Kornimate/medical-research-clean huggingface dataset:
a study to evaluate abp 206 compared with opdivo® (nivolumab) in subjects with unresectable or metastatic melanoma

Conditions: Melanoma

Summary: the purpose of this study is to assess the efficacy, safety, and immunogenicity of abp 206 compared with nivolumab in subjects with treatment-naïve unresectable or metastatic melanoma.

eligible subjects will be randomized (1:1) to receive investigational product (abp 206 or nivolumab). all subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment. the total duration of study participation for each subject will be approximately 26 months.

Eligibility criteria:
key inclusion criteria: * at least 18 years of age. * histologically confirmed unresectable or metastatic melanoma. * subject has no prior systemic treatment for advanced disease. * subject must have measurable disease according to response evaluation criteria in solid tumors (recist version 1.1). * tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized. * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1. key exclusion criteria: * subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma. * known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug. * subject has active central nervous system (cns) metastases not previously treated. * ocular melanoma. * subject has active or known immune-mediated disorders. * subject has had prior treatment with pd-1/pd-l1 and cytotoxic t lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways. * subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product. other protocol-defined inclusion/exclusion criteria apply.

Keywords: treatment-naive unresectable melanoma metastatic melanoma
efficacy and safety study of bdb-001 injection in patients with moderate to severe hidradenitis suppurativa (hs)

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to explore whether bdb-001 injection is effective and safe in the treatment of moderate to severe hidradenitis suppurativa(hs).


Eligibility criteria:
inclusion criteria: * subjects who signed the informed consent to participate in the sts-bdb001-06 clinical study and completed all follow-up of the study as required by the protocol, or who withdrew early due to treatment failure or other objective reasons and completed the early withdrawal visit (at least 4 weeks of treatment) exclusion criteria: * never participated in the clinical study of sts-bdb001-06； * subjects withdrew from the sts-bdb001-06 clinical study due to an intolerable adverse event related to the study drug.
diagnosis of adrenal insufficiency in liver cirrhosis patients

Conditions: Adrenal Insufficiency; Liver Cirrhosis

Summary: patients with liver cirrhosis (lc) often exhibit fatigue, poor oral intake, and abdominal discomfort, which are the symptoms that are also shown in subjects with adrenal insufficiency (ai). controversy exists upon over-diagnosis of adrenal insufficiency in patients with lc, because decreased albumin and/or cortisol binding protein lower total cortisol levels while free cortisol increases/or is preserved. the investigators assumed that measuring salivary cortisol or direct free cortisol using mass-spectrometry would provide a more accurate level of cortisol in lc patients. 50 patients with lc will be recruited and undergo a rapid acth stimulation test and their blood/ saliva will be collected and analyzed. the difference between serum free cortisol and total cortisol, as well as between salivary cortisol and total cortisol will be investigated to find the optimal way to diagnose ai in lc patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed of liver cirrhosis exclusion criteria: * pregnant * history of getting surgery of pituitary resection or adrenalectomy * patients with diagnosis of pituitary adenoma or adrenal adenoma * patients take steroid within 3 months * patients take medication related to synthesis of steroid or cortisol binding protein within 3 months (i.e. ketoconazole, etomidate, sex hormone, oral contraceptive) * patients take albumin, free frozen plasma, terlipressin, glypressin within 1 month * patients with acute medical condition
effects of bcg on influenza induced immune response

Conditions: Influenza Virus Infection; Trained Immunity

Summary: in the present study, the investigators want to investigate whether prior bcg-vaccination improves the efficacy of influenza ("the flu") vaccination in young and/or old healthy volunteers and consequently could protect against influenza virus infection.

influenza virus infection leads to millions of cases of severe illnesses worldwide and up to an estimated 500.000 deaths annually. the potential for the sudden emergence of pandemic influenza strains represents an incessant threat on even a larger scale. seasonal influenza vaccination is the backbone of influenza management. however, antibodies generated by vaccination, most often do not effectively neutralize emergent strains due to the high mutation rate of the influenza viral genome. in addition, although vaccination is effective in up to 85% of healthy adults, only 40-60% of the elderly are able to mount an protective antibody response due to an agerelated decline in immune function (so-called immunoscenescence). as a result, the protective effects of influenza vaccination are limited, and strategies to improve host immune defenses against influenza virus infection per se, and following influenza vaccination, are highly warranted. it is suggested that prior vaccination with bacille calmette-guérin (bcg) could enhance resistance to other infectious diseases in addition to protection to tuberculosis (tbc) and, in mice, protection of prior bcgvaccination against influenza infection was demonstrated long ago. however, only recently substantial evidence for these nonspecific beneficial effects of bcg-vaccination in humans has been provided by several randomized clinical trials. considering these potentiating effects of bcg-vaccination, it could be a viable strategy to improve efficacy of influenza vaccination, and/or enhance immune defenses against influenza virus infection per se. if so, this would have an enormous impact on clinical practice.

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤35 yrs * male * healthy exclusion criteria: * history of influenza vaccination within the year prior to study entry * history of bcg vaccination within 5 years prior to study entry * history of mantoux testing within the year prior to study entry * vaccination other than bcg or influenza, within 3 months prior to study or within study period * medical history of any disease associated with immune deficiency * clinically significant acute illness, including infections, within 4 weeks before vaccination * participation in a drug trial or donation of blood 3 months prior to study entry * use of recreational drugs within 21 days prior to experiment day * recent hospital admission or surgery with general anaesthesia (\<3 months) * known chronic kidney or liver disease * latent or active tuberculosis infection

Keywords: influenza trained immunity bcg
ledipasvir/sofosbuvir fixed-dose combination plus ribavirin in participants with chronic hcv with advanced liver disease or post-liver transplant

Conditions: Chronic HCV Infection

Summary: this study will evaluate ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) plus ribavirin (rbv) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis c virus (hcv) infection. * cohort a: decompensated cirrhosis (advanced liver disease), no prior liver transplant; * cohort b: post-liver transplant, with or without cirrhosis; * group assignment within cohorts is based on severity of liver impairment at screening (child-pugh-turcotte (cpt) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (fch) groups) * randomization is 1:1 within groups to 12 or 24 weeks of ldv/sof+rbv treatment.


Eligibility criteria:
inclusion criteria: * able to provide written informed consent * chronic genotype 1 and/or 4 hcv infection * normal ecg * negative serum pregnancy test for female subjects * male subjects and female subjects of childbearing potential must agree to use contraception * able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits exclusion criteria: * serious or active medical or psychiatric illness * hiv or hepatitis b viral (hbv) infection * stomach disorder that could interfere with the absorption of the study drug * treated with an anti-hcv medication in the last 30 days * any prior exposure to an hcv nonstructural protein (ns)5a-specific inhibitor * use of human granulocyte-macrophage colony-stimulating factor (gm-csf), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening * history of clinically significant medical condition associated with other chronic liver disease * active spontaneous bacterial peritonitis at screening * females who are breastfeeding * infection requiring systemic antibiotics * participated in a clinical study with an investigational drug or biologic within the last 30 days * active or history (last 6 months) of drug or alcohol abuse * history of organ transplant other than liver, kidney, or corneal.
association of ttga (tissue transglutaminase antibody) and histopathologic findings in thyroidectomy patients

Conditions: Thyroid Fibrosis

Summary: gluten sensitivity is the most common auto-immune disease associated with auto-immune thyroiditis. this association is through elevated anti-tissue transglutaminase (anti-ttg) levels both in celiac disease and thyroiditis. in our study we tried to find if there is any correlation in between anti-ttg and degree of fibrosis in thyroid tissue (post-operative specimen).

most common auto-immune disease associated with celiac disease is autoimmune thyroiditis. this association in between celiac disease and aout-immune thyroiditis is related with asymptomatic rise in anti-ttg levels. in our study, we planned to show that if there is any correlation of thyroiditis related fibrosis in thyroid tissue with anti-ttg iga ( immune-globulin a) and igg (immune-globulin g).

Eligibility criteria:
inclusion criteria: * thyroiditis patients operated for any indication exclusion criteria: * patients with known iga deficiency
multiple transplantation of bone marrow derived cd133 cell in cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) is condition, sometimes thought of as a group of disorders that can involve brain and nervous system functions such as movement, learning, hearing, seeing, and thinking.cerebral palsy is caused by injuries or abnormalities of the brain. most of these problems occur as the baby grows in the womb, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.bone marrow derived stem cells are known as a effective therapy. in this study the investigators evaluate the side effect of multiple intrathecal injection of bone marrow stem cell in patients with cerebral palsy.

in this study,we evaluate the safety of multiple transplantation of bone marrow derived stem cells.the children(4-12years)with definite diagnose of cerebral palsy enroll to the study.first of all all the physical exam,laboratory test,eeg and mri is done.after hospital admission,the patient underwent bone marrow transplantation.in laboratory,the cells are separated and prepared for injection.after 24hours the neurosurgeon inject the cells(intrathecal).the patient would be under observed for 48hours.if no allergic reaction or abnormal neurological symptoms accrued,patients can be discharged and would be followed up 1,3 and 6months after injection.at the end of the 6months,the patients would receive second injection as same as the previous process.then they are followed at 1,3 immediate local and systemic side effect(fever,respiratory distress,erythema,rash,increase of heart rate or blood pressure)and neurological symptoms:motor dysfunction,sensory dysfunction,sphincter dysfunction,nausea,vomiting,head ache.eeg,mri,gmfm66

Eligibility criteria:
inclusion criteria: * diagnosis of spastic quadriplegic cp children must be between the ages of 4 and 12 years children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature \> 40 degrees) children must be seizure-free or seizure controlled exclusion criteria: * children who have a diagnosis of "mixed" types of cp (i.e. athetosis) or other movement disorders (i.e. ataxia) children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal baclofen, or have changed their spasticity medications in the past 6 months. children who have a metallic or electrical implants

Keywords: cerebral palsy cd133 cells intrathecal injection
preventive effect of leg wrapping combined with trendelenburg position on hypotension induced by propofol

Conditions: Hypotension; Propofol

Summary: although propofol is widely used as an induction agent for a general anesthesia, it can induce a profound hypotension, which leads to the hypo-perfusion of end organs and eventually increases morbidities. theoretically, applying trendelenburg position (head down and leg up position) increases cardiac preloads and cardiac outputs. however, in past researches, changing to trendelenburg position alone is not enough and does not prevent propofol induced hypotension. previous studies proved that leg wrapping effectively prevent hypotension after neuraxial anesthesia during cesarean section. the leg wrapping prevents hypotension by increasing vascular resistance of lower extremities. the investigators made a hypothesis that applying both trendelenburg position and leg wrapping prevent propofol induced hypotension more effectively than either applying trendelenburg position only or taking no preventive measures.

\*\* study procedure 1. check baseline blood pressure ( systolic, diastolic, mean) and heart rate. 2. apply pre-defined measures to each group(arm) ( summarized in arms and interventions section ) 3. induction using propofol 2mg/kg 4. after bispectral index (bis) goes below 60 \& patient become unconsciousness, inject rocuronium 0.6mg/kg 5. intubate patient between 3 and 4 minutes after propofol injection 6. measure blood pressure ( systolic, diastolic, mean ) \& heart rate at 1,2,3,4,5 minutes after propofol injection 7. phenylephrine injection if hypotension develops

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic status class 1, 2, and 3. * under general anesthesia exclusion criteria: * severe cardiac/pulmonary/liver/renal disease * bmi \> 30 kg/m2 * known or risk factor of increased intraocular pressure or intracranial pressure * uncontrolled hypertension * high risk for propofol allergy * allergies to medications related to anesthesia * mechanical difficulties with leg wrapping ( wound on legs, devices on legs ) * emergent operation * high risk of gastric aspiration ( gastrointestinal obstruction, short nil per os(npo) time ) * patient wearing elastic stocking for therapeutic purpose

Keywords: hypotension propofol trendelenburg leg wrapping
clearance of 25-hydroxyvitamin d in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the goal of this study is to define 25(oh)d3 catabolism in cf patients using gold standard pharmacokinetics studies. specifically, the investigators will evaluate the metabolic clearance of 25(oh)d3 among participants with cf and matched control subjects. the goal of this work is to provide the first comprehensive characterization of vitamin d metabolism in cf patients and promote novel hypotheses for subsequent studies.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * serum total 25(oh)d 10-50 ng/ml * diagnosis of cystic fibrosis in accordance with cf foundation guidelines; or, normal control exclusion criteria: * primary hyperparathyroidism * gastric bypass * tuberculosis or sarcoidosis * current pregnancy * child-pugh class b or c cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin \>=2 mg/dl, serum albumin \ = 4 seconds) * history of kidney transplantation or end stage renal disease treated with dialysis * use of vitamin d3 or vitamin d2 supplements exceeding a mean daily dose of 400 iu, within 3 months (wash-out allowed) * use of 1,25(oh)2d3 or an analogue, calcimimetics, or medications known to induce cyp24a1 within 4 weeks (wash-out allowed) * serum calcium \> 10.1 mg/dl * hemoglobin \< 9 g/dl

Keywords: cystic fibrosis vitamin d catabolism
an implantable spinal cord stimulation pain management system

Conditions: Chronic Pain; Pain, Intractable; Pain; Back Pain; Failed Back Surgery Syndrome

Summary: there are many treatment options available for the management of chronic pain . some include, but are not limited to, over-the-counter medications, non-steroidal anti-inflammatory drugs, physical therapy, transcutaneous electrical nerve stimulation (tens) and nerve blocks. historically, the mainstay of pain treatment has been pharmacotherapy. however, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (scs), proven to be an effective therapy to more than half of those failing conservative treatments . over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing scs, have their pain levels successfully managed. scs is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.

this clinical trial was a confirmatory study for the advanced bionics totally implantable spnial cord stimulation(scs) system, the stimulus system. this system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: dailed back surgery syndrome, intractable low backpain and leg pain.

Eligibility criteria:
inclusion criteria: 1. diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain. 2. be an appropriate candidate for surgery. 3. be capable of giving informed consent. 4. be capable and willing to follow all study related procedures. exclusion criteria: 1. have an inability to operate the system either by self or care-giver. 2. are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study. 3. have any implanted electrical devices, regardless of whether active or inactive. 4. have any active implantable device regardless of whether stimulation is on or off.

Keywords: pain chronic pain neurostimulation
measuring acute drug demand in humans

Conditions: Opioid Use Disorder; Opioid Dependence

Summary: this research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.

this research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs. suvorexant is not approved as a treatment to reduce drug use but is approved by the food and drug administration (fda) to treat insomnia (trouble falling asleep or staying asleep). this study consists of a screening visit and an approximate 14 to 16 day inpatient (overnight) stay at the johns hopkins bayview medical center. participants will be stabilized on hydromorphone, randomly assigned to receive either suvorexant or placebo, and complete 5 experimental sessions that include taking blinded study medications.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years old * meets diagnostic and statistical manual-5 criteria for opioid use disorder (oud) (moderate or severe) * lifetime substance use history criterion \[blinded\] * medically cleared to take suvorexant and blinded study medications * be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests exclusion criteria: * pregnant or breast feeding * seeking opioid use treatment * significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff * known contraindications or allergies to suvorexant and/or the blinded study medications
a phase ii trail of chidamide ,rituximab and methotrexate in lymphoma patients

Conditions: Central Nervous System Lymphoma

Summary: this study will evaluate the efficacy, safety and patient reported outcomes of chidamide 20 mg biw po day1-14 and rituximab 375 mg/m2 iv given on day 1 and methotrexate 3.5g/m2 iv given on day 2 of every 21-day cycle for 6 cycles in untreated patients with primary central nervous system lymphoma. the primary study endpoint will be complete response (cr) rate as assessed by the investigator. the hypothesis is previously untreated patients with primary central nervous system lymphoma could achieve a cr rate of 80% with c-r-hdmtx.


Eligibility criteria:
inclusion criteria: 1. ecog performance status of 0, 1, or 2 2. previously untreated patients with primary central nervous system lymphoma with pathologically confirm 3. at least one bi-dimensionally measurable lesion, defined as \>1.0 cm in its longest dimension as measured by mri 4. signed written informed consent form 5. hematologic function,defined as follows: * hemoglobin ³ 9.0 g/dl without packed rbc transfusion during 14 days before first treatment * anc ³ 1,000/µl * platelet count ³ 80,000/µl 6. adequate liver and kidney function function,defined as follows: serum ast and alt≤ 2.5 \*uln ，total bilirubin ≤ 1.5 \* uln serum creatinine clearance ≥ 50 ml/min (using cockcroft-gault formula) exclusion criteria: 1. evidence of extracranial involvement (such as testis and breast) and secondary cns involvement 2. evidence of pleural fluid, ascites and pericardial effusion 3. history or presence of prolonged qtc interval in ecg, qtc interval\>470ms in female and \>450ms in male 4. history of other malignancy in 5 years 5. positive test results for hepatitis c, hiv and rpr. 6. positive test results for chronic hepatitis b infection (defined as positive hepatitis b surface antigen \[hbsag\] serology) patients with occult or prior hepatitis b infection (defined as positive total hepatitis b core antibody and negative hbsag) may be included if hepatitis b virus (hbv) dna is less than 10e4 at the time of screening. 7. pregnancy or lactation or intending to become pregnant during study 8. prior organ transplantation 9. known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or significant infections within 2 weeks before the start of cycle 1. 10. evidence of significant, uncontrolled, epilepsy