Kornimate/medical-research-clean huggingface dataset:
the efficacy and safety study of rikkunshito in patients with functional dyspepsia

Conditions: Functional Dyspepsia

Summary: the purpose of this study is to assess the efficacy and safety of rikkunshito compared to placebo in japanese subjects with functional dyspepsia (fd).


Eligibility criteria:
inclusion criteria: * -patients diagnosed with fd according to the rome iii criteria i) criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to obtaining informed consent ii) have not received upper endoscopy within the last 6 months prior to enrollment and do not have evidence of structural/organic disease iii) must have one or more of the following symptoms: 1. bothersome postprandial fullness 2. early satiation 3. epigastric pain 4. epigastric burning * at least one of the fd-related symptoms on the global overall symptom (gos) scale (bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning) is ≥4, whereas heartburn is ≤3. * total score of depression-related symptoms on hospital anxiety and depression score (had) is ≤10. * type of visit: outpatient * provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study. exclusion criteria: * confirmed ulcer (excluding scars) or malignant tumor in the upper gi * suspected organic lesions in the hepato-biliary-pancreatic regions such as cholelithiasis, hepatitis, pancreatitis * history of upper gi resection * serious complications (liver, kidney, heart, or blood disease or metabolic disease) * less than a year since testing positive for h. pylori or have undergone a successful eradication therapy * use of prohibited medications * neuropsychiatric disorders * use of or planned use of any investigational drugs * unable to take drugs orally * history of allergic reactions to kampo medicines * pregnant or lactating women or those who are planning to conceive during the study period * deemed ineligible by principal investigator or sub-investigator

Keywords: rikkunshito double blind functional dyspepsia (fd)
validity and reliability of smartphone inclinometer application for measurement of cervical range of motion

Conditions: Joint Function Disorder

Summary: nowadays, smartphone technology provides opportunities for assessing and treating patients in clinical facilities and during the follow-up of the patient's progress. to date, many studies have assessed the validity and reliability of the smartphone application against universal goniometer for various joint motions, for instance, the spinal column, knee, and ankle. this study aims to determine the validity and reliability of smartphone inclinometer application for measurement of cervical region range of motion.


Eligibility criteria:
inclusion criteria: * adults aged 18 to 33 years. * both genders. * subjects that are cooperative to follow my instructions exclusion criteria: * subjects with severe spinal pathology. * pregnancy and lactation. * any musculoskeletal diseases that affect the cervical spine. * any neurological diseases that affect the cervical spine. * history of trauma in the cervical spine. * signs of cervical radiculopathy. * signs of cervical myelopathy. * signs of serious pathology. * subjects have a pacemaker or any other medical equipment that the magnet might have compromised.
is labetalol more effective than metoprolol for controlled hypotensive anesthesia during endoscopic nasal surgeries?

Conditions: Hypotension Drug-Induced

Summary: background: mucosal bleeding is the most frequent complication with endoscopic nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, leading to increased complications, operation duration, and blood loss. there are several pharmacological techniques for the appropriate control of intraoperative bleeding. objectives: to compare the safety and efficacy of oral labetalol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during endoscopic nasal surgeries. patients and methods: this is a randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for endoscopic nasal surgeries under general anesthesia at our hospital. patients were randomly allocated into two equal groups; group l, received oral labetalol, and group m, received oral metoprolol.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status ≤ ii * age from 21 to 50 years * body mass index (bmi) ≤ 35 kg/m2 exclusion criteria: * asa physical status \> ii * age \ 50 years * pregnant women * breastfeeding * bronchial asthma * chronic obstructive pulmonary disease * hypertension * ischemic heart disease * rheumatic heart disease * heart failure * heart block * sick sinus syndrome * sinus bradycardia * chronic hypotension * anemia (hb \< 10 g/dl) * renal or hepatic dysfunction * central nervous system disease * bleeding diathesis * diabetes mellitus * allergic fungal sinusitis * patients on beta-blockers, tricyclic antidepressants, alcohol or drug abuse, anticoagulation therapy, agents influencing the autonomic nervous system * patients using pacemakers * allergy to the study drugs * any contraindication of oral intake

Keywords: controlled hypotension endoscopic nasal surgery labetalol metoprolol
incidence of lactose intolerance among self-reported lactose intolerant people

Conditions: Lactose Intolerance

Summary: this is a 3-sites, double-blinded, randomized, 2x2 cross-over study aiming to compare effects of milk containing only a2 type beta casein versus milk containing both a1 and a2 beta casein proteins on the gastrointestinal symptoms for the health people who self-reported to be lactose intolerant.

study sites: shanghai, guangzhou, beijing eligible subjects were enrolled in the study and randomized into one of the 2 study arms: sequence a1-a2: oral consumption of milk containing both a1 and a2 type beta casein at visit 1 and milk containing only a2 type beta casein at visit 2; sequence a2-a1: oral consumption of milk containing only a2 type beta casein at visit 1 and milk containing both a1 and a2 type beta casein at visit 2. washout period: 2 weeks between visit 1 and visit 2

Eligibility criteria:
inclusion criteria: * 20\~50 years old male or female subjects; * non-regular milk drinker with self-reported intolerance to commercial milk; * suffered from mild to moderate digestive discomfort after milk consumption; * have normal electrocardiograms (ecg) and blood pressure during quiet respiration; * agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk; * be willing to comply with all the requirements and procedures of the study; * agree to sign the informed consent form; * agree not to enroll in another interventional clinical research study while participating in this study; * fully understand the nature, objective, benefit and the potential risks and side effects of the study. exclusion criteria: * female on pregnant or feeding； * have known dairy allergy; * have severe response to milk intolerance; * have history of faecal impaction; * trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months ; * have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening; * currently taking medicines for cardiovascular or metabolic disease; * have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory and cardiovascular diseases; * current or previous alcohol abuser, currently taking or took illicit drugs, substance or otc prescription drugs in regular frequency which may affect gastrointestinal disorders and study result; * currently suffering from any gastrointestinal disorders or gastrointestinal disease, including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(ibs); * had hospitalizations within 3 months before screening; * currently drug frequency user of that may affect the gastrointestinal function or immune system. as judged by investigator.
identification and therapy of postpartum depression

Conditions: Depression

Summary: this study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.

depression is a serious illness that can interfere with everyday life. researchers believe that it is one of the most common complications during and after pregnancy. depression after pregnancy is called postpartum depression and may be caused by a rapid change in hormone levels during and immediately after pregnancy. postpartum depression can occur anytime within the first year after childbirth and can negatively affect both mothers and their children. mothers with postpartum depression may experience low energy, difficulty concentrating, irritability, and inability to meet their children's needs for love and affection. as a result, women with postpartum depression may feel guilty and lose confidence in themselves as parents. research shows that children of mothers with postpartum depression may have delays in language development, difficulty with emotional bonding to others, behavioral problems, lower activity levels, sleep problems, and distress. this study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women. participants in this single blind study will be randomly assigned to receive either enhanced treatment as usual or telephone-based care management for the first year postpartum. all participants will have a 90-minute in-home interview upon study entry to assess depressive symptoms, functional status, medical history, and post-pregnancy plans. participants assigned to care management will receive two calls in the first month postpartum, followed by monthly calls for the remainder of the first postpartum year. during each 10- to 20-minute call, participants will be asked to provide information regarding current depressive symptoms, steps they have taken to seek depression-related care, and any barriers they have encountered in the process. in addition, a care manager will act as an advocate for the participants and assist in obtaining specialized services as necessary throughout the year. participants assigned to receive enhanced treatment as usual will not receive monthly phone calls or tailored care management. all participants will receive follow-up calls at 3, 6, and 12 months postpartum to assess outcome measures; these calls will last about 30 minutes.

Eligibility criteria:
inclusion criteria: * 4-6 weeks postpartum * english-speaking * score of at least 10 on the edinburgh postnatal depression scale exclusion criteria: * dsm-iv diagnosis of bipolar disorder or psychotic episode * active substance abuse within 6 months prior to study entry * has not received obstetrical care * history of a suicide attempt within 6 months of study entry

Keywords: postpartum depression telephone care management screening for postpartum depression
influence of low energy availability on skeletal muscle and cardiovascular health

Conditions: Diet; Deficiency; Exercise Intervention

Summary: the project is designed as a randomized controlled intervention trial in which 60 young trained (n = 30) (population a) and recreationally active (n = 30) women (population b) with regular menstruation are divided into four groups. population a will receive a low-calorie diet + exercise or an energy balanced diet + exercise over 10 days. population b will receive a low-calorie diet without exercise, or an energy balanced diet over 10 days. the participants are matched in pairs based on training history and randomized. before the diet period, the groups will undergo a 6-day control period, during which all participants must take an energy-balanced diet (± training). after the 10 days of the diet intervention period, the groups will receive an energy-balanced diet for 2 days. before, during, and after the trial period, participants will perform performance tests. in addition, 3 muscle biopsies, 2 adipose biopsies, blood samples, urine samples will be taken during the period, as well as resting metabolic rate, electrocardiogram, flow-mediated vasodilation, and body composition over the trial period. muscle protein synthesis rate will be measured over the period using stable isotope technique, which includes ingestion of heavy water (d2o) and collection of saliva samples daily (days 0 to 16). the primary measurement parameter is changes in muscle protein synthesis rate.


Eligibility criteria:
inclusion criteria: * age 18-30 * bmi 18.5-30 * regular training at least 4 times a week and a maximum of 10 times a week (≥1 times strength training, ≥1 times endurance training / interval training or interval-based sports exclusion criteria: * • irregular menstruation within the last 6 months (shorter end 24 days or longer end 35 days cycle) * used hormonal contraception within the last 3 months for the trial. * injuries / pain in the lower body, which prevents participation in intense strength training * medication consumption that may affect protein metabolism and inflammatory parameters. * diabetes * smoking * unstable weight / major weight loss (weight fluctuations of more than 5 kg in the last six months) * do not eat animal products * eating disorder * pregnancy * blood donor within the last month * cannot read or understand danish
improving diabetes care for african americans

Conditions: Diabetes

Summary: the goal of this study is to investigate methods of improving diabetes care for african americans in primary care clinics. primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports.

effective solutions are needed to address the parallel persistence of a quality chasm and racial disparities in diabetes care. many large health care systems are adopting components of the chronic care model to achieve substantial gains in diabetes care, though few health systems have successfully incorporated elements specific to minority health. we have previously identified racial disparities in key diabetes outcomes measures within an integrated health care delivery system, harvard vanguard medical associates (hvma). this project will use a randomized, controlled study design within hvma to evaluate whether enhancements to the chronic care model can produce significant improvement in the quality of diabetes care for black patients. intervention clinicians will receive monthly panel-level disparities report cards, health navigation training, and cultural competency training, while control clinicians will function within the context of the generic chronic care model. the study will occur over a 12 month period and involve 4,000 white patients and 2,500 black patients with diabetes receiving care at 8 health centers. the primary outcomes will include rates of glucose (hba1c \<7.0), ldl cholesterol (\<100 mg/dl), and blood pressure (\<130/80) control. we will use patient focus groups to identify significant barriers to care and guide health navigation training. we will survey clinicians pre- and post intervention to assess the effect of the intervention on knowledge and attitudes towards disparities. patient experiences will be assessed pre- and post-intervention using a validated instrument to determine whether the intervention can reduce existing racial disparities in patient reports of quality. we will perform a cost analysis related to the intervention using a health system perspective. in summary, this project will provide health systems with a rigorous analysis of a defined set of tools to improve diabetes care for minority populations.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus (based on fasting glucose, hba1c, and problem list) * at least 18 years old * at least one face-to-face visit with harvard vanguard primary care clinician in the last 2 years exclusion criteria: * any patient not categorized as either white or black based on race identifier in the electronic medical record

Keywords: diabetes mellitus quality of health care cultural competency performance feedback health navigator health disparities racial disparities
effects of different stretching techniques on extensibility, strength and range of motion in football athletes

Conditions: Asymptomatic Condition

Summary: to compare the effects dynamic stretching, passive stretching and self-stretching of the quadriceps muscle on muscle extensibility, hip strength and hip range of motion


Eligibility criteria:
inclusion criteria: * footbal athletes * limited range of motion in ely's test exclusion criteria: * previous surgery in the lower limb * previous physiotherapy threatment in the thigh * stretching contraindications

Keywords: stretching extensibility strength range of motion
circadian health and influential factors

Conditions: Chronobiology Disorders

Summary: this study evaluates the quality of sleep of patients admitted to medical and intensive care units. all of them will have a clock placed to measure their circadian activity. also, data will be recorded through questionnaires about the unit, patient habits and medical problems.

the investigators found an extensive bibliography related to the quality of sleep and its effects on health. however, it should be noted the literary emptiness in relation to the influential factors in it. chronobiology is the science responsible for studying the rhythmic changes in living beings; where the investigators include the circadian rhythm. in this way, all the "cycles" will be influenced by a series of factors that allow its correct operation, being in this case the light-dark cycle (ld), together with the temperature compensation, these being the determinants that allow, or not homeostasis. the sleep - wake pattern is one of the most important circadian rhythms that happen in the organism. the dream is an unconscious process by which, despite the muscular relaxation that occurs, it is accompanied by continuous brain activity along with sensitive perception, where several of the organ systems come into play. this cycle is composed of two factors: a homeostatic one directly proportional to the time we are awake, and another circadian, dependent on the secretion of melatonin and the body's regulation of temperature. this fact can be compromised by the appearance of both external and internal stimuli, altering normal functioning, which is translated into sleep deprivation, which, if extended over time, can have physical and mental consequences, some of them are: deterioration of the immune function, an increase in the incidence of cardiovascular diseases, memory deficit, early aging, mood swings, difficulty in healing, greater probability of developing metabolic syndromes, cognitive, affective disorders and even some types of cancer the results obtained will facilitate the elaboration of action protocols focused on improving sleep quality in hospitalized patients.

Eligibility criteria:
inclusion criteria: * subjects over 18 years of age, minimum duration of the hospitalization process of 96h, conscious and oriented with constancy in their clinical history (hc) and who give their consent. exclusion criteria: * personas con discapacidad visual y/o auditiva documentada en su hc, en el caso de los pacientes de unidades de cuidados intensivos (ucis) se excluirán a aquellos que obtengan una puntuación inferior a 8 en la escala glasgow. pacientes con cualquier tipo de aislamiento y aquellos incluidos en el plan de cuidados paliativos.

Keywords: sleep quality circadian rhythm nursing activities
a study evaluating the safety and efficacy of edit-301 in participants with severe sickle cell disease (ruby)

Conditions: Sickle Cell Disease; Hemoglobinopathies

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of treatment with edit-301 in adult and adolescent participants with severe sickle cell disease (scd).

this is a phase 1/2 single-arm, open-label, multicenter study evaluating the safety and efficacy of a single unit dose of edit-301 for autologous hematopoietic stem cell transplant (hsct) in subjects with severe scd. planned study subjects will be comprised of male and female adult and adolescent subjects with severe scd, from 12 to 50 years of age, inclusive.

Eligibility criteria:
key inclusion criteria: diagnosis of severe sickle cell disease as defined by: * documented scd genotype (βs/βs, βs/β0, βs/β+, or others) and * history of at least two severe vaso-occlusive events per year requiring medical attention despite hydroxyurea or other supportive care measures in the two year-period prior to provision of informed consent or assent, as applicable karnofsky (for subjects \>16 years of age) or lansky (for subjects ≤ 16 years of age) performance status ≥ 80% normal transcranial doppler velocity in subjects 16 years of age or younger key exclusion criteria: * available 10/10 hla-matched related donor * prior hsct or contraindications to autologous hsct * any contraindications to the use of plerixafor during the mobilization of hematopoietic stem cells (hscs) and any contraindications to the use of busulfan and any other medicinal products required during the myeloablative conditioning, including hypersensitivity to the active substances or to any of the excipients * unable to receive red blood cell (rbc) transfusion for any reason * unable or unwilling to comply with standard of care changes in background medical treatment in preparation of, during, or following hsct, including and not limited to discontinuation of hydroxyurea, voxelotor, crizanlizumab, or l-glutamine * any history of severe cerebral vasculopathy * inadequate end organ function * advanced liver disease * any prior or current malignancy or immunodeficiency disorder * immediate family member with a known or suspected familial cancer syndrome * clinically significant and active bacterial, viral, fungal, or parasitic infection other protocol defined inclusion/exclusion criteria may apply

Keywords: anemia anemia, sickle cell anemia, hemolytic, congenital anemia, hemolytic genetic diseases, inborn cell disorders, sickle hbs disease sickling disorder due to hemoglobin s hematologic diseases
systematic follow-up of patients surviving an episode of acute hypercapnic respiratory failure in the icu

Conditions: Acute Hypercapnic Respiratory Failure

Summary: there is currently no good description of patients surviving an episode of acute hypercapnic respiratory failure in the icu. for instance, the prevalence of osa and sleep hypoventilation in a stable clinical condition is not known in this population. this prospective cohort describes the clinical profile, predictors of readmission (followed over a year), and the prevalence of sleep-related breathing disorders (polysomnography in a stable clinical condition 3 months after icu discharge) in patients treated for an episode of acute hypercapnic respiratory failure in the icu.


Eligibility criteria:
inclusion criteria: * \> 18 years informed consent surviving an episode of acute hypercapnic respiratory failure exclusion criteria: * iatrogenic hypercpania pregnant woman

Keywords: icu, copd, ohs, osa, heart failure