Kornimate/medical-research-clean huggingface dataset:
multi-center phase ii study to compare mer-101 20mg tablets to intravenous zometa 4mg in male bisphosphonate-naive, hormone refractory prostate cancer patients

Conditions: Hormone-Refractory Prostate Cancer

Summary: the objective of mer-101-03 is to examine the effects of two different dosing regimens of mer-101 20mg tablets versus zometa 4mg iv infusion once-monthly therapy. the effects will be monitored on a weekly basis by measuring various markers of bone metabolism. patients to be enrolled will be those who have not received any previous bisphosphonate therapy. the study will be carried out on prostate cancer patients who are no longer on hormone therapy. treatment in the study will be for a 2-month period.


Eligibility criteria:
inclusion criteria: * prostate cancer with rising psa levels after hormone treatment and bone metastasis based on an x-ray. exclusion criteria: * already be on a bisphosphonate treatment (zometa, fosamax, actonel)

Keywords: prostate cancer, hormone resistant, bisphosphonate
the potential value and impact of diagnostic biomarkers for mafld using machine learning methods

Conditions: Metabolic Dysfunction-associated Fatty Liver Disease

Summary: this is a case-control study that aims to build a predictive model for mafld based on machine learning.

metabolic dysfunction-associated fatty liver disease (mafld) also known as non-alcoholic fatty liver disease (nafld), is one of the most prevalent liver diseases worldwide with high prevalence and economic burden, which affects 25% of global adult population. despite extensive research on understanding the inner pathophysiology of mafld, it still keep growing with no approval therapy. therefore, preventive measures are particularly important in diagnosing mafld. so far the liver biopsy is still the gold standard for diagnosis of mafld, however considering the invasive process and potential risks, it still has low acceptance for asymptomatic patients, thus non-invasive methods are necessary for this reason. the purpose of this study is to establish a prediction model to identify mafld patients, which can accurately predict whether the participants have mafld according to the relevant metabolic indicators of the participants, without the need for invasive examinations such as tissue biopsy.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 75 years; 2. meeting the diagnostic criteria of mafld; 3. no other organic lesions were found in imaging examination; 4. willing and able to sign informed consent. exclusion criteria: 1. significant drinking history (weekly alcohol consumption ≥ 140g for male, or weekly alcohol consumption ≥ 70g for female); 2. presence of evidence for having hepatic steatosis, viral hepatitis, history of hepatic cancer, drug-induced liver injury, liver cirrhosis and other liver and biliary tract diseases; 3. major organ malfunction, severe systemic illnesses, mental health issues, or inability to complete examination; 4. pregnant or pregnancy planning female; 5. missing of important clinical data.
the effect of supplementation with species of lactobacillus on anthropometric measurements

Conditions: Overweight and Obesity

Summary: the investigators aimed to study the effect of supplementation with species of lactobacillus on anthropometric measurements, body composition, appetite and serum lipid profile in overweight and obese adults

the objective of this study was evaluating the effect of supplementation with species of lactobacillus on anthropometric measurements include weight, waist and hip circumference , body composition include body fat and muscle percent, appetite measured by visual analogues scale and serum lipid profile in overweight and obese adults.

Eligibility criteria:
inclusion criteria: * age 18-65 years * bmi more than 25 kg/m2 exclusion criteria: * taking drugs that could affect weight change, including anti-diabetic drugs, lipid lowering drugs * endocrine,cardiovascular, thyroid, or chronic liver disease. * had received surgery to reduce weight * taking probiotics or antibiotics within one month * pregnancy or lactation or menopause * a history of cancer * heart disease - cardiovascular, pulmonary, renal and diabetes * a history of autoimmune disease * taking certain medications such as blood pressure control, statins, insulin sensitivity enhancers * weight change over five percent within three months * change in activity or diet habit

Keywords: probiotics lactobacillus obesity body composition
upper extremity pathologies in spinal cord injuries

Conditions: Spinal Cord Injuries; Upper Extremity Problem; Musculoskeletal Pain

Summary: this study aims to determine the relationship between upper extremity pathologies and demographic data, duration of manual wheelchair use, duration of injury, physical examination and musculoskeletal ultrasound measurements in patients with spinal cord injuries.

spinal cord injury is a neurological condition that can result from traumatic or non-traumatic causes, leading to motor, sensory and autonomic dysfunctions. following a spinal cord injury, the upper extremity becomes increasingly used for mobility, weight-bearing, and transfer activities, making functionality crucial in daily life. wheelchairs, commonly used by individuals with spinal cord injuries for daily activities, can lead to injuries and pain or degeneration in the upper extremities due to repetitive transfer activities. as a result, individuals with spinal cord injuries are at high risk for shoulder, elbow, wrist and hand injuries. neuromuscular ultrasound (nmus) has become increasingly important in clinical use in the evaluation of peripheral nerves and muscles in patients with spinal cord injuries in recent years, due to the advantages of ultrasonography such as providing dynamic and real-time evaluation, not containing radiation, and being painless. this study aims to determine the relationship between upper extremity pathologies and demographic data, duration of manual wheelchair use, duration of injury, physical examination and musculoskeletal ultrasound measurements in patients with spinal cord injuries.

Eligibility criteria:
inclusion criteria: * patients who have experienced spinal cord injury, can comply with two-stage verbal commands, voluntarily agree to participate in the study and are medically stable. exclusion criteria: * tetraplegia * a significant comorbid condition such as severe heart disease and uncontrolled hypertension. * cognitive dysfunction * active infection * malignancy * history of trauma to the upper extremity * brachial plexus and peripheral nerve injury * history of surgery on the upper extremity
study of d-methadone in patients with chronic pain

Conditions: Pain; Bladder Cancer; Breast Cancer; CNS Cancer; Colon Cancer; Esophageal Cancer; Pancreatic Cancer; Prostate Cancer; Uterine Cancer; Head and Neck Cancer; Eye Cancer; Otorhinolaryngologic Neoplasms

Summary: the purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. patients are being asked to participate in the phase i portion of this study.


Eligibility criteria:
inclusion criteria: phase i and phase ii portions of the study: * 18 years of age or older * chronic pain with average 24 hour intensity rated at least 3 on a verbal numerical scale from 0-10 during the 24 hours prior to study entry. * give informed consent to participate in this study. * karnofsky performance score (kps) \>= to 80 * negative urine pregnancy test, verified by the study nurse, at study entry (for women of child-bearing potential). patients must also use a medically approved contraceptive method during the study period. phase i only: * responsible companion living with patient during study. phase ii only: * group 1 -- patients must be taking chronic opioid therapy (long acting morphine, long acting oxycodone, transdermal fentanyl) at a stable dose for a minimum of four days. the dose of as needed short acting opioid does not need to be stable. * group 2 -- patients must not be receiving opioids and must have cancer related neuropathic pain secondary to post-chemotherapy peripheral neuropathy, post-radiation and/or post surgical plexopathy, radiculopathy or neuropathy, or post- herpetic neuralgia. exclusion criteria: phase i and phase ii: * known hypersensitivity to methadone * patient taking methadone or with a history of methadone treatment within one month of study enrollment. * patient that requires changes in the dose of one of the following medications within 2 weeks of study enrollment: * abacavir, * benzodiazepines, * carbamazepine, * efavirenz, * fluconazole, * fluvoxamine, * fos amprenavir, * fosphenytoin, * naltrexone, * nelfinavir, * nevirapine, * phenytoin, * rifampin, * rifapentine, * risperidone, * ritonavir, * st. john's wort, * zidovudine * hepatic function tests (sgot, alkaline phosphatase, bilirubin) greater than 2 times the upper limit of normal or creatinine greater than 1.4 within 30 days of study entry. * neurologic or psychiatric disease sufficient, in the investigator's opinion, to compromise data collection. * women who are pregnant or nursing. * women of childbearing potential who do not agree to use a medically recognized method of contraception during the study period.

Keywords: pain heent cancer
abdominal wall block study

Conditions: Umbilical Hernia; Obesity

Summary: compare the ability of the transversus abdominis plane block (tapb) and rectus sheath block (rsb) to provide surgical anesthesia for overweight and obese patients undergoing umbilical hernia surgery.

the purpose of this research study is to compare the ability of the tapb and rsb to provide anesthesia for overweight and obese patients undergoing abdominal wall surgery. at the present time, this procedure is performed under general anesthesia, which often poses increased risks for overweight and obese individuals. it is not known if these blocks could be used to avoid the use of general anesthesia.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age undergoing umbilical hernia repair * overweight and obese individuals (defined as a body mass index of ≥ 25 and 30 kg/m2, respectively) * ability to understand and provide informed consent exclusion criteria: * patient refusal or inability to provide informed consent * true allergy, not sensitivity, local anesthetics * true allergy, not sensitivity, propofol * true allergy, not sensitivity, general anesthetic agents * pregnancy * severe hepatic impairment * evidence of infection at or near the proposed needle insertion site * any sensorimotor deficit, whether acute or chronic, as determined by the pi * chronic use of opioid medication

Keywords: truncal block surgical anesthesia postoperative pain control
open-label clinical trial of lacosamide in als

Conditions: Amyotrophic Lateral Sclerosis

Summary: lacosamide is administered for patients with amyotrophic lateral sclerosis (als).

lacosamide is administered for patients with amyotrophic lateral sclerosis (als). this clinical trial is open-label, single group and before and after comparison study. dosage of lacosamide is increased from 100mg to 400mg for 4 weeks. safety of lacosamide administration in als is primary endpoint. nerve excitability, fasciculation and muscle cramp are investigated before and after administration for secondary endpoints.

Eligibility criteria:
inclusion criteria: * over 20 year old * probable or definite als disease evaluated by awaji electrophysiological criteria * subjects provided informed consent. exclusion criteria: * patient without ability to comprehend informed consent * patient with uncompensated medical illness * patient with cardiac disease (myocardial infarction, valvular disease and cardiomyopathy etc.) * patient with arrhythmia (incomplete atrioventricular block and bundle branch block etc.) * patient with sodium channel disorders, such as brugada syndrome * patient already administered anti-arrhythmic drug which prolongs pr interval (interval between arterial and ventral contraction measured by ecg) * pregnant or breast-feeding woman * patient with forced vital capacity of \< 60% predicted * patient already performed tracheotomy or tube feeding * patient who takes any other experimental agents 3 months before. * not enough compound muscle action potential amplitude in the median nerve to be performed nerve excitability test * patient who plans to change medicine which affects nerve excitability during this trial 4 weeks * familial als * patient who is judged inappropriate for this trail by doctors responsible for this trial
effects of electromyography-triggered constraint-induced movement cycling therapy on patients with chronic stroke

Conditions: Stroke

Summary: the study investigates the potential of electromyography (emg)-triggered constraint-induced movement cycling therapy (cimct) versus general cycling training (gct) to enhance balance, strength, and daily activities in chronic stroke patients. over a period of four weeks, this single-blind randomized controlled trial aims to explore how these interventions can assist in stroke rehabilitation. the research has been approved by the ethics committee of kyungdong university and adheres to the ethical standards laid out in the declaration of helsinki.

this research evaluates the effectiveness of emg-triggered cimct in improving balance, lower extremity strength, and activities of daily living (adls) for chronic stroke patients with hemiplegia, a condition typically resulting from a stroke. the study's scope includes: duration and type: a four-week, single-blind randomized controlled trial. participants: chronic stroke patients diagnosed with stroke-induced hemiplegia for more than six months, possessing specific levels of cognitive and motor recovery. interventions: participants are randomly assigned to one of two groups: cimct group: utilizes an emg-triggered constraint-induced movement therapy device designed to engage the affected lower extremity actively. gct group: engages in activity using a standard stationary bicycle without emg facilitation.

Eligibility criteria:
inclusion criteria: * patients with chronic stroke-induced hemiplegia * diagnosed with stroke for more than 6 months * achieving a minimum score of 24 points on the mini-mental state examination * demonstrating motor recovery at or above level 3 according to the brunnstrom stages exclusion criteria: * individuals with neurological damage unrelated to their stroke * orthopedic issues such as fractures or peripheral nervous system damage in the lower limbs * visual or auditory impairments * those who had experienced more than one stroke * those with less than an 80% participation rate in the study

Keywords: postural balance electromyography muscle strength stroke
novel web-based, self-directed intervention for chronic pelvic pain

Conditions: Chronic Pelvic Pain; Endometriosis

Summary: the study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with chronic pelvic pain (cpp). the overall hypothesis is that patients with chronic pelvic pain that have access to the my pelvic plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.


Eligibility criteria:
inclusion criteria: * participants have chronic pelvic pain, defined by the protocol for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month. * must be currently receiving care within department of obstetrics and gynecology at the university of michigan for treatment of chronic pelvic pain * access to internet via computer or smartphone * english-language proficiency (current version of the website is in english) exclusion criteria: * underwent gynecologic surgery within 3 months of screening visit * plan to undergo gynecologic surgery within 6 months following screening visit * pregnant (self-reported) at time of screening visit. will not exclude patients that become pregnant during the course of the study. * severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness) * current psychiatric disorder with history of psychosis (for example, schizophrenia, schizoaffective disorder, delusional disorder), * current suicidal ideation or suicide attempt within 2 years of screening visit. the study will screen for severe depression and suicidality at each questionnaire time point and have developed a robust triage and referral plan.

Keywords: quality of life cognitive behavioral therapy
a prospective observational study evaluating c-met expression and egfr gene mutation correlation with erlotinib response

Conditions: Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Recurrent

Summary: 1. trial design: prospective observational study 2. target population: 200 nsclc patients with histologically or cytologically confirmed stage iv or recurrent nsclc who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria 3. primary objective: to investigate c-met expression/amplification and egfr gene mutations in nsclc patients treated with erlotinib * c-met expression by ihc c-met amplification by sish egfr mutation by real time pcr 4. we will also assess the correlation of egfr mutations and c-met with clinical outcome (overall response rate, progression free survival ) 5. duration of trial recruitment: 2 years


Eligibility criteria:
inclusion criteria: * informed consent * 19\~80 year old male or female * histologically proven advanced or metastatic nsclc * failed to 1st line chemotherapy * tumor tissue for genetic analysis * evaluable target lesion by recist v1.1 * ecog performance from 0 to 3 * expected survival more than 12 weeks exclusion criteria: * previous treatment of egfr-tyrosine kinase inhibitors * severe hypersensitivity to erlotinib * residual toxicities (above grade 2) after previous chemotherapy * total bilirubin more than 1.5x of upper normal limit liver function tests more than 2.5x of upper normal limits
computer controlled local anesthesia in children

Conditions: Pain Perception of the New Device; The Pain Related Behavior; The Effectiveness of Anesthesia

Summary: • introduction: effective pain control is critical in pediatric dentistry. the effectiveness of pain control in children can be influenced by child characteristics . objectives: the purpose of the study is to compare the pain perception and the effectiveness of anesthesia between the computer-controlled local anesthetic delivery system (cclad) and the traditional inferior alveolar nerve block (ianb) in pulptomies of the mandibular second primary molars. materials and methodology: the study sample includes 90 healthy children who are selected randomly from the r4 electronic filing system in king abdulaziz university hospital (kauh) with age range from 5-9 years. the child is required local anesthesia for pulpotomies in the mandibular second molars. the sample will be divided randomly to one of these 3 groups: group a is composed of 30 patients who will be anesthetized by the traditional ianb. group b includes 30 patients will be anesthetized by the ianb using cclad. while, the remaining 30 patients will be assigned in group c and will be anesthetized by periodontal ligament injection anesthesia using the cclad. the pain perception levels after the injection is assessed by a wing-baker faces pain scale. effectiveness of the anesthesia during each step in pulpotomy is measured using sounds, eyes and motor (sem) scale. after the treatment by 24 hours parents will be contacted by the telephone to ask about the presence of postoperative pain or lip biting. statistical analysis is carried out using spss version 16.00.

ethical consideration: the ethical committee of king abdulaziz university kaauec approved the study . subjects' selection: the sample includes children who are randomly selected by the r4 electronic file system in the pediatric dentistry specialty clinics at king abdulaziz university hospital (kauh). a total of 2100 pediatric screening had been registered between april 2013 and november 2013 .these files will be checked for the eligible age in the study which is 5-9 years. then, the inclusion and exclusion criteria will be checked, and the patients will be selected by systemic random sample. study design: this is a randomized single blind clinical trial study.

Eligibility criteria:
the inclusion criteria: 1. age of the children was ranged from 5-9 years. 2. children were healthy physically and mentally; all children had no contraindications to local anesthesia. 3. children were assessed as being cooperative, had behavioral ratings "positive" or "definitely positive" according to the frankl (frankl et al 1962) behavior classification scale (appendix1). 4. children were diagnosed with carious mandibular second primary molars that required treatment with pulpotomies. the exclusion criteria: 1. disapproved consent. 2. medically compromised children. 3. uncooperative children.

Keywords: computer controlled anesthesia (cclad) pain perception effectiveness primary molars behavior
the hypoglycemic effect of cyclocarya paliurus extract on hyperglycemic populations

Conditions: Hyperglycemia

Summary: this is a randomized double-blind controlled trial，aiming to investigate the hypoglycemic effect of cyclocarya paliurus extract and cyclocarya paliurus compounds on hyperglycemic populations without modifying their original treatment plans.


Eligibility criteria:
inclusion criteria: * pre-diabetic or type 2 diabetic patients who are treated with only one oral antidiabetic agent and whose fasting plasma glucose is lower than 8.4 mmol; * age:20-65 years; * bmi :20-35kg/m2. exclusion criteria: * type 1 diabetic patients; * type 2 diabetic patients with insulin treatment； * pregnant or lactating women； * adverse effect on intervention； * acute or chronic inflammatory conditions; * severe hepatic,kidney or other complications; * other situations ineligible to intervention.

Keywords: cyclocarya paliurus extract hyperglycemia pre-diabetes and diabetes
assessment of professional practices in muscle rehabilitation of chronic hemodialysis

Conditions: Chronic Kidney Diseases

Summary: aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (stage 5d), the effect of a muscle strengthening program (training against resistance vs endurance training by elliptical bike) during a observational period (12 weeks per program) on frailty, risk of falling, muscle strength and mass, endurance, physical activity, quality of dialysis, nutritional status and neuromuscular sensitivity.


Eligibility criteria:
inclusion criteria: * chronic kidney disease patient on dialysis (stage 5d) for more than 3 months * age \> 18 years old * stable clinical condition * absence of musculoskeletal disorders exclusion criteria: * cardiovascular contraindication * amputation of lower limb not allowing use of elliptical bike

Keywords: chronic kidney disease patient on dialysis (stage 5d) muscle mass and strength training survival