Kornimate/medical-research-clean huggingface dataset:
confocal endomicroscopy based diet trial in ibs

Conditions: Irritable Bowel Syndrome

Summary: after a thorough baseline evaluation, ibs patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (cle). patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion. the aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in cle upon nutrient exposure.


Eligibility criteria:
inclusion criteria: * age 18-70 y/o (70 years included) * male or female subjects * ibs-d and ibs-m (i.e. ibs-non-c) according to rome iv criteria * moderate to severe symptom severity as defined by the irritable bowel syndrome severity scoring system (ibs-sss) (i.e. ibs-sss \>175 points) * provide written informed consent to participate in the study * women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (iuds), sexual abstinence, or vasectomized partner. women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses. * subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements. exclusion criteria: * - pregnant or breastfeeding women * history of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed) * symptoms predominantly associated with functional dyspepsia or gastro-esophageal reflux disease * immunoglobuline e (ige)-mediated food allergies identified by immunocap blood tests or skin prick testing * known underlying organic gastrointestinal disease * current or recent use of nsaids, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (need to be stopped at least 2 weeks). use of antibiotics in the past 6 weeks. * allergy to fluorescein, xylocaine or propofol * known celiac disease * following a diet interfering with the study diet in opinion of the investigator
trabeculectomy with mmc versus ahmed glaucoma implant for treatment of pediatric aphakic glaucoma

Conditions: Pediatric Aphakic Glaucoma

Summary: in this randomized clinical trial we compare trabeculectomy with mitomycin-c (t+mmc) and ahmed glaucoma implant (agi) in treatment of aphakic glaucoma in children under 16 years of age.complete and qualified success were defined as 5≤iop≤21mmhg without and with medication respectively and we came to this point that; t+mmc and agi are comparable in terms of success rate and complications in pediatric aphakic glaucoma.


Eligibility criteria:
inclusion criteria: * congenital cataract * history of cataract surgery * under 16 years old * ocular pressure more than 21 mmhg exclusion criteria: * interruption of the follow up before 6 month * anterior segment dysgenesis

Keywords: aphakic glaucoma trabeculectomy with mitomycin- c ahmed glaucoma implant
effects of probiotics on symptoms of constipation in adults with functional constipation

Conditions: Functional Constipation (FC)

Summary: the purpose of this study was to evaluate the efficacy of 1 capsules of abkefir per day on symptoms of constipation in subjects with functional constipation by clinical trial.

this randomized, placebo-controlled clinical trial will be conduct for 8 weeks with one hundred and sixty-five adults. subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 55; (2) low dose of abkefir , n = 55; (3) high dose of abkefir, n = 55. during the first 4 weeks of supplement, the subjects should take one capsule of placebo or abkefir daily. apart from containing no probiotics, the content of placebo is same as abkefir. after that, the next 4 weeks is to have a follow-up of subjects. during this phase, subjects don't need to supplement. subjects should complete the assessment of anthropometric measurement, defecation questionnaire , food record, feces and blood collection at week 0, 4 and week 8.

Eligibility criteria:
inclusion criteria: * male or female * aged 18-75 years old * fulfill rome iv criteria for functional constipation * have not participated in similar research in the past three months exclusion criteria: * personal or family history of colon cancer, celiac disease, and inflammatory bowel disease * irritable bowel syndrome diagnosed during colonoscopy * those who are pregnant recently (including men and women), or are pregnant or breastfeeding women. * taking antidepressants, anti-anxiety drugs and other psychotropic drugs. * long-term medication is required to improve constipation * those diagnosed with myocardial infarction, cerebral infarction, malignant tumor and/or other serious diseases are not suitable for participating in the study. * allergic symptoms to probiotics or any ingredients * having a history of serious mental illness * drug-related crimes or alcohol problems * have recently traveled to areas where parasitic diseases are prevalent.
phase 2 study of nv-5138 in adults with treatment resistant depression

Conditions: Treatment Resistant Depression

Summary: this study will evaluate the efficacy and safety of nv-5138 in adults with trd

the is a multicenter, randomized, double-blind, flexible- dose, placebo-controlled, parallel design of adjunctive nv-5138 in adults with trd.

Eligibility criteria:
inclusion criteria: * male or female, aged 18 to 70 years at screening. * diagnosis of major depressive disorder (mdd) according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) for either recurrent or single episode mdd without psychotic features that is confirmed by the mini international neuropsychiatric interview (mini). * montgomery-asberg depression rating scale (madrs) total score of ≥26 for the current mde at all screening visits and baseline (day 1). * cgi-s score of ≥4 (moderately ill or worse) at all screening visits and baseline. * history of inadequate response to ≥2 but ≤4 prior adt therapies (including the current adt for the current mde) ≥ 2 weeks at screening and ≥ 8 weeks at baseline. * stable therapeutic dose of one of the following adts for the current mde for ≥2 weeks prior to screening and maintain the therapeutic dose throughout the study: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (ir or xr), desvenlafaxine, or vortioxetine. * detectable blood level of the approved adt at visits 1 and 2 of the screening period. exclusion criteria: * madrs total score improvement of ≥25% from the highest to the lowest score at any visit during the screening period. * clinically significant abnormal laboratory profiles, vital signs, or electrocardiograms (ecgs), per investigator judgment. * judged by the investigator to be at significant risk for suicide, violence, or homicide; or answers 'yes' to items 4 or 5 on the suicidal ideation section of the c-ssrs at screening or at baseline; or has attempted suicide within the 6 months prior to screening. * history of psychotic disorder, including but not limited to schizophrenia, mdd with psychotic features, or bipolar i/ii disorder with psychotic features. * history of ptsd, ocd, panic disorder, intellectual disability, autism, acute stress disorder, or cluster a or b personality disorder (per dsm-5 criteria). * any condition or procedure that may interfere with the absorption, metabolism, or elimination of the study medication (e.g., cholecystectomy or gastric bypass). * in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason. * history of alcohol and/or substance use disorder within 6 months prior to screening or is currently using or has positive results at screening for drugs of abuse or has a positive alcohol result at any screening or baseline visit.
comparison of combined spinal-epidural analgesia versus epidural analgesia for pain management during labor

Conditions: Labor Long; Labor Pain; Labor Fetal Anoxia

Summary: the investigators want to compare the safety and efficacy between the combined spinal-epidural analgesia and epidural analgesia during labor.

participants who request neuraxial labor analgesia are randomized to receive combined spinal-epidural analgesia or epidural analgesia during labor. the investigators collect the data on the duration of three stages of labor, the mode of delivery, neonatal apgar scores, vas scores, modified bromage scores.

Eligibility criteria:
inclusion criteria: * healthy women at term (37 to 42 weeks of gestation), vertex presentation, singleton pregnancy who desired vaginal delivery were eligible to participate. exclusion criteria: * contraindications to neuraxial techniques such as clinically significant coagulopathy and increased intracranial pressure, and patients with preterm labor, multiple pregnancies, non-vertex presentation, cephalopelvic disproportion and severe obstetric complications

Keywords: combined spinal-epidural analgesia epidural analgesia labor duration
characteristics and outcomes of gastrointestinal manifestations of covid-19

Conditions: Infectious

Summary: patients confirmed covid-19 with gastrointestinal manifestations will be included. characteristics and outcomes will be described for them.

patients diagnosed as confirmed covid-19 according to who and egyptian ministry of health and population (moh) definitions will be included.the following will be done for all patients: demographic characters; age, sex, presence of co-morbidities such as hypretension, diabetes mellitus, obstructive lung diseases, ischemic heart diseases...etc, history of contact to covid-19 patients or recent travelling abroad.clinical characteristics: by recording of clinical manifestation such as fever, cough, shortness of breath, sore throat, change in taste or smell, nausea,vomiting and diarrhea will be done. complications and the type of treatment received by the patients will also be described including mechanical ventilation. laboratory data will also be included : blood picture, liver enzymes, esr,crp, serum ferritin, d-dimer and troponin. follow up of the patients will be done until improvement, deaths or complications to determine disease outcomes.

Eligibility criteria:
inclusion criteria: * confirmed covid-19 with git manifestations exclusion criteria: * patients refuse to participate

Keywords: covid-19 characteristics outcome egypt
efficacy of home-based posture exercises as an addition to pharmacological treatment in fibromyalgia

Conditions: Fibromyalgia

Summary: this interventional study aimed to evaluate the effects of home exercise in addition to pharmacological treatment on pain threshold and spinal mobility in fibromyalgia patients.


Eligibility criteria:
inclusion criteria: * participants were between the ages of 18 and 65, * no diagnosis of rheumatic disease, * no diagnosis of chronic comorbid disease, * participants diagnosed with fibromyalgia syndrome according to the european league against rheumatism (eular) criteria will be included as volunteers. exclusion criteria: * patients under 18, over 65 years of age * those diagnosed with chronic comorbid diseases * those with a history of rheumatic disease

Keywords: fibromyalgia home-based therapy pain quality of life
effect of lidocaine in reducing opioids requirement in day care surgery

Conditions: Pain; Post-operative Pain Control; Post-operative Pain

Summary: 1. \*reduced opioid consumption 2. \*decreased pain scores 3. \*fewer opioid-related side effects 4. \*improved patient satisfaction

studies have shown that lidocaine can reduce opioid consumption by 20-50% in the perioperative period. studies have shown that lidocaine can reduce opioid consumption by 20-50% in the perioperative period. by reducing opioid consumption, lidocaine can also decrease the incidence of opioid-related side effects, such as nausea, vomiting, and respiratory depression. lidocaine's analgesic effects can improve patient satisfaction and reduce anxiety related to pain

Eligibility criteria:
inclusion criteria: * asa 1 and 2 * patient age between 18 and 65 years * patient undergoing ambulatory surgeries exclusion criteria: * pregnant women * allergic to lidocaine patient who had fever and treated with antibiotic and steroid in last month

Keywords: lidocaine opiods peri-operative pain decrease opioid requirement ambulatory surgeries
the effect of oral feeding model with a chronobiological approach in neonates

Conditions: Preterm; Chronobiology; Human Milk/Breastfeeding; Bottle Feeding; Sleep Disorders, Circadian Rhythm

Summary: the ideal food for healthy term babies as well as preterm babies and sick term babies is breast milk. there are many studies showing that the composition of breast milk can vary from mother to mother, according to the baby's gestational age and gender. new studies on the content of breast milk suggest that breast milk is different during the day and at night, that micro and macronutrient content, hormones and some enzymes are secreted at different levels at different times of the day and that breast milk has a circadian rhythm. this study was designed as a prospective, randomized, controlled study. the study will be conducted to evaluate the effect of the chronobiological approach feeding model application on the baby's sleep characteristics and physiological conditions in preterm babies hospitalized in the neonatal intensive care unit (nicu). the simple randomization method will be used in the study and the babies will be divided into intervention (n=30) and control (n=30) groups. the study was conducted with 60 infants followed in the neonatal intensive care unit. the milk of the intervention group patients will be given to the babies by matching them circadianly , while the milk of the control group patients will be given without matching according to clinical routine practice. demographic data and sleep measurements (time and quality) of all infants will be recorded in the "baby monitoring form" created by the researcher.

circadian fluctuations in breast milk content are very important in preterm infants fed with breast milk. the composition of breast milk changes throughout the day. there is no randomized controlled study in the literature suggesting that breast milk should be matched to the infant's circadian. this study aimed to evaluate the effect of the chronobiological nutrition model application on the sleep characteristics and physiological conditions of preterm infants in the neonatal intensive care unit. it is aimed to increase the sleep duration and depth of infants, shorten the crying periods and increase the quality of nursing practices by circadian matching with breast milk in the feeding of preterm infants.

Eligibility criteria:
inclusion criteria: * infants with family consent, * 32 0/6 - 36 6/7 weeks of gestation, * exclusively breastfed, * infants who have switched to full oral feeding exclusion criteria: * intravenous fluid therapy, * feeding intolerance * sepsis, necrotizing enterocolitis, major congenital anomaly, * mechanical ventilation support.

Keywords: preterm human milk circadian rhythm neonate, sleep, cry
medytoxin® treatment in patients with benign masseteric hypertrophy

Conditions: Hypertrophy of Masseter Muscle

Summary: this study design is a randomized, double-blind, multi-center, phase ii optimal dose-finding study to determine the safety and efficacy of meditoxin® in subjects in benign masseteric hypertrophy.

subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the placebo to find appropreate dose for the treatment of benign masseteric hypertrophy. thereafter, follow-up visits will be made and efficacy and safety assessment will be conducted.

Eligibility criteria:
inclusion criteria: 1. subject who shows benign masseteric hypertrophy 2. male or female subject over 19 years of age and written informed consent is obtained from the patient or lar. 3. subject who has bisymmetry of masster at visual assessment. 4. subejects who qualifies the standard meets on ultrasonics wave value. 5. subjects who can and will comply with the requirements of the protocol. exclusion criteria: 1. diagnosis of myasthenia, facial palsy or severe facial asymmetry 2. subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 1 year. 3. subject who had previously received botulinum toxin within 3 months prior to the study entry 4. subject who is participating in other investigational study at present or 30 prior to the screening date. 5. subject with known hypersensitivity to botulinum toxin 6. subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study preiod. 7. subjects who are not eligible for this study at the discretion of the investigator.

Keywords: masticatory muscles
spinal cord stimulation research study

Conditions: Chronic Low Back and Leg Pain

Summary: the purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * candidate for scs device trial * subject is ambulatory * diagnosed with low back pain or low back pain plus leg pain for at least 6 months * undergoing treatment for low back pain or low back pain plus leg pain * does not have or has not had a previous scs implant * willing and able to complete protocol requirements * willing and able to sign the study-specific informed consent form * male or non-pregnant female exclusion criteria: * have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study * cancer or any other malignant disease * present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder * a pain-related surgery in the previous 12 weeks of enrollment, the intent to undergo surgery during the period of the study * non-english speaking or an inability to complete questionnaires accurately

Keywords: activity, spinal cord stimulation, pain
the effectiveness and safety of body posture in preventing postoperative recurrence for chronic subdural hematoma

Conditions: Chronic Subdural Hematoma; Recurrence

Summary: this study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma

this study is a multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment to evaluate the effects of body posture on hematoma recurrence. patients will be assigned in a 1:1 ratio to body posture group(upper body lay flat, lower body elevate 30° or 20-30cm, head turn to affected side) or control group(supine position) randomly. after operation, patients will be required to keep respective body posture at sleep time for 3 months. instead of body posture, patients will receive routine treatment.

Eligibility criteria:
inclusion criteria: 1. chronic hematoma is diagnosed with ct/mri scan; thickness of hematoma is more than 1 cm; 2. more than 60 years of age or 60 years; 3. mgs-gcs (markwalder's grading scale and glasgow coma scale) is less than or equal to 2; 4. patients have neurological symptom caused by csdh before surgery, such as headache, dizziness, nausea, vomiting, numbness or weakness of limb, instability to walk, unconsciousness, trouble speaking, insensitive, etc. 5. receive burr hole drainage; 6. sign informed consent voluntarily. exclusion criteria: 1. pregnancy or lactation; 2. have hernia of brain or acute massive cerebral infarction that have to perform craniotomy 3. have serous cancer, hemorrhagic disease, cardiac dysfunction and other serious disease that may aggravate patient's condition and impact follow-up; 4. patients can not stay in bed for long-term due to mental illness or spinal disease(kyphotic deformity); 5. ct scan showed that no obvious brain compression or midline shift; no symptom before surgery; neurosurgeon evaluate that patients do not require surgery; 6. have csdh for more than 1 year or organized hematoma; 7. csdh caused by over v-p shunting; 8. during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia; 9. during burr hole drainage, patients have cerebral contusion or drainage catheter insert into brain unexpectedly; 10. have venous thrombosis of lower extremity or pulmonary embolism; 11. cannot regular reexamine within 1 year for any reason; 12. life expectancy less than 1 year; 13. participating other ongoing clinical trial; 14. patients are not qualified for other reason evaluated by two neurosurgeons; 15. have bile reflux gastritis and esophageal diseases.

Keywords: chronic subdural hematoma body posture intracranial pressure
treatment of unstable distal clavicular fractures (neer 2b): hook plate vs locking plate

Conditions: Clavicle Injuries

Summary: the investigators propose to test the hypotheses that compared with hook plate (hp), locking plate (lp) reduces the postoperative complications and leads to a better functional recovery after unstable distal clavicle fractures (neer 2b).

controversy exists regarding the optimal treatment for patients with unstable distal clavicular fractures (neer 2b). the recognized treatment alternatives are hook plate.notably, criticisms on this fixation method also appeared and the potential risks of hook migration, loosening, subacromial impingement or rotator cuff injury, and acromial osteolysis were still unsolved. recently, herrmann et al.and largo et al.stabilized the distal clavicle with locking plate (lp) and these studies offered encouraging support for lp. because of small sample size (27 patients) and nonrandomization, the convictive power of these researches is not strong enough.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years 2. unstable fractures of distal clavicle (neer 2b fractures), acute or chronic and unilateral fractures. 3. normal shoulder functions before injury. 4. internal fixation with either hp or lp. 5. the subjects were in good health and were able to comply with all prescribed follow-up procedures. exclusion criteria: 1. patients who present multiple traumas. 2. patients with other serious injuries to either upper limb that would interfere with rehabilitation. 3. patients with a pathological, recurrent or open clavicle fracture. 4. patient unwilling to give written informed consent. 5. patients with cognitive impairment unable to comply with treatment programme. 6. patients with a serious disorder of bone metabolism other than osteoporosis (e.g., endocrine bone diseases, osteomalacia and paget's disease)

Keywords: unstable distal clavicular fractures (neer 2b) study protocol fracture fixation