Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of pegozafermin in participants with compensated cirrhosis due to mash

Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Summary: the study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to mash (biopsy-confirmed fibrosis stage f4 mash \[previously known as nonalcoholic steatohepatitis, nash\]).


Eligibility criteria:
key inclusion criteria: * males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (icf). * at least 1 metabolic risk factor. * biopsy-confirmed fibrosis stage f4 mash (per non-alcoholic steatohepatitis \[nash\] clinical research network (crn) system) with compensated cirrhosis. * body mass index (bmi) at screening ≥25.0 (≥23.0 for asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2). key exclusion criteria: * liver disorder other than mash. * history or evidence of hepatic decompensation. * history or evidence of hepatocellular carcinoma. * have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus. * alt or aspartate aminotransferase (ast) ≥250 units per liter (u/l). * participants taking vitamin e (\>400 international units \[iu\]/day) must be on stable dose for at least 6 months prior to screening. other inclusion and exclusion criteria may apply.

Keywords: liver disease fatty liver digestive system diseases metabolic diseases metabolic dysfunction-associated steatohepatitis mash nonalcoholic steatohepatitis nash metabolic dysfunction-associated steatotic liver disease masld nonalcoholic fatty liver disease nafld fibrosis cirrhosis
sputum labeling utilizing synthetic meso-tetra (4-carboxyphenyl) porphine (tcpp) for detection of lung cancer

Conditions: Lung Cancer

Summary: this is a single center study to assess the efficacy of cypath® early detection lung cancer assay to detect lung cancer cells from deep lung sputum.

meso tetra (4-carboxyphenyl) porphine (tcpp) is a porphyrin that can label cancer cells by reacting to the increased number of low-density lipoproteins coating the surface of cancer cells and the porous nature of the cancer cell membrane, causing the cell to fluoresce under specific wavelengths of light. the primary objective of this clinical trial is to determine the the presence or absence of red fluorescent \[ie, cancer\] cells (rfcs) from deep-lung sputum samples using the cypath® early lung cancer detection assay from one cohort of participants who are healthy. the results from this trial will be compared with two additional cohorts of participants including individuals at high risk for lung cancer and individuals diagnosed with lung cancer. collection of the sputum samples from high-risk individuals and lung cancer patients is complete (nct00894127). participants who satisfy the inclusion/exclusion criteria will be enrolled into the study and assigned to the healthy cohort. the sputum samples will be collected at the study site or at the participant's home after explanation of the collection procedure by study staff. samples will be identified with an identification number blinding the sample identity. each subject's sputum specimen will be processed onto 13 microscope slides at the university of texas health science center of san antonio (uthscsa) laboratory. the uthscsa laboratory will process each sputum sample onto slides using the thinprep t2000 processor for use in the cypath® early lung cancer detection assay. twelve slides from each sputum sample will be labeled with cypath®. one slide will be used to preform pap staining for the presence of macrophages. macrophages are an indication that the sputum sample is from deep within the lungs. a cytopathologist will review the slide and record results on a specimen adequacy form. bioaffinity researchers who will be blinded as to the participant's identity will perform the cypath® labeling and scoring of the slides. the study results of the healthy cohort will be used for comparison with the results of a closed study in which the sputum from individuals at high risk of lung cancer and individuals diagnosed with lung cancer was compared. findings of the cypath® assay will not be used in the diagnosis or treatment of participants.

Eligibility criteria:
inclusion criteria: * participants who have never smoked nor have known lung diseases exclusion criteria: * severe obstructive lung disease * angina with minimal exertion * pregnancy * have or have had cancer other than lung cancer * worked in the mining industry

Keywords: lung cancer porphyrin fluorescence diagnostic sputum cytology early detection
pharmacokinetics of high-dose tigecycline in critically ill patients

Conditions: Septic Shock; Antibiotic Resistant Infection; Critical Illness

Summary: the objective of this study is to describe the pharmacokinetics of tigecycline in critically ill patients receiving continuous venovenous haemodialysis (cvvhd) and to evaluate the frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200 mg loading dose and 100 mg/12h).

this is a prospective observational study performed on critically ill patients. inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. both medical and surgical patients will be included. any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) antibiotics regimen includes: tigecycline (200 mg every 12 hours intravenously), meropenem (2 grams every 8 hours intravenously). blood samples (3 ml) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline for 3 consecutive days. the standard arterial canula will be used to obtain samples. in each case cvvhd will be started and continued for at least 3 days' period. 30 minutes after a collection each sample will be centrifuged for 10 minutes at 3,000 rpms. subsequently, supernatant will be collected and frozen. serum tigecycline concentration will be measured with high performance liquid chromatography. each patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (picco). other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required.

Eligibility criteria:
inclusion criteria: * patients who require icu treatment due to severe sepsis * age 18-80 years * cvvhd treatment * an eligible consent obtained from the patient or his/her attendant exclusion criteria: * allergy to tigecycline or meropenem * contraindication to cvvhd * lack of consent to participate in the study * age of patients below 18 or above 80 years

Keywords: tigecycline pharmacokinetics
effects of a telephone based peer support to reduce depressive symptoms and improve social support in women with chd

Conditions: Depressive Symptoms; Low Perceived Social Support; Coronary Heart Disease

Summary: in a randomized controlled trial the investigators intended to evaluate the effect of a telephone based peer support intervention on depressed or anxious women with coronary heart disease (chd). the investigators intended to include 198 depressed or anxious women aged over 18 years with chd. participants were randomized to intervention (ig) or waiting list (wl). ig was offered immediate telephone-based contact to peer counselors while wl received the offer with a 6-month delay. all participants got at least one telephone call by a clinical psychologist (study information, feedback about the individual level of distress, proposal to get help). main outcome variables were depressive symptoms (phq-9) and perceived social support (f-sozu k-14). in an additional quasi-experimental trial, the investigators included 11 peer counselors and 11 matched controls not taking part in the intervention. main outcome variables were mood states (poms) and perceived social support (f-sozu k-14).


Eligibility criteria:
inclusion criteria: * coronary heart disease * depressive symptoms (hads \>7) * insurants of former kaufmännische krankenkasse (kkh)-allianz * german speaking * at least 18 years old * written informed consent exclusion criteria: * hardness of hearing * severe somatic illness * current severe depressive episode or current suicidal tendency * severe mental illness (dementia, psychosis)

Keywords: depressive symptoms perceived social support coronary heart disease peer support women
ultrasound vs palpation for infant lumbar puncture

Conditions: Spinal; Puncture, Complications

Summary: the purpose of this study is to determine if performing an ultrasound to identify the space to insert the needle before performing a lumbar puncture will improve success of the procedure and patient safety.

the investigators are conducting a single-center, prospective two-arm parallel group randomized clinical trial in an urban pediatric emergency department to determine if performing an ultrasound prior to lumbar puncture procedure improves success of the procedure. patients will be block-randomized into two groups to receive procedural interspace selection via 1) standard anatomic palpation technique or 2) visualization with pre-procedural ultrasound (experimental group). 1. standard anatomic palpation technique: participants randomized to this group will receive standard of care treatment with providers using the palpation technique to select an interspace. as variations on the palpation technique exist, the investigators will provide a standardized educational cognitive aid that clinicians can use for this approach. 2. pre-procedural ultrasound: clinicians will first use the standard palpation technique to select an interspace for ultrasound evaluation. a select group of pediatric emergency medicine attendings and fellows who have already trained to a mastery standard with the ultrasound protocol will then conduct the pre-procedural ultrasound. the clinicians performing the lumbar puncture will be provided the following information to conduct the lumbar puncture: i. assessment for fluid at the level selected (and the number of interspaces above that have fluid without conus present) ii. measurements of appropriate angle and depth iii. evaluation of any overlying vasculature post-lumbar puncture: after the lumbar puncture, infants randomized to both groups will receive a post-procedural ultrasound scan performed by one of the mastery trained ultrasound physicians.

Eligibility criteria:
inclusion criteria: * patient is less than 90 days old. * patient is receiving a lumbar puncture exclusion criteria: * patient is clinically unstable * patient had a previous lumbar puncture in the past 24 hours * an outside consultant (not working in ed) is performing the lp * patient has developmental delay or neurological impairment * there is no legal guardian present * the legal guardians speak neither english nor spanish * there is no ultrasound personnel available to enroll

Keywords: infant lumbar puncture patient safety ultrasound
covid-19 vax booster dosing in patients with hematologic malignancies

Conditions: Multiple Myeloma; AL Amyloidosis; Chronic Lymphocytic Leukemia

Summary: to determine whether protective antibody levels increase after booster dosing with the moderna covid-19 vaccine in patients diagnosed with hematologic malignancies who have low antibody levels after a prior first vaccination with any of the sars-cov2 vaccines that were authorized for use in the usa. researchers will also assess whether the booster dosing with the moderna covid-19 vaccine is safe in patients with multiple myeloma, amyloidosis, or other blood cancers.

the specific hypothesis being tested is that it may be possible to induce a protective humoral immune response with a booster dose of the moderna covid-19 vaccine in patients with hematologic malignancies who did not have an adequate response to first vaccination with any of the available covid-19 vaccines. to test this hypothesis, t a phase ii singlestage trial in which patients with a negative or weak positive anti-sars-cov2 igg antibody test (defined as \<1.00 s/co and 1.00-1.99 s/co, respectively) will receive a single standard dose of the moderna covid-19 vaccine intramuscularly, and then have anti-sars-cov2 igg antibody levels checked 28 days (+/-3 days) later.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 18 years of age or older 4. previously diagnosed with mm/al amyloidosis (cohorts 1 or 3) or other hematologic malignancy (cohorts 2 or 3). 5. previously received any one of the available covid-19 vaccines (between 4 and 36 weeks prior to enrollment) 6. anti-sars-cov2 igg antibody titer of results less than 1.0 units (cohorts 1 and 2), or 1.0-1.99 units (cohort 3). antibody titers will be measured within 14 days of enrollment. 7. if currently receiving potentially immunosuppressive anti-neoplastic therapy for their underlying hematologic condition, a two-week interruption in therapy before and after the booster dose of vaccine is encouraged but not required (physician discretion).- exclusion criteria: 1. daily corticosteroids at a dose equivalent to prednisone 20 mg/day or greater during the period two weeks before enrollment to the trial. intermittent steroid dosing at or above this level is permitted (i.e., weekly dexamethasone dosing as part of myeloma therapy) 2. history of previous severe reaction to any available covid-19 vaccine (defined as any grade 3 or higher reaction) 3. febrile illness within 3 days of booster dosing. 4. documented sars-cov2 infection within 2 weeks of enrollment. 5. less than 3 months post-autologous or allogeneic stem cell transplant (note: transplant between initial standard vaccine administration and enrollment is not otherwise grounds for exclusion from participation).
screening for obstructive sleep apnea among members of an internet weight loss community

Conditions: Obstructive Sleep Apnea

Summary: the current study was a pilot, double blind, randomized controlled trial to (1) evaluate the feasibility of an online obstructive sleep apnea (osa) screening intervention, (2) estimate effect size for planning of future studies, and (3) test the hypothesis that the intervention, compared to a control condition, would lead more individuals to discuss osa with their healthcare provider.


Eligibility criteria:
inclusion criteria: * member of sparkpeople.com community and logged on within previous month * live in the us exclusion criteria: * prior diagnosis of osa * prior discussions with healthcare provider about osa

Keywords: obstructive sleep apnea internet screening health belief model
study to test the combination of voriconazole and anidulafungin in patients who have, or are thought to have, invasive aspergillosis and who are unable to take a common antifungal therapy (polyene)

Conditions: Aspergillosis

Summary: this study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy.

the study was terminated on january 12, 2009 due to the overall low rate of enrollment. the decision to terminate the trial was not based on any safety concerns. patients who were enrolled in the study prior to january 12, 2009 were allowed to remain in the study until completing their participation as specified in the protocol.

Eligibility criteria:
inclusion criteria: proven or probable invasive aspergillosis. patient is intolerant to polyene therapy. exclusion criteria: patients with invasive aspergillosis for more than 30 days at the time of study entry. patients with uncontrolled bacterial or viral infection at the time of study entry. patients with significant liver dysfunction or who are taking certain medications which interact with voriconazole.

Keywords: invasive aspergillosis, opportunistic mold infection
to assess the predictive value of d-dimer level on the occurrence of cardiovascular events

Conditions: Atrial Fibrillation

Summary: the primary aim of the study was to assess whether d-dimer level at entry or an increase of d-dimer level during the follow-up could predict the occurrence of subsequent cardiovascular events in patients with atrial fibrillation.

patients will be followed-up every 4 months with clinical assessment and d-dimer blinded measurement.

Eligibility criteria:
inclusion criteria: * atrial fibrillation exclusion criteria: * follow-up not possible, poor prognosis within 3 months

Keywords: atrial fribrillation, cardiovascular events, aging, d-dimer
functional prognosis in patients with ischemic stroke according to the therapeutic strategy used

Conditions: Ischemic Stroke

Summary: the current management of ischemic stroke is based on different strategies that may be combined: intravenous thrombolysis in a stroke icu, intravenous thrombolysis in a telemedicine procedure, endovascular thrombectomy. given this now rich therapeutic arsenal, it seems necessary to evaluate practices in local care in the field and the impact of these on the prognosis of ischemic stroke victims. the aim of this observational study is to compare these different care practices without interfering with the choice of strategy. a blood sample will also be taken at different times to study the value of growth differentiation factors (gdf) 8, 11 and 15, and brain-derived neurotrophic factor as prognostic biomarkers


Eligibility criteria:
inclusion criteria: * patients with symptomatic ischemic stroke defined according to who criteria and treated by intravenous thrombolysis at the stroke icu at dijon chu, intravenous thrombolysis by telemedicine with subsequent transfer to the dijon stroke icu, and/or endovascular thrombectomy at dijon chu) * patients aged over 18 years. * patients who have provided written informed consent to take part in the study. exclusion criteria: * patients who refuse to take part in the study. * subjects in custody. * patients (or a person of trust) who cannot be contacted by telephone during the follow-up.
trajectories and reactions of users and relatives consulting french youth addiction services

Conditions: Addiction

Summary: in france, the "consultations jeunes consommateurs" (cjc) are the services specialized in the reception of young people for addiction problems. there are more than 500 cjcs throughout france. depending on the situation, the cjc develops an early intervention strategy aimed either at reducing the risk of developing an addiction or at accelerating entry into appropriate care. the cjcs also meet with family members or professionals who may also independently request help or advice. set up by the state since 2004, the action of the cjcs has never been formally evaluated. only descriptive studies, carried out by the french observatory of drugs and drug addiction (ofdt), have made it possible to better understand the profile of people who consult cjcs. however, no longitudinal study has yet been carried out to understand the factors associated with the overall evolution of users consulting cjcs, nor with the level of satisfaction of users and those around them. such objectives are complex, due to the diversity of situations encountered in cjcs and the heterogeneity of the cjcs themselves.

this multicenter study will be open to 19 cjc (consultations jeunes consommateurs), based on a pre-selection by the partners of structures that are particularly willing to participate in the study (fédération addictions, addictions-france). however, other cjcs may be included depending on the progress of recruitment. this recruitment of additional cjcs will be stratified to target a sample of cjcs representative of the cjcs on the metropolitan territory on the following characteristics: * region (13 major regions) * rural or urban area, as defined by insee * number of annual consultations

Eligibility criteria:
inclusion criteria: for users : * first consultation in cjc * from 12 to 25 years old for caregivers : * first consultation in cjc (with or without the youth) or second consultation if accompanying a user * ≥ 18 ans exclusion criteria: * inability to reach by phone * insufficient french level
atrial fibrillation/sinus rhythm before and after cardioversion

Conditions: Atrial Fibrillation

Summary: this study´s aim is to collect scientific data about patients with atrial inflammation by two principles of sensors measuring congestive heart failure.


Eligibility criteria:
inclusion criteria: * patients with atrial fibrillation and planned cardioversion * male and female patients aged at least 18 years * patients being able to understand and to follow the study staff´s instructions * signed informed consent exclusion criteria: * persons being hosted in an institution by administrative order or court injunction * pregnancy or breast feeding * persons not being able to consent * persons with implanted electronic devices * material incompatiblity * acute or chronic inflammation of the external or middle ear canal * abnormal anatomic ear canal (congenital or pathological) * persons in a dependent relationship to the investigator or employment contract
safety and efficacy of ipamorelin for management of post-operative ileus

Conditions: Ileus

Summary: the purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.

the safety and efficacy of ipamorelin in the management of post-operative ileus

Eligibility criteria:
inclusion criteria: * willing to comply with protocol * undergoing bowel resection surgery * asa class i-iii * females must not be pregnant * body weight 40-150 kg exclusion criteria: * mentally incompetent or unable to provide informed consent * clinically unstable * significant liver disease * clinically significant lab or ekg abnormalities * alcohol or illicit drug abuse * history of or current surgery that would prevent proper evaluation of safety or efficacy of drug

Keywords: postoperative ileus
comparison of wire assisted percutaneous balloon mitral valvulotomy with standard inoue balloon valvulotomy

Conditions: Rheumatic Heart Disease

Summary: the goal of this randomised study is comparison of wire assisted balloon mitral valvulotomy to standard inoue balloon technique on patients with rheumatic mitral stenosis. the main question it aims to answer is whether procedure time is reduced using the wire assisted method. participants will be randomized to one of the two methods.

background: rheumatic valvular disease, a chronic sequela of acute rheumatic fever, is a leading cause of cardiovascular mortality in developing countries. the available options of management include surgical treatment and balloon valvulotomy. among various forms of rheumatic valvular lesions, severe mitral stenosis with favorable morphology can be successfully treated by balloon valvulotomy. methods: the study is a randomized controlled trial with intervention in both arms. the objective of this study is to compare procedural time as a primary end point.

Eligibility criteria:
inclusion criteria: * significant mitral stenosis * low wilkins score (\< 10) * mitral regurgitation grade not more than 2 exclusion criteria: * high wilkins score (\>10) * unfavourable anatomy * presence of left appendage thrombus * non-conclusive periprocedural trans oesophageal echocardiography imaging