Kornimate/medical-research-clean huggingface dataset:
misopristol versus pitocin for second trimester abortion

Conditions: Abortion, Missed

Summary: second trimester abortion can be done surgically or medically. medical abortion with mifepristone and misopristol is one of the common protocol, but misopristol have high rate side effect. the investigators recent study proved the efficacy of pitocin after mifepristone in second trimester abortion with minimal side effects. working hypothesis and aims: to compare misopristol and pitocin after mifepristone preparation in second trimester in seccess rate, interval to abortion, side effects and patient satisfaction.


Eligibility criteria:
inclusion criteria: * midtrimester late abortion * midtrimester induced abortion exclusion criteria: * placenta previa * infected abortion * rupture of membranes * s/p cesarean section \*2 or more
novel pharyngeal metrics to predict dysphagia outcomes

Conditions: Dysphagia; Swallowing Disorders

Summary: this multi-site trial will follow a cohort of veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. a non-dysphagic veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. the investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures. the investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. this research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in veterans.

this multi-center trial will follow a cohort of veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. veterans with dysphagia will be assessed at three time points: baseline, 6-4 weeks post-treatment, and 8 weeks post-treatment. a non-dysphagic veteran control group (n=50) will also undergo data collection at parallel time points, without completion of a treatment paradigm. the investigators will then compare patients to nondysphagic controls using phrm, videofluoroscopy, diet assessment, functional reserve tests, and patient reported outcome measures. the investigators aim to 1) quantify change in phrm measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or phrm-based metrics best track with patient-reported outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. this research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in veterans.

Eligibility criteria:
inclusion criteria: * signed an informed consent form * receive a dysphagia diagnosis by a speech-language pathologist * must have a dysphagia treatment plan with the goal of strengthening the oropharyngeal musculature * english speaking exclusion criteria: * history of allergic response to barium * history of allergic response to topical anesthetics

Keywords: dysphagia manometry swallowing veterans
evaluation of the epiglare tester for the measurement of glare-induced changes in bscva in subjects with and without cataracts

Conditions: Cataract

Summary: the epiglare tester will identify visual disability resulting from the glare experienced by subjects with cataracts in the glare-induced change in best spectacle corrected visual acuity (bscva).

inclusion criteria: 1. are 18 years of age or older. 2. have been evaluated by an opthalmologist and have a lens determination of either normal or cataract in each eye based on slit lamp examination. 1. normal = lens opacity of clear or trace 2. cataract = lens opacity of 2+ or greater 3. have written informed consent as required by the site's irb and received a copy. 4. are willing and able to comply with testing according to the investigator. exclusion criteria: 1. best corrected visual acuity is worse than 20/60 in either eye 2. have occular pathology including corneal or macular disease or advanced glaucoma 3. have cognitive dysfunction which limits the ability to cooperate with testing. 4. have presence or history of any other condition or finding or concomitant medication that, in the investigator's opinion, makes the subject unsuitable as a candidate for epiglare or study participation or may confound the outcome of the study.

Eligibility criteria:
inclusion criteria: clear lenses ou cataracts ou willing to comply with testing exclusion criteria: bcva \< 20/63 either eye ocular pathology (ie corneal, macular disease, advanced glaucoma) cognitive dysfunction other conditions that in the investigators opinion made the subject unsuitable candidate

Keywords: disability glare contrast sensitivity cataract method evaluation glare test
effectiveness of a prehabilitation program for hip or knee arthroplasty surgery.

Conditions: Prehabilitation; Knee Osteoarthritis; Hip Osteoarthritis; Physical Therapy Modalities

Summary: we live in an increasingly aging society in which the incidence of osteoarticular diseases increases, among which osteoarthritis (oa) stands out. oa is a degenerative disorder of the different components of the joint leading to a progressive destruction of the same. the hip and knee being the most affected joints, oa presents multiple symptoms such as pain, stiffness and functional limitation, also causing psychological disorders such as anxiety, depression, quality of sleep and poor perception of quality of life. conventional treatment is aimed at alleviating symptoms, but when conservative therapies fail in the more advanced stages of the disease, total joint replacement surgery or arthroplasty is the therapeutic option of choice. strength physical exercise (pe) and aerobic training have been shown to be effective in oa, obtaining positive effects on the symptoms and on variables that deteriorate this disease. the concept of pre-habilitation or preoperative rehabilitation has been shown through other studies in different pathologies (cardiopulmonary and musculoskeletal) to have positive effects at a clinical and functional level, however, the planning of a pre-habilitation protocol in hip or knee arthroplasty is still controversial. the purpose of this study is to determine the effect that a prehabilitation program will produce and its possible usefulness in those subjects who are waiting for a hip or knee arthroplasty. it is expected to find favorable results that support this therapy when it comes to reducing postoperative recovery times, functional capacity and other psychological variables of interest. this powerful tool could represent a non-pharmacological and non-invasive therapy, as well as being useful and economical in the management of patients with oa in advanced stages.


Eligibility criteria:
inclusion criteria: * diagnosis of hip oa stage i-iii of the tönnis classification or diagnosis of knee oa stage i-iv of the ahlbäck classification * patients requiring hip/knee arthroplasty surgery * signed informed consent * obtaining a score equal to or greater than 8 repetitions in the sit to stand test * patients with the ability to walk without technical aids or in need of some help (up to two canes or a walker) exclusion criteria: * cognitive deficit/dementia states * cancer processes * associated vascular and inflammatory pathologies * associated neurological pathologies * contraindications to physical exercise

Keywords: prehabilitation knee osteoarthritis hip osteoarthritis physiotherapy preoperative
the pharmacokinetics of cannabidiol (cbd) and its effects in children with severe epilepsy

Conditions: Dravet Syndrome; Lennox Gastaut Syndrome

Summary: the purpose of this study is to determine if cannabidiol (cbd) obtained via the state of minnesota reduces seizures in patients with severe intractable epilepsy (dravet syndrome or lennox gastaut syndrome), and to measure blood levels of cbd to help determine cbd concentration-response characteristics.

patients with medically refractory epilepsy who are registering to take cbd in the state of minnesota will be offered the opportunity to participate in this study. if consent to participation is obtained, the patient (or more likely, the patient's guardian) will be asked to begin a seizure diary for at least a 7-day period prior (ideally, longer) to receiving the cbd, and to continue tracking seizures throughout the study. upon receipt of cbd from the minnesota dispensary, subjects will take their cbd as directed and will return to the clinic for a repeat visit (which is part of standard care) occurring 2-8 weeks after continual use of cbd. during these clinic visits, patients undergo blood draws to monitor their other prescribed aed concentrations as part of standard of care. in addition to the standard blood draw, the research participant will be asked to provide a blood sample of 5 ml to measure cbd concentrations. as most patients are instructed to take cbd two hours prior to their standard of care aeds, clinical experience indicates that most patients are taking cbd quite early in the morning (around 6 am). thus, the time of sample collection will be recorded as hours post-dose, and will likely be nearer peak serum concentrations. if a study participant has an indwelling intravenous access port, they will be asked to provide an additional sample of 5 ml at least one hour after the initial sample. during the repeat visit, subjects will be asked to continue documenting seizure activity in their seizure diary while they continue their cbd treatment. any changes to aeds administered concurrently with cbd will also be recorded. subjects who are already on a stable regimen of cbd will also be eligible to participate. at a clinic visit, they will be asked to provide a blood sample of 5 ml, the time of each sample will be recorded as hours post-dose of cbd. they will also be asked to begin a seizure diary and continue tracking seizure activity. if a patient terminates their cbd treatment, they will be asked to continue tracking seizure activity after their last cbd dose until their follow-up clinic visit, to determine change in seizure activity while on and off cbd.

Eligibility criteria:
inclusion criteria: * diagnosed with dravet syndrome or lennox-gastaut syndrome * patients who are planning to obtain medical cannabidiol * patients who are already taking medical cannabidiol and are planning to stop taking it. exclusion criteria: * patients without a diagnosis of dravet syndrome or lennox-gastaut syndrome

Keywords: cannabidiol dravet syndrome lennox gastaut syndrome
long-term follow-up observation after surgical treatment of peri-implantitis in multicenter post market clinical study

Conditions: Peri-implantitis

Summary: the objective of this non-interventional long-term follow-up observation is to evaluate the long-term sustainability of two surgical treatments of peri-implantitis with and without geistlich bio-oss® and geistlich bio-gide® from a previous study

the study is a non-interventional long-term follow-up observation without any study specific procedure outside normal clinical routine. patients from a previous study are selected to participate in this study within a standard maintenance programm. primary and secondary oucomes refer to the previous study

Eligibility criteria:
inclusion criteria: * implant survival at the treated site from the previous study * written informed consent exclusion criteria: * implant failure at the treated site * severe trauma to implant site causing removal of the implant since the last visit of previous study
changes in the gut microbiota of patients undergoing allogeneic stem cell transplantation (collect)

Conditions: Acute Myeloid Leukemia; Graft-versus-host-disease; Allogeneic Hematopoietic Stem Cell Transplantation; Stem Cell Transplant Complications

Summary: collect is a monocentric, prospective, observational study, which aims to assess the association between changes in the intestinal microbiota and the incidence of gastrointestinal graft-versus-host diseases (gvhd). patients admitted for performance of an allogeneic hematopoietic stem cell transplantation (hsct) or patients with a first diagnosis of an acute myeloid leukemia (aml) will be enrolled and stool samples will be analyzed using next-generation sequencing. in addition to stool, blood and urine samples will be collected for cytokine and 3-indoxylsulfate analysis. exposure to drugs will not be influenced and remains at the discretion of the treating physician.

documentation of patient is performed by using the web-based survey platform www.clinicalsurveys.net which was set up by researchers of the university hospital of cologne. this survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. it has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards. the following data items of patients with a written informed consent are prospectively documented into our database: * demographics * chemotherapeutic agents * other immunosuppressives * radiation treatment * antibiotic prophylaxis and treatment * bowel movement abnormalities * hsct donor and recipient information * status of hematological disease * days with neutropenia * fever and infectious complications the following samples of patients with a written informed consent are prospectively collected, stored and analyzed: * stool samples (16s rrna analysis) * urine (3-is analysis) * ethylenediaminetetraacetic acid (edta) blood samples (pbmcs fluorescence-activated cell sorting (facs) analysis) * citrate blood samples (cytokine analysis)

Eligibility criteria:
inclusion criteria: * age of at least 18 years * patients admitted for performance of an allogeneic hsct or * patients with a first diagnosis of an acute myeloid leukemia * no contraindication for an allogeneic stem cell transplantation * subject is not legally incapacitated * written informed consent from the study subject has been obtained exclusion criteria: * active inflammatory bowel disease * ongoing gastroenteritis at the time of inclusion * patient has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the patient participating in the study, would make it unlikely for the patient to complete the study, or would confound the results of the study * persons with any kind of dependency on the investigator or employed by the sponsor or investigator * persons held in an institution by legal or official order

Keywords: allogeneic hematopoietic stem cell transplantation graft-versus-host-disease acute myeloid leukemia
a study to demonstrate the analgesic efficacy of oxycodone/naloxone prolonged release tablets in addition to pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from moderate to severe pain due to diabetic polyneuropathy

Conditions: Moderate to Severe Pain Due to Diabetic Polyneuropathy

Summary: to show superior analgesic efficacy of oxn pr in addition to a patient's current dose of pregabalin compared to pregabalin alone.

study oxn2502 is a pilot, exploratory, randomised, placebo-controlled, double-blind, single-dummy, parallel group study to assess efficacy and safety of oxn pr in addition to a patient's current dose of pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from moderate to severe pain due to diabetic polyneuropathy.

Eligibility criteria:
inclusion criteria: * moderate to severe pain due diabetic polyneuropathy * opioid-naive subjects exclusion criteria: * females who are pregnant or lactating * subjects with evidence of significant structural abnormalities of the gastrointestinal tract * subjects with evidence of impaired liver/kidney function upon entry into the study
dose linearity study of codeine sulfate under fasted conditions

Conditions: Pain

Summary: the objective of this study was to examine the dose linearity of roxane laboratories' 15 mg, 30 mg, and 60 mg codeine sulfate tablets under fasted conditions


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to codeine sulfate or any comparable or similar product.
construction of clinical model of primary sjogren's syndrome combined traditional chinese and western medicine

Conditions: Primary Sjögren Syndrome

Summary: this study aims to establish a large sample cohort of patients with primary sjogren's syndrome, collect multi-omics information of patients with primary sjogren's syndrome, and construct disease diagnosis model and disease prognosis prediction model.


Eligibility criteria:
inclusion criteria: * meets the 2002 aecg or 2016 acr/eular classification criteria of primary sjögren's syndrome. exclusion criteria: * comorbid connective tissue disease other than the disease under research. * women who are pregnant or breastfeeding. * combined severe cardiovascular or cerebrovascular disease, hepatic or renal failure, or severe malignant tumors. * other conditions (e.g., cognitive impairment) that the investigators consider ineligible for enrollment.
cost of care for juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: this project seeks to collect data on healthcare utilization and expenditure rates in juvenile idiopathic arthritis (jia) patients from across the us, correlate these costs with disease activity and outcome measures and determine methods by which to reduce the economic impact while improving outcomes.

specific aims and objectives the specific aims of this registry protocol are: * to create and maintain a secure online database of patients with jia * to collect data elements related to cost of care in patients with jia * compare standard outcome and disease activity measures to health care expenditures in jia * to determine methods by which to reduce costs while improving outcomes and quality of care the study plans to enroll 300 or more subjects from 3 medical centers in the us over a 24 month period. subjects in the study are patients with juvenile idiopathic arthritis. enrollment into the protocol will include key demographic and clinical data including, medication exposures, disease severity, and function including disease-specific data elements; and estimates of health care service utilization and health care expenditures. data will be collected once per subject within the context of a standard of care visit.

Eligibility criteria:
inclusion criteria: * subject has been diagnosed with jia by a pediatric rheumatologist according to published criteria. * person providing consent must be able to read english. * subject (and/or parent/legal guardian) is able to provide informed consent and willing to comply with study procedures. exclusion criteria: * subject/ legal guardian is unwilling to provide consent, cannot read english, or does not meet published criteria for jia. * coexisting rheumatologic disorder * diagnosis of fibromyalgia * participation in a drug trial in the past 6 months.

Keywords: jia juvenile idiopathic arthritis cost of care quality of life qol
rainbow acoustic monitoring (ram) clinical engineering data collection

Conditions: Sleep Apnea

Summary: to capture high resolution waveform data and numerical data from investigational and fda-released ram sensors in the neonatal, infant, pediatric, and adult patient population


Eligibility criteria:
inclusion criteria: * male or female subjects that are between 0 to 70 years old. * neonate, infant, pediatric, adult, and pregnant subjects with fully developed skin. exclusion criteria: * patients with skin abnormalities at the planned application sites that would interfere with sensor, cannula or electrode applications. * patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the principal investigator (pi). * patients who the pi deems ineligible at the pi's discretion
steady-state feedback actions of testosterone on luteinizing hormone secretion in young and older men

Conditions: Hypogonadism

Summary: this study is being done to learn how the male hormone , testosterone, affects pituitary hormones in younger and older men. the pituitary is a gland in the brain that secretes hormones, some of which normally control growth and fertility.

concentrations of bioavailable testosterone decline by 1.0-1.5% annually as men age. reduced systemic testosterone availability is associated with decreased muscle mass, strength and aerobic capacity, decreased bone-mineral density and increased risk of hip fracture, waning sexual interest, inpaired spatial cognition and increased risk of visceral obesity, impaired glucose tolerance and coronary artery disease. luteinizing hormone (lh) secretion often fails in healthy older individuals. in addition, aging is marked by an acceleration of lh pulse frequency, loss of high-amplitude lh pulses and disorderly release of lh and testosterone, as measured by the approximate entropy statistic. the mechanisms that underlie such complex adaptations are not known, but appear to involve multiple loci of regulatory failure.

Eligibility criteria:
* healthy men ages 18-80 * all ethnicities eligible * men with indeterminate erectile dysfunction eligible with normal serum gonadotropin, total testosterone, prolactin and tsh concentrations and documented integrity of the neurovascular, cardiovascular, hepatorenal systems
safety and efficacy of mbi 226 1.25% and 2.5% topical acne solutions in the treatment of acne

Conditions: Acne Vulgaris; Acne; Propionibacterium Acnes

Summary: this is a phase ii, randomized, vehicle-controlled, double-blind, multi center study to evaluate the efficacy and safety of topically applied mbi 226 1.25% and 2.5% acne solutions as anti-acne preparations in human subjects with facial acne vulgaris.


Eligibility criteria:
inclusion criteria: * males and females 12 years and older * presence of inflammatory and non-inflammatory lesions exclusion criteria: * acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.) * active facial cysts or any nodulocystic lesions

Keywords: acne vulgaris acne propionibacterium acnes topical inflammatory non-inflammatory lesion counts lesions