Kornimate/medical-research-clean huggingface dataset:
study of kk3910 in healthy volunteers and patients with essential hypertension

Conditions: Healthy Volunteers Essential Hypertension

Summary: part 1 : to evaluate the safety of single-dose kk3910 in healthy volunteers. part 2 : to evaluate the safety of multiple-dose kk3910 in patients with essential hypertension.


Eligibility criteria:
inclusion criteria: part 1 * voluntary consent to participate in this study must be given (in writing) * japanese or non-asian healthy men 18 to \< 55 years at the time of informed consent ( japanese healthy men 65 to \< 80 years for the elderly cohort) * bmi is within the specified range at screening inclusion criteria: part 2 * voluntary consent to participate in this study must be given (in writing) * japanese patients with essential hypertension, aged 18 to \<65 years at the time of informed consent * bmi is within the specified range at screening exclusion criteria: part 1 * history of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator. * history of or current drug allergy * history of or current alcoholism or drug addiction * smoking within the specified period * infection within the specified period * any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study exclusion criteria: part 2 * history of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator. * history or of current drug allergy * history of or current alcoholism or drug addiction * pregnant or breastfeeding patients, or patients willing to have a child during the study * smoking within the specified period * infection within the specified period * any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study
implementation of transdx group for pots

Conditions: Dysautonomia; Anxiety; Depression

Summary: the proposed intervention is focused on developing and implementing a psychological approach incorporated into a group-based outpatient intervention for pediatric autonomic dysfunction. the investigators hypothesize that their intervention will result in improvements in the transdiagnostic mechanisms specifically targeted by components of their intervention including sleep, information processing, and youth/parent experiential avoidance.


Eligibility criteria:
inclusion criteria: * adolescent participants must be 1. between the ages of 13-18 years old, 2. english speaking, and 3. have been diagnosed with autonomic dysfunction, dysautonomia, orthostatic intolerance, and/or pots. * participants must also: 1. endorse symptoms of autonomic dysfunction on the compass 31 (measures are described below), and show 2. moderate functional impairment, and/or 3. some psychiatric symptoms in the domains of anxiety and/or depression. * fdi scores must be greater than 12 (see kashikar-zuck et al., 2011 for an empirical rationale). * must have attended at least one day of school per week during the past month. * on the measures of anxiety (scared) and depression (cdi), the adolescent's scale score must be above the "average" range based on t scores (cdi) or within the "clinical" range (scared). * each participant must have at least one english-speaking parent/legal guardian who can provide informed consent for the adolescent, as well as participate in the study. * each adolescent and their parent/legal guardian(s) must be english-speaking. exclusion criteria: * adolescent participants; 1. wards of the state, 2. endorse active homicidal or suicidal ideation, 3. have an intellectual disability, a pervasive developmental disability or significant developmental delay, 4. endorse an active substance use disorder, and 5. are currently participating in individual or group psychotherapy. 6. do not have in-network health insurance that covers health and behavior interventions, or 7. are unable to self-pay. * parent/legal guardian(s) are 1. unwilling to participate in the study, 2. are non-english speaking, or 3. have an intellectual disability, a pervasive developmental disability or significant developmental delay, and/or 4. do not have legal custody of the adolescent participant.

Keywords: transdiagnostic pots (postural orthostatic tachycardia syndrome) therapy
lenvatinib plus pd-1 antibody versus lenvtinib alone for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with pd-1 antibody compared with lenvtinib alone in patients with advanced hepatocellular carcinoma (hcc)

lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and pd-1 antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. no study has compared the efficacy and safety of lenvatinib plus pd-1 antibody and lenvatinib alone. thus, the investigators carried out this prospective randomized control study to find out it.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * eastern cooperative oncology group performance status of 0 to 2 * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: * platelet count ≥ 75,000/μl * hemoglobin ≥ 8.5 g/dl * total bilirubin ≤ 30mmol/l * serum albumin ≥ 30 g/l * asl and ast ≤ 5 x upper limit of normal * serum creatinine ≤ 1.5 x upper limit of normal * inr ≤ 1.5 or pt/aptt within normal limits * absolute neutrophil count (anc) \>1,500/mm3 * ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma lenvatinib pd-1 antibody
predictive value of ps application in premature infants with rds

Conditions: Respiratory Distress Syndrome

Summary: a multicenter prospective study was conducted to compare the predictive value of 6-zone, 10-zone, and 12-zone lus scores for ps application in early and late preterm infants.


Eligibility criteria:
inclusion criteria: 1. hospital admission within 2 hours after birth; 2. the diagnosis was rds; 3. parents agree to attend exclusion criteria: 1. chromosomal abnormalities or complex congenital malformations; 2. congenital pulmonary disease; 3. severe sepsis, disseminated intravascular coagulation, septic shock and other critical conditions; 4. lus and blood gas analysis have been examined before the application of alveolar surfactant.
the effects of azd2171 in patients with non-small cell lung cancer or head & neck cancer

Conditions: Carcinoma; Non-Small-Cell Lung Carcinoma; Head and Neck Neoplasms

Summary: this study is to examine the effects on tumors of azd2171, in the treatment of nsclc or hnc. the safety and tolerability of azd2171 will also be studied.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed head and neck cancer (hnc) or unresectable stage iiib or iv non-small cell lung cancer (nsclc) * at least one lesion able to be used for tumor biopsy and to be measured by fdg-pet scan * considered suitable for treatment of nsclc with no prior biological or immunological therapy for disease * or considered suitable for treatment for metastatic or recurrent hnc with no prior biological or immunological therapy for disease exclusion criteria: * nsclc: have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of azd2171 * hnc: previous chemotherapy or radiotherapy if received 28 days of first dose of azd2171 * untreatable, unstable brain or meningeal metastases. * abnormal liver and kidney blood chemistries * history of poorly controlled hypertension with resting blood pressure of \>150/100 * recent (\< 14 days) major surgery or a surgical incision not fully healed * diabetes patients with type i insulin dependent diabetes or poorly controlled type ii * significant hemorrhage or hemoptysis * presence of necrotic/hemorrhagic tumor or metastases

Keywords: recentin
a phase i study of tas-102 in patients with advanced gastrointestinal tumors.

Conditions: Advanced Gastrointestinal Tumors

Summary: the purpose of this study is to investigate the safety and determine the maximum tolerated dose of tas-102 administered in combination with cpt-11 in patients with advanced gastrointestinal tumors.

this is an open-label, non-randomized, dose-escalation, phase 1 study of tas-102 administered in combination with cpt-11. the study will be conducted in 2 parts: a dose escalation phase (part 1) to determine the maximum tolerated dose and an expansion phase (part 2) to further evaluate the safety, pharmacokinetics, and preliminary efficacy of the maximum tolerated dose. patients will be assigned to sequential dose-level cohorts with each cohort corresponding to a pre-specified dose of tas-102 and cpt-11 combination. escalation to the subsequent dose level will occur only after the previous dose level is determined to be safe.

Eligibility criteria:
inclusion criteria: 1. has provided written informed consent 2. has advanced gastrointestinal tumors refractory to at least 1 chemotherapy 3. ecog performance status of 0 or 1 4. is able to take medications orally 5. has adequate organ function (bone marrow, kidney and liver) 6. women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. males must agree to adequate birth control. exclusion criteria: 1. has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration 2. presence of serious illnesses or medical condition(s) e.g. brain metastases, systemic infection, heart failure 3. has unresolved toxicity of greater than or equal to ctcae grade 1 attributed to any prior therapies 4. known sensitivity to tas-102, cpt-11, bevacizumab, or their components 5. is a pregnant or lactating female 6. has had either partial or total gastrectomy

Keywords: angiogenesis inhibitor monoclonal antibody vascular endothelial growth factor a (vegf-a)
identifying genetic characteristics that increase risk of primary graft dysfunction following lung transplantation

Conditions: Primary Graft Dysfunction; Lung Transplantation

Summary: primary graft dysfunction (pgd) is a severe lung injury that can occur in the days following lung transplant surgery. the purpose of this study is to identify genetic factors that may put someone at risk for developing pgd.

pgd is a severe complication that affects up to 25% of lung transplant patients following surgery. pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with pgd experience. treatment for this condition is often expensive, and it is the leading cause of death following lung transplant. many potential donors and recipients are considered unsuitable for lung transplant because of concern for the development of pgd. therefore, the ability to accurately predict which individuals are at risk for developing pgd may allow more lung transplants to be performed. specific characteristics in both lung donors and recipients may play an important role in determining the risk of pgd. for example, genetic variations in how the body deals with harmful chemicals called oxidants may be associated with the development of pgd. the purpose of this study is to identify the specific genetic biomarkers in donors and recipients that put individuals at risk for developing pgd following a lung transplant. this study will enroll individuals who are undergoing lung transplantation. blood samples will be collected from lung donors and from participants prior to surgery, immediately following surgery, and 24 hours after surgery. study researchers will monitor participants for 72 hours following surgery for symptoms of pgd. there will be no additional study visits.

Eligibility criteria:
inclusion criteria: * undergoing lung transplant surgery exclusion criteria: - individuals undergoing multi-organ transplantation except heart/lung transplants

Keywords: pgd
effect of probiotics as supplement to non-surgical periodontal treatment

Conditions: Periodontitis

Summary: the present study is a double-blinded randomized clinical trial with a duration of 12 weeks.

the present study is a double-blinded randomized clinical trial with a duration of 12 weeks . 60 patients with periodontitis stage 2-3, grade b-c, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline. the intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks. clinical measurements and sampling will be performed at baseline, week 6 and week 12. primary endpoint: changes in microbial composition. secondary endpoints: changes in clinical and immunological parameters

Eligibility criteria:
inclusion criteria: * periodontitis stage 2-3, grade b-c, generalized exclusion criteria: * • use of systemic antibiotics within the latest three months.
monitoring in intensive care unit of neuromuscular blocking agents used for acute respiratory distress syndrome after cardiothoracic surgery

Conditions: Acute Respiratory Distress Syndrome

Summary: mortality in acute respiratory distress syndrome (ards) is high (40 to 60 %). protective mechanical ventilation is the cornerstone of the ards therapeutic strategies. recently, a prospective multicenter study demonstrates that short-term infusion of neuromuscular blocking agents (nmba) reduces hospital mortality. however, the mechanisms through which nmbas could improve survival remain speculative and the dose of nmba needed to observe a beneficial effect is still debated. in hypoxemic ventilated patients, continuous cisatracurium infusion with an objective of no response at orbicularis oculi to train-of-four (tof) stimulation and an objective of two responses had similar effects on respiratory parameters. in their study, papazian and colleagues used cisatracurium with an initial standard dose of 15 mg followed by a continuous infusion of 37.5mg/h, based on previous results of studies with patients monitored for paralysis. atracurium and its stereoisomer cisatracurium are non-depolarizing neuromuscular blocking drugs, both used in anaesthesia and intensive care units. the aim of this study was to compare in ards patients a dose adjustment of continuous-atracurium intravenous infusion with an end point of one or two response at orbicularis oculi to tof stimulation, and a dose adjustment to achieve clinical goals of protective ventilation without monitoring of tof stimulation.


Eligibility criteria:
inclusion criteria: * ards with a pao2 / fio2 \ 5 since less than 48 hrs * informed consent exclusion criteria: * nmba allergy * continuous administration of nmba for ards prior inclusion * age \< 18 yrs

Keywords: respiratory distress syndrome, adult neuromuscular blocking agents atracurium mechanical ventilation ards partial pressure of oxygen(pao2) /inspired oxygen (fio2) < 200 positive end expiratory pressure (peep) > 5 since less than 48 hrs
fecal microbiota transplantation in recurrent or refractory clostridium difficile colitis

Conditions: Clostridium Difficile; Clostridium Difficile Infection

Summary: the host gastrointestinal microbiota is significantly influenced by antibiotic treatment which might favor clostridium difficile infection (cdi), a frequent cause of community- and hospital-acquired, potentially life-threatening diarrhoea. cdi is followed by recurrence in 19-35% of patients despite adequate first line antimicrobial therapy. currently there is no standardized therapy of recurrent or refractory cdi, but recent studies show remarkable effects of fecal microbiota transplantation (fmt). in the current project, we aim to ideally match host and donor for fmt success in recurrent or refractory cdi. we will establish a clinical standard operating protocol for fmt, we will evaluate its safety and efficacy, and the patient acceptance and quality of life before and after fmt. we will analyse persistence of the donor microbiota within the recipient, define predictive clinical recipient and donor factors for fmt success and correlate them with microbial host and donor metagenomics. we hypothesize that our work will yield novel, individualized strategies for recurrent or refractory cdi. in perspective, our results may be expanded to treatment of other inflammory bowel diseases.


Eligibility criteria:
inclusion criteria: * recurrent or refractory cdi * previous antimicrobial therapy includes at least on course of vancomycin 4x125 (or higher doses) for at least 7d * cdi, defined as: 3 or more loose bowel movements/d and (presence of c.diff. toxin in stools or toxin producing c. diff. strain) or (endoscopic or histologic evidence of pseudomembraneous colitis) exclusion criteria: * no informed consent * no ability to provide informed consent * immune suppression (continuous immune-suppressive drugs; steroids: prednisolone-equivalent \> 20 mg for 14d or longer) * lack of appropriate donor * pregnancy

Keywords: fecal microbiota transplantation microbiota clostridium difficile clostridium difficile infection efficacy of fmt
selective internal radiotherapy (sirt) versus transarterial chemoembolisation (tace) for the treatment of cholangiocellular carcinoma (ccc).

Conditions: Intrahepatic Cholangiocellular Carcinoma

Summary: selective internal radiotherapy is superior to transarterial chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (ccc).


Eligibility criteria:
inclusion criteria: * ≥18 years * intrahepatic ccc, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (cea or ca 19-9) * tumor confined to the liver * at least one measurable lesion in magnetic resonance imaging (mri) * tumor load ≤ 50% * preserved liver function (child pugh a and b) * ecog performance status ≤2 exclusion criteria: * patients feasible for curative treatment (e.g. resection or local ablation) * previous tace or sirt * prior chemotherapy * child pugh stage c * ecog performance status \>1 * tumor involvement \>50% of the liver * extrahepatic tumor * serum bilirubin \>2.0 mg/dl; serum albumin 2.8 g/dl, serum creatinine \>2 mg/dl; leukocytes \<3000/ml; thrombocytes \<50000/ml * clinically apparent ascites (ascites only in ct/mri is no exclusion criteria) * esophageal bleeding during the last 3 months * hepatic encephalopathy * transjugular intrahepatic portosystemic shunt (tips) * infiltration or occlusion of the main portal vein * hepatofugal blood flow in the portal vein * hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan (maa-scan) * contraindications against angiography * pregnancy

Keywords: cholangiocellular carcinoma tace sirt
αβt cell/cd19+ b cell depletion for alternative donor allogeneic hematopoietic cell transplantation (hsct)

Conditions: Hematopoietic Stem Cell Transplantation; Hematologic Malignancy

Summary: this is a study utilizing the magnetic-activated cell sorting (clinimacs®) alpha-beta t-cell (αβt)/cluster of differentiation 19 (cd19), also called b lymphocyte antigen cd19 depletion device for children and young adults with hematologic malignancies undergoing alternative donor allogeneic hematopoietic cell transplantation (hsct). patients will receive an allogenic hsct from a matched unrelated donor (mud), mismatch unrelated donor (mmud) or a mismatched related (haploidentical) donor. patients will receive a granulocyte-colony stimulating factor (g-csf) ± plerixafor donor mobilized peripheral stem cell donor transplant following clinimacs® αβt cell/cd19+b cell depletion. cluster of differentiation 34 (cd34) and αβt cell content of the graft is determined based on the transplant indication.


Eligibility criteria:
inclusion criteria: * age ≤ 30 years * patients who will benefit from an allogenic stem cell transplant to treat underlying primary hematological malignancy and lacks a suitably available matched sibling donor. * karnofsky index or lansky performance scale ≥ 60 % on pre-transplant evaluation. * karnofsky scores must be used for patients \> 16 years of age and lansky scores for patients ≤ 16 years of age. * patient or legal guardian must give informed consent if patient is ≥ 18 years. legal guardian must give informed consent (and patient must give assent if appropriate) if patient is \< 18 years. * adequate organ function (within 4 weeks of initiation of preparative regimen). for patients receiving myeloablative conditioning (mac) on this platform, they should meet organ function to tolerate mac. similar if patients are receiving reduced intensity conditioning (ric). * high resolution human leukocyte antigen (hla) available exclusion criteria: * patient does not have a suitable donor who is willing and able (meets donor criteria). * patient reports a history of allergic reactions to murine protein * pregnant or lactating females are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants. female patients of childbearing potential females ≥11 years of age or post- menarche and should have a negative pregnancy test * patients with hiv or uncontrolled fungal, bacterial or viral infections are excluded. patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by ct evaluation. viremia by pluripotency check (pcr) analysis is not considered an active infection but may require immediate viral prophylaxis. patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic - * patients receiving umbilical cord blood and matched sibling donor transplants
intraseasonal short-time up-dosing with alutard sq grasses

Conditions: Allergy

Summary: test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing


Eligibility criteria:
inclusion criteria: * history of grass pollen induced allergic rhinoconjunctivitis * positive skin prick test exclusion criteria: * uncontrolled severe bronchial asthma * previous treatment with immunotherapy within the previous 5 years * contraindication for specific immunotherapy