Kornimate/medical-research-clean huggingface dataset:
mitochondrial functions and oxidative stress in als patients

Conditions: Amyotrophic Lateral Sclerosis

Summary: in amyotrophic lateral sclerosis (als), malnutrition is frequent (16 to 50 % of the patients) and is an independent prognostic factor. one of the implicated factors is the increase of resting energy expenditure (ree) which can be found in about 50 % of als patients. the origin of this hypermetabolism is currently unknown but could be located in the mitochondria. in fact, some studies have found mitochondrial abnormalities and the existence of an oxidative stress. thus, the aim of this study is to characterize the mitochondrial abnormalities and the oxidant/antioxidant status of als patients and to determine their relationship with the metabolic status, hypermetabolism or normometabolism. three groups of patients will be studied : 20 hypermetabolic als patients, 20 normometabolic als patients and 20 healthy volunteers paired for age and sex.

in amyotrophic lateral sclerosis (als), malnutrition is frequent (16 to 50 % of the patients) and is an independent prognostic factor. one of the implicated factors is the increase of resting energy expenditure (ree) which can be found in about 50 % of als patients. the origin of this hypermetabolism is currently unknown but could be located in the mitochondria. in fact, some studies have found mitochondrial abnormalities and the existence of an oxidative stress. thus, the aim of this study is to characterize the mitochondrial abnormalities and the oxidant/antioxidant status of als patients and to determine their relationship with the metabolic status, hypermetabolism or normometabolism. three groups of patients will be studied : 20 hypermetabolic als patients, 20 normometabolic als patients and 20 healthy volunteers paired for age and sex.

Eligibility criteria:
inclusion criteria: * male or female * age \> 30 years * definite or probable als according to the el escorial criteria, bulbar or spinal form, als diagnosis \< 1 year and treatment by riluzole. exclusion criteria: * family history of als, * oral, enteral or parenteral nutritional supply, * vitamin or trace element supplementation * confusing illness (cancer, diabetes, chronic infectious or inflammatory disease,thyroid disorders, recent surgery...), * current tobacco use, * alcoholism * treatment by corticosteroids, * diuretics, * anorectics * nsaids * cytotoxics * anticoagulants...

Keywords: hypermetabolism mitochondrial abnormalities oxidant/antioxidant status
hearing screening outcomes of two screening tests in newborns of gestational diabetic mothers

Conditions: Gestational Diabetes; Hearing Loss

Summary: in this study, the investigators have aimed to investigate whether gdm is a risk factor for hearing impairment in newborns. to the investigators knowledge, this study is the first prospective, controlled study on this subject.

gestational diabetes mellitus (gdm) is an increasingly frequent condition in the world causing significant morbidity and mortality. gdm is a metabolic disease that develops in pregnancy, and may result in complications in the pregnant women, similar to other patients with diabetes. the prevalence of gdm varies in relation with the population and the diagnostic criteria. diabetes affects 6-9% of pregnant women; 99% of the cases have gdm, and diabetes is diagnosed before pregnancy in the remaining 1% \[(pre-gestational diabetes mellitus (pre-gdm)\]. hearing loss is one of the most common birth defect in newborns. the incidence of congenital hearing impairment is 2-3 per 1000 births. early diagnosis and treatment is very important for the development of auditory pathways and protection of cognitive functions. therefore, newborn hearing screening programs have been in use in a number of countries. transient evoked otoacoustic emissions (teoae) and auditory brainstem response (abr) have been identified as basic convenient and applicable tools for neonatal screening of hearing. suboptimal glycemic control during pregnancy has adverse fetal effects. congenital malformations, preterm birth and neonatal respiratory distress in the newborn are more common, at varying rates, pre-gdm and gdm. compared to the normal population, the risk of congenital malformations is 1.9-10 fold higher in presence of pre-gdm, and 1.1-1.3 fold higher in presence of gdm. despite our awareness on these important complications, the effect of intrauterine hyperglycemia on hearing of the newborn has not yet been studied in detail. diabetes mellitus (dm) often causes hearing impairment, however little is known whether gdm is an antenatal risk factor for cochlear damage and hearing loss.

Eligibility criteria:
inclusion criteria: * women with gestational diabetes * women without diabetic pregnancy exclusion criteria: * admitted to the neonatal intensive care unit for more than five days * perinatal asphyxia * craniofacial abnormalities * i̇ntrauterine infections * hyperbilirubinemia requiring exchange transfusion * very low birth weight (\<1500 g) * gestational hypertension * preeclampsia

Keywords: gestational diabetes hearing loss newborns
cvc-sad (clinician vs coach)self-help versions in a rct

Conditions: Social Anxiety Disorder

Summary: background: social anxiety disorder (sad) is a common mental problem, where people experience severe and disabling anxiety about social situations and interactions. it is highly prevalent world-wide and in hong kong, causing significant suffering/distress. while evidence-based interventions exist, e.g., cognitive behavioural therapy (cbt), there will be not enough trained therapists to meet the treatment demand so that the majority of the sad patients receive no treatment. internet-based therapies may offer a solution, given that they deliver treatment more cost-efficiently by requiring lesser therapist time so that more patients can be treated with the same therapist resources. one uk internet-based cbt protocol for sad, icbt(c\&w), shows high efficacy and efficiency in initial uk and hong kong trials with englishspeaking patients. objectives: 1. to develop and confirm the efficacy of a chinese-language version of icbt(c\&w), administered by clinical psychologists in standard therapist-guided format. 2. to develop an even more cost-efficient new self-help format with some minimal 'coaching' performed by trained psychology bachelor-level graduates - its efficacy expected as 'noninferior' to that of the therapist-guided format. overall design: three-arm parallel group randomised controlled noninferiority trial: standard therapist-guided ict-sad vs. guided self-help ict-sad vs. waitlist method: the icbt(c\&w) protocol will be translated into chinese. approximately 110 chinese adults with sad will be recruited in hong kong and randomised into one of two treatment conditions, therapist-guided versus self-help. the treatment lasts 14 weeks. the primary outcome measure will be liebowitz social anxiety scale (self-report version).


Eligibility criteria:
inclusion * meets dsm-5 criteria for sad (sad must be generalised, not the 'performance only' subtype) * considers sad their main problem * age 18 or over (no upper age limit) * no current psychotropic mediation, or on a stable dose for at least two months without improvement, and willing to remain at this dose throughout trial * participant agrees not to start any other forms of treatment during the trial * chinese resident of hong kong * proficient in written traditional chinese and spoken cantonese * internet access from home exclusion * current or past psychosis, bipolar disorder, or borderline personality disorder * active suicidality * 'moderate' or 'severe' alcohol use disorder or substance use disorder (based on dsm-5) * no current or previous cbt for sad (defined as at least 5 sessions, and including an exposure component), including internet-cbt studies * not another current emotional problem that is the participant's main concern (participant must not be largely absorbed in another emotional problem, for which it would be unethical not to address as a priority)
growth hormone use in cystic fibrosis - a multicenter study

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is the most common lethal genetic disorder in america. previous studies by our group and others have shown that human recombinant growth hormone (gh) improves height velocity, weight velocity, lean body mass (lbm) and pulmonary function. these positive results have prompted us to ask further questions regarding gh use in cf including: a) do patients with better baseline body weight and pulmonary function derive more benefit from treatment than those with worse weight and pulmonary function?, b) does gh use improve the patient's quality of life?, c) once gh is discontinued, are the positive effects sustained? we hypothesize that gh treatment in cf patients will improve their clinical status and their quality of life. we further hypothesize that these effects will be present regardless of baseline body weight or pulmonary function, and that positive outcome will be sustained for at least one year after gh treatment is discontinued. to test our hypothesis, we will recruit 40 prepubertal children from five cf centers across the united states (8 per center). patients will be randomly assigned to receive treatment with gh (0.3mg/kg/wk) during either the first or the second year. all subjects will be seen every three months. we will evaluate the following parameters every three months: 1) height, height velocity and z-score, 2) body weight and weight velocity. every six months we will measure: 1) lean body mass utilizing dexa, 2) pulmonary function, including measurement of respiratory muscle strength (peak inspiratory and peak expiratory pressure), 3) quality of life (qol), quantitated from qol forms specific for cf ("the cystic fibrosis questionnaire"). after one year of study, subjects will "cross-over" to the other treatment arm. this 24 month study will allow us to statistically compare outcome measures in 20 treated and 20 nontreated subjects from multiple centers, and will allow us to assess sustained effect in the 20 subjects who receive gh during the first year, by comparing their results to results obtained during the year post treatment.


Eligibility criteria:
inclusion criteria: * cf patients ages 5-12 who are less than the 25th percentile for age and sex normal values for height and/or weight
individualized analgesia after adenotonsillectomy

Conditions: Analgesia

Summary: a high incidence of respiratory morbidity after adenotonsillectomy is reported in children with obstructive sleep apnea syndrome (osas). so we designed a prospective, double-blind, randomized controlled study to determine the effects of individualized opioid analgesia compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy in children with osas.

all children were randomized 2 groups based on a computer-generated random number. the main interventions were occurred in post anesthetic care unit (pacu). in the operating room, all patients received a standardized anesthetic regimen by one anesthetist. sevoflurane was used for maintenance without any opioids. before the end of the procedure, spontaneous respiratory was recovered. all the patients were given 1 mcg/kg fentanyl intravenous injection after the end of the procedure. the positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. the result of fentanyl test submitted to assistant, and prepared the rescue analgesic drugs according to this result. one group: positive result 10μg/kg morphine; negative result 50μg/kg morphine. another group: all received 25μg/kg morphine .the trachea was extubated when patients were awake, and then transported to the pacu. patients with a children's hospital of eastern ontario pain scale score\>6 received rescue analgesic drugs and observe respiratory morbidity in each group.

Eligibility criteria:
inclusion criteria: * children with obstructive sleep apnea syndrome undergoing elective t\&a, asa physical status i-ii exclusion criteria: * developmental delay cardiac and craniofacial abnormalities asa classification iii or more body mass index more than the 95th percentile for age

Keywords: respiratory adverse events adenotonsillectomy opioid analgesia children
persistence with prolia® (denosumab) in postmenopausal women with osteoporosis

Conditions: Osteoporosis, Age-Related

Summary: the objective of this study was to describe persistence with prolia® 60 mg administered subcutaneously (sc) every 6 months (q6m) at 12 and 24 months.

the study was a multi-center, single-arm, prospective, non-interventional observational study in postmenopausal women with osteoporosis who had been treated with prolia® for osteoporosis in routine clinical practice.

Eligibility criteria:
inclusion criteria: * enrollment within 4 weeks following administration of the first prolia® (denosumab 60 mg) injection * received prolia® subcutaneously for treatment of osteoporosis consistent with local (us/canada) product label * subject or subject's legally acceptable representative has provided informed consent. exclusion criteria: * participation in ongoing or previous denosumab clinical trials * currently enrolled in another investigational device or drug study, or less than 6 months since ending another investigational device or drug study(s), or receiving other investigational agent(s) * contra-indicated for treatment with prolia® according to the approved applicable local product label (us/canada) * subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
a phase 1b study assessing the pk, pd, safety & tolerability of sb414 in atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of sb414 in subjects with mild to moderate ad.

this is a phase 1b, multi-center, randomized, double-blind, vehicle-controlled study to be conducted in approximately 48 non-immunocompromised adult subjects with mild to moderate ad. subjects will be randomized to 2 active and 1 vehicle treatment arms. subjects will apply the study drug (sb414 or vehicle) to affected areas twice daily for 2 weeks (14 days).

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age and older, and in good general health; * easi score \>1 and ≤21, involving ≥5% body surface area (bsa). * two target lesions at least 5 cm2 with a tlss ≥5. target lesions can not be located on the groin, hands, elbows, feet, ankles, knees, face or scalp. * willing to not use any other products for ad during the study; * women of childbearing potential (wocbp) must have a negative urine pregnancy test (upt) prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit. exclusion criteria: * concurrent or recent use of topical or systemic medications without a sufficient washout period; * immunocompromised subjects including those who are known hiv positive or receiving current immunosuppressive treatment, * female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study; * active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
detection, education, research and decolonization without isolation in long-term care facilities

Conditions: Methicillin Resistant Staphylococcus Aureus

Summary: our hypothesis for the derail mrsa program is that one can safely remove the colonization risk from nearly all residents (patients) in a way that does not interfere with the desired life-style for persons in these facilities and thereby reduce the risk of infection and lower the cost of care by avoiding preventable disease.

the primary endpoint will be measuring the reduction in mrsa colonization prevalence (percentage rate) in the intervention arm as compared to the control arm. one secondary endpoint is to compare the rate of mrsa disease (number of infections per 1,000 patients and 10,000 patient days) in the intervention and control arms. the other secondary endpoint is to determine the cost of mrsa screening and decolonization and compare it to the cost of mrsa disease treatment (both medication cost and the expense of any needed hospitalization for therapy of mrsa infection therapy) in the control arm. achieving our primary goal of mrsa control will also demonstrate two secondary goals wthe investigators aim to achieve: one being that a scientific, planned approach to the issue of specific healthcare-associated infection in ltcfs can resolve these problems and the other that a partnership between acute and long-term care (e.g., ongoing relationship spanning at least 5 years) is beneficial in dealing with patient safety and quality practices across the united sates healthcare continuum.

Eligibility criteria:
inclusion criteria: * all patients in 18 ltcf nursing units randomly selected as intervention or control units exclusion criteria: * patients that choose not to be included in the program

Keywords: mrsa cluster randomized trial infection control intervention
single blinded first cmc osteoarthritis treatment

Conditions: Osteoarthritis Thumb

Summary: single blinded prp vs. corticosteroid vs. placebo (normal saline) intra-articular injection for basal joint arthritis.


Eligibility criteria:
inclusion criteria: * stage 1-3 osteoarthritis of the basal joint exclusion criteria: * patients with stage 4 1st carpometacarpal joint arthritis as described by eaton * patients who have received a corticosteroid injection in the last year to the 1st cmc joint on the proposed study side * patients who have scaphotriquetral, radioscaphoid, or scaphotrapezial osteoarthritis * patients who have concurrent dequervain's tenosynovitis or intersection syndrome or have been treated for either of these in the last 3 months * patients undergoing evaluation of cervical radiculopathy * patients with fibromyalgia or inflammatory rheumatic disease * patients with pressier disease, kienbock's, or avascular necrosis of the scaphoid * patients with any history of primary or secondary bone tumor * patients that are pregnant or terminally ill
impact of pharmaceutical care on drug-related problems in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: the aim of this study is to evaluate the impact of pharmaceutical care on the number of drug-related problems, clinical outcomes and quality of life of patients with parkinson's disease.

this is a randomized controlled study that will be conducted in parkinson's disease and movement disorders clinic, siriraj hospital, thailand. the participants and assessors evaluating mds-updrs were blinded in this study. the participants will be divided into two groups by block randomization: intervention group and usual care group. for the intervention group, the clinical pharmacists will conduct medication reviews, patient education, and counseling. moreover, the clinical pharmacists will identify drug-related problems (drps) and provide the information through written pharmacist notes to physicians at the clinic. for patients randomized to the control group will attend the medical follow-up as usual and receive usual care. telepharmacy will be conducted 2-7 days before the doctor visit and within 1 week after the doctor visit. data collection will be conducted at baseline, week 12, and week 24 in both groups. after the follow-up, the pharmacist will count the number of drug-related problems identified after the doctor visit. the primary outcome of the study is comparing the number of drug-related problems per person changed from the start of the study to the end of week 24 between two groups.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. diagnosed with idiopathic parkinson's disease according to the uk parkinson's disease society brain bank criteria for at least 3 years 3. modified hoehn and yahr stage 2-4 4. patient had received at least one of antiparkinsonian drugs the following: levodopa, mao-b inhibitors, dopamine agonists, comt inhibitors, amantadine, and trihexyphenidyl 5. patient has given a written informed consent to participate in the study. if the patients are unable to give an informed consent, it must be obtained from the caregiver. exclusion criteria: 1. patient is unable to communicate via telephone or mobile phone or internet. 2. patient who is terminal illness 3. patient who is bed ridden 4. patient with other movement disorders include corticobasal syndrome, multiple system atrophy, progressive supranuclear palsy and essential tremor 5. moderate to severe dementia as evidenced by mini mental state examination (mmse) or thai mental state examination (tmse) less than 20 and without the caregiver 6. patient who is planning to undergo surgery or have a history of surgical treatment for parkinson's disease such as pallidotomy, thalamotomy, or deep brain stimulation 7. patient with hearing impairments which affects communication via telephone or electronic media 8. unable to communicate thai language
pulsatile perfusion preservation in kidney transplantation from expanded criteria donors

Conditions: Chronic Renal Failure

Summary: our hypothesis is that the waters medical® pulsatile perfusion machine (rm 3) is a way to improve delayed graft function (dgf) in marginal grafts, and some perfusion profiles (flow, pressure, resistance index, venous effluent ph) are correlated with better recovery of renal function (without dialysis during the first week after transplant). observation or investigation method used : the study is multicenter, prospective, open, controlled and randomized:grafts are divided into two parallel groups: * group 1 corresponds to a conservation of grafts in static incubation * group 2 corresponds to conservation using a pulsatile perfusion machine duration and organizational arrangements for research : the total duration of the study is planned for 36 months. this duration includes: * an inclusion period that will last 24 months, * the follow-up of recipient patients from the day of transplantation until twelve months after the operation


Eligibility criteria:
inclusion criteria for marginal graft: * donors over 60 years of age * donors between 50 and 60 years of age with at least one of the following characteristics : * history of diabetes mellitus * history of high blood pressure * serum creatinine \>1,5 mg/dl * death by stroke (haemorrhagic or thrombotic) inclusion criteria for recipient : * patients registered on the kidney transplant waiting list likely to receive a marginal kidney * immunized patients whose anti-hla antibody specificities have been determined exclusion criteria for recipient: * pregnant or breastfeeding women * people who have been incarcerated * minors * adults under guardianship * people who are not affiliated with the french healthcare system * people with hla immunization whose hla antibody specificities have not been determined

Keywords: chronic renal failure transplantation marginal kidney graft pulsatile perfusion machine