Kornimate/medical-research-clean huggingface dataset:
a study to evaluate effectiveness and safety of surgeries in elderly nsclc patients

Conditions: Non-small Cell Lung Cancer

Summary: the trial was designed to compare effectiveness and safety of surgeries in the patients with non-small cell lung cancer

the trial is a multi-centre, real-world, non-interventional, observational study. the chinese elderly pathologically diagnosed patients with early-stage non-small cell lung cancer enrolled from 2015 to 2017 who received lobectomy or segment/wedge dissection were included and the study data on patient demographic/tumor biological characteristics, and clinical treatments were retrospectively collected to evaluate effectiveness and safety of the surgeries.

Eligibility criteria:
inclusion criteria: * patients who received surgeries from 2014 to 2017; * patients who received lobectomy or segment/wedge dissection; * pathologically diagnosed patients with non-small cell lung cancer; * patients with age \>=65 years old. exclusion criteria: * patients who received neoadjuvant therapy prior to surgery.

Keywords: chinese real-world evidences nsclc surgeries
mecki-amyloidosis: assessment of the exercise capacity and prognosis of patients with cardiac amyloidosis

Conditions: Cardiac Amyloidosis

Summary: this study aims to advance the understanding of cardiac amyloidosis, its effects on exercise capacity, and its prognostic implications. by conducting a systematic investigation with particular emphasis on longitudinal evaluation, we aim to provide valuable insights to guide clinical practice and improve the management of patients with cardiac amyloidosis. our study intends to follow patients for a period of two years, evaluating them every six months. this longitudinal approach allows us to monitor changes in exercise capacity and other relevant clinical parameters over time. furthermore, it enables the development of a prognostic tool similar to the mecki score, capable of assessing the risk of adverse events in patients with cardiac amyloidosis based on their exercise performance. by comparing our results with data from heart failure patients already included in the mecki score database, we also aim to highlight any differences in prognosis between patients with cardiac amyloidosis and those with general heart failure. finally, we aim to characterize cardiac amyloidosis by differentiating it from general heart failure. by comparing our results with data from heart failure patients already included in the mecki score database, we can clarify the distinct exercise limitations in cardiac amyloidosis and shed light on how they differ from more conventional heart failure.


Eligibility criteria:
inclusion criteria * age \> 18 years * diagnosis of cardiac amyloidosis obtained by mri or scintigraphy * ability to perform a cardiopulmonary exercise test exclusion criteria * severe obstructive pulmonary disease * exercise-induced angina * significant ecg changes * presence of clinical comorbidities that interfere with exercise performance
university of delaware parkinson's disease registry

Conditions: Parkinson Disease

Summary: the purpose of this parkinson's disease registry is to assist with recruitment of willing participants into future parkinson's disease research studies at the university of delaware.

there is an urgent need for parkinson's disease research due to its increasing global prevalence. participant recruitment is a significant challenge to the success of parkinson's disease research and we need your help more than ever in moving the field forward and improving the lives of people who have parkinson's disease. recruitment of study participants can be facilitated by maintaining registries of people who agree to be contacted for future studies. the purpose of the university of delaware participant recruitment registry for parkinson's disease research is to create a registry that includes the contact information and basic health information pertaining the participant's diagnosis of parkinson's disease. the registry will streamline recruitment and enrollment in a variety of research studies focusing on topics such as, but not limited to: brain changes in parkinson's disease, balance and gait in parkinson's disease, exercise and its effect on motor function. to be in the registry individuals must have a clinical diagnosis of parkinson's disease and have an interest in participating in research studies. to become a member of this registry, primary information including contact information and some general medical information are needed.

Eligibility criteria:
inclusion criteria: * individual 21 years old or older * a clinical diagnosis of parkinson's disease * interest in participating in one or more investigator-led research studies at the university of delaware exclusion criteria: * individuals with a clinical diagnosis of parkinsonism that is not considered primary (e.g. vascular parkinsonism) or an atypical parkinsonian syndrome (e.g., progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration etc.) * clinical diagnosis of dementia

Keywords: parkinson's disease
longitudinal observational study of chinese with nafld/nash

Conditions: Non-Alcoholic Fatty Liver Disease (NAFLD); Non-Alcoholic Steatohepatitis (NASH)

Summary: this is a 10-year, longitudinal, observational study of patients with nafld/nash designed to specifically address important clinical questions that remain incompletely answered from registration trials. in addition to the study database, the biospecimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

non-alcoholic fatty liver disease (nafld) is an excess accumulation of fat in the liver cells. it is associated with obesity, high blood pressure, high cholesterol, and diabetes. some people with nafld only have excess fat in the liver. however, other people may develop a worse form of nafld with liver injury and scarring. this form, called non-alcoholic steatohepatitis (nash), can lead to liver failure, liver cancer, and death. not much is known about why some people develop nash and others do not. this study aims to determine and elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of nafld, and in particular its more severe form of nash and its complications in chinese subjects.

Eligibility criteria:
inclusion criteria: * males or females aged 18 and older; * adults being managed or treated for nafl or nash; * be able to communicate meaningfully with the investigator and be legally competent to provide written informed consent. exclusion criteria: * incompetent to understand and/or sign the informed consent; * ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female; * causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis * diagnosis of liver cirrhosis and/or hepatocellular carcinoma; * diagnosis of chronic inflammatory disease (i.e. inflammatory bowel disease, rheumatoid arthritis, inflammatory lung disease, severe infectious diseases), other than nafl/nash.
overall performance of a 1-day silicone hydrogel lens when habitual soft lens wearers are refit

Conditions: Myopia

Summary: the objective of the study is to compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon a lenses.

this will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. participants were recruited into one of two groups - participants who habitually wore etafilcon a: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (freq).

Eligibility criteria:
inclusion criteria: * a person is eligible for inclusion in the study if he/she: 1. is at least 17 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction or the assigned study lenses; 5. habitually wears either etafilcon a lens or any frequent replacement contact lenses (as defined in 4.1.1); 6. habitually wear contact lenses with a power between -1.00 and -6.00d (diopters) (inclusive) in both eyes; 7. demonstrates an acceptable fit with the study lenses; 8. is usually able to wear contact lenses for at least 8 hours per day. exclusion criteria: * a person will be excluded from the study if he/she: 1. is participating in any concurrent clinical or research study; 2. has any known active\* ocular disease and/or infection; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. has known sensitivity to the diagnostic substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study; 6. is aphakic; 7. has undergone refractive error surgery. 8. has participated in the previous somfofilcon a study (ore# 20893) * for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
a study of mehd7945a versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck

Conditions: Head and Neck Cancer

Summary: this phase ii, open-label, randomized study will evaluate the efficacy and safety of mehd7945a versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. patients will be randomized to receive either mehd7945a 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. patients treated with cetuximab (arm b) may cross-over to mehd7945a (arm a) upon central confirmation of progressive disease and upon meeting eligibility criteria. anticipated time on study treatment is until disease progression or intolerable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically confirmed stage iii or iv recurrent/metastatic squamous cell carcinoma of the head and neck (r/m scchn) * progressive disease on or after first-line platinum-based chemotherapy regimen for r/m scchn (maximum of 6 cycles) * no more than one platinum-based chemotherapy regimen for r/m scchn is allowed * prior platinum-based treatment as definitive chemo/radiotherapy for locally advanced disease is allowed if completed/terminated \>/= 6 months before the platinum-based regimen for r/m scchn * consent to provide archival tumor tissue for biomarker testing * measurable disease per recist v1.1 * ecog performance status of 0, 1 or 2 * adequate hematologic, renal and liver function exclusion criteria: * nasopharyngeal cancer * prior treatment with an investigational or approved agent for the purpose of inhibiting her family members * this includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and lapatinib * prior treatment with an egfr inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed \>/=1 year before study enrollment * leptomeningeal disease as the only manifestation of the current malignancy * active infection requiring iv antibiotics * active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs * current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures) * history of heart failure or serious cardiac arrhythmia * history of myocardial infarction within 6 months of cycle 1, day 1 * clinically significant liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, or current alcohol abuse * hiv infection * primary central nervous system (cns) malignancy or untreated/active cns metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) * pregnant or lactating women * malignancies other than scchn within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
the effect of genetic variation in tmprss6 gene (snp rs855791) on oral iron absorption: an iron stable isotope study

Conditions: Iron Metabolism Disorders

Summary: iron deficiency is considered the most common nutritional deficiency worldwide and affects children and women in both non-industrialized as well as industrialized countries. the main regulatory molecule of iron metabolism is hepcidin, a hormone produced in the liver that regulates intestinal iron absorption, placental transport, recycling of iron by macrophages and release from stores. the expression of hepcidin is regulated by many mediators, one of which is matriptase-2 - a transmembrane protease. complete loss of function leads to the rare disease iron-refractory iron deficiency anemia (irida). matriptase-2 is encoded by the gene tmprss6 and the single nucleotide polymorphism (snp) rs855791 causes a non-synonymous substitution (v736a) that reduces the activity of the protease to inhibit hepcidin transcription. genome wide association studies have identified the tmprss6 snp rs855791 has a strong association with red blood cell and iron parameters in the general population. the objectives of the study is to measure oral iron absorption and systemic iron utilization into red blood cells (rbc) using oral isotopic labels in subjects homozygotes for common variants of the tmprss6 gene with the snp rs855791 (a736v); aa vs. vv subjects. the aim is to conduct an iron absorption study in 80 taiwanese women of reproductive age, non-pregnant, non-anemic, investigating the effect of the genetic variants of the snp rs855791. the participants will be split in two groups of equal size; wild type aa vs. mutation vv. iron absorption and systemic utilization will be assessed by two test meals containing stable isotopes of iron.the primary outcome of the trial is the oral iron absorption from a test meal as compared between the two genotypes aa vs. vv. secondary outcomes are the comparison iron status markers between the two genotypes.


Eligibility criteria:
inclusion criteria: * subjects homozygotous for the for aa (cc), or vv (tt) variant of the snp rs855791 of the tmprss6 gene. * females 20 - 45 years of age (premenopausal status) * obtained informed consent * regular menstrual cycle, ± 2 days exclusion criteria: * pregnancy or lactating (assessed by pregnancy test and self-declaration, respectively) * anemia defined as hb \< 120 g/l * plasma ferritin \ 120 µg/l * c-reactive protein \> 5 mg/l * body weight \> 65 kg * body mass index (bmi) 18.5 - 25 * diagnosed metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal. * blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months, prior the first study day. * subjects who cannot be expected to comply with study protocol (e.g. non-residents). * use of long-term medication during the study * subjects that will take part of another clinical study at the same time or had within the last 30 days before the first study day * intake of mineral/vitamin supplements 2 weeks before the first study day and during the study
induction of donor-specific tolerance in recipients of live donor stem cell infusion (compassionate use)

Conditions: Renal Failure

Summary: four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (fcrx)

four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (fcrx) and living donor kidney transplant.

Eligibility criteria:
inclusion criteria: * patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure * patient is receiving first renal transplant * patient is receiving a renal transplant only * the crossmatch is negative between donor and recipient * women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of initiating total body irradiation (tbi) and agree to use reliable contraception for 1 year following transplant * potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving granulocyte colony-stimulating factor (g-csf) * no evidence of donor-specific antibody presently or historically exclusion criteria: * clinically active bacterial, fungal, viral or parasitic infection * pregnancy * clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant * previous radiation therapy at a dose which would preclude tbi * positive crossmatch between donor and recipient * evidence for immunologic memory against donor * bmi \>35 or \<18 * re-transplant * positive serologies for hepatitis b virus (hbv), hepatitis c virus (hcv), hiv

Keywords: kidney transplantation
neurocognitive effects of fmt in mdd patients with and without ibs

Conditions: Major Depressive Disorder; Irritable Bowel Syndrome

Summary: this study is a phase 2/3 open-label controlled trial (ct) in which adults with major depressive disorder (mdd) and adults who have mdd plus comorbid inflammatory bowel syndrome (ibs) will be assigned to either receive oral fecal microbiota transplantation (fmt) or to continue with the treatment they are currently receiving in a treatment as usual (tau) arm. an ibs alone group receiving tau will be recruited as a clinical control group. the primary goals of this study are to determine effectiveness, safety and tolerability of oral fmt in adults with mdd and in mdd who have comorbid ibs. additional goals are to characterize patterns and progressions of cognitive and neural correlates associated with mdd and with mdd + ibs and to determine if they improve with fmt. it is known that both, individuals with mdd and those with mdd and ibs show cognitive alterations as well as changes in neural structures, but this study is designed to see if those are changed with treatment response to fmt."


Eligibility criteria:
inclusion criteria: 1. between 18-60 years of age: participants should be at least 18 years old and not older than 60 years at the day of screening 2. have a primary diagnosis of mdd as assessed/confirmed by the m.i.n.i. international neuropsychiatric interview (mini) 3. have had a well-documented inadequate response to at least 2 approved antidepressants 4. a madrs score of ≥ 19 at screening and visit 2a 5. have a comorbid diagnosis of ibs. ibs patients can include any of the following: diarrhea predominant ibs (ibs-d), constipation predominant ibs (ibs-c), ibs with mixed bowel habits (ibs-m), or unclassified with ibs (ibs-u) as confirmed by the referring doctor using rome iii criteria 6. moderate-to-severe ibs symptoms, as indicated by a score of ≥175 on the ibs severity scoring system (ibs-sss) exclusion criteria: 1. participant meets diagnostic and statistical manual of mental disorders (dsm-5)\[1\] criteria for the following conditions according to the m.i.n.i: 1. substance use disorder within the last 3 months. \*(criteria should include alcohol and non-alcohol substances except cannabis) 2. moderate or severe substance use disorder for cannabis use the last 3 months 3. active anorexia nervosa or bulimia nervosa 4. schizophrenia, schizoaffective or bipolar disorder 5. active suicidality 2. regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the three (3) months prior to study entry 3. use of prebiotics or probiotics for medical purposes for more than two (2) weeks within the last three (3) months 4. conditions causing immunosuppression 5. women who are breastfeeding, pregnant or seeking to get pregnant during the course of this study. not using an acceptable method of birth control (implants, injectable, combined oral contraceptives, iuds, sexual abstinence or a vasectomized partner)

Keywords: major depression ibs fecal microbiota transplantation gut microbiome fmri
safety, tolerability and efficacy of actimmune® dose escalation in friedreich's ataxia study

Conditions: Friedreich's Ataxia

Summary: the purpose of this phase 3 multi-center, open-label extension study is to evaluate the long-term safety of actimmune® (interferon-γ 1b) in participants with friedreich's ataxia.

participants who complete 26 weeks of blinded treatment in hznp-act-301 (nct02415127), will be eligible to enter this 6-month study. all participants will receive actimmune® 3 times a week (tiw) for 26 weeks. in order to maintain the study blind in hznp-act-301 (nct02415127), all participants in this open-label extension study will undergo actimmune® titration, regardless if they received actimmune® or placebo in hznp-act-301 (nct02415127). the week 26 visit from hznp-act-301 (nct02415127) will serve as the baseline visit (day 1) for this study. during the treatment period, additional clinic visits are scheduled at weeks 4, 13, and 26; in between clinic visits, participants (and/or caregivers) will be monitored via emails/phone calls on a weekly basis until participants reach their maximum tolerated dose, and on a monthly basis thereafter. study with completed results acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * written informed consent and child assent, if applicable. * completed 26 weeks of blinded treatment in study hznp-act-301 (nct02415127). * if female, the subject is not pregnant or lactating or intending to become pregnant during the study, or within 30 days after the last dose of study drug. female subjects of child-bearing potential must have a negative urine pregnancy test result at baseline/day 1 (week 26 of study hznp-act-301 \[nct02415127\]), and agree to use a reliable method of contraception throughout the study and for 30 days after the last dose of study drug. exclusion criteria: * subjects will be ineligible if, in the opinion of the investigator, they are unlikely to comply with the study protocol or have a concomitant disease or condition that could interfere with the conduct of the study or potentially put the subject at unacceptable risk. note: additional inclusion/exclusion criteria may apply.

Keywords: interferon gamma