Kornimate/medical-research-clean huggingface dataset:
multi-center clinical study of guli capsules in the treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: previous study showed that guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients. to further verify the clinical effect of guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.

guli capsule, an approved chinese patent drug, its main indications are for rheumatism, rheumatoid arthritis. previous study showed that guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients. to further verify the clinical effect of guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.

Eligibility criteria:
inclusion criteria: * ages between 40 and 70 years, both gender * kellgren and lawrence grades of i to iii; * the subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily. * meet the following clinical and radiological criteria for diagnosis: * clinical criteria: 1. most of the time have knee pain nearly a month 2. bone fricative 3. morning stiffness is less than or equal to 30 min 4. age is more than or equal to 38 years 5. bony enlargement. who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis. * radiological criteria: 1. most of the time have knee pain nearly a month 2. the x-ray showed osteophyte formation 3. joint fluid examination confirmed with osteoarthritis 4. age is more than or equal to 40 years 5. morning stiffness is less than or equal to 30 min 6. bone fricative. meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) + (6). exclusion criteria: * patient with a history of allergy to similar constituents or chemical components of the drug; * patients with limited liver and kidney function; * patients with hematopoietic system disease; * patients with diabetes, cushing's syndrome and other endocrine disorders; * patients with severe heart and brain disease; * patients with low immunity; * patients directly involved with the staff in the study; * women during pregnancy or lactation; * participating in other clinical studies or participated in 3 months; * the investigators judged who be unfit for the study.

Keywords: guli capsule knee osteoarthritis changing of womac and vas score
addition of radiotherapy to standard medical treatment for stage iv nsclc

Conditions: Radiotherapy; Non Small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Quality of Life

Summary: the hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage iv nsclc.

primary objective: to assess whether the addition of radiotherapy to the remaining thoracic tumor burden following standard medical treatment results in a superior quality of life measured with lung cancer symptom scale (lcss) in patients with stage iv non-small cell lung cancer. the comparison will be made at three months after randomization. secondary objectives: overall survival, progression-free survival, toxicity and longitudinal quality of life measurements. design: multicentre, randomized, phase iii trial. patients will be registered for the study up-front but randomization will be performed after evaluation of response, three months after initiating medical treatment with chemotherapy/ chemo-immunotherapy or immunotherapy. randomization will be to thoracic radiotherapy or follow-up (1:1).

Eligibility criteria:
inclusion criteria: * histological or cytological confirmed non-small cell lung cancer (nsclc) * stage iv disease * previously untreated disease (before first line treatment) * no symptomatic brain metastases * performance status (who) 0-2 * fev1 (forced expiratory volume one second) ≥ 1 l or \>40% of predicted * written informed consent * life expectancy ≥ 12 weeks * platelet count ≥ 100,00/mm3 * hemoglobin ≥ 10 g/dl * wbc (white blod cells) ≥ 3,000/mm3 * kidney function allowing chemotherapy * patients scheduled for standard platinum based chemotherapy, chemo-immunotherapy or immunotherapy * willing and able to comply with study treatment exclusion criteria: * requirement for daily supplemental oxygen * second primary malignancy within 3 years, except for any of the following which can be included even if diagnosed within the past 3 years: carcinoma in situ of the cervix, nonmelanoma skin cancer, history of low-grade (gleason score ≤ 6) localized prostate cancer, definitely treated stage i breast cancer, other malignancy that was diagnosed and definitely treated ≥ 3 years ago with no subsequent evidence of recurrence * concurrent severe and/or uncontrolled medical condition, including any of the following: * angina pectoris * congestive heart failure within the past 3 months, unless lvef (left ventricular ejection fraction) \> 40% * myocardial infarction within the past 6 months * clinically significant infection * psychiatric illness or social situation that would limit compliance with study requirements * egfr (epidermal growth factor receptor) mutation or alk (anaplastic lymphoma kinas) - rearrangement detected

Keywords: nsclc radiotherapy quality of life
study to assess the clinical activity of a sequential dose of regn846 on refractory pruritus in patients with atopic dermatitis

Conditions: Pruritus; Atopic Dermatitis

Summary: the purpose of this study is to assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (iv) dose of regn846 in adult patients with moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: inclusion criteria include, but are not limited to the following: 1. men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile 2. patients must have applied a stable dose of an additive-free, basic, bland emollient twice daily for at least 7 days before the baseline visit 3. chronic atopic dermatitis (ad) 4. body mass index (bmi) between 18.0 and 30.0 kg/m2, inclusive. 5. refractory pruritus for ≥ 6 weeks before screening. pruritus should be associated only with ad and not with any other condition(s). 6. itching associated with ad exclusion criteria: exclusion criteria include, but are not limited to the following: 1. a history of listeriosis. 2. presence of any 1 of the following tuberculosis (tb) criteria: 1. a history of active tb 2. a positive quantiferon tb test at the screening visit 3. chest radiograph (posterior-anterior and lateral views) at screening or within 3 months before the screening visit (radiology report must be available) with results consistent with prior tb infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). this does not include non-caseating granulomata. 3. persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit. 4. any clinically significant physical abnormalities observed during the screening visit. 5. diabetic, hypertensive, or any known atherosclerotic vascular disease. 6. hospitalization for any reason within 60 days of the screening visit. 7. history of or positive human immunodeficiency virus (hiv) screen result at the screening visit. 8. history of positive blood test for hepatitis b/hepatitis c or positive hepatitis screen result at the screening visit. 9. known sensitivity to doxycycline or tetracycline. 10. known sensitivity to any of the components or excipients of the investigational product formulation or history of hypersensitivity to any biologic agent. 11. participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit. 12. any medical or psychiatric condition that in the opinion of the investigator or regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results.

Keywords: itching
treatment of chronic hepatitis c infection by ledipasvir/sofosbuvir in naïve children

Conditions: Hepatitis C, Chronic

Summary: chronic hepatitis c virus (hcv) infection represents a crucial health problem in children that greatly influence their quality of life. many efforts have been directed toward the investment of effective drugs with high safety profiles and with oral administration for better compliance. the development of a new direct-acting antiviral (daa) made it possible to achieve these goals.

the calculated sample size of the study was ....participants at 5% level of significance and 80 % power, using the following formula: n= (z1-α/2+z1-β) 2 σ1\* σ2 / δ 2 this study aims to evaluate the safety and efficacy of the combined sofosbuvir/ ledipasvir regimen given for 12 weeks in children aged 12-18 years or weighing at least 35 kg with hcv genotype 4 infections. patients will receive ledipasvir-sofosbuvir fixed-dose combination one tablet (90 mg ledipasvir, 400 mg sofosbuvir) taken orally once daily at a fixed time with or without food for 12 weeks. visits will be arranged at 4, 8, and 12 weeks. patients will have easy access to the pediatric hepatology unit and the treating physician if any urgent problem happens in between the visits. the spss software version 24, spss was used for data processing

Eligibility criteria:
* inclusion criteria: * chronic hcv infection (≥ 6 months). * weighing at least 35 kg. * treatment-naïve children with chronic hcv infection without cirrhosis or with compensated cirrhosis. * parent or legal guardian must provide written informed consent. * exclusion criteria: * patients with comorbidity of chronic medical illness (decompensated heart disease, severe renal impairment (gfr \< 30) or esrd, uncontrolled dm). * concomitant hbv or hiv infection. * medications (amiodarone, beta-blockers).

Keywords: chronic hepatitis c egyptian children sofosbuvir ledipasvir
preoperative detection of muscle invasion in bladder cancer with contrast-enhanced ultrasonography

Conditions: Bladder Cancer

Summary: to evaluate the diagnostic accuracy of ceus for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies.

bladder cancer can be grouped into non-muscle invasive bladder cancer (nmibc) and muscle invasive bladder cancers (mibc), the latter displaying high aggressiveness, a high degree of malignancy, complicated treatment, high propensity to metastasis, and poor prognosis. currently, the clinical feasibility and accuracy of preoperative detection of muscle invasion in bladder cancer with contrast-enhanced ultrasonography (ceus) are unclear. to evaluate the diagnostic accuracy of ceus for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies.

Eligibility criteria:
inclusion criteria: * (a) eligible patients should be 18-year-old or older; * (b) patients should have a histologically or cytologically confirmed diagnosis of primary bladder cancer; * (c) patients should not have had any surgery, chemotherapy, immunotherapy, or any therapy before ceus diagnosis. exclusion criteria: * (a) participants with confirmed to have no carcinoma of the bladder; * (b) participants with previous pelvic surgery, who had undergone therapy, any bladder surgery, or had received chemotherapy, radiotherapy or immunotherapy; * (c) participants diagnosed with tumor recurrence or metastasis; (d) participants who were allergic to ultrasound contrast agents or could not tolerate ceus examination, for instance, with recent myocardial infarction, angina pectoris, cardiac insufficiency, severe cardiac arrhythmia, a right/left cardiac shunt, severe pulmonary hypertension, uncontrolled systemic hypertension, acute respiratory distress syndrome, or chronic obstructive pulmonary disease.

Keywords: bladder cancer contrast-enhanced ultrasonography
a study of three modified-release formulations of ro4917523 in healthy volunteers

Conditions: Healthy Volunteer

Summary: this single-center, open label, randomized, 3-period cross-over study will compare 3 modified-release formulations of ro4917523 in healthy volunteers. subjects will be randomized to one of six sequences to receive single oral doses of ro4917523 slow, target and fast release modified release (mr) capsules along with a reference intravenous microdose with the target capsule. a washout period of at least 21 days will occur between treatments.


Eligibility criteria:
inclusion criteria: * healthy male and female volunteers, 18 - 55 years of age inclusive healthy status will be defined by absence in evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination * body mass index (bmi) of 18 to 30 kg/m2, inclusive, and body weight of at least 50 kg * females of child-bearing potential must agree to use effective contraception as defined by protocol * non-smoker for at least 90 days prior to dosing on day 1 exclusion criteria: * history or presence of a clinically significant psychiatric condition as defined by protocol * participation in an clinical study with an investigational drug within 60 days or 5 times the half-life (whichever is longer) preceding first administration of study drug. participation in more than 3 other drug studies within 10 months preceding first administration of study drug. * clinically significant disease or disorder * personal or family history of long qt syndrome or sudden death * any suspicion or history of alcohol and/or other substance abuse or dependence in the last 6 months * subject likely to need concomitant medication during the study (including for dental conditions), except for hormonal contraception or hrt * pregnant or lactating women, or women who intend to become pregnant during the course of the study * positive for hepatitis b, hepatitis c or hiv infection * any confirmed significant allergic reactions against any drug, or multiple allergies
clinical trial on the effect of the flexible suturing system with anchors (fssa) in full-thickness rotator cuff tendon tears

Conditions: Rotator Cuff Tears

Summary: the purpose of this research study is to evaluate tendon healing when using the flexible suturing system with anchors (fssa) to surgically repair full-thickness rotator cuff tendon tears.


Eligibility criteria:
inclusion criteria: subjects must meet all the following criteria to be included in the study: 1. underwent surgery to repair a torn rotator cuff tear with the flexible suturing system with anchors (fssa) and is able to obtain a follow-up mri within 12 months +4 months / -1 month from the surgery date. 2. tear size of the supraspinatus (ssp) with or without involvement of the infraspinatus (isp), confirmed intra-operatively or with the pre-procedural mri, is greater than or equal to 1 cm. 3. between 18 and 70 years old at the time of surgery. 4. able to understand the content of the subject information / informed consent form (icf) and is willing and able to participate in the prospective data collection protocol and comply with the required data collection. exclusion criteria: subjects will be excluded from the study if they meet any of the following criteria: 1. had a prior rotator cuff surgery on the index shoulder. 2. has a subscapularis tear with a lafosse score of 3 or greater, or a teres minor tear requiring repair. 3. identified as being repaired in a hybrid approach, where a non-fssa anchor is used in the case for ssp and/or isp rotator cuff repair. 4. ssp and / or isp tendon ruptures that are considered irreparable or only partially repairable at the time of the intervention. 5. at any time during the previous 18 months was involved in a workers compensation case or litigation related to bodily injury, whether related or unrelated to the index shoulder. 6. has a history of chronic opioid use. 7. subjects with condition(s) that contraindicate or complicate outcomes of arcr such as: * current or prior infection of the ipsilateral shoulder * known inflammatory arthropathy or history of inflammatory arthropathy * chronic joint disease * concomitant labral fixation * concomitant os acromial fixation * glenohumeral joint instability (multiple dislocations/subluxations) * subacromial or intra-articular injection within 3 months prior to surgery * oral or injected steroid use in the following timeframe: 4 weeks prior to surgery through current date * hamada 3 or greater rotator cuff arthropathy on x-ray * goutallier atrophy \> grade 3 * proximal humeral fracture or scapular fracture * avascular necrosis of humeral head or glenoid * immunodeficiency disorders * chronic inflammatory disorders * osteoarthritis \>2 (samilson-prieto) 8. has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study. 9. subjects who are unable to tolerate magnetic resonance imaging (mri), due to psychiatric or medical contraindications.
an open label, multi-center, follow-on study examining the long-term safety and efficacy of insulin viaject™ in subjects with type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: follow-on study to the viaject™-08j study to evaluate the long-term safety and efficacy of viaject™ when used as prandial insulin in combination with lantus® in subjects with type 2 diabetes mellitus. the viaject™-08j study is the efficacy and safety study for insulin viaject™ to demonstrate equivalent blood glucose control in patients with type 2 diabetes mellitus with viaject™ insulin or regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for viaject™ in comparison to human insulin.


Eligibility criteria:
inclusion criteria: 1. completed the viaject™-08j protocol 2. informed consent must be obtained in writing for all subjects. exclusion criteria: 1. history of frequent severe hypoglycemia within the prior six months which prevent study participation at the discretion of the investigator 2. history of known hypersensitivity to any of the components in the study medication 3. progressive disease likely to prove fatal 4. known significant hepatic disease or serum ast or alt values \> 3 times the upper limit of normal or bilirubin levels \> 1.5 times the upper limit of normal 5. severe complications of diabetes mellitus including a history or finding of stage iii or iv diabetic retinopathy (see appendix b), proteinuria \> 2+ by urine dipstick, serum creatinine of \>1.8 mg/dl for males or \>1.5 mg/dl for females, history of renal transplant, severe peripheral vascular disease, which has resulted in amputation or recent onset of chronic foot ulcers or claudication, or the recent, clinically documented loss a pedal pulse. 6. history of moderate to severe ketoacidosis within the 3 months preceding screening for the study 7. current drug or alcohol abuse, or a history which in the opinion of the investigator will impair subject safety or protocol compliance. 8. current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator 9. a sexually active woman of childbearing age not actively and consistently practicing birth control by using a medically accepted device or therapy or a woman intending to become pregnant during the study 10. abnormal ecg, safety lab or physical examination results which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe 11. a history of lack of compliance with medical instructions, recent drug or alcohol abuse, or other reasons which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe
hyperbaric oxygen therapy for metabolic dysfunction-associated steatotic liver diseases

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease; Hepatic Steatosis; Non-alcoholic Fatty Liver Diseases

Summary: the goal of this clinical trial is to learn if hyperbaric oxygen therapy (hbot) works to treat metabolic dysfunction-associated steatotic liver diseases (masld). the main questions it aims to answer are: does hbot decreases the fat content and fibrosis state of liver in adult masld patients? does hbot improves the liver function and metabolic condition in adult masld patients? participants will: receive hbot for 20 times in 1 month or recerive regular drug; visit the clinic for checkups and tests at the starting, ending of the therapy and 6 month after the therapy.

metabolic dysfunction-associated steatotic liver diseases (masld) patients who meet our principles would be randomized into 2 groups: the hbot group and con group. the entire project is not blinded. in hbot group, participants will receive hbot for 20 times in 1 month (2.0ata, 60min), which is the common setting in clinical use.the con group, which means the control group, recerives regular drug, like liver-protective drugs and hypoglycemic drugs. the visiting times are week 0 (starting of the project), week 4 (ending of the therapy), week 28 (6 months after the therapy), when participants get checkups and tests. the primary outcome of our study are the change of liver fat content and stiffness in fibroscan. the secondary outcomes invovle changes of liver function enzymes and metabolism.

Eligibility criteria:
inclusion criteria: * metabolic dysfunction-associated steatotic liver disease patients exclusion criteria: * participants are unfit for hyperbaric treatment. * participants with prior oxygen therapy within the last 6 months. * participants with history of viral hepatitis, hemochromatosis, wilson disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction, alpha-1 antitrypsin deficiency. * participants with severe organ dysfunctions or malignant tumors. * participants have weight loss plan or major operations within the last 6 months. * participants are unable to provide informed consent or currently participating in or has within the last 3 months participated in any other clinical trial. * participants are pregnant or lactating. * participants with claustrophobia or that cannot decompress properly.

Keywords: metabolic dysfunction-associated steatotic liver disease hyperbaric oxygen therapy non-alcoholic fatty liver diseases oxygen therapy