Kornimate/medical-research-clean huggingface dataset:
letigen® and cardiovascular morbidity

Conditions: Stroke; Myocardial Infarctions; Sudden Death

Summary: letigen® was a combination drug containing ephedrine, an adrenergic agonist with lipolytic and appetite-inhibiting properties. the drug was used as adjuvant treatment of obesity from 1990 and up to 2002 when it was withdrawn from the market by the manufacturer. the basis for this was a number of spontaneous reports about patients that died during treatment with letigen®. the causal relation has never been addressed. there are only sparse data from randomised studies and the above-mentioned reports are not conclusive. we propose a controlled study based on data from statistics denmark that hold a complete copy of the prescription register of the danish medicines agency and the danish hospital discharge register. the aim of the study would be to determine whether there is an excess frequency of deaths and serious cardiovascular events that can not be explained by particular characteristics of users of the drug. a well-known problem in such observational studies is a fundamental incomparability between users and non-users of drugs. in the present setting, it should be expected that use of letigen® is associated with high bmi, smoking, alcohol abuse, type-2 diabetes, mild hypertension, low physical activity and other indicators of unhealthy lifestyle. thus, an uncritical comparison between users and non-users of letigen® regarding serious cardiovascular events will probably show an excess frequency that can not necessarily be attributed to the drug. this problem can be addressed by a special epidemiological technique - the case-crossover design - which is particularly robust to such comparability problems. in brief, only cases should be included. controls are the same persons at an earlier time, , where the case-defining disease has not yet developed. the exposure of cases will be compared with the exposure of the same persons' case history. to account for the effect of chronic exposure, we also perform, as a secondary analysis, a conventional case-control study nested within the cohort of letigen users, and employing a risk-set sampling technique.


Eligibility criteria:
inclusion criteria: * use of letigen tm within the period jan 1995 - dec 2001 * the occurrence of a case-defining event exclusion criteria: * a cancer diagnosis other than non-melanoma skin cancer * age outside the range 18-70
subcostal approach to anterior quadratus block versus thoracic paravertebral block for laparoscopic nephrectomy

Conditions: Anesthesia; Analgesia; Acute Pain; Patient Controlled Analgesia

Summary: in this study, it was aimed to evaluate the effects of subcostal anterior quadratus lumborum block (s-qlb3) and thoracic paravertebral block (tpvb) on postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic nephrectomy surgery.

laparoscopic partial or radical nephrectomy is associated with severe acute postoperative pain. acute pain is mediated by inflammation, activation of spinal pathways and muscle spasm. poor pain control may reduce patient satisfaction, delay postoperative ambulation and increase the incidence of pulmonary and cardiac complications. facial plane blocks, an important element of multimodal analgesia, can reduce the dosage of opioids, minimize side effects and improve the quality of postoperative recovery. quadratus lumborum (ql) block is a relatively new technique. subcostal anterior ql block (s-qlb3) involves injection in the plane between the psoas and ql muscles. thoracic paravertebral block (tpvb) is frequently used in thoracic and general surgery and its significant analgesic efficacy has been demonstrated in the literature. it has been used successfully as part of multimodal analgesia in renal surgery. in this study, it was aimed to evaluate the effects of s-qlb3 block and tpvb block on pain scores and opioid consumption in patients undergoing laparoscopic nephrectomy. patients will be divided into two groups: group s-qlb3:a unilateral s-qlb3 block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline). in addition, iv morphine-pca will be applied postoperatively for 24 hours. group tpvb: a unilateral tpv block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400,000 adrenaline). in addition, iv morphine-pca will be applied postoperatively for 24 hours.

Eligibility criteria:
inclusion criteria: * asa i-ii patients aged 18-70 y, scheduled for elective laparoscopic unilateral nephrectomy(partial/radical) exclusion criteria: * age \ 70y * obesity (bmi\> 30 kg / m2) * pregnancy * contraindication of regional anesthesia (coagulopathy, abnormal inr, thrombocytopenia, infection at the injection site) * serious cardiac, hepatic, and cerebrovascular disease * hypersensitivity to local anesthetics or a history of allergy * patients with a history of opioid use longer than four weeks * patients with psychiatric disorders or communication difficulties * patients who do not want to participate * asthma/chronic obstructive pulmonary disease, chronic pain syndrome, substance use disorder, or sleep apnea

Keywords: regional anesthesia acute pain scores subcostal anterior quadratus lumborum block thoracic paravertebral block morphine consumption
impact of a built-in insulin calculator feature on diabetes control - pilot study

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to investigate the effect of using freestyle insulinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * subject with type 1 diabetes on mdi (3 or more insulin injections per day (u100 insulin)) for at least 1 year and insulin adjusting * hba1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive * age 18 and over * in the investigator's opinion, thought technically capable of using masked cgm * subject self reporting a minimum of 21 smbg tests per week prior to study enrolment * willing to perform a minimum of 4 smbg tests per day during study exclusion criteria: * subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety * subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management * subject is pregnant / planning to become pregnant within the planned study timeline * subject is known to require a dose of more than 50 units of u100 insulin in any one bolus injection * subject is currently on an insulin pump * subject is currently using the freestyle insulinx * subject is currently using the freestyle freedom lite * subject is currently using cgm * subject has an allergy to medical grade adhesives

Keywords: diabetes smbg insulin calculator
outcomes of esophageal self dilation for benign refractory esophageal stricture management

Conditions: Esophageal Dilation; Refractory Benign Esophageal Stricture

Summary: this study is being done to see which treatment is more effective in improving the difficulty of swallowing. researchers are comparing self-dilation to endoscopic dilation.

benign esophageal strictures can be challenging condition to treat. the mainstay of treatment is endoscopic dilations. however, 30 to 40% of these strictures recur despite rigorous dilations. although a consensus definition does not exist, a stricture is typically termed as a refractory benign esophageal stricture (rbes), when there is a failure to maintain luminal patency after at least 5 endoscopic dilations. patients with rbes are extremely difficult to manage and the current armamentarium includes repeated endoscopic dilations, corticosteroid or mitomycin c injections, incisional therapy, and/ or temporary stent placement. these procedures are costly, their efficacy can be short-lived, and are associated with great burden both for the patient and clinician. esophageal self -dilation therapy (esdt) is where the patient learns to pass a polyvinyl dilator orally on a routine basis. in past, smaller studies, esdt appears to be effective for rbes, reducing the number of endoscopic dilations from an average of 21.7 to an average of 1.

Eligibility criteria:
inclusion criteria: * refractory benign esophageal stricture defined as an esophageal stricture with persistent dysphagia despite undergoing 5 endoscopic dilations within a 1 year period. persistent dysphagia will be considered if patients has solid food dysphagia at least once a week exclusion criteria: * patient with malignant esophageal stricture * angulated stricture which prevents safe passage of maloney dilator in office setting * in ability to achieve an esophageal diameter of 10 mm with endoscopic dilation * known significant esophageal motor disorder (i.e. achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)\* * the presence of esophageal stent * inability to learn self-dilation secondary to blindness or cognitive dysfunction * use of chronic anticoagulants
endometrial thickness and subendometrial vascularity in anovulatory polycystic ovarian syndrome patients treated by metformin

Conditions: Polycystic Ovary Syndrome; Anovulatory

Summary: the participants will receive metformin 500mg 3times per day for 3months and one month is left for spontaneous pregnancy to occur or not (primary outcome ) and the investigators will check endometrial thickness and subendometerial vascularity as markers of endometrial receptivity before and after the treatment.


Eligibility criteria:
inclusion criteria: * pco syndrome patients have the following criteria: age of the patient between 20 - 40 years old. all subjects are not on a specific diet nor a certain program of physical exercise complaining of infertility either primary or secondary due to pcos. n.b: the diagnosis of pco syndrome was made according to the androgen excess and polycystic ovarian syndrome society: the presence of the following criteria have been required for the diagnosis of pco syndrome: hyperandrogenism: hirsutism and/or hyperandrogenaemia ovarian dysfunction : oligo-anovulation and /or polycystic ovaries exclusion of other androgen excess or related disorders as :( deficient nonclassic adrenal hyperplasia, androgen-secreting neoplasms, androgenic/anabolic drug use or abuse, cushing's syndrome, the hyperandrogenic-insulin resistance-acanthosis nigricans syndrome, thyroid dysfunction, and hyperprolactinemia). exclusion criteria: * age below 20 or above 40. women who intended to start a diet or a specific program of physical activity. concurrent medical illness as cardiovascular, neoplastic and hepatic disorder. pelvic pathology. tubal, uterine, male factor of infertility. endocrinological factors including: diabetes mellitus,hypothyroidism, hyperprolactinaemia, cushing's syndrome, and non- classical congenital adrenal hyperplasia. patients who are ovulatory during the ovarian cycle
a real-world evidence study evaluating oral health related quality of life with use of a stannous fluoride anti-sensitivity toothpaste for dentin hypersensitivity management

Conditions: Dentin Sensitivity

Summary: this study will evaluate the impact of long-term use of a desensitizing toothpaste containing 0.454 percent (%) stannous fluoride (snf2) on oral health related quality of life (ohrqol) in a population of self-reported dentin hypersensitivity (dh) sufferers. data generated will provide real world information on the dh experience and dh management with a daily use anti-sensitivity treatment.

this will be a decentralized, prospective, 24-week, monadic design, open label, study in a dh population. the study will evaluate changes in ohrqol in participants with self-reported dh symptoms over 24 weeks of use of a dh treatment (anti-sensitivity toothpaste). ohrqol will be measured using a validated questionnaire, the dentin hypersensitivity experience questionnaire (dheq-48), completed by study participants at baseline, and weeks 4, 8, 12, 16, 20, 24.

Eligibility criteria:
inclusion criteria: * participant who has provided consent indicating they have been informed of all pertinent aspects of the study. * all genders who, at the time of screening, are aged between 18 and 65 years (inclusive). * participant who is willing to complete all the assigned activities. * participant who is able to independently complete all the assigned activities on their smart devices. * participant who has tooth sensitivity (self-reported symptoms). exclusion criteria: * participant whose sensitivity could be caused by other factors or clinical pathology than dh, as self-reported on the screening questionnaire, which include: 1. participant who has been/is on multiple prescription medications to treat severe acid reflux on a regular basis or has had surgery for acid reflux. 2. participant with full or partial denture(s). 3. participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment for periodontal or gum disease. 4. participant who has been informed by a dental health care professional (dhcp) that they have active periodontitis. 5. participant who has been informed by a dhcp that they have active caries. 6. participant with any chronic and/or severe painful health condition(s) which lead to regular use of pain relief medications (more than 3 days a week). * participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
landmark trial: a randomised controlled trial of myval thv

Conditions: Aortic Valve Stenosis

Summary: the primary objective of this study (landmark) is to compare the safety and effectiveness of the myval thv series with contemporary valves (sapien thv series and evolut thv series) in patients with severe symptomatic native aortic valve stenosis. this study will be done in total 768 subjects (384:384, myval thv series vs. contemporary valves) the randomisation will be carried out with an allocation ratio of 1:1 between myval thv series vs. contemporary valves (sapien thv series and evolut thv series)

landmark trial is a prospective, randomised, multinational, multicentric, open-label non-inferiority trial of total 768 subjects (384:384, myval thv series vs. contemporary valves) with severe symptomatic native aortic valve stenosis via transfemoral approach. * device sizes applicable for the myval thv series: 20 mm, 21.5 mm, 23 mm, 24.5 mm, 26 mm, 27.5 mm, and 29 mm diameter. * device sizes applicable for the sapien 3 thv series: 20 mm, 23 mm, 26 mm, and 29 mm diameter. * device sizes applicable for the evolut thv series: 23 mm, 26 mm, 29 mm, and 34 mm diameter. a non-randomised nested registry will be conducted to include patients requiring extra-large size of myval thv series (xl nested registry) - device sizes applicable for the xl nested registry: 30.5 mm and 32 mm. a non-randomized registry will include patients implanted with the myval thv series (lead-in set). - the investigators have to perform a minimum of 2 lead-in cases (non-randomised) under the guidance of the lead-in evaluation committee.

Eligibility criteria:
inclusion criteria: 1. patient ≥18 years of age. 2. patient or their legal representative has provided written informed consent as approved by the institutional review board (irb)/institutional ethics committee (iec) of the investigational site to participate in the study. 3. as per local heart team assessment, patient is eligible for tavi and the patient is suitable for implantation with all three study devices. exclusion criteria: 1. patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study. 2. any condition, which in the investigator's opinion, would preclude safe participation of patient in the study.

Keywords: landmark trial trial to evaluate safety & effectiveness of myval thv ce approved myval thv series
healthy caregivers-healthy children

Conditions: Obesity; Child, Only

Summary: the purpose of the study is to further develop and examine the health caregivers healthy children (hc2) program, which encourages obesity prevention through promoting healthy eating and physical activity.


Eligibility criteria:
center inclusion criteria: 1. have \>30 children ages 2-to-5 with a with or at-risk for a disability or special healthcare need 2. serve low income families 3. reflect the ethnic diversity of the miami dade county public school system (60% hispanic, 20% non-hispanic black, 20% non hispanic white). child inclusion criteria: 1. children with an individual education plan or at-risk based on social and economic variables 2. child ages 2-5 3. child enrolled in a childcare center exclusion criteria: 1) children with feeding tubes or those that bring their own meals due to dietary restrictions

Keywords: obesity prevention childhood special needs
relationship between linq™ subcutaneous impedance and right-sided hemodynamic measurements

Conditions: Heart Failure

Summary: the purpose of the relinquish study is to characterize the relationship between subcutaneous impedance and hemodynamic measurements in patients with heart failure. additionally, the relationship between changes in subcutaneous impedance and other physiologic parameters during acute decompensated hf events will be characterized.


Eligibility criteria:
inclusion criteria: * patients meeting at least 1 of 3 criteria will be included in the study: * patients with symptomatic systolic or diastolic heart failure who in the clinician's judgment have a high likelihood of undergoing serial right heart catheterizations to aid in clinical management of their heart failure * patients with dyspnea on exertion in whom exercise hemodynamics is indicated to diagnose diastolic dysfunction * patients who have or will be implanted with a pulmonary artery pressure monitor * patient is 18 years of age or older * patient (or patient's legally authorized representative) is willing and able to provide written informed consent * patient is willing and able to comply with the protocol, including follow-up visits and carelink transmissions. exclusion criteria: * patient has an existing medtronic implantable cardiac device * patient has a left ventricular assist device (lvad) * patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment) * patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a medtronic study manager
safety, radiological and patient reported outcomes of i-factor+ matrix bone graft device - a canadian, multicenter, post-market clinical investigation

Conditions: Degenerative Disc Disease

Summary: the study intends tracking the usage patterns of a bonegraft device within spine surgery in a multicenter setting in canada.

the study wil track the usage patterns of a bone graft by identifying and classifying spine surgery procedures by access and segment type within the spins and furthet, record and analyse safety and performance measures associated with each classification. this is a post-market surveillance study

Eligibility criteria:
inclusion criteria: * adult patient subjects not responding to conservative management of neck / arm or back/leg pain and requiring spinal fusion between levels c1 - t2 or l1 - s1 * informed consent exclusion criteria: * hypersensitivity to i-factor bone graft devices * adult spinal deformity, spinal cord injury * infection * compromised renal function
a study of galcanezumab (ly2951742) in participants 12 to 17 years of age with chronic migraine

Conditions: Chronic Migraine

Summary: the main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. the primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.

the study includes a 3-month, randomized, double-blind treatment period in which participants receive either galcanezumab or placebo, followed by a 9-month open-label extension in which all participants receive galcanezumab. enrollment in the european union may also include participants 6 to 11 years of age.

Eligibility criteria:
inclusion criteria: * have a diagnosis of chronic migraine as defined by the ihs ichd-3 guidelines (1.3 according to ichd-3 \[2018\]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month. exclusion criteria: * participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). prior use of therapeutic antibodies is allowed if that use was more than 12 months prior to baseline, except for antibodies to cgrp or its receptor, which are not allowed at any time prior to study entry. * known hypersensitivity monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients. * current use or prior exposure to galcanezumab, another cgrp antibody, or cgrp receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a cgrp antibody. participant must also not have prior oral cgrp antagonist use within 30 days prior to baseline. * history of ihs ichd-3 diagnosis of new daily persistent headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine). * history of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury. * participants with a known history of intracranial tumors or developmental malformations including chiari malformations.

Keywords: pediatric children prevention prophylaxis headache pediatric migraine
a study of mk0431 in patients with hepatic insufficiency (0431-017)(completed)

Conditions: Liver Insufficiency

Summary: a study to compare the plasma concentrations of mk0431 at different times in patients with hepatic insufficiency vs healthy control subjects.


Eligibility criteria:
inclusion criteria: * if female, non pregnant, bmi less than 40 kg/m2 * patient has chronic, stable hepatic insufficiency exclusion criteria: * patient unwilling to refrain from alcohol and grapefruit juice prior to and shortly after study drug administration * patient has diabetes, had a heart attack or stroke, or uncontrolled congestive heart failure during the past 6 months * patient has a history of drug or alcohol abuse * patient smokes \> 10 cigarettes per day * patient consumes more that 6 cups of caffeinated beverages per day * patient has had surgery, donated blood or participated in another clinical trial within the past 4 weeks