Kornimate/medical-research-clean huggingface dataset:
safety and tolerability study of rifaximin in participants with a history of hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: this study will look at the safety of a drug used in participants who have had hepatic encephalopathy (he) in the past.

eligible participants had a history of he, a conn score of 0 to 2 at enrollment, and either had successfully participated in a previous he study with rifaximin (that is, rfhe3001 \[nct00298038\]), or were new participants enrolled with ≥1 verifiable episode of he (equivalent to a conn score of ≥2) associated with cirrhosis or portal hypertension within 12 months of screening. successful participation in a previous rifaximin study was defined as having received ≥80% and ≤120% of the expected tablets, having been reasonably compliant with study procedures, and having not been discontinued from the previous study due to study drug-related adverse events. participants who experienced he or associated symptoms during or after the rfhe3001 study were considered eligible for entry into this open-label study if the participant and investigator did not perceive study medication as a possible cause of the he episode or associated symptoms. participants who did not participate in a previous he study with rifaximin were eligible if this open-label study was the only rifaximin he study available at an individual site.

Eligibility criteria:
inclusion criteria: * must sign an informed consent form * in remission from past he * appropriate birth control measures * more than or equal to 18 years of age * must be potential for benefit from treatment * recent he episodes * capable and willing to comply with all study procedures * participant has support network exclusion criteria: * significant medical conditions or investigator decision not to include the participant * allergies to the study drug or similar drugs * laboratory abnormalities * recent participation in another clinical trial * problems experienced in a previous he trial * pregnant or at risk of pregnancy * recent alcohol consumption * active or latent bacterial or viral infections * bowel issues * recent active cancer * on a prohibited medication
hematopoietic stem cell transplant for dyskeratosis congenita or severe aplastic anemia

Conditions: Dyskeratosis Congenita; Aplastic Anemia

Summary: fludarabine-based preparative regimen followed by an allogeneic hematopoietic stem cell transplant using related or unrelated donor in persons 0-70 years of age diagnosed with dyskeratosis congenita or severe aplastic anemia who have bone marrow failure characterized by a requirement for red blood cell and platelet transfusions. three different preparative regimens are included based on disease and donor type.


Eligibility criteria:
inclusion criteria: * aged 0 - 70 years * acceptable hematopoeitic stem cell donor * dyskeratosis congenita (dc) with evidence of bm failure defined as: * requirement for red blood cell and/or platelet transfusions or * requirement for g-csf or gm-csf or erythropoietin or * refractory cytopenias having one of the following three * platelets \<50,000/ul or transfusion dependent * absolute neutrophil count \<500/ul without hematopoietic growth factor support * hemoglobin \<9g/ul or transfusion dependent * diagnosis of dc with a triad of mucocutaneous features: * oral leukoplakia * nail dystrophy * abnormal reticular skin hyperpigmentation, or * diagnosis of dc with one of the following: * short telomeres (under a research study) * mutation in telomerase holoenzyme (dkc1, tert, terc, nop10, nhp2, tcab1) * mutation in shelterin complex (tinf2) * mutation in telomere-capping complex (ctc1) * severe aplastic anemia (saa) primary transplant with evidence of bm failure: * refractory cytopenia defined by bone marrow cellularity \<50% (with \< 30% residual hematopoietic cells) * diagnosis of saa with refractory cytopenias having one of the following three: * platelets \<20,000/ul or transfusion dependent * absolute neutrophil count \<500/ul without hematopoietic growth factor support * absolute reticulocyte count \<20,000/ul * severe aplastic anemia (saa) requiring a 2nd transplant * graft failure as defined by blood/marrow chimerism of \< 5% * early myelodysplastic features * with or without clonal cytogenetic abnormalities * adequate organ function defined as: * cardiac: left ventricular ejection fraction ≥ 35% with no evidence of decompensated heart failure * pulmonary: dlco ≥30% predicted, no supplemental oxygen requirement * renal: glomerular filtration rate (gfr) ≥30% predicted * voluntary written consent exclusion criteria: * acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy * pregnant or lactating * uncontrolled infection * prior radiation therapy (applies to saa patients only) * diagnosis of fanconi anemia based on deb * diagnosis of dyskeratosis congenita with advanced mds or acute myeloid leukemia with \>30% blasts

Keywords: severe aplastic anemia hematopoietic stem cell transplant
intensive medicines monitoring study of toripalimab monoclonal injection (tuoyi) .

Conditions: Melanoma; Lung Cance; Breast Cancer

Summary: this study was a prospective, single-arm, multi-channel, multicenter, non-interventional real-world study to evaluate the safety and efficacy of toripalimab injection in the treatment of unresectable or metastatic melanoma with previously systemic failure . the study population currently included only in the melanoma cohort-unresectable or metastatic melanoma patients who had previously failed systemic therapy. if new indications are approved during the implementation of the project, patients with new indications using toripalimab injection will also be included in this study as a new cohort.this study uses offline (physical hospital) and online (dtp pharmacy and lingke (yinchuan) internet hospital) to collect data and information, relying on lingke technology (beijing) co., ltd. edc (medical research cloud) database for data collection and processing. the classification of adverse events was based on the general toxicity evaluation standard nci ctcae 5.0 of the national institute of oncology (chinese version).


Eligibility criteria:
inclusion criteria: 1. patients with approved indications of toripalimab injection; 2. patients treated with toripalimab injection; 3. patients who agreed to participate in this study and signed an informed consent form. exclusion criteria: 1. refused to participate or refused to cooperate with the procedure; 2. those who participated in the intervention study of other unapproved drugs / therapies and less than 5 half-lives after the last use of the study drugs.
andalusian experience in the use of fostamatinib in patients with itp. fostasur study

Conditions: Primary Immune Thrombocytopenia

Summary: description of the use of fostamatinib in patients with pti in the andalusian region.

fostamatinib is a splenic tyrosine kinase (syk) inhibitor whose indications include the treatment of chronic primary immune thrombocytopenia (pti) refractory to first-line treatments. data from two phase 3 studies in pti, together with supporting safety data from a comprehensive program in 3,437 subjects with rheumatoid arthritis, led to the approval and registration of fostamatinib by health authorities in the us and in europe. given the recent commercialization of fostamatinib for pti, there is little data in real clinical practice that helps its general management: how to perform tapering, response rates in less refractory patients, experience in subjects with associated immunosuppressive therapies or thrombopoietin analogues, etc. these studies outside the clinical trial environment are relevant to plan needs, consumption, efficacy, and safety results in real clinical practice in our environment, the andalusian region. the pivotal studies present experience on 102 cases and the real-life experience is of case series of less than 5 patients, with the population of patients treated in the andalusian region as of december 31st being greater than 40 cases. for all these reasons the andalusian group of congenital coagulopathies proposes collecting what the experience has been like in their environment. participation in this study is not intended to change the routine treatment patients receive as determined by their prescribing physicians. no clinic visits, procedures, evaluations, or tests will be required for the purposes of the study. this is multicenter retrospective data that will be collected from information generated during routine examinations and treatments performed by the investigator according to the standard of care.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years or older. 2. patients with itp criteria according to clinical practice guidelines. exclusion criteria: 1. patients with any medical or psychological condition that prevents them from following the procedures of normal clinical practice as determined by the investigator. 2. subjects with other concomitant hemostatic defects. 3. documented history or clinical evidence of medical conditions (other than itp) that consider the underlying cause of thrombocytopenia. 4. diagnosis of secondary immune thrombocytopenia. 5. subject has a known allergy to fostamatinib or any of the ingredients included in its formulation.
andosan in allergic and asthma patients

Conditions: Allergic Asthma; Allergic Rhinoconjunctivitis; Immune Tolerance

Summary: examine whether daily oral ingestion of a immunomodulatory mushroom extract (andosantm) in patients with asthma and allergy, undergoing allergen specific immunotherapy experience clinical and biochemical improvement in their disease. a prospective randomised study comparing the mushroom extract with placebo.

asthma and allergy are increasing in norway and western countries. treatment is still mostly symptomatic. extracts of the immunomodulatory and edible mushroom agaricus blazei, such as andosan™, have been shown to protect against asthma and allergy in murine models by changing the t helper cell 1(upregulation)-t helper cell 2 (downregulation) balance in the immune system. positive effects on allergy were also shown in a rct on blood donors with selfreported allergy. andosan™ is produced in japan and approved as food (mushroom juice) in norway. the aim of this study is to examine whether andosan™ i) has similar clinical effects against allergy and asthma in patients as it has in mice, and as earlier shown in a study on blood donors with allergy ii) wether patients taking andosan has any clinical impact on asthma while taken as supplementary treatment in addition to other medication compared to a placebo group while going through allergen specific immunotherapy (asit). if the extract shows effect on these patients it support the hypotheses that andosan helps against atopic diseases and facilitate the shift from th-2 to th-1 responses at a cellular level.

Eligibility criteria:
inclusion criteria: * asthma or allergy patients that are eligible for asit (allergen specific immunotherapy). * age above 18. * able to understand written and oral norwegian exclusion criteria: - none other than not meeting the inclusion criteria

Keywords: asit slit andosan
safety, efficacy, and pharmacokinetics of amphotericin b lipid complex

Conditions: Invasive Cryptococcosis

Summary: the purpose of this study is to determine if initial therapy with ablc at 10/mg/kg/d for 7 days are at least effective as ablc at 5.0 mg/kg/d x 14 days as induction treatment of patients with disseminated cryptococcosis and hiv.

this is a randomized, open label, prospective study of ablc at 5.0 and 10.0 mg/kg/d for treatment of patients with cryptococcal meningitis. patients will be randomly assigned in a 1:1 ratio to receive 5.0 or 10.0 mg/kg/d of ablc as induction therapy for cryptococcal meningitis. patients receiving 10 mg/kg/d doses will be treated with ablc for 7 days whereas patients receiving ablc at 5.0 mg/kg/d will receive 14 days of ablc therapy. after completion of induction therapy subjects will receive long-term fluconazole maintenance therapy at the discretion of the treating physician. the study will be conducted at the washington hospital center

Eligibility criteria:
inclusion criteria: 1. diagnosis of cryptococcal meningitis based on any of the following: * cerebrospinal fluid positive for c. neoformans * cerebrospinal fluid positive for cryptococcal antigen 2. male or female 18 years of age or older. 3. all female patients must be non-lactating and have a negative serum pregnancy test at time of screening. females of childbearing potential must be using a medically acceptable method of contraception and agree to continue its use during the study period, or must be one year postmenopausal, or have been surgically sterilized. 4. willing and able to give a signed informed consent, or have a legally authorized representative who is willing or able to give consent exclusion criteria: 1. a history or evidence of hypersensitivity to amb or any of its metabolites. 2. a history or evidence of any psychiatric, neurological metabolic, or other chronic condition, which in the investigator's opinion, would make the patient unsuitable for the study or interfere with the evaluation of ablc. 3. inability to comply with the procedures of the study. 4. patients who have received greater than 72 hours of therapy with another systemic antifungal agent within 2 weeks prior to enrollment 5. patients with any of the following abnormal laboratory values * baseline creatinine clearance of less than 50. * bilirubin of greater than 5 times the upper limit of normal * ast or alt of greater than 10 times the upper limit of normal 6. life expectancy of less than 72 hours

Keywords: ablc cryptococcosis
association of vitamin d intake, and associated factors with low back pain: a retrospective cohort study

Conditions: Vitamin D

Summary: while there have been studies indicating a connection between insufficient levels of vitamin d and persistent low back pain (lbp), there is still a lack of definitive evidence. the primary objective of this study was to evaluate the correlation between vitamin d intake, and associated factors with chronic lower back pain.


Eligibility criteria:
inclusion criteria: * we included patients that were presented at our institute with chronic lbp and no associated comorbidities. exclusion criteria: -

Keywords: : low back pain, vitamin d, pain, disability, oswestry low back disability questionnaire
use of localized nb-uvb (levia®) in the treatment of plaque-psoriasis

Conditions: Psoriasis

Summary: the purpose of the study is to test the effect of a localized narrow band ultraviolet (nb-uvb) phototherapy compared to visible light that does not produce uvb on the clearance of psoriasis plaques and resolution of itching. localized nb-uvb (levia®) phototherapy device is cleared by the u.s food and drug administration (fda).

this will be an ascending dose study with treatments three times per week, initial treatment dose and increasing regimen is adjusted according to the subject skin type. a suggested treatment regimen schedule provided from lerner medical devices, inc: for subjects with skin type i: starting dose of 195 mj/cm2, for subjects with skin type ii: starting dose of 330 mj/cm2, for subjects with skin type iii: starting dose of 390 mj/cm2, for subjects with skin type iv: starting dose of 495 mj/cm2, for subjects with skin type v: starting dose of 525 mj/cm2, for subjects with skin type vi: starting dose of 600 mj/cm2. the dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness.

Eligibility criteria:
inclusion criteria: * adults 18 years or older with bilateral psoriasis plaques, in general good health as determined by the principal investigator by medical history and physical exam. * able to understand consent procedure * able to comply with protocol activities * must have baseline symmetric target lesions with baseline target lesion score (tls) of 6 or higher (scale of 0-12), i.e., moderate in intensity for each target. target lesion scoring: thickness, scaling and erythema of the plaques are rated each on a scale of 0-4. the three scores are summed. the minimum score is 0; the maximum is 12. scores of 6 or greater are considered moderate to severe. exclusion criteria: * patients less than 18 years old * patients not able to understand consent procedure * patients unable to comply with protocol activities * non-english speakers: the study assessments/questionnaires/evaluations are not scientifically validated in languages other than english * baseline target lesions scores of less than 6 * patients with a photosensitive disorder or on a medication which has been demonstrated in these patients to cause photosensitivity * patients receiving concomitant phototherapy to test sites * patient receiving topical medication to test sites within 2 weeks of study initiation * patient receiving methotrexate, acitretin, cyclosporine, or other oral medications for psoriasis within 4 weeks of study initiation * patients receiving etanercept (enbrel®) within the past 2 months of study initiation * patients receiving infliximab (remicade®), ustekinumab (stelara®), golimumab (simponi®) adalimumab (humira®) or alefacept (amevive®) within the past 3 months prior to study initiation * receipt of an investigation agent within the past 4 weeks (or within 5 half lives) prior to study ignition * systemic corticosteroid therapy within the past month * concurrent use of prohibited medications
iber salvage treatment followed by ibrutinib maintenance for relapsed or refractory pcnsl

Conditions: Primary Central Nervous System Lymphoma

Summary: this is a multicenter, single-arm, prospective phase ii study to evaluate the efficacy and safety of a novel combination regimen for relapsed/refractory pcnsl. specifically, ibrutinib will be administered in combination with ifosfamide, etoposide and rituximab (iber) as a salvage chemotherapy, which is followed by maintenance ibrutinib monotherapy of fixed duration.

given the limited activity of salvage therapy with high-dose methotrexate re-treatment and/or alkylator-based treatment in patients with relapse or refractory pcnsl, the development of novel salvage chemotherapy regimen remains an area of clinical unmet need. ibrutinib, an oral inhibitor of bruton tyrosine kinase (btk), is known to induce death of diffuse large b-cell lymphoma (dlbcl) cells with dysregulated b-cell receptor (bcr) signaling and has shown promising activity in patients with a variety of b-cell malignancies. recently, several studies reported that ibrutinib may have an excellent single-agent clinical activity against relapsed or refractory pcnsl. furthermore, proven pharmacokinetic data suggested that ibrutinib successfully penetrated the bbb and reached the achievable concentration in cerebrospinal fluid. when ibrutinib is administered in combination with bbb-destructing chemotherapeutic agents (such as, temozolomide or etoposide) for salvage treatment of pcnsl, therefore, anti-lymphoma activity of ibrutinib could be maximized. in this context, this phase ii study is designed to evaluate the efficacy and safety of iber salvage chemotherapy followed by ibrutinib maintenance for transplant ineligible patients with relapsed or refractory pcnsl.

Eligibility criteria:
inclusion criteria: * histologically confirmed pcnsl of cd20+ diffuse large b cell lymphoma (dlbcl) * pcnsl relapsed or refractory after frontline methotrexate-based chemotherapy (with or without radiation therapy) * at least one measurable lesion, which is defined as longest diameter of lesion \> 0.5 cm, by contrast-enhanced mri * ecog performance status 0-2 * normal function of major organs exclusion criteria: * pcnsl other than dlbcl * primary ocular lymphoma * pcnsl accompanied by systemic involvement * active infection with hepatitis b or c virus * known history of human immunodeficiency virus (hiv) infection * therapy with myelosuppressive chemotherapy or biologic therapy \< 21 days prior to registration
low-protein diet with low-protein foods versus a lpd without lp foods in patients with chronic kidney disease (ckd)

Conditions: Chronic Kidney Disease Stage 3B; Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 5; Chronic Kidney Disease Stage 3A

Summary: the kdoqi 2020 - clinical practice guideline for nutrition in chronic kidney disease (ckd) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. flavis® is a product line of hypoprotein foods specially developed for the treatment of ckd.the use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.


Eligibility criteria:
inclusion criteria: * ckd patient stage 3a-5 (\<60 ml/min/1.73 m² estimated by ckd-epi formula) and not on dialysis, * with a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, bmi and no clinical and paraclinical criteria of malnutrition), * above 1g protein/ kg bw (ideal body weight), * lpd-naïve patient, * motivated to lpd introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up), * available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires), * subject affiliated to a health insurance system or is a beneficiary (art. l.1121-11, code of public health, france), * having given their informed written consent regarding its participation to the protocol. exclusion criteria: * patient for whom dialysis or transplantation is planned/expected within the next 12 months * known allergic reactions to the ingredients present in flavis products (milk, eggs, soy, nut), * uncontrolled diabetes (hba1c \>8.5%), * active cancer (including a 5 years remission period), * psychiatric disorders or inability to follow the protocol, * evidence of any active infectious or uncontrolled inflammatory diseases, * inability to provide blood samples (poor venous capital), * inability to perform correct 24-hours urine collection, * any change of the chronic medication within 1 month before screening, * presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator, * patient with an active implanted medical device * simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial. * vulnerable subjects (art. l. 1121-5 à 8 et l. 1122-1-2, code of public health, france) are also excluded from the clinical trial.

Keywords: low-protein diet low-protein foods flavis compliance effectiveness safety
reducing hazardous alcohol use in social networks using targeted intervention: 21 rising

Conditions: Alcohol Drinking; Alcohol; Harmful Use

Summary: the primary goal of this study is to determine whether change in alcohol use among college students can be transmitted through social network ties to other members in the network. members of one college class at a northeastern university will be enrolled in a longitudinal study in which they will provide self-reported behavioral information and information about their social ties to others in their college class. a subset of heavy drinking participants will be asked to meet in person to complete an interview about their alcohol use - called a brief motivational interview. there is evidence that this sort of interview can reduce harmful alcohol use. the investigators expect that following the brief motivational interview others in their friendship clusters will show reduced harm associated with alcohol use as well.


Eligibility criteria:
inclusion criteria: • must be a member of the class of 2021 or 2021.5 at the site university exclusion criteria: • none