Kornimate/medical-research-clean huggingface dataset:
registry to evaluate the rox coupler in patients with resistant or uncontrolled hypertension

Conditions: Hypertension; Blood Pressure, High; Blood Pressure, Resistant; Blood Pressure, Uncontrolled

Summary: the purpose of this registry is to evaluate the safety and performance of the rox coupler in patients with treatment-resistant or uncontrolled hypertension.


Eligibility criteria:
inclusion criteria: * diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination. exclusion criteria: * any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.

Keywords: hypertension high blood pressure resistant blood pressure uncontrolled blood pressure
hyperpolarized 129xe mr imaging of lung function in healthy volunteers and subjects with pulmonary disease

Conditions: Asthma; COPD; Interstitial Lung Disease; Cystic Fibrosis; Pulmonary Hypertension; Pulmonary Infection; Other Lung Disease

Summary: the purpose of this study is to develop and evaluate the usefulness of hyperpolarized (hp) 129xe gas mri for regional assessment of pulmonary function.

this is an unblinded, open-label study with \~160 subjects with diagnosed pulmonary disease and \~100 healthy controls. subjects to be enrolled will include males and females 18-80 years old. evaluation will be on an outpatient basis. imaging will be done on a single day and will involve administration of up to four 1-liter doses of hp 129xe plus one 129xe calibration dose (\~300-400ml hp 129xe). in addition to 129xe mri, a series of anatomical conventional 1h mr images will be collected including a localizer scan, breath-hold spin echo image, and breath-hold steady-state free precession image to highlight the vasculature. all subjects will be evaluated at one center: the university of kansas medical center, ks usa.

Eligibility criteria:
inclusion criteria: healthy volunteers: * subject has no diagnosed pulmonary conditions * ability to read and understand english or spanish subjects with lung disease: * subject has a diagnosis of pulmonary dysfunction made by a physician * no acute worsening of pulmonary function in the past 30 days * ability to read and understand english or spanish exclusion criteria: * mri is contraindicated based on responses to mri screening questionnaire * subject is pregnant or lactating * subject does not fit into 129xe vest coil used for mri * subject cannot hold his/her breath for 15-16 seconds * subject deemed unlikely to be able to comply with instructions during imaging * oxygen saturation \<88% on room air or with supplemental oxygen * cognitive deficits that preclude ability to provide consent * institutionalization

Keywords: hyperpolarized 129xe mri
photodynamic therapy associated with full-mouth ultrasonic debridement in the treatment of severe chronic periodontitis

Conditions: Chronic Periodontitis

Summary: background: photodynamic therapy (pdt) is a method of microbial reduction which can benefit periodontal treatment in areas of difficult access, such as deep pockets and furcations. the aim of this randomized controlled clinical trial was to evaluate the effects of pdt as an adjunct to full-mouth ultrasonic debridement in the treatment of severe chronic periodontitis. methods: twenty-two patients with at least one pocket with probing depth (pd) ≥ 7 mm and one pocket with pd ≥ 5 mm and bleeding on probing (bop) on each side of the mouth were included, characterizing a split mouth design. the control group underwent full-mouth ultrasonic debridement and test group received the same treatment associated with pdt. the following clinical parameters were evaluated: plaque index, gingival index, bop, gingival recession (gr), pd, and clinical attachment level (cal). all parameters were collected before, 1, 3 and 6 months after treatment.

the present study was a randomized, blinded, controlled clinical trial, which used a split-mouth design. prior to commencement, the study design was approved by the ethics committee of bahiana school of medicine and public health (12/2008). all patients were informed individually about the nature of the proposed treatment, and informed consent forms were signed.

Eligibility criteria:
inclusion criteria: * diagnosis of severe chronic periodontitis by the presence of periodontal pockets with clinical attachment loss (cal) ≥ 5 mm, bleeding on probing (bop) and radiographic bone loss12; * minimum of 2 teeth with probing depth (pd) ≥ 7 mm and 2 other teeth with pd ≥ 5 mm, all with bop and located on opposite sides of the mouth; and * ≥ 16 teeth in both jaws (wisdom teeth excluded). exclusion criteria: * periapical alterations on qualifying teeth, * systemic diseases that require prophylaxis antibiotic coverage or that could influence progression and response to treatment * periodontal treatment in the preceding 6 months, * consumption of antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant or calcium channel blocker within the past 3 months; pregnancy; * orthodontic therapy, * smoking and * cardiac pace-makers users

Keywords: laser clinical trial non-surgical periodontal therapy periodontitis bleeding on probing and radiographic bone loss minimum of 2 teeth with probing depth (pd) ≥ 7 mm and 2 other teeth with pd ≥ 5 mm mininum 16 teeth in both jaws
eating to adjust the timing system

Conditions: Dietary Intervention

Summary: the goal of this clinical trial is to test the effects of dietary composition on the rhythms of food intake, appetite regulation, and rhythms of energy expenditure. participants will: complete 2 field-based dietary interventions be provided with standard meals record daily food intake in a real-time manner complete 2 inpatient stays be provided with standard meals have frequent blood draws provide urine, saliva, and stool samples

obesity is an ongoing epidemic and a serious public health problem. recent insights into the involvement of the circadian system (i.e., an internal biological rhythm) in energy expenditure and appetite control offer a new perspective to understand the relationship between dietary composition and weight management. particularly, dietary composition may impact whole-body physiology in part through changes in the circadian system. the study protocol is designed to test the effects of dietary composition, on the rhythms of food intake and appetite regulation, and rhythms of energy expenditure. this study seeks to understand the relationship between dietary composition and weight control in order to lay the groundwork for evidence-based dietary intervention to combat obesity.

Eligibility criteria:
inclusion criteria: * 18-45 yr old * bmi 18.5-29.9 * no acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.) * without medication use (except oral contraceptives) exclusion criteria: * currently smoking/vaping or 5 or more years of smoking/vaping * history of drug or alcohol dependency * history of psychiatric illness or disorder * people with food allergies/intolerances or following specific diets

Keywords: circadian rhythm energy expenditure appetite regulation
study on the efficacy and safety of oral probucol tablets in patients with hyperlipidemia - post-marketing surveillance

Conditions: Hyperlipidemia

Summary: the primary objective of this post marketing surveillance (pms) is to determine the safety and efficacy of probucol in lowering the level of serum cholesterol in the blood.

this nationwide post marketing surveillance targets to recruit a total of 3,000 patients with hyperlipidemia. duration of treatment is 60 days. the usual starting dose for lorelco is 500 mg administered daily, divided into two (2) doses (250mg bid) and given after meals. the dose may be adjusted according to the patient's age and condition. lipid serum test will be obtained at day 0 (baseline). in subjects requiring antihyperlipidemics that fulfill the inclusion criteria, lorelco 250 bid will be started. there will be 2 follow-up visits after baseline on day 30 and day 60. both lipid serum tests and ecg will be done on these 2 follow-up visits. during each visit the investigator will assess the subject's vital signs and symptoms and check for any adverse events. the primary outcome of measure is the percentage reduction or increase in total cholesterol and triglycerides from baseline values at week 0 to week 4 and week 8 using the following scale: total cholesterol triglycerides 1. markedly reduced 2. moderately reduced 3. slightly reduced 4. unchanged 5. increased reduction of ≥ 15% reduction of ≥ 10% but \< 15% reduction of ≥ 5% but \< 10% change of \< 5% increase of ≥ 5% reduction of ≥ 30% reduction of ≥ 20% but \< 30% reduction of ≥ 10% but \< 20% change of \< 10% increase of ≥ 10% the percentage change on the last week of treatment will be the final evaluation. the secondary outcome is measured by the changes in symptoms and vital signs. using the following scale: 1. markedly improved 2. improved 3. slightly improved 4. unchanged 5. aggravated 6. unknown (not assessable) safety will be measured by the incidence of adverse events to be collected. overall efficacy and safety will be evaluated to assess the usefulness of lorelco using the following scale: 1. very useful 2. useful 3. somewhat useful 4. not useful 5. unfavorable 6. unknown (not assessable)

Eligibility criteria:
inclusion criteria: diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma. exclusion criteria: none
compassionate use of pennsaid topical lotion (diclofenac) in osteo or rheumatoid arthritis

Conditions: Osteoarthritis of the Hand

Summary: this was a compassionate use, open treatment safety study of pennsaid topical lotion (diclofenac) for osteo or rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * diagnosed osteo or rheumatoid arthritis * oral nsaids were not deemed appropriate treatment * completed diclofenac sensitivity patch test with negative result * signed informed consent form exclusion criteria: * at the discretion of the physician and hpb
inner nuclear macular microcyst is a risk factor for macular cystoid changes after phacoemulsification in eyes with previous vitrectomy and macular pucker removal

Conditions: Macular Pucker; Macular Cyst

Summary: to evaluate the visual acuity, macular thickness, morphological changes after cataract surgery in eyes with previous vitrectomy for macular pucker. associated risk factors were also investigated.


Eligibility criteria:
inclusion criteria: * patients had macular pucker surgery before cataract surgery. * follow up over 1 year. exclusion criteria: * patients had any surgical complications such as posterior capsule rupture, vitreous loss, prolapse through the wound or iris trauma * patients had diabetes mellitus. * patients had uveitis or other inflammatory eye disease. * patients had history of retinal vein occlusion. * patients had retinal detachment; or previous vitrectomy for a disease other than macular pucker.

Keywords: macular edema pseudophakic cystoid macular edema macular pucker internal limiting membrane peeling pars plana vitrectomy
progesterone for first trimester vaginal bleeding

Conditions: Threatened Abortion; Pre-Eclampsia; Abruptio Placentae; Fetal Growth Retardation; Premature Birth

Summary: the purpose of this study is to investigate whether treatment with progesterone for patients with first trimester vaginal bleeding will alter the rates of obstetrical complications and adverse pregnancy outcomes.

first trimester vaginal bleeding is one of the most common pregnancy complications affecting 15-25% of all pregnancies. threatened abortion is defined as bleeding through a closed cervical os in the first half of pregnancy. a subchorionic hematoma (sch) is found in 18-39% of women with a threatened miscarriage and around 70% of women with a sch will experience vaginal bleeding. data on the relationship between first trimester vaginal bleeding and obstetric outcome is described mainly in retrospective and noncontrolled studies. it is hypothesized that first trimester bleeding is an indicator of a general tendency for complications (such as: preterm premature rupture of membranes (pprom), preterm delivery (\< 37 weeks gestation; ptd) low birth weight (\<1500g; lbw) neonates, small for gestational age (sga) neonates, placenta previa, placental abruption and stillbirth) later on in pregnancy. nowadays, there are not scientific based treatments for the prevention of complications associated with sch and vaginal bleeding. nevertheless, recent data have suggested that prophylactic administration of progesterone leads to a significant reduction in the rate of preterm deliveries and sga neonates among patients with ptd or sga neonates in the past. although progesterone administration for threatened miscarriage was not studied, many physicians treat patients with first trimester vaginal bleeding with progesterone. in this era of evidence based medicine, the researchers aim to investigate whether treatment with progesterone for patients with first trimester vaginal bleeding will alter the rates of obstetrical complications and adverse pregnancy outcomes. the researchers hypothesize that treatment with progesterone for first trimester vaginal bleeding will alter the rates of the above mentioned obstetrical complications and adverse pregnancy outcomes.

Eligibility criteria:
inclusion criteria: * low risk pregnancies * intrauterine pregnancy documented sonographically * singleton pregnancy * known gestational age * healthy women exclusion criteria: * women after reproductive assistant techniques * women treated with progesterone * multiple pregnancies

Keywords: threatened abortion progesterone subchorionic hematoma pre-eclampsia abruptio placentae fetal growth retardation premature birth
safety and efficacy of empagliflozin (bi 10773) and sitagliptin versus placebo over 76 weeks in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study will investigate the efficacy and long term safety and tolerability of bi 10773 in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: 1. patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy. 2. signed and dated written informed consent by date of visit 1 in accordance with good clinical practice and local legislation. exclusion criteria: 1. patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23. 2. indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial. 3. impaired renal function defined as glomerular filtration rate\<30 ml/min (severe renal impairment, modification of diet in renal disease formula) as determined during last visit of preceding trial. 4. contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23 5. pre-menopausal women (last menstruation \< or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner. 6. alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake. 7. participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23). 8. any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.
impairment of sleep and pattern of breathing before and after opioid withdrawal in comparison to patients without opioid withdrawal

Conditions: Sleep Architecture Under Opioid Medication

Summary: main of the study is to assess the influence of high-dose opioids on the sleep architecture and patterns of breathing using non-invasive polysomnographic measurements before and after opioid withdrawal in patient who undergo opioid withdrawal independently from the present study. these data will be compared to polysomnographic data of patients under opioid treatment who do not undergo opioid withdrawal as well as to patients without opioid treatment.


Eligibility criteria:
inclusion criteria: * older than 18 year, indication for opioid withdrawal (cohort 1), opioid intake (cohort 1 and 2) exclusion criteria: * plaster allergic reactions, opioid withdrawal (cohort 2), opioid intake (cohort 3)
bhcg level in day 4,7, in comparison to day 10 as an indicator for treatment success

Conditions: Ectopic Pregnancy

Summary: the investigators want to compeer bhcg levels after methotrexate ( mtx). treatment for ectopic pregnancy in days 4 and 7 after mtx. to day 10 . the hypothesis is that "bhcg" level in day 10 is the best indicator for treatment success , superior to day 4 and 7 . according to the investigators impression bhcg level rises in days 4 and 7 due to destruction of the trophoblast tissue , and only day 10 is an indicator for treatment success


Eligibility criteria:
inclusion criteria: * patients with ectopic pregnancy * healthy * hemodynamic stable * first ectopic exclusion criteria: * hemodynamic non-stable * abnormal liver or kidney function * allergy reaction to mtx

Keywords: mtx ectopic pregnancy medical treatment
ani versus standard care in surgical patients receiving balanced sevoflurane-fentanyl anesthesia

Conditions: Acute Pain

Summary: this study aims to be a randomized, controlled study of ani-guided opioid administration versus standard clinical practice in surgical patients undergoing general anesthesia with balanced sevoflurane-fentanyl. patients will be randomly assigned to 2 groups- ani vs. standard care. the intraoperative and postoperative management of all patients will be standardized by protocol. the pacu nurses and postop assessor will be blinded as to which group the patient is in.


Eligibility criteria:
inclusion criteria: * 18-75 years old * asa 1-2 * bmi 19-35 kg/m2 * patients undergoing surgery with general anesthesia with sevoflurane- fentanyl * planned abdominal or spinal surgery lasting 1-3 hours * willing and able to consent in english or spanish * no current history of advanced pulmonary or cardiovascular disease exclusion criteria: * age less than 18 or older than 75 * patient does not speak english or spanish * patient refusal * monitored anesthesia care (mac) or regional anesthesia planned * pregnant or nursing women * "stat" (emergent) cases * ecg rhythm other than regular sinus rhythm * implanted pacemakers * on antimuscarinic agents, alpha 2 agonists, antiarrhythmics, or beta blockers * presence of pacemaker * autonomic nervous system disorder * use of chronic opioids
digital ulceration

Conditions: Systemic Sclerosis; Digital Ulcers

Summary: the cap study is a multicenter, observational, clinical study in patients with systemic sclerosis. the study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. the study will enroll 500 patients at 70 centers.


Eligibility criteria:
inclusion criteria: for all patients: * signed informed consent prior to enrollment * male or female, ≥ 18 years of age * diagnosis of systemic sclerosis (ssc) according to the american college of rheumatology and/or limited cutaneous ssc or diffuse cutaneous ssc according to leroy criteria for patients with no history of digital ulcers (du) and no du at enrollment only: - enrollment must be within 2 years of the first physician-documented non-raynaud clinical feature exclusion criteria: * ssc sine scleroderma (without any skin involvement) * patients who underwent stem cell transplantation * participation in interventional clinical trials within 3 months prior to enrollment and/or during the study * inability to undergo nailfold videocapillaroscopy (nvc) assessment (e.g., inability to extend fingers sufficiently)
association study between cyp1a2 gene polymorphisms and metabolism of theophylline

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to determine whether common cyp1a2 gene polymorphisms effect metabolism of theophylline in han and uygur patients with chronic obstructive pulmonary disease patients.


Eligibility criteria:
inclusion criteria: * aged 18-75 years,weight 40-80kg copd patients, male or female; regularly visiting our hospital; taking a sustained-release preparation of theophylline continuously for at least 2 weeks exclusion criteria: * patients with renal or hepatic dysfunction; patients with congestive heart failure; patients with hypothyroidism or hyperthyroidism; patients currently taking drugs likely to effect theophylline metabolism or who had taken such drugs in the preceding week; patients with extreme obesity patients with very severe chronic obstructive pulmonary disease(copd)

Keywords: copd cyp1a2 theophylline
evaluation of dexketoprofen in total knee arthroplasty

Conditions: Postoperative Pain; Analgesia

Summary: pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions. dexketoprofen is a new nsaid treating acute postoperative pain. the purpose of this study is to evaluate the analgesic effect when it is given intravenously or as part of the local infiltration analgesia in patients under spinal anesthesia undergoing unilateral total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * unilateral total knee arthroplasty * accept to enter the study * asa score i or ii * hospitalization for at least 2 days exclusion criteria: * allergy in any given medications * active gastrointestinal bleeding or other active bleeding * history of peptic ulcer * renal failure * hepatic failure * chronic heart failure