Kornimate/medical-research-clean huggingface dataset:
congenital cytomegalovirus infection in vietnam (cymevie)

Conditions: Prenatal Infection; Congenital Infection; Neonatal Disease

Summary: to estimate the prevalence of congenital cmv infection in vietnamese neonates and relating morbidity within 2-year follow-up. along with evaluating the predictive value of the presence and the level of cmv replication in the first trimester in a highly seropositive population

congenital cytomegalovirus infection (ccmv) is the main non-genetic cause of sensorineural hearing loss (snhl), and a major cause of neuro-disability. high maternal cmv prevalence seems to be consistently associated with high prevalence of ccmv infection but the associated morbidity might be different from one population to another. there exists no serologic marker useful to differentiate non-primary infection from primary infection. since the morbidity of ccmv is similar between both primary and non-primary maternal infection, and to be infected in the first trimester is the major risk factor for long-term sequelae in neonates. hence, it is needed to focus on finding markers that predict ccmv after maternal infection in the first trimester of pregnancy. to date, the epidemiology of ccmv, the morbidity related to ccmv in vietnamese population and the predictive value of cytomegalovirus polymerase chain reaction (cmv pcr) in maternal blood and urine in the first trimester remain unknown. therefore, it is necessary to conduct this study.

Eligibility criteria:
inclusion criteria: * vietnamese pregnant women in the first trimester of pregnancy and at delivery and subsequent live neonates at birth. * informed consent exclusion criteria: * women under 18 years old. * miscarriages * stillbirths * premature delivery before 34th gestational week * loss to follow-up maternal monitoring. * participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality.

Keywords: cymevie cytomegalovirus congenital cytomegalovirus infection cmv pcr cmv ccmv
photobiomodulation laser therapy following arthroscopic rotator cuff repair

Conditions: Rotator Cuff Tears

Summary: rehabilitation following rotator cuff surgery is characterized with high levels of pain, limited range of motion, and decreased quality of life. the purpose of this study is to evaluate the b-cure laser photobiomodulation home-use device in addition to standard care, for the reduction of pain, increase in functionality, and improvement of life quality during rehabilitation following rotator cuff arthroscopic surgery.

patients planned to undergo rotator cuff arthroscopy will be randomized to receive active or sham devices for self-application at home in addition to standard care. patients will be invited to up to 5 visits at the clinic: baseline (before surgery), post-operative day 1, and 1, 3, and optionally 6 months after surgery. evaluations will include physical examination, physical activity tests, range of motion measurements, constant score, thermal imaging, and patient reported outcomes including subjective pain level by visual analogue scale, functional and quality of life questionnaires. the study hypothesis is that b-cure laser treatments, applied, at home, by the patient, can reduce pain and accelerate healing over standard care thereby improving the rehabilitation process following rotator cuff arthroscopic surgery.

Eligibility criteria:
inclusion criteria: * age 40-65 * men or women * full or partial rotator cuff tear * scheduled to undergo rcas because of failure of conservative therapy (injections, medication, physiotherapy) * is willing to perform the full protocol * voluntarily sign and date an informed consent form * be able to understand and complete the various questionnaires exclusion criteria: * is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits * participation in another clinical study within 30 days before screening * scheduled to undergo an elective medical procedure during the study timeframe that will interfere with the study as deemed by the pi * pregnant * has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for shoulder pain * use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light * has osteoarthritis * other chronic pain conditions: fibromyalgia, failed back surgery, back pain * avascular necrosis * rheumatoid arthritis * psychiatric disorders including major depression, schizophrenia, bipolar disease

Keywords: photobiomodulation low-level laser therapy
beneficial effect of intravenous magnesium sulphate in term neonates with hypoxic ischemic encephalopathy(hie)

Conditions: HIE

Summary: neonatal mortality rate is the highest in pakistan. and birth asphyxia is one of the main reversible causes. outcomes related to birth asphyxia can be improved, if intervention done in time with proper measures. mgso4 is cheaper and easily available drug.

some studies showed positive results if given within 6 hours of birth asphyxia, whereas some are not supportive. but still less know about this drug, especially in low income countries. objective of this study is to see beneficial effects of mgso4 in neonates presenting with birth asphyxia.

Eligibility criteria:
inclusion criteria: * after informed consent, any child who is term, inborn or out born fulfilling the definition of hypoxic ischemic encephalopathy according to history, apgar or scoring system and reaching within 6 hours of delivery in nursery department of pediatric medicine unit-ii, services hospital, lahore exclusion criteria: * preterm syndromic/dysmorphic child term child with hie and arriving after 6 hours of life. term child with unrelated co morbidities eg congenital heart defects, renal failure etc

Keywords: hie, mgso4
a study in healthy women to test whether bi 1358894 influences the amount of a contraceptive in the blood

Conditions: Healthy

Summary: this study aims to investigate the effect of multiple doses of bi 1358894 on pharmacokinetics of ethinylestradiol (ee) and drospirenone (drsp) (yasmin®)


Eligibility criteria:
inclusion criteria: 1. healthy premenopausal female subjects according to the assessment of the investigator, as based on a complete medical history including a physical and gynaecological examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests 2. age of 18 to 35 years (inclusive) 3. body mass index (bmi) of 18.5 to 29.9 kg/m2 (inclusive) 4. signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ich-gcp) and local legislation prior to admission to the trial 5. female subject who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion: * use of an oral hormonal contraception method in combination with a barrier contraception method and willing to stop the hormonal method and to continue using the barrier method plus yasmin® for the duration of the trial * use of non-hormonal intrauterine device (iud) * sexually abstinent * female subject who underwent tubal ligation * a vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant exclusion criteria: 1. any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator (e.g. pronounced varicosis, thrombophlebitis, and evidence of peripheral circulatory disturbances) 2. repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmhg), diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) 3. any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) 7. diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 8. history of relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply
adjunctive effect of photodynamic therapy on halitosis

Conditions: Periodontitis; Halitosis

Summary: the present study aims to evaluate bad breath in patients undergoing gingival treatment combined with tongue scraping and laser and to assess its potential benefits for both periodontal and microbiological condition. firs patients will be selected among those who participated in a privies study. additional patients will be also invited. they must have gum disease and bad breath. treatments will be completed within 24 hours and oral samples will be collected with thin paper points. bad breath will be evaluated by a professional and a specific gas machine.

the present study aims to evaluate halitosis in patients undergoing non-surgical periodontal therapy \[(full-mouth disinfection (fmd) combined with tongue scraping and antimicrobial photodynamic therapy (apdt), and to assess its potential benefits for both periodontal and microbiological condition. a pilot study will be performed with participants who took part almost 10 years ago in the study nct02368678. they will be invited by phone contact. in addition, new participants will be recruited by convenience in dental clinics from the federal university of minas gerais until completion of 20 participants per group. individuals with stage iii periodontitis and halitosis (organoleptic method \> 2), will be allocated into two periodontal treatment groups. halitosis will be assessed using the organoleptic method and gas chromatography (oralchroma device) at three time points: before and after treatments. microbiological samples will be collected before and after treatments from periodontal pockets and pooled samples from the tongue dorsum. these samples will be analyzed by using real-time pcr (q-pcr) aiming at detecting target bacterial species.

Eligibility criteria:
inclusion criteria: * self-reported halitosis; * organoleptic score \>2; * stage iii periodontitis; * at least 14 teeth. exclusion criteria: * smokers or former smokers; * individuals diagnosed with diabetes and/or immune diseases; * pregnant or lactating women; * individuals with removable partial dentures and/or fixed or removable orthodontic appliances; * systemic use of antibiotics or anti-inflammatory drugs in the last three months; - individuals who required prophylactic antibiotics for periodontal exams and treatments; * individuals who regularly used or had used any type of mouthwash in the past three months; * individuals who underwent periodontal treatment in the six months prior to the study.

Keywords: halitosis periodontitis full-mouth disinfection antimicrobial photodynamic therapy real time polymerase chain reaction bacteria
effect of neuromuscular electrical stimulation on dysphagia in children with down syndrome

Conditions: Rehabilitation

Summary: although some western studies have been conducted to determine the nature of eating problems and oral motor training in children with down syndrome, these studies are limited. most of the studies were done in down syndrome infants. since feeding is a skill that develops by 2 years of age and refines till 6 years of age (delaney \& arvedson 2008), it is essential to study the children in this age group as well. moreover, there is a dearth of studies investigating the impact of oral motor exercises on feeding problems of the child, which may, in turn, hinder the progress of the child during the intervention. blissett j., (2018) reported that the behaviours of both caretaker, therapist and infant during feeding contribute significantly to the overall success of the feeding interaction as well as feeding performance. parents/caregivers play an important role in feeding the child, as they have the first-hand exposure and experience in feeding their child, awareness of the child's feeding behaviours, likes and dislikes of food and communication behaviour during hunger. consequently, they are the best people to describe their child's feeding problems. hence, this study involves the administration of a scale on the parent/caregiver to elicit information about the physical, functional and emotional aspects of drooling. such studies in the egyptian context are limited. the paucity of literature makes it clear that there are deeper underlying complex issues about oral motor exercises in children with down syndrome that needs to be investigated. the in-depth assessment and treatment of oral motor skills will provide valuable input to the physical therapists during the treatment of feeding problems in children with down syndrome. this would help the therapist and clinician in planning and prioritizing the goals during therapy. the information will also help in counselling the caregivers, deciding the success or failure of feeding therapy and thereby help in predicting the prognosis of the child.


Eligibility criteria:
inclusion criteria: * 1- their age ranged from 3 to 6 years. 2- both genders were included. 3- the participating children having the ability to understand and follow simple instructions (iq level not less than 50). 4- they did not have any visual or auditory problems. 5- they did not be treated with special medications affecting mental functions. 6- they had score from 4 to 7 according to functional oral intake scale. exclusion criteria: * 1- children with history of epilepsy. 2- children with dental deformities. 3- children with chest infections or unstable cardiac status. 4- children with infective skin conditions. 5- children with gum disorders.
the therapeutic value and mechanism of recombinant human interleukin-2 in children with henoch-schönlein purpura

Conditions: Purpura, Schoenlein-Henoch

Summary: the study aims to explore the therapeutic value and mechanism of interleukin-2 on children with henoch-schönlein purpura.

the investigators designed a single center, open-label, prospective study that routinely administered low-dose il-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.for all patients,rhil-2(500,000 unit per square meter) infusions seven days;recurrent patients were applied again for 7 days;patients who were diagnosed hspn were treated on a routine basis for 7 consecutive days, and then once every two week for 3months.

Eligibility criteria:
inclusion criteria: 1. age \<18 years old 2. meet the eular/printo/pres for the diagnosis of hsp 3. hiv negative;negative for hbv and hcv. exclusion criteria: 1. heart failure (cardiac function ≥ grade iii nyha) 2. liver insufficiency (upper limit of normal range of transaminase \> 2 times) 3. renal insufficiency (creatinine clearance ≤30ml/min) 4. acute or severe infections such as bacteremia and sepsis 5. malignant tumor 6. high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month 7. mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information 8. intestinal ischemia or perforated gastrointestinal bleeding requires surgery 9. inability to comply with il-2 treatment regimen.

Keywords: hsp
trial of liposomal doxorubicin (doxil) and weekly docetaxel (taxotere)

Conditions: Cancer; Carcinoma

Summary: this study is for patients with advanced cancer that has failed treatment with conventional therapy or for which no standard treatment exists. the purpose of this study is to determine the highest dose that can be given of 2 chemotherapy drugs, docetaxel (also called taxotere) and liposomal doxorubicin (also called doxil), when given together and to determine the side effects of this combination. both taxotere and doxil are chemotherapy drugs that can decrease the size of several different tumors. taxotere is approved by the food and drug administration (fda) for the treatment of breast and lung cancers, and doxil is approved for the treatment of ovarian cancer.


Eligibility criteria:
inclusion criteria: * histological proof of advanced or recurrent solid tumor which has failed prior therapy, or for which no effective therapy is available. * ovarian cancer patients (or primary peritoneal carcinoma) whose only manifestation of disease is an elevated cancer antigen (ca) 125 of \> 100 are eligible. * swog performance status 0-2. * absolute granulocyte count (agc) greater than or equal to 1.5; platelets greater than or equal to 100,000. * total bilirubin less than or equal to the upper limit of normal (uln). * transaminases (sgot and/or sgpt) may be up to 2.5 x institutional upper limit of normal (uln) if alkaline phosphatase is \ 1.5 x uln and alkaline phosphatase \> 2.5 x uln are not eligible for this study (due to decreased clearance of docetaxel and increased risk of toxicity). * age greater than or equal to 18 years. * fully recovered from acute toxicities from chemotherapy, radiation, or surgery. * negative serum pregnancy test, if patient is female, still fertile, and sexually active. exclusion criteria: * prior treatment with doxil or weekly docetaxel. prior docetaxel administered every 3 weeks is allowed. * evidence of moderate peripheral neuropathy greater than or equal to grade 2. * medical, social, or psychological factors interfering with compliance. * known history of cardiac disease (congestive heart failure, coronary artery disease) that would preclude treatment with doxil in the opinion of the investigator. * cardiac ejection fraction \< 50% * pregnancy

Keywords: phase 1 phase i phase one solid tumor
cognitive behavior group therapy in adolescents with attention deficit hyperactivity disorder

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: attention deficit hyperactivity disorder (adhd) is a neurodevelopmental disorder which starts in childhood and is characterized by symptoms of attention deficit, hyperactivity and impulsivity. persistence into adolescence is frequently associated with among other low educational achievement, interpersonal difficulties, anxious and depressive symptoms and sleep problems. treatment guidelines recommend psychological treatment as part of the treatment plan, however compared to children and adults, there is still a substantial lack of knowledge about appropriate psychological treatment in adolescents. the present study examines a psychological intervention for adolescents with adhd, cognitive behavior group therapy. the intervention consists of 12 weekly cognitive behavioral therapy sessions addressing core difficulties and concerns of the adolescent population with adhd. the investigators wish to determine the efficacy of group therapy in adolescents with adhd who receive medical treatment but still have impairing adhd symptoms.

change february 1st 2017: inclusion of patients with mild to moderate behavioral problems in order to achieve enough participants in the study. change february 1st 2017: the study primarily recruits patients who are on pharmacological treatment for adhd. however, for ethical reasons and in order to achieve enough participants, the study will also recruit patients who have not responded to at least two drug trials or have been unable to continue pharmacological treatment because of intolerable side effects. change february 1st 2018: the weiss functional impairment rating scale, rosenberg and brief questionnaires will not be collected at the 9-month follow-up due to lack of resources (project assistance).

Eligibility criteria:
inclusion criteria: * attention deficit hyperactivity disorder (icd-10) * clinical global impression (cgi) \>=3 * informed consent patient * informed consent parents * if on medication, dosage is stable since at least 2 months exclusion criteria: * mental retardation * behavioral problems * drug addiction * psychosis * suicidal

Keywords: behavior therapy cognitive therapy adolescents psychotherapy, group
glubran mesh fixation in lichtenstein hernioplasty

Conditions: Inguinal Hernia

Summary: the purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty.

repair of inguinal hernia in one of the most frequently performed surgical operation in western world. the technique of choice is currently to support inguinal tissues by using polypropylene mesh. chronic postoperative pain and discomfort occur in 25-30% of patients after inguinal hernioplasty. pain might be related to mesh fixation by sutures. this randomized study investigates whether mesh fixation by tissue glue (cyanoacrylate) is better than sutures. the patients are followed 1 year postoperatively. pain, quality of life, operative parameters (time, cost) and recurrences are reported.

Eligibility criteria:
inclusion criteria: * inguinal hernia * adult patient exclusion criteria: * patient not willing * multiple recurrences * inguinal pain without evidence of hernia * femoral hernia * large scrotal hernia

Keywords: inguinal hernia inguinal hernioplasty mesh fixation lichtenstein hernioplasty
natural antioxidants in the treatment of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to compare the effectiveness of three antioxidant regimens in treating the symptoms of multiple sclerosis (ms).

multiple sclerosis (ms) is an immune mediated disease of the central nervous system that affects over 350,000 americans. t lymphocytes, macrophages and soluble mediators of inflammation cause demyelination and axonal injury in ms. activated macrophages release nitric oxide and oxygen free radicals that cause demyelination and axonal injury in ms and experimental autoimmune encephalomyelitis (eae). natural antioxidants may favorably influence the course of ms by decreasing oxidative injury. chronic relapsing eae in mouse models is clinically and pathologically useful for testing potential therapies for ms. this study will assess three natural antioxidant regimens for their potential as treatments for ms: ginkgo biloba, alpha-lipoic acid/essential fatty acids, and vitamin e/selenium. the effects of each regimen will be compared to determine which regimen appears most effective at suppressing eae and decreasing markers of oxidative injury in patients with ms. as part of this study, two smaller trials will be conducted. a phase i/ii trial in patients with ms will determine if the selected antioxidant regimen can decrease disease activity as detected with gadolinium-enhanced magnetic resonance imaging. the results of this study will serve as the basis for a phase iii trial to assess the long term effectiveness of natural antioxidant therapy in ms.

Eligibility criteria:
exclusion criteria: * pregnant * other significant health problems