Kornimate/medical-research-clean huggingface dataset:
study to evaluate rituximab and bortezomib in patients with newly diagnosed acquired hemophilia a

Conditions: Acquired Hemophilia A

Summary: the purpose of this prospective study is to determine the efficacy and safety of rituximab plus bortezomib in patients with newly diagnosed acquired hemophilia a.

this is a prospective, single-arm, open-label clinical trial to evaluate the efficacy and safety the regimen of bortezomib with rituximab as first-line treatment to eradicate anti-factor viii antibodies in newly diagnosed acquired hemophilia a. all of enrolled patients in this study will be injected bortezomib plus rituximab. this study will be performed for about 2 years and approximately 22 patients will be enrolled in our insititution. after obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed. patients who meet the inclusion/exclusion criteria will be received the regimens: bortezomib (1.3mg/m2 d1,4,8,11) with rituximab (375mg/m2 for one dose). the information of adverse events will be collected. in case that the evaluation of treatment response might be performed in regular clinical practice, those data will also be collected as well.

Eligibility criteria:
inclusion criteria: 1. must be ≥ 18 years; 2. understand and voluntarily sign an icd prior to any study related assessments/procedures are conducted; 3. diagnosis of acquired hemophilia a； 4. acute bleeding episodes(≥once). exclusion criteria: 1. uncontrolled systemic infection; 2. allergy to rituximab; 3. positive for lupus anticoagulant; 4. life expectancy \< 3 months; 5. pregnant and breastfeeding women; 6. neuropathy\>grade 1; 7. positive for hepatitis b surface antigen or hepatitis c antibody or human immunodeficiency virus（hiv）antibody; 8. patients with poor compliance； 9. patient who is considered by the investigator not suitable for clinical study.
a study comparing the efficacy of intravenous followed by oral itraconazole with intravenous caspofungin for empiric antifungal therapy in neutropenic participants with hematological malignancy

Conditions: Hematologic Neoplasms

Summary: the purpose of this study is to investigate the hypothesis that the efficacy of intravenous (iv) itraconazole followed by oral itraconazole is non-inferior to that of intravenous caspofungin as empiric therapy for suspected fungal infection participants with fever and neutropenia.


Eligibility criteria:
inclusion criteria: * participant must be hospitalized with hematologic malignancy treated by myelosuppressive therapy and/or hematopoietic stem cell transplantation * participant must have a diagnosis of neutropenia with neutrophil count \< 500/microliters (mcl) (0.5 × 10\^9/ liters \[l\]) for at least 96 hours at screening * participant must have a diagnosis of fever and meet the following criteria: 1) oral/rectal temperature greater than or equal to (\>=) 38 degree celsius or axillary temperature (\>=) 37.5 degree celsius and is not considered related to blood products transfusion or drug fever, 2) not responding to broad-spectrum gram-positive and gram-negative antibiotics for 4-7 days with or without signs and symptoms that potentially attributable to deep fungal infection and 3) defervescence within 3 days after the first broad-spectrum antibiotics but recurrence afterwards. * a woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[b hcg\]) and pregnancy test at screening * a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study period and until the menstrual period following the end of study treatment exclusion criteria: * is concomitantly using other systematic antifungal drugs as empirical treatment * has evidence of inadequately managed bacterial infection * is currently receiving any cytochrome p450 3a4 (cyp3a4)-metabolized/p-glycoprotein-transported drugs (including but not limited to cisapride, pimozide, quinidine, dofetilide, levacetylmethadol, terfenadine, astemizole, mizolastine, bepridil, sertindole, 3-hydroxy-3-methyl-glutaryl-coenzyme a reductase (hmg-coa reductase) inhibitor \[for example, simvastatin, lovastatin\], oral midazolam, triazolam, ergot alkaloids \[eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine\] and nisoldipine) that should be prohibited in this study * has known allergy, intolerance or hypersensitivity to azole and echinocandin antifungals or its excipients * has a contraindication to the use of sodium chloride injection
the influence of the sleep apnea on the neurological and functional recovery

Conditions: Sleep Apnea, Obstructive

Summary: the sleep respiratory troubles (central apnea or cheynes-stokes dyspnea) are frequent after stroke. the association of the sleep respiratory troubles with a reserved functional prognosis is debated. the purpose is to find out the frequency of the sleep respiratory troubles after stroke in a prm department and to study their relationship with functional and neurological recovery.

the sleep respiratory troubles (central apnea or cheynes-stokes dyspnea) are frequent after stroke. the association of the sleep respiratory troubles with a reserved functional prognosis is debated. the purpose is to find out the frequency of the sleep respiratory troubles after stroke in a prm department and to study their relationship with functional and neurological recovery. forty-five patients with the average of 58,2 years had been included in this prospective monocentrical study. the detection of the sleep respiratory troubles was realised using a nocturnal oxymetry device and measuring the inspiratory flow, gathering the index of apnea-hypopnea. the nihss, the fim and the fugl-meyer scales were used at the moment of inclusion and two months afterwords.

Eligibility criteria:
inclusion criteria: patient's or one family member's agreement for participation in the study being aged over 18 years stroke history in the past 6 months (ischemic or hemorrhagic) hospitalisation in prm department and participation to a rehabilitation program during study patient belonging to the social security system exclusion criteria: patient having a sleep apnea syndrome known prior to inclusion patient presenting a cardiorespiratory insufiency patients being inable to carry-out the tests or presenting a mental disorder patients who started already their rehabilitation program before in another prm center or department

Keywords: sleep apnea nihss scale fim scale fugl-meyer scale
span-c-sbrt for pancreatic cancer

Conditions: High Risk Localised Pancreatic Cancer

Summary: to assess the freedom from local failure at 12 months after stereotactic body radiotherapy (sbrt). also to assess the safety, efficacy and feasibility of sbrt in the treatment of high risk localised pancreatic cancer.

patients must have histologically or cytologically confirmed high risk localised adenocarcinoma of the pancreas, including patients with extrapancreatic extension (stage iia), node positive (stage iib), borderline resectable or locally advanced pancreatic cancer as defined by australasian gastro-intestinal trials group (agitg) guidelines. ecog performance status 0-1, suitable for chemotherapy and radiotherapy. after a minimum of 2 months of neoadjuvant chemotherapy using either an oxaliplatin- based regimen (folfox, folfirinox, mfolfirinox)+/- immunotherapy/molecular agent or gemcitabine based chemotherapy (eg gemcitabine / gemcitabine/abraxane). participants will receive sbrt (30-45gray in 5 fractions over 2 weeks. prior to sbrt, fiducial markers will be placed to aid with image guidance during radiation delivery. four weeks after completion of sbrt participants will have re-staging using positron emission tomography (pet) and computed tomography (ct) scan. participants will be discussed in the multidisciplinary team meeting for consideration of surgery. those considered to be resectable will proceed to have surgery 6-10 weeks post sbrt.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and able to give informed consent * patients with histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas, including patients with extrapancreatic extension (stage iia), node positive (stage iib), borderline resectable or locally advanced as defined by agitg guidelines * ecog performance status 0-1 * measurable disease as defined by recist 1.1 * have received or plan to receive chemotherapy * successful insertion of fiducial markers exclusion criteria: * patients with metastatic pancreas cancer * prior abdominal radiotherapy * active malignancy excluding non melanomatous skin cancer * neuroendocrine pancreatic carcinoma * pregnant or lactating women * tumour size greater then 70mm * age \>85
chemsex, perceived risks and coping strategies.

Conditions: Sexual; Sexual Desire; Illicit Drugs; MSM

Summary: the research hypothesis is that access to prevention and harm and risk reduction associated with the use of psychoactive substances in a sexual context is insufficient for msm practicing chemsex. this would lead to a lack of awareness of the risks taken and insufficient or inadequate strategies to protect themselves. this qualitative study has a comprehensive objective. the aim is to identify the risks perceived by msm practicing chemsex and their coping strategies. the study is based on individual semi-directed interviews and focus group. the criteria for inclusion are: an age greater than or equal to 18 years, being a man having sex with men and having used psychoactive substances in a sexual context at least once in the past 12 months. participants were recruited through a gay geo-social networking app on mobile phones on a voluntary basis. at the same tim+e, flyers presenting the study are also distributed to the "chemsex" consultations at the montpellier university hospital in france as well as to an association fighting against aids in montpellier. data are subjected to an inductive method analysis, bringing out by constant comparison conceptualizing categories illustrating the experience and making it possible to identify and understand the risks felt and the coping strategies.


Eligibility criteria:
inclusion criteria: * an age greater than or equal to 18 years * being a man having sex with men * having used psychoactive substances in a sexual context at least once in the past 12 months. exclusion criteria: - to refuse to participate to the study

Keywords: screening msm qualitative research hiv transmission men who have sex with men risk reduction behavior harm reduction recreational drugs sexualised drug use
use of extracorporeal blood purification therapies for acute poisoning

Conditions: Poisoning; Extracorporeal Blood Purification Therpay

Summary: extracorporeal blood purification therapy, including intermittent hemodialysis (hd), continuous renal replacement therapy (crrt), plasma exchange (pe), and hemoperfusion (hp) are potentially life-saving treatments for some poisonings. this study aimed to determine extracorporeal blood purification's effect on clinical outcomes in critically poisoned patients in jiangsu province, china.


Eligibility criteria:
inclusion criteria: * 12 years of age and older * history of acute poisoning exclusion criteria: * missing records in survival outcome
realm china extension study

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to conduct an investigator initiated observational study to continue to follow up the china subset of study participants for another 5 years after they complete participation in the realm study


Eligibility criteria:
inclusion criteria: 1. patients completed realm study in china 2. patients willing to sign the consent to continue anti-viral treatment or post-treatment follow up, and agree his/her legacy data and blood/liver histology samples collected in realm study may be used for the analyses planned for this new study. exclusion criteria: 1. patients who do not provide consent to participate in this study; 2. patients are formally enrolled into any investigational drug clinical trial after the realm study.

Keywords: chronic hepatitis b
epidemiologic features of kawasaki disease in shanghai from 2013 through 2017

Conditions: Mucocutaneous Lymph Node Syndrome

Summary: to investigate the epidemiologic features of kawasaki disease (kd) in shanghai from 2013 through 2017 and identify the risk factors for coronary artery lesions.

based on the kd research group network established during the first survey in shanghai, a set of questionnaires and diagnostic guidelines for kd will be sent to 50 hospitals providing pediatric medical care in shanghai, china. medical records of participants with kd diagnosed from january 2013 through december 2017 will be retrospectively analyzed. data are collected by pediatricians, including demographic information, clinical manifestations, prognosis, laboratory indexes, treatment and echocardiographic findings. age and seasonal distribution at onset, treatment and cardiac abnormalities wil be described. univariate and multivariate analyses will be performed to identify risk factors for coronary artery lesions.

Eligibility criteria:
inclusion criteria: - meeting the diagnostic criteria for kawasaki disease released by american heart association 2017 exclusion criteria: * not in acute phase; * repeated cases;

Keywords: kawasaki disease coronary artery lesion epidemiology
a study to assess the safety, tolerability and pharmacokinetics of azd0914

Conditions: Gonococcal (GC) Infection

Summary: the purpose of this study is to assess the safety and tolerability of orally administered azd0914 in healthy adult subjects.

a phase i, randomized, placebo-controlled, single-center study to assess the safety, tolerability, and pharmacokinetics of azd0914 after a single oral administration and to assess the effect of food in healthy adult volunteers

Eligibility criteria:
inclusion criteria: * healthy male and female (of non-childbearing potential)subjects aged 18 to55 years (inclusive). * have a body mass index (bmi) between 18.00 and 30.50 kg/m2 and weigh at least 50 kg and no more than 100 kg * male subjects should be willing to use barrier contraception, ie, condoms, from the day of dose administration until at least 3 months after dose administration of the ip exclusion criteria: * history of any important clinically significant disease or disorder which, in the opinion of the pi, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * any clinically important illness, medical/surgical procedure, or trauma within 4 weeks from the first administration of ip as judged by the pi * history of gastrointestinal ulcer disease, inflammatory bowel disease, indigestion symptoms \>3 times a week, or blood in stool in previous 6 months not related to anal trauma

Keywords: phase 1 healthy volunteers first time in man pharmacokinetics
high-dose intravenous lipid for very preterm or very low birth weight infants effects on growth

Conditions: Very Preterm Birth

Summary: this is a rct study conducted in cipto mangunkusumo hospital in very preterm infants. the investigators compared early intravena lipid start with 2 gram per body weight and 1 gram per body weight and observed the time to reach birth weight.

neonates with \<32 weeks gestation age or \<1500 gram birth weight gets early intravena lipid start with 2 gram per body weight and 1 gram per body weigh then observed the time to reach birth weight

Eligibility criteria:
inclusion criteria: * birth weight below 1500 gram or gestational age below 32 weeks exclusion criteria: * mayor congenital abnormalities
68ga-psma hbed-pet/ct in the evaluation of the biochemical relapse in patients with a history of prostate cancer radically treated

Conditions: 68Ga-PSMA HBED-PET/CT; Prostate Cancer

Summary: single-center, prospective, diagnostic trial in radically treated patients with biochemical recurrence of prostate cancer. patients with radically treated prostate cancer with biochemical relapse and negativity of all traditional morphological and functional imaging (transrectal ultrasound, bone scan, 18f-fmc pet/ct, ct/mri) or doubtful imaging of 2-deoxy-2-\[fluorine-18\] (18f)-fluoromethylcholine (fmc) pet/ct will receive a gallio-68 (68ga)- prostate specific membrane antigen (psma) positron emission tomography (pet)/computed tomography (ct) scan.

single-center, prospective, diagnostic trial. the primary objective of this study is to evaluate the sensitivity of 68ga-psma pet /ct defined as the ratio between the number of 68ga-psma pet /ct positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging. the secondary objectives are: * sensitivity for different prostatic specific antigen (psa) values (ranges) * sensitivity for different lesion sites * treatment response assessment with a second pet * false positives detection during follow up (fup) (with other standard methods and eventually optional biopsy) for patient without any treatment * safety 67 evaluable patients will be injected with 100-200 megabecquerel (mbq) 68ga-psma intravenously

Eligibility criteria:
inclusion criteria: 1. patients must have histologically or cytologically confirmed prostate cancer 2. male, aged \>18 years. 3. radical treatment for prostate cancer (radiotherapy or surgery) 4. 18f-fmc pet/ct negative or doubtful 5. negativity of all the other traditional morphological and functional imaging (transrectal ultrasound, bone scan, ct/mri) 6. patients with psa progression defined as psa ≥ 1,0 ng/ml and/or psa rising defined as 2 subsequent values showing psa increase at least 1 week apart. 7. male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter 8. participant is willing and able to give informed consent for participation in the study. exclusion criteria: 1. no hormonotherapy in the last 6 months 2. no radiotherapy in the last 6 months. 3. patients with psa \< 1.0 ng/ml 4. participation in another clinical trial with any investigational agents within 30 days prior to study screening. 5. history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent. 6. medical or psychological conditions that would not permit the subject to complete to sign informed consent

Keywords: 68ga-psma hbed-pet/ct biochemical relapse prostate cancer radically treated
improving characterization of calcifications with contrast-enhanced mammography

Conditions: Mammography

Summary: the purpose of this study protocol is to assess whether contrast-enhanced mammography (cem) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.


Eligibility criteria:
inclusion criteria: * women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography. * at least 30 years of age. * able to understand and willing to sign an irb-approved written informed consent document * gfr ≥ 30 ml/min/1.73 m2 exclusion criteria: * pregnant * prior history of allergy or hypersensitivity reaction to iodinated contrast * history of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery) * patients with known thyroid disorders, pheochromocytoma or sickle cell anemia
dose-escalation study of htx-034 following bunionectomy

Conditions: Bunions

Summary: this is a phase 1b/2, randomized, blinded, active-controlled study. phase 1b will evaluate escalating doses of htx-034 compared with bupivacaine hcl. phase 2 will be a dose-expansion phase to evaluate additional subjects treated with the htx-034 dose selected based on phase 1b compared with bupivacaine hcl.


Eligibility criteria:
inclusion criteria: * is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia). * has an american society of anesthesiologists (asa) physical status of i, ii, or iii. * female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study; sterile, or using acceptable contraceptives. exclusion criteria: * had contralateral foot bunionectomy in the past 3 months. * has a planned concurrent surgical procedure. * has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. * has received or is taking a contraindicated or prohibited medications. * received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives. * has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. * has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months. * has a history of coronary artery bypass graft surgery within 12 months. * has a history of known or suspected coagulopathy. * as per subject history and/or medical records, has active infection or is currently undergoing treatment for hepatitis b, hepatitis c, or human immunodeficiency virus (hiv). * has uncontrolled anxiety, psychiatric, or neurological disorder. * had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * has undergone 3 or more surgeries within 12 months. * has a known history of glucose-6-phosphate dehydrogenase deficiency. * has any of the following laboratory abnormalities during screening (1 retest permitted): * severe liver function impairment. * severe kidney function impairment. * platelet count \<100,000/μl, hemoglobin \<12 g/dl, or hematocrit \<35%. * has a body mass index (bmi) \>39 kg/m2.

Keywords: analgesia bunionectomy
a registered cohort study on amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a kind of motor neuron degeneration disorder without effective therapy. this registered cohort study will provide further insights into the clinical course of als, and investigate disease-relative risk factors and the genetic background of chinese als patients.

amyotrophic lateral sclerosis (als) is the most common form of motor neuron disease (mnd), which is characterized with highly clinical heterogeneity and no effective treatment is available now. the purpose of this registered cohort is to observe the natural history of als patients in china, and then identify some factors correlated with disease progression. besides, als-related gene mutations will be screened and explore novel disease causing gene as well.

Eligibility criteria:
inclusion criteria: * amyotrophic lateral sclerosis patients fulfilling the el escorial criteria (including definite, probable and possible) * progressive muscular atrophy * primary lateral sclerosis * progressive bulbar palsy exclusion criteria: * history of serious head trauma or neuropsychiatric disease * decline to participate

Keywords: amyotrophic lateral sclerosis natural history genetics prognostic factors