Kornimate/medical-research-clean huggingface dataset:
the box: using smart technology to improve one-year outcome of myocardial infarction patients

Conditions: Myocardial Infarction

Summary: study to investigate whether a smart technology intervention can improve clinical and cost-effectiveness of one-year follow-up in patients who suffered from acute myocardial infarction.

rationale: smart technology could improve quality of care in patients after acute myocardial infarction (ami) with either st or non-st elevation. objective: the objective of this study is to measure the effect of a smart technology intervention on patients after ami. study design: the design of the study is a single-center, open randomized-controlled trial. study population: the study population consists of patients who have been discharged from the ward of the cardiology department of the leiden university medical center after primary percutaneous coronary intervention (pci) for either st or non-st elevation myocardial infarction. intervention: patients will be randomized to either "the box" or regular follow-up. patients who have been randomized to the box will receive a box containing a smartphone compatible electrocardiogram (ecg) monitor, a weight scale, an activity tracker and a blood pressure monitor. if patients are randomized to the box, two of the four outpatient clinic visits will be replaced by an e-consult, in which a patient does not have to go to the hospital, but talks with his or her doctor or nurse practitioner via a secured video connection. main study parameters/endpoints: the primary endpoint of the study will be the percentage of patients with controlled blood pressure in both groups.

Eligibility criteria:
inclusion criteria: * patient is admitted with acute myocardial infarction * patient is able to communicate in english or dutch at b1 level exclusion criteria: * body mass index \> 35 kg x m-2 * included in another randomized controlled trial * patient is \<18 years of age * patient is considered an incapacitated adult * patient is pregnant * patient is unwilling to sign the informed consent form

Keywords: myocardial infarction e-health mhealth mobile phones smartphone follow-up
a multicenter rct of "3+7" vs venetoclax + cacag in newly diagnosed mid/high-risk aml patients

Conditions: Acute Myeloid Leukemia; First Line Therapy

Summary: the purpose of this study is to compare the efficacy and safety of venetoclax combined with the cacag regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (aml).

despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. in order to improve the outcome of patients with de novo aml, we developed a venetoclax combined with cacag regimen in the treatment of de novo aml. in this study, we intent to compare the efficacy and safety of venetoclax combined with cacag regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia.

Eligibility criteria:
inclusion criteria: age 14 to 75 years (no gender limitation) newly diagnosed with intermediate- or high-risk aml (excluding m3) liver function: alt and ast ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal renal function: creatinine ≤ upper limit of normal no uncontrolled infections, organ dysfunction, or severe mental illness ecog performance status score of 0-2 and predicted survival ≥ 4 months no severe allergic constitution exclusion criteria: allergy or contraindication to the study drug pregnant or breastfeeding female patients known history of alcohol or drug addiction (due to potential non-compliance) mental illness or conditions preventing protocol compliance less than 6 weeks after major organ surgery liver function: alt and ast \> 2.5 times upper limit of normal; bilirubin \> 2 times upper limit of normal renal function: creatinine \> upper limit of normal deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.) -
use of 1-mna to improve exercise tolerance and fatigue in patients after covid-19

Conditions: Covid19; Fatigue Syndrome, Chronic

Summary: coronavirus disease 2019 (covid-19) is a serious respiratory disease that results from infection with a newly discovered coronavirus (sars-cov-2). unfortunately, covid-19 is not only a short-term infection but that patients (pts) recovering from sars-cov2 infection complain of persisting symptoms including: fatigue, diffuse myalgia and weakness, which may lead to chronic fatigue syndrome. there is currently no evidence that nutritional supplements and/or physical exercise can assist in the recovery of pts with chronic fatigue syndrome. 1-methylnicotinamide (1-mna) is an endogenic substance that is produced in the liver when nicotinic acid is metabolized. 1-mna demonstrates anti-inflammatory and anti-thrombotic properties. therefore, we investigated whether 1-mna supplements could improve exercise tolerance and decrease fatigue among patients recovering from sars-cov-2.

the study population was composed of pts after covid-19, expressing subjective feelings of limited tolerance to exercise. the selected pts were randomized into two groups: grm0 - without supplementation; grm1 - with 1-mna supplementation. at the beginning of the study (phase 0), in both groups, a 6-minute walk test (6mwt) was carried out and fatigue assessment with fatigue severity scale (fss) was performed. after 1 month (phase 1), a fol-low up fss and 6mwt once more were performed in both groups.

Eligibility criteria:
inclusion criteria: * patients after covid-19 * patients expressing subjective feelings of limited tolerance to exercise and above 50% greater fatigue compared to their pre-covid-19 levels (symptoms must have continued for at least four weeks since the last symptoms of infection) exclusion criteria: * patients with cardiological complications * patients with pulmonological complications * patients with chronic obstructive pulmonary disease and/or asthma

Keywords: covid19 chronic fatigue syndrome 1-mna 1-methylnicotinamide post-covid syndrome
mirt and rotigotine in the early stage of pd

Conditions: Parkinson's Disease

Summary: to test whether a multidisciplinary intensive rehabilitation treatment (mirt) slowed down the progression of the disease in parkinson's disease (pd) "de novo" patients, all treated with rotigotine, in a randomized controlled study with a 18 months follow-up.

in the last years different rehabilitation treatments have been proposed to address specific motor deficits in parkinson's disease. nevertheless, the evidence of a possible neuroprotective action of exercise in pd has been obscured by the facts that all studies were performed in patients in different disease stages and under a variety of pharmacological treatments. our objective is to test whether a multidisciplinary intensive rehabilitation treatment (mirt) slowed down the progression of the disease in pd "de novo" patients, all treated with rotigotine, in a randomized controlled study with a 18 months follow-up. 40 patients at the initial stages of pd (h\&y stages 1,5-2) treated only with rotigotine will be enrolled and randomly assigne into two groups. patients in group 1 (20 subjects) will be undergone 2 mirt cycle (at t0 and t3). mirt consist of a 4-week cycle of physiotherapy that entailed three daily sessions 5 days a week (frazzitta g. et al., neurorehabilitation \[30\] 2012, 295-301). patients in group 2 (20 subjects) will continue with drug therapy alone. for the group 1, unified parkinson's disease rating scale (updrs) ii, updrs iii, six-minute walking test (6mwt), berg balance scale (bbs), timed-up-and-go test (tug), comfortable and fast gait speed, self-assessment parkinson's disease disability scale and l-dopa equivalents will be assessed at baseline t0, t1 (discharge after the first mirt cycle), t2 (control at 6 months after discharge), t3 (hospitalization for second mirt cycle), t4 (discharge after the second mirt cycle) and t5 (end of the protocol, 18 months); for the group 2, updrs ii, updrs iii, six-minute walking test (6mwt), berg balance scale (bbs), timed-up-and-go test (tug), confortable and fast gait speed, self-assessment parkinson's disease disability scale and l-dopa equivalents will be assessed at baseline t0, t1 (check-up at 6 months), t2 (check-up at 12 months), t3 (check-up at 18 months).

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease according to gelb et al., ability to walk without any physical assistance, no cognitive impairment (mmse score \> 26), no comorbidity unrelated to parkinson's disease, no vestibular/visual dysfunction limiting locomotor or balance. exclusion criteria: * atypical parkinsonisms, cognitive impairment (mmse \< 26), other comorbidities not related to pd, vestibular/visual dysfunction limiting locomotor or balance.

Keywords: rehabilitation treatment
dosimetry and preliminary clinical application study of a novel probe targeting cd73

Conditions: Malignant Tumour

Summary: as a new cd73-targeted pet radiotracer, 68ga-dpne, is promising as an excellent imaging agent applicable to various cancers. in this study, we observed the safety, biodistribution and radiation dosimetry of 68ga-dpne in human volunteers. furthermover, we conducted a comparative analysis of 68ga-dpne and 18f-fdg imaging to assess both the radiation dosimetry and diagnostic efficacy of 68ga-dpne.

the boom in radiopharmaceuticals continues to persist, including their driving effects in the field of immunotherapy. cd73 (ecto-5'-nucleotidase), a key purine metabolic enzyme, catalyzes the conversion of extracellular nucleotides to adenosine, promoting tumor immune evasion and unfavorable clinical outcomes. notably, cd73 is highly expressed in 74.3% of breast cancer cases, with its prevalence exceeding 45% in liver, gastric, colorectal, and ovarian cancers. as a new cd73-targeted pet radiotracer, 68ga-dpne, is promising as an excellent imaging agent applicable to various cancers. the present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68ga-dpne, and performed a head-to-head comparison with 18f-fdg pet/ct scans in patients with various cancers.

Eligibility criteria:
inclusion criteria: signed informed consent and be able to follow up. exclusion criteria: pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
contribution of the eyemax™ 11fr (micro-tech) digital single-operator cholangioscope with a wide working channel

Conditions: Cholangiocarcinoma; Biliary Stenosis; Bile Duct Stones; Bile Duct Stenosis

Summary: background and aims digital single-operator cholangioscopy (dsoc) enhances biliary stricture diagnosis, but the collection of quality samples can be difficult due to the small diameter of the working channel. a new dsoc (eyemaxtm 11fr, micro-tech endoscopy, nanjing, china) with a 2.0 mm working channel, accommodating pediatric forceps (1.6 mm), has been introduced in france. this study reports on the initial french experience. methods a retrospective multicenter observational study on dsoc was conducted across five endoscopy units within the cregg (french society of private hepato-gastroenterology). satisfaction and procedural evaluations were recorded using a visual analog scale (vas) and compared with the spyglasstm ds ii dsoc (boston scientific).


Eligibility criteria:
inclusion criteria: * all consecutive patients who were referred to one of the participating expert tertiary endoscopy units for an ercp for a bile duct stenosis exclusion criteria: * patients with significant tissue mass that could easily be punctured by eus-fnb were not included. * non-accessibility to the bile duct due to a history of billroth ii or roux-en-y reconstruction, * coagulation disorders (such as partial thromboplastin time \> 42 seconds, prothrombin time \[quick value\] \< 50%, or platelet count \< 50,000/mm³), or treatment with clopidogrel.

Keywords: cholangioscopy digital single-operator cholangioscope
study of nerve block pain management in patients undergoing a double mastectomy with immediate reconstruction

Conditions: Breast Cancer; Breast Cancer Female

Summary: the purpose of this study is to determine if the injection site or sites used for administering pain medication (nerve blocks) before a double mastectomy with immediate reconstruction with tissue expanders reduce the need for pain medication after surgery.


Eligibility criteria:
inclusion criteria: * female patients \>/= 18 years old * undergoing bilateral mastectomy with immediate reconstruction (bmw/ir) * scheduled for surgery at josie robertson surgical center (jrsc) * must be appropriate for an agree to receive a nerve block * must be appropriate for randomization * able to read and speak english * willing and able to provide written informed consent exclusion criteria: * none applicable, as exclusion occurs prior to consent

Keywords: mastectomy double mastectomy mastectomy with reconstruction double mastectomy with reconstruction double mastectomy with immediate reconstruction mastectomy with immediate reconstruction memorial sloan kettering cancer center 19-238
asthma data innovation demonstration project

Conditions: Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Summary: propeller health is collaborating with the city of louisville and other local partners to carry out a focused demonstration project that will evaluate the effectiveness of the propeller health approach to asthma management while exploring means to use real-time data on asthma exacerbations in a public health setting. the asthma data innovation demonstration project (adid) will use wireless sensor technology to develop spatial and temporal data on the use of rescue inhalers by 120 study subjects with asthma in the louisville metropolitan area. propeller health will process these data to support two general strategies. asthma self management: rescue inhaler actuation data will be compiled into individualized feedback reports to support asthma self management. propeller health will combine information on individual rescue inhaler actuations with evidence-based asthma management tips into real-time reports that will be provided to subjects. adid staff will evaluate any resulting improvements in asthma control that may be based on this information. subjects may share reports with their healthcare providers. municipal purposes: the second strategy is to provide aggregated and de-identified, spatial and temporal asthma rescue inhaler actuation data to city personnel and authorized public health researchers in louisville. these data will show the times and locations of the use of rescue inhalers by the 120 study subjects throughout the greater louisville area. adid staff will work with city personnel and researchers to investigate how this unprecedented level of detailed information on exacerbations can be used best to increase public awareness of environmental triggers while supporting public health surveillance efforts around respiratory diseases.


Eligibility criteria:
inclusion criteria: * self-reported provider diagnosis of asthma * prescription for short acting beta agonist (saba) at study intake exclusion criteria: * subject is under the age of 5 at the beginning of the study * subject does not speak english * subject does not have access to the internet or email to receive reports * subject has substantial co-morbidity (self-reported provider diagnosis of copd)

Keywords: asthma asthma control healthcare utilization costs community hotspots public health research
study of vinorelbine liposomes injection for advanced solid tumors, non-hodgkin's lymphoma or hodgkin's disease

Conditions: Tumors; Hodgkins Disease; Non-Hodgkins Lymphoma

Summary: this phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (vli) in patients with advanced solid tumors, non-hodgkin's lymphoma, or hodgkin's disease.

the objectives of this study are: * to assess the safety and tolerability of treatment with vli. * to determine the maximum tolerated dose (mtd) of vli. * to characterize the pharmacokinetic (pk) profile of vli. * to explore preliminary tumor response of vli.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy is known to exist, or relapsed and/or refractory non-hodgkin's lymphoma or hodgkin's disease 2. adequate hematologic, hepatic and renal functions as defined by laboratory tests. 3. at least 18 years of age. 4. have a life expectancy of at least 12 weeks. 5. patients must give written informed consent. 6. ecog or zubrod performance status of 0, 1, or 2. exclusion criteria: 1. primary tumors of central nervous system (cns). symptomatic brain metastases (unless patient is stable without requirement of steroids and/or antiseizure medications for at least 3 months) or leptomeningeal tumor involvement. 2. prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin c). 3. planned concurrent systemic therapy and/or radiotherapy drug study treatment. 4. use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study. 5. active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment. 6. prophylactic hematologic growth factors administered less than or equal to 2 weeks prior to start of therapy with vli (excluding darbepoetin alfa, epoetin alfa). 7. female patients who are pregnant or lactating. 8. dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.

Keywords: vinorelbine solid tumors hodgkins non hodgkins lymphoma advanced solid tumors
safety, tolerability, pharmacokinetics, and preliminary efficacy of spl84 in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the goal of this clinical trial is to learn if drug spl84 is safe for adult patients with cystic fibrosis (cf). it will also learn if the drug works to treat works to treat cf with a specific mutation. the purpose of this research study is to: * test the safety and effectiveness of multiple doses of the study drug, spl84 * test how multiple doses of the drug are processed by the body researchers will compare drug spl84 to a placebo (a look-alike substance that contains no drug) to see if drug spl84 is safe and if it works to treat cf. participants will: take drug spl84 or a placebo by inhalation every week for 9 weeks months visit the clinic approximately 14 times over 17.5 weeks for checkups and tests


Eligibility criteria:
inclusion criteria: * diagnosis of cf and two cf causing mutations; 3849+10 kb c-\>t mutation on one allele in the cf transmembrane conductance regulator (cftr) gene (homozygote or compound heterozygote). source documentation from a certified genetic laboratory is required. * body mass index (bmi) of ≥ 17 kg/m2. * fev1 40-90% predicted at screening. * non-smokers or vapers for at least 180 days (6 months) prior to screening, per participant report. exclusion criteria: * use of kalydeco, orkambi, symdeko/symkevi or trikafta/kaftrio within 30 days of first dose with study intervention. * use of any investigational drug (other than spl84) or device within 30 days of first dose with study intervention. * use of systemic steroids over 3 consecutive months in the last 6 months prior to screening, or use of systemic steroids in the last month prior to screening. use of inhaled steroids above 1 mg. * use of cf medications, e.g. inhaled antibiotics, dornase alfa (pulmozyme), hypertonic saline and physiotherapy should be on stable regimen for the period 28 days prior to screening; those participants taking inhaled antibiotics for prophylaxis must be on a stable regimen of these drugs for at least 90 days prior to first dose with study intervention. * any acute infection including acute upper respiratory or lower respiratory infections, pulmonary exacerbation, changes in therapy for pulmonary disease, or any non cf-related illness which results in the initiation of any new therapy within 14 days prior to first dose with study intervention. * hemoptysis of greater than 30 ml within 90 days prior to day 1, or hospitalization for hemoptysis within 6 months of first dose with study intervention. * liver disease characterized by clinically significant cirrhosis and/or documented portal hypertension. * history of any organ transplantation. * documented coronavirus disease (covid-19) infection within 4 weeks prior to dosing.
surgical treatment of women with deep endometriosis

Conditions: Deep Endometriosis; Surgery

Summary: trend trial is aimed to collect data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis. the main purpose of this project is to gather a large series of cases treated using standardized surgical procedures, allowing a precise evaluation of complications and long-term outcomes.


Eligibility criteria:
inclusion criteria: * age \>/= 18 years; * presence of deep endometriotic nodule(s) infiltrating the tunica muscularis of the sigmoid colon/rectum. exclusion criteria: * age \<18 years: * presence of coexisting inflammatory bowel disease; * patients who have received previous pelvic radiotherapy.
multicenter study of safety and efficacy nivolumab at the fixed dose 40 mg (nivo40) in combination with chemo-immunotherapy for the treatment of newly diagnosed pmbl

Conditions: Primary Mediastinal Lymphoma

Summary: this compares the effects of nivolumab at a fixed dose of 40 mg with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal b-cell lymphoma (pmbcl). immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. treatment for pmbcl involves chemotherapy combined with an immunotherapy called rituximab. chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. rituximab is a monoclonal antibody. it binds to a protein called cd20, which is found on b cells (a type of white blood cell) and some types of cancer cells. this may help the immune system kill cancer cells. giving nivolumab with chemo-immunotherapy may help treat patients with pmbcl.


Eligibility criteria:
inclusion criteria: - patient must have histologically confirmed primary mediastinal b-cell lymphoma (pmbcl) as defined by world health organization (who) criteria age 18-70 years old ejection fraction greater than 50% ecog 0-2 status signed informed consent no severe concurrent illness measurable disease (at least one lesion that can be accurately measured in at least two dimensions on a ct scan, at least \>15 mm in largest diameter exclusion criteria: * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * severe organ failure: creatinine more than 2 norms; alt, ast more than 5 norms; bilirubin more than 1.5 norms * karnofsky index \<30% * pregnancy * somatic or psychiatric disorder making the patient unable to sign an informed consent * active or prior documented autoimmune disease requiring systemic treatment.

Keywords: pet-adapted treatment nivolumab at the fixed dose 40 mg r-da-epoch