Kornimate/medical-research-clean huggingface dataset:
ketogenic and nutritional interventions for first episode bipolar disorder

Conditions: Bipolar I Disorder; Psychosis; Schizoaffective Disorder

Summary: this is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.

several lines of evidence show energy metabolism and redox dysregulation in bipolar disorder and psychotic disorders. ketogenic interventions targeting energy metabolism are promising therapeutic approaches to improve mood and psychosis in bipolar disorder and other psychotic disorders. early intervention is also critical to helping people achieve their goals for recovery after a first episode. investigators aim to use multimodal imaging and metabolic measures to study the effects of a ketogenic diet intervention on energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder. this 12-week randomized controlled trial will assess the benefits of a ketogenic diet in combination with treatment as usual compared to a standard diet. investigators will measure the effects of nutritional ketosis on brain redox and energy metabolism and other neurometabolic markers using magnetic resonance spectroscopy. furthermore, investigators will measure the effects of the ketogenic diet on mood and psychotic symptoms and metabolic measures such as insulin resistance.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 45. * ability to adhere to study diets. * diagnostic and statistical manual of mental disorders-5 (dsm-5) diagnosis of bipolar i disorder or schizoaffective disorder with onset of illness in the last 7 years. * must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening * must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study. exclusion criteria: * unable to sign informed consent * contraindication to magnetic resonance (mr) scan (including claustrophobia) * unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease) * current dsm-5 substance use disorder * currently pregnant, nursing, or of childbearing potential and not using a medically accepted means of contraception * have a body weight of over 350 lbs or a body mass index (bmi) \<20 * score above 15 on the young mania rating scale (ymrs) * history of significant head injury * current cancer diagnosis * current diagnosis of type 1 or type 2 diabetes mellitus * history of gastric bypass surgery or any weight loss surgery * concomitant treatment with propofol * familial hypercholesterolemia

Keywords: first episode psychosis ketogenic diet keto brain energy metabolism insulin resistance schizoaffective disorder bipolar disorder magnetic resonance spectroscopy (mrs) redox creatine kinase
study aimed at improving height with genotonorm in children born little and/or light with growth retardation at the age

Conditions: Fetal Growth Retardation

Summary: to estimate the percentage of children with serum igf-1 \> 2 standard deviation (compared to a child of the same gender and age and without growth hormone (gh) deficiency) 9 months and 12 months after initiation of gh treatment.


Eligibility criteria:
inclusion criteria: * chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl. * measured height \< -2.5 standard deviation exclusion criteria: * pubertal signs ie: testis volume \> or = 4 ml in boys and breast stage \> or = b2 (tanner) * serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic insufficiency, neoplasia)
the intermediate and long-term follow up of home based pelvic muscle training

Conditions: Pelvic Floor Disorders; Pelvic Organ Prolapse; Stress Urinary Incontinence

Summary: when participants present with symptoms of pelvic organ prolapse (pop) and stress urinary incontinence (sui), the investigators will perform a comprehensive evaluation and initially provide conservative treatment. if conservative treatment fails, invasive treatment will be considered. the investigators will arrange a pelvic muscle training course two to three times a week for a duration of 1.5 months per course. however, participants may complain about the inconvenience of traffic, which may lead to discontinuation of the pelvic training course. therefore, the investigators propose the development of a home-based pelvic muscle training device and will collaborate with information engineering specialists at tamkang university to invent the device for home-based pelvic muscle training.

the investigators will enroll participants with sui or pop and allocate them into either the home-based pelvic floor muscle training (pfmt) group or traditional pfmt group. participant satisfaction will be evaluated using a questionnaire score.

Eligibility criteria:
inclusion criteria: * age \> 18-year-old, non-pregnancy, sui, bladder capacity \> 300ml, ru\<150ml, pelvic organ prolapse exclusion criteria: * recurrent uti, cancer patients, chronic pelvic pain, psychologic problems
thyme honey for management of oral lichen planus

Conditions: Oral Lichen Planus

Summary: the study aimed to assess the effect of topical application of thyme honey in comparison to 0.1% triamcinolone acetonide oral paste on the relief of pain and clinical improvement in patients with olp


Eligibility criteria:
inclusion criteria:• patients clinically and histopathologically (if required) diagnosed as suffering from olp. * patients free from any visible oral lesions other than olp. * patients who agreed to take supplied medications. * patients who agreed for the biopsy (when required). exclusion criteria:• •patients suffering from any systemic disease. * treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks. * treatment with any oral topical medications for at least four weeks prior to the study. * pregnant and lactating women. * in addition, no consideration was given to patients with a history of hypersensitivity to honey.

Keywords: oral lichen planus thyme honey triamcinolone acteonide
assessment of the effect of n-3(omega 3) fortified egg in healthy subjects

Conditions: Healthy Volunteers

Summary: study rationale: as epidemiological research has shown negative effects of high egg consumption on increased all-cause mortality and diabetes and on diabetes outcomes, and egg modification may modulate their effects on diseases risks, it is important to test the effect of eggs with different composition on markers associated with dyslipidemia, dysglycemia and inflammation. the aim of this study is to assess the effect of n-3pufa (omega 3) fortified egg compared to omega-6 israeli regular egg on metabolic, inflammation and other physiologic parameters.

study objectives first endpoint: to assess the effect of high n-3 pufa (omega 3) egg, as compared to regular- high n-6 pufa (omega 6) israeli egg, on glycemic levels after night fasting and post prandial of 2 egg breakfast test meal. secondary endpoint: to compare the effect of high n-3 pufa fortified egg versus high n-6 pufa (regular) egg on measures associated with cvd risks including: crp, ldl oxidation, mda, post prandial flow mediated dilatation (fmd), liver enzymes, and blood lipids and lipoproteins, and further blood chemistry measures. third endpoint: to assess the influence of n-3 egg on erythrocytes fatty acid profile. study design: prospective, crossover, compared study study population: 20 healthy subjects study methods: subjects will complete two study stages. in first stage study participants will get 3 weeks regimen including 2 regular, israeli (high n-6 pufa) eggs/day. in second stage after 3 weeks washout without eggs, study participants will get 3 weeks regimen with 2 high n-3pufa eggs/day.

Eligibility criteria:
inclusion criteria: 1. healthy men volunteers (age 18-45 years) 2. bmi 23-28 exclusion criteria: 1. use of lipid-modifying medications or nutritional supplements 2. known malignancy 3. allergy to eggs or other materials use in the experiment 4. substance abuse (including alcohol

Keywords: egg,omega 3, omega 6
platelet rich fibrin+1% alendronate in treatment of chronic periodontitis

Conditions: Chronic Periodontitis

Summary: the present study is designed to evaluate the combined efficacy of platelet rich fibrin (prf) and 1% alendronate (aln) with open flap debridement (ofd) in treatment of intrabony defects in chronic periodontitis patients.

background: platelet-rich fibrin (prf) is a second-generation platelet concentrate, act as reservoirs of growth factors and cytokines which are the key factors for regeneration of the bone and maturation of the soft tissue. alendronate (aln), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. the present study was designed to evaluate the combined efficacy of prf and 1% aln with open flap debridement (ofd) in treatment of intrabony defects in chronic periodontitis patients. methods: ninety patients with single defects were categorized into three groups: ofd alone, ofd with prf,ofd with prf+1% aln. clinical parameters; site specific plaque index (pi), modified sulcus bleeding index (msbi), probing depth (pd), clinical attachment level (cal) and gingival marginal level (gml) were recorded at baseline before surgery and 9 months post-operatively. percentage radiographic intra-bony defect depth reduction (ibd) was evaluated at baseline and 9 months.

Eligibility criteria:
inclusion criteria * presence of 3-wall ibd ≥3 mm deep (distance between alveolar crest and base of the defect on an intra-oral periapical radiograph \[iopa\]) along with an interproximal probing depth (pd) ≥5 mm after phase i therapy (scaling and root planing\[srp\]) in asymptomatic teeth. exclusion criteria: * aggressive periodontitis patients; * systemic conditions known to affect the periodontal status; * medications known to affect the outcomes of periodontal therapy; * hematological disorders and insufficient platelet count (\<200,000/mm3); * pregnancy/lactation; * smoking and tobacco use in any form * immunocompromised individuals. * those having unacceptable oral hygiene (plaque index27 \[pi\] \>1.5) after reevaluation of phase i therapy . * teeth with furcation involvement, non-vital teeth, carious teeth indicated for restorations and mobility of at least grade ii were also excluded.
effect of alpha-lipoic acid supplementation on the incidence of postoperative atrial fibrillation in cardiac surgery patients

Conditions: Postoperative Atrial Fibrillation

Summary: ala is administered orally since it is without difficulty absorbed in the stomach. ala goes through the blood brain barrier and does not show toxic effects and actions at doses used for prophylactic and therapeutic purposes. this has encouraged us to use an efficient anti-oxidant and anti-inflammatory agent, alpha-lipoic acid (biochemical) as a relevant option to prevent poaf.

investigators computed on the basis of findings from a prior study found the incidence of poaf after cardiac surgery of about 25% . assuming a slightly lower alpha-lipoic acid' effect to previous study. if the true relative risk of af for experimental subjects relative to controls is 0.5 , with α equivalent to 0.5 and power (1 - β) is 0.8, the estimated sample size is 152 experimental subjects and 152 control subjects in order to be able to reject the null hypothesis that this relative risk equals 1 with probability (power) of 0.8. investigators used the uncorrected chi-squared statistics to evaluate this null hypothesis. stata software version and taking into account a possible dropout of 15%, the total sample size was: 304 + 0.15 (304) × 2 = 350 subjects of which there will be 175 controls and 175 experimental subjects %, assuming an enrolment ratio of 1:1.

Eligibility criteria:
inclusion criteria: * i * male or female patients above 18 years of age who are scheduled for cardiac surgery. exclusion criteria: * any urgent or emergency surgery. * poor left ejection volume (ef \< 30%). * intake of steroids or any antiarrhythmic drugs except beta blockers during the last month before surgery * unable or unwilling to provide informed written consent. * pregnancy or lactation * known hypersensitivity to the study drug. * current treatment with antioxidants or alpha-lipoic acid for any indication. * infection or inflammatory disease except coronary artery disease. * left atrium size \>70 mm.
ultrasound guided iv access in a pediatric emergency department

Conditions: Difficult Intravenous Access in Pediatrics

Summary: the primary objective is to determine whether the use of ultrasound guidance compared to standard iv access improves the proportion of successful iv placement on a first attempt for children in a pediatric emergency department who have predicted difficult access by a validated score. secondary objectives include determining whether ultrasound-guided iv access lowers the overall number of iv attempts and/or reduces time to iv access. the investigators will also examine the duration of iv access and any complications related to iv access in both the traditional and ultrasound guided iv access group.

the proposed study is a randomized trial of ultrasound guided iv access compared to traditional iv access in patients determined to have difficult iv access based on the difficult intravenous access (diva) scale. patients enrolled in the study will be randomized to traditional iv access or ultrasound guided iv access. if randomized to ultrasound guided iv access, the iv will be placed under direct visualization. following iv placement or when attempts at iv access have ceased, the patient and family will be asked to complete a series of questions related to their satisfaction regarding iv placement. the follow-up phase examining duration of the iv and any related complications will continue until the iv placed as part of the study has been removed.

Eligibility criteria:
inclusion criteria: * emergency department patients ages 0-18 years * requiring iv access as determined by emergency department attending physician * predicted difficult iv access as defined by a revised diva score \>3 exclusion criteria: * unstable patients triaged as a level 1 triage acuity * patients who refuse iv access * non-english speaking parent/guardian * no study team member available to enroll patient * parent/guardian does not consent * allergy to ultrasound gel

Keywords: vascular access device ultrasonography
cervical cancer the inflammatory index (certifiko)

Conditions: Cervical Cancer

Summary: although significant advances in screening and treatment , cervical cancer is the fifth most common female cancer in europe. major prognostic factors for oncological outcome are used to categorise patients at high, intermediate and low risk groups and to define the type of radical hysterectomy according "querleu-morrow classification". the goal of this prospective observational study is to evaluate the association between several inflammatory markers and risk groups according european guidelines in women with cervical cancer human papillomavirus (hpv)-associated, in order to optimize the treatment.

european guidelines have proposed a risk stratification of patients basing on oncological risk. the type of radical hysterectomy (extent of parametrial resection and type according querleu-morrow classification) should be based upon the presence of prognostic risk factors.major prognostic factors for oncological outcome as tumour size, maximum stromal invasion, lymphovascular space invasion (lvsi) are used to categorise patients at high, intermediate and low risk for treatment failure. the investigators want to identify additional parameters to better define risk profiles. systemic inflammation indices such as neutrophil to lymphocyte ratio (nlr), platelet-to-lymphocyte ratio (plr) and lymphocyte to monocyte ratio (lmr) have shown prognostic value in solid tumors and several inflammatory conditions. therefore, the primary endpoint of the present study is to assess the role of systemic inflammatory indices and risk groups stratification in patients with early cervical cancer.

Eligibility criteria:
inclusion criteria: * at least 18-year-old patients. * patients histologically diagnosed with cervical cancer (squamous cell carcinoma or adenocarcinoma hpv- associated) * patients with (2018 figo) stage ≤ ib2 ("early cervical cancer") * patients undergoing full-body ct-scan 30 days before enrollment. exclusion criteria: * patients unfit to plead * patients with chronic inflammatory diseases (ibds; rheumatic conditions) * synchronous tumors or cancer diagnosis in the previous 3 years * patients undergoing steroid therapy in the last 30 days prior to recruitment

Keywords: cervical cancer neutrophil to lymphocyte ratio (nlr) lymphocyte to monocyte ratio (lmr) platelet to lymphocyte ratio (plr)
local anesthetic continuous preperitoneal infiltration and wound hyperalgesia

Conditions: Pain, Postoperative

Summary: in this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3 : control group without local anesthetics. all patients will receive parenteral analgesia combining acetaminophen and morphine.

besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.

Eligibility criteria:
inclusion criteria: * age 18 to 80 * asa status 1 - 3 * colorectal laparoscopic surgery with piece removal * french speaking * written informed consent exclusion criteria: * laparoscopy without colorectal extraction * chronic pain * analgesic consumption during the 24 hours previous to the surgery * morphine and la intolerance * drug addiction * inflammatory bowel disease * general inflammatory disease * sepsis * anemia \< 10 gr/dl * liver or renal or cardiac insufficiency * uncontrolled diabetes * preoperative consumption of opiate/corticosteroid/beta-blockers, and anti-arrhythmic drugs, maois, neuroleptics. * preoperative consumption of nsaids excluding aspirin referred cardiology

Keywords: pain, postoperative local infiltration hyperalgesia, postoperative local anesthetic, ropivacaine, lidocaine colorectal laparoscopic surgery pain management after colorectal laparoscopic surgery
low intensity extracorporeal shockwave therapy (li-eswt) by 'renova' for patients with erectile dysfunction

Conditions: Vasculogenic Erectile Dysfunction

Summary: this is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with renova (li-eswt) on symptomatic ed patients.

this is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with renova (li-eswt) on symptomatic ed patients to the safety and efficacy of the control sham patients. patients are randomized in a 1:1 ratio of renova to the sham control group.

Eligibility criteria:
inclusion criteria: * good general health * vasculogenic ed for at least 6 months * international index of erectile function 6 (iief-ef) between 11 to 25 * positive response to pde5-i (able to penetrate on demand, responders) * negative response to pde5-i (unable to penetrate on demand even with maximum pde5-i dosage,non-responders) * stable heterosexual relationship for more than 3 months exclusion criteria: * psychogenic ed * neurological pathology * hormonal pathology * past radical prostatectomy * recovering from cancer during last 5 years * any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities * clinically significant chronic hematological disease * anti-androgens, oral or injectable androgens * radiotherapy in pelvic region

Keywords: low intensity shockwave extracorporeal shockwave therapy erectile dysfunction
compression stockings in ankle sprain

Conditions: Ankle Sprain

Summary: this is a multicenter prospective randomized superiority controlled trial comparing leg stockings and standard care to standard care of ankle sprain and testing the hypothesis that compression stockings enable to reduce the median of recovery from ankle sprain by at least 6 days.

introduction: ankle sprain is a frequently encountered trauma lesion in emergency departments and is associated with important health expenses. however, appropriate care of this trauma lesion remains a matter of debate. hypothesis: the tested hypothesis is that compression stockings enable to reduce the median of recovery from ankle sprain by at least 6 days. main end point: delay to recovery of normal painless walking, without any analgesic drug consumption. secondary end points : pain at rest and during walking using a visual analog pain scale, bimalleolar and middle-feet perimeters, number of days with analgesic drug consumption, observance analysis, patient's tolerance using a visual analog scale, delay to recover sport activities in the subgroup of patients having a regular sport activity. methods: multicenter prospective randomized superiority controlled trial comparing leg stockings and standard care to standard care of ankle sprain. standard care include the rice (rest, ice, compression, elevation) protocol at admission, immobilization with ankle bracing (3 to 6 week duration according to severity and clinical course), recommendation for walking (no weight baring, partial weight bearing, total weight bearing), administration of analgesic drugs. the medical device tested in the present study is class ii compressive stockings (compression between 15 and 20 mmhg). number of patients: with an alpha risk of 5%, a beta risk of 5%, 70 patients should be included in each group to be able to detect a 6 day difference in the delay of recovery, defined as normal painless walking without any analgesic drug consumption, taking into consideration 10% of patients lost during follow up. criteria for inclusion: recent (\<48h) ankle sprain without fracture and without other traumatic lesions in adult patients aged between 18 and 55 years. patients with limb arterial disease, diabetes, or any diseases expected to potentially interfere with recovery of walking, are excluded as well as pregnant women. study schedule: inclusion during first visit to the emergency department, then at day 7, 15-21, 30-45, and 90. phone call interviews are performed to define the more appropriate timing of the visits.

Eligibility criteria:
inclusion criteria: * recent (\<48h) ankle sprain without fracture and without other traumatic lesions in adult patients aged between 18 and 55 years. exclusion criteria: * patients with limb arterial disease, diabetes, or any diseases expected to potentially interfere with recovery of walking, are excluded as well as pregnant women

Keywords: trauma ankle sprain emergency compression stocking