Kornimate/medical-research-clean huggingface dataset:
home based infusions for ocrelizumab

Conditions: Multiple Sclerosis

Summary: the goal is to assess the safety and effectiveness of home ocrelizumab infusion.

the safety of home ocrelizumab infusion will be assessed by monitoring for infusion reactions and adverse events, and comparing proportions/rates to existing studies. patient reported outcomes (pros) will compare pre to post infusion.

Eligibility criteria:
inclusion criteria: * current active patient of rocky mountain ms center at the time of final study consent. * between 18-55 years of age at the time of final study consent. * diagnosis of primary progressive or relapsing ms as defined by the 2017 mcdonald criteria.19 * has at minimum completed their first 600 mg dose of ocrelizumab. * is physically residing in the denver metro, fort collins or colorado springs area at the time of final study consent. * has a patient determined disease steps (pdds) between 0 to 6.5 20 * can complete patient reported outcomes developed and validated as english written scales. * must be able and willing to give meaningful, informed consent via electronic signature prior to participation in the study, in accordance with local and fda regulatory requirements. * whose treating neurologist at the rmmsc feels that continuing ocrelizumab s medically appropriate based on at the time of final study consent. exclusion criteria: * not pregnant, intentions to get pregnant or lactating at the time of final study consent and on the day of infusion. * has previously not participated in the sarod trial at the rmmsc site. * any of the following abnormal laboratory results as processed by a university of colorado hospital laboratory site and deemed clinically inappropriate to proceed with a home infusion by the treating neurologist at rmmsc.
pentostatin, and rituximab with and without cyclophosphamide for previously untreated b-chronic lymphocytic leukemia

Conditions: B-Chronic Lymphocytic Leukemia

Summary: this study aims to assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this regimen, and to determine the overall and progression-free survival in cll patients

rationale: research indicates that both cyclophosphamide and pentostatin work synergistically against cancer cells and have a high response rate against chronic lymphocytic leukemia (cll) without creating severe side effects in patients. in addition, studies have shown that rituximab, a therapy that targets the immune system, has the highest efficacy against cll and the lowest toxicity rate when compared with other immunotherapy drugs. studies also show that rituximab enhances the efficacy of the chemotherapy agents cyclophosphamide and pentostatin. this study offers the combination of immunotherapy with two promising chemotherapy agents against cll. purpose: this study is evaluating the efficacy and safety of combination treatment with cyclophosphamide, pentostatin, and rituximab in patients with cll. several tests evaluating the genetic and molecular components of cll will also be performed. some of these tests will be conducted before, during, and after treatments to assess changes resulting from the study drugs. each patient's outcome will be assessed in relation to various aspects of their genes.

Eligibility criteria:
inclusion criteria: * diagnosis of b-cll (no mantle cell) * must have active disease * age \>=18 yo * ecog 0-3 * no radiation or surgery \<4 weeks exclusion criteria: * any of the following comorbid conditions: * new york heart association class iii or iv heart disease * recent myocardial infarction (\<1 month) * uncontrolled infection * active infection with the human immunodeficiency virus (hiv/aids) as further severe immunosuppression with this regimen may occur. * pregnant or nursing women * men or women of child bearing potential must use adequate contraception. * active primary malignancy requiring treatment or limits survival to ≤2 years. * any radiation therapy ≤4 weeks prior to study entry. * any major surgery ≤4 weeks prior to study entry.

Keywords: previously untreated
a trial to find and investigate a safe dose of bi 836858 in combination with decitabine for patients with acute myeloid leukemia (aml)

Conditions: Leukemia, Myeloid, Acute

Summary: phase i dose escalation: primary objective is to determine the maximum tolerated dose (mtd) and the recommended dose for phase i extension. secondary objective is to investigate the safety, pharmacokinetics and efficacy of bi 836858 in combination with decitabine phase i extension: primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the recommended phase ii dose (rp2d) of bi 836858 in combination with decitabine. phase ii: primary objective is to investigate efficacy, safety and pharmacokinetics of bi 836858 in combination with decitabine compared to decitabine monotherapy.


Eligibility criteria:
inclusion criteria: 1) phase i dose escalation: * male or female patients \>/= 18 years of age with relapsed or refractory aml * male or female patients \>/= 65 years of age with previously untreated aml ineligible for receiving standard intensive therapy phase i extension and phase ii: -- male or female patients \>/= 65 years of age with previously untreated aml ineligible for receiving standard intensive therapy 2) histologically or cytologically confirmed aml according to the who classification 3) patients must be eligible for treatment with decitabine 4) eastern co-operative oncology group (ecog) performance score \</=2 at screening further inclusion criteria apply. exclusion criteria: 1. acute promyelocytic leukemia (apl, french-american-british (fab) subtype m3), according to who classification. 2. patients who are candidates for allogeneic stem cell transplantation. 3. active chronic graft versus host disease requiring immunosuppressive treatment. 4. phase i extension and phase ii only: prior treatment with a hypomethylating agent, such as prior treatment for myelodysplastic syndrome (mds). 5. prior treatment with cluster of differentiation 33 (cd33) antibody. further exclusion criteria apply.
the association of helicobacter pylori in the pathogenesis of hyperemesis gravidarum in pregnant women

Conditions: Hyperemesis Gravidarum

Summary: the purpose of this study to explore the association between hyperemesis gravidarum in pregnant women and helicobacter pylori infection.

this study included 90 pregnant women during their first trimester who attended ain shams university maternity hospital antenatal clinic and admitted in the ward. patients were divided into two groups: 46 cases of pregnant women with h.g and 44 healthy control pregnant women with no vomiting. both groups were matched regarding the inclusion criteria which includes maternal age (18-40 years), gestational age (\<16 wks), and signs and symptoms of h.g for cases (vomiting affecting the general condition, ketonuria, weight loss) and excluding cases or controls with multiple gestation, hyadatiform disease or maternal disease causes vomiting such as ; pyelonephritis, gastroenteritis, cholecystitis or hepatitis. the two groups were subjected to full history taking, clinical examination, routine laboratory investigations (urine analysis, cbc, liver, kidney function tests na, k, pt, ptt \& inr) abdominal ultrasound was done to assess fetal life and gestational age and to exclude gestational trophoblastic disease and multiple gestation pregnancy.h.pylori infection was assessed by using one step h.pylori stool antigen test. (cer test biotec) pol. industrial rio gallego ii,calle j, no 1, 50840, san mateo de gallego, zaragoza (spain) for the detection of h. pylori antigen.

Eligibility criteria:
inclusion criteria: * age: 18-40 years old * gestational age: less than 16 weeks confirmed by u/s * excessive pregnancy - related nausea and /or vomiting that prevent adequate intake of food and fluids. * measuring weight loss(\>5% of pre-pregnancy weight) * signs of dehydration: * ketonuria (+1 or more) * hemoconcentration (normal female hematocrit value (36.1-44.3%) exclusion criteria: * multiple gestation pregnancy * hydatidiform molar pregnancy * other causes of vomiting: * gastroentritis * cholecystitis * pyelonephritis * liver dysfunction
genetic information assistant in telegenetics

Conditions: Gene Mutation-Related Cancer; Genetic Predisposition

Summary: the goal of this clinical trial is to learn about different ways cancer genetic screening can be provided to rural communities in participants at high risk for certain cancers. the main question it aims to answer is: • does receiving pre-genetic test education with a chat bot or genetic counselor affect if the participant decides to get genetic testing? participants will: * have a pre-test genetic counselling session with a genetic counselor or the gia chatbot * answer questions about their cancer genetic knowledge and how they are doing * provide a saliva sample for genetic testing to test for cancer gene mutations * have their genetic testing results provided to them. * have the option to share their genetic testing results with family members researchers will compare how many participants who had pre-genetic counseling with the chatbot received genetic testing to how many participants who had pre-genetic counseling with a genetic counselor received genetic testing.

high risk patients will be randomized to standard of care telegenetics with a uva genetic counselor (gc) for pre-test counseling or to the novel interventional arm of pre-test counseling via genetic information assistant (gia). participants in the study will receive their link for a telegenetics appointment or gia link based on randomization and patients will complete pre-test genetic counseling via their assigned treatment arm. participants will not be masked to their trial arm assignment. in the telegenetics arm, patients will be offered a video visit scheduled through epic zoom or a phone visit in our cancer genetics clinic per standard of care. patients randomized to the gia arm will receive a personalized link based on their family history. at the completion of counseling, participants will be offered genetic testing. if they agree, they will be mailed a saliva kit via invitae genetics for panel based genetic testing via the invitae common hereditary cancers panel to analyze 47 genes associated with cancers of the breast, ovary, uterus, and gastrointestinal system, which includes the stomach, colon, rectum, small bowel, and pancreas.

Eligibility criteria:
inclusion criteria: * at high risk for having a genetic pathogenic variant as assessed by a gc or physician according to the nccn guidelines * provision of signed and dated informed consent form. * stated willingness to comply with all study procedures and availability for the duration of the study. * male or female, aged 18 and over. * subjects must have a smartphone with access to cellular and/or internet service or a computer with internet service. * subjects must have technological competency/proficiency to use their smartphone and/or computer in conjunction with the communication aid gia. exclusion criteria: * cannot communicate in english or spanish. * subjects must not have completed panel-based cancer genetic testing in the past.
the effect of different irrigation and disinfection methods on post-operative pain (pp)

Conditions: Post-operative Pain; Apical Periodontitis

Summary: aim: the aim of this study was to examine post-operative pain (pp) severity after conventional irrigation and sonic activation methods, with and without laser disinfection in mandibular molar teeth diagnosed with symptomatic apical periodontitis. methods: in total, 80 patients with symptomatic apical periodontitis were included in this randomized clinical study. there were four different irrigation and disinfection groups. in group 1, conventional irrigation only was applied. in group 2, eddy (vdw, munich, germany), a sonic irrigation activation system, was applied. in groups 3 and 4, irradiation with a 980-nm diode laser was performed, following irrigation with the conventional method (needle irrigation) and eddy (vdw) irrigation system, respectively. pp was assessed using a visual analogue scale (vas). the patients were instructed to record their pp using this scale 8, 24, 48 hours and 7 days post-procedure, in addition to their analgesic intake. a chi-square test, fisher's exact chi-square test and fisher-freeman-halton exact test were used to assess qualitative data. inter-group and intra-group parameters were assessed using the kruskal-wallis test and wilcoxon's test at a significance level of p \< 0.05 (for both).


Eligibility criteria:
inclusion criteria: 1. healthy adult patients aged between 18 and 65 years 2. moderate to severe pain (4-10) according to a visual analogue scale (vas) 3. mandibular molar teeth diagnosed with symptomatic apical periodontitis (a painful response during mastication and/or percussion or palpation) exclusion criteria: 1. pregnancy or lactation 2. taking analgesics or anti-inflammatory drugs 12 hours before the treatment 3. taking antibiotics in the month prior to the treatment 4. teeth with calcified root canals, greater than grade i mobility and a 4 mm pocket depth, non-restorable damage, occlusal trauma and previous root canal treatment or an open apex 5. allergy to articaine or non-steroid anti-inflammatory drugs

Keywords: diode laser eddy post-operative pain sypmtomatic apical periodontitis
effectiveness of an intervention in multicomponent exercise in patients over 70 years in primary care

Conditions: Frail Elderly; Physical Activity

Summary: objective: to evaluate the effect of a multicomponent physical activity program, compared with the usual medical practice, to reverse prefrailty by fried in people over 70 years, one year after the end of the intervention.

objective: to evaluate the effect of a multicomponent physical activity program, compared with the usual medical practice, to reverse prefrailty by fried in people over 70 years, one year after the end of the intervention. location: primary care setting (madrid region). population: non-dependent and pre-frailty patients ≥ 70 years old, who attend the health centers included in the study. design: randomized parallel group multicenter clinical trial. randomization unit and unit of analysis: patient. intervention: multicomponent physical activity program (mefap) with 12 weekly sessions of an hour and a half which includes 1) briefing 2) exercises for improving aerobic resistance, muscle strength, proprioception -balance and flexibility and 3) delivery of exercise chart to do at home (two times per week). main measures: main variable: pre-frailty according to fried phenotype. secondary variables: sociodemographic, clinical and function variables; adherence, user satisfaction, quality of life. analysis: it will be carried out an analysis by intention to treat comparing the retrogression from pre-frailty (1 or 2 fried criteria) to robust (0 fried criteria) at the end of the intervention, 6 months after the intervention and one year after the intervention. cumulative incidence, relative risk and number needed to treat with a 95% confidence interval. a generalized estimating equation logit model will be adjusted to analyze the associated factors.

Eligibility criteria:
inclusion criteria: * individuals aged \>70 years with a barthel test ≥90 and pre-frailty (1-2 fried phenotype frailty criteria). * for health care centers: centers who deliver patient to physiotherapy units who participate in this project. centers where at least two general practitioners accept to participate in the project. exclusion criteria: * moderate to severe dependency (impairment) for daily living activities (barthel test \<90) * enable to achieve health care center for any reason. * moderate to severe cognitive impairment (mec 35 lobo≤21) * severe illness that contraindicates to practice exercise by medical criteria: recent hearth attack (6 months), not controlled arrhythmia, severe hearth valvular disease, not controlled arterial hypertension (systolic blood pressure\>180/diastolic blood pressure\>100), severe heart failure, severe respiratory failure, diabetes mellitus with frequent acute hypoglycemia, any other circumstance that makes the individual unable to do exercise under medical criteria.

Keywords: elderly physical activity exercise frailty
mirna in chronic kidney diseases

Conditions: Chronic Kidney Diseases

Summary: oxidative stress and endoplasmic reticulum (er) stress play a key role in tubular damage in both acute kidney injury and chronic kidney disease (ckd). oxidative stress in the kidneys promotes renal vascular remodeling and increases preglomerular resistance. these are key elements in hypertension, acute and chronic kidney injury, as well as diabetic nephropathy. chronic renal hypoxia is highlighted as the final common pathway to end-stage renal disease (esrd). microrna molecules (mirna) also play an important role in these processes. micrornas (mirnas) are regulators of gene expression and play a role in the progression of renal ischemia-reperfusion injury. although the pathophysiological contribution of micrornas (mirnas) to kidney damage has also been highlighted, the effect of mirnas on kidney damage under conditions of oxidative and er stress remains understudied.


Eligibility criteria:
inclusion criteria: * healthy normotensive adults (egfr ckd-epi \>90 ml/min/1.73 m2, bp \<140/90 mmhg) * hypertensive adults (egfr ckd-epi \>90 ml/min/1.73 m2, bp \>140/90 mmhg) * patients with chronic kidney disease stage 3-5 (egfr ckd-epi\< 60 ml/min/1.73 m2) exclusion criteria: * cardiovascular diseases, but hypertension * diabetes * cerebrovascular diseases * peripheral artery disease

Keywords: chronic kidney diseases mirna oxidative stress hypertension
prospective, non-randomized, safety and efficacy study of a new occluder design for minimally invasive closure of the left atrial appendage (laa) in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this is a prospective, non-randomized, study of the safety and efficacy of the occlutech® laa occluder indicated for percutaneous laa closure in adult male or female patients with atrial fibrillation. safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an occlutech® laa occluder.


Eligibility criteria:
inclusion criteria: * documented paroxysmal, persistent or chronic non-valvular af * calculated cha2ds2 -vasc score equal or greater than 2 and/or has-bled score equal or greater than 2 * patients eligible or non-eligible for lifelong, oral anticoagulation therapy * life expectancy of at least 1 year * written, informed consent by the patient or her/his legally-authorized representative for participation in the study exclusion criteria: * suspected or known intracardiac thrombus * nyha class iv chf * patients who has unstable and intractable angina pectoris * asd and/or atrial septal repair or closure device * recent myocardial infarction within 3 months * severe valvular heart disease, or implanted mechanical valve prosthesis * large pfo with significant atrial septal aneurysm * planned ablation procedure within 30 days of occlutech laa occluder® implant * resting heart rate \> 110 bpm * allergy to nitinol, which is a result of nickel and/or titanium allergies * stroke/tia within the last 30 days * thrombocytopenia, thrombocytosis, leukopenia, or anemia * symptomatic carotid artery disease * lvef \< 30% * mitral valve stenosis
proradium: prospective multi-centre study of prognostic factors in mcrpc patients treated with radium-223.

Conditions: Advanced Prostate Cancer; Castration Resistant; Radium 223

Summary: proradium is a prospective multicentre observational study in metastatic castration-resistant prostate cancer (mcrpc), designed to explore prognostic biomarkers in patients undergoing treatment with radium-223.

this study is a prospective biomarker study of patients with mcrpc undergoing treatment with radium-223 as standard of care treatment. the participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Eligibility criteria:
inclusion criteria: 1. male age ≥ 18 years 2. histologically confirmed adenocarcinome of the prostate 3. ecog performance status ≤ 2 4. castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/ml (\< 2.0 nm). 5. men diagnosed with at least one metastatic lesion on ct or bone scan. 6. documented biochemical and/or radiographic progression to previous treatment according to pcwg2 criteria. 7. patients who are candidates for standard of care treatment with radium-223 55mbq/kg very 4 weeks intravenously 8. availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy. 9. acceptable hematological, hepatic and renal functions. exclusion criteria: 1. previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas. 2. any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data

Keywords: metastatic castration resistant prostate cancer radium-223 biomarkers
diabetes type 1, treatment study atacand/placebo after kidney biopsy

Conditions: Diabetes, Type I

Summary: the type 1 diabetes patients who were still normoalbuminuric and normotensive, after 17 years duration and a second research kidney biopsy, could enter the double blind treatment study of atacand or placebo. the treatment study continues for five years treatment and ends with a third kidney biopsy. the study hypothesis is that the effect of arb during 5 years on the histopathology are more pronounced than the effect on histopathology of placebo.

46 patients performed a first kidney biopsy between 1992-1994. after 6 years 29 accepted to perform a second biopsy. during the follow-up 10 patients developed complications i.e. hypertension or microalbuminuria. 7 of the patients got treatment during follow up and 3 started the treatment after the second biopsy. 19 patients with two kidney biopsies were still normoalbuminuric and normotensive. 13 of them entered the double-blind treatment study of atacand or placebo. 6 denied to participate in the treatment study. the treatment study will continue for 5 years and will end with a third kidney biopsy. also the rest of the patients that have done 2 kidney biopsies will be asked to perform a third biopsy.

Eligibility criteria:
inclusion criteria: * diabetes type 1 patient * normotensive * normoalbuminuric * signed informed consent * female and male * over 17 years of age * diabetes duration over 10 years exclusion criteria: * hypertension * microalbuminuria * pregnancy * lactation * reduced kidney function * artery stenosis * kidney transplantation * allergy to the medication in the study * reduced liver function * alcohol or drug abuse * participation in another drug or clinical test during last 30 days * severe diseases i.e. malignancy * previously enrolment of the present study

Keywords: diabetes kidney function 24 ambulatory blood pressure kidney biopsy