Kornimate/medical-research-clean huggingface dataset:
the effect of topical tranexamic acid on bleeding and seroma formation in after undergoing mastectomy

Conditions: Postoperative Hemorrhage; Breast Neoplasms; Seroma

Summary: after surgical procedures, interventions to reduce postoperative bleeding are of great importance. in this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. the researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer. after surgery for breast cancer patients may also experience problems with long lasting seroma. therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.


Eligibility criteria:
inclusion criteria: * breast cancer * undergoing unilateral mastectomy with or without axillary node dissection * received adequate oral and written information about the study and signed an informed-consent form exclusion criteria: * pregnant or breastfeeding * known thromboembolic disease or with high risk of thromboembolism, warranting extra anticoagulation in connection with the procedure * known allergy to tranexamic acid/cyklokapron®

Keywords: administration, topical tranexamic acid postoperative care mastectomy
longterm postoperative analgesia, intravenous lidocaine infusion

Conditions: Postoperative Pain

Summary: spinal fusion is a painful surgery, and control of postoperative pain is difficult. several studies have indicated that appropriate pain treatment protocols reduce postoperative morbidity, improve the results of the surgery, and decrease hospital costs

forty four patients were randomly allocated into two groups of equal size to receive either lidocaine infusion (lidocaine group) or 0.9% sodium chloride infusion (control group). randomization: was performed using lidocaine group and control group registers, which was placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who prepared the intravenous solution and identified it with the patient number, according to the envelope drawn. the solution was handed to another physician, blind to the prepared solutions' content, who was responsible for the anesthesia. the solution volume was equal. the responsible investigator was remained blind to the chosen group until the end of the study.

Eligibility criteria:
inclusion criteria: age \> 18 years american society of anesthesiologists 1-3 status patients undergoing spinal fusion or fixation exclusion criteria: 1. previous spinal fusion surgery. 2. morbid obesity (bmi \> 40) 3. diagnosis of spinal metastatic cancer 4. allergy to an amide local anesthetic or morphine sulfate 5. history of renal dysfunction, liver dysfunction or congestive heart failure 6. history of substance abuse disorder. 7. chronic opioid use.
a phase 1 study to estimate the relative bioavailability of co-administered formulations of azithromycin microsphere and chloroquine test formulation compared with co-administered immediate release individual azithromycin and chloroquine tablets in healthy adult subjects

Conditions: Malaria Prophylaxis

Summary: estimate the relative bioavailability of co-administered azithromycin microsphere (2000 mg) and the chloroquine (620 mg cq base) test formulation compared to co-administered immediate release individual tablets of azithromycin (2000 mg) and chloroquine (600 mg cq base) in healthy adult subjects.

evaluate the relative bioavailability, assessment of the safety and tolerability of azithromycin microsphere and the chloroquine test formulation compared to immediate release individual tablets.

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests). * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * an informed consent document signed and dated by the subject or a legally acceptable representative. * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * history of febrile illness within 5 days prior to first dose. * treatment with azithromycin within the past 30 days or with chloroquine within the past 45 days. * known immediate family history of prolonged qt syndrome, serious ventricular arrhythmia, or sudden cardiac death. "immediate" is considered "first degree". * known allergy to macrolide antibiotics (eg, erythromycin, clarithromycin, azithromycin) or chloroquine (or other 4 aminoquinolines) or severe allergic reaction to any drug in the past (eg, difficulty breathing, anaphylaxis). * history of intolerance to azithromycin or chloroquine.

Keywords: azithromycin chloroquine microsphere pharmacokinetics bioavailability
accelerated itbs for post partum depression

Conditions: Post Partum Depression

Summary: study 1: the investigators are studying the feasibility and tolerability of 10x/day intermittent theta burst (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over the course of 6 days for women with post-partum depression. the investigators further aim to characterize the anticipated anti-depressant effect of this treatment paradigm. study 2: the investigators are studying the feasibility and tolerability of 12 sessions/day of intermittent theta burse (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over 5 days for women with post-partum depression. the investigators aim to compare the two different treatment schedules.

study 1: this is an open-label study designed to investigate the feasibility and tolerability of a novel tms treatment protocol to treat depression in women with post-partum depression. it is known that tms can effectively treat depression. the fda approved protocol lasts 6 weeks and is not feasible for many women with post-partum depression. the investigators are investigating a 6 day treatment for depression which may be more acceptable for this population. the investigators further aim to characterize the ant-depressant effect of this protocol in order to design a larger trial. study 2: in part 2 of this study, the treatment schedule is 12 sessions over 5 days that can be completed with 8. all other procedures, inclusion/exclusion criteria, and number of total pulses delivered is the same as study 1.

Eligibility criteria:
inclusion criteria: 1. participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 2. participants must be over the age of 18. 3. participants must meet criteria for post-partum depression: a) onset of symptoms in the first year postpartum 4. participants must have a hrsd17 greater than or equal to 14 at baseline. exclusion criteria: 1. participants must not be pregnant. 2. participants must not meet moderate or severe use disorder of any substance with the exception of tobacco use disorder. 3. participants must not have current psychotic symptoms. 4. participants must not have a history of dementia or other cognitive impairment. 5. participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months. 6. participants must not have any contraindications to receiving rtms (e.g. metal implanted above the neck, history of seizure, any known brain lesion). 7. participants must not have any unstable general medical conditions. 8. participants must not have had eclampsia during pregnancy.

Keywords: post partum depression theta burst transcranial magnetic stimulation
enhancing physical therapy best practice for improving walking after stroke

Conditions: Stroke; Cerebral Infarction; Brain Ischemia; Infarction, Brain

Summary: the aim of this study is to assess the effect of implementing best practices into current stroke rehabilitation physical therapy on walking outcomes. participants will also be provided an activity monitor to help them track and target their walking practice to determine if this can improve walking ability.

this multi-site study will have each site start in usual care with participants consented to collecting outcome measures. the twelve inpatient stroke units include: kelowna general hospital, nanaimo regional general hospital, glenrose rehabilitation hospital, saskatoon city hospital, wascana rehabilitation centre, joseph brant hospital, bruyère hospital, freeport grand river hospital, ciusss-de-l'estrie-chus centre de réadaptation de l'estrie, centre interdisciplinaire de recherche en réadaptation et intégration sociale, dr. everett chalmers regional hospital, and queen elizabeth hospital. each site will randomly switch over to enhanced usual care (best practice implementation) where all physical therapists at the site will be educated on delivery of best practice for locomotor retraining. the specific therapy activities are at the discretion of the physical therapist; however, physical therapists must work towards thirty minutes of weight-bearing/stepping activity at greater than forty percent heart rate reserve. participants will continue to be consented to collecting outcome measures. additionally, participants will be given and trained to use activity watches to monitor their own progress.

Eligibility criteria:
inclusion criteria: * admitted by inpatient or day stroke rehabilitation * improved walking is a rehabilitation goal * within 12 weeks post hemorrhagic or ischemic cva with hemiparesis (confirmed by medical chart or motor assessment) * able to ambulate at least 5 steps. may use assistive and/or orthotic device and maximum one person assist * overground walking speed slower than normal * able to understand and follow directions * greater than or equal to 19 years of age * medically stable exclusion criteria: * pre-stroke health included a serious gait disorder or disease that affected ambulation (musculoskeletal conditions, amputation, surgery/arthroplasty in the last 6 months, etc.) * pre-stroke health included a neurological condition (such as parkinson's disease or multiple sclerosis) or other serious medical condition (active cancer, uncontrolled diabetes) * excessive pain in the body/joint preventing participation in an exercise intervention * participating in an experimental drug field study * participating in another formal exercise rehabilitation clinical trial * expected to receive \<2 weeks daily in-/out- patient rehabilitation

Keywords: stroke lower extremity rehabilitation wearable device exercise clinical trial
follow-up assessment of a trial of open-label placebos for women with premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: with the proposed study, the investigators aim to evaluate the long-term efficacy of the open-label placebo (olp) intervention in premenstrual syndrome (pms) and to contribute to a broader understanding of how olps work. it is planned to survey participants of the intervention groups (olp+ and olp-) regarding symptom intensity and impairment due to pms after the conclusion of our randomized controlled trial (rct) and intervention provision. additionally, it will be examined if there is a difference between the olp group with and without a treatment rationale (opl+ vs. olp-) across time. more precisely, it will be investigated whether participants of the intervention groups with and without treatment rationale experience any long-term improvement.


Eligibility criteria:
inclusion criteria: * participants are willing to participate in the follow-up study * participants have the ability to use an electronic device with internet access to complete the online follow-up survey * participants give informed consent * participants have a regular menstruation (i.e., no menopause; pregnancy; cycle inhibiting medication etc.) exclusion criteria: * pregnancy or breastfeeding (currently or within the last three months) * a severe psychological or somatic disease, affecting premenstrual complaints (e.g., cancer of the uterus or fallopian tubes) * commencement of the menopause, sterilization, or (part) resection of the uterus or fallopian tubes * changes in body mass index (i.e., under 18 or above 30)

Keywords: premenstrual syndrome open-label placebo rct follow up
precision therapy in complex high-risk coronary artery disease

Conditions: Coronary Artery Disease

Summary: this is a prospective registry to enroll complex high-risk coronary heart disease patients. the purpose of this study is to compare intracoronary physiology and imaging-guided intervention strategy and angiography-guided intervention strategy for clinical outcomes and health economics.


Eligibility criteria:
inclusion criteria: * bifurcation lesions with branch diameter ≥2.5mm; * chronic complete occlusion (occlusion duration ≥3 months); * left main disease; * long lesions (≥38mm); * multi-vessel percutaneous coronary intervention (simultaneous treatment of ≥2 epicardial vessels during one operation); * multi-stent implantation (≥3 stents); * in-stent restenosis; * moderate to severe calcification on radiography; * intermediate lesion; * thrombotic lesions; * creatinine clearance rate \< 60ml/min) or on dialysis ; * left ventricular ejection fraction \<40% ； * history of cerebral hemorrhage or massive hemorrhage of gastrointestinal tract. exclusion criteria: * informed consent cannot be obtained; * life expectancy \< 1 year.
a randomized, parallel, double-blind, placebo-controlled study of vitamin d as prophylactic treatment for migraine

Conditions: Migraine According to International Headache Society (IHS) Criteria (ICHD-II)

Summary: the trial is primarily designed to investigate whether treatment with vitamin d may influence migraine in a placebo-controlled, blinded study. the hypothesis is that vitamin d may serve as a prophylactic treatment of migraine. the hypothesis is tested by examining the changes in the pain and symptom patterns associated with migraine by treatment with vitamin d, by means of quantitative sensory testing, diaries and blood samples for measurement of vitamin d. other pain biomarkers are also measured to evaluate whether the levels of these biomarkers in the blood is changed by the treatment with vitamin d. the hypothesis here is that levels of those biomarkers will change following the treatment.


Eligibility criteria:
inclusion criteria: * men and women between 18 and 65, migraine must have occurred before the age of 50 years. * diagnosed migraine according to international headache society (ihs) criteria (ichd-ii) exclusion criteria: * other neurological or neurodegenerative disorders * medical conditions that may interfere with the result - violent head trauma, stroke, transient ischemic attacks * musculoskeletal or mental illness * addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs * inability to cooperate * pregnancy or breastfeeding, including women trying to conceive * use of vitamin d supplementation\> 10μg * in treatment with digoxin or thiazide * patients with osteoarthritis, as they are taking or have taken vitamin d supplements * patients with pre-existing hypercalcemia as vitamin d supplements are contraindicated in these patients

Keywords: migraine vitamin d
intervention to change handwashing behaviour in india

Conditions: Hygiene; Handwashing; Behaviour

Summary: the research will test the hypothesis that a scalable behaviour change intervention can improve hand-washing practices in rural indian households. the intervention will be designed using a social marketing approach and will use motivational messages targeting key audiences rather than educational messages about germs and disease which previously have been found ineffective. the intervention will be designed for low-cost, scaleable delivery using a series of visits to target villages by a two-person team on a motorbike. the key goal of the study is to determine the effectiveness of a scaleable, social marketing intervention to promote hand-washing with soap. the study will take the form of a cluster-randomized, controlled intervention trial. villages will be randomized to receive either the intervention or no intervention. the primary outcome measure will be the proportion of key events (defecation, faecal contact or food handling) accompanied by hand-washing with soap. these data will be collected by direct observation. a secondary outcome measure will be the number of soap movement episodes. these data will be collected in a sub-sample of households by using electronic motion detectors embedded in bars of soap. additionally, questionnaires will be used to collect data on social norms, self-reported soap use and habitual soap use. all data will be collected pre and post-intervention.


Eligibility criteria:
inclusion criteria: * households with children of primary school age or younger exclusion criteria: * households without school-aged or younger children

Keywords: diarrhoea handwashing hygiene
emotional awareness and expression therapy for chronic pain and opioid use disorder

Conditions: Chronic Pain; Opioid Use Disorder

Summary: the study is intended to test whether a group-based zoom behavioral treatment can help adults with chronic pain and opioid use disorder (oud) learn effective strategies for reducing pain, disability and other problems that can come with these conditions (such as depression, anxiety, and difficulty managing emotions).

emotional awareness and expression therapy (eaet) is a behavioral therapy that focuses on reducing chronic pain by helping people work on the effects of stress, trauma, and emotions that they have experienced in their lives. it is delivered in group sessions of 5-7 individuals by trained therapists who treat emotions or problems in relationships to reduce chronic pain. pain decreases through increased recognition and expression of emotions, and learning to feel safe in the presence of emotions. the primary aim of the study is to demonstrate the feasibility, acceptability, and preliminary efficacy of the proposed eaet intervention in adults with chronic pain and opioid use disorder.

Eligibility criteria:
inclusion criteria: * be able to read, write and speak english * have internet access and audio-visual conferencing capability (e.g., zoom meetings by phone or computer) in the home * widespread pain and has opioid use disorder (oud) exclusion criteria: * diagnosis of autoimmune disease, spinal cord injury, cancer. * currently receiving cognitive-behavioral therapy, eaet, or other psychological therapies for pain * open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening. * inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols. * pregnant or breastfeeding * any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.
effect of gravity on tracheal colonization during mechanical ventilation in infants

Conditions: Pneumonia, Ventilator-Associated

Summary: ventilator-associated pneumonia (vap) is the leading cause of death among all nosocomial infections in ventilated patients. once intubated, the risk of pneumonia in hospitalized patients is increased 3-10 fold; almost 90% of hospital-acquired pneumonia occurs in intubated patients. each episode of vap is associated with 7-9 days of additional hospital stay with an estimated increase in cost of care that exceeds $40,000. in an effort to control vap, several studies were conducted including oral and gastric decontamination with antibiotics, rotation of the bed, and local instillation of antibiotics via endotracheal tube. despite such efforts, vap is still a major complication for intubated patients. the effect of gravity on bacterial colonization of the endotracheal tube was recently explored in an animal study that was conducted at the united states national institutes of health. the study demonstrated a significantly lower tracheal colonization and decreased alveolar contamination in ventilated sheep when positioned on their side allowing for tracheal drainage by gravity. such findings have not been validated in clinical practice and the need for clinical trials studying the effect of lateral positioning have been demanded. therefore, we aimed our randomized controlled trial to test the hypothesis that intubated infants who are positioned on their side are at lower risk for contracting microbes in their trachea when compared to those in a supine position.

subjects were to be randomly assigned to one of two groups: 1. supine group, in which infants are maintained on their back at all times. the endotracheal tube is held upright in vertical position at all times. the bed is kept horizontal without any angle or tilt. 2. lateral group. infants are maintained on their side while the back supported with a rolled towel. the endotracheal tube is maintained to rest horizontally on the bed.

Eligibility criteria:
inclusion criteria: * term and premature infants \>28 weeks of gestation * postnatal age \<48 hours * mechanical ventilation \>5 days exclusion criteria: * congenital infections * congenital pneumonia * congenital anomalies such as tracheal-esophageal fistula, thoracic cage deformities and diaphragmatic hernia * not maintained on mechanical ventilation for 5 complete days

Keywords: gravity mechanical ventilation infants ventilator-associated pneumonia types of bacterial colonies in subjects at 2-5 days of mechanical ventilation colony count of an organism was cultured