Kornimate/medical-research-clean huggingface dataset:
a study to determine the effect of multiple oral doses and regimens of kd025 in healthy male and post-menopausal female subjects

Conditions: Immune System Disorder (Healthy Volunteer)

Summary: the purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple oral doses and regimens of kd025 in healthy male and post-menopausal female participants.

up to approximately 37 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.

Eligibility criteria:
inclusion criteria: * healthy participants between the ages of 18 and 55 years, inclusive. * female who was not of reproductive potential. * able to provide written informed consent prior to the performance of any study specific procedures. * body mass index (bmi) range of 19-30 kilogram per square meter (kg/m2), inclusive. exclusion criteria: * past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pk evaluations. * known sensitivity to rho-associated coiled-coil containing serine/threonine protein kinases (rock2) inhibitor agents or to any of the constituents of the kd025 formulation. the above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
study to determine relationship between serum infliximab and efficacy in luminal crohn's disease patients

Conditions: Crohn's Disease

Summary: to assess the relationship between the change in crohn's disease activity index (cdai) scores and trough serum infliximab concentration in subjects who are scheduled to receive infliximab infusions at an interval of 8 weeks.

this cross sectional study will evaluate a sample of 360 subjects with luminal crohn's disease who are receiving infliximab in 15-20 canadian infusion centres. the sample will be stratified by disease activity \[mild = cdai \<150, moderate/severe = cdai ≥150\] and whether or not subjects are on concomitant immunosuppressive therapy. thus 4 strata will be created consisting of 90 subjects each. consent will be obtained prior to or at visit 1, subjects will retrospectively complete a cdai diary card for the preceding 7 days and blood work will be drawn prior to infliximab infusion. four weeks thereafter at visit 2, subjects will provide an additional blood sample to measure serum infliximab concentrations and crp levels. between visits 1 and 3, subjects will complete daily cdai diary entries. visit 3 will take place at the next scheduled infusion, 8 weeks after visit 1 (+/- 7 days ).

Eligibility criteria:
inclusion criteria: * adult subjects (18 years of age or older at time of consent) * confirmed diagnosis of inflammatory luminal crohn's disease * receive infliximab therapy and have received a minimum of 5 consecutive infusions at prescribed intervals (minimum of 24 weeks and maximum of 156 weeks on infliximab therapy) * plan to receive the next 2 infliximab infusions at 8-weekly intervals (+/- 7 days) * able to provide written consent exclusion criteria: * active draining fistulizing crohn's disease * presence of an ostomy * diagnosis of ulcerative colitis * infliximab dose of \>5mg/kg

Keywords: luminal crohn's disease infliximab
centralized pan-middle east survey on the undertreatment of hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the ldl-c goals according to the ncep atp iii/updated 2004 ncep atp iii guidelines, overall and by country, in the following sub-populations: * primary/secondary prevention patients. * patients with metabolic syndrome (according to ncep iii definition). in addition, the purpose is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the ldl-c goals according to the third joint european task force guidelines/national guidelines, in the survey population and in the following sub-populations: * primary/secondary prevention patients. * patients with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * on lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks. · * subject must sign informed consent exclusion criteria: * subjects who are unwilling or unable to provide informed consent.

Keywords: hypercholesterolemia the study is focusing on the undertreatment of hypercholesterolemia
bathing additives in pediatric atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the current clinical guidelines for management of atopic dermatitis now recommend bleach baths. this requires simply the addition of regular household bleach to twice-weekly baths. at the mayo clinic, dilute acetic acid (vinegar) has been recommended for decades in wet wraps to treat patients hospitalized for their atopic dermatitis. however, this practice has not been widely adopted in the pediatric dermatology community. will the use of dilute acetic acid (vinegar) in twice weekly baths help manage atopic dermatitis in pediatric patients as well as, or better than, the current accepted guidelines?


Eligibility criteria:
inclusion criteria: 1. patients from 6 months to 17 years of age 2. currently residing in us. 3. follow up visits at 1 month, 3 months and 6 months after initiation of treatment in study (figure 1). 4. last follow-up at 1 year in clinic or via written mailed-out survey. 5. diagnosis of atopic dermatitis and 1. have active signs of bacterial skin infection or 2. any documented suspected history of bacterial skin infection (weeping, crusting, and/or pustules on exam), or 3. prescription for oral antibiotics for skin infection in the past 6 months from any provider). or 4. have been prescribed bleach baths as part of an atopic dermatitis skin care regimen. exclusion criteria: 1. superficial skin infection without diagnosis of atopic dermatitis 2. lack of in-clinic follow up assessment at 6 months
evaluation of the effects of pre-operative deflazacort on post-operative pain, edema and trismus

Conditions: Impacted Third Molar Tooth

Summary: removal of impacted lower third molar teeth is one of the most common oral surgical procedures, and these operations often lead to various complications in patients. antibiotics, analgesics and/or anti-inflammatory drugs are prescribed for the treatment of complications encountered. anti-inflammatory is the property of a substance or treatment that reduces inflammation or swelling. anti-inflammatory drugs make up about half of analgesics, remedying pain by reducing inflammation as opposed to opioids, which affect the central nervous system to block pain signaling to the brain. based on this information, in this study, it is aimed to evaluate the effects of deflazacort preoperatively on the postoperative pain, swelling and trismus.


Eligibility criteria:
inclusion criteria: * absence of any systemic disease, * having bilateral impacted mandibular third molar teeth in a similar position * absence of allergy to any of the drugs used in the study, * absence of pregnancy/lactating state, * no history of any medication use during at least 2 week before the operation. exclusion criteria: * not regularly coming to the controls, * not using their medicines regularly, * using any additional medication that may affect the outcome of the study

Keywords: deflazacort pain edema trismus
detection of arv7 in the plasma of men with advanced metastatic castrate resistant prostate cancer (mcrp)

Conditions: Metastatic Castrate Resistant Prostate Cancer

Summary: demonstrate detection of arv7 splice variant transcripts from exosomes in the circulation of mcrpc patients pre and post treatment with selective androgen pathway inhibitors (i.e. abiraterone and enzalutamide)

primary objective -demonstrate detection of arv7 splice variant transcripts from exosomes in the circulation of mcrpc patients pre and post treatment with selective androgen pathway inhibitors (i.e. abiraterone and enzalutamide) secondary and exploratory objectives * correlate arv7 status with psa response (\>/=50% decline in psa level from baseline, maintained for \>/=4 weeks) at any time after the initiation of therapy. * comparison of median progression free survival (pfs) and overall survival (os). * determine additional molecular lesions in exorna and cfdna in mcrpc patients post-treatment with androgen pathway inhibitors. * correlate other ar-variants (non arv7) with clinical outcomes including psa response.

Eligibility criteria:
inclusion criteria: 1. participants must have histologically confirmed diagnosis of adenocarcinoma of the prostate. 2. clinical or radiographic evidence of metastatic disease. 3. planned therapy with either enzalutamide or abiraterone acetate within the coming 6 weeks. 4. evidence of disease progression on or following most recent therapy as evidenced by the following: * radiographic evidence of disease progression as defined by one or more new bone scan lesions. * growth of soft tissue / visceral metastases to greater than one centimeter in longest diameter. * progressive disease despite 'castration levels' of serum testosterone (\<50ng/dl with continued androgen deprivation therapy. 5. at least two of the following high risk features during screening for rapid disease progression: * anemia with a hemoglobin \<12.0 g/dl * elevated alkaline phosphatase * high lactate dehydrogenase (ldh) * presence of visceral metastasis on imaging * presence of clinically significant pain requiring opioid analgesics. * psa doubling time under 3 months on most recent therapy * psa values obtained 2 or more weeks apart, with last value being 2.0ng/ml or higher. 6. ability to understand and willingness to sign a written informed consent document. exclusion criteria: 1. receiving or intend to receive concurrent chemotherapy 2. hepatitis (all types) in patient's medical record 3. hiv documented in patient's medical record 4. history of intercurrent or past medical history or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible.
correlation between depression scores and serum nf-ĸb/nlrp3 axis, biotinidase, and hmgb after treatment with isotretinoin in patients with acne vulgaris

Conditions: Acne Vulgaris

Summary: acne is a chronic inflammatory disease of the pilosebaceous unit resulting from androgen-induced increased sebum production, altered keratinization, inflammation, and bacterial colonization of hair follicles on the face, neck, chest, and back by, cutibacterium acnes. although all age groups can be affected, it is primarily a disease of adolescence. treatment selection is based on disease severity, patient preference, and tolerability. isotretinoin is drug of chioce used for moderate and severe acne. isotretinoin results in a significant reduction in sebum production, influences comedogenesis, lowers surface and ductal c. acnes and has anti-inflammatory properties. biotin deficiency may be caused by insufficient dietary uptake of biotin, drug- vitamin interactions and increased biotin catabolism during pregnancy and in smokers. biotin deficiency can also be precipitated by decreased activities of biotinidase, which plays a central role in the intestinal absorption of biotin


Eligibility criteria:
inclusion criteria: age of 19 to 35 years. body mass index (bmi) of 18.5 to 23 kg/m2. acne vulgaris (global acne scoring more than 18) exclusion criteria: use of oral steroids, oral contraceptives, oral vitamin a derivatives, antibiotics, or herbal medicines that may affect the test results during the last 4 weeks. alcohol drinking within the last week. smoking. pregnancy or lactation. judgement that physical or mental testing is not appropriate for the clinical trial. participation in other clinical trials that may affect this t
olfaction changes in patients undergoing spine surgery

Conditions: Orthopedic Disorder of Spine; Smell Disorder

Summary: this observational prospective study evaluates perioperative olfaction alterations, comprising changes in threshold value, discrimination and identification, which occur in spine patients. the single group is subjected to a preoperative and a postoperative assessment.


Eligibility criteria:
inclusion criteria: * males or females * caucasian race * between 50 and 85 years of age * candidates to spine surgery * acceptance and signing of informed consent exclusion criteria: * past or present cancer * heart failure * kidney failure (iii-iv) * past or present neuropsychiatric disorders * heavy smokers (over/equal 3 cigarettes per day) * smell disorders * rhinitis * allergies to the respiratory system
the swissprepared study

Conditions: HIV Preexposure Prophylaxis

Summary: nested within the swissprepared program, the "swissprepared study" - a large, multicentric, nation-wide cohort study - aims to longitudinally follow individuals asking for prep prescription over a period of 3 years.

the main aims of the study will be: 1. to obtain epidemiological data on individuals asking for prep in switzerland. we are particularly interested in: * determining the extent of prep use in switzerland; * assessing and monitoring the occurrence of sexually transmitted infections (stis) in this particular population. 2. to assess sexual health and sexual well-being in individuals asking for prep using a questionnaire specifically designed for the swissprepared program.

Eligibility criteria:
inclusion criteria: * participation in the swissprepared program * aged ≥16 years * hiv negative exclusion criteria: * individuals unable to follow program procedures (e.g. language barriers, mental or psychiatric disorders)
taste perception, salivary proteins & the oral microbiome

Conditions: Saliva Altered; Taste, Altered

Summary: genetic differences in taste are believed to play an important role in food selection, especially for strong-tasting foods and beverages. the overall goal of this project is to better understand how genes that control food preferences differ among people and whether saliva composition and oral health are related to these differences. this study examines the effects of a daily cranberry extract oral rinse on salivary protein responses and the oral microbiome (as a proxy measure of oral health). the study will be conducted in healthy adults who are presumably at high-risk (non-tasters of prop; homozygous recessive for tas2r38 gene) or low-risk (super-taster of prop; homozygous dominant for tas2r38 gene) of oral disease. the specific aims are to determine if the use of cranberry polyphenol extract rinse will: 1. alter the oral microbial profile 2. induce changes in the salivary protein response 3. be associated with changes in taste and flavor perception participants will be screened for good overall and oral health (see inclusion/exclusion criteria below). each subject's period of participation will be 2 weeks. days 1-3 of the study is a run-in period. subjects rinse with spring water 2-times/day (after brushing their teeth in the morning and evening). during days 4-14, subjects will rinse in a similar manner with a solution of cranberry-derived polyphenol extract (cpe) in spring water. saliva will be collected from subjects in a brief session (10 min) on days 3 and day 14. saliva samples will be analyzed for salivary proteins and microbial profile analysis. the purpose of this analysis is to measure the relative ratios of beneficial vs. disease-causing microbes in the mouth using 16s rna sequencing. on each of the testing days, subjects will also evaluate food samples for standard taste and flavor attributes.


Eligibility criteria:
inclusion criteria: * prop insensitive individuals (prop non-tasters; homozygous recessive for tas2r38 gene) * prop high-sensitive individuals (prop super-tasters; homozygous dominant for tas2r38 gene) * overall healthy; good oral health and hygiene routine * current on a routine checkup by a oral/dental health professional * recently underwent dental/cleaning by a oral/dental health professional * no ongoing oral health problems * agree to use intervention material as prescribed * agree to refrain from using any other oral rinse material during the term of the study exclusion criteria: * prop medium-taster individuals (heterozygous for tas2r38 gene) * taste or smell dysfunction * pregnant or nursing * oral piercings * smoking * use of medications other than birth control

Keywords: oral microbiome
non-carious cervical lesions and treatments

Conditions: Tooth Sensitivity

Summary: this study will compare clinically the efficacy, time to action and duration of different treatments for patients with non-carious cervical lesions (nccls) that caused dentin hypersensitivity (dh).

this study will compare clinically the efficacy, time to action and duration of different treatments for patients with non-carious cervical lesions (nccls) that caused dentin hypersensitivity (dh). casuistic and methods: 60 participants with nccls and positive for dh will be enrolled in the study to receive randomly the followed treatments: la= 780 nm and 70mw gaalas laser/ 4 sessions; lap= placebo laser/ four sessions; rgi= clinprotm xt varnish/ in-office single session; rx= adhesive relyxtm arc/ in-office single session; de= stannous fluoride dentifrice/30-days-home-use; de-p= placebo dentifrice/30-days-home-use. pain from dh is measured with visual analogue scale (vas), pre-treatment and in accordance with each treatment, immediately after the end of the treatment (s1); one and two weeks (1s and 2s) and one and two months (1m and 2m) after the end of the treatments. strategies of treatments are compared each other in each period of evaluation and along time with pre-treatments values of pain, using kruskall-wallis and friedman test (p\<0.05).

Eligibility criteria:
inclusion criteria: - (a) male or female between 18 to 60 years old; (b) good general (no diseases that could interfere in the results) and oral health (no alterations in hard or soft tissues); (c) a minimum of 24 permanent teeth; (d) presence of non-carious cervical lesion; and (e) compliment of cervical dentin hypersensitivity exclusion criteria: -(a) chronic analgesic or anti-inflammatory therapy; (b) orthodontic treatment or dental prosthesis; (c) desensitization therapy in the preceding 3 months; (d) alimentary disorder or acid diet; and (e) pregnant or lactating women.

Keywords: non-carious cervical lesions dentin hypersensitivity
a multicenter national prospective study of pregnancy and neonatal outcomes in women with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: a multicenter national prospective study of pregnancy and neonatal outcomes in women with inflammatory bowel disease study is being conducted at the university of california san francisco and 30 other sites around the united states who are part of the ccfa clinical alliance. the aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with ibd up to 18 years from birth.

all pregnant women with ibd diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.

Eligibility criteria:
inclusion criteria: * female patients with confirmed ibd diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy exclusion criteria: * pregnant female patients younger than 18 years of age * confirmed multiple gestation

Keywords: pregnant ibd patients
vascular dysfunction and antiangiogenic therapy

Conditions: Solid Tumor; Tumor Angiogenesis; Endothelial Dysfunction; CML (Chronic Myelogenous Leukemia)

Summary: project is a pilot prospective, longitudinal, before-after, open label multicentric study.

antiangiogenic drugs and tyrosine kinase inhibitor (tki) represent a new therapeutic issue in the treatment of several neoplasic tumors (colon, kidney, breast, lung, skin) and hemopathy. antiangiogenic drugs acts through neutralization of the activity (e.g. bevacizumab) or the inhibition of post-receptor tyrosine kinase pathways (e.g. sunatinib, sorafenib), leading to a reduction and inhibition of the tumoral tissular neovascularization. due to the ubiquitous role of and the systemic administration of the antiangiogenic drugs, almost all of them are responsible for several side effects, many involving the cardiovascular system (e.g. arterial hypertension, cardiomyopathies, proteinuria, bleedings,...) and leading to a reduction of the doses or withdrawal of the treatment. to date, the mechanism and the impact of these cardiovascular effects is not well understood involving structural (i.e. capillary rarefaction) and functional vascular dysfunction (i.e. vasomotor dysfunction, stiffening).

Eligibility criteria:
inclusion criteria: * men and women \> 18 years old treated for a solid tumor (kidney, pancreas, breast, lungs, skin) with line antiangiogneic therapy and hemopathy * antiangiogneic therapy can be: bevacizumab, anti- (e.g. sunitinib, sorafenib), proteinate kinases inhibitor (e.g.temsirolimus ) or everolimus or any new allowed therapy with expected antiangiogenic properties and tyrosine kinase inhibitor. * expected life span \> 6 months * clinical state allowing investigations * a blood glucose and lipid tests within the last 3 months exclusion criteria: * informed consent not obtained * patients presenting a clinical state which does not allow for the performance of the vascular investigations (agitation, cutaneous wound, major asthenia, acute dyspnoea, cadiac arhythmia) * pregnant women * patients \> 18 yrs old protected by the french law * patients without national health insurance * patients included in another biomedical study (this criteria is relative to the other studies)

Keywords: antiangiogenic cancer vascular biomarker tyrosine kinase inhibitor
observational study of follow-up of hospitalized patients diagnosed with covid-19 to evaluate the effectiveness of the drug treatment used to treat this disease. covid-19 registry

Conditions: SARS-CoV-2

Summary: the infection caused by covid19 worldwide makes it necessary to monitor drugs administered for the treatment of patients hospitalized with sars-cov-2. in order to know more about the efficacy and safety of the treatments used, researchers from the cantabrian health service have developed an observational study, in the form of an ambispective registry, in which clinical data from patients treated with the different drugs currently recommended by the spanish agency of medicines and health products (samhp) and the ministry of health, or others that may arise, are collected and analyzed. although the conduct of clinical trials is a priority at this time, we cannot lose the clinical experience that is currently being generated, which may allow us to improve the therapeutic strategies for future patients.


Eligibility criteria:
inclusion criteria: * patients of any age and gender, including minors and pregnant women. * hospital admission with diagnosis of covid-19 according to clinical and microbiological criteria established by the health authorities and clinical practice (these may be modified based on the "technical document. clinical management of covid-19: hospital care" of the ministry of health). * patients receiving any specific treatment for covid-19 disease (according to the "technical document. clinical management of covid-19: medical treatment" of the ministry of health, and "available treatments for the management of respiratory infection by sars-cov-2" of the aemps). * patients admitted but not receiving specific treatment for covid-19 disease exclusion criteria: * patients who do not wish to give informed consent once requested.

Keywords: covid19 icu