Kornimate/medical-research-clean huggingface dataset:
mindful-pc for portuguese speakers pilot study 2020

Conditions: Depression; Anxiety Disorders; Stress Related Disorder; Adjustment Disorders; Chronic Illness

Summary: the study evaluates the effects of the mindfulness training for primary care (mtpc) portuguese-adapted version on heart rate variability during a demanding cognitive task. the study also evaluates the effects on mental health, quality of life, self-regulation and behavior outcomes. the study will also complete the mtpc cultural adaptation process for brazilian culture.

this single-arm, pre-post, non-randomized, unblinded, pilot trial evaluates the effects of mindfulness training for primary care (mtpc) portuguese-adapted version on heart rate variability during a demanding cognitive task, i.e., sustained attention to response task (sart). secondary aims are the following: 1) to measure pre/post outcomes for a) mental health (anxiety, depression, stress); b) quality of life; c) self-regulation (self-compassion, mindfulness, interoceptive awareness, difficulties in emotion regulation); and to determine the rate of d) chronic disease self-management action plan initiation; and 2) to complete the mtpc cultural adaptation for brazilian culture through a) satisfaction and suggestions survey; and b) interviews of mtpc group leaders about their experience teaching the program portuguese-adapted version.

Eligibility criteria:
inclusion criteria: * current cha patient with an enrolled cha primary care doctor. * cha patients 18 years of age and older. * able to tolerate and participate in interviews and engage in all procedures. * diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, stress disorders including adjustment disorder related to chronic illness, pain, insomnia, etc.). * must be able to fill out the study questionnaires on a computer or compatible mobile device. * must be willing to attend the two computer task sessions. * able to give written consent in portuguese exclusion criteria: * any cognitive impairment that precludes informed consent. * patients who, in the opinion of the principal investigator, pose an imminent risk of suicide or danger to self or others. * likelihood of potential incarceration such as a conviction or pending charges that may potentially result in imprisonment. * behaviors that may cause disruption to a mindfulness group. * patients with symptoms of psychosis, thought disorder, and/or severe mental illness, including schizophrenia, schizoaffective, bipolar disorder, or a current severe episode of major depressive disorder. * refusal of insurance to cover group psychotherapy treatment may lead to exclusion from participation in groups. * patients in their third trimester of pregnancy who foresee conflicts that preclude their commitment to completing all activities. * patients with highly unstable medical problems that put them at a high risk of hospitalization.
the breathe light study

Conditions: Over-eating; Obesity

Summary: the purpose of this study is to develop a novel, non-invasive method that will provide personalized feedback during dietary interventions as a marker for compliance.


Eligibility criteria:
inclusion criteria: * 18 to 65 years old * overweight (bmi 25-40 kg/m2) exclusion criteria: * metabolic or cardiovascular abnormalities (diabetes, uncontrolled hypertension, etc.) * gastrointestinal disorders * disease that affects macronutrient utilization * medication that affects macronutrient utilization * allergies to foods to be utilized in the study (including but not limited to lactose intolerance/milk allergy) * use of nutritional/sport supplements * pregnant or currently trying to become pregnant

Keywords: obesity carbon13 over-eating metabolic chamber room calorimeter
the utility and feasibility of mt-sdna as a surveillance procedure in colorectal cancer survivors

Conditions: Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Stage I Colorectal Cancer; Stage II Colorectal Cancer; Stage III Colorectal Cancer

Summary: the purpose of this research study is to determine whether testing of stool for a panel of markers will enable us to detect polyps and cancer compared to standard testing.

participants who were diagnosed with stage i-iii colorectal cancer will undergo testing with mt-sdna followed by a questionnaire about satisfaction with mt-sdna (multitarget stool dna panel), prior to their scheduled colonoscopies at years 1 and 4 after diagnosis. participants will be asked to provide a stool sample for mt-sdna (cologuard) testing that will be collected within 90 days before their scheduled colonoscopy. the kit will be given to the participant by study personnel and mailed back directly to exact science.

Eligibility criteria:
inclusion criteria: * diagnosis of stage i, ii or iii adenocarcinoma of the colon or rectum * receipt of preoperative colonoscopy * receipt of bowel resection; use of adjuvant chemotherapy or radiation therapy as clinically indicated exclusion criteria: * stage iv colorectal cancer * surgical treatment with subtotal colectomy or total proctocolectomy * diagnosis of inflammatory bowel disease (ulcerative colitis or crohn's disease) * diagnosis of polyposis syndrome including lynch syndrome or familial polyposis * presence of advanced adenomas (1 cm or larger, villous features and/or high grade dysplasia) that were not removed at the preoperative colonoscopy or contained in the resection specimen. * inability to provide informed consent * inability to understand spoken and written english * medical comorbidities that would be contraindications to sedation or that would preclude any benefit of routine surveillance post-resection. these would be at the discretion of the participant's providers.
trial to assess long-term lacosamide (lcm) monotherapy use and safety of lcm monotherapy and adjunctive therapy for partial-onset seizures

Conditions: Epilepsy

Summary: this open-label extension trial will assess the long-term use of lacosamide monotherapy and safety of lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (sp902).


Eligibility criteria:
inclusion criteria: * subject has entered the maintenance phase of the double-blind trial, sp902, (ie, has taken at least 1 dose of sp902 maintenance phase trial medication) and either completed sp902 or met an exit criterion in sp902; subject is allowed up to 2 concomitant antiepileptic drugs (aeds) exclusion criteria: * subject meets the withdrawal criteria (excluding exit criteria) for the sp902 trial, or is experiencing an ongoing serious adverse event (sae)

Keywords: epilepsy partial-onset seizures lacosamide monotherapy vimpat
clinical characteristics and outcomes of sle patients admitted to critical care unit

Conditions: Systemic Lupus Erythematosus

Summary: the aim of the present work is to determine the frequency of critical complications of sle patients admitted to the intensive care unit,study the risk factors and out comes.

systemic lupus erythematosus (sle) is a systemic heterogeneous autoimmune disease with a highly variable course and prognosis that many different organs may be affected . it has wide spectrum of clinical presentation that affects all ages and ethnicities . child-bearing women most often afflicted by this diseases, but with different disease manifestations and with variable severity . the pathogenesis of sle is complex and still largely unknown. genetic, environmental, and hormonal factors contribute to disease susceptibility . the diagnosis of sle is based on characteristic clinical findings of the skin, joints, kidneys, and the central nervous system, as well as on serological parameters such as antinuclear antibodies (ana) . sle mainly causes damage to the kidney, heart, joints, blood vessels, liver, lungs and the nervous system . since sle is a heterogeneous disease, its complications may vary and the severity or intensity depends on the area affected. pulmonary hypertension, alveolar haemorrhage, thrombocytopenia, catastrophic antiphospholipid syndrome (aps), haemolytic anemia, neutropenia, blood cancer and thrombotic thrombocytopenic purpura, atherosclerosis, pericardial tamponade myocarditis, heart failure, arthritis, vasculitis, adrenal insufficiency, lupus nephritis (ln), neuropsychiatric disorders, pancreatitis, and myelitis are some of the major complications of sle . in a previous study on egyptian sle patients, pleuro-pulmonary system was found to be one of the most commonly affected systems; pleurisy being the most frequent clinical finding followed by pulmonary infection and disease activity was an important predictor for infection . lupus flares and infections are the most common causes of admission to the icu in patients with sle. pertaining to complications from infections, lower pulmonary tract infections are typically more severe and frequent. a number of studies have addressed the characteristics and outcomes of critically ill sle patients. in a cohort of 2870 sle patients retrieved from a national database, the leading causes of icu admission were found to be infections and organ dysfunction (neurological, cardiovascular, and respiratory systems). ethnic differences, availability of therapy, and health-care referral systems may impact sle manifestation and prognosis. few studies have provided a clinical characterization of sle patients admitted to the icu, and data on predictors of patient outcomes are discordant.

Eligibility criteria:
inclusion criteria: * sle patients admitted to icu. exclusion criteria: * patients who stayed \<48 h in icu. * patients with major chronic organ disease not related to sle or terminal cancer.
reach out: to reduce high blood pressure in the emergency department

Conditions: Hypertension; Stroke

Summary: one of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the united states experiencing this condition. hypertension is very prevalent in the emergency department (ed), but significantly undertreated. the overall goal of this project is to develop a text messaging intervention to improve hypertension care in the ed. this will first be done by testing the feasibility of identifying hypertensive patients in the ed, and the response rate to text messages.


Eligibility criteria:
inclusion criteria: * adult (≥18 y/o) * at least one bp of systolic blood pressure (sbp) ≥160 or a diastolic blood pressure (dbp) ≥100 or only bp performed prior to enrollment is sbp ≥160 or a dbp ≥100 (if the patient has repeated measurements after achieving criteria 1, but prior to being enrolled, at least one of the repeat bp remains sbp ≥140 or a dbp ≥90) * must have mobile phones with text-messaging capability * likely to be discharged from the ed exclusion criteria: * adult who is in an urgent condition * unable to read * non-english speaking * incarcerated/ institutionalized resident * pregnant, or has a pre-existing condition that makes follow-up for 4 months unlikely.

Keywords: hypertension treatment stroke prevention
tap block vs lawi for analgesia post-cesarean section

Conditions: Obstetric Pain; Obstetric Anesthesia Problems

Summary: adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. transversus abdominis plane (tap) block and local wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. both the tap block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. so, we hypothesized that the tap block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours


Eligibility criteria:
inclusion criteria: 1. women who underwent cesarean section under spinal anesthesia. 2. aged ≥19 years and less than 40 years. 3. gestational age ≥ 37 weeks. exclusion criteria: 1. body mass index (bmi) ≥40 kg/m2. 2. history of recent opioid exposure 3. hypersensitivity to any of the drugs used in the study. 4. significant cardiovascular, renal, or hepatic disease

Keywords: transversus abdominis plane. vas; visual analogue score; wound infiltration; cesarean section; postoperative pain; analgesia
olmesartan and an add-on treatment in patients with mild to moderate hypertension

Conditions: Essential Hypertension

Summary: this study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.


Eligibility criteria:
inclusion criteria: * male and female patients age greater than or equal to 18 years with mild to moderate hypertension. * pre-treated patients with normal or elevated blood pressure (bp) are eligible to participate if their pre-treatment medication can be withdrawn. at the end of the placebo run-in period sitting systolic bp greater than or equal to 140 and less than 180 mmhg and/or sitting diastolic bp greater than or equal to 90 and less than 110 mmhg at trough. exclusion criteria: * female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception. * patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases. * patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack. * patients with clinically significant elevations in laboratory values at screening visit. * patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or cushing's syndrome. * patients with contraindications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate.

Keywords: olmesartan medoxomil hypertension
safety and immunogenicity of dtap-ipv/hib pentavalent vaccine in chinese 2-month-old infants

Conditions: Pertussis; Diphtheria; Tetanus; Haemophilus Influenzae Type B Infection; Polio

Summary: the main purpose of this study is to evaluate immune persistence at 30 and 36 months of age and pertussis breakthrough infections between 19 and 36 months of age following two regiments of dtap-ipv/hib pentavalent vaccine in healthy 2-month-old infants and children in china.

this study was based on the dtap-ipv/hib pentavalent vaccine basic immunization strategy optimization study cohort ("pentavalent vaccine cohort") and the epidemiological investigation of carrying status of pathogens causing acute respiratory infections (aris) in infants and young children cohort ("pathogen surveillance cohort"). dtap-ipv/hib vaccine basic immunization strategy optimization study is a single-center, randomized, prospective and open clinical trial. the study was designed for two groups: 2, 3, 4, 18 months of age (control group) and 2, 4, 6, 18 months of age (intervention group). subjects were randomly assigned to two groups according to the principle of informed consent. collect basic demographic information of children and their families. the control group received 3 doses of acellular dpt vaccine at 2, 3 and 4 months of age respectively, and 1 dose at 18 months of age; the intervention group received 3 doses of acellular dpt vaccine at 2, 4 and 6 months of age respectively, and 1 dose at 18 months of age. the immunogenicity and safety were observed before and after 28 days of 3 doses of basal immunization, and after 28 days of enhanced immunization at 18 months of age. the pathogen surveillance team included 2-month-old infants and caregivers with whom they shared a life history. after informed consent, the researchers followed up the subjects from 2 months of age to 19 months of age. the main contents of the visit are sample collection and unified questionnaire survey. on the basis of the surveillance of ari aged 2 to 19 months, follow-up was conducted for 17 months. during the follow-up period, ari telephone visit was conducted twice a week. after ari was found, pathogen sampling and testing were conducted for them (participants and their caregivers) to monitor the emergence of pertussis infection. blood samples and throat swabs were collected at 30 and 36 months of age (caregivers were also required to take simultaneous samples), and penta vaccine immunity persistence was observed and multiple respiratory pathogens were monitored.

Eligibility criteria:
inclusion criteria: - (1)received 4 doses of dtap-ipv/hib pentavalent vaccines (2) obtained consent from the participant's caregiver and sign an informed consent form exclusion criteria: -(1) diagnosed by a physician with a coagulation abnormality (e.g., coagulation factor deficiency, coagulopathy, platelet abnormality) (2) any other factor considered to make participation in the trial unsuitable.
quartet 1457q left ventricular (lv) lead investigational device exemption (ide) study

Conditions: Heart Failure

Summary: the primary intent of this study is to assess the safety of the model 1457q quartet lv lead at 3 months in a patient population indicated for cardiac resynchronization therapy.

this is a prospective, multi-center, ide clinical study designed to evaluate the safety of the model 1457q quartet lv lead. a minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide. all subjects successfully implanted with a quartet 1457q lead will be followed every 6 months post implant until pre market approval (pma) is obtained or the study is closed.

Eligibility criteria:
inclusion criteria: 1. meets current st. jude medical clinical indication for implantation of a cardiac resynchronization therapy system: " to provide a reduction of the symptoms of moderate to severe heart failure (new york heart association functional class iii or iv) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged qrs duration, or " to maintain synchrony of the left and right ventricles in patients who have undergone an atrio ventricular nodal ablation for chronic (permanent) atrial fibrillation and have new york heart association functional class ii or iii heart failure. 2. is receiving a new market-approved st. jude medical quadripolar cardiac resynchronization therapy system implant with the quartet 1457q lv lead. 3. have the ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 4. are 18 years or above, or of legal age to give informed consent specific to state and national law. exclusion criteria: 1. had a previous unsuccessful commercial or non-quartet 1457q lv lead implant attempt 2. have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate 3. patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. co-enrollment in other studies may be allowed if pre-approval is granted from the study manager. 4. are pregnant or planning pregnancy in the next 6 months 5. have a life expectancy of less than 24 months due to any condition
comparison of blood loss in using vs not using placental cord drainage after spontaneous vaginal delivery

Conditions: Placental Blood Drainage

Summary: comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood.

the patients will prospectively randomized equally into two groups (100 each in the study and control groups). group-a (study group)-placental blood was drained. group-b (control group)-placental blood was not drained. in all the patients detailed medical and obstetric history will taken. in each patient, the pre-delivery pulse rate, blood pressure, and hb gm% will noted. immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. in the control group, the clamped cord will not released. blood lost in the third stage of labour will measured by collecting the blood measuring bag.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * vertex presentation * gestational age of 37 weeks (or) more * no major medical (or) obstetric complications * spontaneous vaginal delivery exclusion criteria: * hb\\7 gm/dl * history of aph * instrumental delivery * multiple pregnancy * malpresentations * large baby (more than 3.5 kg) * polyhydramnios * known coagulations disorders * previous surgeries on the uterus
diabetes-obstructive sleep apnea treatment trial

Conditions: Type 2 Diabetes; Obstructive Sleep Apnea

Summary: diabetes self-management is important to help adults with type 2 diabetes achieve glucose control. obstructive sleep apnea often co-exists with type 2 diabetes and may act as a barrier to diabetes self-management and glucose control. we will examine if treatment of obstructive sleep apnea with continuous positive airway pressure (cpap), combined with diabetes education, results in improved diabetes self-management and glucose control.

while diabetes self-management has been improved and refined over the last 30 years, many persons with t2dm continue to have difficulty in achieving glycemic goals. obstructive sleep apnea (osa) has a high prevalence among adults with type 2 diabetes (t2dm) and is associated with excessive daytime sleepiness, impaired mood, decreased vigilance, and reduced functional outcomes. the degree that osa affects diabetes self-management, a known determinant of glycemic control, remains unstudied. the most effective treatment for osa, continuous positive airway pressure (cpap), results in improved self-reported daytime functioning. however, the effect of cpap treatment on reception of diabetes education remains unknown. the underlying premise of the proposed study from this new investigator is that osa hinders diabetes self-management in adults with t2dm. our goal is to improve understanding of the effect of osa on diabetes self-management and to determine the efficacy of cpap treatment in improving diabetes outcomes in adults treated with cpap compared to those on sham-cpap. expanding our understanding of the effect of sleep disturbances on diabetes self-management may lead to improved guidelines for screening and treatment of osa in the increasingly large portion of the population with diabetes

Eligibility criteria:
inclusion criteria: * suboptimal glucose control (a1c ≥ 6.5%) * moderate-to-severe obstructive sleep apnea (apnea + hypopnea index \>= 10/hour) * age 18 years and older exclusion criteria: * poor glucose control (a1c \> 11) * type 1 or gestational diabetes * sleep duration \< 4 hrs * acute medical or surgical conditions or hospitalization ≤ 3 months * oxygen or bi-level pap required * prior cpap or persons in household with cpap * employed in safety sensitive job * pregnant

Keywords: sleep apnea diabetes