Kornimate/medical-research-clean huggingface dataset:
spinal abnormalities in neurofibromatosis type 1 (nf1)

Conditions: Neurofibromatosis Type 1

Summary: the purpose of this study is to determine the incidence and clinical history of neurofibromatosis type 1-related spinal abnormalities.

neurofibromatosis type 1 (nf1) is a common genetic disorder that is associated with spinal abnormalities which are varied and may include scoliosis, neurofibromas, meningoceles, and vertebral defects. skeletal abnormalities occur in more than one third of individuals with the disorder. these abnormalities are unpredictable and the pathogenesis, natural history, and clinical outcome remain relatively unclear. the primary objective of this study is to determine the incidence and clinical history of nf1-related spinal abnormalities in children with nf1, over a 3-year period. in the study, researchers will enroll children between ages 6 and 9 years who have been diagnosed with nf1 to look at changes in the spine. participants in the study will be followed yearly for a total of 4 evaluations. evaluations may include bone scans, spinal x-rays, magnetic resonance imaging (mri), computed tomography (ct) scans, and urine samples. information gained from this study may lead to a better understanding of the causes of bone disease in nf1, and improved treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of nf1 * age greater than 6 years at time of enrollment * age less than 9 year and 1 day at time of enrollment * tanner stage not greater than 1 exclusion criteria: * prior surgical repair of spine * short-segment (4-6 vertebrae) curve with a cobb angle of 45°or more * hormone replacement therapy * chronic steroid use * tibial pseudarthrosis * other chronic medical problems known to influence bone health (i.e. diabetes mellitus, cerebral palsy, etc.)

Keywords: neurofibromatosis type 1 spinal abnormalities scoliosis
effect of different frequencies weekly training in overweight/obese women

Conditions: Sensitivity Training Groups

Summary: the aim of this study was to evaluate the effects of a resistance training programme of one or three times a week on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women

this study aimed to determine the effects of supervised structured 6 months resistance training and a restricted caloric diet on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women. 45 women were randomly assigned to one of two groups: a group with a high-weekly frequency of three times a week (high) and a group that performed only one weekly session (low).hba1c, percentage of fat mass and handgrip strength were taken before and after the intervention period.

Eligibility criteria:
inclusion criteria: overweight or obese exclusion criteria: -
safety study of an influenza vaccine against a potential pandemic strain of flu

Conditions: Influenza (Pandemic)

Summary: the purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that may protect against the subjects catching a pandemic strain of flu

pandemic influenza occurs when a strain of influenza to which the human population has not been exposed develops the ability to infect man and spread from person to person. some pandemics can have very severe health impacts and be widespread. this study will evaluate powdermed's particle mediated epidermal delivery (pmed) dna vaccine for pandemic influenza as a potential alternative to other vaccine technologies. this study represents the first study with this vaccine and will provisionally assess its safety and immunogenicity (ability to generate an immune response) at four different dose combinations. the vaccine will be given as a prime-boost regimen with vaccination on days 0 and 28

Eligibility criteria:
inclusion criteria: healthy adults volunteers (women must be of nonchild-bearing potential) provided written informed consent - exclusion criteria: no significant concomitant illness no allergy to gold no immunosuppression due to disease or treatment

Keywords: dna vaccine, influenza, immunogenicity, tolerability, pmed, pandemic
mrd in high-risk ebc

Conditions: Breast Cancer

Summary: this study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of mrd of molecular residual lesions on recurrence events and drug efficacy will be evaluated through dynamic monitoring, so as to further accurately stratify the risk and guide clinical intervention.


Eligibility criteria:
inclusion criteria: * informed consent signed * age ≥18 years old * undergoing breast surgery, the surgical specimen was diagnosed as invasive breast cancer by the central laboratory and met any of the following conditions: 1. hormone receptor-positive/her2-negative breast cancer, the number of lymph node metastases ≥ 4; 2. her2-positive breast cancer, lymph node metastasis≥4; 3. triple negative breast cancer, the number of lymph node metastases ≥ 1; * ecog 0-1 * willing to cooperate in clinical research-related treatment and follow-up, with good patient compliance exclusion criteria: * confirmed distant metastases site * history of other malignancy * psychopaths or other reasons unable to comply with treatment * concomitant uncontrolled lung disease, severe liver and kidney disease, severe infection, active peptic ulcer requiring treatment, coagulation disorders, connective tissue disease, or bone marrow suppression, and cannot tolerate chemotherapy and other related treatments * hiv carrier or hbc/hcv infected * current or recent (within 30 days prior to enrollment) use of participation in another investigational program or use of another investigational drug

Keywords: mrd breast cancer adjuvant therapy
moving mindfully for freezing of gait

Conditions: Parkinson Disease; Mindfulness

Summary: the investigators will conduct an randomized controlled trial (rct) among people with parkinson disease (pd) and freezing of gait (fog) to evaluate the feasibility of a mindfulness intervention compared to a educational program about fog. fog is a severe motor disturbance that prevents people from stepping normally and is associated with anxiety, frustration, sedentary behaviors, poorer quality of life, and falls. mindfulness-based stress reduction (mbsr) is an evidence-based practice that creates a culture to reduce stress and anxiety by increasing conscious awareness and self-compassion. in this study, the investigators will develop a mindfulness-based walking intervention to address both mental health and mobility challenges that constitute fog.

conduct pilot randomized clinical trial to evaluate feasibility and acceptability of the standardized mindfulness based walking therapy (mbwt) program. using the standardized mbwt protocol devised during earlier aims of this study, the investigators will randomize 24 people with pd+fog to mbwt or fog education (i.e., usual care and fog education), examining feasibility elements.

Eligibility criteria:
inclusion criteria: * diagnosed by a neurologist with idiopathic parkinson disease; * age 50 and older; * a score on the hoehn \& yahr (h\&y) scale between i-iv; * history of freezing of gait; * able to provide informed consent; * experience fear or worry in relation to their freezing of gait; * able to walk independently with or without an assistive device for at least five minutes; and * stable medication regimen for one month prior to enrollment. exclusion criteria: * have evidence of dementia (montreal cognitive assessment (moca) - telephone version \< 13) to ensure understanding of materials; * are under consideration for deep brain stimulation surgery within the next six months; neurologic condition other than pd; * inability to cooperate with the protocol; * language, visual, or hearing barriers to participation; or * history of orthopedic or other medical problems that limit ability to participate safely in the intervention.
movement disorders in multiple sclerosis patients

Conditions: Multiple Sclerosis; Movement Disorders

Summary: the aim of this study is to determine the prevalence of movement disorders in ms patients. also,to know the clinical type of movement disorders occurring with multiple sclerosis patients and the mri finding of those patients. moreover, to find the correlation between the movement disorder and the different types of ms.

a randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to mcdonald criteria of ms 2017 (thompson et al. 2018). the investigators will study the prevalence of movement disorders in m.s patients, clinical type of movement disorder and the mri findings. data collected from patients admitted or following at al-azhar university hospitals at al-hussein and el-sayed galal hospitals. the included eligible patients should fulfil the following inclusion criteria: i. full clinical history and neurological assessment. ii. detailed multiple sclerosis history according to ms unit history sheet. iii. detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not). iv. mri brain and spine of the included patient will be photographed. exclusion criteria: 1. patients with multiple sclerosis mimics which can cause movement disorders e.g., systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic failure, renal failure, hyperthyroidism, electrolyte disturbances, behcet's disease or cns infection. 2. patients with primary movement disorders or related to other neurodegenerative diseases.

Eligibility criteria:
inclusion criteria: - we will study the prevalence of movement disorders in m.s patients, clinical type of movement disorder and the mri findings. data collected from patients admitted or following at al-azhar university hospitals at al-hussein and el-sayed galal hospitals. the included eligible patients should fulfil the following inclusion criteria: i. full clinical history and neurological assessment. ii. detailed multiple sclerosis history according to ms unit history sheet. iii. detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not). iv. mri brain and spine of the included patient will be photographed. exclusion criteria: - 1-patients with multiple sclerosis mimics which can cause movement disorders e.g., systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic failure, renal failure, hyperthyroidism, electrolyte disturbances, behcet's disease or cns infection. 2-patients with primary movement disorders or related to other neurodegenerative diseases.

Keywords: multiple sclerosis movement disorders
effects of action observation therapy and mirror therapy in children with unilateral cerebral palsy

Conditions: Cerebral Palsy; Functioning; Upper Extremity Problem

Summary: the aim of this study was to examine the effects of action observation therapy and mirror therapy on upper extremity functions in children with unilateral cerebral palsy. in the study, the 1st group is the action observation therapy group and will receive 18 sessions of practice. the second group is the mirror therapy group and will receive a total of 18 practice sessions. to evaluate the outcome measures of children's upper extremity functions; canadian occupational performance mesure (copm), goal achievement scale (gas), shriners hospital upper extremity function scale (shuee), melbourne unilateral upper extremity function evaluation test and abilhand questionnaire will be used. the satisfaction of the families with the therapy process will be evaluated with the visual analog scale (vas).

the aim of this study was to examine the effects of action observation therapy and mirror therapy on upper extremity functions in children with unilateral cerebral palsy. in the study, the 1st group is the action observation therapy group and will receive 18 sessions of practice. the second group is the mirror therapy group and will receive a total of 18 practice sessions. to evaluate the outcome measures of children's upper extremity functions; canadian occupational performance mesure (copm), goal achievement scale (gas), shriners hospital upper extremity function scale (shuee), melbourne unilateral upper extremity function evaluation test and abilhand questionnaire will be used. the satisfaction of the families with the therapy process will be evaluated with the visual analog scale (vas).

Eligibility criteria:
inclusion criteria: * being between the ages of 5 and 15 * being diagnosed with unilateral cerebral palsy * be in one of the levels 1,2 and 3 according to the macs dexterity classification * upper extremity modified ashworth scale score less than or equal to 2 attending primary school exclusion criteria: * having a visual impairment recorded in the health report * to have any neurological, orthopedic, and psychiatric diagnosis in addition to the diagnosis of cerebral palsy * difficulty understanding and applying verbal and visual commands * to have undergone any surgical intervention or botox in the last 3 months
high intensity interval training in endometrial cancer

Conditions: Endometrial Cancer

Summary: this interventional trial recruits women with endometrial cancer to participate in high intensity interval training (hiit) prior to their standard of care surgery. the study will evaluate tissue and blood to determine if hiit training has anti-cancer effects. p

primary objectives: 1. determine the anti-proliferative effect of hiit on the endometrium of women with endometrial cancer 2. participants will undergo baseline testing, be taught how to perform personalized hiit training prior to surgery, and repeat testing after surgery. tissue specimens will be collected from standard of care biopsy (no extra biopsy needed) and during surgery. blood will be collected twice during standard of care blood draws.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of endometrial cancer who are to undergo hysterectomy and staging * between 40-75 years old * body mass index of 30-50 kg/m2 * endometrioid histology endometrial cancer * presumed clinically early stage disease (disease confined to uterus only) * have access to a smart phone * have access to email * agree to visit the exercise and sport science laboratory within 2 days of soc visit for baseline testing if enrollment procedures cannot be done on the same day. agree to visit clinic 2 (+/-2wks) weeks after surgery for soc follow-up and post surgery visit, or willing to return to exercise and sport science laboratory 2 (+/-2wks) weeks post-surgery exclusion criteria: * meets american college of sports medicine guidelines for physical activity (150 minutes / week) * currently doing hiit * hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months * active diagnosis of psychosis or current uncontrolled substance abuse disorder * insulin-dependent diabetes * currently in another ec intervention * severe dementia or other memory loss condition * severe mental health disorder * severely impaired hearing or speech * inability to speak english * musculoskeletal or neuromuscular condition that limits physical activity any condition, in the opinion of the investigators, which would prohibit safe participation.
development and validity of the dynachron questionnaire for chronic nasal dysfunction

Conditions: Rhinitis; Nasal Polyps

Summary: nasal symptoms are the main elements that lead to a therapeutic decision and allow for evaluating treatment effects or natural evolution. despite availability of several questionnaires with good measurement qualities, no systematic assessment takes into account the specific physical and psychosocial consequences of each of the six main nasal symptoms, independently of the disease. the study proposed to measure these symptoms with the use of a selfreport questionnaire and to test the validity of the questionnaire in a large representative sample of patients attending outpatient rhinologic clinics.

the study was conducted in two parts: (1) expert-based development and testing of the face validity of a questionnaire in french; and (2) validity testing, including construct validity by factor analysis, reproducibility by intraclass correlation coefficient (icc) and bland and altman plots, and sensitivity to change by standardized response means, on a large sample of patients in a prospective multicenter study. dynachron, a questionnaire with 78 items divided into six domains and exploring both the physical and psychosocial repercussions of cnd, was developed. in total, 759 patients completed the questionnaire at a first visit to a clinic, and 539 again 19.5 days later, on average.

Eligibility criteria:
inclusion criteria:patients had to * be older than 18 years * have nasal or sinus dysfunction for more than 3 months * be able to understand and read thefrench language. exclusion criteria: * nasal or sinus tumor or rendu-osler disease, * patients were under immediate post-operative care

Keywords: chronic nasal dysfunction quality of life measurement self-reporting questionnaire development validation
evaluation of fractional co2 laser treatment efficacy and comparison to vaginal estrogen therapy in postmenopausal women with vulvovaginal atrophy

Conditions: Vulvovaginal Atrophy

Summary: forty-five women will be included in a double-blind randomized trial in order to compare fractional co2 laser treatment, local estrogen therapy and the combination of both treatments for vulvovaginal atrophy (vva) and determine the efficacy and possible adverse effects co2 laser treatment.

vulvovaginal atrophy (vva) symptoms are strongly associated with declining ovarian function and estrogen levels in postmenopausal women, having a considerable impact on women's life quality. topical hormonal therapy and hormonal replacement are widely used to alleviate vva symptoms. in this context, minimal invasive fractional co2 laser emerges as an alternative non-hormonal therapy, especially in patients that present contraindications to hormonal therapy. objective: compare fractional co2 laser treatment, local estrogen therapy and the combination of both treatments for vva and determine the efficacy and possible adverse effects co2 laser treatment. materials and methods: forty-five postmenopausal women will be randomized in three double-blinded groups of treatment consisting of co2 laser and placebo of estrogen vaginal cream, placebo of co2 laser and estrogen vaginal cream and co2 laser and estrogen vaginal cream. assessment of baseline characteristics and follow-up will be obtained through self-completion questionnaires (female sex function index, international consultation on incontinence questionnaire-short form (iciq-sf), vulvovaginal symptom questionnaire and the menopause-specific quality of life (menqol)). frost index and vaginal health index (vhi) are part of objective clinical and histologic analyses. colposcopy, vaginal cytology and middle third lateral vaginal wall biopsy will also be performed at baseline and at week 17.

Eligibility criteria:
inclusion criteria: * 45-65 women with amenorrhea for over 24 months. * clinical vaginal atrophy diagnosis. exclusion criteria: * bmi \> 35. * previous use of oral estrogen therapy in the last 6 months. * history or current diagnosis of cancer. * altered cervical smear in the last 12 months. * renal or hepatic insufficiency. * drug-induced menopause. * previous use of steroids. * previous vaginal radiotherapy therapy. * vulvovaginitis.

Keywords: vulvovaginal atrophy menopause fractional co2 laser estrogen cream
neurobehavioral measurement of substance users in outpatient treatment setting

Conditions: Cocaine Dependence; Cocaine Use Disorder; Opiate Dependence; Opioid-use Disorder; Cannabis Dependence

Summary: this study was an internal program effectiveness evaluation of the effects of a four-session weekly individualized cognitive therapy program (called the "mind freedom plan" (mfp)) on substance use outcomes and substance abuse treatment retention in veterans admitted to an intensive outpatient treatment program for substance abuse at the richmond veterans administration medical center (ricvamc). substance use and treatment retention metrics of mfp-assigned veterans were compared with those of veterans assigned to typical case-management-oriented weekly individual sessions.

this study was funded and launched as an internal program evaluation regarding the effects of a four-session weekly individualized cognitive therapy program called the "mind freedom plan" (mfp) on substance use outcomes, impulsivity, and substance abuse treatment retention in veterans admitted to the intensive outpatient (treatment) program (iop) for substance abuse at the richmond virginia hunter holmes mcguire veterans administration medical center (ricvamc). substance use and treatment retention outcomes were compared between veterans randomly assigned to the mfp versus treatment as usual (tau), which consisted of typical case-management-oriented weekly individual sessions. veteran participants were approached and consented within a week of admission to the ricvamc iop and randomly assigned to either an mfp or tau practitioner. assignment was constrained by practitioner new-patient availability in order to place veterans into individualized care sessions as soon as possible. participants completed self-reported and interview-based mood, personality and addiction severity assessments at study entry. after one month, participants were reassessed with psychometric symptomatology questionnaires, and also completed a 60-minute neurobehavioral testing session in a follow-up appointment. subjects completed the delis-kaplan executive function system (dkefs) tower test of planning ability, along with a delay-discounting decision-making task, a stop-signal task, and a go-nogo behavior inhibition task that used emotional and expressionless faces as stimuli.

Eligibility criteria:
inclusion criteria: * enrollment in the substance abuse treatment program - intensive outpatient program * currently meets criteria for an alcohol or substance use disorder per sud clinic intake exclusion criteria: * unable to read and speak english * currently active-duty military * current engaged with legal involvement that is mandating the completion of the substance use program.
anidulafungin in treatment of candidemia in asian subjects

Conditions: Candidemia

Summary: the purpose of this study is to determine whether or not the investigational study drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in asian subjects.


Eligibility criteria:
inclusion criteria: * subjects with at least one positive blood test for candida pathogen from a blood sample taken within 96 hours prior to start of study treatment. * subjects with clinical evidence of candida infection within 48 hours prior to enrollment. * acute physiology and chronic health enquiry (apache) score less than or equal to 20. exclusion criteria: * prior exposure to systemic antifungals for more than 48 hours. * subjects who had, at any time, previously received anidulafungin. * subjects with poor venous (vein) access that would inhibit the administration of the intravenous study drug or withdrawing of multiple blood samples. * life expectancy \< 72 hours.