Kornimate/medical-research-clean huggingface dataset:
a study to evaluate long-term safety and efficacy of asp1941 in diabetes patients

Conditions: Type 2 Diabetes Mellitus

Summary: this study is to evaluate safety and efficacy of asp1941 after 24 week administration to diabetic patients.

subjects will undergo the 6-week screening period before entering the 24-week treatment period and will receive asp1941 before breakfast during the treatment period. all subjects will be followed for 4 weeks after study treatment is discontinued.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients * subject is only on a diet and exercise program or has received a single antihyperglycemic agent or two antihyperglycemic agents (excluding insulin) with low dose (≤50% of the maximum dose of each recommended dosage) * subject has a hba1c value (jds value) between 6.5% and 9.5% and the difference of hba1c values (jds value) within ± 1.0% * bmi 20.0 - 45.0 kg/m2 exclusion criteria: * type 1 diabetes mellitus * subject has received insulin within 12 weeks (84 days) before the study * subject has proliferative diabetic retinopathy * subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant * subject with obvious dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy * subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (nyha class iii-iv) within 12 weeks (84 days). subject has heart disease, cerebral vascular disease which, in the opinion of the principal investigator or the sub-investigator, may interfere with treatment or evaluation of safety of this study. * female subject who is currently pregnant or lactating, or who is possibly pregnant * male and pre-menopausal female subject who cannot use an appropriate contraception during the study * subject has a history of treatment with asp1941 * subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies * subject has a serum creatinine value higher than upper limit of normal range * subject has a urinary microalbumin/ urinary creatinine ratio \> 300 mg/g in urinalysis * subject has uncontrolled severe hypertension (subject whose systolic blood pressure is \> 170 mmhg or diastolic blood pressure of \> 95 mmhg measured in a sitting position after 5 minutes of rest * subject who is judged inappropriate for enrollment into the study by the principal investigator or the sub-investigator

Keywords: glucose excretion ipragliflozin hypoglycemic agents serum insulin diabetes mellitus blood glucose
act for high frequency migraine; a virtual mindfulness intervention

Conditions: Migraine

Summary: mindfulness training specifically for pain to be offered to migraine patients

patients with high frequency migraine will be randomized to uc or intervention. those in intervention will attend a multi session training on acceptance and commitment therapy. all participants will track responses.

Eligibility criteria:
inclusion criteria: * women ages 18-65 * diagnosis of episodic migraine (according to international classification for headache diagnosis criteria) * 4-14 migraine days per month over the past 3 months * no change in medication in the past 3 months * greater than 1 year of migraines * agreeable to participate, commit to all study procedures and to be randomized to either group * fluent in english exclusion criteria: * any unstable medical or psychiatric conditions requiring immediate treatment or could lead to difficulty complying with the protocol * active suicidal ideation * moderate to severe depression * current alcohol or substance abuse * recent cognitive behavioral therapy, mindfulness based cognitive therapy, dialectic behavioral therapy or acceptance and commitment therapy within past 3 years * current use of narcotics * psychiatric hospitalization within past year * comorbid pain condition rated as more painful than migraine * starts new migraine treatment during study * inability to complete study visits

Keywords: migraine high frequency act
promis measures in primary care practice

Conditions: Sleep; Pain; Anxiety; Depression; Fatigue

Summary: the purpose of this study is to determine the effectiveness of providing promis profile scale scores (e.g., sleep, pain, anxiety, depression, energy/fatigue) to physicians on patients' symptoms.

the spade symptoms (sleep, pain, anxiety, depression, and energy/fatigue) are the most common yet undertreated symptoms in clinical practice. using the promis (patient-reported outcome measurement information system) profile scales as a measure of spade symptoms, this study will determine the effectiveness of providing patient symptom scores to clinicians, identify barriers and facilitators to the clinical use of such scores, and evaluate the psychometric properties of the promis profile scales in a primary care population.

Eligibility criteria:
inclusion criteria: patients * adults ≥ 18 years of age, * receiving care from a participating primary care physician * report a moderate level of severity ( ≥ 4 on a 0 to 10 scale) on at least one of 5 symptoms (sleep, pain, anxiety, depression, energy/fatigue) based on a 5-item screener. physicians * primary care physicians within the indiana university health and eskenazi health systems exclusion criteria: patients * patients less than 18 years of age * patients who do not receive care from a participating primary care physician * patients who have less than a moderate level of severity (less than 4 on a 0 to 10 item scale) on each of the 5 symptoms (sleep, pain, anxiety, depression, energy/fatigue) based on a 5-item screener. physicians: * primary care physicians who do not practice within the indiana university health or eskenazi health systems

Keywords: sleep pain anxiety depression fatigue promis primary care
survey to identify burdens and unmet needs of patients with epidermolysis bullosa

Conditions: Epidermolysis Bullosa

Summary: this survey intends to collect information on key aspects of life with epidermolysis bullosa (eb), including diagnostic journey, treatment, management, daily living challenges, and overall psycho-social, socio-economic, academic and family impact. objectives: * to understand the unmet needs for people living with eb in the us * to assess the differences/similarities in the management/treatment of eb patients (including wound care, symptom management and other issues) * to assess the eb patients' and caregivers' perceptions of current management/treatment * to assess the challenges and the burden of daily living with eb * to understand eb diagnostic journey (the time to diagnosis and by what type of healthcare provider) * to identify professional disciplines involved in the diagnosis and management of eb * to understand the psycho-social, socio-economic, academic, and family impact of eb

epidermolysis bullosa (eb) is a rare, often severe genetic disorder characterized by mechanical fragility and blistering or erosion of the skin, mucosa, or epithelial lining of other organs, in response to little or no apparent trauma. eb is chronic, potentially disfiguring, and in some cases fatal. patients with eb have painful wounds and blisters that can lead to infection and scarring. there are many genetic and symptomatic variations of eb, but all forms share the common symptom of fragile skin that blisters and tears, sometimes from the slightest friction or trauma. there is currently no approved treatment for eb. current standard of care consists of pain management and the bandaging and cleaning of open wounds to prevent infection. while there are a number of publications/guidance/consensus statements related to the diagnosis and management of eb from the point of view of the health-care provider/disease expert, there is a need for more research to define the key aspects of life with eb (i.e. diagnostic journey, treatment, management, daily living challenges, and overall disease burden) from the perspective of the patient.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of eb including subtype * resident of the us * informed consent * patient must be 18 years or older * if the survey is done by a caregiver, they must be a parent or legal guardian and must be 18 years or older to answer on behalf of a patient under 18 years or on behalf of a patient 18 years or older who is unable to answer for themselves. * must participate in and complete a one hour telephone interview exclusion criteria: * patient failing to meet the inclusion criteria above

Keywords: epidermolysis bullosa recessive dystrophic simplex junctional non-herlitz
a study of ro4917523 in patients with treatment resistant depression

Conditions: Depression

Summary: this study will evaluate the safety, tolerability and efficacy of ro4917523, in comparison to placebo, in patients with treatment-resistant depression. following a washout period from existing anti-depressant medication, cohorts of patients will be randomized to receive daily oral ro4917523 at up to five different doses (according to the safety and tolerability observed at the lower doses during the study), or placebo. the anticipated time on study treatment is 10 days (in an inpatient unit), and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age; * recurrent major depressive disorder, without psychotic features; * at least 3 lifetime treatment failures, at least 2 of which must have occurred within the current depressive episode; * baseline minimal severity defined by a ham-d score of 18 or above; * willing to be hospitalized for at least 16 consecutive days. exclusion criteria: * history of bipolar disorder, schizoaffective disorder or schizophrenia; * history of psychosis, including psychotic depression; * significant past or present neurological disorder, including seizures, stroke and/or head trauma.
soft tissue massage along with mobilization technique on symptoms and functional status of carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: the objective of this experimental study is to determine the effect of soft tissue massage along with mobilization technique on intensity of pain by visual analog scale and functional status by using jamar hand-held dynamometer, pinch gauge and boston scale for carpal tunnel syndrome questionnaire in carpal tunnel syndrome patients. it is being conducted on patients with carpal tunnel syndrome at sindh institute of physical medicine and rehabilitation, karachi and neurological outpatient department of dr. ruth k. m. pfau, civil hospital karachi among sixty participants with mild and moderate severity of carpal tunnel syndrome will be randomly allocated in two groups after initial screening by a consultant physiatrist according to cts-6 scale. written informed consent will be taken from each participant. group a will be treated with soft tissue massage (medenci hand massage technique) along with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique while group b will be treated with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique only. participant will be evaluated by visual analog pain scale, boston scale of carpal tunnel syndrome, dynamometer and -pinch gauge, center for epidemiologic studies depression scale and pain anxiety symptoms scale on day 1 and last treatment session.


Eligibility criteria:
inclusion criteria: * consultant physiatrist will be diagnosed patients of carpal tunnel syndrome on electro diagnostic test i.e. nerve conduction studies. * mild and moderate severity of carpal tunnel syndrome. * age: 18-50 years * both gender patients with unilateral involvement of the hand exclusion criteria: * exclusion criteria: * in electro diagnostic test, either motor or sensory deficit in the ulnar nerve and radial nerve. * other neurological problems ( cervical myelopathy, motor neuron disease like amyotrophic lateral sclerosis * neoplasm around the affected arm * presence of other musculoskeletal problems of upper quadrant (for example: rheumatoid arthritis or fibromyalgia, cervical radiculopathy) * any recent history of trauma of upper extremity on affected side

Keywords: peripheral neuropathy compression neuropathy entrapment neuropathy soft tissue massage manual therapy massage therapy median neuropathy
smartphone app-assisted ppi

Conditions: Heartburn; Dyspepsia

Summary: proton pump inhibitors (ppis) are frequently prescribed for 30 days but taken infinitely. ppis belong to the most often inappropriate medicines (pims). correct intake of medicines (named adherence) can be supported by digital devices such as smartphone applications. the goal of this interventional study is to test the feasibility of an app-based treatment support provided by community pharmacists in patients prescribed a short-term ppi (30 days). the intervention consists in tracking medication intake, symptom course and well-being over the treatment duration of 30 days with the mednet app on patients' personal smartphones.

this is an exploratory study in a primary care setting with community pharmacists recruiting patients who are newly prescribed a ppi for a short-term treatment (30 days). there is no control group and no randomization. after informed consent and installing the app on their personal smartphones, patients will answer three questions from the app once daily. the questions address medication intake (yes/no), symptom course (better, worse, identical, no symptoms) and well-being (satisfactory/needs improvement). worsening of symptoms will trigger an alarm (via email) at the pharmacy. the pharmacist will call the patients and use information from adherence and well-being to consolidate a supporting counseling. feasibility and a frequency estimation of the interventions will be the focus of the study in view of a larger implementation study with community pharmacies. further implementation outcomes will be assessed through interviews and surveys (satisfaction, interprofessional work).

Eligibility criteria:
inclusion criteria: * is ≥18 years old; * has symptoms that suggest or correspond to gastroesophageal reflux disease (gerd); * is newly prescribed a short-term ppi treatment; * accepts to use of the smartphone app mednet during the study period; * signs the informed consent form; * understands and speaks (swiss) german. exclusion criteria: * in the opinion of the pharmacist or physician, unlikely to comply with the study schedule or are unsuitable for any other reason.

Keywords: medication adherence short-term therapy proton pump inhibitors mobile health implementation
a research study to characterize the pharmacodynamics and safety of repeat dose sp-102

Conditions: Lumbosacral Radicular Pain

Summary: this is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of sp-102 administered by epidural injection.


Eligibility criteria:
main inclusion criteria: * able and willing to read, write, and understand the english language and provide english language written informed consent prior to beginning any study procedures. * age 18 to 70 years (inclusive) at the screening visit. * a diagnosis of lumbosacral radicular pain (sciatica). * agrees to follow study-specific medication requirements. * if sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study. * has reviewed all study specific materials and has, in the opinion of the investigator, the abilities to understand and appropriately complete all study procedures. main exclusion criteria: * has radiologic evidence of a condition that would compromise study outcomes. * has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study. * has been diagnosed with insulin dependent diabetes mellitus. * presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments. * use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study. * has a body mass index ≥40 kg/m2.

Keywords: lumbosacral radicular pain sciatica leg pain
an acceptability study of unflavored asenapine versus raspberry flavored asenapine in stable patients with a psychotic disorder (p07010)(completed)

Conditions: Psychosis

Summary: this trial was a randomized trial to determine a patient's acceptability of unflavored antipsychotic medication compared to raspberry flavored antipsychotic medication. patients received 6 total doses of study drug (2 doses of each asenapine formulation) over 3 consecutive days: 2 different formulations each day, 1 in the morning and 1 in the evening. the formulations were: white unflavored, white raspberry flavored, and red raspberry flavored. patients were given a questionnaire following each dose of study medication (one questionnaire twice per day for 3 days) to measure how acceptable each formulation was.

study drug was administered according to a random selected sequence schedule with 2 constraints: subjects did not receive consecutive doses of the same formulation, and each formulation was given once in the morning and once in the evening over the course of the 3-day treatment period.

Eligibility criteria:
inclusion criteria: * are at least 18 years of age and of legal minimum age for trial participation; * are a male, or a female who is not of childbearing potential * are free from an acute exacerbation of psychosis for at least 3 months; * have a current dsm-iv diagnosis of schizophrenia (paranoid, disorganized, catatonic, or undifferentiated subtype), or schizoaffective disorder; delusional disorder, major depressive disorder, or bipolar disorder, for whom chronic antipsychotic therapy is indicated; * correctly identify 3 out of 4 basic flavors (bitter, sweet, salty, or sour) on a neutral taste paradigm; * are receiving oral antipsychotic medication. exclusion criteria: * an uncontrolled, unstable clinically significant medical condition * clinically significant abnormal laboratory, vital sign, pe, or ecgs findings at screening; * previously experienced nmrb (also known as vasovagal reflex) or sensitivity for fainting; * a positive serum pregnancy test at screening, or the intention to become pregnant within the next 30 days; * a history of seizures; * a history of neuromalignant syndrome; * a current (past 6 months) substance abuse or dependence according to dsm-iv-tr criteria (excluding nicotine); * an imminent risk of self-harm or harm to others; * currently receiving a depot antipsychotic, such as fluphenazine decanoate, haloperidol decanoate, or risperdal consta, within at least 1 dosing cycle of day-5; * any impairment in taste functioning; * receiving lithium or topiramate; * judged by the principal investigator (pi) to be unable to reliably respond to the questionnaire based on clinically significant cognitive impairment.
the effectiveness of yag iridotomy in preventing peripheral anterior synechia after class in primary open angle glaucoma

Conditions: Glaucoma, Open-angle

Summary: to investigate the effectiveness of yag laser iridotomy in preventing peripheral anterior synechia after co2 laser-assisted sclerectomy surgery and the long-term effect of reducing intraocular pressure

group a: yag laser iridotomy was performed one week before operation, followed by co2 laser-assisted sclerectomy surgery; group b: only co2 laser-assisted sclerectomy surgery; the patients were followed up for 1 year to observe and compare the difference of the incidence of peripheral anterior synechia and the effect of long-term intraocular pressure control between the two groups.

Eligibility criteria:
inclusion criteria: * primary open angle glaucoma patients in ophthalmic center; * topical use of hypotensive drugs in the treatment of poor or intolerable intraocular pressure control; * the patients were 18 to 50 years old, regardless of gender; * class operation was performed; * patients are able and willing to comply with the research guidance and may complete all visits required by the research; * informed consent has been signed. exclusion criteria: * allergic to any perioperative medication in this study; * history of ocular trauma; * any previous intraocular surgery; * gonioscopy showed a narrow angle (schaffer iii or below); * secondary glaucoma was diagnosed; * optic atrophy caused by other reasons; * severe complications such as rupture of posterior capsule and choroidal hemorrhage occurred during operation; * patients with severe ocular complications after operation * the patient's history indicated that he had severe dysfunction of heart, lung, liver and kidney; * women in pregnancy, lactation or planned pregnancy; * the researchers believe that the patient's condition may put the patient at significant risk, may confuse the results of the study, or may significantly interfere with the patient's participation in the study.
a woman suffered from leukocytopenia and widespread migration after polyacrylamide hydrogel (paag) injection in epicranial aponeurosis

Conditions: Complication

Summary: polyacrylamide hydrogel (paag) has been used as an injectable filler for soft tissue augmentation in different parts of the body , such as face, breast , or even penis for more than a decade . however, there are never reports about the application of a large amount of paag in epicranial aponeurosis to change the contour of the upper cranium accompanied with leukocytopenia. this fancy application turned out to be a disaster for the women who suffered from leukocytopenia , widespread migration of paag, recurrent swelling of the affected tissues and temporal pain changing with the temperature and the facial expression .


Eligibility criteria:
inclusion criteria: * paag injected into bilateral temporal epicranial aponeurosis exclusion criteria: * paag injected into other parts of the body

Keywords: polyacrylamide hydrogel leukocytopenia migration complication epicranial aponeurosis paag injection