Kornimate/medical-research-clean huggingface dataset:
starting incremental prescription of peritoneal dialysis

Conditions: Peritoneal Dialysis (PD); Kidney Failure

Summary: kidney failure is fatal without dialysis. peritoneal dialysis (pd) completed at home offers greater flexibility and autonomy for patients . however, pd is often prescribed for 24 hours/day, 7 days/week for every patient starting dialysis. this practice is not evidence-informed, may be unnecessary and potentially harmful. the step-pd trial aims to determine the optimal approach to commencing patients on pd through starting at low dose pd and incrementing over time.

the step-pd study is an investigator-initiated, pragmatic, international, multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial led by an international multi-disciplinary team of clinician scientists, nephrologists, consumers, social scientists, trialists, health economists, dialysis nurses, statisticians, and registry experts. the step-pd trial is co-designed with consumers with lived experience of peritoneal dialysis (pd) to determine the optimal approach to starting patients with kidney failure on pd. specifically, this trial will test the hypothesis that, compared with full dose pd, starting patients on incremental start pd preserves symptom burden related quality of life (qol), reduces dialysis burden, is safe, is more environmentally sustainable and costs less for patients, the community and the healthcare system. the step-pd trial has the potential to transform and personalise the treatment of kidney failure globally by providing definitive evidence on the patient-prioritised question regarding the effectiveness and safety of incremental start pd, particularly in relation to the patient-critical outcome of symptom burden-related qol. favourable results would lead to a paradigm shift in how patients are started on pd, thereby mitigating unnecessarily burdensome, expensive, and possibly harmful treatment.

Eligibility criteria:
inclusion criteria: * adults (≥18 years) commencing pd as their first dialysis therapy (and been on dialysis for \<1 month) * able to give informed consent exclusion criteria: * urine output \<0.5l/day * previous kidney transplant * unlikely to be on dialysis for ≥1 year. * known or planned pregnancy during the trial

Keywords: kidney failure kidney disease peritoneal dialysis incremental start pd
a drug-drug interaction study to investigate the effect of coadministration of edp-305 on the pk of a combined oral contraceptive in healthy female subjects

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: a phase 1, open-label, fixed-sequence study to investigate the effects of edp 305 on the pharmacokinetics of a combined oral contraceptive in healthy adult female subjects


Eligibility criteria:
inclusion criteria: * females of childbearing potential, 18 to 45 years of age, inclusive. follicle-stimulating hormone levels may be used to confirm premenopausal status, including females who have had a hysterectomy with ovaries still intact. women who otherwise meet inclusion criteria and who have had tubal ligation, tubal occlusion, or bilateral salpingectomy will be allowed. * body mass index between 18.0 and 32.0 kg/m2, inclusive. * in good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ecg, vital signs measurements, and clinical laboratory evaluations at screening and day -1 of the lead-in period * must not be pregnant or lactating, and must agree to use contraception * subjects must have documentation of normal results of up-to-date cervical cancer screening as specified in the american college of obstetricians and gynecologists guidelines: 1. women aged \< 21 years: no documentation required 2. women aged 21 to 29: normal pap smear test result within previous 3 years 3. women aged 30 to 45: normal pap smear test result and negative high-risk human papilloma virus test within previous 5 years, or normal pap smear test result within previous 3 years if documented results are not available at screening, the subject must provide documentation of normal results prior to day -1 of the lead-in period. * able to comprehend and willing to sign an icf. * willing and able to adhere to assessments, prohibitions, and restrictions as described in this protocol. exclusion criteria: * significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gi, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). * are pregnant, breastfeeding, or are planning to conceive during the study. * have been administered injectable contraceptives within 12 months prior to day -1 of the lead in period, or had exposure to a hormonal intrauterine device or topical controlled delivery contraceptives (patch) within 3 months prior to day -1 of the lead-in period.

Keywords: oc ddi, drug-drug interaction, oral contraceptive
realistic models of gastrointestinal bioelectromagnetism

Conditions: Ischemia

Summary: the purpose of this study is to look at the electrical activity present in healthy and diseased smooth muscle of the intestines; and develop both mathematical and computer models.

the superconducting quantum interference device (squid)is a large cylinder machine located in a large shielded room that measures magnetic activity of the intestines. subjects will be asked to lie underneath and get recordings of the electrical activity of their intestines. they will also be asked to have a ct scan done. from these two procedures, the mathematical and computer models will be developed to determine the difference between normal bowels and those that do not have adequate blood supply.

Eligibility criteria:
inclusion criteria: * normal subjects and those with diseased bowel exclusion criteria: * subjects with claustrophobia

Keywords: blood supply mesentery
southeast netherlands advanced metastatic breast cancer registry

Conditions: Advanced Breast Cancer; Metastatic Breast Cancer

Summary: the southeast netherlands advanced breast cancer (sonabre) registry is a real life multi-center study. the registry aims to include all patients diagnosed with advanced breast cancer as of 2007 in 11 hospitals in the netherlands. data on patient, tumor and treatment characteristics are collected retrospectively from electronic medical files by trained registry clerks.

this sonabre registry is an ongoing observational cohort study aiming at the inclusion of all patients aged ≥18 years and diagnosed with advanced breast cancer since 2007 in 11 hospitals in the southeast of the netherlands. patients with de novo or recurrent advanced breast cancer were identified from the hospital-based management information systems. specially trained registration clerks retrospectively collected data from the medical files of the patients based on extensive medical chart review. information was collected about patient and tumour characteristics, type of treatment (surgery, radiotherapy and systemic treatment, both neo-adjuvant, adjuvant and palliative), palliative treatment changes due to adverse events, hospitalization, comorbidities and outcomes (progression and death). the sonabre registry has already been effectively used to perform real-life studies on the use, safety and (cost-)effectiveness of various systemic treatments used in patients diagnosed with advanced breast cancer.

Eligibility criteria:
inclusion criteria: * diagnosed with de novo or recurrent advanced breast cancer since 2007 * diagnosed with or treated for advanced breast cancer in one of the participating hospitals * participating hospitals (period of inclusion): maastricht umc+ (2007-2025), zuyderland hospitals sittard/heerlen (2007-2025), amphia hospital breda (2013-2025), catharina hospital eindhoven (2007-2025), elkerliek hospital helmond (2010-2025), maxima medical center veldhoven/eindhoven (2007-2025), jeroen bosch hospital den bosch (2013-2025), laurentius hospital roermond (2007-2025), st. annaziekenhuis geldrop (2007-2025), st. elisabeth hospital tilburg (2007-2009), st. jans gasthuis weert (2007-2025), viecuri medical center venlo/venray (2013-2025), all in the netherlands. * hospitals (and periods) were eligible for inclusion if (distant) registration from maastricht umc+ was possible. * the inclusion period may be prolonged after 2025. exclusion criteria: none

Keywords: breast neoplasms neoplasm metastasis registry
tranexamic acid for preventing postpartum hemorrhage following a cesarean delivery

Conditions: Postpartum Hemorrhage

Summary: the aim is to assess the impact of tranexamic acid (txa) for preventing postpartum hemorrhage (pph) following a cesarean section (cs).

regarding the prevention of pph, recent randomized controlled trials (rcts) of unclear quality have suggested that txa may reduce blood loss and maternal morbidity, while a cochrane collaboration review has concluded, that "txa (in addition to uterotonic medications) decreases postpartum blood loss and prevents pph and blood transfusions following vaginal birth and cs in women at low risk of pph based on studies of mixed quality. further investigations are needed on efficacy and safety of this regimen for preventing pph. treatment, that is a 10-ml blinded vial of the study drug (either 1g txa or placebo according to the randomization sequence), will be administered intravenously to the participant women during the third stage of labor of cesarean delivery. the follow-up visit will take place in the postpartum ward of the maternity unit, on d2 postpartum. this stage will include a venous blood sample to measure plasma concentrations of hb and ht, urea and creatinemia, prothrombin time (pt), active prothrombin time (aptt), aspartate and alanine transaminase, total bilirubin and fibrinogen, and the completion of a self-questionnaire about satisfaction by the women, as well as the assessment of the adverse events. at 8 weeks postpartum, a self-questionnaire assessing psychological status and well-being will be sent to the women. at 12 weeks postpartum, all participants will be contacted by phone to assess the incidence of thrombotic and any other significant events.

Eligibility criteria:
inclusion criteria: * : adult women admitted for a cesarean delivery before or during labor, at a term ≥ 34 weeks, * hemoglobin level at the last blood sample \>9g/dl, * available blood test for hb and ht within one week before caesarean delivery, * informed signed consent exclusion criteria: * previous thrombotic event or preexisting pro-thrombotic disease, * epileptic state or history of seizures, * presence of any chronic or active cardiovascular disease outside hypertension, * any chronic or active renal disease and chronic or active liver disease at risk thrombotic or hemorrhagic, autoimmune disease, * sickle cell disease, * placenta praevia, * placenta accreta/increta/percreta, * abruption placentae, * eclampsia, * hellp syndrome, * significant hemorrhage before cesarean section * in utero fetal death, * administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery, * planned general anesthesia, * hypersensitivity to tranexamic acid or concentrated hydrochloric acid, * instrumental extraction failure, * multiple pregnancy with vaginal delivery of the first child, * poor understanding of the french language.

Keywords: randomized double blind placebo controlled trial prevention tranexamic acid postpartum hemorrhage cesarean
impact of glossopharyngeal nerve block on swallowing difficulties caused by gastroesophageal reflux disease

Conditions: Dysphagia

Summary: the goal of this clinical trial is to explore clinical effect of glossopharyngeal nerve block on pharyngeal dysphagia induced by gastroesophageal reflux disease. the main question it aims to answer is: • can glossopharyngeal nerve block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given glossopharyngeal nerve block once a day additionally. the study lasts 20 days for each participant. researchers will compare the rosenbek penetration-aspiration scale, gastroesophageal reflux disease questionnaire, pressure pain threshold, to see if the glossopharyngeal nerve block can help improve the symptom.

gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus. the goal of this clinical trial is to explore clinical effect of glossopharyngeal nerve block on pharyngeal dysphagia induced by gastroesophageal reflux disease. the main question it aims to answer is: • can glossopharyngeal nerve block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given glossopharyngeal nerve block once a day additionally. the study lasts 20 days for each participant. researchers will compare the rosenbek penetration-aspiration scale, gastroesophageal reflux disease questionnaire, pressure pain threshold, to see if the glossopharyngeal nerve block can help improve the symptom.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for gastroesophageal reflux disease. * age between 18 and 85 years. * confirmed tongue-pharyngeal nerve injury by electromyography. * esophageal manometry and barium swallow examination confirming the presence of pharyngeal dysphagia. * normal higher brain function, able to cooperate with treatment. exclusion criteria: * brain vascular disease diagnosed. * clinical assessment and swallowing videofluoroscopic examination revealing cognitive phase, oral preparatory phase, or oral phase disorders. * concurrent presence of other neurological disorders such as alzheimer's disease, traumatic brain injury, parkinson's disease. * esophageal obstruction and severe liver or kidney dysfunction * subjective unwillingness to undergo the treatment and presence of psychiatric abnormalities, etc.
assessment of circulating copeptin levels in healthy subjects and patients with renal insufficiency after oral water load and hypertonic saline infusion

Conditions: Hypoosmolality; Hyperosmolality; Renal Failure

Summary: the are 2 principal goals in this study: 1. to measure plasma copeptin levels in healthy subjects and to correlate them with plasma avp concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states. 2. to measure plasma copeptin concentrations in patients with chronic renal failure under the same conditions described above, in order to characterize the impact of renal function on circulating copeptin levels in correlation to plasma avp and urine osmolality.


Eligibility criteria:
inclusion criteria: * chronic renal failure grade i through iv * healthy age-matched controls exclusion criteria: * chronic renal failure grade v * heart failure * liver disease * nephrotic syndrome * anemia (hemoglobin level \< 100 g/l) * uncontrolled hypertension (systolic bp \> 160 mmhg; diastolic bp \> 95 mm hg) * coexisting severe disease * known thyroid disease * known hypocortisolism * known hypercortisolism * known diabetes insipidus * pregnancy * lactation

Keywords: hypoosmolality hyperosmolality copeptin vasopressin
spinal manipulation and dry needling versus conventional physical therapy in patients with cervicogenic headache

Conditions: Cervicogenic Headaches

Summary: the purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation and dry needling. physical therapists commonly use all of these techniques to treat cervicogenic headaches. this study is attempting to find out if one treatment strategy is more effective than the other.

patients with cervicogenic headaches will be randomized to receive 1-2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) dry needling and hvla thrust manipulation group, or the (2) exercise and non-thrust mobilization group

Eligibility criteria:
inclusion criteria: 1. diagnosis of cervicogenic headache as defined by cervicogenic headache international study group criteria 2. headache frequency of at least one per week for a minimum of 3 months 3. minimum pain score (nprs) of 2/10 and minimum disability score (ndi) of 10/50 exclusion criteria: 1. presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia 2. red flags noted in the patient's neck medical screening questionnaire (i.e. tumors, fracture, metabolic diseases, ra, osteoporosis, history of prolonged steroid use, etc. 3. history of whiplash injury within the last 6 weeks 4. diagnosis of cervical stenosis 5. bilateral upper extremity symptoms 6. evidence of cns involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes (i.e. positive hoffman's and/or babinski reflexes). 7. two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following: 1. muscle weakness involving a major muscle group of the upper extremity. 2. diminished ue deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors 3. diminished or absent sensation to pinprick in any ue dermatome. 8. prior surgery to neck of thoracic spine 9. involvement in litigation or worker's compensation regarding their neck pain and/or headaches 10. pt or chiropractic care treatment for neck pain or headaches in the 3 months prior to baseline exam. 11. any condition that might contraindicate spinal manipulative therapy.
supervised walking groups as a model to increase physical activity in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to evaluate the impact of an exercise programme organized into supervised walking groups on metabolic control, functional capacity and overall quantity of physical activity in subjects with type 2 diabetes.

regular, moderate-intensity physical activity can attenuate hyperglycemia in subjects with type 2 diabetes. in addition, these programmes may favourably affect several other cardiovascular risk factors in these subjects. however, it still remains unclear how this evidence can be transferred into clinical practice, considering the very large number of diabetic patients and the characteristics of this population, made up predominantly of elderly, sedentary and overweight patients. in this regard, a realistic approach to this issue requires simple and easily available intervention models. walking is a typical mild-moderate aerobic physical activity which is easy to organize and does not require specific skills or preliminary sophisticated medical evaluations. this activity could therefore fit well with the need of involvement of large numbers of patients in different logistic situations. however, it has been reported that, due to the low walking speed typical of type 2 diabetic subjects, self-paced walking is inadequate to obtain a significant metabolic improvement in these subjects.

Eligibility criteria:
inclusion criteria: * diabetes known for at least 2 yr * physical inactivity * haemoglobin (hb)a1c between 6.5-9.9% * treatment with oral hypoglycaemic agents alone or associated with a bed-time insulin injection * willingness to participate in a programme of regular physical activity exclusion criteria: * moderate-severe autonomic or somatic neuropathy * severe lower limb vasculopathy * pre-proliferative or proliferative active retinopathy * moderate to severe chronic renal failure * unstable angina or recent (in the previous 3 months) myocardial infarction * acute intercurrent diseases * acute metabolic decompensation (blood glucose \>300 mg/dl or ketonuria in two consecutive checks) * use of beta-blocker drugs * subjects unable to complete a 6-min walk test

Keywords: exercise, walking, type 2 diabetes, therapy
absorption and pharmacokinetics of nitroglycerin to a new formulation

Conditions: Angina Pectoris

Summary: the study evaluate the absorption rate of different sublingual formulation of nitroglycerine (ntg) either in the form of available tablets or a new rapid absorbable gelation capsule formulation "ntg1523" by determining t-max and area under the response curve of nitoglycerine in blood concentration as well as from clinical effects after intake. data is entered on data sheet in anonymous form and processed. the results are presented in anonymous form by publication and lecture. experts are given the supplement: "the applicant's rights in a biomedical research project

ten healthy young volunteers are recruited,, and the experiments begin at 07:45 after an overneight fast. bmi and blod pressure are recorded and a catheter is inserted in an anticubical vein for blood samples. at 08.00 a sublingual tablet (takeda, nitroglycerin 0.4 milligrams) tablet or a "ntg1523" capsule with 0.4 milligrams of nitroglycerine is placed under the tongue in random order. subsequently, blood samples are taken every minute for 10 minutes, then every 10 minutes the following two hours. in addition, blood pressure and puls rate are measured every second minute the first ten minutes, and then every 10 minutes.side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme. the disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. the trial day lasts 2 hours in which blood samples are taken as described above, and blood pressure and records are stored .

Eligibility criteria:
inclusion criteria: * normal healthy volunteers * must be able to swallow tablets exclusion criteria: * insulin dependent diabetes * thyroid disease * any medial treatment