Kornimate/medical-research-clean huggingface dataset:
cp-690,550 and midazolam drug-drug interaction study

Conditions: Healthy Volunteer

Summary: cp-690,550 and midazolam are metabolized by similar enzymes in the liver. this study is designed to assess whether co-administration of cp-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female (non-child bearing potential) subjects exclusion criteria: * clinically significant infections within the past 3 months * history of previously untreated infection with mycobacterium tuberculosis * positive screening test for hepatitis b surface antigen, anti-hepatitis c antibody, or human immunodeficiency virus

Keywords: drug interactions cyp3a4 cyp3a5 midazolam anti-rheumatic agents
mirna machinery in melanoma, melanoma metastases and benign melanocytic naevi

Conditions: Cutaneous Melanoma; Nevi

Summary: micrornas (mirnas) are very small endogenous rna molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. mirnas bind to their target messenger rnas (mrnas), leading to cleavage or suppression of target mrna translation based on the degree of complementarity. mirnas have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. in the present study, the investigators examines the expression profiles of mirna machinery components such as mirna maturation and transport factors, microprocessor complex and risc subunits in cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi.

patients with cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi were included in the study. punch biopsies were harvested from the center of the tumors. the mirna machinery components were detected by quantitative real-time reverse transcriptase polymerase chain reaction.

Eligibility criteria:
inclusion criteria: * cutaneous melanoma * cutaneous melanoma metastases * benign melanocytic nevi exclusion criteria: * other forms of malignancy
vir-7831 for the early treatment of covid-19 in outpatients

Conditions: Covid19

Summary: this is a phase 2/3 study in which subjects with coronavirus disease 2019 (covid-19) will receive vir-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.


Eligibility criteria:
inclusion criteria: * participant must be aged 18 years or older and at high risk of progression of covid-19 or ≥ 55 years old * participants must have a positive sars-cov-2 test result and oxygen saturation ≥94% on room air and have covid-19 symptoms and be less than or equal to 5 days from onset of symptoms exclusion criteria: * currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours * symptoms consistent with severe covid-19 * participants who, in the judgement of the investigator are likely to die in the next 7 days * severely immunocompromised participants

Keywords: sars-cov-2 coronavirus coronavirus disease 2019 covid-19
exploring biomarkers predicting the outcome of acute-on-chronic liver failure

Conditions: Acute-On-Chronic Liver Failure; Cirrhosis and Chronic Liver Disease

Summary: acute-on-chronic liver failure (aclf) is an ailment with high incidence of multiorgan failure (mof) and consequent mortality. systemic inflammation and susceptibility to infection are characteristic pathophysiological features. prostaglandin e2 (pge2) could subdue systemic inflammation and alleviate liver injury in mice model. however, there are no studies evaluating pge2 as a predictor of early mortality.this study is designed to investigate whether plasma pge2 and its receptors are associated with development of mof and predict short-term mortality in patients with acute-on-chronic liver failure. by the way, we will also measure several other potential predictive factors (c-reactive protein,severe hyponatremia, second infections,diabetes mellitus,high density lipoprotein,interleukin-10,serum bile acids,ferritin,the neutrophil to lymphocyte ratio,soluable urokinase plasminogen activator receptor,vwf-ag levels and fviii-to-pc ratios).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute-on-chronic liver failure according to asian-pacific association for the study of the liver (apasl) diagnostic criteria exclusion criteria: * hepatocellular carcinoma(hcc) * portal vein thrombosis * pregnancy * human immunodeficiency virus (hiv) * patients who had received immunomodulator,or cytotoxic/immunosuppressive therapy within at least the preceding 12 months
ak137 (bispecific antibody targeting cd73 and lag-3) in patients with advanced malignant tumors

Conditions: Advanced Malignant Tumors

Summary: a phase i open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of ak137 in patients with advanced malignant tumors.


Eligibility criteria:
inclusion criteria: 1. written and signed informed consent. 2. eastern cooperative oncology group (ecog) performance score of 0 or 1. 3. life expectancy ≥3 months. 4. histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available. 5. subject must have at least one measurable lesion according to recist version1.1. 6. adequate organ function. exclusion criteria: 1. any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast. 2. receipt of any anti-cd73, anti-lag-3 treatment. 3. experienced a toxicity that led to the permanent discontinuation of prior immunotherapy. all adverse events (aes) while receiving prior immunotherapy have not completely resolved or resolved to grade 1 prior to screening. additionally, the use of immunosuppression other than corticosteroids was required. 4. unresolved toxicities from prior anticancer therapy, defined as not having resolved to nci ctcae v5.0 grade 0 or 1, or to levels specified in the inclusion/exclusion criteria, except for toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities). 5. major surgical procedure within 4 weeks prior to the first dose of ak137 or still recovering from prior surgery. 6. history of organ transplant. 7. known allergy or reaction to any component of the ak137 formulation. history of severe hypersensitivity reactions to other mabs.
community and systems-level hiv prevention in peru

Conditions: HIV

Summary: this project involves adapting 3 new intervention components, and then testing them, in combination with a multi-level, community-based intervention, to promote hiv prevention and sexual health among men who have sex with men and transgender women in lima, peru. the total intervention has a community-based intervention and a systems-level intervention at the hospital where people living with hiv get care and medications.

mpowerment (mp) is an evidence-based community-level, structural, social and behavioral intervention for hiv prevention for young men who have sex with men (msm). mp targets individual and community empowerment and community mobilization, self-affirmation, sexual self-knowledge and creation of a supportive and affirming social environment. mp has been widely used in the u.s. but not in peru, with the exception of earlier pilot research. in the earlier research, mp was adapted for the sociocultural issues facing msm and transgender (trans) women in peru, and only focused risk reduction and increasing hiv testing. in addition to the mp (which is called the community-based intervention), a health systems component has been added. the health systems includes (1) sensitization of hospital staff (where people living with hiv obtain their medication) to the issues facing transgender women and msm; (2) the use of navigators, who help msm and trans women at the hospital navigate the system of care and remain in care; and (3) a focus on "positive prevention", in which providers talk about the positive aspects of maintaining in care and being virally suppressed instead of only talking about "avoiding death." there is a 2.5 year implementation of the intervention, called "projecto orgullo plus" or project pride plus, which involves a longitudinal cohort of msm/trans in two large districts of lima, peru. primary outcomes will be unprotected anal sex and hiv testing. secondary outcomes will be self-reported visits to hospital for care and adherence to medications.

Eligibility criteria:
inclusion criteria: * must live in either east lima district or south lima district * identify as man who has sex with men or transgender woman who has sex with men * be between the ages of 18 - 40 exclusion criteria: * not residing in either east or south district of lima * not msm or transgender woman
the effect of psyllium and wheat bran on body weight in people with parkinson's disease and constipation symptoms

Conditions: Parkinson Disease

Summary: this is a 10-week randomized, controlled study to compare the safety and efficacy of two common fiber supplements, psyllium and wheat bran in terms of changes in body weight, nutrition status, and bowel function in patients with parkinson's disease who have constipation symptoms. after a 2-week run-in period, participants will be randomized to receive 10 grams daily of psyllium, coarse wheat bran, or maltodextrin (placebo) for 8 weeks. nutritional and neurological evaluations will be conducted at the beginning and end of the 8-week intervention period.


Eligibility criteria:
inclusion criteria: * physician-diagnosed parkinson's disease * age 40-85 years * drug naïve or on stable dosage of pd medications with no plans to change for the duration of the study protocol * hoehn \& yahr stage \< 4 in the clinical "on" state * using laxatives (miralax, dulcolax, sennosides, etc.) regularly over the past 1 months (≥ 2 days per week) * complete informed consent in english * maintain habitual diet and exercise routine throughout study period * consume the study intervention twice per day during the eight-week intervention period * complete daily and weekly questionnaires, and all dietary recalls over approximately 10 weeks * fast (no food or drink, except plain water, coffee, or tea) at least 12 hours before each study visit exclusion criteria: * atypical or secondary parkinsonism * underweight (bmi \<18.5) * inability to swallow study supplement due to swallowing concerns * currently using a fiber supplement * use of another investigational product within 3 months of the screening visit * being treated for a physician-diagnosed gi disease or condition other than constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease

Keywords: nutrition dietetics fiber weight loss constipation malnutrition parkinson's disease
german evaluation of the effectiveness of the psychological intervention managing cancer and living meaningfully (calm)

Conditions: Depression; Psychological Distress

Summary: purpose of this randomized controlled trial is to test the efficacy of the individual psychotherapeutic intervention managing cancer and living meaningfully (calm) in a german sample of patients with advanced cancer. the interventions aim is to reduce depression and distress and support psychological well-being.

principal hypothesis: the manualized psychotherapeutic intervention (calm) will result in a significantly greater reduction in depression and psychological distress compared to a non-manualized supportive psycho-oncological intervention. secondary hypothesis: the manualized psychotherapeutic intervention (calm) will further result in a significantly improve psychological well-being, quality of life and sense of meaning compared to a non-manualized supportive psycho-oncological intervention.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * fluency in german * no cognitive impairment indicated in the medical record or by the attending oncologist * confirmed diagnosis of solid tumors with uicc (union internationale contre le cancer) stages iii/iv/ metastasized cancer (all with expected survival of 12-18 months) * phq-9 depression score \>=9 or distress thermometer score \>=5 exclusion criteria: * major communication difficulties (including language barriers) * inability to commit to the required 3-6 psychotherapy sessions * a score \<20 on the short orientation-memory-concentration (somc) test, indicating cognitive impairment unless deemed suitable at recruiter's discretion * a score \<70 on the karnofsky-performance status scale, indicating high physical symptom burden impeding study participation * being in psychotherapy
first add-on vs. mono-therapy study of topiramate in neuro-surgical patients

Conditions: Epilepsy

Summary: the purpose of this study is to examine seizure control and tolerability of topiramate after either transitioning from previous antiepileptic drug (aed) or adding on to previous aed.

this is a multicenter, randomized (treatment is assigned by chance), open-label (everyone who is involved in the trial knows the study drug), parallel group trial. the study has three phases: a retrospective baseline assessment of patients (4 weeks), titration period (8 weeks) and maintenance period (8 weeks). after qualifying for trial entry in the retrospective baseline phase, eligible patients will be randomized in 1:1 ratio to receive either topiramate add-on therapy or topiramate monotherapy. during the titration period (period in which the dose of the study drug is increased or decreased at the discretion of investigator), topiramate, given as morning doses, will be started with daily doses of 25 mg/day for one week. after that, topiramate will be given as morning and evening doses, and the doses will be gradually increased every week to reach the initial target dose of 200 mg/day at the end of titration period. during the maintenance period, the dose of topiramate could be increased or decreased according to the investigator's judgment. patients should keep seizure diaries during the 16 weeks of topiramate treated period and are followed with once monthly visits to the clinic, at which safety will be evaluated.

Eligibility criteria:
inclusion criteria: * must be diagnosed with seizure disorder * have been receiving concomitant therapy with one antiepileptic drug (aed), at stable dose prior to trial entry * must be dissatisfied with the current treatment exclusion criteria: * have treatable cause of seizures (eg, metabolic disturbance, toxic exposure, an active infection, or neoplasm) * have grade iv astrocytomas, eg, glioblastoma multiforme (gbm) or metastases with progression * have seizures occurring only in clustered patterns defined as numerous seizures occurring in less than 30 min * have had history (within past six months) of a psychiatric or mood disorder requiring electroconvulsive therapy, major tranquilizers, or monoamine oxidase inhibitors * have had schizophrenic or history of exhibiting psychotic symptomatology * inability to take medication or maintain a seizure calendar, independently or with assistance

Keywords: epilepsy topiramate neuro-surgical patients nervous disorder seizures
effect of cervical mobilization on rotator cuff tendinitis

Conditions: Rotator Cuff Tendinitis

Summary: this study aimed to investigate the effect of 3 types of cervical mobilization on the strength of shoulder abductors, external rotators and pain level in patient with rotator cuff tendinitis. the measurement will be made immediately, 10 minutes, and 30 minutes after mobilization

subjects will be allocated according to the inclusion and exclusion criteria from outpatient clinic at el sahel teaching hospital. they will be assigned randomly into 3 groups, each group will receive certain type of cervical mobilization. the outcome measures will be measured before, immediate, 10 minutes, and 30 minutes after treatment

Eligibility criteria:
inclusion criteria: * patients will be included if they have rotator cuff tendinitis exclusion criteria: * patients will be excluded if they had recent neck trauma or acute whiplash disorder ,any intra articular injection in the gleno-humeral joint during last three months, patients with musculoskeletal disorder (any type of fracture), any history of surgery on that shoulder and tendon calcification, cervical rib, rotator cuff tear.
educational and cultural engagement and incidence of health adverse events

Conditions: Older Adults; Depression; Cognitive Decline

Summary: this study evaluated if the social and cultural activities decrease the incidence of dementia and frailty conditions.

the past decade has been characterized by the involvement of museums in individual health prevention and promotion by using art-based activities to improve quality of life and well-being. visiting museum or over cultural and educational activity could be used for health prevention and promotion. for the development of appropriate educational and cultural activities, there is a need, first, to improve knowledge about social and health condition of older adult, and second to examine the effects of engagement in educational and social activity on incidence of health adverse events.

Eligibility criteria:
inclusion criteria: * being 50 years and over * being enrolled in the canadian longitudinal study on aging * actively involved in social and cultural activities exclusion criteria: * never enrolled in the canadian longitudinal study on aging * less than 50 years old
profiles analysis of genome wide association study (gwas) in acne vulgaris in indonesia.

Conditions: Acne Vulgaris

Summary: this study is a series of descriptive-analytic studies on genomic variants in the facial skin of patients with av at the dermatology and venereology polyclinic by determining the genetic profile by gwas examination in avb and analysing the genetic profile in avb against differences in geographical location. the research design used was a cross-sectional design.

research subjects were obtained from the affordable population who met the research criteria and expressed their willingness to participate in the study. subject selection was carried out by purposive sampling method that met the inclusion criteria. the study will be conducted in one visit where the patient and his/her parents come to be given an explanation about the study with a request for informed consent, screening for inclusion and exclusion criteria, anamnesis of facial complaints, taking data on demographics, patient's medical history, patient's medical history, physical examination, taking clinical photos in 5 positions and ending with taking blood samples of the patient and blood samples from both parents of the patient as much as 10 ml. the study will be conducted in three places, namely in jakarta, padang, and manado. in sampling in padang and manado, to prevent damage to the samples that have been taken, the samples will be stored at a temperature of -20c, then when brought to jakarta will use a cooler box along with an ice pack at a temperature of 2-3c, before being processed in the bioinformatics core facilities imeri laboratory, jakarta. when the samples are collected in jakarta, the blood samples will be immediately stored in the laboratory at -20c.

Eligibility criteria:
inclusion criteria: * males or females with avb aged 17-21 years * both parents of complete subjects with or without a history of acne vulgaris aged up to 60 years * patients and parents are willing to participate in the study and sign informed consent. exclusion criteria: * patients who have other inflammatory or infectious diseases especially on the face * have genetic diseases or disorders * diagnosed with primary or secondary immunodeficiency diseases * using oral or systemic antibiotic, anti-inflammatory, retinoid or hormone therapy in the past month.

Keywords: acne acne vulgaris (av) genome wide association study (gwas) genetic genotype deoxyribonucleic acid (dna) single nucleotide polymorphism (snp)
european multicenter study on surgical management of advanced thyroid cancer

Conditions: Thyroid Carcinoma; Thyroid Cancer; Thyroid Neoplasms; Thyroid Cancer, Papillary; Thyroid Cancer, Follicular; Thyroid Medullary Carcinoma; Anaplastic Thyroid Cancer

Summary: the main aim of the study is to evaluate peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in patients undergoing surgery for advanced thyroid cancer in different european centers using the eurocrine® database.

the incidence of thyroid cancer has risen exponentially over the last decades among developed countries. even though this is mainly attributed to small well differentiated carcinomas (dtc) with excellent prognosis, the rates of advanced disease have also elevated. while the characteristics of advanced thyroid cancer are intuitively recognized by experienced surgeons of the field, a common definition among scientific societies is yet to be reached. the four main features of advanced cancer are locally and regionally advanced disease, distant metastasis, and recurrence. guidelines for the optimal treatment of advanced disease are mainly included in the broader guidelines of each cancer subtype, such as the american thyroid association (ata) guidelines for dtc, medullary thyroid carcinoma (mtc) and most recently anaplastic thyroid carcinoma (atc). in the european setting, the european society for medical oncology (esmo) 2019 guidelines on thyroid cancer include a subsection for the management of advanced disease of each thyroid cancer type. a common limitation among published guidelines is the moderate to low level of evidence upon which the advanced disease recommendations are based; however, broad consensus has been reached regarding the paramount importance of surgery if an r0/r1 resection is achievable. recently, new advances in targeted therapy guided by genetic alterations found in the tumor have provided new treatment options for patients; therefore, latest guidelines encourage the inclusion of patients with advanced disease in these clinical trials. finally, neoadjuvant therapy modalities are constantly gaining ground with promising results allowing a greater portion of patients to benefit from surgery.

Eligibility criteria:
inclusion criteria: * all adult (18 years old and older) patients * underwent surgery * final histology of advanced thyroid carcinoma * among european centers that participate in the eurocrine® database between 2015 and 2021 exclusion criteria: * patients \<18 years old

Keywords: thyroid carcinoma eurocrine surgical management stage iv