Kornimate/medical-research-clean huggingface dataset:
to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of gx-i7 in healthy volunteers

Conditions: Leukopenia

Summary: a phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of gx-i7 in healthy volunteers

a phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of gx-i7 in healthy volunteers to show aba and mass balance of gx-i7

Eligibility criteria:
inclusion criteria: 1. subject is willing and able to give informed consent after listening character of the clinical trial 2. must be 19-45 years of age, inclusive 3. weight 50-100kg, bmi 18-30kg/m2 4. subject who is adequately able to attend the study based on medical history and physical exam, no clinically significant abnormality from vital sign and clinical laboratory values 5. no clinical abnormality from ecg test 6. non-smoker (no smoking or no use of any product containing nicotine least for one month and negative from urine test) exclusion criteria: 1. suspected or confirmed malignancy, or has malignancy history 2. any clinically significant acute or chronic medical condition requiring care of a physician, in liver, biliary tract, renal, nervous system (cns or peripheral). respiratory system, endocrine (diabetes, hyperlipidemia etc), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction etc), hematology, malignancy, urinary disease, mental disorder, musculoskeletal disorder, immune system (rheumatoid arthritis, lupus etc), otorhinolaryngologic diseases 3. positive to hbsag, hepatitis c virus (hcv) ab and hiv ab 4. are considering or scheduled to undergo any surgical or dental procedure during the study 5. administered other investigational product (ip) by attending other clinical study or biological equivalent study within recent 6 months 6. any serious adverse drug reaction (sar) against vaccines or antibiotics, any medical history with serious allergic diseases 7. positive from urine drug screen or respiratory alcohol screen at medical screening 8. history of alcohol, drug, or substance abuse in the past 12 months 9. a heavy alchol consumer (\>21 units/week, 1 unit = 10 g of pure alcohol) or consumption of alcohol within 48 hours prior to hospitalization 10. medications with antacid, analgesic, herbal treatment, vitamin, mineral (except maximum 4 grams of acetaminophen) hormone, steroids, insulin, hypoglycemic drug or other hormone substitute within 14 days before administration 11. planning pregnancy or donation of sperm/disagreeing proper contraception during the study and 3 months following ip administration 12. do not have veins suitable for cannulation or multiple venipunctures 13. previously donate whole blood within 60 days or component blood within 14 days 14. excessive consumption of foods containing grapefruits 15. any other factor that the investigator thinks will increase subject risk with participation
a study to evaluate the pharmacokinetics, safety, and effectiveness of certolizumab pegol in children with moderate to severe chronic plaque psoriasis

Conditions: Moderate Chronic Plaque Psoriasis; Severe Chronic Plaque Psoriasis; Mixed Guttate/Plaque Psoriasis

Summary: the purpose of the study is to evaluate the pharmacokinetic (pk) of certolizumab pegol (czp) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (pso) in order to support extrapolation of efficacy.


Eligibility criteria:
inclusion criteria: * study participant must have a diagnosis of moderate to severe plaque psoriasis (pso) for ≥3 months and: 1. body surface area (bsa) affected by psoriasis ≥10 % 2. physician's global assessment (pga) score ≥3 (on a scale from 0 to 4) 3. psoriasis area and severity index (pasi) score is ≥12 or 4. pasi score is ≥10 and \<12 with at least one of the following: * clinically relevant facial or scalp involvement * clinically relevant genital involvement * clinically relevant palm and sole involvement * clinically relevant axillary involvement study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque pso with \>50 % to \<80 % guttate lesions for ≥3 months, and must meet the same criteria listed above * study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy exclusion criteria: * study participant previously participated in this study or has previously been treated with certolizumab pegol (czp) * study participant has generalized pustular or erythrodermic psoriasis (pso) * study participant has guttate pso without plaque pso * study participant has had a primary failure to an anti-tumor necrosis factor agent * study participant has had prior exposure to \>2 biologic therapies * study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("yes") to either question 4 or question 5 of the "screening/baseline" version of the columbia suicide severity rating scale (cssrs) at screening

Keywords: chronic plaque psoriasis certolizumab pegol cimzia pediatric study phase 3
effects of kinesio taping on pain, endurance, proprioception, mobility and disability in lumbar disc herniation

Conditions: Lumbar Disc Herniation; Lumbar Disc Disease; Chronic Pain

Summary: in addition to the physical therapy program, taping was applied to 90 patients diagnosed with lumbar disc herniation. 90 patients were randomized into 3 groups. group 1 received star-shaped taping to the lumbar region in addition to physical therapy, group 2 received i-shaped taping to the erector spinae muscles in addition to physical therapy, and group 3 was planned as the control group. in the first evaluation, sociodemographic information and disease duration (months) were questioned. then, pain, muscle strength and endurance mobility, lumbar proprioception, functional level, and disability were evaluated. evaluations were performed before treatment, after taping and at the end of the 12th week.

the study included 90 patients aged between 18-65 years who were diagnosed with ldh by magnetic resonance imaging (mri), had moderate to severe low back pain (numeric rating scale \>4) for at least 6 weeks, and were planned to receive a physical therapy program (10 sessions of hotpack, transcutaneous electrical nerve stimulation (tens), and ultrasound every day for 2 weeks). the 90 patients included in the study were randomized into 3 groups using the computer-assisted randomization method. group 1 received star-shaped taping to the lumbar region in addition to physical therapy (5 times in total every 3 days), group 2 received i-shaped taping to the erector spinae muscles in addition to physical therapy (5 times in total every 3 days), and group 3 was planned as the control group. in the first evaluation, sociodemographic information (age, gender, height (m), weight (kg), bmi (kg/m2)) and disease duration (months) were questioned. then, pain (pain intensity and pressure pain threshold), muscle strength (lumbar extensor muscle strength) and endurance (trunk extensor muscle endurance), mobility (lumbar lordosis angle, joint range of motion), lumbar proprioception, functional level, disability evaluations were performed. evaluations were performed before treatment, after the taping application and at the end of the 12th week. post-treatment evaluations were performed the day after the tape was removed.

Eligibility criteria:
inclusion criteria: * having moderate to severe low back pain (numeric rating scale\>3) for at least 6 weeks * voluntariness to participate in the study exclusion criteria: * history of lumbar fracture or tumor * previous lumbosacral or abdominal surgery * ankylosing spondylitis, spondylolisthesis, fibromyalgia, peripheral neurogenic disease * pregnancy * history of cancer * demonstrated allergy/intolerance to kinesiotaping during a test performed before the initial evaluation

Keywords: taping low back pain lumbar disc herniation muscular fitness proprioception mobility disability
a prospective, single-centre, open-label study to confirm the efficacy and safety of vitamin d3 b.o.n. intramuscular injection in adults with vitamin d deficiency

Conditions: Vitamin D Deficiency

Summary: a prospective, single-centre, open-label study to confirm the efficacy and safety of vitamin d3 b.o.n. intramuscular injection in adults with vitamin d deficiency


Eligibility criteria:
inclusion criteria: * subjects with vitamin d deficiency exclusion criteria: * subjects who experienced a hypersensitivity to the cholecalciferol * subjects with hypercalcemia * subjects with hypercalciuria * subjects with renal impairment * subjects with calcium stone * subjects diagnosed with sarcoidosis or pseudo-hypoparathyroidism * subjects who are to take vitamin d supplements during the study period
confocal laserscanning microscopy for detection of barretts esophagus

Conditions: Barrett Esophagus

Summary: four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. the ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. a potential candidate to fill this gap could be confocal fluorescence microscopy (cellvizio®-gi and mauna kea technologies). to compare the gold standard with the confocal fluorescence microscopy for detection of metaplastic - or intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has been initiated.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * regular esophagogastroduodenoscopy for patients with known barrett esophagus (at least stadium c0m1) * patients presenting for endoscopic mucosectomy with intraepithelial neoplastic changes \<1cm * patients presenting with suspected intraepithelial neoplastic changes * patients receiving acid suppressive therapy in standard dose for at least 4 weeks exclusion criteria: * no informed consent * thrombocytopenia, quick \ 50 sec * patients with coronary heart disease or existent valve plasties * women with potential pregnancy * patients with chronic renal failure * patients with allergies * patients with chronic obstructive pulmonary disease
vaginal versus intramuscular progesterone for the prevention of recurrent preterm birth

Conditions: Premature Birth

Summary: the purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth (ptb) in women with a prior spontaneous preterm birth, vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth.

preterm birth is one of the leading causes of neonatal morbidity and mortality. one of the greatest predictors of preterm birth is a history of prior spontaneous preterm birth. presently 17 hydroxyprogesterone caproate (intramuscular) is the only fda approved product for the prevention of recurrent preterm birth, however recent studies suggest that vaginal progesterone may be used for this purpose, and may even be superior. the american college of obstetrics and gynecology does not specify the optimal route of progesterone administration for the prevention of recurrent preterm birth. it is our intention to compare vaginal and intramuscular progesterone to see if one is superior.

Eligibility criteria:
inclusion criteria: * pregnant women with singleton pregnancies * ≥18 years old * estimated gestational age less than 24 0/7 weeks * prior spontaneous preterm birth of a singleton pregnancy between 16 0/7-36 6/7 weeks. * patients are also required provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol. exclusion criteria: * history of an adverse reaction to progesterone; * a contraindication to progesterone treatment; * placenta previa or accreta; * major fetal anomaly diagnosed on ultrasound or known chromosomal disorder; * multifetal gestation; * preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment

Keywords: progesterone prevention of preterm birth
a long-term follow-up study for cardiac safety in the patients with her2 (+) breast cancer who have completed the sb3-g31-bc

Conditions: Breast Neoplasms

Summary: a long-term follow-up study for cardiac safety in the patients with her2 positive early or locally advanced breast cancer who have completed the sb3-g31-bc


Eligibility criteria:
inclusion criteria: * subjects who received the study treatment of sb3-g31-bc. * subjects who provide informed consent. exclusion criteria: * subjects unwilling to follow the study requirements are not eligible for the study.

Keywords: her2 trastuzumab biosimilar cancer breast positive
a study for participants with metastatic renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma

Summary: this study will compare the effects of enzastaurin plus sunitinib versus sunitinib alone in metastatic renal cell cancer.

this is a multicenter, phase 2 study of enzastaurin and sunitinib versus placebo and sunitinib as first-line therapy in participants with metastatic renal cell carcinoma, containing 2 parts. part 1 is a safety lead-in study with 12 participants and possible dose escalation. part 2 is a randomized, double-blind, phase 2 study in 110 participants.

Eligibility criteria:
inclusion criteria: * participants with metastatic renal cell carcinoma (rcc) who have not received prior treatment with systemic (adjuvant or neoadjuvant) therapy for rcc (including targeted therapy such as tyrosine kinase inhibitors or bevacizumab, immunotherapy, chemotherapy, hormonal, or investigational therapy) * histologically confirmed rcc with metastases with a component of clear (conventional) cell histology * evidence of unidimensional measurable disease, measured by computed tomography (ct) scan or magnetic resonance imaging (mri) * primary tumor has been surgically removed by nephrectomy or nephron-sparing surgery * eastern cooperative oncology group (ecog) performance status score of 0 or 1 * participants must sign an informed consent document exclusion criteria: * have received prior treatment with sunitinib or enzastaurin * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * have had any of the following within 12 months prior to study drug administration: * myocardial infarction, * severe/unstable angina, * coronary/peripheral artery bypass graft, * symptomatic congestive heart failure (chf), * cerebrovascular accident, * transient ischemic attack, or * pulmonary embolism * note: ongoing treatment with therapeutic doses of coumadin® (warfarin) or a derivative of coumadin or phenprocoumon is not allowed, but prophylactic, low-dose coumadin (≤ 2 mg daily) for deep vein thrombosis is allowed. in such cases, prothrombin time/international normalization ratio (pt/inr) should be very closely monitored as clinically indicated * ongoing cardiac arrhythmias \>new york health association class ii, atrial fibrillation of any grade, or prolongation of the qtc interval to \>450 millisecond (msec) for males or \>470 msec for females. * have uncontrolled hypertension \[\>150/100 millimeter of mercury (mm/hg) despite optimal medical therapy\], or history of poor compliance with antihypertensive treatment * require concomitant use of potent cytochrome p450 3a4 (cyp3a4) inducer, for example, rifampicin or potent cyp3a inhibitors, such as ketoconazole. * significant surgery or radiation therapy \<4 weeks of starting study treatment. prior palliative radiotherapy to metastatic lesion(s) is/are permitted, provided there is at least 1 measurable lesion that has not been irradiated * participants who are pregnant or breast feeding
barbed sutures versus conventional sutures in laparoscopic excision of endometrioma

Conditions: Endometriosis

Summary: the aim of this randomized controlled trial is to compare operative data and early postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with those of laparoscopic excision of endometrioma using conventional sutures.

several authors reported the use of barbed sutures in myomectomy , hysterectomy and closure of vaginal vault. a recent meta-analysis comparing the efficacy of laparoscopic suturing using barbed suture or conventional sutures in myomectomy or hysterectomy revealed that suturing with barbed sutures was associated with less suturing time and operative time. although numerous studies revealed the advantages of using barbed sutures , no studies have yet evaluated the use of barbed sutures in laparoscopic excision of endometrioma. the aim of this randomized controlled trial is to compare operative data and early postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with those of laparoscopic excision of endometrioma using conventional sutures.

Eligibility criteria:
inclusion criteria: * unilateral endometrioma more than 3 cm in mean diameter exclusion criteria: * bilateral endometriomata * conversion of laparoscopy to laparotomy * contraindications for general anesthesia

Keywords: endometriosis laparoscopy barbed sutures
doac or vka in patients with af and stroke while on doac - a pilot trial

Conditions: Atrial Fibrillation (AF); Stroke (in Patients With Atrial Fibrillation)

Summary: people with atrial fibrillation who have a stroke while receiving a doac are at increased risk of experiencing another stroke. physicians do not know the best medication to prevent another stroke in this group of people. options include continuing the same doac, switching to another doac or switching to warfarin. the investigators of the switch-af trial are trying to find out whether switching to warfarin or continuing a doac is better for preventing stroke. the purpose of this study, called a pilot study, is to test the study plan and to find out whether enough participants will join a larger study that answers the question. a pilot study involves a small number of participants and it is not expected to tell us which treatment is better.


Eligibility criteria:
inclusion criteria: 1. written informed consent provided. 2. age \>18 years. 3. documented history of af or atrial flutter. 4. ischemic stroke while on a doac within 14 days prior to enrollment identified on imaging. 5. in the opinion of the investigator, it is safe to initiate oral anticoagulation with either a vka or a doac within 24 hours of randomization- exclusion criteria: 1. there is strong evidence for the qualifying stroke event to be associated with permanent discontinuation of doac therapy (for any reason) 2. patient is unable or unwilling to take oral anticoagulation 3. history of intracranial bleeding. 4. patient is on chronic hemodialysis or likely to need renal replacement therapy during the course of the trial.

Keywords: stroke atrial fibrillation a-fib switch-af doac warfarin anticoagulant
effect of ginger supplement on non-alcoholic fatty liver

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the hypothesis of this study was that ginger supplement consumption can be introduced as a new therapeutic strategy for non-alcoholic fatty liver disease through the improved body antioxidant activity, reduced levels of inflammation and insulin resistance. a randomized double-blind study was designed to evaluate this hypothesis in order to examine the effectiveness of ginger supplement in patients with non-alcoholic fatty liver disease.


Eligibility criteria:
inclusion criteria: * presence of steatosis on ultrasound examination * high concentration of liver enzyme (alanine aminotransferase (alt) greater than normal range of 1.5 times) exclusion criteria: * various types of hepatitis * diabetes mellitus * cancer inherited disorders affecting liver condition (storage disorders of iron, copper, and others) * non-treated hypothyroidism * using alcohol * consumption of phenytoin amoxyfan and lithium * using minerals multivitamin supplements such as vitamin e, vitamin d, supplements made from silybum marianum extract like livergol * weight loss surgery in the last year or strict diets to weight loss in the past three months pregnancy * lactation * autoimmune diseases
immunogenicity and safety following in-house recombinant hepatitis b vaccine in indonesian population (phase iii)

Conditions: Vaccine Reaction; Vaccine Adverse Reaction

Summary: this is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. the primary objective of this study is to assess the protectivity of in-house recombinant hepatitis b vaccine 28 days after 3 doses immunization.

this is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. a total of 540 subjects will be involved in this study. the primary objective of this study is to assess the protectivity of in-house recombinant hepatitis b vaccine 28 days after 3 doses immunization.

Eligibility criteria:
inclusion criteria: 1. healthy individual aged 10 - 50 years old, as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator. 2. subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form. 3. subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: 1. subject concomitantly enrolled or scheduled to be enrolled in another trial. 2. subjects with known history of hepatitis b contained vaccination in the last 10 years. 3. evolving severe illness and/or chronic disease and fever (axillary temperature \>= 37.5 c) within the 48 hours preceding enrollment. 4. known history of allergy to any component of the vaccines (based on anamnesis). 5. hbsag positive. 6. known history of immunodeficiency disorder (hiv infection, leukemia, lymphoma, or malignancy). 7. history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 8. subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppressant. 9. pregnancy \& lactation (adult). 10. subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.

Keywords: hepatitis b vaccine, vaccine