Kornimate/medical-research-clean huggingface dataset:
investigation of the anti-cancer activity of artichoke extract in an asbestos-exposed population

Conditions: Asbestos Exposure

Summary: this is a single-arm phase ii trial to assess the biological activity (in a sub-cohort using a simon two-stage phase ii design) and toxicity of artichoke whole phytocomplex concentrate (wpc). the objective of the study is to explore the potential for a non-toxic phytocomplex extract from the artichoke plant as a chemoprevention agent.

in individuals exposed to asbestos and affected with asbestosis or asbestos-related benign pleural disease, and therefore at increased risk of mesothelioma, the investigators will evaluate whether the treatment with the commercially-available artichoke whole phytocomplex concentrate (artichoke wpc) for 90 days will decrease mesothelin serum levels. although the investigators have general information on toxicity in humans, the investigators will monitor and assess the potential toxicity of artichoke wpc in this patient population. in addition to mesothelin, the investigators plan to evaluate the effects of artichoke wpc on serum micrornas (mirnas). the use of mirnas as minimally-invasive biomarkers has opened new opportunities for the diagnosis of cancer. a number of studies have addressed the potential association of disregulated mirna profiling and benign asbestos-related disease and mesothelioma. thus, the investigators will evaluate serum mirna profiling before and after treatment with artichoke wpc.

Eligibility criteria:
inclusion criteria: 1. asbestosis (defined as diffuse lung scarring based on increased profusion of interstitial fibrosis) 2. benign pleural disease (defined as thickening or fibrotic plaques on pleural surfaces of the lung bilaterally) exclusion criteria: 1. prior systemic chemotherapy, radiation therapy or both. 2. a current or previous history of primary malignancy. 3. known allergy to artichoke. 4. known bile duct obstruction. 5. known pregnancy or lactating women. 6. known psychiatric illness/social situations that would limit study compliance. 7. receiving any other investigational agents. 8. inability to understand or unable to provide written informed consent.

Keywords: prevention non-malignant asbestos-related disease benign pleural disease asbestosis
coronary artery disease (cad) in women marathon runners

Conditions: Coronary Artery Disease

Summary: the aim of this study is to determine the effects of extreme fitness in women. the incidence of coronary artery disease observed via multislice computed tomography (msct) angiogram will be compared with age and risk-matched controls from both sedentary and fitness activity groups who have never been significant runners. life style, training volume and risk factors will be assessed.

single-center, non-randomized, prospective, observational study. the study population will be up to 100 female athletes who are competitive long distance runners, and have been so for a minimum of 10 years. multi-slice computed tomography (msct) will be used to characterize the amount, severity and type of atherosclerotic lesions. mscta will be performed per usual practice using a minimum x-ray dose protocol. the study will determine whether moderate to high intensity, long term athletic training and competition is associated with enhanced coronary artery disease in women. each participant will complete a life-style, training volume and risk factor questionnaire. these participants will be compared to an age, gender and risk factor matched cohort.

Eligibility criteria:
inclusion criteria: * female athletes who have run marathons competitively for a minimum of 10 years. * age \> 40 years old * agree to participate and sign an informed consent form exclusion criteria: * allergy to x-ray contrast * creatinine ≥ 2.0 * pregnant female * has run a marathon within the past 2 weeks

Keywords: mscta marathon runners
effectiveness and safety of dabrafenib in combination with trametinib as adjuvant treatment for chinese patients with stage iii braf v600 mutation-positive melanoma after complete resection

Conditions: Melanoma

Summary: this is a prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for chinese patients with stage iii braf v600 mutation positive melanoma after complete resection.

the study will consist of a treatment phase and follow-up phase. the treatment period is 12 months. discontinuation of study treatment may occur earlier than 12 months for disease recurrence, death, unacceptable toxicity or withdrawal of consent. patients will be followed for disease recurrence every 6 months and up to 24 months after the end of treatment (eot)

Eligibility criteria:
inclusion criteria: patient(s) must meet all of the following criteria to be eligible for inclusion: 1. ≥18 years old of age at the time of informed consent and of chinese descent 2. signed written informed consent 3. going to receive commercial dabrafenib and trametinib according to approved label 4. completely resected histologically confirmed stage iii braf v600 mutation positive cutaneous or mucosal melanoma as defined by the following staging systems: * for stage iii cutaneous melanoma: as per american joint committee on cancer (ajcc) 8th edition for melanoma * for stage iii mucosal melanoma of the head and neck origin: as per ajcc 8th edition for mucosal melanoma of the head and neck * for stage iii mucosal melanoma of anal canal, rectum and genital track origin: as per chinese guidelines on the diagnosis and treatment of melanoma 2019 edition 5. must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment 6. recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains) 7. eastern cooperative oncology group (ecog) performance status of 0-1 exclusion criteria: patient will be excluded from this study if he/she meets any of the following criteria: 1. known ocular melanoma 2. patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before icf signature) 3. patient is not able to comply with the planned study procedures 4. taken an investigational drug within 28 days prior to enrolment 5. history of another malignancy (including melanoma) or a concurrent malignancy, except malignancies that were treated curatively and have not recurred within 2 years prior to treatment.

Keywords: braf v600 mutation-positive melanoma cutaneous or mucosal melanoma china dabrafenib trametinib
development,validity and reliability of a caregiver version of the breathlessness beliefs questionnaire

Conditions: Cystic Fibrosis; Parents

Summary: the goal of this methodological study is to determine the reliability and validity of the the breathlessness beliefs questionnaire caregiver version (bbq-c) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis.

cystic fibrosis (cf) is an inherited disease characterized by pulmonary involvement. children with cf may have obstructive lung disease and related dyspnea, which may progress to respiratory failure and mortality. dyspnea may lead to activity limitation. parents who take care of children with cf may be protective of their children's social environment for some reasons such as the risk of infection. the breathlessness beliefs questionnaire (bbq) is a turkish validated scale developed to assess dysfunctional beliefs about dyspnea. based on the idea that parents may develop dysfunctional dyspnea belief behavior in their children with cf, the aim of this study was to develop a caregiver version of the bbq (the breathlessness beliefs questionnaire caregiver version-bbq-c) and to investigate the validity and reliability of the scale in assessing dysfunctional dyspnea beliefs in parents of children with cf.

Eligibility criteria:
inclusion criteria: * to be between 25-75 years old, * to be literate in turkish, * being a mother, father or other caregiver of a child, * voluntarily agreeing to participate in the study, * be taking care of the child for at least one year exclusion criteria: * having cognitive impairment at a level that prevents cooperation with the scales, * not living in the same household with a child with cystic fibrosis.
implant/abutment module stability of original vs compatible connections

Conditions: Bone Loss, Alveolar; Dental Implant Failure Nos

Summary: together with materials and type of retention, the stability of the implant abutment connection represents one of the key factor for the success rate of an implant supported restoration. the recent diffusion of high quality and easy to use cad/cam systems has contributed to market launch of a number of competing companies that offer the so called "clonical" or "compatible" restorative components. although they are claimed to be identical, the original abutments are supposed to present maximum accuracy and consequently lower microleakage. the aim of the present randomized controlled trial will be to analyze the implant abutment junction stability comparing implant-supported crowns restored with original components and compatible non-original abutments. the hypothesis is that original components will present significantly better stability than non-original abutments.


Eligibility criteria:
inclusion criteria: * any healthy patient scheduled for an implant-supported restoration will be considered for inclusion in this study, independently of the implant and prosthetic protocols used. exclusion criteria: * general medical contraindications to oral surgery (american society of anesthesiologist, asa, class iii or iv), * patients \<18 years of age, * smoking habit (\>10 cigarettes/day), * sites with acute infection or requiring regenerative procedures, * full mouth plaque score * full mouth bleeding score \>25 %, * pregnant and lactating.
evaluation of the efficacy of transcranial magnetic stimulation on resistant auditory hallucinations in schizophrenia

Conditions: Schizophrenia; Transcranial Magnetic Stimulation; Hallucinations, Verbal Auditory

Summary: this open naturalistic study aims to evaluate the efficacy of rtms in routine practice on auditory resistant hallucinations (ahr) of patients with schizophrenia. to this end, two stimulation methods will be offered to patients: the rtms stimulation method and the ctbs stimulation method.we principally use the ahrs scale to evaluate the effectiveness of rtms on rah in patients with schizophrenia. our main hypothesis is that rtms used under naturalistic conditions, in addition to antipsychotics, would allow a relative improvement of resistant auditory hallucinations assessed by the ahrs scale between baseline and end of treatment in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age * patient diagnosed with schizophrenia according to dsm-v criteria (diagnostic and statistical manual of mental disorder v5, 2013) * presence of auditory hallucinations: resistant auditory hallucinations: resistance to treatment with 2 different well-conducted antipsychotics. * patient agreeing to participate in the study and having signed an informed consent * patient with french language skills * affiliation to a social security system * women of childbearing age must be on contraception and have a negative pregnancy test (βhcg) exclusion criteria: * have a contraindication to mst: intracranial foreign body, unstabilized epilepsy, cochlear implant * presence of an unstabilized medical condition * pregnant woman (women of childbearing age without effective contraception) * current or less than one month old engagement in another research protocol * a person who is subject to a safeguard of justice measure * an adult under curatorship * minor patients with mental health problems * pregnant or breastfeeding women * a person in a social fragility (persons deprived of liberty by a judicial or administrative decision, hospitalized persons) * persons incapable or unable to give consent

Keywords: hallucinations resistant auditory hallucinations schizophrenia tms transcranial magnetic stimulation tbs theta burst stimulation a improvement real-life conditions
the effect of surgically induced weight loss on endocrine function, cardiovascular function and body composition

Conditions: Bariatric Surgery

Summary: this study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. the investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. the investigators believe the most beneficial and safest procedure will be the roux-en-y.

the study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called glucagon like peptide 1 (glp-1), which is released from your gut to maximally stimulate your pancreas. the release of this hormone increases when you eat food and it causes the pancreas to release more insulin than does sugar alone. volunteers will have 22 visits over a two year period. only people having roux-en-y gastric bypass surgery, gastric sleeve surgery, duodenal switch gastric surgery or lap-band/gastric banding surgery may join. seventy volunteers will be recruited to take part in this study.

Eligibility criteria:
inclusion criteria: * male and female volunteers 21-65 years. * bmi \> 40. * preoperative hematocrit level of at least 34% for women and 38% for men. * postoperative hematocrit level of at least 34% for women and 36% for men. exclusion criteria: * volunteers whose hematocrit level does not meet the above criteria. * pregnant and or lactating females.

Keywords: bariatric surgery glucose regulation cardiac function body composition
effect study of montelukast to treat asthma detected by ltd4 bronchial effect study of montelukast to treat asthma detected by ltd4 bronchial provocation test

Conditions: Bronchial Asthma

Summary: to determine whether ltd4-bpt could be an effective indicator for predicting efficacy of anti-leukotriene therapy, allowing objective proofs for the use of ltra among asthmatics in a specific sensitive to leukotriene population of asthma. hypothesis ：monteluakst can better improve pre-challenge fev1 from baseline in leukotriene-sensitive group than leukotriene-insensitive group.


Eligibility criteria:
inclusion criteria: 1. aged 15-60 years, male or female. 2. mild to moderate persistent asthma. 3. mini aqlq score ≤6 or acq score ≥1. 4. giving written informed consent. exclusion criteria: 1. current smoker or quitted smoking ≤12 months. 2. significant allergen exposure. 3. respiratory tract infection within 2 weeks before or during the study. 4. cardiovascular disease. 5. history of malignant disease within the preceding 5 years. 6. and/or concomitant pulmonary disease. 7. pregnant or breast-feed period. 8. use of leukotrienes receptor antagonist within 5 days

Keywords: leukotriene leukotriene receptor antagonist
a study of anticoagulation treatment patterns and outcomes of participants hospitalized with coronavirus disease 2019 (covid-19) in japan

Conditions: COVID-19

Summary: the purpose of this study is to describe demographic and clinical characteristics of participants who are hospitalized due to coronavirus 2019 (covid-19), treatment use for covid-19 and covid-19 symptoms, and composite outcomes of covid-19. this study will also compare composite outcomes between covid-19 participants treated with and without anticoagulant therapy during follow-up period.


Eligibility criteria:
inclusion criteria: • at least one diagnosis code for covid-19 (international classification of diseases (icd)-10: u07.1 or b34.2) during hospitalization exclusion criteria: • none

Keywords: anticoagulant apixaban bms-562247 coronavirus disease 2019 covid-19
a study of vascular endothelial growth factor (vegf) inhibition in patients with unilateral upper extremity lymphedema following treatment for cancer

Conditions: Lymphedema

Summary: the major purpose of this study is to determine if a new drug called pazopanib decreases lymphedema in subjects previously treated for cancer. lymphedema, or swelling of the arm, is a result of damage to the lymphatic vessels in the arm during surgery and/or radiation. the damaged vessels can not adequately drain fluid from the arm, resulting in increased pressure and swelling. pazopanib has not previously been studied as a treatment for lymphedema.

pazopanib inhibits the growth of blood vessels in tumors by inhibiting a protein called vascular endothelial growth factor (commonly called vegf). pazopanib is not currently approved by the us food and drug administration (fda) and therefore considered an experimental medication. high levels of vegf cause blood vessels to leak fluid, increasing the pressure in tumors similar to the increased pressure in lymphedema. previous studies have found that treatment with pazopanib decreases the fluid pressure in tumors. that is why we think pazopanib might be an effective treatment for lymphedema.

Eligibility criteria:
inclusion criteria: * have unilateral lymphedema of the ipsilateral arm attributed to prior surgical treatment or radiation therapy for cancer that is severe enough to warrant therapy in the opinion of the patient and treating physician. * all patients must have greater than a 3 cm total difference in arm circumference between the affected and unaffected arm measured at five defined points (see protocol). * be at least 18 years of age * have adequate organ function as specified in the protocol. * agree to use effective contraceptive methods during the course of the study if the patient has child-producing potential * have an ecog performance status of 0 or 1 exclusion criteria: * pregnant, lactating, or unwilling to use appropriate birth control * active infection * patients may not have clinically significant cardiovascular disease including myocardial infarction within 6 months prior to initiation of therapy, unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure, grade ii or greater peripheral vascular disease, uncontrolled hypertension defined as sbp\>160 or dbp\>90. patients may not have any prior history of cerebrovascular disease including tia or stroke. * locally recurrent or metastatic disease * concurrent therapeutic anticoagulation or any history of dvt or pe. * major surgery within 4 weeks of starting protocol therapy (non-operative biopsy or placement of a vascular access device is not considered major surgery) * radiation therapy or chemotherapy within the past 6 weeks or currently undergoing radiation therapy or chemotherapy (concurrent adjuvant hormonal therapy is allowed.) * altered the physical therapy regimen within the past month * indwelling venous device in the ipsilateral arm * bilateral lymphedema * concomitant requirement for medication classified as substrates for the cyp450 enzymes and listed as prohibited in the protocol.
knee arthroscopy cohort southern denmark (kacs)

Conditions: Meniscus Injury; Knee Osteoarthritis

Summary: purpose: to investigate the natural time course of patient-reported outcomes after meniscus surgery and identify factors associated with good and bad outcome after surgery.


Eligibility criteria:
inclusion criteria: * assigned for arthroscopy on suspicion of a medial and/or lateral meniscus tear. * age \>18 years at time of recruitment * having an email address * able to read and understand danish exclusion criteria: * patients who will or have previously undergone surgical reconstruction of the anterior or posterior cruciate ligament (acl or pcl) in either knee * fracture to the lower extremities (i.e. hip, leg or foot) in either leg within the last 6 months prior to recruitment * not mentally able to reply to the questionnaire
ulonivirine (mk-8507) in participants with mild or moderate hepatic impairment (mk-8507-014)

Conditions: Hepatic Insufficiency

Summary: the purpose of this study is to evaluate pharmacokinetics (pk) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (hi). it is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (auc0-∞) in participants with mild or moderate hi is similar to that of healthy control participants.


Eligibility criteria:
inclusion criteria: mild and moderate hi (panels a and b): * has a diagnosis of chronic (\>6 months), stable hi with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) healthy controls (panel c): * is in good health all participants (panels a to c): * has a body mass index (bmi) ≥18.5 and ≤40 kg/m\^2, inclusive * if male, uses contraception in accordance with local regulations * if female, is not pregnant or breastfeeding and one of the following applies: 1) is not a woman of childbearing potential (wocbp), or 2) is a wocbp and is abstinent/uses acceptable contraception, has a negative highly sensitive pregnancy test within 24 hours of receiving study intervention, and provides medical/menstrual/recent sexual history for review by the investigator exclusion criteria: mild and moderate hi (panels a and b): * has a history of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study * is not in sufficient health * is institutionalized/mentally or legally incapacitated * is positive for human immunodeficiency virus (hiv)-1 or hiv-2 * has received antiviral and/or immune modulating therapy for hepatitis b virus (hbv) or hepatitis c virus (hcv) within 90 days prior to study start * is taking medication for a chronic condition and has not been on a stable regimen for ≥ 1 month healthy controls (panel c): * has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * is mentally or legally incapacitated * is positive for hepatitis b virus surface antigen (hbsag), hepatitis c antibodies, hiv-1, or hiv-2 * is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to first dose of study drug all participants (panel a to c): * has a history of cancer (malignancy) * has a history of significant multiple and/or severe allergies * has known hypersensitivity to the active substance or any of the excipients of the study drug * has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to screening