Kornimate/medical-research-clean huggingface dataset:
vasomotor symptoms (vms) progesterone study: vasomotor symptoms and endothelial function - trial of oral micronized progesterone

Conditions: Menopause

Summary: the primary purpose of this study is to determine the effects of a full dose (300 mg at hs) of oral micronized progesterone (omp) on vasomotor symptoms \[vms\] (hot flushes/night sweats), on forearm blood flow and on lipid levels and blood pressure in menopausal women without cardiovascular disease and with moderate to severe vms. the hypotheses are that progesterone will improve hot flushes, increase endothelium-dependent forearm blood flow and will decrease blood pressure without change in lipid levels.

in this 4-month study, menopausal women are randomized to either placebo or oral micronized progesterone (prometrium®). participants maintain a daily diary to keep track of their vasomotor symptoms and other factors. forearm blood flow will be assessed by venous occlusion plethysmography at baseline and after three months of therapy. screening tests at baseline to rule out heart disease include measurement of blood pressure and heart rate, electrocardiogram (ecg) and blood tests - fasting blood glucose and lipid profile. collection of serum and plasma samples at baseline and end of therapy for analysis of cardiovascular markers (e.g., c-reactive protein) and clotting and fibrinolytic markers. continued daily diary collection for one month after therapy discontinuation to look for possible rebound effects. analysis of outcomes will be by analysis of covariates, with final value as the outcome, therapy as factor and baseline values as covariate.

Eligibility criteria:
inclusion criteria: 1. menopausal women (final menstrual period one or more but less than 10 years before) 2. no evidence of vascular disease (normal bp; without diabetes mellitus; normal cholesterol levels and non-smoker for at least a year; and normal ecg.) 3. moderate to severe vms during the day and night. exclusion criteria: 1. any menstruation in the preceding year. 2. history of hysterectomy without ovariectomy unless 60 years of age. 3. use of ovarian hormone therapy (estrogen, progestin, progesterone or androgen) or selective estrogen receptor modulator (serm) therapy (raloxifene or tamoxifen) in the preceding six months. 4. body mass index (bmi) over 35 or less than 20. 5. mean of several pre-treatment blood pressures over 145/95. 6. documented abnormal cholesterol; abnormal fasting capillary glucose; abnormal angiogram; ecg or exercise stress tests or a diagnosis of diabetes mellitus; or any history suggestive of angina.

Keywords: vasomotor symptoms menopause
a study to evaluate the efficacy and safety of oral hrs-5965 in adult paroxysmal nocturnal hemoglobinuria (pnh) patients who are naive to complement inhibitor therapy

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: a study of the efficacy and safety of hrs-5965 capsules compared to eculizumab for 24 weeks in patients with pnh.


Eligibility criteria:
inclusion criteria: 1. diagnosis of pnh confirmed by flow cytometry with clone size \> 10%. 2. have not received complement inhibitor therapy; 3. ldh \> 1.5\*uln at screening. 4. hemoglobin level \< 10 g/dl at screening. exclusion criteria: 1. known or suspected hereditary or acquired complement deficiency; 2. patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/l; platelets \<30x109/l; neutrophils \<0.5x109/l); 3. presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of hrs-5965; 4. history of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.) 5. positive of hiv, hbsag or hcvab.
mindfulness-based cognitive therapy for suicide prevention

Conditions: Suicide

Summary: the purpose of this study is to test a psychotherapeutic intervention that integrates cognitive therapy and mindfulness meditation techniques to prevent suicide in military veterans.

every month the va becomes aware of approximately 1,100 veterans in va care who attempt suicide. while the va has implemented a comprehensive, multifaceted suicide prevention approach, it has yet to implement nationally any evidence-based psychotherapies targeting suicide, a gap due largely to the dearth of evidence-based therapies for suicide. primary aims of this proposal are to conduct a randomized controlled trial testing an adaptation of a cognitive-behavioral intervention, mindfulness-based cognitive therapy (mbct), for veterans on the va's high risk for suicide list. the investigators' adapted version of mbct for suicide (mbct-s) integrates mindfulness meditation techniques with the va safety plan to enhance patients' awareness of suicide triggers and appropriate coping strategies. this study has the potential to increase the range of cost effective treatment alternatives for the large number of suicidal veterans for whom evidence-based therapies are severely limited.

Eligibility criteria:
inclusion criteria: the following criteria were formulated to recruit a sample at high risk for suicide behavior. * the subject has experienced a suicidal event during the past 30 days. a suicidal event involves * 1) psychiatric hospitalization due to suicidal risk, * 2) psychiatric hospitalization if subject was already on the high risk for suicide list, * 3) suicidal ideation with suicidal intent, * 4) suicidal preparatory behaviors, or * 5) actual, interrupted, or aborted suicide attempt. and * the subject is on or will be placed on the va high risk for suicide list * or the subject had an actual, interrupted, or aborted attempt in the last year * or in the study clinician's opinion (i.e., masters or doctoral level study personnel with formal mental health training) in consultation with the pi, the suicidal event is significant enough to warrant treatment to reduce suicidal risk. exclusion criteria: * cognitive deficits that decrease the likelihood of benefit from mbct-s * severe symptoms of hallucinations or delusions * disorganized or disruptive behaviors * medically unstable * current mindfulness-based psychotherapy or receipt of 2 or more sessions of a mindfulness-based psychotherapy in the last 12 months

Keywords: suicide prevention mindfulness-based cognitive therapy mindfulness meditation veterans safety planning
iv acetaminophen for postoperative pain after pelvic organ prolapse repair

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to determine whether preoperative iv acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.

this randomized controlled trial of iv acetaminophen compared to placebo will evaluate the effect of preoperative iv acetaminophen on postoperative pain scores and narcotic requirements in women undergoing surgical repair of pelvic organ prolapse. 204 women will randomly receive 1000 mg of iv acetaminophen or saline preoperatively within 30 minutes of surgical incision. subjects will be offered narcotic and non-narcotic pain medications as needed during the postoperative period. visual analogue pain scales (vas) will be obtained at 4, 8, 12, 16, 20 and 24 hours postoperatively. narcotic consumption will be recorded in morphine-equivalents. we hypothesize that women receiving iv acetaminophen will have lower vas scores and decreased narcotic requirements compared to controls.

Eligibility criteria:
inclusion criteria: * women ≥ 18 years of age * scheduled to undergo surgery for pop via a vaginal or minimally invasive (laparoscopic/robotic) route at the university of pittsburgh medical center * women anticipated to have a hospital stay ≥24 hours exclusion criteria: * allergy/intolerance to acetaminophen * hepatic dysfunction * significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day

Keywords: iv acetaminophen postoperative pain pelvic organ prolapse surgery pelvic organ prolapse repair
cohort study of risk factors for postoperative cognitive decline

Conditions: Cognitive Decline

Summary: presently, the role of either genetic factors or biological sex in the development of postoperative cognitive dysfunction (pocd) is unknown. there is a critical need to determine which individuals are at high-risk for developing pocd by virtue of biological sex or genetic predisposition. the knowledge gained in the described research has the potential to shed light on mechanistic pathways, a necessary next step in order to ultimately identify therapeutic strategies.

adults 65 years and older represent the fastest-growing age group in the united states, and account for one third of all surgical patients. these older adults are at the highest risk for deleterious postoperative neurocognitive outcomes. postoperative cognitive dysfunction (pocd) occurs in up to 40% of older adults after major non-cardiac surgery. pocd is a syndrome characterized by a decrease in performance on neuropsychological test battery from before to after surgery. neuropsychological testing for pocd typically spans cognitive domains including memory, attention, concentration, and/or executive function. there is an increasing body of literature suggesting that exposure to surgery and anesthesia increases the risk of alzheimer's disease (ad). surgery and anesthesia enhance neuropathologic changes known to underlie ad including amyloid beta accumulation and aggregation, neuroinflammation, increased levels of tau and tau phosphorylation, and memory decline. however, not everyone with a history of surgery and anesthesia develops pocd, suggesting biological risk factors are involved.

Eligibility criteria:
inclusion criteria: * scheduled for an in-patient, elective spine surgery where subject will receive general anesthesia * presenting to spine clinic and undergoing conservative, non-surgical management of spine disorder * subjects must have sufficient vision and hearing to complete neuropsychological testing * proficient in spoken and written english language exclusion criteria: * diagnosed dementia or dementia-related treatment (i.e. donepezil prescription, or memory-care facility residence) * significant disease of the central nervous system (cns) (i.e. parkinson's disease) * history of stroke or traumatic brain injury * major psychiatric disorder (i.e. schizophrenia) * alcohol or drug abuse according to dsm-v within the last 2 years * need for urgent/emergent surgery * surgery/anesthesia within prior 12 months * refusal of consent

Keywords: anesthesia, risk factors, age
transcranial photobiomodulation for the treatment of opioid cravings

Conditions: Opioid-use Disorder; Depression, Anxiety; Craving

Summary: the investigators wish to test the hypothesis that transcranial photobiomodulation (tpbm) (i.e., 4-minutes of 810nm near-infrared light at 250 mw/cm2 by led to the forehead at f3 or f4 versus an indistinguishable placebo treatment) can safely reduce opioid craving in individuals with opioid dependence in a within-patient study.

opioid use disorders (oud) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. the investigators have developed a novel treatment that combines transcranial photobiomodulation (t-pbm) and schiffer's dual brain psychology (dbp) the investigators will use a randomized, double-blind, placebo-controlled protocol in which 22 patients with significant opioid cravings and a history of recent or current oud attended three one-hour weekly sessions. after baseline measures of opioid craving, and other psychometrics, subjects will receive two unilateral t-pbm applications (810 nm cw led, 250 mw/cm2, 60 j/cm2, 4 min) or a sham (foil-covered led) at f3 or f4. prior to any treatment, the investigators will use 2 tests to determine which hemisphere is more associated with a negative outlook and cravings and will treat that side before the more positive hemisphere. the primary outcome measure will be an opioid craving scale (ocs). plus weekly hamilton depression (hdrs) and anxiety (hars) rating scales prior to treatments. patients will be closely monitored for any possible adverse side-effects from the treatment.

Eligibility criteria:
inclusion criteria: * patients complain of opioid cravings * between the ages of 18 and 65. * meet criteria for a history of opioid dependence by dsm v. exclusion criteria: * a past history of a psychotic disorder (including schizophrenia or schizoaffective disorder) * a history of violent behavior * a history of a past suicide attempt * a history of current suicidal ideation * a history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), pregnancy, * any current acute or chronic medical condition that might confound the study. * any patient judged by an investigator to have an impaired decision-making capacity

Keywords: opioid craving opioid use disorder depression anxiety transcranial photobiomodulation near infra-red light dual-brain psychology cerebral laterality
recovery after critical covid-19 infection

Conditions: Covid-19

Summary: the study focuses on the recovery of respiratory, cardiovascular and neurological/neuropsychological recovery after intensive care treatment for covid-19. the results will be compared with those obtained from patients treated in the regular wards for covid-19, persons with home treated covid-19 and non-covid controls.

eligible patients who have been treated in the intensive care units of helsinki university hospital are invited to participate. controls are recruited from follow-up clinics, and with announcements in media and websites. the participants receive an invitation to a follow-up clinic where their experiences from the icu treatment and recovery will be discussed. the investigators will perform neuropsychologic testing (6 months post-discharge), a telephone interview (3 months) and send written questionnaires (3, 6 and 24 months) to the participants. the participants will undergo mri imaging of the brain and laboratory tests will be taken. the olfactory function will be tested at a follow-up clinic. data on the patients´ respiratory function from clinical spirometry and diffusion capacity testing 3 and 6 months after discharge are collected. the patients will perform a 6 min walk test. data on coagulation laboratory values will be registered from acute phase and 6 months after discharge. the investigators will also analyse apoe alleles, neurofilament light and nad-metabolites and study their correlation with neuropsychologic findings and long term symptoms (up to 5 years after hospital discharge). participants will also undergo magnetic resonance imaging of the heart at 6-12 months after the hospital discharge, and laboratory samples, a symptom questionnaire and electrocardiogram are collected. inflammatory parameters and variables associated with regulating inflammation and coagulation will be analysed. clinical data from the acute and post-acute phase and demographic data are collected from the patient data management systems. the target patient number is 75 intensive care treated patients and 50 control persons in each three control group.

Eligibility criteria:
inclusion criteria: * age 18-100 * positive pcr for sars-cov-2 (except non-covid controls, who must be negative) * native language finnish or swedish * informed consent to study to study participation exclusion criteria: * age under 18 * pregnant or lactating * major neurologic diagnosis (tbi, dementia, stroke, parkinson´s disease before covid-19) * substantially impaired hearing or vision * developmental disability. * no consent to study participation * contraindication to mr imaging (such as cardiac pacemaker, allergy to contrast)

Keywords: intensive care unit cognitive function delirium post-traumatic stress
prevention of persistent pain with lidocaine infusions in breast cancer surgery (plan)

Conditions: Post-mastectomy Pain Syndrome; Breast Cancer; Pain, Postoperative; Pain, Chronic

Summary: phase iii, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.

plan is a multicentre, parallel-group, blinded, randomized controlled trial of 1,602 patients undergoing breast cancer surgery. consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room). patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution). study medications will be prepared in blinded 50 ml syringes and labelled as per regulatory requirements. patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or brca gene mutation) exclusion criteria: 1. previous breast surgery within 6 months of index surgery 2. undergoing any autologous flap procedure during index surgery 3. presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery 4. documented hypersensitivity or allergy to lidocaine 5. surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block) 6. history of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker 7. known cirrhotic liver disease 8. pregnant 9. unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)
smart - systems medicine of heart failure

Conditions: Aortic Valve Disease

Summary: the onset and course of heart failure (hf) is triggered by a complex regulatory network that includes stressors (pressure overload by individual anatomic hemodynamic settings), intrinsic (genes), environmental (regulating epigenetics), and modifying factors (such as hor-mones and the immune system). smart aims to establish individualized strategies for the prevention and management of hf by early detection of the physiological, genomic, proteo-mic and hemodynamic mechanisms that lead from onecommon cause of ventricular dysfunction (pressure overload) to maladaptive remodelling and irreversible hf. to cope with the complexity of hf, smart will interrelate models describing the interplay between ge-nome, proteome and cell function, regulating hormones, tissue composition and hemody-namic whole organ function up to a whole body description of a patient and patient cohorts. the ultimate goal is to demonstrate proof-of-concept tools for predicting disease evolution and efficacy of treatment in a given patient. to achieve this task smart will apply * a modelling framework that couples multi-scale mechanistic models with in-depth genome/proteome, cell physiology and whole organ (biomechanical and fluid dynamic) models * subsequently, investigate methods validity and relevance for "quantitative prediction" of treatment outcome in a clinical proof-of-concept trial (demonstrator) of patients with aortic valve desieases.


Eligibility criteria:
inclusion criteria: * aortic valve stenosis exclusion criteria: * coronary heart disease
real-world treatment patterns and clinical outcomes in egfr-mutant unresectable locally advanced nsclc

Conditions: Non Small Cell Lung Cancer; Stage III Non-small-cell Lung Cancer; EGFR Mutation-Related Tumors

Summary: the investigators will obtain a cohort of patients from multiple large cancer centers in china and try to unravel the efficacy of "radiotherapy combined with egfr-tki", which may provide some evidences for the treatment of stage iii-inoperable nsclc.

the frequency of egfr mutations in patients with stage iii inoperable adenocarcinoma or non-squamous cell carcinoma is 17-31%, which is relatively low. compared to patients with egfr wild type, the efficacy of radiotherapy or chemo-radiotherapy may be different in egfr mutant patients. some small sample studies showed, compared with patients with egfr wild type, patients with egfr mutations have a lower risk of local recurrence and a higher risk of distant metastasis under the standard treatment for stage iii lung cancer, which demonstrate the strength of systemic therapy may help. radiotherapy combined with egfr-tyrosine kinase inhibitors(tki) is a feasible treatment strategy. in view of the low mutation frequency and few prospective research results, the investigators try to explore the survival differences of three treatment strategies used in clinical practice based on the real world data. the investigators will obtain a cohort of patients from multiple large cancer centers in china and try to unravel the efficacy of "radiotherapy combined with egfr-tki", which may provide some evidences for the further study.

Eligibility criteria:
inclusion criteria: * histologically confirmed nsclc with adenocarcinoma * stage iii (ajcc 7th edition) * inoperable or refuse surgery * egfr-tki mutation, specimen from tissue or blood exclusion criteria: * the pathology was not adenocarcinoma * stage i,ii and iv * anaplastic lymphoma kinase (alk) rearrangement * no follow-up data achievable
application of ectoine nasal spray in comparison with cromolyn sodium containing nasal spray in patients with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: this is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of ectoin allergy nasal spray. in addition the effectiveness and safety shall be compared to a cromoglycid acid containing nasal spray. the patient applies ectoin allergy nasal spray or cromoglycid acid containing nasal spray according to the instructions for use. the observation takes place over a period of 14 days. response to treatment is recorded at day 7 and day 14 by the physician and by the patient in a dairy at defined time intervalls.


Eligibility criteria:
inclusion criteria: * female or male individuals ≥ 18 years * patients with proven allergic rhinitis which are treated with ectoin nasal spray or -cromoglycic acid nasal spray during the observational period exclusion criteria: * contra indications according to the label

Keywords: ectoine bitop allergic rhinitis