Kornimate/medical-research-clean huggingface dataset:
patient-clinic-community integration to prevent obesity among rural preschool children

Conditions: Pediatric Obesity; Preventive Medicine; Mentoring; Food Supply

Summary: the goal of this research study is to compare two enhancements to well-child visits at geisinger designed to promote family-centered counseling for the prevention of obesity in a high-risk population of rural, lower income, preschool-aged children. compared to the standard well-child visit, enhancements will offer advantages to obesity prevention, parent involvement in counseling, lifestyle behaviors, and food resource management.


Eligibility criteria:
inclusion criteria: * age (20-months to 59-months, 29-days old) * bmi-for-age and -sex \>50th percentile based on who growth standards * parent commitment to participate in 18-month study * plans to attend scheduled wcv and recommended follow-up wcv in 12 months * no plans to move or change health systems in 2 years * parent age \> 18 years * parent is english-speaking * household is considered lower-income (i.e., eligible for or receiving special supplemental nutrition program for women, infants and children \[wic\], supplemental nutrition assistance program \[snap\], temporary assistance for needy families \[tanf\], medicaid, or children's health insurance program \[chip\]) or screens positive for food insecurity. exclusion criteria: * another child in family is participating * pre-existing medical exclusions (cancer, type 1 diabetes, major developmental delays such as autism) * parents with self-reported major depression will be excluded.
hypofractionated whole-pelvis radiotherapy (wprt) vs conventionally-fractionated wprt in prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this research study is to determine if 5 (five) fractions of external radiotherapy with higher radiation doses per fraction to the pelvis leads to similar results to the standard of care external radiotherapy treatment that is comprised of 25 fractions of external radiotherapy with lower radiation doses per fraction to the pelvis. this study aims to investigate the impact in quality of life associated with hypofractionated whole pelvis radiotherapy (wprt) in comparison to conventionally-fractionated wprt in patients with unfavorable-intermediate and high-risk prostate cancers. this information is valuable as hypofractionated wprt is a more attractive and convenient treatment approach, and may become the new standard of care if proven to be well-tolerated and effective. therefore, this study aims to provide a more rational justification for use of hypofractionated wprt in future larger randomized trials by comparing this strategy with the current standard of care. this study will also provide an initial understanding of the toxicity profile and cancer control associated with hypofractionated wprt and high dose rate brachytherapy (hdr-bt).


Eligibility criteria:
inclusion criteria: * age 18 or older * study informed consent provided * pathologically proven diagnosis of prostatic adenocarcinoma * unfavorable intermediate risk \[with greater than 15% chance of node involvement based on memorial sloan kettering cancer center (mskcc) nomogram https://www.mskcc.org/nomograms/prostate\] or high or very-high-risk prostate cancer based on national comprehensive cancer network (nccn) classification \[prostatic specific antigen (psa) \> 20 ng/ml or clinical ct3a or ct3b or gleason 8-10\] * eastern cooperative oncology group (ecog) performance status 0-1 * no prior history of pelvic irradiation, brachytherapy, cryosurgery, high-intensity focused ultrasound (hifu), transurethral resection of the prostate (turp) or radical prostatectomy exclusion criteria: * presence of nodal or distant metastasis, as confirmed by magnetic resonance imaging (mri) or computerized tomography (ct) of the chest/abdomen/pelvis and bone scan within 45 days of randomization * plan for adjuvant docetaxel post-radiotherapy * serious medical comorbidities or other contraindications to hdr-bt * presence of inflammatory bowel disease * presence of connective tissue disease * medically unfit for general anesthesia * unable or unwilling to complete questionnaires

Keywords: unfavorable intermediate risk high risk
repeated injection of gnrh agonist to reduce ovarian hyperstimulation syndrome

Conditions: Infertility and at High Risk of OHSS

Summary: gonadotropin releasing hormone (gnrh) agonist is sufficient for triggering final oocyte maturation in gnrh antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (ohss) in high-risk patients. however, lower oocyte yield was reported in patients with lower luteinizing hormone (lh) level post trigger with single injection of gnrh agonist, which might be related to the shorter duration and lower amount of lh induced by gnrh agonist. our aim is to study repeated injection of gnrh agonist for preventing ohss and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in gnrh antagonist protocol.

this was a prospective cohort study of all women attending the center for reproductive medicine, department of gynecology and obstetrics, nanfang hospital, affiliated with southern medical university for in vitro fertilization and/or intracytoplasmic sperm injection . women at high risk of ohss who received ivf and/or intracytoplasmic sperm injection (icsi) treatment with a flexible gnrh antagonist protocol were recruited to participate in this study. all patients underwent standard ovarian stimulation protocol with gonadotropins, standard individualized adjustment of medication dose, and standard egg retrieval procedure. patients were triggered with a single bolus of 0.2 mg triptorelin at night and had second injection of 0.2 mg triptorelin 12 hours later when the criteria for administration of the ovulation trigger were met.

Eligibility criteria:
inclusion criteria: * patients with polycystic ovarian syndrome * patients with polycystic ovarian morphology on ultrasound * patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins exclusion criteria: * patients undergoing coasting * patients with past ovarian surgery

Keywords: ovarian hyperstimulation syndrome luteinizing hormone polycystic ovarian syndrome ovarian yield ovarian maturity
sentinel lymph node biopsy in early breast cancer: a real-world multicenter cross-sectional study (cabs001 study)

Conditions: Breast Cancer; Sentinel Lymph Node

Summary: objective: to investigate the current clinical practice of sentinel lymph node biopsy (slnb) in patients with early stage breast cancer in china. methods: the data of early breast cancer patients who underwent slnb in 40 grade iii level a hospitals in china in 2018 will be collected. different centers, tracer methods, molecular typing and neoadjuvant chemotherapy will be used as stratification factors to analyze the implementation rate, number of detections, positive rate of slnb and the follow-up treatment.


Eligibility criteria:
inclusion criteria: * breast cancer confirmed by fine needle aspiration or biopsy * slnb with or without axillary lymph node dissection * receiving conventional systematic treatment or regional treatment * complete medical record. exclusion criteria: * iv stage breast cancer * combined with secondary invasive malignant tumor * diagnosed with other serious disease, including congestive heart failure (nyha cardiac function grade ii, iii, iv) or congestive heart failure, unstable angina pectoris, myocardial infarction, high-risk uncontrollable heart rate disorder or other serious cardiovascular diseases within 6 months * difficulty breathing at rest or need oxygen therapy * severe infection * uncontrolled diabetes * serious psychological or mental disorders * poor compliance.
suturing distance from the wound edge, 2 mm vs 5 mm

Conditions: Cutaneous Sutures and Scar Cosmesis

Summary: this study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. in other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. the investigators wish to compare the effects of two versus five millimeter spacing between sutures.

sutures are the standard of care in repairing cutaneous wounds. the majority of surgical reconstructions following a mohs micrographic surgery and standard surgical excisions require two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer. the deep layer dissolves naturally whereas the top layer may necessitate removal if non-absorbable sutures are used. this study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. in other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. the investigators wish to compare the effects of two versus five millimeter spacing between sutures. it is possible that fewer, more widely spaced sutures may leave more open space in the wound, leaving more tension to pull on those few sutures, possibly encouraging the wound to dehisce and make it harder to approximate the wound edges yielding a less cosmetically appealing scar compared to placing many closely approximated sutures which would decrease the tension and likely better approximate the wound edges yielding a more cosmetically appealing scar. on the other hand, the investigators may find that suture spacing has no effect on wound cosmesis and that placing fewer, more widely spaced sutures is much more time efficient. the investigators may also find that the effect of suture spacing on wound cosmesis is dependent on wound tension. for example, perhaps the suture pacing would have no effect on the cosmesis of a wound under no tension, however, for a wound under high tension, it is possible that many closely approximated sutures would yield better cosmetic results for the reasons listed above.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * able to give informed consent themselves * patient scheduled for cutaneous surgical procedure on the trunk and extremities with predicted primary closure * willing to return for follow up visit. exclusion criteria: * mentally handicapped * unable to understand written and oral english * incarceration * under 18 years of age * pregnant women * wounds with predicted closure length less than 4 cm

Keywords: cutaneous sutures scar cosmesis linear wound closure wound cosmesis
cognitive and psychomotor stimulation in the physical and cognitive function in the functional capacity of older adults

Conditions: Mild Cognitive Impairment

Summary: the population is increasingly older and this means that there are more and more dependent older people, for this reason it is necessary to achieve the best quality of life for the older adult population by promoting active and healthy aging.


Eligibility criteria:
inclusion criteria: * have a mild dependency according to the barthel index (score greater than 60 points). * not present serious cognitive impairment, nor serious psychiatric or somatic disorders, nor disruptive and inappropriate behaviors. * be able to understand each of the self-administered questionnaires and perform the tests. exclusion criteria: * have vision problems. * be enrolled in a physical exercise program.
detection of internal tremors by oscillometry in parkinson's patient

Conditions: Parkinson Disease

Summary: the goal of the present study is to objectively access the presence of an internal tremor in parkinson's disease. inertial sensors will be used to detect the presence of a rhythmic oscillation of 3-4 hz. the study will be performed in both parkinson's disease patients and healthy controls to ascertain the specificity of this type of tremor.

the interest in finding prodromal symptoms in parkinson's disease has been growing. internal tremor, felt subjectively by the patients, have been reported in some studies as being present on the prodromal phases of the disease. an objective identification of this tremor has never been made. in this study we propose to objectively access the presence of internal tremor in parkinson's disease patients using accelerometers. a control population of healthy subjects will also be evaluated to confirm the specificity of tremor for a pd population.

Eligibility criteria:
inclusion criteria: (for the experimental group) * patient with idiopathic parkinson's disease * mini mental state evaluation score above or equal to 25 * hoehn and yahr scale score of ≤3 in the off phase, with postural stability allowing the patient to stand unaided for 1 minute. * able to walk unassisted * no major osteoarticular issues * presence of another neurological condition that may affect gait * willing to undergo accelerometry in the off state (for the control group) * healthy volunteer subjects matched for age (+/- 5 years) and sex * mini mental state evaluation score above or equal to 25 exclusion criteria: (for the experimental group) * patients with an atypical parkinsonian syndrome * patients unable to walk or stand for more than one minute in the off state * parkinson's patients treated with deep brain stimulation, apomorphine pump, or duodopa intestinal infusion, and foslevodopa * pregnant patients (for the control group) * participants with significant gait impairment (osteoarticular disorder) * those with a neurological disease that, in the investigator's judgment, may interfere with the study's outcome measure * participants with a clinical tremor that may interfere with the measurement of the primary outcome (e.g., essential tremor, thyroid disease, or tremors induced by medication) * pregnant participants

Keywords: parkinson internal tremor tremor wearable devices accelerometer parkinson&#39;s disease
study evaluating long-term safety of moa-728 in participants with opioid-induced constipation

Conditions: Constipation

Summary: this study is designed to evaluate the long-term safety and tolerability of the subcutaneous (sc) injection form of n-methylnaltrexone bromide (moa-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. the study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. participants will need to agree to self-administer sc injections, complete daily diaries, and check-in via a daily telephone call during the study.


Eligibility criteria:
inclusion criteria: * men and women 18 years or older. * a history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition. * a history of constipation due to opioid use during 1 month before the screening visit. exclusion criteria: * a diagnosis of significant gastrointestinal (gi) disorder such as bowel obstruction, fecal incontinence or rectal prolapse. * a history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit. * a history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit. * a history of chronic constipation before initiation of opioid therapy.

Keywords: treatment for opioid-induced constipation
clinical extension study for safety and efficacy evaluation of cellavita-hd administration in huntington's patients.

Conditions: Huntington Disease

Summary: cellavita-hd is a stem-cell therapy for huntington's disease. open label, single treatment, extension study for long-term safety and efficacy evaluation of cellavita-hd intravenous administration in huntington's disease patients who participated of adore-dh trial.

this extension study will include the subjects who participated the study phase ii for dose-response evaluation of cellavita-hd intravenous administration in huntington's disease patients (maximum 35 subjects). because it is a extension study, with an open scenario, the subjects will receive the maximum dose tested in the last clinical trial (adore-dh), corresponding to 6 x 10\^6 cells/weight range for each treatment cycle planned. throughout of 24 months, the subjects will receive total dose planned divided into three administrations per cycle (2 x 10\^6 cells/weight range), that each will occur every 30 days. the maintaining the effectiveness of intravenous administration of cellavita-hd product over time on clinical progression huntington's disease will be verified by comparing the uhdrs total score at the end of the 24th study month against baseline score. secondary evidences of efficacy will be evaluated by through the data of functional state, total functional capacity, functional independence, psychiatric symptoms and cognition from uhdrs scale. additionally, related data to clinical worsening, change of body mass index (bmi), risk of suicide attempt and neurological image improvement will be evaluated. safety evaluation will included the incidence and classification of the adverse events experienced by the subjects during the study.

Eligibility criteria:
inclusion criteria: 1. phase ii study participants (adore-dh) who express interest in participating in the extension period and who may have significant clinical benefits (motor, cognitive, behavioral and functional capacity) at the investigator's judged after intravenous application of the cellavita-hd product; 2. provide consent by signing in two copies of the informed consent form; 3. participant using an acceptable contraceptive method. exclusion criteria: 1. history of malignant neoplasia; 2. present any clinical and laboratory condition or comorbidity that, at the physician's judged, may endanger the health of the research participant and prevent him / her from being part of the extension study; 3. known hypersensitivity to the investigational product and / or products of bovine origin; 4. research participant who has participated in clinical trial protocols in the last twelve (12) months, unless the investigator believes that there may be direct benefit to it (resolution cns 251 of august 7, 1997, item iii, sub-item j); 5. pregnant or lactating participant; 6. in use or anticipated use of immunosuppressive drugs as well as any other drug in which the use is restricted to this research protocol.

Keywords: huntington disease stem cell therapy dental pulp stem cell
internet-based cognitive behavioral therapy: a factorial randomized controlled trial about treatment content and support

Conditions: Depression Symptoms; Anxiety Symptoms

Summary: the purpose of this study is to investigate the differences in treatment outcomes between individually tailored and transdiagnostic internet-based cognitive behavioral therapy (icbt), as well as the differences between weekly support by a specific therapist and weekly support by a team. the target group is adults (18 years or older) who experience mild to moderate depression symptoms, anxiety, stress or other psychological symptoms. the icbt, in both types of treatment contents, consists of modules that the participants will work with for eight weeks in total. participants will be recruited in sweden with nationwide recruitment.

this study is a factorial randomized controlled trial with the aim to investigate icbt with two kinds of treatment contents and two kinds of support. participants will either be randomized to an individually tailored treatment, where they will be selecting their own modules that they wish to work with, or be randomized to a transdiagnostic treatment, that consists of unified protocol that is developed by david barlow and colleagues. participants will also be randomized to either get weekly support by one specific therapist or get support by "a team", meaning that the participant will get support from different therapists each week. in both kinds of support, the participant will have the opportunity to ask for support during the other times of the week as well. primary outcome measures are depression symptoms (measured with beck depression inventory-ii) and anxiety symptoms (measured with beck anxiety inventory). other, secondary, outcome measures used will for example be about stress symptoms, insomnia symptoms, and quality of life. pre-treatment measurement, post-treatment measurement and one-year follow up is planned to be collected through an online survey.

Eligibility criteria:
inclusion criteria: * experience mild to moderate psychological symptoms or problems * 18 years or older * ability to speak, read and write in swedish * have access to the internet and a smartphone, computer or other device exclusion criteria: * severe psychiatric or somatic illness that makes participation harder or impossible * ongoing addiction * acute suicidality * other ongoing psychological treatment * recent (within the latest month) changes in the dose of psychotropic medication or planned change of dose during the treatment weeks

Keywords: internet-based cognitive behavioral therapy (icbt) internet intervention depression anxiety individually tailored transdiagnostic alliance
evaluating the relationship between inflammation, genetics, and stress in the development of high blood pressure

Conditions: Hypertension

Summary: high blood pressure affects nearly one third of all individuals in the united states. if left untreated, it can lead to stroke, heart failure, heart attack, kidney failure, or blindness. for many people, the exact cause of high blood pressure is unknown, but it is believed that both genetic and environmental factors contribute to the development of the condition. the purpose of this study is to examine the importance of genetics, inflammation, and stress on the development of high blood pressure.

high blood pressure is a complex condition that can be caused by many factors, including obesity, diet, genetics, or stress. maintaining a healthy balance of sodium in the body is important for adequate blood pressure control. some individuals experience sustained high blood pressure during periods of extended stress, combined with the inability to excrete enough sodium through urine to re-establish normal blood pressure levels. this type of stress-induced high blood pressure is related to interleukin-6 (il-6), a protein that stimulates inflammation and immune responses. to determine the interaction between stress, inflammation, and genetics, this study will examine the role of il-6 in regulating sodium levels and blood pressure in individuals undergoing stress. this information will be useful in determining new ways to evaluate risk factors for high blood pressure. this study will examine previously collected dna samples from young adults who participated in prior genetic studies. there will be no study visits for participants. il-6, il-6r, glycoprotein 130 (gp130), and c-reactive protein (crp) genes will be analyzed in all samples; changes in plasma levels of il-6 and crp in response to stress will be examined in selected samples. the parents of participants will be asked to provide cheek swabs for additional dna analysis.

Eligibility criteria:
inclusion criteria: * participated in two previous nih funded studies hl073260, hl077230 * biological parents willing to participate in the study * african american or european origins exclusion criteria: * non-biological parents

Keywords: blood pressure, high stress inflammation