Kornimate/medical-research-clean huggingface dataset:
comparison of two doses of carbetocin for prevention of uterine atony, during elective cesarean section

Conditions: Uterine Atony; Post-partum Hemorrhage

Summary: the purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.

postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. to prevent this complication, uterotonic medication is used during elective cesarean section. carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. this medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * ≥ 37-week pregnancy * singleton pregnancy * elective cesarean section with a low transverse incision * asa i or ii exclusion criteria: * personal history of uterine atony or postpartum hemorrhage * abnormal placental implantation (known or suspected) * \> 3 cesarean sections in the past * personal history of a classic uterine incision * estimated fetal weight \> 4500g * hemoglobin \< 100 g/l * regular use of tocolytic drugs * cesarean section under general anesthesia * known allergy to carbetocin * refusal * inability to obtain informed consent

Keywords: carbetocin uterotonic drug elective cesarean section
histocompatibility leukocyte antigen (hla)-a*2402 restricted peptide vaccine therapy in patients with colorectal cancer

Conditions: Colorectal Cancer; Colon Cancer; Rectal Cancer

Summary: the purpose of this study is to evaluate the safety and time to progression of hla-a\*2402 restricted epitope peptides rnf43, tomm34, vegfr1 and vegfr2 emulsified with montanide isa 51 in combination with tegafur/uracil/folinate chemotherapy.

rnf43 and tomm34 have been identified as cancer specific molecules especially in colorectal cancer using genome-wide expression profile analysis by cdna microarray technique. vegf receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific ctl response in vitro and vivo. according to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. patients will be vaccinated twice a week for 8 weeks. on each vaccination day, rnf43 peptide (1mg), tomm34 peptide (1mg), vegfr1 peptide (1mg) and vegfr2 peptide (1mg) mixed with montanide isa 51 will be administered by subcutaneous injection. the patients will also receive oral chemotherapy (tegafur/uracil/folinate) simultaneously. repeated cycles of the vaccine and the chemotherapy will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. in the phase i study, we evaluate the safety and tolerability of these peptide vaccine. in the following phase ii study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility criteria:
inclusion criteria: * advanced or recurrent colorectal cancer * resistant against chemotherapy including cpt-11, l-ohp、+/- 5-fu +/- bevacizumab or difficult to continue the chemotherapy due to intolerable side effect(s) * ecog performance status 0-2 * life expectancy \> 3 months * hla-a\*2402 * laboratory values as follows * 2000/mm3\<wbc\<15000/mm3 * platelet count\>100000/mm3 * bilirubin \< 3.0mg/dl * asparate transaminase \< 150iu/l * alanine transaminase \< 150iu/l * creatinine \< 3.0mg/dl * able to receive oral tegafur/uracil/folinate therapy * able and willing to give valid written informed consent exclusion criteria: * pregnancy(woman of childbearing potential:refusal or inability to use effective means of contraception) * breastfeeding * active or uncontrolled infection * unhealed external wound * concurrent treatment with steroids or immunosuppressing agent * prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks * uncontrolled brain and/or intraspinal lesion(s) * history of allergy to tegafur, uracil, and/or folinate * decision of unsuitableness by principal investigator or physician-in-charge

Keywords: hla-a*2402 peptide vaccine rnf43 tomm34 vegfr1 vegfr2
prokinecitine in acute myocardial infarction

Conditions: ST Elevatation Myocardial Infarction (STEMI)

Summary: the study aims to investigate the presence of a substance in the blood called prokinecitine, which is released by the heart when a heart attack occurs. several venous blood samples at the arm are withdrawn at admission, h6, h12, h24, h48 and h72 in order to measure the concentration of this substance in the blood. the usefulness of this new blood marker is going to be determsined to seek if it would be of help to better diagnose or estimate the gravity of heart infarction after a heart attack.


Eligibility criteria:
inclusion criteria: * patients with acute st elevation myocardial infarction of less than 6 hours * age\>18 y/o exclusion criteria: * previous myocardial infarction * lbb, rbb * renal insuffiency mdrd\<30 ml/min * patient with pace-maker or icd.
smoking cessation for smokers with sleep problems

Conditions: Nicotine Dependence; Cigarette Smoking; Insomnia

Summary: this is a pilot research study examining two types of behavioral counseling along with the nicotine patch for smoking cessation. the study is designed to find out whether one of these counseling interventions is more effective for smoking cessation among individuals with sleep problems. the study has three parts: 1) an intake session; 2) a 10-week treatment phase, and 3) a 1-month follow-up.

this is a developmental study to: 1) create and test an integrated cognitive-behavioral smoking cessation and insomnia intervention with 30 smokers who report current insomnia. participants are randomized to 1 of 2 counseling conditions. the cognitive-behavioral intervention provides standard care smoking counseling along with counseling to address insomnia. the smoking counseling intervention provides standard care smoking counseling adapted from the american lung association freedom from smoking program. efficacy data from this trial will be used to determine effect size estimates for biologically confirmed self-reported point prevalence smoking abstinence at the end of treatment and 1 month after completing treatment. changes in sleep efficiency and self-control to resist smoking urges will also be examined. if the effect size estimates are sufficiently large and medically important to pursue a definitive trial, these data will be used to propose a full scale large study.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 75. * smoking 10 or more cigarettes per day for at least 1 year. * an expired air breath carbon monoxide level \> 10 ppm. * motivated to stop smoking. * understand english. * meet dsm-iv criteria for insomnia. * report sleep latency or waking after sleep onset \>30 minutes on ≥6 occasions within past month. exclusion criteria: * history of allergic reactions to adhesives. * unstable psychiatric/medical conditions such as current suicidal or homicidal ideation, acute psychosis, dementia. * have a current diagnosis of dsm-iv alcohol or drug dependence other than nicotine. * use of tobacco products other than cigarettes or use of marijuana. * intention to use nicotine replacement therapy, varenicline, or bupropion during study participation. * females of childbearing potential who are pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide). * new onset of psychiatric disorders or new psychotropic medications within the past 3 months. * inability to read/understand english. * history of sleep apnea based on responses to berlin questionnaire. * history of restless leg syndrome. * current night or rotating shift work. * proposed travel across 2 or more time zones during study participation. * medical/psychiatric conditions contraindicated for sleep restriction (i.e., seizure disorders, severe excessive daytime sleepiness - epworth scale \>18, and bipolar disorder).

Keywords: smoking nicotine nicotine polacrilex nicotine replacement
reduction of perineal pain after vaginal birth with black tea: pilot randomized study

Conditions: Perineal Pain

Summary: perineal trauma is common during vaginal birth. the discomfort this causes can interfere with a woman's recovery and early motherhood.mothers are offered a standard treatment after childbirth, water soaked frozen peri pads (ice packs), to alleviate the discomfort. however, a cochrane review questions the efficacy of ice packs treatment. an alternative treatment that may be more comfortable and effective for women is warm water soaked black tea bags. medicinal use of black tea bags has been based on their astringent (shrinking or constricting) properties and have been used for various medical applications. the investigators will conduct a pilot randomized controlled trial (rct) of 40 pregnant mothers randomized to either intervention group (tea bags; n=20) or control group (ice packs; n=20). the goal of this pilot is to test the feasibility of a larger rct by assessing recruitment, testing the protocol, and evaluating a proposed primary outcome objective of analgesic use during hospitalization as an indicator of pain. the investigators expect this pilot study to demonstrate feasibility for a large scale rct to formally evaluate the efficacy of black tea bags to reduce perineal pain in this patient population.


Eligibility criteria:
inclusion criteria: * primiparous women (delivering their first baby) over the age of 19 who have delivered vaginally at abbotsford regional hospital and cancer centre exclusion criteria: * multiparity (women who have delivered vaginally more than once), vbac (vaginal birth after cesarean section), active sexually transmitted infection lesions, vulvar varicosities, third and forth degree perineal tear, hematoma, retained placenta/products, substance abuse, and other medical conditions requiring frequent analgesia

Keywords: perineal postpartum pain treatment ice and black tea maternal satisfaction
prognostic value of three new biomarkers of multiple sclerosis in patients with radiologically isolated syndrome

Conditions: Multiple Sclerosis; Radiologically Isolated Syndrome

Summary: to look at the prognostic value of new biomarkers in csf and serum for characterisation of multiple sclerosis


Eligibility criteria:
inclusion criteria * patients have given their free consent for use of their samples in research * patients have at least 2 years of clinical and radiological follow-up data available exclusion criterion * no follow-up of patients
positron emission tomography (pet) study investigating dopamine and serotonin receptor occupancy after multiple oral dosing of lu af35700

Conditions: Schizophrenia

Summary: the purpose of this pet study is to verify the binding of lu af35700 after multiple oral dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.

there were 3 to 4 cohorts of 2 patients per receptor group. lu af35700 was administered as multiple oral doses for up to 21 days before the pet scans were performed. the doses in all groups were selected with the aim of characterising the exposure response (occupancy) curve. the doses for all groups, with the exception of a1, b1, and c1, were subject to change within the dose range already investigated and found tolerable. the next dose for the groups was established at a dosing conference based on an evaluation of the occupancy obtained, and safety, tolerability, and pharmacokinetic data from all previous cohorts.

Eligibility criteria:
inclusion criteria: 1. the patient is a man aged between ≤18 and ≥60 years 2. bmi of ≥19 kg/m2 to ≤ 37 kg/m2 3. the patient has a primary diagnosis of schizophrenia according to dsm-5™ (code 295.90) 4. the patient has a clinical global impression - severity of illness (cgi-s) score ≤ 4 (moderately ill) at screening and safety baseline 5. the patient is currently under oral therapy with one or more of the antipsychotic medications listed in appendix ii. 6. the patient has a positive and negative syndrome scale (panss) total score ≤ 80 7. the patient has a score of ≤ 4 (moderate) on the following panss items at screening and at safety baseline: p7 (hostility), g8 (uncooperativeness) exclusion criteria: 1. the patient experienced an acute exacerbation requiring hospitalization within the last 3 months. 2. the patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks. 3. the patient has a diagnosis or history of substance use disorder (except nicotine) according to dsm-5-tr® criteria ≤3 months prior to screening 4. the patient is at significant risk of harming himself or others according to the investigator's judgment or as indicated by an answer of "yes" to the question 4 or 5 on the columbia-suicide severity rating scale (c-ssrs) at the screening visit within the last six months on the lifetime version of c-ssrs. 5. based on investigators judgment the patient has a medical or neurological disorder or treatment for such disorder that could interfere with the study treatment or impair treatment compliance. 6. the patient has had past episodes of extrapyramidal symptoms (eps) under current medication within the last 3 month 7. the patient takes other medication than those listed as allowed concomitant medication in appendix iii 8. the patient is occupationally exposed to significant levels of ionizing radiation. other protocol-defined inclusion and exclusion criteria may apply
triage survey for infectious disease eligibility

Conditions: Vaccination; Infection; HIV-1-infection; Infectious Disease

Summary: swift-id-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials for diagnosis, treatment, or prevention of infectious diseases such as in the areas of hiv, vaccines, and other infectious-diseases areas. a physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical/surgical history, physical examination, comorbidities, and any current symptoms. informed consent will be done electronically (preferable) or on paper. informed consent may be done in-person or remotely, depending on patient preference. information related to hiv, hepatitis b and c, other infectious diseases, or substance use disorder will also be obtained if applicable. site staff may collect vital signs, fingerpick testing, urine drug screens, blood draws, ekg, and pregnancy tests. some testing may be recommended in a fasting condition. a doctor will review medical history and results of the above evaluations with the participant to determine study suitability via clinical interview. the doctor may reach out to the patient's current treating physicians, other providers, and pharmacies to determine eligibility for clinical trials. a follow-up phone call may be needed to discuss testing results and/or trial eligibility. if a participant is deemed eligible for future trials and if the participant remains interested, counseling on contraception requirements for trials will be discussed.


Eligibility criteria:
inclusion criteria: - 1. participant or legally authorized representative has signed an icf prior to study-specific procedures being performed. 2. participant is at least 18 years old. exclusion criteria: 1. participants are pregnant, breast-feeding, or planning to become pregnant. 2. history of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results or makes them unsuitable for the study for another reason. 3. current or recent moderate or severe substance use disorder impacting their ability to follow study related procedures. 4. reported history of coagulopathy or bleeding disorder considered a contraindication to phlebotomy. 5. any condition that in the investigator's opinion makes a participant unsuitable for the clinical trial study. 6. currently employed by swift clinical research group, inc. or any of its subsidiaries, including brooklyn clinical research, or a first-degree relative of an employee.
the cardio-ttransform scintigraphy sub-study

Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Summary: the purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ion682884-cs2 (nct04136171) study, up to 150 participants, after treatment with eplontersen or placebo based on scintigraphy scans performed at week 140 using the perugini grade score method.

participants who were randomized in study ion-682884-cs2 (nct04136171) and have had a baseline scintigraphy scan will be offered the opportunity to participate in this sub-study which involves optional scintigraphy scans.

Eligibility criteria:
inclusion criteria: * participants must have been properly randomized into the ion-682884-cs2 study (nct04136171) and should have had a baseline scintigraphy scan (99mtc-dpd, 99mtc- pyp, and 99mtc-hmdp) within 12 months prior to screening for ion-682884-cs2 with planar and spect or spect/ct images that can be read by the central reader. exclusion criteria: * must not meet any of the exclusion criteria of the study protocol ion-682884-cs2 (nct04136171). * must not have weight or body girth that exceeds the limits of the equipment specifications. * should not have any previously reported hypersensitivity reaction to technetium-99m.

Keywords: ttr amyloidosis cardiomyopathy
effects of creatine supplementation in addition to resistance exercise training in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: despite the past decade being dedicated to bone and joint disease, the incidence and prevalence rates of osteoarthritis continues to rise, and till date not curative treatment has been identified for the management of knee osteoarthritis. in terms of conservative management of knee osteoarthritis, pharmacological management has been the mainstay of treatment, however is associated with numerous adverse effects with prolonged use, and it is important to look into the non-pharmacological alternates for the management of knee osteoarthritis. research has shown resistance exercise training to be the most effective non-pharmacological treatment option for the management of knee osteoarthritis, and the purpose of the current study is to determine if the addition of a non-pharmacological dietry supplement like creatine can amplify the beneficial effects of resistance exercise training in patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * age 40-70 years * knee oa with history not less than three months. * radiological evidences of grade iii or less on kellgren classification. * knee pain on vnrs no more than 8/10 exclusion criteria: * neuromuscular conditions that may lead to fatigue such as multiple sclerosis * signs of serious pathology (e.g., malignancy, inflammatory disorder, infection). * history of trauma or fractures in lower extremity. * signs of lumbar radiculopathy or myelopathy. * history of knee surgery or replacement. * patients on intra-articular steroid therapy within two months before the commencement of the study. * impaired skin sensation. * impaired renal function
blood sample collection to evaluate biomarkers in subjects with untreated melanoma

Conditions: Melanoma

Summary: the primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

subjects will have been recently diagnosed with untreated melanoma. subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. there will be no further follow-up.

Eligibility criteria:
inclusion criteria: 1. subject is male or female \> 18 years of age. 2. subject has an untreated primary melanoma. or subject has high suspicion of primary malignancy of melanoma based on skin exam or imaging. 3. subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. exclusion criteria: 1. any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers). 2. chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection. 3. any treatment for the primary malignancy or sites of metastases. subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection. 4. less than 3 days between fine needle aspiration (fna) of target pathology and blood collection. 5. less than 5 days between biopsy (other than fna) of target pathology and blood collection. 6. iv contrast (e.g. ct and mri) within 1 day \[or 24 hours\] of blood collection. 7. individual has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.