Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy and safety of ppc-06 (tepilamide fumarate)

Conditions: Psoriasis

Summary: this is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of ppc-06 (tepilamide fumarate) extended release in subjects with moderate-to-severe plaque psoriasis.

this is a phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of ppc-06 in subjects with moderate-to-severe plaque psoriasis. study subjects will be enrolled at approximately 75 sites in the united states (us). approximately 400 subjects who meet the study entry criteria will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms: 1. ppc-06 400 mg once daily (qd) 2. ppc-06 400 mg bid 3. ppc-06 600 mg bid 4. placebo bid the maximum study duration for each subject will be approximately 29 weeks.

Eligibility criteria:
inclusion criteria: * generally healthy males or non-pregnant females age ≥18 years at the time of screening (or who have reached the state minimum legal age of consent). * stable, moderate-to-severe plaque psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator or as reported by the subject). * severity of disease meeting all 3 of the following criteria prior to randomization (at the baseline \[day 0\] visit): 1. pasi score of ≥12 2. total body surface area (bsa) affected by plaque psoriasis of ≥10% 3. iga score of \>3 * must be a candidate for phototherapy and/or systemic therapy for psoriasis. exclusion criteria: * subjects with non-plaque psoriasis (ie, predominantly inverse, erythrodermic, predominantly guttate, or pustular psoriasis). * subjects with drug-induced psoriasis or subjects with drug-exacerbated psoriasis that has not resolved within 4 weeks prior to screening. * subjects who have received systemic non-biologic psoriasis therapy or phototherapy (including either oral and topical psoralen and ultraviolet a (puva) light therapy, ultraviolet b, or self-treatment with tanning beds or therapeutic sunbathing) within 4 weeks prior to the baseline visit. * subjects who had topical psoriasis treatment within the previous 2 weeks prior to the baseline visit. * subjects with history of concurrent or recent use of any biologic agent within the following washout periods prior to baseline visit: * etanercept - 35 days * infliximab, adalimumab - 12 weeks * ustekinumab - 24 weeks * any other biologic agent \<5 half-lives prior to the baseline visit * subjects with history of use of any investigational drug within 28 days prior to randomization, or 5 pharmacokinetic/ pharmacodynamic half-lives (whichever is longer).
quality of life in patients post radiofrequency ablation

Conditions: Radiofrequency Catheter Ablation; Quality of Life; Arrhythmia

Summary: radiofrequency ablation is a procedure done in the catheterization laboratory to help correct specific problems that cause the heart to beat faster than it should. quality of life includes the physical as well as the emotional aspects of a patient. doctors have always tried to take care of a medical problem with minimal physical and emotional risk. it is assumed that once the medical problem is fixed, the patient will have an improved quality of life. to know if this assumption is true, the investigators are asking children scheduled for this procedure, along with their family, to answer questions before the ablation, then answer the same questions 5-6 months after the ablation.

when a patient (age 5-18 years) is scheduled for an ablation at children's healthcare of atlanta, the research coordinator contacts the family prior to the procedure and describes the study to them, details the goals, benefits versus risks, and answers any questions they may have. written consent is obtained from the parents. assent is obtained from the child. both the parent and child are given the age appropriate peds ql (tm) pediatric quality of life inventory, version 4.0. the forms are returned to the research coordinator. if the child is ablated, then 5-6 months after the ablation, the same questionnaire is sent to the child and parent. data are entered into a database.

Eligibility criteria:
inclusion criteria: * 5-18 years of age * english is the primary language * scheduled for an ablation at children's healthcare of atlanta * normally structured heart exclusion criteria: * congenital heart defect * english is not the primary language * children with significant neurocognitive deficits as determined by the investigator

Keywords: pediatrics cardiology radiofrequency ablation structurally normal heart
amlodipine valsartan efficacy in hypertensive patients.a real world trial

Conditions: Essential Hypertension

Summary: to determine the efficacy of valsartan/amlodipine 80/5 mg once daily dose is reducing mean sitting systolic blood pressure (mssbp) and mean sitting diastolic blood pressure (msdbp) after 8 weeks of therapy.

avsar in tablet form which contains two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin ii antagonist class of medicines amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin ii by selectively blocking the binding of angiotensin ii to the at1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland international studies are available concerning the single pill combination therapy used in blood pressure reduction. to determine the clinical significance of single pill combination, conducted multi center real life study i.e.; "alert trial" in our local population. through this study, observed the effect of single pill combination on bp reduction and adverse events in health care settings. antihypertensive drugs use in a single pill combination may further enhance bp control by reducing pill burden and improve patient compliance.

Eligibility criteria:
inclusion criteria: * patient whose bp is \>139/89mmhg and on monotherapy with minimum last 30 days * male or female aged (18 years - 70 years) * signed informed consent exclusion criteria: * secondary hypertension * pregnant or lactating mother * hypersensitivity to any active ingredient * peripheral artery disease * hepatic disease or biliary tract obstruction * chronic kidney disease

Keywords: alert, mssbp, msdbp
hemodynamic impact of the administration of paracetamol in patients hospitalized in the intensive resuscitation medicine department [parea]

Conditions: Intensive Care Unit Syndrome

Summary: paracetamol is commonly used in case of pain or fever. few previously clinical studies has highlighted an arterial hypotension linked to intravenous administration of paracetamol. currently, fewer data are available on the link of intravenous administration of paracetamol and effects on arterial tension. the aim of this study is to describe the frequency of occurrence of significative arterial hypotension within one hour following intravenous or per os administration of paracetamol . other factors who can be associated to occurence of significative arterial hypotension will be also observe (for example age, weight, pain, vasopressor dosage or sedative...)


Eligibility criteria:
inclusion criteria: inclusion: * 18 years of age or older * patient with arterial catheter * indication of paracetamol's administration by the patient's attending practitioner. * no opposition to patient or support person participation in the study if the patient is unable to participate exclusioncriteria: * no social security patient * pregnant or nursing patient. * patient with a legal protection measure * hypersensitivity and/or allergy to paracetamol. * contraindication to the use of paracetamol. * patient opposition to health data collection.

Keywords: intensive care unit paracetamol blood pressure
a study to evaluate mk1903 in patients with dyslipidemia (mk1903-004)

Conditions: Dyslipidemia

Summary: this study will evaluate the lipid-modifying effect and tolerability of mk1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.


Eligibility criteria:
inclusion criteria: * participant is not on a statin or other lipid-modifying therapy * low or moderate risk participant * male participants, and female participants not of reproductive potential exclusion criteria: * female participant of reproductive potential * participant is pregnant, breastfeeding, or expecting to conceive during the study * participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer) * participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse * participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study * participant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week * participant is currently experiencing menopausal hot flashes * participant currently engages in vigorous exercise or an aggressive diet regimen * participant is at high risk for heart conditions * participant has type 1 or type 2 diabetes mellitus * participant has poorly controlled cardiac arrhythmias * participant has a history of stroke or other hemorrhage * participant has poorly controlled high blood pressure * participant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids * participant has a disease of the kidney or liver * participant has an ulcer within 3 months of screening * participant is human immunodeficiency virus (hiv) positive * participant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy * participant is taking or has taken an organic anion transporter (oat1/3) inhibitor/substrate within 3 days of screening * participant has taken an anti-obesity medication within 3 months of screening * participant is taking coumarins * participant is taking non-steroidal anti-inflammatory drugs (nsaids) (acetaminophen and cyclooxygenase-2 (cox-2) inhibitors are allowed) * participant is taking more than 100 mg aspirin per day * participant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents
clinical trial to evaluate the model sc9 iol compared to the model li61se iol (bausch & lomb)

Conditions: Cataract

Summary: to evaluate the model sc9 intraocular lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal iol.

subjects will be randomized to one of two groups. group a, (test lens, model sc9) or group b, (control lens, model li61se, bausch and lomb). both groups will be randomized to receive either unilateral or bilateral implantation. no bilateral implantation is allowed in phase 1. (50 subjects). subjects will be followed for 36 months.

Eligibility criteria:
inclusion criteria: * twenty-two years or older at the time of surgery and diagnosed with bilateral cataracts * able to comprehend and sign a statement of informed consent * willing and able to complete all required postoperative visits * calculated lens power within the available range for the study iol's * planned cataract removal by phacoemulsification * potential postoperative visual acuity of bcdva 0.2 logmar (20/32) or better in both eyes * subjects with less than 1.0d of corneal astigmatism * clear intraocular media other than cataract in the study eye * preoperative bcdva worse than 0.2 logmar (20/32) with or without glare * pupil size greater or equal to 6.0mm after dilation exclusion criteria: * any corneal abnormality, other than regular corneal astigmatism * subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logmar (20/32) * previous refractive surgery * amblyopia * clinical severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy) * diabetic retinopathy * extremely shallow anterior chamber, not due to swollen cataract * microphthalmos * previous retinal detachment * previous corneal surgery * recurrent severe anterior or posterior segment inflammation of unknown etiology * rubella or traumatic cataract * iris neovascularization * glaucoma (uncontrolled or controlled with medication) * aniridia * optic nerve atrophy * damaged incomplete zonules * systemic disease that could increase the operative risk or confound the outcome * medications that, in the opinion of the investigator may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (flomax) or other medications with similar side-effects (floppy iris syndrome)
effect of ttns and pns on neurogenic overactive bladder symptoms in female patients with multiple sclerosis.

Conditions: Multiple Sclerosis; Overactive Bladder Syndrome

Summary: this study aims to evaluate the use of transcutaneous tibial nerve stimulation (ttns) and parasacral nerve stimulation (pss) methods in the treatment of overactive bladder (oab) symptoms in patients with multiple sclerosis (ms), including urination frequency, urgency, urinary incontinence, post-void residue, maximum micturition rate. to investigate the effect on parameters such as voiding volume and quality of life and to compare the final results between groups.

participants will be divided into 3 groups: ttns, pns, and placebo groups, and all participants will be given behavioral treatment. tibial nerve stimulation will be given to the ttns group, sacral nerve stimulation will be given to the pns group, and sham current will be given to the placebo group. stimulation treatments will be applied 2 days a week for 30 minutes each for 6 weeks. participants will be evaluated before and after treatment. the parameters of urination frequency, urgency, and urinary incontinence will be evaluated with a 3-day voiding diary (bd), maximum flow rate (qmax), time to reach maximum flow (tqmax), average flow rate, flow time (tw), voiding time and voiding volume (vv) values will be evaluated by uroflowmetry, post-voiding residual (pvr) volume will be evaluated by ultrasound, and quality of life will be evaluated by king's quality of life questionnaire (khq); expanded disability status scale (edss), overactive bladder form (oab-v8), incontinence severity index (isi), neurogenic bladder symptom score (nbss) will be recorded.

Eligibility criteria:
inclusion criteria: * having symptoms related to overactive bladder (oab-v8 score ⩾8), * over 18 years of age * no relapse for at least 1 month * all types of ms, including those with relapses * female ms patients with an expanded disability status scale (edss) score below 7.0 * agreeing to participate in the research exclusion criteria: * patients with urinary tract infections * patients diagnosed with diabetes mellitus * patients using diuretic drugs or patients with a clean intermittent catheter * patients with a history of different urological diseases * patients with heart or brain pacemaker users, those with epilepsy, and patients with language and cognitive limitations * patients who are pregnant or in the postpartum period * lack of activity performance for 2 weeks (regardless of which group)
infrapopliteal drug eluting angioplasty versus stenting

Conditions: Arterial Occlusive Disease

Summary: in total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. the patients randomized in the drug coated balloons (dcb) study arm will undergo a percutaneous transluminal angioplasty (pta) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (des) study arm will undergo primary stenting using drug-eluting stent(s). the study's primary endpoints will be the 6-month angiographic binary restenosis rate. secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.

patients programmed to undergo pta due to angiographically-proven infrapopliteal arterial disease in our department will be randomized in the above mentioned study arms. the studies primary endpoint will be assessed with the use of intra-arterial digital subtracted angiography and subsequent quantitative vascular analysis (qva) analysis.clinical follow-up is set at 1, 3 and 6 months. patients' baseline demographics and procedural details will be recorded and analyzed.

Eligibility criteria:
inclusion criteria: * angiographically documented infrapopliteal disease. * rutherford category of peripheral arterial disease between class 3 to 6 * lesion length between 70 to 220 mm * lesions situated in the proximal, mid and mid to distal segments of the tibial vessels. exclusion criteria: * lesion length \ 220 mm. * lesions situated in the distal third of the tibial vessels

Keywords: drug coated balloons drug eluting stents
study of the association between the type of attachment and the risk of post-traumatic stress disorder

Conditions: Post-Traumatic Stress Disorder

Summary: attachment theory models the emotional bonding that is activated in situations of danger, via mental representations of self and others. four types of attachment (ta) exist in adults: 3 insecure (preoccupied, detached, fearful) and 1 secure. attachment type is a major factor in the development of post-traumatic stress disorder (ptsd), a frequent and disabling mental disorder that occurs after a traumatic event. a meta-analysis based on anglo-saxon studies including various populations (general, military or clinical) (n=9268 patients) suggested an association between fearful bp and high level of ptsd symptoms (r=0.44). nevertheless, these results did not allow the identification of variations related to the individual risk factors (rdfs) of the subject and his environment, especially in the french socio-cultural context. the investigators propose to study the association between lds and the risk of ptsd in the days following exposure, their mutual influence in the months following, and their associated factors. thus, a prospective cohort study among french adult victims of a traumatic event could objectify the link between bp - as close as possible to the event - and the risk of ptsd.


Eligibility criteria:
inclusion criteria: * major patient * having experienced a potentially traumatic event within 3 days and according to dsm5 criterion a: exposure to actual or potential death, serious injury, or sexual violence in one (or more) of the following ways: directly experiencing the traumatic event, witnessing the event in person by others, learning that the traumatic event (violent or accidental) was experienced by a close family member or friend, experiencing repeated or extreme exposure to the harrowing details of the traumatic event (e.g., first responders or police officers) (exposure through electronic media, television, films, or photographs, if the exposure is work-related) * good understanding of oral and written french * having given written consent * patient affiliated to a social security scheme exclusion criteria: * psychiatric pathology with current clinical instability (agitation, maladaptive consciousness...) or patient unable to understand questionnaires * vulnerable adult (curatorship, guardianship) * non french resident

Keywords: attachment ptsd risk factor
effect of nutrition education on energy availability, body composition, eating attitude and sports nutrition knowledge

Conditions: Relative Energy Deficiency in Sport

Summary: this study investigates the effects of a series of nutrition education sessions conducted by a registered dietitian on energy availability, various anthropometric measurements, eating attitudes, and sports nutrition knowledge in young female endurance athletes aged 15-18 years (football, basketball, volleyball) who engage in training for more than 10 hours per week (n=83).

participants were randomly divided into two groups with 45 individuals receiving six physical nutrition education lectures, and the remaining 38 participants receiving no nutrition education. participants completed the the low energy availability in females questionnaire (leaf-q), eating attitude test (eat-26) and sports nutrition knowledge questionnaire (snkq). energy and nutrient intakes were evaluated thorough 3-day food records, while exercise energy expenditure was assessed using 3-day activity logs. all of the questionnaires were repeated after a 6-months period. at baseline, the prevalence of lea among athletes was determined to be 63.8%. in the intervention group, energy availability (ea) and snkq scores increased, and leaf-q scores decreased significantly (p \< 0.05). however, there was no significant change in eat-26 scores between the two groups. energy intake, weight, fat free mass and resting metabolic rate has been increased significantly in the intervention group (p \< 0,05). these findings suggest that nutrition education proves beneficial in enhancing dietary intake, positively influencing body composition and improving nutrition knowledge, ultimately contributing to increased energy availability in female athletes over the short term.

Eligibility criteria:
inclusion criteria: non-contraceptive using competitive female endurance athletes 14-18 years of age training minimum 6 hours a week not taking a break from sports for more than 3 months due to injury exclusion criteria: pregnancy or planned pregnancy chronic diseases (e.g. diabetes, crohn's disease, thyroid dysfunction) use of any medication that may disturb hormonal balance