Kornimate/medical-research-clean huggingface dataset:
a study to evaluate safety and tolerability of aducanumab in participants with alzheimer's disease who had previously participated in the aducanumab studies 221ad103, 221ad301, 221ad302 and 221ad205

Conditions: Alzheimer's Disease

Summary: the primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).


Eligibility criteria:
key inclusion criteria: core treatment period: * participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies). * has one care partner who, in the investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities. lte treatment period: * participant must have completed the core study period (week 102) and adequately tolerated 10 mg/kg of aducanumab during the core study period in the opinion of the investigator. * has one informant/care partner who, in the investigator's opinion, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities. key exclusion criteria: core treatment period: * any medical or neurological condition (other than alzheimer's disease) that might be a contributing cause of the participant's cognitive impairment. * stroke or any unexplained loss of consciousness within 1 year prior to screening. * clinically significant unstable psychiatric illness in past 6 months. * history of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to screening. * a seizure event that occurred after the last visit of the feeder study and before screening for this study. * evidence of impaired liver function as shown by an abnormal liver function profile at screening. * history of or known seropositivity for hiv. * clinically significant systemic illness or serious infection within 30 days prior to or during screening. * contraindications to having a brain magnetic resonance imaging (mri). lte treatment period: * any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the investigator, will substantially increase the risk associated with the participant's enrollment in and completion of the study. note- other protocol defined inclusion/exclusion criteria may apply.
using mri to visualize regional therapy response in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of this study is to determine whether magnetic resonance imaging (mri) using inhaled hyperpolarized 129xe gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129xe is a special type of xenon gas and when inhaled during mri may be able to show areas of abnormal thickening of parts of the lungs. these images combined with images taken with injected contrast agents or other types of mri may provide a better way to look at lung structure and function in patients with ipf. the ultimate goal is to predict how a particular patient might respond to a particular therapy and to observe such responses earlier than conventional tests. the investigators anticipate that the images acquired in this study will provide more specific information about lung disease than standard lung function tests. the use of 129xe mri is investigational. "investigational" means that these tests have not yet been approved by the us food and drug administration and are being tested in research studies like this one. in addition, standard mri with contrast is not typically done as standard of care for monitoring progression of ipf, therefore, its use in this study is also considered investigational. healthy volunteers are being asked to participate in this study because the investigators need to develop a database of functional images that are representative of healthy lungs.


Eligibility criteria:
inclusion criteria: 1. healthy volunteer (technical optimization) 2. outpatients of either gender, age \> 18. 3. willing and able to give informed consent and adhere to visit/protocol schedules. (consent must be given before any study procedures are performed.) 4. clinical diagnosis of ipf by established means exclusion criteria: 1. subject is less than 18 years old 2. mri is contraindicated based on responses to mri screening questionnaire 3. subject is pregnant or lactating 4. respiratory illness of a bacterial or viral etiology within 30 days of mri 5. subject has any form of known cardiac arrhythmia 6. subject does not fit into 129xe vest coil used for mri 7. subject cannot hold his/her breath for 15 seconds 8. subject deemed unlikely to be able to comply with instructions during imaging 9. recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids 10. medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Keywords: idiopathic pulmonary fibrosis xenon gas
implementation effectiveness and safety of tenofovir gel provision through family planning services

Conditions: HIV

Summary: the purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.

the caprisa 008 trial is a two-arm, open-label, randomized controlled trial that is being conducted at the caprisa ethekwini and caprisa vulindlela clinics and their neighboring public sector family planning services in kwazulu-natal, south africa. up to 700 consenting sexually active, hiv-uninfected women aged 18 years and older who previously participated in an antiretroviral (arv) prevention study will be enrolled and followed for a maximum 30 months. all women will be provided with 1% tenofovir gel but will be randomised to either receive their gel through a public sector family planning services with 2-3 monthly provision (intervention arm) or through the caprisa research clinics with monthly provision (control arm). all women in the trial will be provided with the standard package of hiv prevention and reproductive health services. participants in both study arms will be provided with a supply of single-use, pre-filled applicators of 1% tenofovir gel. while in the study, participants will be advised and supported to follow the caprisa 004 pre- and post-dosing strategy, namely bat24, where the first dose of tenofovir gel is applied within 12 hours before anticipated coitus and a second dose as soon as possible but within 12 hours after coitus, with a maximum of two doses of gel in a 24-hour period. the primary objective of this trial is to assess the effectiveness of an implementation model for tenofovir gel provision through family planning services.

Eligibility criteria:
inclusion criteria: * age 18 years and older * women who previously participated in an arv prevention study * currently utilizing or agreeing to attend designated public sector family planning services * able and willing to provide first person informed consent to be screened for, and to enroll in, the study * able and willing to provide adequate locator information for study retention purposes * sexually active (at least one coital act in the last 3 months prior to screening) * hiv negative (by hiv testing performed by study staff within 30 days of enrollment) * negative pregnancy test performed by study staff within 21 days of enrollment * agree to use a non-barrier form of contraceptive * agree to adhere to study visits and procedures exclusion criteria: * has a creatinine clearance \< 50ml/min * has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Keywords: microbicides women hiv prevention prep tenofovir gel
sustained mood improvement with laughing gas exposure: a randomized controlled pilot trial

Conditions: Treatment Resistant Depression; Major Depressive Disorder

Summary: the purpose of the study is to investigate a short-term treatment option for major depressive disorders by administering nitrous oxide gas. at this time, the main purpose is to complete a feasibility study with 40 participants suffering from treatment-resistant depression. participants will be randomized to (1) study group: nitrous oxide (inhaled) + solution of saline (injected) and the (2) control group: oxygen (inhaled) + midazolam (injected) as an active placebo.


Eligibility criteria:
inclusion criteria: 1. 18 to 65 years of age 2. meeting diagnostic and statistical manual for mental disorders (dsm-5) criteria for major depressive disorder (mdd) 3. current major depressive episode as confirmed by the mini international neuropsychiatric interview (mini) for dsm-5 4. experiencing moderate to severe depressive episode, as defined by the hamilton depression rating scale (hamd)\>17 5. failure of two trials of antidepressant therapy of adequate dose and duration, during the current depressive episode 6. for women of childbearing potential, use of highly effective or double-barrier methods of contraception. abstinence is acceptable if it is the preferred and usual lifestyle of the female participant 7. capacity to provide informed consent. exclusion criteria 1. acute suicidality defined as score ≥3 on hamd item 3 2. major depressive episode in people with bipolar disorder 3. current substance abuse or dependence and/or history of alcohol abuse or dependence within the past year 4. dementia 5. current or lifetime history of schizophrenia or schizoaffective disorder 6. current history of dissociative disorders 7. known history of hypersensitivity or allergy to nitrous oxide, midazolam or any ingredients in the study formulations 8. contraindication to receiving nitrous oxide 9. chronic cobalamin or folate deficiency 10. contraindication to receiving the placebo midazolam 11. use of centrally acting medicinal products, such as opioid agonists, morphine derivatives, benzodiazepines and/or other central nervous system depressants such as barbiturates and alcohol 12. pregnancy or breastfeeding in female participants 13. electroconvulsive therapy within the current depressive episode 14. receiving ketamine treatment within the current depressive episode 15. unwilling to maintain current antidepressant regimen.

Keywords: feasibility trial nitrous oxide
self-discontinuation of a transurethral catheter

Conditions: Postoperative Urinary Retention

Summary: this study is to determine if self-discontinuation of transurethral foley catheters in patients diagnosed with postoperative urinary retention (pour), which is defined as the continued need for catheterization, following impatient pelvic organ prolapse surgery is non-inferior to office-discontinuation.

postoperative urinary retention (pour) is a common issue following urogynecologic surgery, with incidence rates of 1.4-43%. the wide range of incidence is due to the lack of a standardized definition of pour. generally speaking, pour can be characterized by any impairment in bladder emptying following surgery. while the gold standard for assessing voiding function remains measurement of a postvoid residual (pvr), there are many voiding trial (vt) methods being used across institutions. historically, the most widely accepted postoperative vt for the assessment of voiding function was the backfill method. an alternative assessment of voiding function is the spontaneous vt, where the indwelling catheter is removed and a patient is asked to void spontaneously when a patient has the urge. it is controversial which of these methods are superior, and studies are conflicted. nevertheless, both of these methods were studied in a clinical setting, and we lack information on self-discontinuation efficacy at home. managing an indwelling urinary catheter and returning to the outpatient clinic only a week after discharge from the hospital can be overwhelming for patients and their involved caregivers. given the low incidence of pour at one-week postoperative and patient dissatisfaction with urinary catheter management, home self-removal of indwelling urinary catheters is an important topic of investigation. we are trying to compare the incidence of pour between self-discontinuation and office-discontinuation of urinary catheters. the results of this study could impact on the decision regarding catheter use following inpatient pelvic organ prolapse surgery.

Eligibility criteria:
inclusion criteria: * undergoing vaginal vault suspension or robot-assisted laparoscopic sacrocolpopexy by a physician at cincinnati urogynecology associates, trihealth inc.for the treatment of pelvic organ prolapse * failed voiding trial prior to discharge * concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy exclusion criteria: * physical or mental impairment that would affect the subject's ability to self-remove indwelling urinary catheter, including patient's with multiple sclerosis, dementia, parkinsonism, or those who have impaired mobility or are wheelchair bound * bladder injury, fistula repair or other need for prolonged catheterization
a study of imvotamab in severe systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus; Lupus Erythematosus

Summary: the purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies. participants will be given imvotamab through a vein (i.e., intravenously).

this is a phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of imvotamab in adult participants with systemic lupus erythematosus (sle). approximately 18 participants will be assigned to different sequentially dose escalation cohorts.

Eligibility criteria:
key inclusion criteria: * age ≥ 18 years at the time of signing icf * diagnosis of sle according to the 2019 european league against rheumatism/american college of rheumatology (acr) classification criteria at least 16 weeks or more prior to screening * highly active sle disease, as demonstrated by a total systemic lupus erythematosus disease activity index (sledai-2k) total score of ≥ 10 at screening * active sle disease despite treatment with at least 1 immunosuppressive or biologic standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab, anifrolumab) determined at the discretion of the investigator after at least 3 months of treatment. * it must be planned that the background standard-of-care treatment remains at a stable dose throughout the screening period and up to week 8. key exclusion criteria: * pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab. * any lupus-associated neuropsychiatric disease. * active lupus nephritis with estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2, calculated according to the chronic kidney disease epidemiology collaboration equation, classified as world health organization (who) class iv. * prednisone-equivalent \> 30 mg/day, including immediate and extended-release oral formulations. * drug-induced lupus. * participants with a history of catastrophic or severe anti-phospholipid syndrome within 12 months prior to screening.

Keywords: lupus sle severe lupus severe systemic lupus erythematosus systemic lupus erythematosus
direct acting antiviral therapy in donor hcv-positive to recipient hcv-negative kidney transplant

Conditions: Kidney Failure; Kidney Diseases; Hepatitis C

Summary: this is a proof of concept, single center study for the donation of hcv-positive kidney to hcv negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available daa therapy to prevent hcv transmission upon transplantation.

the goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic daa therapy after kidney transplantation prevents the transmission of hepatitis c virus (hcv) infection from an hcv positive donor kidney to an hcv naïve recipient.

Eligibility criteria:
inclusion criteria: * met mgh transplant center criteria and already listed for kidney transplant * no available living kidney donor * has ≤ 730 days (two years) of accrued transplant waiting time if blood type a and ≤ 1095 days of accrued transplant waiting time if blood type b or o. * on chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate \<15ml/min/1.73m2 at the time of screening * must agree to birth control. women must agree to use birth control in accordance with mycophenolate risk evaluation and mitigation strategy and at least one barrier method * weigh at least 50kg * serum alt within normal limits with no history of liver disease * able to sign informed consent exclusion criteria: * ab blood type * bmi \> 35 * any liver disease in recipient * pregnant or nursing (lactating) women * known allergy or intolerance to tacrolimus that would require administration of cyclosporine rather than tacrolimus given the known drug-drug interaction between cyclosporine and mavyret * cardiomyopathy (lv ejection fraction \< 50%) * albumin \< 3g/dl or platelet count \< 75 x 103/ml * positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist * positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist * hcv rna positive * hepatitis b surface antigen positive * any known liver disease or elevated liver transaminases * patients with primary focal segmental glomerulosclerosis (fsgs), fsgs recurring after previous transplant, or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or the investigator team * any contra-indication to kidney transplantation per mgh center protocol * patients on the following medications who cannot stop therapy: carbamazepine, rifampin, st. john's wort, and ethinyl estradiol-containing oral contraceptives.

Keywords: ckd hcv hepatitis c transplant
a multicenter comparison of fluconazole (uk-49,858) and amphotericin b as treatment for acute cryptococcal meningitis

Conditions: Meningitis, Cryptococcal; HIV Infections

Summary: to compare the safety and effectiveness of fluconazole and amphotericin b, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * immunosuppressant therapy. * antiviral therapy such as zidovudine. * prophylaxis for pneumocystis carinii pneumonia. concurrent treatment: allowed: * radiation therapy for mucocutaneous kaposi's sarcoma. written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian. * no prior systemic antifungal therapy for cryptococcosis. * relapse after prior therapy. * success of prior therapy must have been documented by negative cerebrospinal fluid (csf) culture at the end of therapy. following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin b in the 4 weeks before entry into study. prior medication: allowed: * immunosuppressant therapy. * antiviral therapy such as zidovudine. * prophylaxis for pneumocystis carinii pneumonia. exclusion criteria co-existing condition: patients with the following are excluded: * evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. * history of allergy to or intolerance of imidazoles, azoles, or amphotericin b. * moderate or severe liver disease. * comatose. * unlikely to survive more than 2 weeks. concurrent medication: excluded within 4 weeks of study entry: * greater than 1 mg/kg/wk amphotericin b. * coumadin-type anticoagulants. * oral hypoglycemics. * barbiturates. * phenytoin. * immunostimulants. * investigational drugs or approved (licensed) drugs for investigational indications. concurrent treatment: excluded: * lymphocyte replacement. patients with the following are excluded: * evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. * history of allergy to or intolerance of imidazoles, azoles, or amphotericin b. * moderate or severe liver disease. * comatose. * unlikely to survive more than 2 weeks. prior medication: excluded within 4 weeks of study entry: * greater than 1 mg/kg/wk amphotericin b. * coumadin-type anticoagulants. * oral hypoglycemics. * barbiturates. * phenytoin. * immunostimulants. * investigational drugs or approved (licensed) drugs for investigational indications. prior treatment: excluded: * lymphocyte replacement.

Keywords: aids-related opportunistic infections meningitis cryptococcosis drug therapy, combination fluconazole flucytosine acquired immunodeficiency syndrome amphotericin b
a study for dynamic prediction model of breast cancer bone metastases

Conditions: Breast Cancer; Bone Metastases

Summary: the purpose of this study is to identify the risk factors of bone metastasis in breast cancer patients so as to develop a dynamic prediction model using real world clinical data. the multicenter data will be retrospectively collected, and the clinical characteristics related to bone metastasis will be analyzed.

breast cancer is the most common malignant tumor in women worldwide and bones are the most common sites of metastases in breast cancer patients(\~70%). bone metastasis often leads to skeletal-related events (sres) ,which may not only reduce the quality of life in patients, but also affect the long-term survival. therefore, early detection and early intervention of bone metastasis are particularly important for breast cancer patients.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with breast cancer by histopathology; 2. age between 20 and 70 years old; 3. the first diagnosis time is between 2010 and 2020; 4. complete diagnosis and treatment information, including basic information, breast cancer diagnosis, surgery, recurrence diagnosis data (including the diagnosis of the metastasis sites), anti-tumor treatment data, bone health and bone metastasis-related diagnosis and treatment data, etc.; 5. sufficient available follow-up information. exclusion criteria: 1. missing important basic information (including initial and recurrent pathology, stage, pathological grade and time, surgery time, and drug treatment); 2. with distant metastasis at the initial diagnosis; 3. patients with autoimmune diseases or aggressive viral infections (such as hiv or hepatitis); 4. other malignant tumors; 5. unclear information about distant metastasis.