Kornimate/medical-research-clean huggingface dataset:
il-2 for multi drug resistant nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: the aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical and immunologic effects of repeated administration of recombinant low dose il2 (proleukin) in 5 patients with idiopathic nephrotic syndrome unresponsive to drugs (steroids, calcineurin inhibitors, rituximab), following the therapeutical scheme indicated for crioglobulinemic nephropathy: cycle1: il2 1x106 /m2 s.c for 5 consecutive days cycle2: il2 1.5 x106 / m2 s.c for 5 consecutive days, starting from 3 weeks after the first cycle. cycle3: il2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first cycle. cycle 4: il2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first cycle. current therapy with steroids and calcineurin inhibitors (prograf) will be maintained during the first cycle and progressively reduced during the subsequent cycles. the first cycle will be performed during hospitalization in the investigators unit; subsequent cycles will be performed at nephrology outpatients. all laboratory values normally utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be evaluated during the first week of treatment and at the end of the protocol, together with specific cellular values (tregs, b cells, nk).


Eligibility criteria:
inclusion criteria: * drug resistance: persistence of proteinuria in nephrotic range after a cycle of steroids of at least 3 months and an association with cyclosporine/tacrolimus for at least other 6 months * parents'/guardian's written informed consent, and child's assent given before any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care. * age between 2 and 18 years * histological pattern of minimal change disease, mesangial proliferation with igm deposits or focal segmental glomerulosclerosis exclusion criteria: * positivity to autoimmunity tests (ana, dsdna, anca). * reduction of c3 levels. * hystological pattern characterized by elements suggestive for congenital disease: diffuse mesangial sclerosis without igm deposits, cystic-like tubular dilatation, mitochondrial abnormalities evident on electron microscopy, if suggestive for congenital collagen 4 disease. * histological pattern not suitable with ins in the pediatric age (membranous glomerulonephritis, lupus nephritis, diffuse and/or localized vasculitis, amyloidosis) * homozygous or heterozygous mutations of to the 3 genes (nphs1, nphs2, wt1) whose mutations are known to be responsible of almost 80% of familiar cases
flexor tendon injury rehabilitation regime study

Conditions: Flexor Tendon

Summary: hand flexor tendons bend the fingers down towards the palm, and can be cut during a sharp penetrating injury (e.g. from a knife or saw). damaged flexor tendons are repaired surgically with sutures (stitches). after repair, a splint is applied to the fingers, hand and wrist for six to twelve weeks to protect the repair while the tendon heals and regains its normal strength. most rehabilitation protocols use a splint in which the wrist position is kept straight (neutral) or bent (flexed). some groups have described splinting with the wrist cocked back (extended) and have made the argument that this may improve outcomes, as experimental data suggests that splinting the hand with the wrist extended increases the range of movement of the repaired flexor tendon (excursion), and therefore reduces the chance of the tendon sticking down to the surrounding tissues (adhesion). previous studies have shown no adverse effects from splinting hands with the wrist extended, and no evidence tells us which wrist splint position is better (a state of clinical equipoise or apparently equivalent outcomes). this randomised trial aims to produce this evidence, and therefore improve functional outcomes for patients in future. we propose to carry out a study to compare the outcomes (grip strength and range of movement) of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral position and the other splinted in an extended position during their postoperative rehabilitation. no changes will be made to patient assessment and management,the surgery undertaken and the rehabilitation regime other than those to splint position. previous work suggests that both positions are safe and effective. informed consent will be obtained from all patients enrolled in the trial, and we aim to find out if the extended splint position produces better functional results.


Eligibility criteria:
inclusion criteria: * primary inclusion criteria for the study is patients who have had 100% division by sharp laceration to the flexor digitorum profundus (fdp+)/flexor digitorum superficialis (fds) within zone i or ii and who have undergone repair with cruciate and epitendinous suture. patients with multiple digit involvement will be included in the study. * all repairs performed with 3/0 prolene suture cruciate repair and 6/0 prolene for the epitendinous repair as per departmental protocol. * patients with digital nerve repair along with the above injury will be included in the study exclusion criteria: * patients with associated phalangeal fractures, skin and soft tissue loss or who had vascular compromise will be excluded from the study. * patients with tendon repairs other than cruciate will be excluded from the study
efficacy and safety of lenvatinib as an adjuvant therapy for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma (HCC)

Summary: lenvatinib is the standard of care for patients with advanced hepatocellular carcinoma (hcc). the aim of the single-arm, open-label, phase ii clinical trial is to evaluate the efficacy and safety of lenvatinib as an adjuvant therapy for patients underwent radical resection of hcc with a high risk of tumor recurrence. investigator hypothesize that lenvatinib may be an effective adjuvant treatment for hcc, and 12-month adjuvant treatment with lenvatinib can improve one-year recurrence-free survival rate (rfs) of hcc patients after surgical resection.

there's no widely accepted adjuvant therapy for patients with hcc. lenvatinib, a multi-targeted tyrosine kinase inhibitor, was approved for advanced or unresectable hcc. in this study, investigators aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent curative resection for hcc with high risk of disease recurrence. participants who underwent radical resection for hcc with high risk of tumor recurrence will be recruited in this study. during 4 to 6 weeks after surgery, each participant will receive a screening visit to exclude residual tumors. each eligible participant will be treated with lenvatinib until tumor recurrence, intolerant adverse effect, participant' refusal, or completing 12-month treatment.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18-75; 2. histological diagnosis of hcc; 3. tumor stage before surgery: iib/iiia stage (\>3 tumor nodules, or vascular invasion) hcc according to china liver cancer staging system (or bclc b/c/pvtt); 4. underwent r0 resection (microscopic or macroscopic tumor clearance) in four to six weeks before recruitment; no residual tumor before recruitment by imaging study (mri/ct), nor metastases to other organs; 5. adequate liver, renal functions; 6. written informed consent; 7. ecog 0-1 and child-pugh a. exclusion criteria: 1. wbc\<4.0\*10\^9/l, hb\<80 g/l, and plt\<75\*10\^9/l at blood screening; 2. coagulation function: (prothrombin time) international normalized ratio (inr) \>2.3, or extension of prothrombin time\>6 seconds; 3. liver function: serum albumin (alb)\ 51.3μmol/l, alanine aminotransferase and aspartate aminotransferase (alt and ast)\>5 times the upper limit of normal range; 4. renal function: serum creatinine (cr)\>1.5 times the upper limit of normal range; 5. lymph node metastases; 6. the participant has uncontrolled ascites, hepatic encephalopathy, gilbert's syndrome, and sclerosing cholangitis, etc.; 7. the participant was included in other clinical trials 30 days before the selection; 8. other conditions that the investigators considered that not unsuitable for inclusion.
lipolytic effects of gh in hypopituitary patients in vivo

Conditions: Hypopituitarism; Insulin Resistance; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Pituitary Diseases; Brain Diseases

Summary: growth hormone (gh) is essential for longitudinal bone growth and somatic development. these protein anabolic effects require sufficient nutritional supply. during fasting and caloric restriction gh predominantly promotes fat metabolism. gh counteracts the effect of insulin in many tissues, of which insulin-stimulated glucose uptake in skeletal muscle has been most extensively studied. substrate competition between elevated free fatty acids and glucose is suggested as a mechanism, and this hypothesis can be tested mechanistically by means of acipimox, which is a nicotinic acid that suppresses the fat metabolizing effects of gh. the hypothesis is, that the suppressive effect of gh on insulin-stimulated glucose uptake in skeletal muscle is obviated by acipimox-induced inhibition of fat metabolism. in order to investigate this, eight adult hypopituitary patients with documented gh-deficiency will be studied in the presence and absence of gh and acipimox, respectively, and biopsies from skeletal muscle and subcutaneous adipose tissue will be analyzed. knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in long-sight have great importance for the understanding of growth disorders from overweight and type 2 diabetes to malnutrition and eating disorders.


Eligibility criteria:
inclusion criteria: * hypopituitary patients with documented gh-deficiency exclusion criteria: * other significant disease
effect of v0251 in acute vertigo

Conditions: Acute Vertigo

Summary: assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.


Eligibility criteria:
inclusion criteria: * men or women * age 18 to 70 years * acute vertigo attack due to vestibular disorder exclusion criteria: * signs of brain, brainstem and/or cerebellar dysfunction * concomitant central neurological disorder * psychogenic vertigo * use of ototoxic drugs causing vertigo or dizziness within the last month * use of anti-dizziness medications from the onset of symptoms, except if the dosage had been stable for at least 3 months
speech and swallowing characteristics of patients after laryngectomy and the effect on quality of life

Conditions: Cancer of the Larynx

Summary: swallowing and speech difficulties will be observed in patients post laryngectomy. these difficulties will cause decreased in quality of life.

this study will explore the characteristics of speech and swallowing problems of patients who underwent laryngectomy.the relationship between swallowing disturbances and speech difficulties will be studied and the effect of each problem on quality of life will be messured.

Eligibility criteria:
inclusion criteria: * patients post total laryngectomy with voice prothesis exclusion criteria: * patients who can not read and respod to questions

Keywords: laryngectomy swallowing disturbances speech disturbances speech intelligibility voice prothesis
ultrarunners longitudinal tracking study (ultra)

Conditions: Arthritis; Osteoporosis; Injuries

Summary: health status information and physical activity level will be collected longitudinally on a large group of individuals who are ultramarathon runners at the time of enrollment to determine if very high levels of physical activity alter health risks compared with sedentary or moderately active lifestyles.

the intent of this research is to longitudinally study the health of individuals who have run at least one ultramarathon (50k distance or greater) prior to enrollment.longitudinal data will be collected through periodic (every 1-2 years) survey completion by enrolled subjects over the course of up to 20 years. all surveys will be collected through a secure web-based system used by stanford university qualtrics). minor formatting adjustments will be required when placing into the on-line questionnaire format. we anticipate that the follow-up surveys will be adjusted prior to use, so they will be submitted to the institutional review board as addendum or in continuing review. as indicated elsewhere, subjects will be recruited through an email exchange (referred to as the "ultralist"), various ultramarathon-related web sites and blogs, and ultramarathon-related magazines. initial recruitment will continue for up to 12 months or until we have reached our desired sample size. recruitment material (attached) will include a link to the initial survey. for follow-up surveys, subjects will initially be sent an email (using the address they have provided with the initial survey) that contains a link to the survey and request that they complete the survey. attempt to contact non-responders will be, in this order, through a second email, phone call, letter to their home, email to identified surrogate, phone call to identified surrogate, and letter to identified surrogate. publicly available death records will be examined for cases where follow-up cannot be achieved.

Eligibility criteria:
inclusion criteria:healthy adults, able to provide consent, able to do survey online, must have completed one ultra marathon prior to participating in this study. exclusion criteria:not meeting the inclusion criteria

Keywords: ultrarunners ultramarathon runners ultra physical activity health risks sedentary moderately active
17-alpha-hydroxyprogesterone caproate in pregnant women with placenta previa

Conditions: Placenta Previa

Summary: purpose to evaluate the effects of intramuscular 17-alpha-hydroxyprogesterone caproate (17-ohpc) for prevention of emergent cesarean delivery in symptomatic pregnant women with placenta previa

most authors report an increased risk of bleeding with advancing gestation among women with placenta previa. the american college of obstetricians and gynecologists (acog) and the society for maternal-fetal medicine (smfm) both recommend the use of 17-ohpc to prevent recurrent spontaneous preterm birth. preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are at risk for neurological, respiratory, and gastrointestinal complications. so, it is therefore very important to try to prolong the pregnancy without increasing the risk of emergent delivery in cases with placenta previa. the authors hypothesized that a pharmacological strategy like 17-alpha-hydroxyprogesterone caproate may improve pregnancy outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled cesarean section women with a placenta previa. the aim of this study to evaluate the role of17-alpha-hydroxyprogesterone caproate in the prevention of preterm cesarean delivery (cd) in cases with symptomatic placenta previa with avoids of an emergent cd which affects the maternal outcome and prevents prematurity which affects the prenatal outcome.

Eligibility criteria:
inclusion criteria: * estimated gestational age: between 24 weeks and 37 week's gestation * confirmed placenta previa; either major or minor degrees. * placenta previa with preterm uterine contractions or with a history of at least single attack of mild vaginal bleeding exclusion criteria: * severe attack of bleeding requiring an immediate intervention. * fetal heart rates instability or non-reassuring tracing * intrauterine fetal death or major fetal anomalies. * if associated with abruptio placentae * patients with known bleeding disorders or on anticoagulant therapy * patients with severe medical disorders

Keywords: cesarean section placenta previa antepartum hemorrhage 17-alpha-hydroxyprogesterone caproate
a safety trial of gen1042 in japanese subjects with malignant solid tumors

Conditions: Malignant Solid Tumor

Summary: this study evaluating gen1042 will include multiple parts. in this study, gen1042 alone (phase 1a) or gen1042 in combination with other anticancer drug(s) (phase 1b) will be evaluated in japanese participants. the main purpose is to assess the safety and tolerability of gen1042 monotherapy or gen1042 in combination in japanese study participants with cancer.

this is an open-label, trial to evaluate the safety and tolerability, pharmacokinetics (pk), pharmacodynamics, and antitumor activity of gen1042 in japanese participants with malignant solid tumors. the trial consists of 2 parts: a gen1042 monotherapy dose escalation part (phase 1a); and a combination therapy part (phase 1b). the purpose of dose escalation part (phase 1a) is to evaluate gen1042 as monotherapy in participants with non-central nervous system (non-cns) malignant solid tumors. the combination therapy part (phase 1b) will evaluate gen1042 in combination with pembrolizumab (pembro) or pembro along with the standard of care (soc) chemotherapy in participants with head and neck squamous cell carcinoma (hnscc) and non-small-cell lung cancer (nsclc).

Eligibility criteria:
key inclusion criteria: 1. must have measurable disease according to recist v1.1. 2. eastern cooperative oncology group (ecog) performance status score of 0-1. 3. acceptable organ and bone marrow function. 4. participant must have a life expectancy of at least 3 months. key exclusion criteria: 1. has clinically significant toxicities from previous anticancer therapies. 2. has rapidly progressing disease. 3. has a history of noninfectious pneumonitis/interstitial lung disease. 4. has a history of liver disease. 5. has had an allogeneic tissue/solid organ transplant or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of gen1042. 6. has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke. 7. has had major surgery within 4 weeks before screening. note: other protocol defined inclusion/exclusion criteria may apply.
cangrelor versus standard therapy to achieve optimal management of platelet inhibition.

Conditions: Atherosclerosis; Acute Coronary Syndrome (ACS)

Summary: the primary objective of this study is to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring percutaneous coronary intervention (pci) as measured by a composite of all-cause mortality, myocardial infarction (mi), and ischemia-driven revascularization (idr).


Eligibility criteria:
inclusion criteria: angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronary intervention (pci) with or without stent implantation and diagnosis of acute coronary syndrome (acs) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogram changes + age \> 65 or diabetes. exclusion criteria: 1. not a candidate for pci 2. st-segment elevation myocardial infarction (stemi) within 48 hours of randomization 3. increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (\<1 month) trauma or major surgery \[including coronary artery bypass graft (cabg) surgery\]; currently receiving warfarin, active bleeding 4. impaired hemostasis: known international normalized ratio (inr) \>1.5 at screening; past or present bleeding disorder (including congenital bleeding disorders such as von willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count \<100,000/µl) at screening 5. severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization 6. receipt of fibrinolytic therapy in the 12 hours preceding randomization 7. receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding randomization 8. glycoprotein iib/iiia (gpi) inhibitor usage within the previous 12 hours \[applicable to unstable angina (ua) and non-st-elevation myocardial infarction (nstemi) patients\]

Keywords: percutaneous coronary intervention (pci) acs
prevalence of occult hbv infection among anti-hbc alone group in northern taiwan

Conditions: HBV Coinfection

Summary: atni-hbs to hbsag and anit-hbc was interpreted based on three hepatitis markers for clinical detection of hbv-infections. hbag and anti-hbs were negative and the anit-hbc-positive referred to as anti-hbc alone. when the anti-hbc alone occurs, patients may be due to mutations in hbv hbsag can not be detected due to (1), but if by the molecular diagnostics by polymerase chain reaction (pcr) technology can detect hbv dna present. when anti-hbc alone in patients with serum hbv dna can be measured, then there may be occult hbv infection. in different countries, occult hbv infection in the anti-hbc alone group had significant differences in the prevalence (2.9 \~ 22.8%) (2), but prevalence survey in taiwan there are very few studies on this , it is hoped to be able to investigation the prevalence of occult hbv infection among anti-hbc alone.

the main use of this program, taipei medical university - wan fang hospital in clinical specimens using the roche system (corbas e601) operating hbsag, anti-hbs, anti-hbc to screen for the anti-hbc alone group. recycling roche molecular system (taq48) real-time pcr to detect all anti-hbc alone population to understand their serum hbv-dna viral load, in order to understand occult hbv infection in the anti-hbc alone group, the prevalence and viral load changes in these studies through the clinical units to provide occult hbv infection as a reference basis.

Eligibility criteria:
inclusion criteria: hbsag(-)；anti-hbs(-)；anti-hbc(+) exclusion criteria: none

Keywords: anti-hbc alone ；occult hbv infection