Kornimate/medical-research-clean huggingface dataset:
the efficacy and safety of at-home transcutaneous electrical nerve stimulation in insomnia

Conditions: Insomnia

Summary: the purpose of this study is to explore the effects and safety of transcutaneous electrical nerve stimulation (tens) at home for patients diagnosed with insomnia on the improvement of insomnia and nervous stability.


Eligibility criteria:
inclusion criteria: * men and women between the ages of 19 and under 65 * those who meet the criteria for the diagnostic and statistical manual of mental disorders (dsm-5) for insomnia * those with a score of 8 or higher based on the korean version insomnia severity index (isi-k) * a person whose sleeping environment and habits are regular, usually between 9:00 p.m. and 1:00 a.m., go to bed, lie down for 7 to 10 hours, and wake up between 5 and 10 a.m. * in the case of patients who regularly take drugs for improving insomnia at least once a week, those who agree to discontinue taking the prohibited drugs in this study for a total of 5 weeks, 1 week to remove the drug effect after screening and 4 weeks for the clinical study period * persons who do not have a reason to prohibit the use of electrotherapy that can significantly affect biomarkers in relation to this study * a person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and understanding a sufficient explanation about this clinical trial exclusion criteria: * those who have been diagnosed with sleep arousal disorders other than insomnia (hypersomnia disorder, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep arousal disorder, parasomnia) * those who have insomnia due to physical illness or medications being taken * patients with major medical and neuropsychiatric diseases other than sleep disorders * persons who have had or are currently undergoing dental treatment with a history of implanting metallic materials into the upper body, such as the transcranial or face, neck, etc., where non-invasive electrical stimulation is difficult or impossible * compliance was evaluated by writing a sleep diary for 1 week from the start of treatment, and if a sleep diary of 3 days or less was kept for 1 week, it was excluded from the study. * those who have changed the type and dose of drugs used within the last 3 months, or the type and time of cognitive behavioral therapy * if you are currently registered in another clinical trial or use another clinical trial drug or device within 60 days from the time of screening exclusion criteria prior to intervention (after the sleep diary for one week after the screening test, if the following criteria are met, the patient will be excluded from participation in the study before the intervention.) * those with less than 8 points based on the korean version of insomnia severity index (isi-k) * when writing a sleep diary for a week, if it is written for less than 3 days or has an irregular sleep schedule

Keywords: transcutaneous electric nerve stimulation, tens insomnia trigeminal nerve stimulation
culturally based brief expressive writing intervention for the improvement of health in chinese immigrant stage 0-iii breast cancer survivors, writing to heal study

Conditions: Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage 0 Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8

Summary: this clinical trial studies the effect of a culturally based brief expressive writing intervention in improving the health of chinese immigrant stage 0-iii breast cancer survivors. culturally based brief expressive writing interventions may help researchers learn more about the experiences of chinese immigrant breast cancer survivors and how writing about their experiences may affect their health.

primary objectives: i. to determine the health benefits of expressive writing compared with the control condition. ii. to characterize how acculturation moderates the effects of expressive writing interventions. iii. to identify mechanisms explaining the benefits of the interventions using mixed methods. outline: patients are randomized to 1 of 3 arms. arm i (control): patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions. arm ii (self-regulation): patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions. arm iii (self-cultivation): patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions. after completion of study, patients are followed up at 6 weeks and at 6 and 12 months.

Eligibility criteria:
inclusion criteria: 1. being diagnosed with stage 0-iii breast cancer. 2. completed primary treatment, including surgery, chemotherapy, radiation therapy, immune therapy, and/or targeted therapy within the preceding 5 years. 3. foreign-born chinese women (aged 18 and older) who lived in the u.s. for at least six months in the past. exclusion criteria: 1. exclusion criteria include inability to provide informed consent
as703569 and gemcitabine combination in advanced malignancies

Conditions: Pancreatic Cancer

Summary: in clinical practice and research, combination of anticancer agents is often used to improve efficacy of treatment. in vitro and in vivo experiments have shown additive-synergistic anti-tumour effects of as703569 treatment when combined with gemcitabine. specifically, additive-synergistic anti-tumour effects were noticed when the two agents were given sequentially and not concomitantly i.e. as703569 given the day before or the day after gemcitabine. this trial was designed to investigate in parallel two regimens testing sequential administration of as703569 either the day after gemcitabine infusion, (regimen 1) or the day before (regimen 2).


Eligibility criteria:
inclusion criteria: histologically/cytologically confirmed diagnosis of measurable or assessable malignancy, who meets one of the following conditions: subject with a tumour for which gemcitabine is approved, subject with a tumour for which gemcitabine is considered standard of care, subject with other tumour type either refractory or intolerant to or for whom there is not an accepted standard treatment. male or female with at least 18 years of age. life expectancy of at least 3 months. eastern cooperative oncology group (ecog) performance status \< 2. no more than 3 prior chemotherapy regimens for advanced/metastatic disease. at least 4 weeks since last chemotherapy, hormonal therapy, immunotherapy, biological or any other pharmacological or investigational treatment or radiotherapy (6 weeks wash-out for nitrosoureas and mitomycin c, 5 half-lives for non-cytotoxics). subjects on chronic hormonal therapy may continue with the same treatment unchanged. adequate renal, hepatic and bone marrow functions (assessed 7 days before inclusion in the trial) as defined by: serum creatinine

Keywords: as703569 msc1992371a aurora kinase inhibitor cancer treatable with gemcitabine
influence of oral doxycycline on wound healing after endonasal endoscopic sinus surgery for chronic rhinosinusitis with and without nasal polyposis: a double-blind randomized placebo-controlled trial

Conditions: Chronic Rhinosinusitis; Nasal Polyps

Summary: this is a randomized, double blind, placebo controlled, parallel group, study in patients with chronic rhinosinusitis with or without nasal polyps. the objective is to test the clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery.


Eligibility criteria:
inclusion criteria: * at least 18 years of age, of either sex and any race * diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the epos guidelines research * subjects should be regularly scheduled for bilateral functional endonasal endoscopic sinus surgery * subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety. * subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries. * nonpregnant women of childbearing potential must use a medically acceptable, adequate form of birth control. exclusion criteria: * women must not be pregnant, breast feeding, or premenarcheal. * subjects who have required oral corticosteroids within the previous four weeks prior to surgery. * subjects who have required nasal corticosteroids within the previous one week prior to surgery. * subjects with known allergic reaction on tetracyclines, diabetes (type 1 and 2), renal insufficiency, severe liver disease, systemic diseases affecting the nose (e.g. m. wegener), prior surgeries of the paranasal sinuses. * patients with the following diseases should be excluded : 1. cystic fibrosis based on positive sweat test or dna alleles 2. gross immunodeficiency (congenital or acquired) 3. congenital mucociliary problems e.g. primary ciliary dyskinesia (pcd) 4. non-invasive fungal balls and invasive fungal disease 5. systemic vasculitis and granulomatous diseases 6. cocaine abuse 7. neoplasia

Keywords: rhinosinusitis doxycycline chronic rhinosinusitis with or without nasal polyps
postpartum anemia and postpartum depression

Conditions: Postpartum Depression

Summary: postpartum anemia (ppa) and postpartum depression (ppd) are common afflictions affecting women after childbirth. both disorders have a significant impact on women's health and functional status. despite common symptoms and characteristics, a link between these entities has not been adequately studied. the objective of this study is to determine whether postpartum anemia is an independent risk factor for the development of postpartum depression. this prospective cohort study will include all women delivered by elective term cesarean delivery. hemoglobin and iron levels will be measured, standardized questionnaires for assessment of ppd, functional status and lactation will be administered before discharge and at 3 \& 6 weeks post partum. hemoglobin levels at each time point will be analyzed for correlation with depressive symptoms, functional status and lactation success.


Eligibility criteria:
inclusion criteria: * women after term elective cesarean section exclusion criteria: * age \< 16 years, preterm (\< 37 weeks) delivery, multiple gestation, symptomatic anemia necessitating blood transfusion, significant fetal anomalies or infant not discharged with mother for other reason, preexisting severe chronic maternal illness, preexisting maternal depression and/or current use of antidepressants, other psychiatric illness (e.g. bipolar disease, schizophrenia) or preexisting hemoglobinopathy

Keywords: postpartum anemia, postpartum depression
tranexamic acid to reduce blood loss in women having planned cesarean section

Conditions: Cesarean Section; Blood Loss During Surgery

Summary: this clinical trial was done to find out if tranexamic acid (txa) can safely reduce the amount of blood loss during cesarean (c-section) deliveries. heavy bleeding is a major risk during childbirth, especially in c-sections, and can be life-threatening. the main question this study wanted to answer was: does giving tranexamic acid before surgery reduce the amount of blood lost during a planned c-section? in this study, 68 women who were scheduled for elective (planned) c-section deliveries were randomly assigned to receive either tranexamic acid or a placebo (a look-alike substance with no medicine in it) before surgery. the medication was given by slow injection just 15 minutes before the operation. all surgeries followed the same procedure and were done by experienced obstetric surgeons. the amount of blood lost during surgery was carefully measured and compared between the two groups. the goal was to find a simple and safe way to lower the risk of blood loss and its complications during c-sections, improving outcomes for mothers.


Eligibility criteria:
inclusion criteria: * women age 20-45 years * at 37-40 weeks of gestation (on lmp) * planned to undergo cesarean section under spinal anesthesia exclusion criteria: * women with previous history of thromboembolic events * allergy to tranexamic acid * women with morbidly adherent placenta (on antenatal usg)

Keywords: tranexamic acid elective cesarean section intraoperative blood loss
venous cannulation pain to guide choice of anesthetic method

Conditions: Pain, Postoperative; Pain Prediction; Laparoscopic Surgery; Venous Cannulation Pain; Anesthesia Opioid Free

Summary: the investigators have recently shown that pain associated with peripheral venous cannulation can be used to predict the risk of postoperative pain, where patients grading their pain associated with venous cannulation (vcp) above 2.0 vas units had 3.4 times higher risk of moderate or severe postoperative pain after laparoscopic cholecystectomy and 1.7 times higher risk in a mixed group of patients and surgeries. the aim of this study is to investigate whether pain sensitivity measurements using vcp can be used to choose anesthesia treatment protocol with the aim to lower acute postoperative pain in those with high risk. in patients with low risk we aim to lower the amount of opioids given.

the investigators will perform a randomized controlled trial randomizing patients to different treatment protocols depending on their pain associated with venous cannulation. there will be two set of instructions for perioperative treatment, one for those grading pain associated with venous cannulation \<2.0 (low-pain) and another for those grading vcp ≥2.0 (high-pain). the low-pain group will be randomized to standard treatment or opioid-free anesthesia. the high-pain group will be randomized to standard treatment or extra in form of additives like esketamine and clonidine. in the low-pain group the investigators aim for non-inferiority with the gain being avoiding opioids. in the high-pain group the investigators aim for lower post-operative pain.

Eligibility criteria:
inclusion criteria: * adults with an american society of anesthesiologists (asa) physical status i or ii, undergoing elective laparoscopic surgery at hallands´ hospital. exclusion criteria: * inability to understand information regarding the study. refusal to give consent. severe cardiovascular disease. av-block ii. requirement of additional procedures during surgery, like conversion of laparoscopic to open surgery, incomplete registration of study measurements.

Keywords: postoperative pain pain prediction vcp venous cannulation pain
efficacy of transcranial magnetic stimulation (tms) in central post stroke pain ( cpsp)

Conditions: Central Post Stroke Pain

Summary: the aim of the study is to evaluate the analgesic effects of navigated repetitive transcranial magnetic stimulation in central post stroke pain. mri based navigation is used to determine the exact locations for stimulation.

central post stroke pain is often very resistant to treatment. tms has been shown to be a promising tool in treating difficult pain conditions. the best sites for stimulation are still not known and navigation has been used only in few studies. the aim is to evaluate the analgesic effects of navigated repetitive transcranial magnetic stimulation ( nrtms ) on pain in a three armed crossover study. the navigation is done by using magnetic resonance imaging and stereotactic camera system. the three arms include stimulation to m1, s2 and sham stimulation to m1. 10 hz repetitive stimulation is given to a specified location once a day 5 days a week for two weeks in each of the three arms. a months washout period is kept between each arm of the study. pain and other variables are followed before, during and after the study for 6 months.

Eligibility criteria:
inclusion criteria: * mri defined brain infarction or hemorrhage before or at the age of 65 years * cpsp diagnostic criteria is met (definite), verified by a neurologist * stable analgesic medication * average pain nrs 4 or more exclusion criteria: * epilepsy * difficult aphasia * dementia * contraindication for tms or mri * alcohol and/or drug abuse

Keywords: ich stroke navigated placebo tms
balloon catheter vs. basket catheter in pancreatic duct stone clearance

Conditions: Chronic Pancreatitis

Summary: the aim of the study is to compare the safety and efficacy of the basket catheter with that of the balloon catheter for endoscopic extraction of pancreatic stones.

this is a retrospective cohort study. patients with chronic pancreatitis who underwent ercp for pancreatic duct stone extraction using either a basket or a balloon catheter were enrolled in this study.

Eligibility criteria:
inclusion criteria: * cp patients with main pancreatic duct (mpd) stones who underwent ercp exclusion criteria: * patients had undergone pancreatic surgery or gastrectomy with billroth ii reconstruction prior to the ercp procedure * patients were suspected of having a malignant tumor * patients combined with bile duct stones * patients had severe pancreatic duct structure * patients with insufficient clinical data * patients with previous ercp treatment * patients had received both catheters

Keywords: pancreatic stone endoscopic retrograde cholangiopancreatography (ercp) basket catheter balloon catheter stone clearance
continuous postoperative use of low-dose combined oral contraceptivesfor for endometriosis-related chronic pelvic pain

Conditions: Endometriosis; Chronic Pelvic Pain

Summary: because ovarian sex steroids fluctuations during the menstrual cycle are implicated in the pathogenesis of the endometriosis-related chronic pelvic pain (cpp), the oral contraceptives (ocs) are used with non-contraceptive indication for this disorder. to date, ocs are widely used as medical treatment in patients with endometriosis, in addition, they are recently experimented as post-surgical therapy. traditional cyclic regimen, with 21 days of active pills with 7 days of placebo or suspension, is usually adopted. furthermore, recent studies suggested that long-term continuous ocs use can be effective in the postoperative period both as second- and third- line treatments after cyclic regimen failure. in these studies a combined treatment with ethinilestradiol (0.02 mg) plus desogestrel (0.15 mg) were used and compared with baseline or ciproterone acetate. a recent study showed a deeper ovarian and endometrial suppression with continuous ocs in comparison with cyclic ocs, providing a physiological rationale for continuous ocs use for noncontraceptive indications. furthermore, to date, no study compared post-operative continuous versus cyclic ocs in patients with endometriosis-related cpp.

premenopausal women with endometriosis-related cpp scheduled for laparoscopic surgery to our academic department of gynecology will be consecutively enrolled. subjects with hystologically confirmed endometriosis at laparoscopy (stage i-iv of the american society reproductive medicine), a subjective severity of pelvic pain by using a visual analogue scale (vas 1-100) of at least 70, and without immediate desire of pregnancy will be enrolled. briefly, all patients will undergo conservative laparoscopic surgery for endometriosis. thereafter, a low-dose monophasic oc containing 2.0 mg clormadinone acetate plus 0.03 mg ethinil-estradiol (belara®, grunenthal, milan, italy) will be administered. patients from the experimental group will be treated with a continuous regimen, while patients from the control group will receive the oc with a cyclic regimen consisting of 21 days of active pills with 7 days of placebo. the drug and the placebo will be similar and will be labelled according to the subject number. for the overall study-period, operators and patients will be blind to the treatment allocation.

Eligibility criteria:
inclusion criteria: * premenopausal state * endometriosis-related chronic pelvic pain * hystologically confirmed endometriosis at laparoscopy * subjective severity of pelvic pain by using a visual analogue scale of at least 70 * no immediate desire of pregnancy exclusion criteria: * age ≤18 or ≥ 40 * previous use of drugs for treating cpp (wash-out period of 3 months), with exclusion of non-steroidal anti-inflammatory drugs * contraindication to estro-progestin compounds * major medical diseases * psychiatric disorders * pelvic inflammatory disease * adnexal patologies * unability to complete the daily diary * history of alcohol or other drugs abuse
technology-assisted rehabilitation after acute stroke

Conditions: Stroke

Summary: the aim of the study is to evaluate the effects and costs of an intensified rehabilitation for stroke patients. using novel technologies the patients will receive an augmented exercise therapy during the first weeks after stroke. the effects on restoration of functions as well as on the costs incurred from social and health care services will be assessed and compared to the conventional rehabilitation over 6 month follow-up.

the intervention consists of technology-assisted multidisciplinary rehabilitation for 3 weeks followed by an 8-week period of supervised home-based telerehabilitation and a weekly group exercise in an outpatient clinic. the effects on mobility, upper extremity motor functions and activities of daily living will be assessed using fac, hand grip force, shoulder elevation test, whodas 2.0 and promis scales. the costs incurred from social and health care services over 6 months will be compared to the control group receiving conventional rehabilitation. patients aged 18 or more with their first stroke and stable cardiopulmonary condition will be consecutively recruited first into the control group (n=20) and thereafter into the experimental group (n=20). patients with a severe cognitive deficit or aphasia will be excluded.

Eligibility criteria:
inclusion criteria: * age 18 or more * first stroke exclusion criteria: * unstable cardiopulmonary condition * severe cognitive disorder * aphasia