pulley. grade ii (active) demonstrable entrapment, but the patient can actively extend the finger. grade iii (passive) demonstrable entrapment, patient requires passive extension iiia or inability to actively flex iiib. grade iv (contracture) demonstrable entrapment with fixed flexion contracture of the pip. exclusion criteria: * thumb * polydigital * allergy to local anesthetics and/or vasoconstrictor agents. * previous surgery * patients who, in the researcher's opinion, are not good candidates for the study (e.g. inability to comply with the follow-up program, comorbidity, poor physical or mental health in general, drug or alcohol abuse problems...).
approach modification for total knee arthroplasty in morbidly obese patients

Conditions: Arthropathy; Incision, Surgical; Obesity, Morbid

Summary: the study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations


Eligibility criteria:
inclusion criteria: * morbid obese patients with body mass index more than 45 requiring total knee arthroplasty for any cause exclusion criteria: * candidates not meeting the inclusion criteria

Keywords: total knee arthroplasty obese
homeopathic preparation plumbum metallicum for lead poisoning

Conditions: Lead Poisoning

Summary: saturnism, or lead poisoning, is defined by clinical symptoms (affecting primarily the nervous, hematopoietic, gastrointestinal, cardiovascular, musculoskeletal, renal and reproductive systems) compatible with exposure, in the short or long term, to lead or to its compounds, and can manifest as acute or chronic symptoms, pursuant to the intensity and duration of the signs and symptoms. measuring serum concentration is the primary method for diagnosing and accompanying exposed workers. presently, elevated lead counts are reversed by using drugs whose effectiveness is contested on various fronts. experimental studies shows the efficacy of homeopathic preparations in controlling blood lead levels in laboratory animals, creating the need for controlled studies that evaluate the effectiveness and safety of these preparations in humans.the objective of this study was evaluate the effectiveness of the homeopathic preparation plumbum metallicum in reducing the blood lead level of workers exposed to this metal.


Eligibility criteria:
inclusion criteria: * had not taken a leave of absence for any reason for a period greater than seven days in the 60 days prior to the intervention; * where in good medical condition, as analyzed by their medical records and physical exam; * had an initial blood lead level less than the maximum biological concentration permitted, which is 60µ/dl in brazil. exclusion criteria: * workers who, in the last six months, had used medication that interferes/d with the level of lead in the blood, such as edta, bal, penicillinase and dmsa; * workers who had the right to vacation during the study period; * workers who did not give their consent to participate in the study.

Keywords: this study included workers exposed to lead.
pro-self pain management in norway

Conditions: Cancer; Pain

Summary: the main aim of this study is to evaluate whether a patient education programme on cancer pain management compared to standard care decreases pain and increases patients quality of life. the investigators hypothesis is that patients and family caregivers who receive the intervention will have improved outcomes. patients and family members are seen in their homes by the nurses doing the intervention over 6 weeks. patients keep a diary of their pain and medication intake.

the undertreatment of cancer pain remains a significant clinical problem. the pro-self pain control program is a 6 week psychoeducational intervention that was shown to improve pain management in oncology outpatients with pain from bone metastasis. however, this promising intervention requires replication in samples of oncology patients with cancer pain outside of the united states. the purpose of the study was to test the effectiveness of the pro-self pain control program in norwegian cancer patients and their family caregivers. only data on patient outcomes will be presented. the theoretical framework for this study incorporated elements of orem's self-care theory, as well as the principles of academic detailing and nurse coaching to change patients' self-care behaviors regarding cancer pain management. two hundred adult cancer patients with pain from skeletal metastasis and their caregivers participated in this study. patients were randomized to either the pro-self program or standard care. patients completed questionnaires about pain, physical functioning, quality of life, anxiety, and depression at the time of enrollment and after 6 weeks. data on analgesics were collected through chart reviews and patient diaries. both groups received home visits and telephone calls by an oncology nurse over a period of six weeks. participants in the intervention group received education about pain management and were coached to improve their pain management behaviors. two-way repeated measures analyses of variance will be done to determine differences in pain intensity scores and to evaluate the differences over time in the total amount of opioid analgesics taken by the patients.

Eligibility criteria:
inclusion criteria: * greater than 18 years of age * radiographic evidence of bone metastasis * able to read and write norwegian * average pain intensity of greater than 2.5 exclusion criteria: * brain metastasis

Keywords: cancer pain bone metastasis patient education psychoeducational education side effects analgesics
safety and efficacy of top1630 for dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: in subjects with dry eye syndrome: the primary objective of this study is to compare the safety and tolerability of top1630 ophthalmic solution to placebo. the secondary objectives are to compare the efficacy of top1630 ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

this study is designed to assess the safety, tolerability and efficacy of top1630 ophthalmic solution in subjects with dry eye syndrome. eligible subjects will be randomized double masked to either top1630 or placebo. part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort. part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy

Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a reported history of dry eye; * have a history of use of eye drops for dry eye symptoms; additionally for part 2 symptoms of dry eye syndrome including: * ocular discomfort * conjunctival redness * tear film break up time * schirmer test score signs of dry eye syndrome including: conjunctival staining score exclusion criteria: * have any clinically significant slit lamp findings at entry visit ; * be diagnosed with an ongoing ocular infection; * have any significant ocular lesion that could interfere with assessment of safety or efficacy or prevent study conduct in the opinion of the pi; * have any planned ocular and/or lid surgeries over the study period; * have an uncontrolled systemic disease; * be a woman who is pregnant, nursing or planning a pregnancy; * be a woman of childbearing potential who is not using an acceptable means of birth control; * have a known allergy and/or sensitivity to the test article or its components; * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
prescription and persistence of antithrombotic agents in acute ischemic stroke or transient ischemic attack patients with mca(middle cerebral artery) disease

Conditions: MCA - Middle Cerebral Artery Dissection

Summary: prescription and persistence of antithrombotic agents in acute ischemic stroke or transient ischemic attack patients with mca(middle cerebral artery) disease.


Eligibility criteria:
inclusion criteria: * 19 years later, men and women exclusion criteria: * subject who is judged to be ineligible by investigator
food supplementation with eufortyn colesterolo plus for ldl modulation in subjects with polygenic hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: this is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in italy. the objective of this study is to evaluate the effect of dietary supplementation of a combined supplement containing bergamot (vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (pycrinil®, cynara cardunculus) and cynara scolimus, associated with high coenzyme q10 bioavailability (q10 phytosome® ubiqsome) and zinc, on the glycometabolic structure of subjects with suboptimal levels of ldl cholesterolemia compared with placebo.


Eligibility criteria:
inclusion criteria: * subjects agree to participate in the study and having dated and signed the informed consent form. * subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements. * male or female aged ≥ 18 years and ≤ 70 years old. * ldl-cholesterol plasma levels \>115 mg/dl and \< 190 mg/dl. * tg\<400 mg/dl. * subjects who, according to the score charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to esc/eas guidelines 2019, the intervention strategy does not require a pharmacological lipid lowering intervention. exclusion criteria: * subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 5%; * obesity (bmi\>30 kg/m2) or diabetes mellitus; * assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism; * antihypertensive treatment not stabilized since at least 3 months; * anticoagulants therapy * uncontrolled hypertension (systolic blood pressure\> 190 mmhg or diastolic arterial pressure\> 100 mmhg); * known current thyroid, gastrointestinal or hepatobiliary diseases; * any medical or surgical condition that would limit the patient adhesion to the study protocol; * abuse of alcohol or drugs (current or previous); * history of malignant neoplasia in the 5 years prior to enrolment in the study; * history or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids; * history or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study; * known previous intolerance to one component of the tested nutraceuticals * women in fertile age not using consolidated contraceptive methods * pregnancy and breastfeeding.
effects of radiation therapy on the body in patients with stage iii non-small cell lung cancer

Conditions: Lung Cancer; Malnutrition; Weight Changes

Summary: rationale: learning about the effects of radiation therapy on the body's muscles, organs, and bones in patients with stage iii non-small cell lung cancer may help doctors plan the best treatment. purpose: this clinical trial is studying the effects of radiation therapy on the body in patients with stage iii non-small cell lung cancer.

objectives: primary * to determine energy and protein consumption on an average radiotherapy treatment day using the multiple pass method 24-hour analysis of food recall at baseline and treatment end. * to compare energy and protein by mouth intake from baseline to treatment end. * to measure and compare diet quality from baseline to radiotherapy treatment end by healthy eating index (hei) score. * to determine lean body mass versus fat mass using a bioelectrical impedance analysis machine. * to compare body fat to lean body mass percentage at baseline with that at radiotherapy treatment end. * to correlate energy and protein consumption with lean body mass at baseline and treatment end. * to determine the change in appetite throughout radiotherapy by comparing data obtained by interview at baseline and radiotherapy treatment end. * to determine the change in performance level (karnofsky percentage) associated with the radiotherapy through a series of questions asked at baseline and treatment end. outline: patients receive radiotherapy as planned for 7 weeks. patients undergo an interview on treatment day 1 (before initiation of radiotherapy) and treatment day 35 (after completion of radiotherapy) regarding recent food consumption history and appetite. patients' standing weight and height are measured on these days and their body composition, measured with a bioelectrical impedance analysis (bia) device, are also taken. patients' karnofsky performance score are obtained from their medical record.

Eligibility criteria:
disease characteristics: * diagnosed with stage iii non-small cell lung cancer (nsclc) * plan to begin radiotherapy for nsclc * radiotherapy is the only planned therapy for this cancer * no brain metastases patient characteristics: inclusion criteria: * must be able to stand without assistance exclusion criteria: * unable to comply with study requirements * native language other than american english * pacemaker or implanted defibrillator prior concurrent therapy: exclusion criteria: * receiving chemotherapy in combination with radiotherapy * concurrent megace or steroids

Keywords: weight changes malnutrition stage iii non-small cell lung cancer