Kornimate/medical-research-clean huggingface dataset:
effects of continuous combined hormone replacement therapy and clodronate on bone mineral density (bmd) in osteoporotic women

Conditions: Osteoporosis

Summary: recent studies suggest that the combination of two inhibitors of bone resorption may induce a greater increase in bone mineral density (bmd) than either agent alone. in this 5-year partly randomized study the investigators examined the effects of hormone therapy (ht) with or without bisphosphonate on bmd on osteoporotic women. in the kuopio osteoporosis study (ostpre) a population based sample of 3200 women were selected for bmd measurement by lunar dpx in 1995-1997. in all 167 women aged 61±2.7 years (11±4.9 years postmenopausal), and the t-score \< -2.5 sd at either the lumbar spine or femoral neck were recruited for this sub-study. they received daily estradiol hemihydrate (e2) 2mg + norethisterone acetate (neta) 1mg (kliogest®, novo nordisk, denmark) and were randomized to get additional boneplac, which consisted of either 800mg clodronate (bonefos®, leiras ltd, finland) (n=55, kb-group) or placebo (n=55, k-group). in case of contraindications or refusal from ht, the women were offered clodronate 800 mg/day (n=57, b-group) to be taken to empty stomach with a glass of water 30 minutes to two hours before breakfast. bmd was measured at time intervals 0, 1, 3 and 5-years. all repeated bmd values were interviewed by one investigator and primarily the vertebrae l2-l4 were followed. in case of spinal deformities during the study (38.3%) other lumbar levels were followed. the baseline bmd values (lumbar spine bmd 0.839±0.072 g/cm², femoral neck bmd 0.759±0.094g/cm²) were similar between the groups.


Eligibility criteria:
inclusion criteria: * postmenopausal * bmd t-score \<-2.5sd exclusion criteria: * none

Keywords: osteoporosis bone mineral density clodronate hrt postmenopausal
impact of school-based delivery of long lasting insecticide nets

Conditions: Malaria

Summary: insecticide-treated nets (itns), and more recently long lasting insecticide nets (llins), have been shown to effectively protect those groups most biologically vulnerable to the burden of malaria across africa. however, achieving universal coverage, especially in poor and remote areas, has proved a particular challenge and there remains a need to explore alternative delivery mechanisms. the recent introduction of universal primary education in kenya has meant that even the poorest households are sending at least one child to school, providing a complementary, potentially equitable, mechanism through which to distribute llins. the delivery of llins through schools will be piloted by population services international in schools situated along the tana river in north eastern kenya. this proposal seeks to evaluate the impact of this programme on both household use of school donated, free llins and the health of schoolchildren. the study hypothesis is that the free delivery of long lasting insecticide nets (llins) through schools will increase household llin coverage among younger siblings not enrolled in school and will reduce rates of malaria infection and anaemia among school children. the study will be an impact evaluation of a programme delivering llins through schools, which is to be implemented by population services international (psi)-kenya. the programme will be implemented in 50 schools and due to psi-kenya's roll out, the programme will be phased in over two years. will be phased in over two years. the 50 schools will be randomly divided into two groups, the first 25 schools will receive llins in 2009 and the second group will receive them in 2010. in each school, five households will be randomly selected and household surveys will be conducted to collect information on household net use and household demographic and socio-economic status. school health surveys will be completed at the end of the programme to assess programme impact on malaria infection and anaemia.


Eligibility criteria:
inclusion criteria: * pupil enrolled at participating schools in standards 1-7; * provision of informed consent from parent or guardian; and * provision of assent by student. exclusion criteria: * non-provision of informed consent; or * pupils unwilling to participate in the study.

Keywords: malaria long lasting insecticide nets anaemia schools
phase ii study of subcutaneous injection depot of leuprolide acetate in patient with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of cam2032 versus eligard, in patients with prostate cancer. all patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.


Eligibility criteria:
inclusion criteria: * men ≥40 and ≤85 years of age * histological or cytological proven adenocarcinoma of the prostate requiring hormone therapy * life expectancy over 12 months * world health organisation/ the eastern cooperative oncology group (who/ecog) performance status of 0, 1 or 2 * adequate and stable renal function * adequate and stable hepatic function exclusion criteria: * evidence of brain metastasis, spinal cord compression, or urinary tract obstruction * serum testosterone levels below 150 ng/dl at screening visit * medical or radiological prostate cancer treatments within 2 months prior to the screening visit * surgical treatment of prostate cancer within 2 weeks prior to the screening visit * prior orchiectomy, hypophysectomy, or adrenalectomy * prior use of lhrh agonists within 12 months prior to the screening visit and during the study

Keywords: prostate cancer leuprolide
cardiac output monitoring in burn patients

Conditions: Burns

Summary: the purpose of this study is to describe the use of non-invasive cardiac output monitors (nicom) in patients with burn injuries and to develop a protocol for nicom in a burn unit.

appropriate fluid resuscitation in the first 24 hours after a burn injury directly influences patient outcome and morbidity. currently, there is some controversy surrounding the over and under-resuscitation and endpoints of resuscitation using older fluid resuscitation formulas in patients with burn injury. the nicom has been used in the resuscitation of patients with sepsis. the nicom will be used in patients with burn injury to determine the patient's fluid responsiveness and the need for additional fluid boluses versus medications to increase the patient's blood pressure.

Eligibility criteria:
inclusion criteria: 1) burn greater than 20% tbsa (total body surface area) exclusion criteria: 1) burn less than 20% tbsa (total body surface area)

Keywords: cardiac output low blood pressure total body surface area (tbsa)
bioavailability of a fixed dose combination tablet with empagliflozin (bi 10773) and metformin compared with the monocomponents and effect of food on bioavailability

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the current study is to determine the relative bioavailability of a bi 10773 / metformin fixed dose combination tablet compared to single tablets of bi 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet


Eligibility criteria:
inclusion criteria: 1. healthy males and females according to the following criteria 2. body mass index 18.5 to 29.9 kg/m2 (incl.) exclusion criteria: 1. any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance 2. any evidence of a clinically relevant concomitant disease
immunological biomarkers in tuberculosis management

Conditions: Tuberculosis; Tuberculosis Infection

Summary: tuberculosis (tb) is the leading cause of death by infectious disease in the world, responsible for 1.6 million deaths in 2017. the treatment of active tb requires at least a 6-month combined antibiotic regimen and can cause heavy side effects. as a consequence, treatment adherence is not optimal, particularly in primary care settings. rapid and reliable monitoring of anti-tb treatment adherence and efficacy is critical to provide adequate patient care and curb relapse episodes and acquired drug resistance. investigators propose to evaluate the performance in terms of diagnosis accuracy and outcome prediction of four new biomarkers of active tb: 1) a double igra (interferon gamma release assay) including quantiferon-gold plus® and hbha; 2) a whole blood transcriptomic analysis of mrna (messenger ribonucleic acid) expression of a panel of 150 genes; 3) a whole blood proteomic analysis; 4) an ex vivo immunophenotyping using flow and mass cytometry to characterize the lymphocyte populations.


Eligibility criteria:
inclusion criteria: adult ≥ 18 year-old * patients having given written consent * patients accepting a follow up ≥ 6 months * proven active tuberculosis (positive direct examination and/or pcr) * latent tuberculosis infection assessed by positive igra exclusion criteria: * malignant solid tumor * malignant hemopathy * solid organ transplantation or hematopoietic stem cell transplantation * immunosuppressive treatments (i.e. biologics, calcineurin inhibitors, corticosteroids) * auto-inflammatory disease * chronic liver diseases * chronic infection with hiv, hcv (hepatitis c virus) or hbv (hepatitis b virus) * antimycobacterial treatment initiated \> 7 days * pregnancy or breastfeeding * refusal to participate to the study * persons deprived of their liberty by judicial or administrative decision * protected adults * patients not affiliated to health-care social security * the homeless
nrs 2002 as a predictor of prognosis in copd with respiratory failure

Conditions: Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Summary: this is a prospective study of patients diagnosed with chronic obstructive pulmonary disease (copd) with respiratory failure and admitted in west china hospital during april 2017 to march 2019. the following variables will be prospectively studied: age, sex, height, weight, respiratory function indicators, arterial blood gas analysis results, biochemical data, nutritional risk screening 2002 (nrs 2002) score, short-term and long-term prognostic outcomes. the purpose of this study is to assess whether nrs 2002 is a useful prognosis predictor in copd patients with respiratory failure.


Eligibility criteria:
inclusion criteria: * newly diagnosis of copd at west china hospital during april 2017 to march 2019 * partial pressure of o2 (pao2) \ 50 mmhg * age ≥ 18 years * respiratory rates \> 23 bpm exclusion criteria: * pregnancy or during lactation * ventilatory dysfunction due to neuromuscular disorders, acute and chronic thromboembolic disease, severe illness in other systems * refused to participate in this study
radiofrequency in the female stress urinary incontinence

Conditions: Urinary Stress Incontinence

Summary: urinary stress incontinence ( sui ) is defined as an involuntary loss of urinary complaint no effort according to the consensus of the international continence society (society continence international - ics) . sui prevalence of adult female population and 25 % to 30 %.however, despite the high prevalence, many women who have symptoms of sui or not seek treatment remain without resolution of symptoms.then there is the possibility of using non-invasive radiofrequency and non-ablation in external urethral meatus in order to stimulate collagen production, as one of the pathophysiological mechanisms of stress urinary incontinence is the collagen deficit in the urethral wall. it is a randomized clinical trial and the group experimental will utilize radiofrequency and kinesiotheraphy ( clinical and in home) and the group control utilize turn off- radiofrequency and kinesiotherapy (clinical and in home). the protocol f the kinesiotherapy is the same both the group, and the protocol radiofrequency the group experimental will 5 sessions (one per week) with temperature 38ºc during 2 minutes. the group control will 5 sessions (one per week) but the radiofrequency will off but glycerin is heated, for masking for the patient, during 2 min. the result of the treatment is assessed by pad test 1 hour and have others outcomes ( quality of life- sf-26 ans king health- and sexual function- fsfi questionaire)


Eligibility criteria:
inclusion criteria: * 21 women with age between 18-59 years old, * women with diagnosis of urinary incontinence and have a pelvic floor muscle contractility was assessed by digital palpation using the validated modified oxford scale (mos) greater than or equal to three exclusion criteria: * patients with cognitive deficits or psychiatric illness; * suffering from chronic degenerative neurological diseases; which have greater than 50 ml post-voiding residue ; * sensory deficit in the genital region; * people with pacemakers and implantable cardioverter-defibrillator and pregnant women will be excluded from the study

Keywords: urinary stress incontinence radiofrequency women
mesenchymal stem cells for radiation-induced xerostomia

Conditions: Radiation Toxicity; Xerostomia Due to Radiotherapy; Dry Mouth; Hyposalivation; Mesenchymal Stem Cells; Mesenchymal Stromal Cells; Long Term Adverse Effects

Summary: a prospective study for long-term follow-up (ltfu) to evaluate safety and efficacy in subjects who participated in the phase 1/2 randomized placebo-controlled trial mesrix.

this is a ltfu study to assess the long-term and late effects of treatment with mscs or placebo given ultrasound-guided into the submandibular glands in subjects participating in the mesrix trial. study participants from the mesrix trial will be invited for a clinical visit. the visit will include medical history, an ent examination; measurements of the saliva production by sialometry, a magnetic resonance imaging scan (mri) and obtaining data on the patient-reported outcome with xerostomia questionnaire (xq) and visual-analogue-symptomatic scale (vas). subjects, who are not able or willing to attend a clinical visit, will be encouraged to fill out the questionnaires online or on paper. if a study participant has deceased, information of the cause of death will be investigated in the danish register of causes of death

Eligibility criteria:
inclusion criteria: 1. assessment of safety and treatment efficacy in subjects who were enrolled in the mesrix phase i/ii clinical trial 2. subjects who were treated with either autologous mesenchymal stem cells or placebo 3. subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the trial exclusion criteria: 1. subjects who were not enrolled in the mesrix trial

Keywords: xerostomia due to radiotherapy
impact of sleep apnea on diabetic foot wound.

Conditions: Diabetic Foot; Sleep Apnea

Summary: sleep apnea syndrome (sas) is a common comorbidity of type 1 and type 2 diabetes. a low transcutaneous oxygen tension (ptco2) measured on the foot is pejorative prognostic factor for the healing of a diabetic foot wound. sas causes intermittent nocturnal hypoxia and sympathetic overactivity. the investigators hypothesized that sas could be a factor reducing the ptco2.therefore, the main objective of this study is to assess the variation in ptco2 between the end of the night and midday in patients with -or at risk of- diabetic foot wound according to the presence or not of sleep apnea syndrome.the secondary objective is to address the microvascularisation of diabetic patients having foot wounds according to their status regarding sleep apnea syndrome.

the study is observational, cross-sectional. presence of sleep apnea syndrome will be assessed on the same night than the main outcome, that is the difference in ptco2 between 5:00 am and 12:00am. microvascularisation will be assessed by laser speckle contrast imaging analysis (lasca). sample size is estimated at 60 patients based on previous revascularisation studies having ptco2 as main outcome. an intermediary analysis is planned after 40 inclusions.

Eligibility criteria:
inclusion criteria: * types 1 or 2 or mody diabetes with diabetic foot wound (or at risk of foot wound stage 2 and 3 (see reference pmid:18442189). * patients covered by social insurance exclusion criteria: * patients with sleep apnea syndrome previously treated by positive airway pressure therapy. * patients previously treated by additional oxygen therapy. patient with unstable psychiatric disease

Keywords: diabetes sleep apnea diabetic foot microcirculation
assessment of digital and clinical workflow using patient specific sticky bone /implant housing peek shell in anterior atrophic maxilla: a case series

Conditions: Ridge Augmentation

Summary: 10 patients having horizontally deficient anterior maxillary areas will be recruited and a preoperative cbct will be done. the plan is to graft the defective ridges with simultaneously placing dental implants using a peek shell that will be specifically designed, constructed and 3d printed to act as a surgical guide for osteotomy drilling and implant placement as well as housing both the implant and the sticky bone (using a mixture of autogenous bone harvested from the symphysis area and xenograft both mixed with plasmatic matrix); that will be added to augment the defective ridge; the peek shell will also act as a barrier membrane for guided bone regeneration and will add more stability to the placed implants that will be fixed to the peek shell occlusally with a ti - based abutment. primary stability will be measured using ostell and an immediate postoperative cbct will be done and superimposed on the preoperative cbct and an accuracy of plan transfer will be measured to make sure the planning was followed accurately. then 6 months later, another cbct will be done to check the bone gain and quality and a second surgery will be done to remove the peek shell and proceed with the conventional implant prosthetic phase.


Eligibility criteria:
inclusion criteria: * patients with multiple missing maxillary anterior teeth with horizontally defective ridges having adequate soft tissue ample. * patients who already gave their consent for this trial. * males and females both will be included. exclusion criteria: * patients on bisphosphonates or drugs altering bone metabolism, within 2 months before initiating the study. * subjected to irradiation in the head and neck region within the last year * patients allergic to drugs used in the study like ( articaine, lidocaine, * patients having a history of a major medical condition (asa 3,4) * untreated periodontitis. * poor oral hygiene and motivation. * uncontrolled diabetes. * pregnant or nursing. * substance abuse. * psychiatric problems or unrealistic expectations. * severe bruxism or clenching. * immunosuppressed or immunocompromised. * treated or under treatment with intravenous amino-bisphosphonates. * active infection or severe inflammation in the area intended for implant placement. * unable to open mouth sufficiently to accommodate the surgical tooling. * patients participating in other studies, if the present protocol could not be properly followed. * referred only for implant placement or unable to attend a 5-year follow-up.
formative usability assessment of wireless thermal anisotropy devices

Conditions: Hydrocephalus

Summary: measurements of shunt flow will be performed non-invasively. this study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.


Eligibility criteria:
inclusion criteria: 1. existing ventricular csf shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device 2. signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 3. subject or caregiver can clearly communicate and document information in english 4. verbal assent by minors 12 years of age and older who can understand the study and communicate their decision 5. subject is at least 5 years old but not more than 80 years old exclusion criteria: 1. presence of an interfering open wound in the device application region 2. subject-reported history of adverse skin reactions to adhesives
gain project: gastric cancer and artificial intelligence

Conditions: Gastric Cancer

Summary: our gain project comprises four core work packages (wps): wp1. nation-level randomized controlled trial; wp2. development of an innovative ai tool; wp3. novel microsimulation modelling; wp4. patient inclusion. the nation-level multi-center tandem randomized controlled trial (wp1) will contribute to a better understanding of how the real-time ai algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. moreover, the innovation project will contribute to development of a novel ai tool (wp2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. furthermore, a microsimulation modelling will allow us to predict how the use of ai can prevent gastric cancer and affect cost and patients' burdens. the assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (wp3). finally, we will take care of patients' perspective throughout the study project by including patient organization in both wp1, 2, and 3 (wp4).


Eligibility criteria:
inclusion criteria: * all \>60 years-old patients undergoing upper-gastrointestinal (gi) endoscopy for selected indications in italian areas at high-risk of gastric cancer (lombardia, emilia romagna, veneto, friuli-venezia giulia). exclusion criteria: * contraindications to upper-gi endoscopy. * contraindications to biopsy. * active upper-gi bleeding or urgent upper-gi endoscopy. * patients with previous upper-gi surgery involving the stomach. * patients who were not able or refused to give informed written consent.
tele-harm reduction

Conditions: IV Drug Usage; HIV Infections; Hepatitis C

Summary: the purpose of this study is to test 2 different methods for offering medications that treat hiv, cure hepatitis c virus (hcv) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.


Eligibility criteria:
inclusion criteria: * age 18 or older * able to speak english * enrolled in idea miami or idea tampa ssps * injection drug use in past 12 months by self-report * willing and able to sign informed consent, provide locator information and medical records release * testing reactive for hiv by rapid test * hiv rna\>200 copies/ml as determined by on-site labs or abstracted medical records (result within 3 months of randomization date) exclusion criteria: * testing hiv negative via rapid test * receipt of thr intervention in the past 6 months * inability to provide informed consent * planning to leave the area within 12 months * principal or site investigator discretion * currently in prison or jail * enrollment in clinical trials network 121

Keywords: heroin needle exchange syringe services program
manageability and safety assessment of sepraspray in abdominal surgery.

Conditions: Adhesion Prevention

Summary: this study will examine the performance of seprasspray in patients undergoing abdominal surgery (laparoscopic).


Eligibility criteria:
inclusion criteria: * patients 18 years old and over that require laparoscopic abdominal surgery exclusion criteria: * patients who are pregnant or have an ongoing infectious complications from a previous surgery