Kornimate/medical-research-clean huggingface dataset:
study of various treatments in non-alcoholic fatty liver disease (nafld) patients who have aspects of non-alcoholic steatohepatitis (nash)

Conditions: Non-alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis

Summary: this clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of various single and combination treatments in adult patients with non-alcoholic fatty liver disease (nafld) who manifest a non-alcoholic steatohepatitis (nash)-like biomarker phenotype.

this was a phase ii, non-confirmatory, multicenter, open label, platform study in nafld participants with a nash-like biomarker phenotype to examine the effects of single and combination therapies over 12 weeks of treatment. the study consisted of four distinct study periods: * screening period (day -60 to -28): lasted up to a maximum of 33 days where participants were assessed for inclusion and exclusion criteria prior the baseline assessments. * baseline period (day -27 to -1): lasted up to a maximum of 27 days and comprised baseline assessments and randomization. * treatment period (day 1 to 85): participants were randomized in a 1:1 ratio to lys006 20 mg (twice a day) arm or to lys006 20 mg (twice a day) and tropifexor 200ug (once a day). participants were treated daily during 12 weeks. * follow-up period (day 85 to 113): after completion of the treatment period, participants were observed until the end of study (eos) visit at day 113.

Eligibility criteria:
inclusion criteria: phenotypic diagnosis of nash based on the presence of all of the following: * alt ≥ 43 iu/l (males) or ≥ 28 iu/l (females) * bmi ≥ 27 kg/m2 (race other than asian) or ≥ 23 kg/m2 (asian race) * history of type 2 diabetes mellitus with hba1c ≤ 9% * elf test score ≥ 8.5 and ≤ 10.5 * liver fat ≥ 8% * patients must weigh between 40 kg (88 lbs.) and 150 kg (330 lbs.) exclusion criteria: * use of other investigational drugs within 5 half-lives of randomization or within 3 months, whichever is longer * use of obeticholic acid (oca) or pharmacologically-active weight loss drugs within 1 month of randomization * use of strong cyp3a4/5 inhibitors or strong cyp3a4 inducers within 5 half-lives or 7 days of randomization, whichever is longer * history or presence of other concomitant liver diseases * history or current diagnosis of ecg abnormalities * patients with contraindications to mri imaging * current or history of significant alcohol consumption * clinical evidence of hepatic decompensation or severe liver impairment * women of child bearing potential (unless on highly effective methods of contraception) * presence of liver cirrhosis * use of oat3 inhibitors within 5 half-lives or 7 days of randomization, whichever is longer

Keywords: non-alcoholic fatty liver disease nafld non-alcoholic steatohepatitis nash platform design lys006 ljn452 tropifexor
impact of donor-recipient abo matching on haploidentical stem cell transplantation

Conditions: Hematological Malignancies; Haploidentical Stem Cell Transplantation

Summary: the impact of donor-recipient abo matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation

the impact of donor-recipient abo compatibility on transplant outcomes had been evaluated in different transplant settings, but had shown different results. the investigators set out to investigate the impact of abo incompatibility on post-transplant outcomes, engraftment kinetics and blood product requirements, transfusion independence, the incidence of poor graft function (pgf) in anti-t-lymphocyte globulin (atg) based haplo-sct with pbsc grafts.

Eligibility criteria:
inclusion criteria: 1. the subjects or their legal representatives signed the informed consent before the clinical study. 2. subjects aged 15-70 years. 3. patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation 4. patients have no suitable hla identical sibling donor 5.patients with malignant hematological diseases plan to receive hla haploidentical stem cell transplantation 6. subjects with ecog score of 0-2. exclusion criteria: 1.patients have suitable hla identical sibling donor 2. patients with severe liver and kidney function (alanine aminotransferase \> 2.5 times of the upper normal limit, serum creatinine \> 1.5 times of the upper normal limit), cardiopulmonary dysfunction (cardiac function nyha iii / iv, cardiac ejection fraction \ 2; 6. patients with secondary tumor; 7. patients who cannot independently choose to enter or exit clinical trials due to serious central nervous system disease or mental disease.

Keywords: haploidentical stem cell transplantation hematological malignancies abo incompatibility
detection of sars-cov-2 rna in coughed droplets from patients with covid-19

Conditions: Covid19

Summary: the purpose of this study is to learn how to better detect infection and understand how severe acute respiratory syndrome coronavirus 2 (sars-cov-2) causes lung disease and is spread. the novel device called pneumoniacheck is a safe way to collect material from the lung from coughs. study participants will collect cough specimens over a 24 hour period.

a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (sars-cov-2), was detected in association with cases of severe respiratory illness and pneumonia (covid-19) in wuhan city, hubei province, china in december 2019. the virus subsequently spread widely throughout china and globally. addressing this unprecedented global pandemic is requiring all available tools to diagnose infection, manage ill patients, understand disease pathogenesis and virus transmission to guide efforts to decrease transmission and rapidly develop anti-viral drugs and vaccines. the researchers of this study propose to use the pneumoniacheck™, a device developed collaboratively by investigators at the georgia institute of technology (ga tech) and the centers for disease control and prevention (cdc), to help address these issues. this device, non-invasively, captures coughed droplets onto a filter with minimal contamination from upper airway secretions. in preliminary studies in cystic fibrosis, mycobacterium tuberculosis (tb) patients and control patients, the researchers detected bacterial dna by pcr, inflammatory cytokines and chemokines by multiplex luminex assays, surfactant by enzyme immunoassay (eia), and amylase by enzymatic assay. these data show that this device can provide high quality specimens from the lung with minimal risk to the patient and healthcare provider and much lower risk than invasive procedures such as bronchioloalveolar lavage. in addition, with this device, the researchers can acquire specimens from patients who do not have a productive cough (dry cough), a commonly reported symptom for covid-19, and specimens with minimal upper respiratory contamination unlike a sputum specimen. thus, this device can provide lung secretion specimens to improve detection of sars-cov-2 rna (lung specimens are better for detecting virus than upper respiratory tract specimens) and detect inflammatory and other biomarkers to explore pathogenesis of disease, identify inflammatory processes that might be amenable to intervention, and identify biomarkers of disease severity for patient management and evaluation of vaccines and anti-viral drugs. the goal of this study is to determine how pneumoniacheck™ can help diagnose, manage, and understand pathogenesis of disease and transmission risk of covid-19.

Eligibility criteria:
inclusion criteria: * being treated for an acute respiratory illness either as inpatients or outpatients at emory university hospital * english is a primary spoken language exclusion criteria: * none inclusion criteria for healthy volunteers: * prior registration in an adult participant database and agreed to be contacted for future studies * english is a primary spoken language
absorbed tumor dose in peptide receptor radionuclide therapy with long-acting somatostatin analogues - atsa trial

Conditions: Neuroendocrine Tumors; Neuroendocrine Tumor Grade 1; Neuroendocrine Tumor Grade 2; Neuroendocrine Neoplasm

Summary: according to current guidelines, patients have to withhalt long-acting somatostatin analogues (la-ssa) for 4-6 weeks prior to every 177lutetium-dotatate administration. the primary objective of the study is to investigate the effect of la-ssa on the absorbed dose in tumor lesions during prrt.

the study population includes all patients aged over 18 with a neuroendocrine tumor grade i and ii and a clinical indication for prrt. patients treated for at least three months with la-ssa are randomized over two interventional arms: one arm where patients discontinue la-ssa 4-6 weeks before the first prrt treatment and one arm where patients continue la-ssa treatment and receive the first prrt administration within one week after the most recent la-ssa injection. patients in the control arm who have not been treated with la-ssa in the last three months will start prrt according to standard local protocol.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * able to provide spoken and written informed consent for the trial; * histopathological confirmed neuroendocrine tumor; * fulfill the clinical criteria for prrt; * at least one soft tissue lesion \> 2 cm; * aimed administered activity of 7400 mbq; * ecog score (performance status) 0-2. exclusion criteria: * not possible to discontinue la-ssa for 4-6 weeks; * use of short-acting ssas; * pregnancy and lactating female patients; * inability to comply to the study procedures; * factors that might affect the biodistribution (for example, indication for furosemide directly after prrt infusion, limited fluid intake, any renal catheters, etc.).

Keywords: peptide receptor radionuclide therapy prrt lutetium dotatate
incidence of cut-out using intramedullary nails with double cephalic screw vs. unique in pertrochanteric fractures

Conditions: Proximal Femoral Fractures

Summary: the goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. the main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out). participants will be treated using open reduction and internal fixation with a proximal femoral nail. researchers will compare intramedullary nailing with a single cephalic screw (gamma nail) and with a double cephalic screw (chimaera nail) to see the cut-out rate.

randomized, open and prospective clinical trial. following the surgical indication for open reduction and internal fixation as treatment for proximal femoral fractures, patients will be randomly assigned (ratio 1:1) to one of the following treatments: control group: a gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture. experimental group: a chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture. patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study. after the surgery, patients will be followed-up at 6 weeks, 3 and 6 months. at those times, data related to the radiological examination, the appearance of complications and the walking ability evaluation scale (fac) will be collected.

Eligibility criteria:
inclusion criteria: * patients with proximal femur fracture (ota/ao 31-a1, a2 and a3) requiring surgical treatment. * signing of written informed consent according to current legislation before collecting any information, either by the patient or by the legal representative or by people linked by family ties. exclusion criteria: * presence of other fractures in the ipsilateral femur that condition the surgical treatment of the pertrochanteric femur fracture. * subcapital fracture of the proximal femur. * subtrochanteric fracture of the proximal femur. * pathological fracture.

Keywords: proximal femoral fracture hip fracture cut-out
multichannel emg diagnosing true preterm labor

Conditions: Pregnancy Preterm; Labor; Irregular; Preterm Labor

Summary: we have designed new electromyography sensors for measuring uterine activity. these sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions. by measuring the synchronization of the regions of the uterus during contractions we intend to non-invasively determine if any patient is in-labor or not-in-labor. accurately diagnosing true preterm labor allows timely intervention to avoid preterm birth; accurately diagnosing false preterm labor avoids needlessly treating patients who would not benefit.

the legacy device for assessing uterine contractions is the tocodynamometer (toco). the toco is plunger-driven device that measures the uterine shape change that occurs with a contraction. toco only reports the timing of contractions, not the contraction strength, and cannot distinguish between false and true labor. our overarching goal is to validate our method of determining if a patient experiencing contractions is in true labor or false labor. we will accomplish this by applying new knowledge to an old technology - uterine emg. this trial is based on our advanced understanding of how the uterus generates coordinated contractions without a pacemaker or dedicated electrical conduction pathways - mechanotransduction and intrauterine pressure - but also uses bioelectrical signaling for local tissue recruitment. the uterus emits bioelectrical signals with each contraction that can be detected by electromyography (emg). to observe uterine bioelectrical signals, we created a novel emg sensor, we call the "area sensor". this sensor is directional - capable of preferentially reporting muscle contractions from immediately below the sensor location. in this clinical trial we use multiple area sensors placed on the maternal abdomen to directly observe how well the regional contractions are synchronized. our hypothesis to be tested is that highly synchronized contractions predicts true labor, unsynchronized predicts false labor. patients with unclear labor status, or those in early labor will be studied. we will correlate the results of the synchronization analysis against the patient's progress over the ensuing 24 hours. these data will validate the ability to identify false and true labor using multichannel emg and area sensors.

Eligibility criteria:
inclusion criteria: * pregnant * one living fetus * experiencing frequent uterine contractions exclusion criteria: * cervical dilation \> 4 cm * ruptured membranes * maternal or fetal indications for immediate delivery

Keywords: preterm labor detection labor detection false labor
multiple sclerosis pelvic floor telerehabilitation

Conditions: Multiple Sclerosis

Summary: the goal of this clinical trial is to compare the effects of two different pelvic floor telerehabilitation protocols on selected measures of quality of life and health in females with relapsing-remitting multiple sclerosis (rrms). the main questions it aims to answer are: * is telerehabilitation sufficient to improve quality of life and health in females with rrms, in particular dedicated to pelvic floor training? * are self-administered training protocols or remotely-supervised training protocols equally effective? participants will be randomized to two intervention groups: a self-administered training protocol (self) and a remotely-supervised (remote) training protocol. both protocols will consist in 10 sessions of pelvic floor training lasting 45 min each, once every 5 days. at the start and at the end of the protocol, all participants will complete 6 questionnaires regarding pain, quality of life and health.

in this study, the authors aim to evaluate the efficacy of two telerehabilitation protocols dedicated to pelvic floor and urogynecological health in females with relapsing-remitting multiple sclerosis (rrms). in particular, the included participants will be randomized to: * self protocol: 10 sessions of pelvic floor exercises, self-administered with a set of videos where a physiotherapist showed the different exercises in order to complete a 45 minutes session. * remote protocol: 10 sessions of pelvic floor exercises, remotely conducted and supervised by a physiotherapist with a one-to-one videocall, showing and monitoring the exercises in order to complete a 45 minutes session. one week before the first session and one week after the last session, all the participants will be asked to complete a set of surveys and questionnaires to investigate participants' pain perception, reported quality of life and health-related parameters.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsing remitting multiple sclerosis confirmed by a neurologist and based on the mcdonald criteria from not less than 1 y * edss \<4.5 * self reported symptoms of urinary incontinency exclusion criteria: * females in menopause * previous history of bladder or urogynaecological surgery * previous history of major abdominal surgery * females with a delivery \< 6 months from the start of the study * bmi \> 30

Keywords: multiple sclerosis pelvic floor telerehabilitation exercise
perineal echography in the delivery room for the detection of anal lesions

Conditions: Parturition

Summary: the main objective of this study is to compare the rate of anal incontinence (measured by the wexner score, qualitative and quantitative (\> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.


Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 3 months of follow up * the patient is delivering her first child; vaginal delivery * the patient has a minimum stage 2 perineal lesion * the patient accepts perineal echography exclusion criteria: * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * cesarien section * no perineal lesion (intact perineum) * emergency situation which hinders screening for anal lesions under good medical conditions * previous vaginal delivery

Keywords: second degree vaginal tear perineal ultrasound anal incontinence
predicting progression of developing myeloma in a high-risk screened population (promise)

Conditions: Multiple Myeloma

Summary: the promise study aims to establish a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (mgus) and smoldering multiple myeloma (smm). we will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.

the goal of the promise research study is to determine clinical/genomic alterations present in individuals with mgus and smm, who are diagnosed through screening of a high-risk population. we also seek to determine clinical/genomic/epigenetic and immune environmental predictors of progression to multiple myeloma in patients with mgus and smm.

Eligibility criteria:
inclusion criteria: * age ≥ 30 years * aa race (self-identified) and/or first-degree relative of a patient with a plasma cell dyscrasia such as mgus, smm, mm, and waldenström's macroglobulinemia, or another blood cancer. * those over 18 are also eligible if they have 2 or more family members with a blood cancer exclusion criteria: \* • persons diagnosed with cancer at any site (including hematologic cancers) with symptomatic disease requiring active therapy. • persons with an already diagnosed plasma cell dyscrasia such as mgus, smm, mm, and waldenström's macroglobulinemia first-degree relatives would not need to be identified by the participant. this study includes all special populations who fall within the eligible high-risk age range, ≥ 30 years of age, including adults unable to consent, pregnant women, and prisoners. these populations will not be excluded as this is a non-therapeutic study.

Keywords: multiple myeloma
black education and treatment of hypertension (beat htn)

Conditions: Hypertension

Summary: clinical trials have yet to test the adequacy of htn control in african americans (aa) when both control and intervention groups are given free antihypertensive medications and are involved in usual versus intensive intervention strategies. because of this, it has not yet been determined whether the method of prescribing antihypertensive medications according to jnc 7 guidelines is more, less, or equally as effective as prescribing antihypertensive medications and providing intensive behavioral and clinical interventions. knowledge in this area of htn treatment should better able medical and health practitioners to help their aa subjects control htn. the beat hypertension clinic will evaluate this method of htn control by proposing a program that will evaluate the difference in htn control among subjects receiving usual care and free medications and subjects also receiving free medications, but additionally being treated in a clinic that operates in a more intensive manner in relationship to patient behavior modification, patient-clinician interactions, and physical and social environments. at the conclusion of the study, the beat hypertension clinic investigators will report findings and help to answer the question of whether medication alone or medication combined with intensive behavioral and clinical treatment is more effective in htn control in the aa population.


Eligibility criteria:
inclusion criteria: 1. demographics: men or women of self-declared african-american heritage between 25 and 80 years of age residing in the omaha, nebraska metropolitan area 2. history of documented uncontrolled (treated or untreated) hypertension (htn) as defined by jnc 7 guidelines 3. study eligibility will be based on the subject's current blood pressure control based on the average of two seated blood pressure measurements at two consecutive clinic visits at least one week apart 1. untreated subjects with elevated blood pressure (\> 140/90 mmhg or \< 130/80 mmhg for diabetics) 2. subjects treated with antihypertensive therapy whose blood pressure does not meet current jnc 7 guidelines (\< 140/90 mmhg for non-diabetics and \< 130/80 mmhg for diabetics) exclusion criteria: 1. myocardial infarction or stroke in the previous 6 months 2. symptomatic heart failure or a left ventricular ejection fraction \< 35% 3. angina pectoris in the prior six months 4. coronary revascularization procedure in the prior 6 months 5. renal insufficiency defined as a serum creatinine \> 2 mg/dl 6. illicit drug or alcohol abuse in the prior 6 months 7. dementia or other organic brain disease 8. serious systemic illness with a shortened life expectancy or other limitation that precludes participation in this trial 9. secondary htn 10. concurrent participation in an investigational medication trial

Keywords: african american