Kornimate/medical-research-clean huggingface dataset:
the effect of orthopulse™ photobiomodulation on tooth movement and treatment time when used with invisalign treatment

Conditions: Malocclusion

Summary: the aim of the study is to determine if, and to what degree photobiomodulation treatment with orthopulse has an effect on the rate of tooth movement during alignment for patients receiving invisalign orthodontic aligner treatment.


Eligibility criteria:
inclusion criteria: * invisalign "full treatment" product only * have a permanent dentition * 18 years-old * angle class i or ½ cusp class ii molar and canine relationship * moderate to mild crowding in at least one arch exclusion criteria: * subjects who do not fulfill all inclusion criteria requirements * craniofacial anomaly present * past or present signs and symptoms of periodontal disease * a significant medical or medication history that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement * previous orthodontic or orthopedic relapse within 1 year * history of trauma, bruxism, or parafunction * skeletal jaw discrepancy * use of osteoporosis drugs * initial use of auxiliary mechanics such as elastics

Keywords: alignment phase photobiomodulation orthodontic treatment malocclusion orthopulse™ invisalign
virtual reality in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: objective: to investigate whether vr videogames plus conventional therapy improves motor control compared with conventional therapy in children with cerebral palsy (cp). methods: thirty participants with cp were included. a baseline (a0), a post-conventional intervention (a1), a post-experimental treatment (a2) and a two-month follow-up (a3) assessment were performed. experimental intervention was based on videogames treatment (kinect-kbox360tm) added to their conventional physiotherapy. motor and the process skills were evaluated by the assessment of motor and process skills (amps); balance by the pediatric reach test (prt); gait speed by the 10-meters walk test (10mw); and running and jumping capacity by the gross motor function measure (gmfm).

thirty participants were recruited, seventeen were boys and thirteen were girls, with a mean age of 8.41 years (sd 2.55). the inclusion and exclusion criteria children were recruited from public schools of madrid (spain) and they were classified according to their gross motor function classification system (gmfcs) level. the inclusion criteria were a diagnostic of mild-moderate hemiplegic and diplegic cp, age between four to eleven years and receive physiotherapy treatment in the public school related with this project. the exclusion criteria were not have visual impairments, severe cognitive disability, surgical intervention in the year before study onset, botulinum injections in the six months before study onset and non-controlled epilepsy. six participants were classified as gmfcs level i and twenty-four was level ii, all with spastic involvement. all were receiving physiotherapy at the time of enrollment by the same therapist. all children were enrolled in age-appropriate classes in regular public schools; 100% did receive some extra help for mild learning issues. statistical analyses: we used a repeated measures analysis of variance (anova) to assess differences among the four assessments in each of the variables, using paired t-test with bonferroni correction when a significant effect was detected. we performed all the analysis by the statistical package for social sciences (spss 19.0 version).the statistical analysis was conducted at a 95% confidence level. a p value \<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * diagnostic of mild-moderate hemiplegic. * diplegic cerebral palsy. * age between four to eleven years. * receive physiotherapy treatment in the public. * school related with this project exclusion criteria: * not have visual impairments. * severe cognitive disability. * surgical intervention in the year before study onset. * botulinum injections in the six months before study onset. * non-controlled epilepsy.

Keywords: cerebral palsy child rehabilitation video games virtual reality.
performance of novosyn® in patients undergoing uterus closure in cesarean section

Conditions: Cesarean Section Complications; Cesarean Section; Infection

Summary: the aim of this study is to collect clinical data on the use of novosyn® applied for the uterus closure in cesarean section. diverse parameters have been selected to assess that the safety and effectiveness of novosyn® is comparable to published results, where the rate of ssis in patients undergoing uterus closure in cesarean section was 10.6%.


Eligibility criteria:
inclusion criteria: * female patients. * age ≥ 18 years * patients undergoing one of the following gynaecologic surgeries: * scheduled (elective) cesarean section * cesarean section in labour * urgent cesarean section * use of novosyn® following routine clinical practice. * patients with available electronic health records (ehr). exclusion criteria: * any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures. * participation in any clinical trial
breastfeeding improvement following tongue-tie and lip-tie release

Conditions: Ankyloglossia; Breastfeeding

Summary: this study is an observational study to determine outcomes of surgical release of tongue-tie and lip-tie in babies who are experiencing difficulty with breastfeeding.

breastfeeding rates in the united states initiate at around 80%, but many mothers are unable to effectively breastfeeding because of problems with latch and suction generation. previous studies have demonstrated how nipple pain is directly linked to ankyloglossia, but most of these studies are done with poor methodology. clinically, tongue-tie and lip-tie have correlate with numerous other symptoms besides nipple pain. these babies tend to be inefficient nursers, which can affect weight gain. abnormal intake of air because of the poor latch/seal can lead to reflux symptoms. finally, there is a significant psychological toll on mothers who want to breastfeed but cannot do so. this study aims to prospectively analyze these outcomes by using validated tools.

Eligibility criteria:
inclusion criteria: * healthy babies who are breastfeeding 0-12 weeks of age exclusion criteria: * serious comorbid conditions (heart, lung, brain) * prior maternal breast surgery * insufficient glandular tissue * previous tongue/lip surgery * twins/triplets
study of adjunctive ganaxolone treatment in children and young adults with cdkl5 deficiency disorder

Conditions: CDKL5 Deficiency Disorder

Summary: a clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed cdkl5 gene mutation.

the marigold study is a global, double-blind, placebo-controlled, phase 3 clinical trial that will enroll approximately 70 patients between the ages of 2 and 21 with a confirmed disease-related cdkl5 gene variant. patients will undergo a baseline period before being randomized to receive, in addition to their existing anti-seizure treatment, either ganaxolone or placebo for 17 weeks. following the treatment period, all patients that meet certain eligibility requirements will have the opportunity to receive ganaxolone in the open label phase of the study. the study's primary efficacy endpoint is percent reduction in seizures. secondary outcome measures will include non-seizure-related endpoints to capture certain behavioral and sleep disturbances that have been seen in previous clinical studies with ganaxolone.

Eligibility criteria:
inclusion criteria: * genetically confirmed cdkl5 gene mutation, seizure onset by 1 year of age and lack of independent ambulation by 2 years of age * failure to control seizures despite 2 or more anti-seizure medications * at least 16 seizures per 28 days of primary seizure types * on a stable regimen of 0-4 anti-seizure medications (vagus nerve stimulator, ketogenic diet, and modified atkins diet do not count towards this limit) * additional inclusion criteria apply and can be discussed with study team exclusion criteria: * previous exposure to ganaxolone * west syndrome with hypsarrhythmia pattern on eeg or seizures predominantly of infantile spasms type * use of adrenocorticotropic hormone (acth), prednisone or other glucocorticoid or use of moderate or strong inducers or inhibitors of cyp3a4/5/7 are prohibited * use of tetrahydrocannabinol (thc) or cannabidiol (cbd) is prohibited during the double-blind phase, unless patient has a prescription of epidiolex® * exposure to any other investigational drug within 30 days or fewer than 5 half-lives prior to screening * plasma allopregnanolone-sulfate (allo-s) levels greater than or equal to 6.0 ng/ml at screening visit * additional exclusion criteria apply and can be discussed with study team

Keywords: refractory seizures genetic pediatric encephalopathies epilepsy in children seizure disorder
impact of maternal body mass index on infant hypoxic events at time of delivery ,cross-sectional study.

Conditions: Maternal Obesity; Hypoxia Neonatal

Summary: offspring from overweight or obese mothers appear to be at up to 38% increased risk of being admitted to the neonatal intensive care unit than the offspring of mothers with a normal bmi. in terms of apgar scores at birth, babies of obese mothers have been reported to have a 31% excess risk of having a low apgar score (defined at \<7 at 1 minute) . infants born to obese mothers demonstrate a spectrum of outcomes, suggesting that there is a complex interplay of factors that defines the precise altered metabolic environment to which the fetus is exposed and that determines the risk of complications

the investigators need to improve understanding of the specific molecular factors that contribute either individually or synergistically to detrimental fetal outcomes. moreover, the investigators need to identify the essential maternal markers that need to be tightly regulated during pregnancy to improve outcomes. here in, the investigators discuss the influence of maternal obesity and factors associated with the obesogenic intrauterine environment on fetal lung development and respiratory outcomes in offspring at birth importantly, the investigators identify a series of molecular changes encountered during pregnancy that may program the observed respiratory outcomes in clinical practice. the effects of maternal obesity on severe neonatal asphyxia may be partly explained by traumatic labor, which often results from macrosomia. another consequence of maternal obesity is fetal hyperinsulinemia, which may be related to chronic hypoxia even without diabetes . other mechanisms that explain the effect of maternal obesity on neonatal asphyxia include lipotoxicity, placental inflammation and vasculopathy, and cord coiling. evidence has demonstrated altered gene expression in full-term newborns of mothers with obesity, involving dysregulation of brain development, inflammatory and immune signaling, glucose and lipid homeostasis, and oxidative stress

Eligibility criteria:
inclusion criteria: 1. age of 18 - 40 years. 2. term pregnancy (37 weeks gestation or more) 3. singleton pregnancy 4. cephalic presentation at time of delivery 5. in labour exclusion criteria: 1. any medical disorders that affect neonatal outcomes (diabetes mellitus, hypertension, mixed connective tissue disorders) 2. scarred uterus (myomectomy, previous cesarean section) 3. macrosomic baby\>4 kgs 4. condition jeopardizing the maternal or fetal life (for example: antepartum hemorrhage, pathological ctg, cord prolapse) 5. liquor abnormalities (oligohydramnios or polyhydramnios). 6. other indications for cesarean sections for example: placenta accreta spectrum 7. smokers. 8. any abnormalities in follow up of delivery regarding partogram.

Keywords: maternal obesity hypoxia neonatal
efficacy and safety of endoscopic resection

Conditions: Endoscopic Resection; Gastrointestinal Neoplasms

Summary: an observational, prospective, multicentre and international study. this will be a non-interventional study to evaluate the efficacy and safety of endoscopic resection of gastrointestinal lesions and to determine what are the factors related to complications, and to describe these lesions according to the different morphologic and histologic classifications.


Eligibility criteria:
inclusion criteria: * female and male patients who are at least 18 years old. * clinical indication for endoscopic exam and endoscopic resection * patients must freely accept their involvement in this study. they shall give a written informed consent exclusion criteria: * patients who do not desire to be included in this study
the effect of music therapy on vital signs and heart rate variability of pediatric patients during the extubation process.

Conditions: Respiratory Failure; Intensive Care Pediatric

Summary: the extubation process is critical to the future health outcomes of the pediatric patient because it tests the ability of the respiratory system to function without the support of mechanical ventilation. however, extubation can cause stress, pain, anxiety, or discomfort in the patients, which results in an increased likelihood of reintubation. music therapy has been shown to be effective in reducing anxiety and stress levels in ventilated adult patients, but studies evaluating the effect of music therapy on vital signs in pediatric patients during extubation are lacking. the aim is to determine the effect of music therapy on vital signs and heart rate variability of pediatric patients during extubation in in two high-complexity health care institutions in colombia. this study is a randomized clinical trial (rct) with two parallel arms. the intervention group (ig) will receive standard care during the extubation process + music therapy and the control group (cg) will receive standard care only. the primary outcome measure is heart rate (hr) measured every minute for 5 minutes before extubation, during extubation, and up to 10 minutes after extubation. secondary measures are: oxygen saturation, respiratory rate, blood pressure, duration of the procedure, number of reintubations, and heart rate variability.


Eligibility criteria:
inclusion criteria: * pediatric patients hospitalized who are undergoing an extubation process. exclusion criteria: * pediatric patients with accidental extubation or deterioration of the respiratory pattern after extubation that precludes monitoring for 10 minutes post-extubation will be excluded.

Keywords: vital signs pediatric intensive care unit extubation music therapy mechanical ventilation hear rate
comparison of hypopressive breathing and noble technique on dra in postpartum women.

Conditions: Diastasis Recti Abdominis

Summary: the aim of study is to compare the effect of hypopressive breathing and noble technique on width of diastasis recti abdominis, lumbopelvic pain and maternal functioning in postpartum women.

candido shows that caesarean section increased the likelihood of experiencing an increase in the inter-rectus distance during the postpartum period. diastasis recti abdominis (dra) is a common condition in postpartum women that can cause abdominal muscle separation. however, there is a lack of direct comparison between these two techniques. this study aims to compare the effectiveness of the hypopressive breathing and the noble technique in improving dra in postpartum women.

Eligibility criteria:
inclusion criteria: * multiparous women * history of cesarean section and vaginal delivery * \> 12 weeks postpartum * measurement is 2cm or more then 2cm of dra is included by using finger width palpation and nylon digital caliper * lumbopelvic pain (nprs 3 to 8) exclusion criteria: * exclude women who need surgical correction for dra * pelvic organ prolapse * para umbilical hernia * malignancy * bone tuberculosis * fibromyalgia

Keywords: hypopressive noble technique dra postpartum women
adherence by music to exercise in dementia: group therapy

Conditions: Dementia

Summary: the aim of this study is to asses the effect of a music and video-based group exercise therapy on motivation, physical functioning, cognition and well-being in older adults with moderate dementia.


Eligibility criteria:
inclusion criteria: * men and women with moderate dementia (mmse between 12 and 20) * age 65 years or older * resident in nursing home for at least 30 days * able to stand (supported) for 10 seconds with supervision exclusion criteria: * inadequate functional hearing * uncorrected visual problems * rehabilitating from an orthopedic or neurologic insult * known disability that significantly influences 6 month prognosis

Keywords: exercise therapy rehabilitation physical therapy frailty treatment adherence and compliance cognition physical functioning
the oxford risk factors and non-invasive imaging study

Conditions: Cardiovascular Diseases; Cardiovascular Risk Factors

Summary: orfan is a prospective, multi-centre, multi-ethnic cohort observational study collecting ct scans, biological material and outcomes data, to develop and validate novel biomarkers of cardiometabolic and other disease risk.

the orfan registry will include unselected, consecutive patients undergoing ct scans (coronary ct angiograms (ccta), ct chest, abdomen and pelvis scans) collected at the participating centres. the study will combine imaging data with patient demographics and clinical information (including prospective outcomes) to aid the development and/or validation of new or existing image analysis algorithms and software tools to improve diagnosis, clinical risk discrimination and prediction. specifically, orfan will evaluate the specificity, utility and predictive value of newly developed image analysis methods. orfan will recruit and follow-up patients prospectively, linking the index ct scan with blood biomarkers, genetic information as well as information on disease progression (recorded through follow-up ct scans) and clinical outcomes data. the study will also collect ct scans performed in the past and link them with clinical factors and prospective outcomes data collected after the index scan was performed.

Eligibility criteria:
inclusion criteria: inclusion criteria for study arms 1, 2 and 3: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 -99 years. inclusion criteria for study arm 4: • male or female, aged 18 -99 years. exclusion criteria: exclusion criteria for study arms 1, 2 and 3: * unable or unwilling to consent * active cancer exclusion criteria for study arm 4: * participation in study arms 1, 2 or 3 * existing opt-out from use of data for research purposes
evaluation of postoperative radiotherapy and concurrent chemotherapy effectiveness in cervical cancer

Conditions: Cervical Cancer; Toxicity Due to Radiotherapy

Summary: the present study is a randomized, control, phase ii/iii study of early stage (figo ia2-iib) cervical cancer after radical hysterectomy in northwest china treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. all the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). the effectiveness, and side effects will be evaluated according to standard who response criteria, and nci common toxicity criteria for adverse events(nci-ctc-ae) v3.0.

to the cervical cancer patient who accepted radical hysterectomy, whether the adjuvant therapy should be received or the method of adjuvant therapy are determined by the postoperative pathology. in the traditional opinion, the postoperative risk factors were divided into two groups: intermediate risk factors, including large tumor size, deep stromal invasion and lymphovascular space invasion, and high risk factors, including non-squamous cell carcinoma, marginal positive, parametric invasion and pelvic lymph node(ln) metastasis. patients with intermediate risk factors should accepted adjuvant radiotherapy only and who with high risk factors should received adjuvant concurrent chemoradiotherapy. cisplatin weekly(40mg/m2) was the standard regimen of concurrent chemotherapy. however, we retrospectively analyzed 801 cervical cancer patients with postoperative radiotherapy and found that distant metastasis was the main cause of current treatment failure(84.5%), which suggested the current regimen of chemotherapy was insufficient and might be strengthened in future.

Eligibility criteria:
inclusion criteria: * 18 years to 70 years * histologically proven cervical cancer, figo stage ia2-iib,and no previous chemotherapy and radiotherapy * accepted radical hysterectomy 3-4 weeks before * karnofsky score \>70 * postoperative pathology with following risk factors: non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter\>4cm) or pelvic ln metastasis. patients with pelvic ln metastasis and combination of any two or more risk factors mentioned above were included. * examination results showed no radiation or chemotherapy contraindication * willing to accept treatment * ability to comply with trial requirements exclusion criteria: * postoperative residual * postoperative recurrence or metastasis * without lymph node dissection * postoperative pathology showed aortic lymph node metastasis * examination results showed radiotherapy contraindications * no indications for radiotherapy

Keywords: cervical cancer postoperative risk factor treatment