Kornimate/medical-research-clean huggingface dataset:
mindfulness for irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: this study investigates the effectiveness of a 6 week mindfulness intervention in reducing symptoms of irritable bowel syndrome (ibs). all participants will receive treatment. participants will be randomly allocated to an immediate treatment group and a waiting list control group.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * diagnosed with ibs by gastroenterologist or general practioner (gp), meeting rome iii criteria for ibs, symptom onset at least 6 months prior to inclusion, discomfort or pain at least 2-3 days per month * participants speaks english fluently or at a native level * participant has normal or corrected to normal vision exclusion criteria: * participant has insufficient manual dexterity for the computerized tasks * severe diagnostic and statistical manual (dsm) axis i or ii psychiatric disorder (diagnosis of dementia, amnesia, delirium, a dissociative disorder, a personality disorder, schizophrenia or any other psychotic disorder, a substance-related or induced disorder (such as alcoholism), attention deficit hyperactivity disorder (adhd), attention deficit disorder (add), primary diagnosis of obsessive compulsive disorder (ocd), current suicidality, regular non-suicidal self-injury. * recent bereavement (within one year) * gi diagnosis other than ibs (ibd, coeliac disease, another fgid) * pregnancy * no access to the internet * prior participation in an 8-week mindfulness course (mbsr, mbct) or any other structured mindfulness training. prior participation in vipassana meditation courses. regular meditation practice (meditating more than once per month). * not able or unwilling to commit to amount of practice (sessions and home practice). * participant is currently enrolled in another ibs treatment study (psychological or pharmacological).

Keywords: ibs
assessment of safety and efficacy of vilaprisan in subjects with uterine fibroids

Conditions: Uterine Fibroids

Summary: the primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (hmb) in subjects with uterine fibroids compared to placebo.the secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.


Eligibility criteria:
inclusion criteria: * women, 18 years or older at the time of visit 1 * diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter of ≥ 30 mm (alternatively, of 30 mm or more) * heavy menstrual bleeding (hmb) in at least 2 bleeding periods during the screening period each with blood loss volume of \>80.00 ml documented by the menstrual pictogram (mp) * use of an acceptable non-hormonal method of contraception * an endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology exclusion criteria: * pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) * hypersensitivity to any ingredient of the study drugs * hemoglobin values ≤6 g/dl or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dl will be recommended to use iron supplementation) * any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including * abuse of alcohol, drugs, or medicines (eg: laxatives) * undiagnosed abnormal genital bleeding * any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
a study of amivantamab in combination with lazertinib, or amivantamab in combination with platinum-based chemotherapy, for common epidermal growth factor receptor (egfr)-mutated locally advanced or metastatic non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the primary purpose of the study is to assess how well amivantamab subcutaneous (sc) administration in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (egfrm) non-small cell lung cancer (nsclc; that is one of the major types of lung cancer).


Eligibility criteria:
inclusion criteria: * have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (nsclc) that is not amenable to curative intent therapy * epidermal growth factor resistance-mutation (egfrm) must be an ex19del or ex21 l858r substitution, as detected by food and drug administration (fda)-approved or other validated test in a clinical laboratory improvement amendments (clia)-certified laboratory in accordance with site standard of care * have at least 1 measurable lesion, according to recist version (v)1.1, that has not been previously irradiated * any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (nci-ctcae) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade \<=2 peripheral neuropathy, or grade \<=2 hypothyroidism stable on hormone replacement) * have an eastern cooperative oncology group (ecog) performance status of 0 to 1 exclusion criteria: * medical history of active interstitial lung disease (ild), including drug-induced ild or radiation pneumonitis * had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study * participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing) * received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) or within 12 months before the planned first dose of study treatment or is currently enrolled in an investigational study * has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
post surgically treated peritonitis complications

Conditions: Peritonitis

Summary: the purpose of this observational study is to investigate the management and the complications associated wtih surgically treated peritonitis. data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

anonymous data will be collected by study coordinators in a secured e-database. cross audit will be performed to check data.

Eligibility criteria:
inclusion criteria: * nosocomial surgically treated peritonitis * or community-acquired surgically treated peritonitis * or post-operative surgically treated peritonitis exclusion criteria: * consent withdrawal

Keywords: nosocomial peritonitis community-acquired peritonitis post-operative peritonitis
dermacyd femina delicata (lactic acid)- photo dermatological evaluation of the irritation and sensitivity potential

Conditions: Hygiene

Summary: to prove the absence of photo irritation and photo sensitivity potential of the product dermacyd femina delicata.


Eligibility criteria:
inclusion criteria: * phototype skin ii and iii; * integral skin test in the region; exclusion criteria: * lactation or gestation; * use of anti-inflammatory and/or immuno-suppression drugs 15 days before the selection; * diseases which can cause immunity decrease, such as hiv, diabetes; * use of drug photosensitizer; * history of sensitivity or irritation for topic products; * active cutaneous disease which can change the study results; * history or photodermatosis active; * family or personal antecedent of cutaneous photoinduced neoplasias; * presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium; * intense solar exposure in the study area; * use of new drugs or cosmetics during the study; the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study to assess the long-term use of alprazolam extended release (xl) in the treatment of adolescents with panic disorder

Conditions: Panic Disorder

Summary: the purpose of this study is to evaluate the long-term (6-month) efficacy, safety, and tolerability of alprazolam xr in adolescents with panic disorder.

due to recruitment difficulties in this adolescent population, the clinical program for alprazolam xr was cancelled and this study was terminated on 1 september 2004. there were no safety concerns that led to this decision.

Eligibility criteria:
inclusion criteria: * a primary diagnostic and statistical manual of mental disorders, fourth edition, text revision diagnosis of panic disorder with or without agoraphobia based on the mini-international neuropsychiatric interview for children and adolescents * subjects with an average of 1) at least one 4-symptom panic attack per week over the last 4 weeks before screening; 2) at least one 4-symptom panic attack per week over the last 4 weeks before baseline; and 3) at least one 4-symptom panic attack in the 7 days prior to baseline * to enter study a6131007, subjects must have completed study a6131002, had an acceptable tolerability to study drug, and in the clinical judgment of the investigator, could have benefited from continued study treatment. exclusion criteria: * subjects must continue to meet all of the exclusion criteria enumerated in the acute efficacy study (protocol a6131002) with the following exception: subjects will be allowed to undergo cognitive-behavioral or other panic-specific therapy and any other psychotherapy (e.g., supportive and/or family therapy) during the expected study period in this study.
the comparison of changes of qtc, tp-e interval, and tp-e/qt ratio, tp-e/qtc ratio on the ecg during living donor liver transplantation under desflurane and total intravenous anesthesia -randomized controlled trial

Conditions: Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation)

Summary: prolonged corrected qt interval (qtc) has been observed in about half of patients with liver cirrhosis. marked prolongation of qtc (ie, 500 msec) has been considered to be a risk factor for fatal ventricular arrhythmia, such as torsade de pointes,7,8 which has been reported in liver transplantation (lt) surgery. in a previous study, prolonged qtc interval ( 500 msec) was frequently observed throughout the procedure of lt, even among patients with baseline qtc 440 msec. therefore, it is important to optimize electrolyte balance and hemodynamic status to reduce greater risk of perioperative arrhythmias. the investigators hypothesized that the change of qtc interval might be differ according to method of general anesthesia (inhalation agent vs. intravenous agent).


Eligibility criteria:
inclusion criteria: * patients with liver cirrhosis who will undergo planned liver transplantation exclusion criteria: * 1. emergent liver transplantation * 2. unstable angina * 3. recent mi(myocardial infarction) * 4. uncontrolled hypertension (diastolic bp \> 110mmhg) * 5. implantable cardiac defibrillator * 6. severe obesity (bmi\>30kg/m2) * 7. allergy to propofol
study of the effectiveness of the covid-19 vaccine

Conditions: COVID-19

Summary: this descriptive study examines neutralizing antibody levels against covid-19 in health workers before and after the 2nd booster of the covid-19 vaccine in surakarta, indonesia.

this research is a cross-sectional study with a descriptive-analytic design, community-based, of adults who live in surakarta (age 18 years and over) using the google form. the inclusion criteria were health workers receiving the third or second dose of the covid-19 vaccine. quantitative antibody titers are checked at prodia's laboratory. other variables examined were the number and date of vaccination, age, sex, comorbid diseases, body mass index, aefi symptoms after the vaccine, and history of being infected with covid-19. in the statistical analysis using the different and regression correlation tests, the significance level of p is less than 0.05.

Eligibility criteria:
inclusion criteria: * health workers who receive the second booster of covid-19 vaccination exclusion criteria: * pregnancy

Keywords: covid-19 vaccine, health worker
efficacy of offering a self-sampling device by the gp to reach underscreened women

Conditions: Cervical Cancer

Summary: the essag trial invests the impact of offering a free self-sampling device (ssd) on the cervical cancer screening rate of underscreened women. this study is aimed at women between the age of 31 and 65 who did not have a smear taken during the last 6 years. in order to assess the effect of a) providing the ssd, and b) the intervention of the general practitioner (gp) (either face-to-face, either by sending the ssd by letter), a randomized control trial is set up with three arms. the essag trial evolves from a collaboration between universiteit gent and vrije universiteit brussel, katholieke universiteit leuven, universiteit antwerpen, sciensano, het centrum voor kankeropsporing en het belgisch kankerregister, and is funded by "kom op tegen kanker".


Eligibility criteria:
inclusion criteria: * women between 31-64 years old * living in flanders * eligible for the flemish actions with regard to population screening * without a smear registered in the belgian cancer registry in the last 6 years * registered as gmd patient in one of the participating gp practices exclusion criteria: * hysterectomy * pregnancy * (past) diagnosis of cervical cancer

Keywords: prevention screening
collection and storage of human biospecimens for research into rare diseases and medical conditions

Conditions: Rare Genetic Disorders

Summary: the objective of this protocol is to enable collection of biospecimens to facilitate current and future multidisciplinary research in rare genetic disorders and medical conditions.


Eligibility criteria:
inclusion criteria: * willing and able to provide written, signed informed consent * willing and able to comply with all study procedures exclusion criteria: * use of any investigational product or investigational medical device within 30 days prior to screening, except as part of a biomarin-sponsored study * concurrent disease or condition that would interfere with study participation or safety.
paediatric subjects - special survey

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in japan. the aim of this study is to collect safety and efficacy data when using insulin aspart in children with diabetes under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * subjects with diabetes requiring insulin therapy exclusion criteria: * subjects who had treatment history of insulin aspart
exercise, arterial cross-talk modulation and inflammation in an ageing population

Conditions: Cardiovascular Disease; Obesity; Atherosclerosis; Heart; Disease, Activity

Summary: the aims of the study are twofold. in the cross-sectional approach (part i), the study will be conducted in an older population to assess the association of physical fitness on different parts of the human vascular bed. in the interventional approach (part ii), it aims to investigate whether and to what extent advanced vascular ageing (ava) in older subjects with increased cardiovascular risk can be reversed by regular walking- based high intensity interval training.

in the cross-sectional part the investigators analyze physical fitness, vascular health and further outcomes in a healthy older active, a healthy older sedentary and a obese sedentary group with increased cardiovascular risk. the investigators will analyze large and small artery function, physical fitness and activity as well as inflammatory parameters in these three groups. here the investigators will investigate the influence of physical activity and inflammatory parameters on the vascular health in different beds. in the intervention part the older sedentary group with increasing cardiovascular risk (osr) will be randomized in a control and an intervention group. the intervention group will get a high intensity interval training which is walking based and individual adjusted. the control group will get general lifestyle recommendations. after 12 weeks of training osr group will be tasted again. the aim of the second part is to assess the effect of high intensity interval training on vascular health and inflammatory parameters.

Eligibility criteria:
inclusion criteria: * men and women aged 50-79 years * active lifestyle: \> 9 met/week (\> 3hours moderate walking/week); 18.5≤ bmi ≤ 29.9 kg/m2 * sedentary lifestyle: ≤ 3 met/week (≤ 1 hour moderate walking/week); 18.5≤ bmi ≤ 29.9 kg/m2 * sedentary men and women aged 50-79 years with increased cardiovascular risk are allowed to have ≥ one additional cardiovascular risk factor exclusion criteria: * history of cardiovascular, pulmonary or chronic inflammatory disease * blood pressure ≥ 140/90 mmhg during 24h monitoring * current or past smoker (in healthy group) * macular degeneration or glaucoma * compromising orthopaedic problems

Keywords: arterial stiffness retinal vessels physical activity ageing
association between the menstrual cycle and weight loss

Conditions: Overweight; Obesity

Summary: this is a research study to look at the association between weight loss and the menstrual cycle in healthy, overweight, premenopausal women. participants will be asked to follow a reduced-calorie diet and exercise plan for 3 months.

two different reduced calorie diet and exercise plans will be compared. one plan changes diet and exercise prescription with the phases of the menstrual cycle, while the other is a standard reduced calorie diet and exercise plan based on mypyramid.gov website.

Eligibility criteria:
inclusion criteria: * healthy females between the ages of 18-40 (inclusive) * bmi between 26.5-35.4 kg/m² (inclusive) * regular menstrual cycle (28 ± 3 days) * weight stable (within ± 3-kg) 2 months prior to study inclusion * must use barrier contraception (e.g. male/female condom) for the study's duration * must be willing to follow the prescribed diet/exercise plan for the study's duration exclusion criteria: * on hormonal contraceptives or any other daily use of medications which can make the subject unsuitable for inclusion in the study. * any significant health problem (history of cancer, hiv/aids, diabetes, cardiovascular disease, untreated hypothyroidism, etc.) * restrictions against participating in cardiovascular exercise and strength training * any condition, which in the opinion of the investigator makes the subject unsuitable for inclusion in the study. * women who are pregnant, lactating, or planning to become pregnant during the study period
ca-125 and severity of pre-eclampsia

Conditions: Pre-Eclampsia

Summary: the aim of this study is to determine the relationship between serum concentrations of cancer antigen-125 (ca-125) and pre-eclampsia severity.

although the source of ca-125 during pregnancy is the fetal chorion, amniotic fluid, and maternal decidua, the perinatal dynamics of maternal serum ca-125 requires clarification. clinical studies of ca-125 levels and its function in hypertensive pregnant patients are limited and offered contradictory results (cebesoy et al., 2009). and so we investigate ca-125 in normal pregnancy and in pre-eclampsia, comparing mild and sever pre-eclampsia to determine relationship of ca-125 and severity of the disease. patients will be divided in three groups: * control: 40 normal healthy pregnant women attending the er in labor. * mild pre-eclampsia: 40 patients fulfilling the following criteria. * blood pressure: systolic blood pressure \>140 and \ 90 and \<110 * proteinuria: 300 mg (+) assessed by urine urignost 3a® (urine strips from dialab). * no symptoms of severity as headache. * normal investigations for different organ function (as liver and kidney function). * severe pre-eclampsia :40 patients fulfilling anyone or more of the following criteria (the american college of obstetricians and gynecologists, 2010)(acog): * systolic blood pressure \> 160 mmhg * diastolic blood pressure \> 110 mmhg (on two occasions at least 6 hours apart while the patient is on bed rest) * proteinuria of 5000mg (5g) or higher on a 24-hour urine collection or at least 3+ on two random urine samples collected at least 4 hours apart * oliguria \< 500 ml urine output in 24 hours * cerebral or visual functional disturbances (cns irritability) * pulmonary edema or cyanosis (not due to excessive intravenous volume replacement) * epigastric or right-upper quadrant abdominal pain * impaired liver function on laboratory analysis (elevated aspartate aminotransferase (ast), alanine amino transferase(alt), or lactate dehydrogenase(ldh)) * thrombocytopenia (platelet count \< 150,000/ul) * fetal growth restriction.

Eligibility criteria:
inclusion criteria: * pregnant women 3rd trimester * any age * medically free at least by history * signs and or symptoms of pre-eclampsia exclusion criteria: * other causes elevate ca-125 as: ovarian cancer, endometrial cancer, breast cancer and benign conditions as: endometriosis and liver cirrhosis. chronic hypertension * diabetes mellitus (dm) * liver diseases * thyroid disorders * kidney diseases * cardiac diseases

Keywords: ca-125 pre-eclampsia
memory retrieval and encoding investigated by neural stimulation

Conditions: Epilepsy Intractable

Summary: the purpose of this research is to understand biomarkers of human memory through correlational analyses and to use focal electrical stimulation as a causal manipulation to understand how biomarkers of memory relate to other brain states and behavioral measures.


Eligibility criteria:
inclusion criteria: 1. expected to undergo intracranial implantation and postoperative electroencephalographic monitoring as part of a standard clinical procedure for the treatment of pharmacologically resistant epilepsy 2. age 18 or older exclusion criteria: 1. any physical or cognitive disability or illness that would limit their ability to perform cognitive tasks 2. any medical condition that would, in the investigator's opinion, limit the subject's participation in the study. 3. unable or unwilling to provide informed consent 4. mri contraindications standard clinical care includes a pregnancy test for female patients prior to the surgical implantation of the electrodes. pregnant women are not surgically implanted.

Keywords: episodic memory