Kornimate/medical-research-clean huggingface dataset:
intracoronary stenting and antithrombotic regimen: adjusting antiplatelet treatment in patients based on platelet function testing

Conditions: Coronary Heart Disease

Summary: clopidogrel low response is associated with a significantly higher risk for ischemic complications after percutaneous coronary intervention. ticagrelor and prasugrel are more potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic events as compared to clopidogrel. no direct comparison between ticagrelor and prasugrel in terms of their antiplatelet efficacy exists. the aim of this study is to assess the antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed clopidogrel low responders undergoing percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * successful pci * 600 mg clopidogrel pretreatment * clopidogrel low response assessed with electrode aggregometry (\>= 486 au\*min) * written informed consent exclusion criteria: * contraindications or allergies against study drugs * anemia * any surgery \< 6 weeks * increased bleeding risk * oral anticoagulation * platelet count \< 100.000/µl * prior history of stroke or pathologic intracranial findings * gpiib/iiia antagonists \< 10 days or periprocedural * age \> 80 years, \< 18 years * body weight \< 60 kg * cardiogenic shock * increased risk of bradycardia * moderate liver disease * kidney dialysis * intake of cyp 3a4 inhibitors * pregnancy or lactation * missing pregnancy test for women capable of bearing children

Keywords: clopidogrel low response ticagrelor prasugrel platelet aggregation
safety/tolerability, immunological and clinical activity of a boost immunization with affitope ad02

Conditions: Alzheimer's Disease

Summary: this is a phase ib follow-up study to assess a boost immunization with affitope ad02 with regard to safety/tolerability, immunological and clinical activity in alzheimer patients who have received the vaccine within the clinical study aff002.


Eligibility criteria:
inclusion criteria: * participation in aff002 and aff004 exclusion criteria: * presence or history of allergy to components of the vaccine, if considered relevant by the investigator * contraindication for mri imaging * history and/or presence of autoimmune disease, if considered relevant by the investigator * active infectious disease (e.g., hepatitis b, c) * presence and/or history of immunodeficiency (e.g., hiv) * significant systemic illness
clinical utility of postoperative hemoglobin testing

Conditions: Anaemia Postoperative

Summary: the purpose of this study is to evaluate how many patients have hemoglobin less than 10 g/dl at post-operative day 1

obtaining a complete blood count (cbc) on post-operative day 1 to assess postoperative hemoglobin levels is routine practice at cincinnati urogynecology associates, trihealth inc. after pelvic reconstructive surgery. there is minimal data supporting this practice. multiple studies throughout the gynecology literature suggest that this is not a necessary or cost effective strategy to assess for postoperative anemia. most patients who require blood transfusion or reoperation for bleeding will show clinical signs of anemia. the investigators aim to determine if checking a routine cbc results in clinically relevant changes to patient care in women undergoing pelvic reconstructive surgery with vaginal hysterectomy for treatment of pelvic organ prolapse.

Eligibility criteria:
inclusion criteria: * total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy (cpt 58260, 58262, 58263, 58270, 58290, 58291, 58292, 58294) * at least one of the following vaginal native tissue prolapse repairs * apical repair with uterosacral ligament suspension (cpt 57283) * apical repair with sacrospinous ligament fixation (cpt 57282) * anterior repair (cpt 57240, 57260, 57284, 57285, 57250) * posterior repair (cpt 45560, 56800, 56810, 57200, 57210, 57250) * surgery by one of four fellowship trained urogynecologists at trihealth exclusion criteria: * concomitant surgical procedure by a second surgeon * malignancy identified at the time of surgery or active malignancy * cases converted to open hysterectomy or prolapse repairs * prolapse repair completed robotically * prolapse repair completed with mesh * known coagulopathy * patient on long term preoperative anticoagulant medication (arixtra, coumadin, eliquis, heparin, lovenox, pradaxa, savaysa, xarelto)
gut microbiota, anastomotic leak and colorectal cancer

Conditions: Colorectal Cancer

Summary: this is a prospective study evaluating the relation between the gut microbiota composition, intestinal healing after colorectal surgery and colorectal cancer behavior. our hypothesis is that the gut microbiota composition could predict poor intestinal healing in colorectal surgery, and that the gut microbiota might have an impact on colorectal cancer clinical behavior and may predict disease outcomes.

no more details required

Eligibility criteria:
inclusion criteria: * age 18 years and older * crc diagnosis * upcoming colonic and/or rectal resection with/without anastomosis * individuals without diseases of the colon and rectum (healthy controls) exclusion criteria: * pregnancy * previous stoma * bowel surgery in the last 4 weeks prior to the surgery secondary objectives, inclusion criteria are as follows: * age 18 years and older * rectal cancer diagnosis with histopathological confirmation * abdominoperineal resection with terminal colostomy * expectative non-surgical management ("watch and wait approach")

Keywords: microbiota
evaluation of the fast fill technique for anal acoustic reflectometry (aar) in the incontinent anal sphincter

Conditions: Faecal Incontinence

Summary: anal acoustic reflectometry (aar) is a technique that has been studied in our department over the last 6 years. sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. by gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. this assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles. the gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. however, it has limitations. despite the two measurements being within the normal range, some patients can have significant faecal incontinence. this has prompted clinicians to search for a better investigation to guide the management of this condition. aar is a reproducible and repeatable technique that has been used as a research technique in the assessment of faecal incontinence. it has been shown to correlate with symptom severity and, unlike manometry, is able to distinguish between different symptomatic subgroups with faceal incontinence. in our studies so far the investigators have increased the bag inflation pressure a step at a time which means that each study takes about 20 minutes to perform. the limitation of this method is that during the measurement of squeeze pressure the sphincter muscle is subject to fatigue. a recent study using the acoustic technique in the urethra has demonstrated a faster method of recording measurements over an 8 minute period. the investigators propose to study the fatiguability effects of this faster technique and validate the method against the existing step-wise technique and standard anal manometry. patients will be randomised into two groups: 1. stepwise then fast-fill 2. fast-fill then stepwise


Eligibility criteria:
inclusion criteria: * adults over 18 years * have capacity to consent to the study * patients with symptoms of faecal incontinence exclusion criteria: * minors under age of 18 years old * patients who lack capacity to consent

Keywords: faecal incontinence
a trial comparing deep versus moderate neuromuscular block - in low pressure pneumoperitoneum

Conditions: Nephrostomy; Complications; Pneumoperitoneum; Observation of Neuromuscular Block

Summary: live kidney transplantation is first choice for patients with end-stage kidney disease. therefore, the safety and well-being of kidneys donors are highly important objectives in live kidney donation. low pressure pneumoperitoneum can decrease postoperative pain and therefore also concomitant use of opioids.

however low pressure pneumoperitoneum can also decrease peri-operative conditions. in this trial the researchers will investigate whether peri-operative conditions during low pressure pneumoperitoneum can be optimized by the use of deep neuromuscular block.

Eligibility criteria:
inclusion criteria: * obtained informed consent * age over 18 years exclusion criteria: * chronic use of analgesics or psychotropic drugs * use of non-steroidal anti-inflammatory drugs shorter than 5 days before surgery * known or suspect allergy to rocuronium or sugammadex * significant liver or renal dysfunction * pregnant or breastfeeding
prevalence of molar incisor hypomineralization among a group of egyptian children in giza governorate

Conditions: Molar Incisor Hypomineralization

Summary: - one single operator will assess the prevalence of molar incisor hypomineralization and its severity among a group of egyptian children .

the study is about the prevalance of molar incisor hypomineralization and its severity among a group of egyptian children aged 8-12 years old in giza governorate schools. * participants will be randomly selected from primary and preparatory schools in giza governorate, seated in the school lap or an empty classroom. * clinical examination will be made in the daylight using disposable diagnostic sets (mirror, and explorer). no diagnostic radiographs will be taken. * prior to performing dental examination, index teeth including incisors and 1st permanent molars will be cleaned using a cotton roll. * a dental explorer will be further used for cleaning molar fissures. * the examiner carefully inspect the coronal part of the 1st permanent molars and permanent incisors for demarcated opacities. * a specially made examination chart will be taken for the child including his name, age, address, gender, school, date, medical health and any previous dental treatment. prevalance of molar incisor hypomineralization is measured by presence or absence. severity is measured by modified index based on european academy of paediatric dentistry (eapd) criteria

Eligibility criteria:
inclusion criteria: * schools in giza governorate. * positive patient acceptance for participation in the study. * patients who are apparently medically free from any systemic disease. exclusion criteria: * uncooperative child. * children with appliances.
efficacy study of strattera for treating attention disorders in traumatic brain injury (tbi)

Conditions: Traumatic Brain INjury

Summary: atomoxetine is the only medication that is currently approved by the fda for the treatment of attention deficit hyperactivity disorder in adults. it has gained recent interest as an alternative medication for treating attentional problems related to traumatic brain injury (tbi), but it's effectiveness in this population has not been studied. there are a number of advantages of atomoxetine over traditional neuro-stimulant medications currently used for attentional disorders after traumatic brain injury. this study will use a randomized double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine to improve attention, behavioral function, and depression in adults with tbi


Eligibility criteria:
inclusion criteria: * history of tbi * moderate to severe tbi as indicated by glasgow coma score (gcs) score of 12 or less; or post traumatic amnesia (pta) of seven days or more * at least one year post injury * between the ages of 18-65 (inclusive) * symptoms consistent with attentional dysfunction * consent to participate in study exclusion criteria: * history of any conditions that would prohibit standard neuropsychological testing * non-english speaking (to the extent that would limit ability to complete study measures) * prior history of significant psychiatric illness requiring hospitalization * epilepsy * cardiovascular disease or risks including: dysrhythmias, angina, myocardial infarction, uncontrolled hypertension, valvular heart disease including mitral valve prolapse * use of any monoamine oxidase inhibitor or any other drug affecting brain monoamine concentrations * severe renal or hepatic impairment * pregnant or lactating

Keywords: attention traumatic brain injury atomoxetine strattera
improving psychosocial quality of life in women with advanced breast cancer

Conditions: Breast Cancer

Summary: through a patient participation aid (ppa) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active participants in clinical encounters.

the team has developed a brief patient participation aid (ppa) to promote patient health literacy and encourage women to be active in the decisions that are being made about their healthcare which will lead to their satisfaction with healthcare and improves their psychosocial well-being. the paper-based ppa uses adult learning principles to limit and sequence plain language messages that have been framed from a patient's perspective. the ppa uses theory-based design to increase patients' involvement in the medical visit by modeling - through text and images - how a patient can: 1) set the visit agenda, 2) formulate questions, and 3) assert personal preferences. the specific aims of this study are to: 1- assess the effectiveness of the ppa to increase patient involvement during clinical encounters. 2- evaluate the effectiveness of the ppa to improve patient psychosocial outcomes. 3- explore if the effect of the ppa varies by patients' literacy skills. to achieve this aims, the investigators will conduct a randomized controlled trial to evaluate the ppa among patients with a new diagnosis or progression of metastatic breast cancer at two cancer centers that serve diverse patient populations.

Eligibility criteria:
inclusion criteria: * female patients with metastatic breast cancer seeing one of the study physicians at one of the identified study clinics * age 21 or older * having suspected progression of metastatic disease exclusion criteria: * patients with an uncorrectable hearing impairment or having limited english proficiency, as this would adversely affect their ability to communicate with the physician * patients with uncorrectable vision impairment, as this would make it impractical for the patient to read the intervention * patients too ill to meaningfully converse with the physician

Keywords: metastatic quality of life decision making
an efficacy, safety, and tolerability study of canagliflozin in the treatment of patients with type 2 diabetes mellitus with inadequate glycemic control on metformin monotherapy

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

this is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo-controlled, parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in appearance to canagliflozin but does not contain active drug) in patients with type 2 diabetes mellitus (t2dm) who are not achieving an adequate response from current antihyperglycemic therapy with metformin to control their diabetes. canagliflozin (a sodium-glucose cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with t2dm. patients will take single-blind placebo capsules orally (by mouth) for 2 weeks before randomization. patients will be randomly assigned canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if applicable, for up to 18 weeks. the dosing time of metformin should remain the same throughout the study.

Eligibility criteria:
inclusion criteria: * all patients must have a diagnosis of t2dm and be currently treated with metformin * patients in the study must have a hba1c between \>=7 and \<=10.5% * patients must have a fasting plasma glucose (fpg) \<270 mg/dl (15 mmol/l) exclusion criteria: * history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Keywords: canagliflozin placebo metformin hemoglobin a1c type 2 diabetes mellitus
study on intravenous injection of shr-1906 in the treatment of idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: to evaluate the efficacy and safety of intravenous shr-1906 in the treatment of idiopathic pulmonary fibrosis. the study is divided into four stages: screening period, baseline period, treatment period and safe follow-up period. it is planned that 108 patients will be randomly assigned to the following three treatment groups for treatment


Eligibility criteria:
inclusion criteria: 1. age 40 to 80, inclusive, at the time of screening； 2. ipf diagnosed according to ats/ers/jrs/alat guidelines (2022) (hrct diagnosis uip type/possible uip type (standard hrct confirmed by central review in recent 3 months) with or without pathological uip type/possible uip type (pathology refers to frozen lung biopsy or surgical/thoracoscopic lung biopsy)； 3. 90% ≥ fvcpp ≥ 45% during screening period and the first day; 4. the percent of predicted dlco value (corrected by hb value) at screening is ≥ 30% and ≤ 90%; 5. before the screening period, pirfenidone or nidanib with stable dose ≥ 8 weeks (pirfenidone ≥ 1200 mg/denidanib ≥ 200 mg/d) can continue to maintain treatment with stable dose during the study period; or at least 4 weeks before the screening period, pirfenidone or nidanib was not used (pirfenidone or nidanib was refused due to intolerance or various factors) ； exclusion criteria: 1. evidence of any of the following significant obstructive pulmonary disease: (1) the ratio of forced expiratory volume/forced vital capacity (fev1/fvc) at the first second is \< 0.70 (after using bronchodilator) or (2) hrct shows that emphysema is greater than fibrosis; 2. interstitial lung diseases (ild) other than ipf include but are not limited to: any other type of idiopathic interstitial pneumonia; lung diseases related to contact with fibroblasts or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung disease; pulmonary vascular disease; systemic diseases include vasculitis infectious diseases (i.e. tuberculosis) and connective tissue diseases if the diagnosis is unclear, serological examination and/or multidisciplinary expert group review should be conducted to confirm ipf or other types of ild diagnosis; 3. a history of other types of respiratory diseases, including respiratory tract, lung parenchyma, pleural cavity, mediastinum, diaphragm or chest wall diseases or disorders, such as acute respiratory infection, active tuberculosis, etc., which researchers believe will affect the primary endpoint of the study or otherwise affect the participation of subjects in the study;
placebo-controlled safety study of ritlecitinib (pf-06651600) in adults with alopecia areata

Conditions: Alopecia Areata

Summary: this is a global phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ritlecitinib in adults aged 18 to ≤50 years of age with ≥25% scalp hair loss due to alopecia areata (aa).


Eligibility criteria:
inclusion criteria: * diagnosis of alopecia areata, including alopecia totalis and alopecia universalis. * at least 25% hair loss due to alopecia areata * must have normal hearing and normal brainstem auditory evoked potentials (baeps) * must have a normal neurological exam; can have a stable unilateral median neuropathy or ulnar neuropathy * signed informed consent * stable regimen for other medications before and during the study exclusion criteria: * other significant medical conditions * occupational or recreational noise exposure * history of peripheral neuropathy or first degree relative with a hereditary peripheral neuropathy * hba1c \> or = 7.5% at screening * recurrent or disseminated herpes zoster * active or chronic infection; or infection requiring hospitalization or iv antimicrobials within 6 months * active or latent (insufficiently treated) hepatitis * active or latent (insufficiently treated) tb * concomitant medications associated with peripheral neurologic or hearing loss * protocol specific laboratory abnormalities

Keywords: alopecia totalis alopecia universalis hair loss alopecia jak ritlecitinib pf-06651600 double-blind placebo-controlled phase 2a
effect of iron/zinc-biofortified pearl millet on growth and immunity in children aged 12-18 months in india

Conditions: Iron Deficiency; Zinc Deficiency

Summary: in this study, iron- and zinc-biofortified pearl millet will be fed to young children in mumbai, maharashtra, india over a period of nine months to measure growth and immune function in comparison to children receiving non-biofortified pearl millet.

iron and zinc deficiency remain a major worldwide public health problem, especially in developing countries such as india. in this randomized study, 700 children aged 12-18 months from mumbai, maharashtra, india will be fed either iron and zinc biofortified pearl millet or control pearl millet three times per day, six days per week, for nine months. the goal of this study is to examine the effects of iron and zinc biofortified millet on immune function, growth, and cognitive function in this age group. the key outcome measures are biomarkers of iron and zinc status, growth, and immune function. serum concentrations of hemoglobin, ferritin, serum transferrin receptor, and zinc will be assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endline). additionally, we will measure concentrations of c-reactive protein (crp) and alpha 1-acid glycoprotein (agp), as iron and zinc biomarkers can be influenced by inflammation. to assess cognitive function in a subset, multiple specific aspects of memory, attention, and processing speed will be assessed. higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will also be assessed.

Eligibility criteria:
inclusion criteria: * age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit) * hemoglobin ≥9 g/dl exclusion criteria: * age less than 12 months, 0 days or older than 18 months, 30 days (at time of screening/baseline visit) * hemoglobin \< 9 g/dl and/or hemoglobinopathy * presence of severe malnutrition according to wellcome classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score \< -3) * prior diagnoses of hiv/aids or tuberculosis, or current diagnosis of hiv/aids, malaria, dengue fever, tuberculosis requiring \>1 day hospitalization * children who do not have a caretaker to bring him/her to feeding center * possibility of migrating out of the slum dwelling for longer than 4 weeks * prior or current consumption of iron or zinc supplements in the past 1 year * any known dietary allergies

Keywords: iron zinc pearl millet india children trial randomized