Kornimate/medical-research-clean huggingface dataset:
ticagrelor versus high-dose clopidogrel in patients with high platelet reactivity on clopidogrel after pci

Conditions: Coronary Artery Disease

Summary: to determine the safety and efficacy of ticagrelor versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.

this is a multi-center, randomized, single-blind, investigator-initiated study with a parallel design. patients with coronary artery disease undergoing percutaneous coronary intervention and presenting high platelet reactivity on clopidogrel as assessed with the pl-11 analyzer (platelet maximum aggregation ratio \[mar%\] ≥ 55 %) at 2 hours post-clopidogrel 300mg ld (day 0), will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: group α: ticagrelor 180 mg immediate loading (on day 0) followed by 180mg/day starting from day 1 until day 365 (12 months after randomization). group β: clopidogrel 150mg per day, starting from day 1 until day 365 (12 months after randomization). platelet reactivity assessment will be performed before randomization (day 0), and 3-day after randomization (day 3). documentation of major adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, revascularization procedure with pci or cabg) and serious adverse events (bleeding, other adverse events) will be performed until 12 months.

Eligibility criteria:
inclusion criteria: * patients who agreed to the experimental plan which was permitted by irb; * patients planned to take dual antiplatelet therapy for 12 months. exclusion criteria: * severe hepatic dysfunction defined as serum transaminase \> 3 times normal limit; * renal dysfunction defined as egfr \< 30ml/min/1.73m\^2; * co-morbidity with an estimated life expectancy of \< 50 % at 12 months; * scheduled surgery in the next 12 months, which resulted protocol changes; * known allergy against study drug or device; * use of glycoprotein iib/iiia inhibitor during the perioperative period; * anticoagulation treatment including warfarin.
effects of classical massage and benson relaxation exercise on heart failure patients

Conditions: Heart Failure; Symptoms and Signs; Quality of Life

Summary: patients with heart failure will be entered. participants will be randomized to one of three study arms: arm 1: classical massage, arm 2: relaxation, arm 3: control hypothesis: classical massage and benson muscle relaxation will decrease frequency, severity, discomfort of symptoms and improve quality of life.

previous reports have revealed that classical massage and benson relaxation exercise are promising for physiological parameters such as respiratory rate, pulse, blood pressure in heart failure patients. on the other hand, research examining effects of these approaches on physical symptom status that is including dyspnea, orthopnea, fatigue, chest pain, peripheral edema, sleep problems and dizziness and quality of life is limited. the present study investigates the effects of classical massage and benson relaxation exercise in a single-site, 3-arm, randomized, controlled study of 96 patients with heart failure. arm 1: classical massage; arm 2: benson relaxation exercise; arm 3: control. the investigators hypothesize that classical massage and benson relaxation exercise will decrease frequency, severity, discomfort of symptoms and improve quality of life.

Eligibility criteria:
inclusion criteria: * being at least primary school graduates, * being over 18 years old * being diagnosed stage iii-iv with heart failure * not using any other complementary or integrative therapy during the study period exclusion criteria: * having an additional disease such as advanced stage chronic obstructive pulmonary disease, asthma, cancer * stage i-ii diagnosed with heart failure * having an active thrombosis * having a coagulation problem * not volunteering to participate in the research * patients who have been hospitalized for 5 days or less and discharged before five days after the start of the application.

Keywords: classical massage,heart failure,nursing,relaxation
d081ac00001 food interaction with olaparib capsule in patients with solid tumours

Conditions: Solid Tumours

Summary: this is a 2 part study for patients with solid tumours. the purpose of part a is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie, regular and none). in part b patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum). treatment can continue for as long as the patient is benefitting. throughout the study patients will be monitored for any side effects.


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years, male and female * able to eat a high-fat breakfast within a 30-minute period, as provided by the study site * histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy and for which no suitable effective standard therapy exists * ecog performance status ≤2 * normal organ and bone marrow function measured within 28 days prior to administration of ip as defined in protocol exclusion criteria: * participation in another clinical study with an ip during the last 14 days (or a longer period depending on the defined characteristics of the agents used) * patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 2 weeks prior to study treatment (or a longer period depending on the defined characteristics of the agents used). * toxicities (≥ctcae grade 2) caused by previous cancer therapy, excluding alopecia * patients unable to fast for up to 14 hours or who have type i or type ii diabetes * patients who have gastric, gastro-oesophageal or oesophageal cancer

Keywords: oncology, cancer, tumour, neoplasm, anticancer drug, food effect, area under the curve, pharmacokinetics, olaparib, solid tumour, metabolites, drug availability
lidocaine spray vs coughing for pain relief during colposcopy

Conditions: Colposcopy

Summary: cervical cancer is the third most common genital cancer worldwide. the diagnosis of cervical cancer is performed with the cervical biopsy which is guided by the colposcopy. the colposcopy guided cervical biopsy creates pain and several methods have been reported to overcome the pain related with this procedure. local anesthetic agent injection into the cervix has been studied and found to be effective and also, forced coughing was compared with local anesthetic injection and it is found to be more effective. in fact local injections can create the pain by itself.however no study compared the effect of forced coughing to local anesthetic spray. the study aims to evaluate the comparison of forced coughing with local anesthetic spray with respect to perceived pain during colposcopy guided biopsy.


Eligibility criteria:
inclusion criteria: * patients with age \>18, * presence of cervix, * patients who need a diagnostic work up for abnormal cervical smear results. exclusion criteria: * pregnancy, * presence of already known invasive cancer, * allergy to anesthetic agents.

Keywords: colposcopy pain coughing anesthetic spray
health benefits of whole grain oats in population at risk of cardio-metabolic disease

Conditions: Cardiovascular Disease; Hypercholesterolemia

Summary: intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia and heart disease, however the mechanisms by which oats or oat fractions exert this effect is not totally clear. furthermore, several large epidemiological studies and a number of recent meta-analyses of nutritional interventions have reported a positive association between increased whole grain intake and reduced risk of developing a range of chronic diseases. recognising the important role of the gut microbiota in metabolism and metabolic disease risk, we examined the impact of whole grain oats on the human gut microbiota and cardio-metabolic risk factors. the main aims of this human study is to determine the effectiveness of a low gi whole grain oats breakfast cereal compared to a high gi, refined breakfast cereal to beneficially modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and inflammation markers in an at risk of cardio-metabolic disease population


Eligibility criteria:
inclusion criteria: * men and women (age range 23-64 y) * bmi of 18-30kg/m2 * fasting glucose concentration \>5.5 but \<7.5mmol/l * total cholesterol \>5.2 but \<7.8mmol/l exclusion criteria: * medical history of heart disease, diabetes mellitus, cancer, pancreatitis or renal disease * use of lipid lowering drugs, systemic corticosteroids or drugs for regulating hemostasis * exposure to any investigational agent \<42 d before the study * presence of gastrointestinal disorder or use of a drug likely to alter gastrointestinal motility or nutrient absorption * history of substance misuse or alcoholism * current pregnancy, planned pregnancy, or given birth in the past 12 months * antibiotic treatment 6 weeks previous to study start date * allergy or intolerance to intervention breakfast cereals components * smoking
a study of efficacy and safety of sepranolone (uc1010) in patients with premenstrual dysphoric disorder (pmdd)

Conditions: Premenstrual Dysphoric Disorder

Summary: the objective of this phase iib study is to evaluate the effect and safety of sepranolone (uc1010) on premenstrual symptoms in women with premenstrual dysphoric disorder (pmdd). patients will be taking sepranolone or placebo (blinded to patient and study doctor) during the two weeks preceding the menstruation of three menstrual cycles. effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of pmdd symptoms. sepranolone is an endogenous steroid.

the objective of this phase iib study is to evaluate the effect and safety of two doses of sepranolone (uc1010) on premenstrual symptoms in women with premenstrual dysphoric disorder (pmdd) in comparison to placebo, administrated during the luteal phase of three consecutive menstrual cycles. effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of pmdd symptoms and impairment of symptoms on daily life of the patients. the scale is daily record of severity of problems (drsp). preceding the treatment period, the diagnosis of pmdd will be established in the study participants by at lest two menstrual cycles of prospective drsp ratings by the patients. this period will also constitute the baseline data. the effect of study medication will be assessed as the change in symptoms from baseline to during treatment. the total symptom score of the drsp will constitute the primary variable and the late luteal phase ratings in the respective menstrual cycles, before and during treatment, will be used. the study will also include a follow-up (no treatment) cycle before patients final visit. the study is conducted in four european countries (sweden, germany, poland and united kingdom) and will include up to 225 patients.

Eligibility criteria:
main inclusion criteria: * have pmdd according to dsm-5 verified in two menstrual cycles * have a regular menstrual cycle of 24-35 days cycle, * use double barrier contraception, non-hormonal iud, be truly sexually abstinent, or subject or her partner has been surgically sterilized, main exclusion criteria: * steroid hormonal treatment or treatment with psychopharmaceuticals during previous three months * treatments for premenstrual syndrome (pms) or pmdd * history of or significant medical condition ongoing * be pregnant or plan a pregnancy within the study period
diagnostic tools for parkinson's disease

Conditions: Parkinson Disease

Summary: the study aims to identify genetic variants associated to parkinson's disease through the analysis of exome-sequencing data of familial cases and controls. the identified variants will be used to generate a diagnostic tool for the identification of genetic risk profiles.

1. clinical evaluation of pd patients and relatives 2. high throughput analysis of genetic variants in genome exomes 3. genotype-phenotype association testing 4. identification of genetic risk variants for pd

Eligibility criteria:
inclusion criteria: * presence of at least two out the following cardinal signs: resting tremor, cogwheel rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to l-dopa (levodopa) exclusion criteria: * previous thalamotomy on the implanted sided, significant brain atrophy or structural damage seen on ct or mri, marked cognitive dysfunction, active psychiatric symptoms, or concurrent neurological or other uncontrolled medical disorders.
acute kidney injury in poly trauma patients

Conditions: Kidney Injury

Summary: the aim of this study is to identify the incidence and the factors associated with acute kidney injury in adult poly trauma patients

trauma causes significant morbidity and mortality in all age groups but particularly for those below 60 years and is one of the top 5 causes of death (1,2).most deaths occur in adults who are between 15 and 44 years(3).polytrauma originates from the greek words poly which means multiple and trauma which means wounds. the term polytrauma, which was defined using the new berlin definition, as cases with an abbreviated injury scale (ais)≥3 for two or more different body regions and one or more additional variables from five physiologic parameters (hypotension\[systolic blood pressure≤90 mmhg\], unconsciousness\[glasgow coma scale score≤8\], acidosis \[base excess≤ -6.0\], coagulopathy \[partial thromboplastin time≥40 s or international normalized ratio≥1.4\], and age \[≥70 years\]) \[4\].there are complex pathophysiological changes that happen in a polyrauma patient which requires effective treatment for improving morbidity and mortality outcomes. hemorrhage, systemic inflammatory response syndrome (sirs) and multiple organ dysfunction syndrome (mods) are some of the complications of trauma whose effects are not only local but also systemic. there are mechanisms and triggers which result in cardio-vascular shock, hemostasis, apoptosis, organ dysfunctions and immune suppression (chaos) \[5\]. these local and systemic pathophysiological changes that occur in polytrauma (chaos) eventually lead to acute kidney injury (aki) which further worsens their outcomes \[6,7\].

Eligibility criteria:
inclusion criteria: * the present study will be conducted on patients with multiple trauma of both genders "without intently selected certain gender" who have no previous history of kidney disease or chronic illness. exclusion criteria: * • patients who are less than 16 years old. * patients with preexisting kidney disease or localized individual trauma. * patients with diabetes and hypertension. * patients post cardiac arrest * patients leaving the hospital on the same day or transferred to a different hospital will be excluded from this study. * patients refusing study will be excluded.

Keywords: polytrauma
anesthetic block of the erector muscles of the lumbar spine to relieve acute lumbar pain: pilot study

Conditions: Lumbago

Summary: this study concerns the treatment of recent lumbago and aims to evaluate the efficacy of an anesthetic block of the erector spinae muscles combining ropivacaine and dexamethasone. this treatment is routinely used in several institutions in france, but has never been the subject of a randomized placebo-controlled study to assess its efficacy at d4 of treatment. the bloclomb comparative, randomized, double-blind study aims to validate the efficacy, over the first 4 days, of anesthetic blocks of the erector spinae muscles, during recent lumbago, on the pain of muscular contractures.


Eligibility criteria:
inclusion criteria: 1. patient with lumbago lasting less than 7 days despite analgesic / nsaid treatment. 2. patient with ns pain \> 6 3. patient with oswestry score \> or equal to 30 4. patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure, 5. patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol, 6. patient affiliated to a social security or any health insurance. exclusion criteria: 1. presence of "red flag" (non-disc lumbago): * motor deficit or signs of horsetail irritation * inflammatory pain waking up in the 2nd half of the night * tumoral context * infectious context or fever * altered general condition * traumatic context * osteoporotic context 2. risk of infection 3. patient with poor local skin condition 4. patient on avk or anti-xa anticoagulation, or bleeding disorder (antiaggregants authorized) 5. patients with hypersensitivity to ropivacaine or any of its excipients: sodium chloride, hydrochloric acid sodium hydroxide 6. patient with sciatica 7. patient with chronic respiratory insufficiency 8. patient with cardiac rhythm disorders 9. pregnant or breastfeeding woman or woman refusing effective contraception 10. patient deprived of liberty or under legal protection (guardianship or curator) 11. patient participating in another clinical research protocol involving a drug or medical device 12. patient unable to follow the protocol, as judged by the investigator 13. patient refusing to participate in the study

Keywords: anesthetic blocks pain
feasibility study of a novel subcutaneous continuous glucose monitoring system in diabetics

Conditions: Diabetes

Summary: mono-centre, open label (unblinded). 8 patients + 2 potential replacements. duration up to 9 weeks: up to 6 weeks screening (42 days), 2 weeks of treatment (14 days, depending on sensor functionality) and 1 week of follow up (7 days)

this study is an investigational study, which will be conducted only at one site in germany. the investigators, the patient and the sponsor will be unblinded. as soon as the eligibility of the patient is confirmed the patient is enrolled. the screening results are valid up to 42 days. within that time the first measurement visit including the insertion of the device should be performed. if the first measurement visit is delayed a re-screening has to be performed. should the patient not pass the re-screening, the patient is considered as a screening failure and must be excluded. the trial is structured into three phases, the screening/enrolment phase, the insertion/measurement phase and the follow-up phase. screening/enrolment phase: 6 weeks (42 days), 1 visit insertion/measurement phase: up to 2 weeks (14days), up to 6 measurement visits follow-up phase: 1 week (7 days), 1 visit

Eligibility criteria:
inclusion criteria: * body mass index within the range of 19-40 kg/m2, inclusive * diabetes type 1 and 2 * females (if of childbearing potential) must agree to abstain from sexual intercourse or use reliable forms of contraception e.g. condom or diaphragm with spermicide or oral contraceptives to prevent pregnancy during the study * signed written informed consent exclusion criteria: * inability to follow the protocol schedule * participating in another clinical trial, if it is not a "non-investigational clinical study (nics) * pregnant or lactating females, * any known hypersensitivity to any of the products used in the study, including preservatives etc. * malignancies requiring therapy during the study * severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study * acute severe infection disease at the time of enrolment * alcohol and/or drug abuses * vulnerable patients (e.g. persons kept in detention) * poorly controlled diabetes mellitus with hemoglobin a1c higher than 10%
cervical cancer screening with ngs-hpv technology based on menstrual blood

Conditions: Cervical Cancer

Summary: our study is a population-based, cross-sectional study. this study is conducted to recruit cervical cancer screening participants to evaluate the application value of using high-throughput sequencing technology to detect hpv in menstrual blood for cervical cancer screening. our study is designed as a two-phase study : phase i : this phase, which will be preparing to recruit 5,000 participants, evaluates the accuracy of menstrual blood (mb) self-sampling for detecting cervical intraepithelial neoplasia grade two or worse (cin2+) in the general population, with a secondary objective to evaluate the minipad as a special device to collect mb. phase ii : this phase, which will continue to recruit toward the 10,000-participant target, will evaluate additional molecular markers (specifically dna methylation) to optimize alternative triage methods for hpv-positive women in menstrual blood (mb) self-sampling. this phase aims to further reduce unnecessary colposcopies while maintaining high sensitivity for cin2+ detection.

our study will recruit 10,000 participants for cervical cancer screening across seven sites in hubei province from september 1, 2023, to march 31, 2028. the participating sites include: fruit lake community (where zhongnan hospital of wuhan university is located), jiang'an district (wuhan central hospital), huangzhou district of huanggang county (huanggang maternal and child health care hospital), jingling community of tianmen county (the first people's hospital of tianmen), liutang community of huangmei county (huangmei county people's hospital), gongtang community of zhongxiang city (zhongxiang maternal and child health care hospital), and chaihu community of zhongxiang city (people's hospital of zhongxiang).. the procedures were conducted as below: (1) conduct cervical cancer screening (tct+hr-hpv) for all the participants. (2) collect sanitary napkins from participants during their first menstrual period after cervical hpv testing. (3) detect hpv using high-throughput sequencing technology in the menstrual blood (mb) from sanitary napkins. (4) colposcopy referral (biopsy if necessary) for patients with abnormal screening results. (5) compare the concordance between mb-hpv and clinician-collected hpv. (6) evaluate the accuracy of menstrual blood (mb) self-sampling for detecting cervical intraepithelial neoplasia grade two or worse (cin2+) in the general population, with a secondary objective to evaluate the minipad as a special device to collect mb. (7) evaluate additional molecular markers (specifically dna methylation) to optimize alternative triage methods for hpv-positive women in menstrual blood (mb) self-sampling.

Eligibility criteria:
inclusion criteria: 1. plan to undergo cervical screening 2. with regular menstruation (21-35 days) 3. agree to participate in this study and have signed an informed consent form exclusion criteria: 1. with amenorrhea or menopause 2. suffering from genital tract infection 3. refuse to participate in this study

Keywords: hpv menstrual blood cervical cancer screening,