Kornimate/medical-research-clean huggingface dataset:
comparison of amniotic fluid index between before and after maternal position change in upright and left lateral decubitus position

Conditions: Pregnancy Related

Summary: comparison of amniotic fluid index between before and after maternal position change in upright and left lateral decubitus maternal position

amniotic fluid has many important roles in fetal development such as the development of the digestive tract and respiratory system. the quantity of amniotic fluid can be measured by ultrasonography, measuring the deepest pocket in 4 quadrants of uterus then summarize as one value known as "amniotic fluid index"(afi). the afi has the normal range between 5-25 cm. the low afi (\< 5 cm) is associated with abnormal fetal heart rate, and the abnormal afi does affect to the treatment during the antepartum and intrapartum phase. however , there is the study shown that when compared to the single deepest pocket (sdp) , afi could detect the oligohydramnios more which might led to the unnecessary labor induction or operative delivery without the significant change of perinatal outcome. to increase the accuracy of afi, we theorize that maternal position change might affect the amniotic fluid position which would increase the visual of the amniotic fluid as well.

Eligibility criteria:
inclusion criteria: * pregnant women age 20-34 years whose gestational age was confirmed by ultrasonography before 24 weeks of gestation exclusion criteria: * pregnant women with multifetal pregnancy * pregnant women who have underlying disease * pregnant women who have the history of premature rupture of amniotic membrane * pregnant women who have amniotic fluid index below 5 cm (oligohydramnios) * pregnant women who have amniotic fluid index more than 25 cm (polyhydramnios) * pregnant women whose her baby has the fetal anomaly

Keywords: amniotic fluid index
a nation-wide multicenter clinical epidemiologic study of chinese females with advanced breast

Conditions: Advanced Breast Cancer

Summary: to study the epidemiological trends and characteristics for advanced breast cancer patients, to analyze these trends and report the results

in this study, the investigators conducted a hospital-based retrospective clinical study, recruiting female advanced breast cancer patients from 14 tertiary hospitals at 7 classic geographic regions, to study the clinical epidemiologic characteristics of advanced breast cancer and the current standard of clinical diagnosis and treatment in order to provide references for standardized treatment therapy, and to improve the quality of life and prolong survival time. to study the epidemiological trends and characteristics for advanced bc patients, to analyze these trends and report the results. to learn about the current treatment therapy for advanced bc patients in different areas in china.to provide references for standardized treatment therapy, to improve the quality of patients' life and to prolong the survival time for the advanced bc patients.to assess the different treatment therapies for advanced bc with consideration of economic cost-effectiveness

Eligibility criteria:
inclusion criteria: * diagnosed as advanced breast cancer during jan1st,2012-dec31st,2014 * complete with surgical pathology data, auxiliary treatment, there is a clear recurrence, transfer time, place, transfer of recurrence after treatment, and curative effect evaluation details.in any age, ethnic group cases. exclusion criteria: * no available medical record
lower urinary tract symptoms in transmasculine patients undergoing metoidioplasty and their acceptability of pelvic floor muscle training assessed by a pelvic, obstetric and gynaecological physiotherapist

Conditions: Lower Urinary Tract Symptoms; Transgenderism

Summary: lower urinary tract symptoms in transmasculine patients undergoing metoidioplasty and their acceptability of pelvic floor muscle training assessed by a pelvic, obstetric and gynaecological physiotherapist. study design prospective observational pilot study study participants transmasculine patients undergoing metoidioplasty planned sample size 50 planned study period 2025/26 objectives understand the acceptability of first-line pelvic floor muscle training (pfmt) treatment in transmasculine patients undergoing metoidioplasty background incidence of lower urinary tract symptoms (luts) in transmasculine patients undergoing surgery endpoints acceptability of pfmt questionnaire international prostate symptom score (i-pss) and international consultation on incontinence questionnaire urinary incontinence short form (iciq-ui sf) questionnaires and uroflowmetry


Eligibility criteria:
inclusion criteria: have capacity to consent. diagnosis of gender dysphoria and have lived in a gender role that is congruent to their gender identity for minimum of 12 months. transmasculine patients referred to ccgs for masculinising lower genital reconstructive surgery having received two signatures confirming suitability for reconstructive surgery. undergoing metoidioplasty/phalloplasty. age \>17 years old. on systemic testosterone therapy for more than 12 months. exclusion criteria: * age less than 18 years. not undergoing metoidioplasty/phalloplasty.
meta-analysis plan for pooled data for studies vrx-ret-e22-303 and vrx-ret-e22-304

Conditions: Epilepsy, Partial

Summary: the objective of this meta-analysis is to provide data on long-term safety and efficacy following the recent positive committee for medicinal products for human use (chmp) opinion for retigabine using pooled data from ongoing open-label extension (ole) studies vrx-ret-e22-303 and vrx-ret-e22-304.

data from the october 2009 data-cut of ongoing studies vrx-ret-e22-303 (study 303) and vrx-ret-e22-304 (study 304) will be pooled, summarized, and published with the goal of providing updated long-term safety and efficacy information for subjects and prescribers following the recent positive chmp opinion for retigabine for adjunctive use in patients with partial seizures. studies 303 and 304 are the open-label extensions of two phase 3 studies (vrx-ret-e22-301 and vrx-ret-e22-302), respectively. studies 301 and 302 were randomized, double-blind, placebo-controlled, parallel-group, multicenter studies of 600 mg and 900 mg per day (study 302) and 1200 mg per day (study 301). all subjects who wished to enter the ole studies and, in the opinion of the investigator, were expected to benefit from participation in the oles, entered a 6-week (study 301) or 4-week (study 302) transition phase in which their dose of retigabine was titrated to or maintained at 400 mg tid (study 301) or 300 mg tid (study 302). upon completion of the transition phase, subjects enrolled into the extension studies. once enrolled in the ole, doses could be adjusted within the range of 600 mg to 1200 mg per day. treatment in studies 303 and 304 is planned to continue until regulatory approval and commercialization of retigabine or until the program is discontinued.

Eligibility criteria:
this is meta-analysis therefore inclusion/exclusion criteria are not applicable.

Keywords: retention rate epilepsy responder rate seizure freedom discontinuation rate safety assessment reduction in seizure frequency open-label
an italian multicentric retrospective observational study to assess effectiveness and safety of the combination of tafasitamab and lenalidomide in diffuse large b-cell lymphoma patients treated under named patient program

Conditions: Diffuse Large B Cell Lymphoma (DLBCL)

Summary: the study is pilot, observational, retrospective, italian multicenter study.

the study will involve the collection of patient data from medical records of patients with r/r dlbcl treated with at least one dose of tafasitamab in association with lenalidomide as part of standard of care under the npp (d.m. 7 sep 2017), between april 2022 and december 2022, in several selected italian centres. the observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. in fact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of r/r dlbcl. 2. patientswho received at least one dose of tafasitamab in association with lenalidomide under the npp (d.m. 7 sep 2017), between april 2022 and december 2022. 3. age ≥ 18 years at enrollment. 4. signature of written informed consent (if applicable). exclusion criteria: 1) r/r dlbcl patients who received tafasitamab in association with lenalidomide in a clinical trial context.

Keywords: tafasitamab lenalidomide
a study to evaluate the safety and tolerability of azd7442 in healthy chinese adults

Conditions: Coronavirus Disease 2019 (COVID-19); Healthy Volunteer

Summary: to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), and immunogenicity of azd7442 in healthy chinese adults. vs. placebo

a phase i double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of azd7442 in healthy chinese participants 18 to 55 years of age, approximately 60 participants will be randomised in a 4:1 ratio to either azd7442 or placebo, administered by intramuscular (im) injection or intravenous (iv) infusion, and approximately 479 days in duration for each participant.

Eligibility criteria:
inclusion criteria: 1. adults 18 to 55 years of age 2. healthy by medical history, physical examination, and baseline safety laboratory tests 3. negative results of both sars-cov-2 qrt-pcr and serology tests within 14 days prior to randomisation. 4. contraceptive within 365 days post dosing exclusion criteria: 1. medical condition: * known hypersensitivity to monoclonal antibody (mab) or investigational product (ip) component. * acute illness including fever on the day prior to or day of dosing. * any other significant disease increase the risk to participant study. 2. laboratory related: * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> upper limit of normal (uln), or alkaline phosphatase (alp) or tbl (total bilirubin) \> 1.5 × uln * serum creatinine \> uln * haemoglobin \< lower limit normal (lln) * platelet count \< lln * white blood cell or neutrophil count outside normal reference ranges * other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results.

Keywords: coronavirus covid-19 azd7442 evusheld laab tixagevimab azd8895 cilgavimab azd1061
individualization of music-based cueing during gait in parkinson's disease.

Conditions: Gait Disorders, Neurologic; Parkinson Disease

Summary: spatio-temporal correction of the step is a key component of gait rehabilitation in parkinson's disease. walking rehabilitation techniques using visual or auditory cueing of the cadence or step length have been tested to prevent or correct the lack of consistency of the step. an auditory cue of the duration of the step, encouraging it to be extended according to patient own capacities during gait has been proposed. the cue is integrated into music and is presented in an open-loop approach. the present study aimed to evaluate the effect of the individual music-based cueing of the step length on gait in parkinson's disease.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * idiopathic parkinson's disease based on ukpdsbb criteria * 10-meter walking comfortable speed between 0,30 and 1,10 m/s * capacities to walk with shoes during at least 20 minutes without assistance * signature of informed consent exclusion criteria: * non-affiliation to social security * person under protection (e.g. under protection of justice) * auditory disorders without treatment * cognitive disorders that limit the understanding of the study according to the medical investigator * other neurological or orthoêdic disorders that addect walking * participating in another category 1 or 2 interventional clinical study for the duration of the trial
study investigating the safety and efficacy of hp802-247 in the treatment of venous leg ulcers

Conditions: Venous Leg Ulcers

Summary: this study is being done to find out if an investigational product called hp802-247 can help people with venous leg ulcers. investigational means that hp802-247 has not been approved by the u.s. food and drug administration (fda). this research is being done to compare the efficacy of hp802-247 plus compression therapy against vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. vehicle looks the same as hp802-247 but contains no cells.


Eligibility criteria:
inclusion criteria: * provide informed consent. * age ≥ 18 years and of either sex. * willing to comply with protocol instructions, including allowing all study assessments. * have a venous leg ulcer (vlu) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2 * venous insufficiency confirmed by duplex doppler ultrasound examination for valvular or venous incompetence. * arterial supply adequacy confirmed * target ulcer involves a full thickness skin loss, but without exposure of tendon, muscle, or bone. * target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months). * acceptable state of health and nutrition exclusion criteria: * history of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin b. * prior diagnosis of systemic lupus erythematosus with elevated anti-dna antibody titers, buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication. * therapy with another investigational agent within thirty (30) days of screening, or during the study. * a target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic). * documented history of osteomyelitis at the target wound location within 6 months preceding the screening visit. * refusal of or inability to tolerate compression therapy. * therapy of the target ulcer with autologous skin graft, apligraf™, or dermagraft™ within 30 days preceding the screening visit. * history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers). * any prior exposure to hp802-247 or its vehicle.

Keywords: venous leg ulcer ulcer venous stasis compression venous venous stasis ulcer vlu
acceptance and commitment therapy for religious ocd

Conditions: Obsessive-Compulsive Disorder (OCD)

Summary: the purpose of the study is to examine the effects and feasibility of a specific form of psychotherapy, acceptance and commitment therapy (act), on religiously oriented obsessive and compulsive disorder (ocd).


Eligibility criteria:
inclusion criteria: * 18 years old * meet cutoff scores for scrupulosity exclusion criteria: * presence of psychotic symptoms within six months of screening * current suicidal/homicidal plan/intent and/or a suicide/homicide attempt within 6 months of screening * non-suicidal self-injury within 6 months of screening * narcotics use within 3 months of screening * purging/restricting behavior within 3 months of screening.

Keywords: scrupulosity religion acceptance and commitment therapy obsessive-compulsive disorder ocd
a prospective randomized controlled trial to evaluate the effectiveness of the two different appliances in the treatment of class ii division 1 malocclusion

Conditions: Class II Division 1 Malocclusion

Summary: twin-block treatment and dynamax treatment for class ii division 1 malocclusion do not have different effects with regards to treatment duration, the quality of dento-occlusal outcome, skeletal and soft tissue profile, patient discomfort and gingival health.

the dynamax appliance is a relatively new appliance for the treatment of class ii malocclusion and was introduced in 2003. the appliance has the theoretical advantages of incremental mandibular advancement without the need for bite registration, and the ability for the operator to simultaneously provide the functional and fixed appliance phases of treatment. furthermore, the dynamax appliance is designed to limit lower both lower incisor proclination and upper incisor retroclination without an increase in lower facial height. there has been limited research into this appliance and only one trial has been carried out. in this study the effects of the dynamax were compared with the twin-block, unfortunately, the trial was not carried out to contemporary standards and suffered from severe shortcomings. for example, the non compliance rate was not accounted for in the sample size calculation, the randomisation sequence was not clear, the investigators did not carry out an intention-to-treat analysis, the statistical analysis was simplistic and the study was carried out in a single dental school setting. this raises the question about the efficiency of the dynamax appliance and whether or not they are effective in a 'real' world setting. the aim of this study is to compare the effectiveness of the dynamax appliance and the twin-block appliance for the treatment of class ii division 1 malocclusion.

Eligibility criteria:
inclusion criteria: * patients with a class ii malocclusion as defined by british standards institute classification. * overjet greater than 6mm * aged 10-14 years * clinical examination indicates a functional appliance is not contraindicated exclusion criteria: * orthognathic treatment is required or there is a strong indication it will be required in the future * possession of a craniofacial anomaly * previous orthodontic treatment and/or premolar extraction * hypodontia of more than one teeth in any quadrant excluding third molars * inadequate oral hygiene

Keywords: orthodontic treatment of class ii division 1 malocclusion
phase 1 thorough qt (tqt) study in young healthy volunteers

Conditions: Fibromyalgia

Summary: this phase 1 study will assess the effects of esreboxetine on the heart. in particular the effects on a specific electrocardiogram (ecg) measurement called qtc will be measured.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects aged 18 to 55 years * body mass index of approximately 18 to 30kg/m2 * informed consent document signed by the subject or a legally acceptable representative * subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures exclusion criteria: * evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening * conditions possibly affecting drug absorption * 12-lead ecg demonstrating qtc \> 450ms or any other clinically significant abnormalities at screen * positive urine drug screen * hypersensitivity to moxifloxacin * unwilling or unable to comply with the lifestyle guidelines in the protocol treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication

Keywords: thorough qt/qtc study
boron neutron capture therapy using cics-1 and spm-011 for malignant melanoma and angiosarcoma

Conditions: Malignant Melanoma; Angiosarcoma

Summary: among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with bnct using cics-1 and spm-011 (borofalan (10b)). through this trial, safety and appropriate treatment dose will be determined.


Eligibility criteria:
inclusion criteria: 1. patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically 2. patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less 3. patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor 4. patients with lesions in the head, neck, chest, or extremities 5. patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration exclusion criteria: 1. patients with obvious disseminated lesions 2. patients who have undergone previous treatment of radiation therapy exceeding 75 gy for the target lesion. 3. patients with active lesions / active multiple cancers in addition to the target lesion 4. patients with infections that require systemic treatment. 5. patients with active implantable medical devices 6. patients with a history of bnct treatment

Keywords: bnct boron neutron capture therapy borofalan melanoma angiosacronoma skin cancer
old school hip hop: parent follow-up & spanish speakers inclusion

Conditions: Alzheimer Disease; Dementia

Summary: these are the exploratory aims of the original trial cohort study "old school hip hop rct (aaar5473)," which recruited 783 parents. 1. continued follow-up of these families to learn more about the durability of the program through similar assessments to those used during the pre-specified 3-month initial study timeframe - aiming to understand participant knowledge and personal experiences with family members or friends affected by alzheimer's disease (ad). 2. further examining the degree of comfort with dementia, as measured by a simplified version of the dementia attitudes scale (das) focused on observable behaviors in children by their parents - aiming to understand the extent of stigmatization of dementia in communities served by this program, and if the trial impacted evidence of stigma. 3. enrolling up to 75 parents who primarily spoke spanish who were originally contacted in the rct but were not eligible for completion of the original round of surveys given that all study materials were in english. this approach aims to better understand the impact of the program and alzheimer disease on these families. hypothesis 1: for the delayed follow-up with parents, the investigator anticipates that those with high dementia literacy or the largest dementia literacy improvement would sustain knowledge over 15-month period. hypothesis 2: children who received the intervention arm of the trial, who also have regular contact with a close friend or family member with dementia, will demonstrate positive dementia attitudes relative to students in the control arm. hypothesis 3: semi-structured interviews with spanish speaking families will help program capacity to better serve the population and improve involvement in ad care and research.

the goal of the r01 study is to educate children and thereby parents/guardians on health education content through live educators, music, and videos. the study curriculum focuses on healthy aging vs dementia/alzheimer's disease (ad), nutrition, and overall health. the investigator wishes to learn if children are able to absorb these health topics and share what they learn with their parents/guardians. that part of the program has been completed with students. this non-r01 portion of the study is designed to look at the long-term effect of the program, how it may have affected spanish speaking families that were not approached during the first portion.

Eligibility criteria:
inclusion criteria: * parent that participated in the oshh trial * parent that expressed interest in participating, but originally excluded from oshh trial due to language barrier exclusion criteria: * did not have a participating child in oshh trial

Keywords: dementia schools nutrition health education