Kornimate/medical-research-clean huggingface dataset:
an exploratory study of tmc207 in japanese participants with pulmonary multi-drug resistant tuberculosis (mdr-tb)

Conditions: Tuberculosis, Multidrug-Resistant

Summary: the purpose of this study is to explore safety and efficacy of tmc207 administered as part of a multi-drug regimen for 24 to 48-week treatment in japanese participants with pulmonary multi-drug resistant tuberculosis (mdr-tb), and to evaluate pharmacokinetics (pk) of tmc207 and its primary metabolite m2.

this is an open-label (everyone know the study intervention), single-arm, multicenter trial to explore safety, efficacy and pk of tmc207 in japanese participants with pulmonary mdr-tb. the participants will receive tmc207 for 24 weeks in combination with individualized br drugs selected by the investigator on day -1. participants will primarily be assessed for sputum culture conversion at week 24. safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * must have confirmed pulmonary multi-drug resistant tuberculosis (mdr-tb) infection, which is defined as infection by a strain of m. tuberculosis resistant to both rifampicin and isoniazid (rfp and inh) by previous screening from a tb treatment * must have confirmed positive results for acid-fast bacilli (afb) on direct smear examination of expectorated sputum specimen (more than \[\>\] 1+ smear-positive) during the screening phase or sputum culture positive for m. tuberculosis within the preceding 3 months * a women must not be of childbearing potential: postmenopausal or permanently sterilized or otherwise be incapable of pregnancy, or if childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods and a man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control * must be willing and able to adhere to the prohibitions and restrictions specified in this protocol * must sign an informed consent form (icf) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * has any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency that would make implementation of the protocol or interpretation of the study results difficult or otherwise make the subject a poor candidate for a clinical study * has complicated or severe extra-pulmonary manifestations of tb, including central nervous system infection * participants with significant cardiac arrhythmia requiring medication * participants with the abnormal electrocardiogram (ecg) parameters as defined in protocol * has human immuno deficiency virus (hiv) antibody positive during the screening phase

Keywords: pulmonary multi-drug resistant tuberculosis (mdr-tb) tmc207 bedaquiline
problem management plus mindfulness-informed legal education for addressing gender-based violence and improving parenting

Conditions: Depression, Anxiety; Trauma; Anxiety; Parenting Intervention; Woman Abuse; Child Behaviour; Stress

Summary: gender-based violence and, more specifically, domestic violence is a prevalent problem globally and in nigeria. its effect significantly impacts women and also the wellbeing of their families. limited access to support has posed a constraint in effectively addressing the issues suffered by affected victims in nigeria. in addition, gender-based violence could affect parenting due to factors such as anxiety, trauma, depression, poor social support, limited awareness of legal channels for complaint and harsh parenting to children. the implication is that it could not only have a negative impact on the affected victim but also on their parenting styles or caring responsibilities, which could be detrimental to the child development, wellbeing and the potential subsequent resort to criminal behaviours. in essence, the current study aims to test the feasibility and acceptability of a novel cross disciplinary intervention titled, problem management plus mindfulness-informed legal education (pm+mile) for addressing gender-based violence and improving parenting in nigeria in comparison to the waitlist control group for the purposes of improving social cohesion, legal awareness, wellbeing and reducing depression, including trauma and anxiety as a result of experiencing gender-based violence, in nigeria.


Eligibility criteria:
inclusion criteria: * 18 years and above * female with child(ren) or with caring responsibilities for child(ren). * able to provide full consent for their participation. * a resident of the study areas (delta, jos, lagos state, etc.) exclusion criteria: * less than 18 years * unable to consent * currently undergoing severe mental healthtreatment * unable to speak the english language fl uently

Keywords: depression stress anxiety trauma gender-based violence parenting domestic violence women
efficacy study of temperature controlled laminar airflow (tla)-treatment in perennial allergic asthma

Conditions: Asthma

Summary: the purpose of this study is to determine whether nocturnal environmental control with temperature controlled laminar airflow (tla) is effective as add on treatment in patients with perennial allergic asthma.

exposure to inhaled allergens is a pathogenetic factor in allergic asthma. however, physical, chemical and combined methods aiming to reduce airborne allergen levels have shown little or no effect in reducing asthma symptoms in people who are sensitive to perennial allergens.aims and objectives: this study aims to investigate treatment with temperature controled laminar airflow (tla) with a very low particle concentration directed to the breathing zone in subjects with allergic asthma during night sleep. the hypothesis is that the decreased allergen exposure during the night will have an effect on quality of life and bronchial inflammation. method: this is a multicentre, double blind, randomized 52 week parallel trial comparing active tla treatment with placebo. for ethical reasons the randomization is 2 to 1 for active and placebo treatment, respectively. a 2 weeks run-in period is inserted between inclusion and randomization, during which the patient shall get familiar with the use of the patient asthma diary and to adhere to the requirements of the study participation. first 12 weeks an unchanged maintenance medication will be kept and week 13-52 medication will be modified to obtain asthma control according to international guidelines (gina). after inclusion, run-in, randomization and baseline measurements active/placebo treatment with aa will be implemented over 52 weeks.

Eligibility criteria:
inclusion criteria: * consent to participate voluntarily. willing and able to comply with the study specific procedures. signed informed consent prior to any study procedure. * perennial allergic asthma, male and female, age 7 through 70 years, at time of randomization. * a miniaqlq/paqlq score of ≤ 5.5. * sensitive to pet allergen and/or house dust mites as demonstrated by changed to rast 0.70 or positive skin prick test (wheal reaction similar to histamine control). * daily maintenance dose of at least ics ≥200µg/day of budesonide or ≥100µg/day of fluticasone since at least 6 months * features of partly controlled asthma according to gina exclusion criteria: * current smoker (non-smoker is defined as abstinent since \> 1 year). children: parents'indoor smoking. * participation in another allergen avoidance program * participation in drug trial the preceding 3 months * multiple chemical sensitivity (e.g. paint, petrol, perfumes) as primary etiology * allergen injection or sublingual treatment in the preceding 2 years * ics ≥1200µg/day of budesonide or 1000µg/day of fluticasone * significant cardiovascular disease * participation in the present trial of a family member within the same household other protocol-defined exclusion criteria may apply

Keywords: asthma temperature controlled laminar airflow tla perennial allergy quality of life environmental control
biomarkers of chronic obstructive pulmonary disease

Conditions: COPD; Asthma-COPD Overlap Syndrome; Asthma

Summary: there are few studies about immunological explorations in copd. because of the complications of lung biopsies, analyses are generally made on blood samples instead of lung tissue. no study tried to classify copd vs asthma vs acos. the investigators wondered if there were differences in biomarkers between these groups. the investigators decided to open a pilot-study among copd patients followed in amiens-university hospital. each patient will be examined and a blood-test will be performed.


Eligibility criteria:
inclusion criteria: * bpco patients * acos patients * asthmatic patient without bpco exclusion criteria: * infection * exacerbation * immunosuppressive treatment * immunosuppressive disease

Keywords: copd asthma-copd overlap syndrome asthma
grip strength or pinch strength in lateral epicondylitis

Conditions: Lateral Epicondylitis

Summary: grip strength can be decreased in lateral epicondylitis. pinch strength is also affected in people suffering from lateral epicondylitis. in this study, participants will be evaluated using a hydraulic dynamometer, a pinch meter and we will evaluate pain, disability and quality of life.

newly diagnosed patients with lateral epicondylitis and healthy controls will be included in the study with an allocation ratio of 2:1. using a hydraulic dynamometer grip strength will be evaluated three times, one minute between each measurement. then palmar pinch, key pinch and tip pinch measurements will be evaluated for three times each. for each measurement, the participants will rest one minute between repetitive measurements, and five minutes between each parameters. the order of measurements will be randomized for each participants to avoid bias. then the participants will be evaluated using different scales for pain, disability and quality of life.

Eligibility criteria:
inclusion criteria: * pain in elbow for at least two weeks exclusion criteria: * nonsteroidal antiinflammatory drug usage during last week. * rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, etc.) * malignancy * extracorporeal shock wave therapy in last six months * lateral epicondylitis injection in last six months or any treatment. * lateral epicondylitis brace usage

Keywords: disability evaluation hand strength quality of life pain pinch strength tennis elbow
fluorine f 18 feqa in patients with stage iii or stage iv non-small cell lung cancer and in healthy participants

Conditions: Lung Cancer

Summary: rationale: fluorine f 18 feqa may be an effective radioactive drug to use with positron emission tomography (pet) scans. purpose: this clinical trial is studying the use of fluorine f 18 feqa in patients with stage iii or stage iv non-small cell lung cancer and in healthy participants.

objectives: * determine the biodistribution of fluorine f 18 feqa in patients with stage iii or iv non-small cell lung cancer (nsclc) and in healthy participants. * determine whether fluorine f 18 feqa can be used as an imaging agent with positron emission tomography in patients with stage iii or iv nsclc. outline: this is a pilot study. patients and healthy participants receive fluorine f 18 feqa iv and then undergo whole-body dynamic scans comprising positron emission tomography. blood is collected during and after imaging to measure radioactivity. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * must meet 1 of the following criteria: * diagnosis of non-small cell lung cancer by ct scan, bone scan, or biopsy * stage iii or iv disease * clinically assessed with * healthy participant exclusion criteria:

Keywords: stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
health effects of salmon fishmeal in humans

Conditions: Impaired Glucose Tolerance

Summary: diabetes contributes significantly to the burden of disease in norway and cardiovascular disease is the main cause of mortality. both lean and fatty fish are shown to have beneficial health effects. in addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin d, vitamin b12, iodine, selenium and more unspecified components such as bioactive peptides. with the expected growth in the aquaculture sector, more protein-rich by-products will become available. the overall aim of this project is to investigate the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers. we will include subjects with impaired glucose tolerance to a randomized controlled parallel study. the subjects will receive capsules with fishmeal or placebo.


Eligibility criteria:
inclusion criteria: * fasting plasma glucose ≥ 5.6 mmol/l or * plasma glucose ≥ 6.5 mmol/l 2h after an ogtt or * hba1c ≥ 5.8 % exclusion criteria: * diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after ogtt or hba1c ≥ 6.5 %) * high fish intake (\> 450 gram/week) or fish allergy * age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmhg, \> 40-70: ≥ 170/100 mmhg and ≤ 40 år: ≥ 160/100 mmhg) * use of prescription medicines related to diabetes, inflammation, systemic use of corticosteroids. * non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs, drugs affecting appetite, dietary supplements (including n-3) * high intake of protein supplements powder * pregnancy * planning pregnancy or changes in body weight
a study to evaluate the clinical pharmacology and safety of c1-esterase inhibitor administered by the subcutaneous route

Conditions: Hereditary Angioedema Types I and II

Summary: the aim of the study is to assess what happens to c1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. three different dosing regimens of c1-esterase inhibitor will be assessed. each subject will be assigned to receive 2 of the 3 dosing regimens, each for 4 weeks. the activity and concentration of c1-esterase inhibitor in the blood will be measured during each 4-week period. the study will also examine how well c1-esterase inhibitor administered under the skin is tolerated by the subjects.


Eligibility criteria:
inclusion criteria: * males or females aged 18 years or older. * laboratory-confirmed hereditary angioedema type i or ii. * less than two hereditary angioedema attacks per month in the last three months. * body weight of 50.0 kg to 110.0 kg. exclusion criteria: * receiving prophylactic c1-esterase inhibitor therapy. * received c1-esterase inhibitor, ecallantide, icatibant or any blood products for the prevention or treatment of hereditary angioedema within 7 days before the screening visit. * intends to use recombinant c1-esterase inhibitor or fresh frozen plasma for the acute treatment of hereditary angioedema during the study. * received androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 30 days before the screening visit. * female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing products) within 3 months prior to the screening visit. * known or suspected hypersensitivity to the study product, or to any excipients of the study product. * pregnancy or lactation.
effect of benadryl sedation during ercp or eus

Conditions: Gallbladder Disease; Gallstones; Pancreatitis; Abdominal Pain; Jaundice

Summary: the purpose of the study is to determine if adding benadryl improves sedation for patients scheduled to undergo ercp or eus procedures.

the usual sedatives used for endoscopy are meperidine (demerol) and midazolam (versed). benadryl (diphenhydramine) is often used in addition to these medications in an effort to improve sedation. there is little published information regarding the use of diphenhydramine in conscious sedation. it is recognized that certain patients have features that predict difficult sedation such as prescription sedative use or heavy alcohol use. in addition, prolonged procedures like ercp and eus require higher doses of sedatives. diphenhydramine may improve the quality of sedation in patients undergoing endoscopic retrograde cholangio-pancreatography (ercp) or endoscopic ultrasound (eus) procedures. you are being asked to participate because you are already scheduled to undergo one of these procedures.

Eligibility criteria:
inclusion criteria: * patients between 18 and 65 years of age who present for outpatient ercp or eus at strong memorial hospital endoscopy center will be included exclusion criteria: * allergy to diphenhydramine, narrow angle glaucoma, or inability to consent

Keywords: ercp eus
control and intervention programme on alzheimer's disease risk factors

Conditions: Alzheimer's Disease

Summary: recent epidemiologic studies are identifying a number of modifiable risk and protective factors that may influence in the incidence of alzheimer's disease (ad). therefore, the combination of an early detection of individuals at risk together with interventional studies targeted to the control of modifiable risk factors makes primary prevention programmes to become a new and real therapeutic strategy. in this scenario, the investigators have designed the alfalife study, a programme of control and intervention on the modifiable ad risk factors. throughout this study, participants will be given a number of healthy lifestyle guidelines that are personalised depending on their specific risk profile. these guidelines refer to smoking and dietary habits and physical, cognitive and social activity. the investigators hypothesis is that the follow-up of these guidelines will favor a change of participants' lifestyle habits towards healthier ones. in addition, the investigators hypothesise that changes in these lifestyle habits will have an effect on objective physiological measures (such as blood pressure and cholesterol levels).


Eligibility criteria:
inclusion criteria: * participants in the alfa study (nct01835717) * computer literacy * accept study's tests and procedures * signature of informed consent exclusion criteria: * cognitive impairment assessed by clinical criteria that, according to the investigator's evaluation could interfere with the study's follow-up. * anxiety or depression assessed by clinical criteria that, according to the investigator's evaluation could interfere with the study's follow-up. * visual and/or hearing impairment severe enough to impede tests realization. * major psychiatric or neurological disorder or other diseases that according to the investigator's evaluation could interfere with the study's follow-up. * antecedents of infarction, ischemic heart disease, stroke, peripheral vascular disease, stent or aneurysm clip

Keywords: primary prevention
hla-b35 alleles and aids

Conditions: HIV-1; AIDS

Summary: this study will identify variations in the genome of the human immunodeficiency virus (hiv) early after infection and following the development of aids. it will analyze genetic material and clinical data from hiv-positive individuals to assess differences in viral epitopes between patients with two different gene alleles (alternative forms of a gene)-b\*3501 and b\*3503. (an epitope is a molecular region on the surface of an antigen capable of eliciting an immune response and of combining with the specific antibody produced by such a response.) hiv disease in people with the b\*3503 allele progresses significantly faster than it does in people with the b\*3501 allele. this study might provide information that is potentially useful in developing a successful hiv vaccine. blood samples and clinical data for analysis will be obtained from the johns hopkins bloomberg school of public health; the university of pittsburgh; the john h. stroger, jr. hospital of cook county; the howard brown health center; northwestern university; and the university of california at los angeles.

the purpose of this study is to identify variations in the genome of hiv early after infection and following the development of aids to determine the location of escape mutations that might provide information about potential b\*35 epitopes. these data will be useful in explaining the difference in disease progression between individuals possessing b\*35 px alleles and those with b\*35 py alleles. we have previously shown that individuals with b\*35 px alleles progress at a significantly faster rate compared to those with b\*35 py alleles. this study might provide information which is potentially useful in the development of a successful hiv vaccine.

Eligibility criteria:
* inclusion and exclusion criteria: sera and relevant clinical data from properly consented hiv positive seroconverters will be provided to the lgd for analysis. no available subjects will be excluded to maximize power. we will request an accrual ceiling of 100 participants.

Keywords: immunity mutations viral selection disease progression rna
glucosamine and chondroitin in gut in preventing people from inflammation

Conditions: Healthy Subject

Summary: this trial studies glucosamine and chondroitin in preventing inflammation. glucosamine and chondroitin often used as a dietary supplement to promote joint health may have a preventive role in inflammation and cancer. this trial may help identify the bacteria that help process them in the gut.


Eligibility criteria:
inclusion criteria: - from the greater seattle area exclusion criteria: * chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases) * pregnancy or lactation * currently on a weight-loss diet * alcohol intake of greater than 2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine or 90 ml spirits) * current use of prescription or over-the-counter medications other than oral contraceptives and hormone secreting intrauterine device (iud)s, multivitamin pills or infrequent use of aspirin and nonsteroidal anti-inflammatory drugs (nsaids), or use of aspirin or nsaids more than 2 days per week * abnormal renal, liver or metabolic test * inability to swallow pills * known allergy to shellfish * not willing to take pills made from shellfish or animal sources * intention to relocate out of study area within next 2 months * any antibiotic use in the past 6 months