Kornimate/medical-research-clean huggingface dataset:
real-word study of the de novo extended-release tacrolimus in kidney transplantation using an artificial intelligence

Conditions: Chronic Renal Disease

Summary: the purpose of this study is to assess the clinical efficacy of the lcpt en-varsus \[life-cycle pharma tacrolimus\] initiated in de novo (day 0 of transplantation) using the biopsy proven acute re-jection and ibox (full and abbreviated algo-rithms).

novostart is a descriptive study, prospective, multicenter, real-world evidence de-signed to evaluate the clinical efficacy and safety of once-daily extended-release tacroli-mus in kidney transplantation using the ibox prognostic system. the novostart study will be conducted at 13 academic hospitals in france performing kidney transplants. the study population will comprise three cohorts of patients: * cohort of patients treated with life-cycle pharma tacrolimus-based immunosuppression: our single-arm study addresses the primary objective. * cohorts transplant reference: two control groups (twice-daily tacrolimus and once-daily tac-rolimus) to determine the main secondary objective.

Eligibility criteria:
inclusion criteria: * kidney recipients aged 18 years and older. * kidney recipients were transplanted from living or deceased donors * patients receiving envarsus® \[life-cycle pharma tacrolimus\] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics. * patients are willing to participate in the study and do not oppose the use of their data. * patients are either affiliated with or beneficiaries of a social security scheme. exclusion criteria: * contraindications to the use of life-cycle pharma tacrolimus (envarsus®). * pre-transplant desensitization. * abo is incompatible with a living donor. * combined transplant (e.g. kidney-heart transplant, kidney-liver transplant). * previous bariatric (or bypass) surgery. * gastrointestinal problems are likely to affect the absorption of the life-cycle pharma tacrolimus (envarsus®). * diagnosis of parkinson's disease or any other neurological syndrome causing tremor. * patients who are part of another clinical trial or in a period of exclusion from another clinical trial with a molecule under study. * pregnant women or breastfeeding. * patients under legal protection (guardianship, curatorship) or deprived of their liberty through judicial or administrative decisions. * patients under state medical assistance.
assessing the impact of self-directed care, within a medicaid-funded environment,on participation and community living

Conditions: Major Depression; Bipolar Disorder; Schizophrenia

Summary: this project proposed to demonstrate the effectiveness, costs, and benefits to participation and community living self-directed care programming within a financially sustainable medicaid managed care environment. the study examined outcomes associated with the implementation of a novel self-directed care (sdc) approach being implemented in delaware county, pennsylvania in which consumers were able to access a set amount of renewable funds per year and direct how they were spent, both to purchase the types and amounts of rehabilitation and treatment services they desire (and from whom they choose) and to purchase a broad-range of individualized resources and services that are generally outside of medicaid funding (e.g., health club memberships, yoga classes, support in taking care of bills).


Eligibility criteria:
inclusion criteria: 1. adults between 18-65 who are currently receiving medicaid-reimbursed services in delaware county, pennsylvania for either a schizophrenia-spectrum, major depression, or bipolar disorder; 2. individuals with a cost profile within the 60-90% band of all magellan-administered medicaid recipients in the county (estimated service costs between $10,048 and $22,324); 3) no more than two inpatient hospitalizations of 10 days per stay, over a 2 year period prior to the study; 4) no hospitalization within 6 months of the study; 5) ability to understand self-directed care requirement and express interest in working with a "recovery coach." exclusion criteria: 1. do not speak english; 2. have a legal guardian; 3. are unable to give informed consent

Keywords: self-directed care serious mental illness
effects of tremella fuciformis on improvement in cognitive-bio-markers of cognitive functions

Conditions: Healthy Adults With Subjective Memory Complaints

Summary: the objective of this study is to demonstrate the cognitive enhancement effect and safety of tremella fuciformis, using the cognitive and clinical indicators (e.g. memory, attention, and psychomotor speed) and the latest brain imaging methods for healthy adults suffering subjective cognitive impairment.


Eligibility criteria:
inclusion criteria: * age between 40 and 65 years old * global deterioration scale score (gds) of 2 * high school or higher levels of education. exclusion criteria: * current pregnancy or breast-feeding * evidence of neurologic or medical conditions * axis i diagnosis when assessed by the board certified psychiatrist using the structured clinical interview for the diagnostic and statistical manual of mental disorder, 4th edition (dsm-iv)(scid-iv) * mini-mental status examination score of 24 or less * clinical dementia rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits * intelligence quotient less than 70 * contraindications to magnetic resonance imaging (mri) * use of psychotropics in last 3 months * use of oral contraceptive medication * participation in other clinical trials during the study period that might affect the outcome of the present study * allergic adverse reactions to mushrooms
adjusting the dose of therapeutic exercise to prevent neurotoxicity due to anticancer treatment (atento)

Conditions: Breast Neoplasm

Summary: the purpose of this study is to determine whether a multimodal program based on therapeutic exercise and vagal activation techniques for newly diagnosed breast cancer women has better results in terms of neurotoxicity prevenion before or during medical treatments.

one of the most common side effects of breast cancer and its treatments is neurotoxicity of central and peripheral nervous system. neurotoxicity is present in up to 75% of this population, which implies a large impact in quality of life. there is a special interest in the preventive possibilities of therapeutic exercise relating to these neurological sequelae, whose benefits could improve thanks to the combination with vagal activation techniques. this superiority randomized controlled trial will be aimed to check the effects of a multimodal intervention (atento) based on moderate-high intensity and individualized therapeutic exercise (aerobic and strength exercises) and vagal activation techniques (myofascial stretching and breathing exercises), on neurotoxicity prevention in women with breast cancer before starting potentially neurotoxic treatments (atento-b) versus throughout them (atento-t). a sample of 56 women newly diagnosed with breast cancer calculated with a power of 85% will be allocated into two groups. this study could provide an impetus for the introduction of early multimodal intervention methods of preventing neurotoxicity and consequently avoid the current qol deterioration that breast cancer patients suffer throughout their treatments.

Eligibility criteria:
inclusion criteria: * to have 18 years or older * to have a breast cancer diagnosis (stage i-iii) * to be on waiting list for medical adjuvant treatment with risk of central and/or peripheral neurotoxicity. * to have signed the informed consent. * to have medical clearance for participation. exclusion criteria: * to have a previous history of cancer or any cancer treatment. * pregnant patients. * to participate in another intervention that could influence on the outcomes. * to have a neurodegenerative disease that affects central or peripheral nervous system and could influence the results.

Keywords: breast neoplasm breast cancer therapeutic exercise neurotoxicity vagal activation techniques
a trial of hr18034 in inguinal hernia repair

Conditions: Inguinal Hernia Repair

Summary: phase i, randomized, double-blind, comparator-controlled study to assess the safety, pk, and efficacy of single postsurgical application of hr18034 compared with naropin®


Eligibility criteria:
inclusion criteria: able and willing to provide a written informed consent 2、male or female between 18 and 70 years of age 3、scheduled to undergo a primary, inguinal hernia repair with mesh, and be able to use the anesthesia regimen 4、meet the body mass 5、conform to the asa physical status classification exclusion criteria: 1. clinically significant abnormal clinical laboratory test value 2. subjects with poor blood pressure control after medication 3. subjects with atrioventricular block or cardiac insufficiency 4. subjects with a history of myocardial infarction or unstable angina pectoris 5. subjects with a history of ischemic stroke or transient ischemic attack 6. combination of other pain conditions that may affect postoperative pain assessment 7. allergic to a drug ingredient or component 8. persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer 9. history of alcohol abuse or prescription and/or illicit drug abuse within 1 years 10. subjects with special diets (including tobacco, grapefruit and caffeine) 11. positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse. 12. history of human immunodeficiency virus (hiv), hepatitis c, syphilis antibody，or hepatitis b. 13. use of any of the following medications within 14 days or as specified prior to the study surgical procedure: 14. have had an inguinal hernia repair in the last 3 months before the study surgical procedure or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with a large scrotal component that would be difficult to reduce surgically 15. participated in clinical trials of other drugs (received experimental drugs) 16. history or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition. 17. pregnant or nursing women 18. no birth control during the specified period of time 19. the inestigators determined that other conditions were inappropriate for participation in this clinical trial
airxpanders aeroform tissue expander system for breast reconstruction

Conditions: Breast Cancer

Summary: this study is designed to allow existing investigators continued access to the aeroform tissue expander to treat patients while airxpanders completes a marketing application and during the review process by fda.

this is a prospective, multi-center, single arm, open-label, continued access clinical study. subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and implanted with the investigational aeroform tissue expander. if the subject is having a bilateral procedure, the aeroform expander will be implanted in each side. subjects will be followed until the first post-operative visit after explant of the tissue expander(s) and exchange for permanent implant(s).

Eligibility criteria:
inclusion criteria: * subject is female between the ages of 18-70 * subject requires tissue expansion as part of breast reconstruction * subject is able to provide written informed consent * subject is able and willing to comply with all of the study requirements * subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen exclusion criteria: * subject's tissue integrity is unsuitable for tissue expansion * subject has residual gross malignancy at the intended expansion site * subject has current or prior infection at the intended expansion site * subject has a history of failed tissue expansion or breast reconstruction * subject has any co-morbid condition determined by the investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes) * subject is taking any concomitant medications determined by the investigator to place the subject at an increased risk of complications (e.g., prednisone, coumadin).

Keywords: tissue expansion tissue expander breast tissue expansion breast tissue expander breast reconstruction 2 stage breast reconstruction
effects of ten-weeks power training on neuromuscular performance, heart rate variability, sleep quality and mobility in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (me) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. the symptoms associated with ms include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. strength training has been shown to improve strength and mobility in persons with ms.


Eligibility criteria:
inclusion criteria: * mild or moderate disability with clinical mild spastic-ataxic gait disorder. * stable phase of the disease. exclusion criteria: * expanded disability status scale (edss) \< 6. * relapsing disease within the preceding 12 months. * corticosteroid treatment within the last months before study inclusion.
real-world effectiveness of afatinib (gilotrif) following immunotherapy in the treatment of metastatic, squamous cell carcinoma of the lung: a multi-site retrospective chart review study in the u.s.

Conditions: Non-squamous, Non-Small Cell Lung Cancer

Summary: characteristics of patients with neuregulin-1 (nrg1) gene fusion-positive solid tumors treated with afatinib, and characteristics of those treated with another systemic therapy.


Eligibility criteria:
inclusion criteria: * adults, 18 years of age or older, at the time of diagnosis with any solid tumor. * confirmed nrg1 gene fusion in any solid tumor. * initiated afatinib or other systemic therapy (in any line of therapy) for treatment of a solid tumor with nrg1 gene fusion on or after 01/01/2017 through 03/31/2020. * followed up for ≥3 months after initiation of afatinib or other systemic therapy (unless deceased prior to 3 months of follow-up). exclusion criteria: - treatment with any tyrosine kinase inhibitor (tki)/erbb-directed therapy other than afatinib
peers and technology for adherence, access, accountability, and analytics

Conditions: Hypertension; Medication Adherence

Summary: the overall objective of this project is to utilize the precede-proceed framework to conduct transdisciplinary, translational implementation research focused on improving medication adherence for hypertension control. the central hypothesis is that peer delivery of medications integrated with hit (pt4a) will be effective in improving hypertension medication adherence, contributing to improved blood pressure among patients with uncontrolled hypertension in western kenya. this study record will focus on sub-aim 2.2: a pilot of the intervention and a survey questionnaire with patients, peers, and clinical staff to evaluate feasibility. the investigators will evaluate impact on systolic blood pressure, medication adherence, and fidelity of implementation. the investigators will also create a retrospective comparator (control) group of cdm patients, through querying amrs, matched by sex, age, location and initial blood pressure level. the investigators will then use their recorded blood pressure over a comparable period of up to 1 year and to allow for comparison to the blood pressure changes observed in the patients enrolled in the pt4a program to help understand the magnitude and variance of the intervention effects.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years old * enrolled in the ampath cdm program * have uncontrolled hypertension (defined as systolic blood pressures ≥ 140 or diastolic blood pressure ≥ 90) exclusion criteria: * acute illness requiring immediate medical attention * terminal illness * inability to provide informed consent
neoadjuvant radiochemotherapy combined with cadonilizumab for local advanced esophageal squamous cell cancer

Conditions: Esophageal Squamous Cell Carcinoma

Summary: esophageal squamous cell cancer (escc) has a high incidence in china. although the fast development of immune check point inhibitors (icis), the rate of pcr is limited with the mode of icis combined with neoadjuvant radiochemotherapy. the rate of pcr under icis combined with neoadjuvant radiochemotherapy was reported around 50%, which means more than half of those patients could not obtain pcr in reality. in order to explore a more effective mode of neoadjuvant therapy for escc, we designed this study to evaluate the effect of pd-1/ctla-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy in local advanced escc.


Eligibility criteria:
inclusion criteria: * diagnosed with esophageal squamous cell cancer; * staged with ct1n+m0/ct2-3n0-3m0; * experienced no cancer-related treatment; * ecog 0-1; * expected survival more than 6 months; * aimed at neoadjuvant therapy for surger; * have adquate organ function. exclusion criteria: * diagnosed with other types of cancer during last five years; * have a tendency to bleed; * accepted any type of cancer-related therapy.
tocolytic therapy in conservative management of symptomatic placenta previa

Conditions: Placenta Previa

Summary: the objective of our study is to determine the clinical utility related to the maintenance oral nifedipine therapy in patients with symptomatic placenta previa. this study is a prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of hospitalized patients with symptomatic placenta praevia. all patients may initially receive oral nifedipine therapy with steroid prophylaxis for 48 hours. after then, patients are randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one every 8 hours) until 37 weeks of gestation. the primary outcome for the trial is the length of pregnancy in days after the enrollment. a sample size calculation is designed to detect at least a 14 -day difference in time gained in patients with maintenance oral nifedipine therapy. a sample size of about 52 patients per group would have a 80 % chance of detecting this difference at the 5 % level of significance.


Eligibility criteria:
inclusion criteria: * placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasonography * placenta previa may be symptomatic with at least one episode of bleeding * estimated gestational age within 24 to 34 weeks * maternal age \> 18 years * informed consent after received an explanation of the study and an information sheet * social affiliation exclusion criteria: * premature rupture of membranes * severe bleeding requiring an immediate termination of pregnancy * abnormal fetal heart rates requiring an immediate termination of pregnancy * intrauterine fetal death * pre-eclampsia, chorioamnionitis, liver disease, severe chronic renal disease, heart disease * abruptio placentae * nifedipine sensibility * drugs interaction with nifedipine
comparison of iv nalbuphine versus ibuprofen for postoperative pain control in cesarean section

Conditions: Pain Management

Summary: the local data is insufficient to directly compare iv nalbuphine versus ibuprofen among people in this region. the findings of this study would add to the existing data and would be helpful for health providers to opt for a better option for postoperative pain relief following a cesarean section under general anesthesia.


Eligibility criteria:
inclusion criteria: * parturient females * aged between 18-45 years * gestational age above 32 weeks * asa class i to ii * anticipated hospital stay for at least 24 hours exclusion criteria: * known allergy to the drugs being evaluated in this study * renal and/or hepatic impairment (as per medical record) * history of bronchial asthma or history or risk of intracranial hemorrhage (as per medical record) * low platelets count (\&lt;70000) or with bleeding diathesis * bmi above 30 kg/m2
a study to determine the safety and tolerability of 2 concentrations of qls-101

Conditions: Sturge-Weber Syndrome (SWS); Glaucoma; Glaucoma Congenital; Ocular Hypertension

Summary: safety and tolerability study of 2 concentrations of qls-101 for adult subjects with sturge weber syndrome (sws)-related glaucoma due to elevated episcleral venous pressure (evp).

masked, randomized, single site, crossover study to compare 2 concentrations of qls-101. subjects will be randomized to one of 2 concentrations of qls-101 for the first 14 days of daily dosing, and after a 14-day washout period they will be crossed over to the other concentration for another 14 days of daily dosing. dose assignment is masked to patient and investigator.

Eligibility criteria:
inclusion criteria: * diagnosed with sws. * elevated intraocular pressure (iop) * willing to continue current dosing regimen of iop-lowering medications * willing to refrain from contact lens use in the study eye. exclusion criteria: * iop with variability of \> 4 mm hg * expected to undergo iop-lowering surgery * incisional or laser surgery of any type * ocular infection, inflammation, clinically significant blepharitis or conjunctivitis * a history of herpes simplex keratitis in either eye. * history of or active clinically significant ocular disease * use of topical ocular corticosteroids in the 6 weeks prior to visit 1

Keywords: sturge-weber syndrome glaucoma elevated intraocular pressure (iop)
treatment success with the coolloop cryoablation system

Conditions: Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Arrhythmias, Cardiac; Cardiovascular Diseases; Heart Diseases

Summary: this clinical study evaluates the safety and efficacy of the treatment with the coolloop® cryoablation system (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted) over a follow-up period of 36 months. a further aim of this study is to evaluate the average duration of procedure and fluoroscopy times.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * atrial fibrillation: permanent af excepted * ecg documented af within the last 6 months * patients planned for an ablation procedure and suitable and planned for treatment with the coolloop® cryoablation system * signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment (patient has received a copy of the icf) exclusion criteria: * indication that the vascular system is not accessible through the left or right groin. * indication that a transseptal puncture cannot be performed. * any previous ablation or surgery due to af. * important comorbidities such as cardiovascular events within six months of enrollment or high-risk surgical patients. * pregnant women at the time of the cryoablation procedure. * any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * participation in interventional trials for cardiovascular devices or drugs.

Keywords: atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation cryoablation cryosurgery