Kornimate/medical-research-clean huggingface dataset:
evaluation of efficacy of skål pro powder on symptoms of irritable bowel syndrome

Conditions: Irritable Bowel Syndrome; Gastrointestinal Diseases; Colonic Diseases, Functional; Intestinal Disease; Digestive System Disease; Pathologic Processes; Colonic Disease; Disease

Summary: the objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of skal pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (ibs), as compared to those who receive no intervention.

irritable bowel syndrome (ibs) is a condition linked to disturbances in the gut-brain axis and dysbiosis. although probiotic modulation of dysbiosis appears promising for ibs treatment, identifying the specific beneficial strains remains uncertain. furthermore, even with an effective probiotic strain, variations in efficacy among populations are observed due to environmental heterogeneity, particularly dietary influences. this study seeks to provide efficacy insights into skal pro powder 2g (containing lactobacillus plantarum 299v 1x10\^10 colony forming unit (cfu) and gos), shedding light on the unique mechanisms of lp299v within the malaysian population through a randomized controlled trial (rct).

Eligibility criteria:
inclusion criteria: * ibs diagnosed using the rome iv criteria * age above 18 years old and any gender * any subtypes of ibs (diarrhea, constipation or mixed) exclusion criteria: * presence of red flag symptoms (weight loss, anemia, night symptoms, abdominal mass, strong family history of cancer) * was prescribed antibiotic (s) within the past one month * medical conditions that contraindicate probiotic use including severe sepsis and pregnancy * presence of bowel malignancy * diagnosis of bowel infection within the past one month * previous abdominal surgeries * patients with overt psychiatric illnesses including schizophrenia and manic disorders * a history of allergy to probiotic * was prescribed probiotic (s) within the past one month * was previously prescribed probiotic skal pro™ (lp299v™)

Keywords: probiotic lactobacillus plantarum 299v randomized controlled study
comparison of standard dose alectinib to alectinib in adjusted dose based on alectinib bloodlevels

Conditions: Drug Monitoring; Carcinoma, Non-Small-Cell Lung; Lung Cancer; Anaplastic Lymphoma Kinase Gene Mutation; Anaplastic Lymphoma Kinase Gene Translocation

Summary: the adapt alec randomized controlled trial (rct) is performed in patients with anaplastic lymphoma kinase (alk) positive non-small cell lung cancer (nsclc). the rct will compare the use of therapeutic drug monitoring (tdm) and dose increases if alectinib 35 ng/ml (arm a) with standard of care (arm b).

the adapt alec trial is a phase iv, rct in patients with alk positive nsclc treated with alectinib. a longer median progression free survival (mpfs) is expected in patients treated with standard dose alectinib when minimum plasma concentrations (cmin) of alectinib exceed 435 ng/ml. the adapt alec trial will investigate whether using therapeutic drug monitoring (tdm) and increasing the dose of alectinib in patients with cmin \<435 ng/ml, will raise the mpfs. we will compare mpfs in the subgroup of patients with an alectinib cmin \<435 ng/ml using tdm and dose increases (arm a) to fixed dosing/standard of care (arm b).

Eligibility criteria:
inclusion criteria: * patients with locally advanced or metastatic nsclc (stage iiib to stage iv by ajcc 8th) * ecog performance status 0-4 * histologically or cytology confirmed nsclc * documented alk rearrangement based on an ema approved test * patients can either be chemotherapy-naïve or have received one line of platinum-based chemotherapy * patients with brain or leptomeningeal metastases are allowed on the study if the lesions are asymptomatic without neurological signs and clinically stable for at least 2 weeks without steroid treatment. patients who do not meet these criteria are not eligible for the study * measurable disease (by recist criteria version 1.1) prior to the first dose of study treatment * signed writte institutional review board (irb)/ethical committee (ec) approved informed consent form, prior to performing any study-related procedures * observational other studies are allwoed for patients included in this study * local radiotherapy is allowed for pain exclusion criteria: * any significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug * consumption of agents which modulate cyp3a4 or agents with potential qt prolonging effects within 14 days prior to admission and during the study (see concomitant medication restrictions) * any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the principal investigator, pose an unacceptable risk to the subject in this study. * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.

Keywords: alectinib randomized controlled trial
cataract surgery with intracameral triamcinolone in infants

Conditions: Cataract

Summary: the aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone. this is a prospective, randomized clinical trial. sixty children will be submitted to congenital cataract surgery younger than 2 years of age. they will be randomly divided in two groups. the study group will receive an intraoperative intracameral triamcinolone acetonide injection. the control group will receive prednisolone syrup postoperatively. the surgical outcomes will be assessed after one year.


Eligibility criteria:
inclusion criteria: * patients younger than 2 years of age * unilateral or bilateral congenital cataracts compromising the red reflex exclusion criteria: * corneal opacity * glaucoma * aniridia * subluxated cataract * traumatic cataract * complex microphthalmia * persistant hyperplastic primary vitreous * retinal detachment * patients with intraoperative complications, such as iol implanted in the sulcus
renal denervation in patients with refractory hypertension

Conditions: Hypertension

Summary: to investigate the clinical utility of renal denervation in the treatment of refractory hypertension.


Eligibility criteria:
inclusion criteria: * \>= 18 years of age. * a systolic blood pressure of 160 mmhg or greater. * receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening. * agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination. * competent and willing to provide written, informed consent to participate in this clinical study. exclusion criteria: * renal arterial abnormalities * end stage renal disease requiring dialysis or renal transplant * serum cr \> 3, or calculated gfr \< 45 ml/min * has experienced mi, unstable angina pectoris, or cva with 6 months * others
ocular findings in women with primary antiphospholipid syndrome

Conditions: Primary Antiphospholipid Syndrome

Summary: antiphospholipid antibody syndrome (aps) is an autoimmune disease characterized by systemic thrombosis and bad obstetric history. aps secondary to another medical disorder is the most common. visual and ocular changes e.g. vaso-occlusive disease of retinal and choroidal vessels are found in patients with secondary aps. patients with primary aps have also been reported to have ocular changes e.g. retinal vascular occlusion the aim of our study to detect prevalence of ocular changes in women diagnosed with primary aps and correlation of these changes with adverse obstetric outcome. if a correlation is present, ocular findings in women with aps could be used in the future as a predictor for poor obstetric outcome.


Eligibility criteria:
inclusion criteria: * age: 18 to 35 years * females with primary antiphospholipid syndrome exclusion criteria: * age: below 18 years and above 35 years * auto-immune diseases e.g. sle and other connective tissue disease * medical diseases causing retinal vascular changes e.g. hypertension, diabetes mellitus, sickle cell anemia. * previous vitreo-retinal surgery

Keywords: antiphospholipid syndrome - bad obstetric history - ocular
tinzaparin in the treatment of the acute pulmonary embolism

Conditions: Acute Pulmonary Embolism

Summary: the purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.

the open-label prospective randomized clinical trial compares subcutaneous lmwh (tinzaparin) administered for 6 months versus initial treatment using subcutaneous lmwh followed by oral anticoagulants given for 6 months in patients with acute venous thrombosis. to evaluate the direct and indirect cost of each treatment regimen in a rural population environment.

Eligibility criteria:
inclusion criteria: * symptomatic pulmonary embolism patients confirmed by: * high probability ventilation/perfusion lung scan according to the pioped criteria * spiral chest computed tomography, or * pulmonary arteriography * aged 18 years or above, of either sex * the patient must provide signed informed consent * patients will be agreed for receiving ambulatory anticoagulant treatment exclusion criteria: * massive pulmonary embolism * allergy to heparin, other components of tinzaparin or acenocoumarol * previous thrombocytopenia induced by heparin * thrombocytopenia \< 100000/mm3 * history/signs/symptoms of congenital bleeding disorder * life expectancy less than 90 days * unfractioned heparin anticoagulation for more than 36 hours prior enrollment * inability to participate in the home tinzaparin program * clinical overt gastrointestinal blood loss due to peptic ulcer, intestinal tumours, oesophagitis or diverticulosis * hemoglobin lower than 7 g/dl or creatinin \> 3mg/dl * cerebral-vascular accident * cerebral, medullary and ophthalmological surgery

Keywords: pulmonary embolism low molecular weight heparin vitamin k antagonist longterm
oral metronidazole with lactobacillus vaginal suppositories to prevent recurrence of bacterial vaginosis

Conditions: Bacterial Vaginosis; Recurrence

Summary: we are trying to determine if oral metronidazole with lactobacillus vaginal suppositories is better than oral metronidazole in preventing the recurrence of bacterial vaginosis

bacterial vaginosis (bv) is the most prevalent cause of symptomatic vaginal discharge in the u.s. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (pid), urinary tract infections (uti) and acquisition/transmission of sexually transmitted diseases (stds) including human immunodeficiency virus (hiv). control of bv has been advocated as a means of decreasing the prevalence of these complications. however, the etiology of bv remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. based on currently national guidelines by using oral metronidazole 400 bid for 7 days, a high recurrence rate of bv were reported. we hypothesize that the oral metronidazole with lactobacillus vaginal suppositories is better than oral metronidazole in preventing the recurrence of bacterial vaginosis

Eligibility criteria:
inclusion criteria: * women be at least 18 years of age * have symptoms of vaginal odor and or/discharge * meet the clinical (amsel) criteria for bv * willing to participate in research exclusion criteria: * presence of another vaginal infection or std * allergy to metronidazole * pregnant or nursing * use of oral or intravaginal antibiotics within the past 2 weeks * hiv or other chronic disease * inability to keep return appointments * contraindications for lactobacillus vaginal suppositories（those without sexual history）

Keywords: recurrence lactobacillus vaginal suppositories
role of rebound therapy in the rehabilitation of children with spastic cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) is a group of disorders of movement and posture, causing several body impairments. cp is caused by non-progressive disturbance that occurred in the fetal or immature brain. cp symptoms include several motor disorders such as disturbances in sensation, coordination, cognition, communication and behavior in addition to disturbances in postural stability, balance and coordination. balance is the ability to maintain the center of body mass over the base of support. cp causes balance impairment which results in decrease in the child's mobility functions and causing activity limitation and participations restrictions. motor coordination is the registration of two or more things such as body movements , timing or sensory feedback into a harmonious relationship. cp causes disturbances in motor coordination such as difficulties in the routine gross movements as running and jumping, and disturbances in common fine movements like buttoning, clothing or brushing hair rebound therapy is an exercise therapy which uses mini trampolines, rebounders , springfree trampoline and swiss balls, to provide opportunity to perform recreational movements for individuals with different body structural and functional impairments.


Eligibility criteria:
inclusion criteria: * spastic cerebral palsy was determined according to the sample size calculation, was selected from the outpatient's clinic of the faculty of physical therapy cairo university. * level i according to the gross motor function classification system (gmfcs). chronological age ranged from 5 to 11 years. * height was above 1 meter. * understand verbal command. * the degree of spasticity ranged from 1 to 1+ according to modified ashworth' scale. rebound therapy using trampoline was used as the method of management in the study group in addition to the selected physical therapy program that was used in both groups, and the treatment sessions was provided in the out-patient clinic of the faculty of physical therapy cairo university. exclusion criteria: * vertigo or dizziness. * epilepsy. * osteoporosis.
the effects of manual and automatic lancets on pain and stress in newborn capillary heel blood collection

Conditions: Newborn; Pain; Stress

Summary: heel blood sampling is a routine but painful procedure for newborns. a limited number of international studies have shown that automatic lancets are more effective with less pain and tissue damage than manual lancets. in line with this information, this study was planned to investigate the effects of manual and automatic lancets on pain and stress in newborn capillary heel blood collection.


Eligibility criteria:
inclusion criteria: * postnatal age zero day * term newborn * no congenital anomalies * no advanced medical intervention at birth * infants not receiving oxygen or respiratory support exclusion criteria: * legal guardian not giving consent to research
children's nail bed injuries : study of the efficacy of the simple relocation of nail plate

Conditions: Nail Bed Injury

Summary: nail bed injuries in children, most frequently under 3 years-old, result in crush injuries. the frequency is around 34 percent of the children hand injuries (claudet et al, 2007). the empirical reparation technique is the nail bed suture and the relocation of the nail plate. however, some authors think that suture the nail bed could increase the traumatism of the nail bed because of the needle, the crush by the clamps and by the stitches too tight (langlois, yam). an author has proposed, in a prospective, randomized clinical trial to treat the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the nail bed. advantages of this technique, claimed by the author, was time saving, with an aesthetical result as same as the treatment with suture of the nail bed. a same study validated the technique in a paediatric population (langlois et al., 2010). so, it seems that it is not necessary to suture the nail bed. but, in our practice, the investigators noted complications not mentioned in previous studies: hematomas causing pain, effusion and dislocation of the nail plate, with constrain the patient to consult in emergency. the 2-octylcyanoacrylate is difficult to use in nail bed injuries and is expensive. our hypothesis is the simple relocation of the nail plate in nail bed injuries in paediatric population is enough to have good to excellent aesthetical results, with less complications and a lower cost, than the other techniques. the aim of this study is to assess the aesthetical results 3 months after simple relocation of the nail plate for nail bed injuries in children.


Eligibility criteria:
inclusion criteria: * age under 18 yo * nail bed injuries and/or nail matrix * nail plate \> 30% of the surface comparing the opposite side * one or more digits * signature of the 2 parents * social security exclusion criteria: * loss of more than 30% of the surface of the nail bed * multiples lesions: nerve injury, tendon, fracture or luxation without indication of osteosynthesis, loss of skin with indication of a flap * osteosynthesis of the distal phalanx * injuries by bite * previous pathology of the nail * contraindication of lidocaine, bicarbonate de sodium, kalinox, biseptine, vicryl rapide, adaptic * no information possible * pregnancy * breastfeeding * other inclusion in another study

Keywords: nail bed injury nail bed injuries nail children fingertip injury
engaging latino families in eating disorders treatment

Conditions: Bulimia Nervosa; Binge Eating Disorder; Eating Disorder Not Otherwise Specified

Summary: promoviendo alimentacion saludable (pas)"promoting healthy eating" is a research project funded by the national institute of mental health. the purpose of this study is to develop and test a treatment for eating disorders in latina adults that is appropriate for their age and includes culturally appropriate family intervention.

research on culturally sensitive assessment and treatment of eating disorders among latinos is scarce. this study is comparing individual cognitive behavioral therapy (cbt) versus cbt with a family adjunctive intervention for eating disorders in latina adults. all treatment will be conducted by trained professionals from either the unc eating disorders program (in chapel hill) or from el futuro, inc. (in carrboro or durham, nc) who have been trained in the treatment of eating disorders. participants will participate in 25, 50 minute-long, face-to-face cbt sessions over 27 weeks. participants will be randomly placed in one of two groups: cbt or cbt with family enhancement. those participants who are randomly placed into the cbt group will participate in 25 individual therapy sessions, 3 sessions with a dietitian, and psychiatry and/or medical assessments as needed. those participants who have been randomly placed into the cbt with family enhancement group will participate in 19 individual therapy sessions, 6 family therapy sessions, 3 sessions with a dietitian, and psychiatry and/or medical assessments as needed. all participants will also be expected to participate in baseline, week 6 (mid-treatment), end of treatment, and 3-month follow-up assessments.

Eligibility criteria:
inclusion criteria: * dsm-iv criteria for bn, bed, ednos (sub-threshold bn) * latina * if taking antidepressant medication, stable dose for at least 3 months prior * willingness to ask a family member or significant other to participate and agreement of family member to participate exclusion criteria: * any major medical condition that would interfere with treatment or require alternative treatment * alcohol or drug dependence in the last three months * current significant suicidal ideation * developmental disability that would impair the ability of the participant to benefit from psychotherapy effectively * psychosis, including schizophrenia, or bipolar i disorder * pregnancy * body mass index below 17.5 kg/m\^2 * if taking antidepressant medication, doses are not stable; individuals taking any medications that can significantly affect appetite or weight.

Keywords: bulimia binge-eating disorder eating disorders
probiotic enteral administration in mechanically ventilated patients

Conditions: Pneumonia

Summary: the objective of this study is to assess the effects of a daily enteral supplementation with probiotics within a population of critically ill, mechanically ventilated patients. especially, the effects of probiotics on mortality rate in intensive care medicine will be analysed.

in a critically ill patient, the gut integrity is rapidly compromised either by the treatments used (such as catecholamine or antibiotics) or by the disease itself. this gut alteration favours the adhesion and/or internalisation of bacteria by intestine cells which lead to the production of large amounts of cytokines that rapidly reach the blood compartment, inducing neutrophils activation and then organ damage. moreover, the imbalance in the normal intestinal flora (demonstrated as early as 24 hours after icu admission) is one of the mechanisms involved in the development of ventilator associated pneumonia (vap). vap is the leading cause of icu-acquired infection and is responsible for prolonged icu stay, increased mortality and costs. probiotics, and especially lactobacillus rhamnosus gg ('lgg'), have been demonstrated to possess beneficial effects in terms of intestine flora imbalance and immune response. objective: to study the effects of a probiotic mixture (containing lgg) enteral administration on the survival and the incidence of vap in mechanically ventilated patients. patients and methods: prospective, randomized, double-blind, placebo-controlled study. after randomization, 740 intubated patients with a predictive length of mechanical support of more than 48 hours will enterally receive either 10.10 cfu of probiotic (ergyphilus, nutergia, france) or a identical placebo daily until withdrawal of mechanical support. the main endpoint is the mortality rate in icu. secondary endpoints include hospital length of stay and mortality rate, vap incidence and the number of days free from antibiotics. length of the study 24 months. perspectives: the objective is to demonstrate a survival advantage due to lgg administration, along with a reduction of vap episodes and antibiotic use.

Eligibility criteria:
inclusion criteria: * patients under mechanical ventilation for at least 48 hours exclusion criteria: * age under 18 * pregnancy * immunocompromised status * short bowel disease * moribund condition

Keywords: ventilator-associated pneumonia probiotic mechanical ventilation intensive care