Kornimate/medical-research-clean huggingface dataset:
school-based asthma therapy: stage 2 effectiveness study

Conditions: Asthma

Summary: asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. in the us, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. while national heart, lung, and blood institute (nhlbi) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the us who should receive preventive medications are not receiving them. the overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. we hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to nhlbi guidelines) and an environmental tobacco smoke (ets) reduction program in the home for smoke-exposed children. our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ets reduction will experience less asthma morbidity than those who receive usual care.


Eligibility criteria:
inclusion criteria: * physician-diagnosed asthma * mild persistent to severe persistent asthma * ages 3-10 years * attending school in the rochester city school district preschools or elementary schools * signed physician permission to enroll the child * parent or caregiver must consent to the intervention exclusion criteria: * inability to speak and understand either english or spanish * no access to a working phone for follow-up surveys * the family planning to leave the school district within fewer than 6 months * the child having other significant medical conditions that could interfere with the assessment of asthma-related outcome measures * children in foster care or other situations in which consent cannot be obtained from a guardian * current participation in other local asthma interventions

Keywords: asthma
single oral dose of beneflax to healthy young and older adults

Conditions: Diabetes Mellitus, Type 2; Hypercholesterolemia

Summary: this study is being done to look at age differences in the way the investigators bodies break down a compound found in flax seed (secoisolariciresinol diglucoside or sdg). it is administered to research subjects in a product called beneflax, which a concentrated version of flax seed containing 38% sdg. it is known that as people age, their bodies undergo physical changes both on the outside and the inside. the aging process may change the way that the investigators bodies deal with compounds the investigators eat. as an important measure of safety, the investigators want to check for evidence whether there is a difference in break down of sdg between different age groups.


Eligibility criteria:
inclusion criteria: * healthy adults: 18-45 and 60-80 years of age exclusion criteria: * strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans) * strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans) * individuals who smoke * individuals who have experienced diarrhea in the last three months * individuals who have taken oral antibiotics in the last three months * individuals who are currently taking warfarin or any of its derivatives * individuals with low haemoglobin (\<121g/l for women and \<137g/l for men) * individuals with bmi under 19 or over 28 * pregnant or lactating women * women with child bearing potential not using contraceptives * current diagnosis of a bleeding disorder or at risk of bleeding * individuals with gastrointestinal problems (such as ulcers), or convulsive, depressive, or hepatic disorders * individuals with diabetes mellitus * individuals currently taking a flax seed supplement * individuals with an allergy to flax seed * individuals who have donated blood or lost \> 450 ml of blood within 56 days of study duration * individuals who have participated in any other clinical trial with and investigational agent within one month of starting this trial

Keywords: flaxseed lignans pharmacokinetics
a study to compare the press fit condylar (p.f.c.) sigma rotating-platform high-flexion (rp-f) versus the press fit condylar (p.f.c.) sigma rotating-platform (rp) knee implants

Conditions: Knee Osteoarthritis

Summary: the main objective of this study is to determine if the p.f.c. sigma rp-f knee delivers a greater post-operative range of motion (rom) compared with the p.f.c. sigma rp knee in primary tka. the secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the depuy p.f.c. sigma rp-f and rp posterior stabilised (ps) knee over 5 years.

primary outcome: change from pre-operative range of motion at 1 year between patients receiving p.f.c. sigma rp vs p.f.c. sigma rp-f secondary endpoints: comparative evaluation of any post-operative variation between subjects receiving primary tka with either of the above devices in terms of knee and osteoarthritis scores (koos), american knee society score (aks), eq-5d score and oxford knee score (oks)

Eligibility criteria:
inclusion criteria: * male or female subjects, aged between 45 and 75 years inclusive. * subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. * subjects who, in the opinion of the clinical investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. * subjects who present with osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty. * subjects who in the opinion of the clinical investigator are considered to be suitable for treatment with either the p.f.c sigma rp-f or the p.f.c sigma rp knee, according to the indications specified in the package insert leaflet. * subjects who have authorised the transfer of his/her pseudonymised information to depuy. exclusion criteria: * subjects who, in the opinion of the clinical investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation. * female subjects who are pregnant or lactating. * subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. * subjects who have participated in a clinical investigation with an investigational product in the last month( 30 days). * subjects who are currently involved in any injury litigation claims. * subjects with a known history of poor compliance to medical treatment. * subjects who have previously had an osteotomy or significant surgery in the affected knee.

Keywords: arthroplasty replacement knee pfc sigma rpf pfc sigma rp
joint position sense, plantar sensation, balance and dual task performance in individuals with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Balance

Summary: diabetes is a chronic disease characterized by hyperglycemia, which occurs when insulin is inadequate or the body's produced insulin cannot be used effectively, but according to the world health organization 2016 global report on diabetes, it is an important public health problem that is one of the four priority non-infectious diseases. in addition to high mortality rates caused by diabetes-related complications, it is known that it can cause low quality of life and many additional problems in individuals. these complications and damage, which may be caused by diabetes, may result in reduced blood flow combined with neuropathy; as a result, foot ulcers, infections and consequently the need for amputation may increase. in addition to the additional complications caused by diabetic neuropathy, protective plantar sensory loss and decreased joint position have been reported in the literature. in particular, investigators did not find any comprehensive studies examining the relationship between these sensory changes and the dual task performance in diabetic subjects. in this study, investigators aimed to investigate the relationship between joint position sense, plantar sensation, balance and dual task performance in individuals with type 2 diabetes and to contribute to the literature with evidence-based, objective results.

the aim of this study is to investigate that the relationships between joint position sensation, plantar sensation, balance and dual task performance in type 2 diabetic patients. first of all, a general evaluation form including demographic information and physical characteristics of the individuals who voluntarily agree to participate in the study and approve the informed consent form, will be filled. then, with the first findings to be obtained, determination of sample size was planned. bilateral ankle joint position sensation with goniometer, bilateral knee joint position sensation with an analog inclinometer (baseline® bubble inclinometer-usa), plantar sensation with semmens-wenstein monofilaments, equilibrium with prokin isokinetic balance system, dual task performance will be evaluated with adding motor and cognitive secondary tasks to the time up and go test and single leg balance tests.

Eligibility criteria:
inclusion criteria: * to accept to participate in the study voluntarily, * to being diagnosed with type 2 diabetes, * to being 30-65 age range. exclusion criteria: * refuse to participate in the study, * not cooperating, * being orthopedic, neurological and any other systemic disease, * being pregnant, * loss of vision, * loss of hearing, * to be a standing diabetic ulcer, * a mini mental test score of 23 or less.

Keywords: type 2 diabetes mellitus joint position sense plantar sensation balance dual task performance
a rollover study for subjects discontinuing from uk-453,061 studies for the treatment of hiv-1

Conditions: HIV-1

Summary: the purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from uk-453,061 qualifying studies.

to assess long term safety and tolerability of subjects who discontinue for any reason from uk-453,061 studies. the study will also assess efficacy of the subsequent regimens in these patients. the trial was terminated prematurely on january 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. the decision to terminate the trial was not based on any safety or efficacy concerns.

Eligibility criteria:
inclusion criteria: * previous participation in a qualifying study. * male or female at least 18 years of age available for a follow-up period of at least 96 weeks. exclusion criteria: * concurrent treatment in another clinical trial. * unwilling or unable to be followed for 12 months

Keywords: hiv-1 rollover safety. hiv infections treatment experienced
a post-marketing surveillance study to assess the safety of oral azacitidine maintenance therapy in korean patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this observational study is to assess the real-world safety of maintenance therapy with oral azacitidine in korean participants with acute myeloid leukemia (aml) who achieved first complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction chemotherapy with or without consolidation therapy, and who are not eligible for hematopoietic stem cell transplantation (hsct).


Eligibility criteria:
inclusion criteria: * adult participants 19 years of age or older * participants who receive oral azacitidine according to the approved label * for the first 2 years after marketing authorization, all participants who have received or are receiving oral azacitidine will also be registered * participants who sign the informed consent form exclusion criteria: * participants who are prescribed oral azacitidine for therapeutic indications not approved in korea * participants for whom oral azacitidine is contraindicated per the korean prescribing information approved by ministry of food and drug safety
coronary and structural interventions - transcatheter aortic valve replacement

Conditions: Aortic Valve Stenosis

Summary: to evaluate the long-term results after transcatheter aortic valve replacement

patients with transcatheter aortic valve replacement are followed for 5 years to demonstrate efficacy and safety.

Eligibility criteria:
inclusion criteria: * aortic valve stenosis * transcatheter aortic valve replacement exclusion criteria: * no written informed consent
clinical effect of laser acupuncture on improving cancer-related fatigue

Conditions: Cancer-related Fatigue

Summary: the aim of this study is to examine the clinical effect of laser acupuncture on improving cancer-related fatigue

this study adopted a randomized controlled design, 2-arm trial cross-over study. all eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of taichung tzu chi general hospital (rec110-09). patients were recruited from the hematology oncology department of taichung tzu chi general hospital. after random assignment to 2 groups, patients in the rs and sr groups will receive real and shame laser acupuncture. before laser acupuncture, one week later, we will evaluate the patient-reported cancer-related fatigue index and other co-morbid symptoms.

Eligibility criteria:
inclusion criteria: * adults between 18 to 85 years old * patients who signed the informed consent form * patients who have been given a diagnosis of cancer * able to communicate verbally and completely fill the questionnaires exclusion criteria: * patients who have given a diagnosis of cognitive impairment are unable to completely the questionnaires

Keywords: laser acupuncture
whole body vibration in middle aged men

Conditions: Bone Density; Muscle Weakness

Summary: this study aims of this clinical trial is to evaluate the effect of an 8-week whole body vibration (wbv) intervention on bone mineral density (bmd), hand grip strength, and vitamin d levels in middle-aged men. findings from this study will contribute to understanding whether wbv is a viable alternative to conventional exercise, especially for those with limitations in physical activity. study objectives: • primary objective: to assess the effectiveness of an 8-week wbv intervention in improving bmd, hand grip strength, and vitamin d levels compared to a placebo intervention.


Eligibility criteria:
inclusion criteria: * male participants aged 50 years or older * participants with physical activity or exercise program involvement * participants with no history of serious medical conditions such as tumors, fractures, epilepsy, cardiac disease, or stroke within the past year. * participants must be non-smokers and not receiving hormone or calcium supplement therapy exclusion criteria: * participants unable to stand on the wbv platform * participants with conditions contraindicating vibration therapy * participants participating in other clinical trials

Keywords: pilot study bone density vibration therapy vitamin d muscle strength
immune responses and immunological tolerance after rabies booster vaccination in hiv-infected adults

Conditions: Rabies

Summary: to study the humoral and cell-mediated immune responses in hiv-infected adults who had previously received rabies booster vaccination more than a year before

previous study has shown the higher immunogenicity response among hiv-infected adults who received a single visit 4-site intradermal rabies booster vaccination than those who received the conventional intramuscular regimen. the investigators follow the persistence of these effects. also, the regulatory t cell levels were examined after the rabies booster vaccination .

Eligibility criteria:
inclusion criteria: * healthy hiv-infected adults * previously received rabies booster vaccination by participation in the previous clinical trials of the investigators. exclusion criteria: * have any active opportunistic infections * received blood or blood product within 3 months * received anti-malarial drugs * received rabies vaccination in a previous year.

Keywords: rabies vaccination
ranibizumab "treat and extend" in diabetic macular edma

Conditions: Diabetic Macular Edema

Summary: this study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.


Eligibility criteria:
inclusion criteria: * visual impairment due to focal or diffuse macular edema with center involvement * diabetes type 1 or 2, hba1c \< 12.0% * crt = or \> 250 μm exclusion criteria: * active inflammation or infection * uncontrolled glaucoma * iris neovascularization, active proliferative retinopathy or vitreomacular traction * prior laser photocoagulation according to defined timelines * history of stroke, uncontrolled hypertension other protocol-defined inclusion/exclusion criteria may apply

Keywords: diabetic macular edema macular edema dme diabetic retinopathy diabetic eye disease anti-vegf ranibizumab lucentis
augmented pulse pressure variation to predict fluid responsiveness in open laparotomy

Conditions: Gynecologic Neoplasms; Abdominal Neoplasms

Summary: pulse pressure variation (ppv) is a well-known and widely used dynamic preload indicator based on heart-lung interaction to predict fluid responsiveness. generally, patients are considered to be fluid-responsive when the ppv value larger than 11-13%. however, several previous researches demonstrated that there is a zone of uncertainty (grey zone) in ppv. to predict fluid-responsiveness accurately in the patients with ppv within grey zone (9-13%), the investigators would evaluate the augmented ppv using augmented ventilation.


Eligibility criteria:
inclusion criteria: * adult patients undergoing elective open laparotomy surgery. exclusion criteria: * irregular heart beats, * cardiac arrhythmia, * moderate or severe valvular heart disease, * preoperative left ventriular ejection fraction less than 40%, * moderate t severe obstructive pulmonary disease, * preoperative need of inotropics infusion, * preoperative serum cr \> 1.3ml/dl, * moderate to severe renal or liver disease, * acute lung injury or acute lung problem, * coexisting open chest condition, * severe bradycardia, * patients with spontaneous breathing
retrospective study on the evaluation of the impact of augmented reality usage in gynecological laparoscopy on patients operated between 2017 and 2021 (impactra)

Conditions: Myoma;Uterus; Adenomyoma of Uterus

Summary: impactra is an observational retrospective study. the management of the patient is not modified by this study. this study will be carried out based on the already existing data of the gynecological ward of chu clermont-ferrand between 2016 and 2021. during this period of time, 17 patients have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, aided by augmented reality (ar). the investigators compared these 17 patients that underwent surgery with ar with 17 control patients that underwent the same surgery with the same indication but without ar.


Eligibility criteria:
inclusion criteria: * age between 18 (included) and 84 (included), * patient operated between 2017\* et 2021, * patient with one or more intrauterine myomas, with surgical treatment by laparoscopic myomectomy with or without ar, * patient with one or more intrauterine adenomyomas, with surgical treatment by laparoscopic adenomyomectomy with or without ar, * patient informed about the use of her data for research. exclusion criteria: * patient who refused the use of medical data for research purposes, * patient operated prior to 2017\* and after 2021, * patient whose medical follow-up did not allow collection of the data required for the study. (\*) an amendment validated by the ethics committee allows inclusion of patients operated during 2016

Keywords: augmented reality uterine myomectomy uterine adenomyomectomy laparoscopic surgery minimally invasive surgery
pilot decentralized trial

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of alto-100.


Eligibility criteria:
inclusion criteria: * have a diagnosis of moderate to severe major depressive disorder * either currently taking a ssri, snri, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication * willing to comply with all study assessments and procedures * must not be pregnant or breastfeeding at time of enrollment or throughout study * must have access with privacy to a computer with a keyboard and internet exclusion criteria: * evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease * active suicidal ideation * severe impediment to vision, hearing, and/or hand movement * diagnosed bipolar disorder or psychotic disorder * has a history of hypersensitivity or allergic reaction to alto-100 or any of its components/excipients * concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
a retrospective observational study comparing outcomes of retrocaecal appendicitis with non-retrocaecal appendicitis

Conditions: Appendicitis; Appendicitis Acute; Retrocecal Appendicitis

Summary: a retrospective observational study investigating whether retrocecal appendicitis associated with worse operative and postoperative outcomes than non-retrocecal appendicitis.

acute appendicitis is the most common cause of acute abdomen requiring acute surgery. the prevalence of the retrocaecal position of the appendix varies significantly between studies from 14 to 36%. appendectomy of a retrocecal appendix is generally considered to be more demanding procedure than appendectomy of appendices in other positions. the aim of this study is to investigate whether retrocaecal appendicitis is associated with a higher rate of perioperative complications and delayed diagnosis when compared with the other positions. a retrospective analysis of prospectively collected data of patients undergoing surgery for signs of acute appendicitis from january 2015 to april 2020 at the university hospital kralovske vinohrady. two groups of patients were be formed: the retrocaecal group and the non-retrocaecal group. the following data were recorded: sex, age, body mass index, length of hospital stay, abdominal drain placement, length of surgery, surgical approach (laparoscopic, open or converted), operative finding (normal appendix or catarrhal, phlegmonous, gangrenous, or perforated appendicitis), position of the appendix (retrocaecal or non-retrocaecal positions), histopathological findings (acute inflammation, chronic inflammation, appendiceal tumour or normal appendix), 30-day postoperative complications, 30-day postoperative mortality, symptoms (abdominal pain, nausea, vomiting, diarrhoea, body temperature above 37 degrees celsius, urological complaints and gynaecological complaints), duration of symptoms (from onset to surgery), serious comorbidities and diabetes mellitus.

Eligibility criteria:
inclusion criteria: * all patients undergoing surgery for signs of acute appendicitis at the department of surgery of the university hospital kralovske vinohrady between january 2015 to april 2020 exclusion criteria: * patients under 18 years of age