Kornimate/medical-research-clean huggingface dataset:
interdisciplinary hospital-home intervention on motor development in premature children

Conditions: Premature Birth

Summary: motor development of the premature infant often exhibits deviations that trigger functional limitations and disability. in colombia, one out of every five births corresponds to premature babies. in preterm infants requiring hospitalization, early clinical interventions focused on home care have been shown to improve motor development and decrease morbidity. however, interdisciplinary work, supported by information and communication technologies (ict), shows a knowledge gap that can be explored. this leads to the following research question: ¿what is the effect of an interdisciplinary hospital-home intervention addressing motor development adaptation in premature infants in colombia in comparison with traditional interventions? objective: to determine the effect of an interdisciplinary hospital-home intervention addressing motor development adaptation in premature infants in colombia in comparison with traditional interventions methodology experimental quantitative study with pre-test and post-test to two groups, experimental and control, which compares before and after the intervention. the intervention will be developed in two scenarios: the hospital and the home. the experimental group will receive the intervention and the control group the traditional care established in the institutions for premature children. the calculation of the sample size is 130 participants. type of results expected to be obtained it is expected to obtain a supported that justifies the importance of education from hospital stay, post discharge follow-up and parental participation in the adequate stimulation of motor development of the premature. it is expected to incorporate the use of ict in home monitoring, while implementing the use of a mobile application for this purpose. it is also expected to contribute to the research training of undergraduate and graduate students. in addition, participate in national and international presentations and in the production of scientific articles.


Eligibility criteria:
inclusion criteria: * premature infants between 34 and 37 weeks of gestation, * infants with weight over 1800gr * hemodynamic stability * interns in nicu of participants institutions (colombia and poland). * infants with residence in a places close to the institutional health care services. exclusion criteria: * premature child with a musculoskeletal deformity. * premature child with diagnosis of a genetic syndrome * premature child with congenital heart diseases. * premature child with brain injuries.

Keywords: infant child development nursing physical therapy specialty
a intra-individual comparison to investigate the efficacy and the safety of las41004 formulation in mild to moderate psoriasis

Conditions: Psoriasis

Summary: proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a las41004 formulation vs active control no formal study hypothesis, but descriptive evaluation (poc).


Eligibility criteria:
inclusion criteria (main): * mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 - 300 cm² and a tss of ≥ 6; * female volunteers of childbearing potential\* must agree to use appropriate and reliable methods of contraception * written informed consent obtained. exclusion criteria (main): * severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis, * treatment with any locally acting medications which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial; * treatment with any systemic medications which might counter or influence the trial aim or phototherapy/puva within 4 weeks preceding the treatment phase of the trial and during the trial; * treatment with vitamin a supplements; * treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months; * treatment with any immunosuppressive medication within 6 months preceding the treatment phase of the trial and during the trial; * known allergic reactions, irritations or hypersensitivity to the active ingredients * contraindications according to summary of product characteristics (smpc) of the active comparator: - pregnancy or nursing;

Keywords: psoriasis, topical
betaseron pregnancy registry

Conditions: Birth Defects; Pregnancy Complications; Multiple Sclerosis

Summary: this is a prospective, observational, registration and follow-up study of women exposed to betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. the betaseron® pregnancy registry is designed to determine whether there is an increased risk or a pattern of birth defects in the offspring of women exposed to betaseron® at conception and during pregnancy compared to rates from women in the general us population. secondarily, the registry will examine rates of spontaneous abortions and other negative pregnancy outcomes in this population. this study will be conducted in the united states (us). the betaseron® pregnancy registry is sponsored by bayer healthcare pharmaceuticals and is managed by the post approval \& strategic services group at inc research, llc. the scientific conduct and analysis of the registry will be overseen by an independent data safety monitoring board (idsmb) consisting of external specialists in teratology, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).

because informed consent is required, the registration process must be initiated by the patient. an hcp who contacts the registry may request an authorization for release of medical information packet or have the eligible patient contact the registry directly. once an eligible subject provides consent and permission to obtain information from her hcp, the registry will contact the obstetric hcp and obtain information on demographics, history of previous pregnancies, maternal risk factors, pregnancy outcome, and neonatal health. data will be collected from the maternal hcp at enrollment, during the second trimester (around week 20), and at outcome. data on live born infants will be collected from the pediatrician at 4 months of age. if a birth defect is reported, targeted follow-up may be conducted. note: this study has previously been posted by berlex, inc. which has since been renamed to bayer healthcare pharmaceuticals, inc. bayer healthcare pharmaceuticals, inc. is the sponsor of this pregnancy registry.

Eligibility criteria:
inclusion criteria: the subjects must meet the following criteria for registration: * enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test) * diagnosed with ms prior to or during the current pregnancy * exposed to betaseron® on or after the first day of the patient's last menstrual period * provide verbal consent to participate in the registry * verbally provide contact information for herself, her hcp, and the infant's hcp (as applicable)

Keywords: birth defects high risk pregnancy multiple sclerosis
a study on intima media thickness (imt) in middle-aged subjects

Conditions: Atherosclerosis

Summary: this is an observational study to measure the thickness of artery walls in the neck (intima media thickness imt) by ultrasound examination in middle-aged subjects with central obesity. the purpose of this study is to obtain local data how common asymptomatic atherosclerosis is, and to investigate the association between cardiovascular disease risk factors and intima media thickness (imt) in the hong kong population. results from this study may enhance the public awareness of asymptomatic atherosclerosis and understand its role in the development of cardiovascular disease in hong kong.


Eligibility criteria:
inclusion criteria: * male or female aged 55 years or above. * waist circumference: male more than 90 cm; female more than 80 cm. exclusion criteria: * any known chronic diseases requiring long-term medication such as hypertension, diabetes and hyperlipidemia. * presence of known cardiovascular diseases including cerebro-vascular disease, coronary heart disease and peripheral artery disease. * presence of any active major diseases that may interfere the physical conditions and body weight of subjects during the study period, which include malignancy, infection, renal or liver function impairment, recent major surgery (within 3 months).

Keywords: asymptomatic atherosclerosis intima media thickness (imt) central obesity cardiovascular disease
a study to evaluate the safety and efficacy of asc40 (denifanstat) tablets in the treatment of patients with moderate to severe acne vulgaris

Conditions: Acne

Summary: this is a multicenter, randomized, double-blind, placebo-controlled phase iii study to evaluate the efficacy and safety of asc40 (denifanstat) tablets compared to placebo in the treatment of patients with moderate to severe acne vulgaris. the proposed plan for this trial is to enroll subjects who are 18-40 years of age (including borderline values), with a diagnosis of moderate to severe acne vulgaris, and an investigator's global assessment (iga) graded as moderate (grade 3) or severe (grade 4). 480 subjects were planned to be enrolled in the trial and placebo groups, with all subjects randomly assigned in a 1:1 ratio to receive either asc40 (denifanstat) tablets dose 1 or placebo, administered orally once daily (taken after dinner) for 12 weeks. there will be a total of 6 visits for screening and follow-up. the tests required by the program included routine blood tests, blood biochemistry, lipid profile, pregnancy test and urine routine, etc..


Eligibility criteria:
inclusion criteria: * age 18-40 years (inclusive of threshold), gender is not limited. * subjects have an investigator's global assessment (iga) score of 3 or 4 (i.e., moderate or severe). * men of childbearing potential and women of childbearing potential willing to use effective contraception from the time of signing the informed consent until 3 months after the last dose of the investigational drug; women of childbearing potential include premenopausal women and women within 2 years of menopause. women of childbearing potential must have a negative pregnancy test result within ≤ 7 days prior to the first dose of the investigational drug. * subjects are willing and able to complete the study, are able to understand and comply with the study requirements, adhere to the study required restrictions and related tutorials, use the investigational drug as prescribed, and are followed up according to the study plan. exclusion criteria: * known hypersensitivity to the ingredients of asc40 (denifanstat) tablets or to any of the excipients. * presence of cystic acne at screening. * patients with secondary acne such as occupational acne (e.g., chloracne) and corticosteroid-induced secondary acne (e.g., chloracne or drug-induced acne) * patients with other significant coexisting skin conditions that may affect the evaluation of facial acne efficacy or require co-treatment, such as solardermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, eczema, etc.. * thicker facial hair, which has been assessed by researchers to impede accurate assessment of acne vulgaris grades or lesion counts

Keywords: acne asc40
evaluation of skin health and qol in pts receiving anti-pd1/pdl1/ctla4 or cdk inhibitors.

Conditions: Lung Cancer; Breast Cancer; Kidney Cancer; Bladder Cancer; Gastric Cancer; Skin Cancer; Melanoma; Head Neck Cancer

Summary: the study aim to investigate the relationship between cutaneous adverse events and quality of life in patients taking immune check point inhibitor or cyclin-dependent kinase (cdk) 4 and 6 inhibitors by two steps. in the first one, it will be investigated the relationship between the skin toxicity related to the use selected therapies and the quality of life of patients already receiving these therapies for treatment of their cancer. in the second one, it will be evaluated the relationship between skin toxicity and quality of life over three months of treatment in patients initially naïve for selected therapies. cancer included in the analysis are nsclc, renal cancer, gastric cancer, breast cancer, bladder cancer, melanoma, squamous cell carcinoma of the head and neck.


Eligibility criteria:
inclusion criteria: (for all groups) 1. age ≥ 18 years. 2. histological diagnosis of solid tumor. 3. patient able to complete the questionnaires submitted during the study. 4. signed written informed consent. (for group i) patients already under treatment for at least three months with anti-pd1/pdl1/ ctla4 or cyclin-dependent kinase (cdk) inhibitors for any type of cancer. treatment considered for each cancer are only those approved by aifa for each tumor. (for group ii) patients eligible for treatment with anti-pd1/pdl1/ ctla4 or cyclin-dependent kinase (cdk) inhibitors for any type of cancer. treatment considered for each cancer are only those approved by aifa for each tumor. exclusion criteria (for all groups): 1. age \< 18 y.o. 2. skin diseases or alterations present before the beginning of anti-pd1/pdl1 or cyclin-dependent kinase (cdk) inhibitors. 3. chronic use of steroids. 4. previous psychiatric disorders or patients taking antidepressant. 5. refusal to sign written informed consent.

Keywords: immunotherapy cyclin-dependent kinase (cdk) inhibitors cutaneous toxicity
evaluation of bone architecture and bone strength in adults with hypophosphatasia (hpp)

Conditions: Hypophosphatasia (HPP)

Summary: the study aims to evaluate the bone architecture and bone strength in adults with hypophosphatasia (hpp).


Eligibility criteria:
inclusion criteria hpp-group: * genetically verified hpp * age: ≥ 18 years * persistently low levels of alkaline phosphatase (alp) ≤ 35 u/l (normal range 35-105 u/l) * at least one of the following symptoms: a) dental manifestations; b) musculoskeletal pain; c) history of fracture(s) * submitted informed consent inclusion criteria control-group: * no alp measurements ≤ 45 u/l and ≥ 50% of all alp measurements, registered in the electronical clinical journal ≥ 55 u/l * normal parathyroid hormone (pth) and pyridoxal-5´-phosphate (plp) * vitamin d3 ≥ 25 nmol/l * submitted informed consent exclusion criteria hpp-group: * pregnancy * skin infection or severe skin affection in the measurement area of microindentation * known allergy to lidocain * former or current medical treatment influencing bone metabolism (oral corticosteroid \> 12 weeks, former or current anti-osteoporosis treatment at any time (regardless drug holiday), all kind of sex steroids (excluding oral contraception), anti-convulsants) * current malignant disorders exclusion criteria control-group: * family history of a genetic metabolic bone disease (hpp, osteogenesis imperfecta) * rickets in childhood * former or current osteoporosis * former or current osteomalacia * known diabetes * former or current medical treatment influencing bone metabolism (oral corticosteroid \> 12 weeks, former or current anti-osteoporosis treatment at any time (regardless drug holiday), all kind of sex steroids (excluding oral contraception), anti- convulsants) * skin infection or severe skin affection in the measurement area of microindentation * chronic liver or gallbladder disease * current malignant disorders * former or current thyrotoxicosis (t4 over normal range ≥ 6 months) * cushing disease * pregnancy
aquatic therapy in patients with adquired brain injury.

Conditions: Acquired Brain Injury

Summary: the aim of this study is to compare the relative effectiveness of three different treatment groups for improvements of postural control and for improvements of balance in these patients using aquatic therapy.

forty-five patients diagnosed with acquired brain injury, with over one year's evolution and independent gait over a distance of 10 meters, with our without the use of an orthopedic aid, were selected and randomized in 3 groups. dry land therapy group (dt group), which received sessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs; experimental group (eg group) , which received ai chi aquatic therapy; combined group (dt+eg group), which received alternate sessions of therapy on dry land and aquatic therapy with ai chi.

Eligibility criteria:
inclusion criteria: * a diagnosis of acquired brain injury traumatic or non-traumatic, with over one year's evolution * the ability to walk independently over a distance of more than 10 meters, with or without an orthopedic aid * scores on the mini- mental state examination \> 24 exclusion criteria: * cardiovascular and/or respiratory problems, a previous history of neurological pathologiesand the presence of coadjuvants to the acquired brain injury

Keywords: aquatic therapy; balance; acquired brain injury.
radioso milan i (radar reflector localisation-scout for carcinoma mammae, the milan ieo experience i)

Conditions: Breast Cancer; Occult Breast Carcinoma

Summary: this is a monocentric prospective observational study for patients with clinical undetectable breast lesions and indications to breast conserving surgery for histological characterization. the scout® radar occult breast lesion localization (srl) consists of an implantable reflector, a detector handpiece and a console and it uses non-radioactive micro-impulses to guide surgical excision in real time. the study describes the experience with 300 patients at the european institute of oncology. the primary endpoints of the study are the rates of successful positioning, localization and recovery of the reflector srl.

it has been estimated that 31,8% of breast cancer patients undergo pre-operational lesion localization. of them, 19% have been previously administered neoadjuvant chemotherapy (nact). based on retrospective data, nact administration is believed to steadily increase by 1,3%, each year. the ieo breast division program aims at improving the treatment and planning options available to patients referred for radio guided breast surgery. at ieo, roll remains the standard of care. from its inception 25 year ago to the present day,the investigators have gained significant expertise and now perform more than 1000 procedures per year. the investigators believe that srl (scout® radar occult breast lesion localization) could be added to the procedure of reference in the following cases, still under investigation, where it seems to present some advantages when compared to roll: 1. long-term positioning of the reflector, as in the case of patients undergoing neoadjuvant treatment 2. reflector placement in malignant lymphadenopathy prior to neoadjuvant chemotherapy 3. placement of multiple reflectors, or use of both srl and roll in patients with multifocal or multicentric neoplasia referred for conservative surgery 4. bi-rads 5 patients suspected for ductal carcinoma in situ (dcis) and eligible for conservative surgery, could undergo reflector placement after vacuum-assisted breast biopsy (vabb) and also be scheduled for monday morning surgery 5. placement of the reflector using mr-compatible introducer needles

Eligibility criteria:
inclusion criteria: * diagnosis of nonpalpable breast or lymph nodes * patients referred to ieo for breast surgery * patients between 18 and 90 years old * female patients * conservative surgery * patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study exclusion criteria: * patients known or suspected to be allergic to materials similar to those in the savi scout components (nickel) * any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion.
effects of salmeterol on walking capacity in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study was designed to test the following hypothesis: the acute changes in exercise tolerance during the endurance shuttle walk will be greater with salmeterol compared to placebo in patients with chronic obstructive pulmonary disease.

background: little is known about the responsiveness of the endurance shuttle walking test (eswt) to pharmacotherapy in patients with chronic obstructive pulmonary disease (copd). this exercise testing modality needs to be further investigated because of its relevance for activity of daily living. objective: to evaluate, in patients with copd, the responsiveness of the eswt to detect improvement in walking performance after single dose of salmeterol. methods: in a randomised, double-blind, placebo-controlled, crossover study, 20 patients with copd will perform, on two separate days, an eswt at 80% of peak capacity, 2 hours after inhaling either a placebo or 50µg of salmeterol. cardiorespiratory parameters will be monitored breath-by-breath during each walking test with a portable telemetric gas analyzer (oxycom mobile, jaeger, germany). inspiratory capacities and borg ratings for dyspnea were obtained every other minute throughout the tests. planned analysis. the main outcome will be endurance time. this variable will be compared between the two treatment arms using a paired t test. the time course of the cardiorespiratory parameters and dyspnea over time will be compared between the two exercise modalities. comparisons will be done using a repeated measure design (anova). significance level will be set at a p value of 0.05.

Eligibility criteria:
inclusion criteria: * age \> 50 years * smoking history \> 10 packs/year * fev1 \< 70% of predicted and fev1/fvc \< 70%. exclusion criteria: * respiratory exacerbation within the 2 months preceding the study * history of asthma * significant o2 desaturation (sao2 \< 85%) at rest or during exercise * presence of another pathology that could influence exercise tolerance.

Keywords: chronic obstructive pulmonary disease (copd) exercise endurance shuttle walking test bronchodilation salmeterol
improving relationships using motivational interviewing

Conditions: Physician-Patient Relations; Diabetes Mellitus, Type 2

Summary: this research aims to optimize patient-clinician relationships through motivational interviewing training in a federally qualified health center (fqhc) to improve health outcomes for african american patients with type 2 diabetes.

motivational interviewing (mi) is an evidence-based approach that has been demonstrated to increase both the patient engagement and activation necessary for effective management of chronic conditions, but is underutilized due to the inadequate training of and implementation by health professionals. this research aims to optimize patient-clinician relationships through mi training in a federally qualified health center (fqhc) to improve health outcomes for african american patients with type 2 diabetes. mi training and cuing in this study will make use of a human-artificial intelligence (ai) teaming solution, real-time assessment of dialogue in motivational interviewing (readmi), a tool that uses natural language processing to provide automatic and immediate metrics relevant for patient-clinician interaction.

Eligibility criteria:
inclusion criteria: * eligible participants are residents in family medicine and internal medicine residency programs at wright state university who will be recruited to participate in the study. exclusion criteria: * none note: patients of these participating residents will be invited to participate in the study by providing survey and health data at specified intervals, but these patients will not be the direct recipients of any intervention in this study. eligible patients will be self-identifying african american individuals ages 18 and over with a diagnosis of type 2 diabetes, and are patients of either family medicine or internal medicine residents participating in this study. the target number of patients is 200.

Keywords: motivational interviewing patient-clinician relationship artificial intelligence