Kornimate/medical-research-clean huggingface dataset:
applying liquid skin barrier film to prevent skin complications around indwelling vascular catheters in pediatric patients: a randomized controlled trial

Conditions: Skin Injury; Skin Allergy

Summary: long-term indwelling vascular catheters including central venous catheters, peripherally inserted central venous catheters, arterial catheters are often essential for medical care. during the routine care, some patients may experience skin damage around the catheter insertion site due to allergic reactions to the catheter dressing material, physical damage during dressing changes, leading to infection, prolonged hospitalization, and unexpected medical costs. if the condition is mild, it may increase the number of dressing changes. in severe cases, it may require changing to a different dressing method, using medication, or even removing the indwelling catheter. this study investigates the efficacy of liquid skin barrier film in preventing skin damage around long-term indwelling vascular catheters. in this randomized controlled trial, the participants aged 0 to less than 18 years who has long-term indwelling vascular catheters inserted at national taiwan university hospital yunlin branch will be recruited. at the time of indwelling vascular catheter insertion, the subjects are randomly assigned to the control group or the experimental group. the control group received standard care according to the hospital's guidelines, using a sterile transparent dressing or gauze to cover the catheter insertion site. the experimental group first applied liquid skin barrier film to the skin, then applied a sterile transparent dressing or gauze to cover the catheter insertion site. the patients are followed for two weeks. the primary endpoint is the need for change of dressing, use of medication, or removal of the catheter due to skin damage around the catheter insertion site. the secondary endpoints are skin breakdown, number of dressing changes, and incidence of bloodstream infection. it is expected that the research results may change the standard clinical management of long-term indwelling vascular catheters.


Eligibility criteria:
inclusion criteria: * age 0-17 years (less than 18 years old) * receiving a central venous catheter, peripherally inserted central catheter, or arterial line insertion exclusion criteria: * the skin around the catheter insertion site is not inact * known allergic to liquid skin barrier film

Keywords: indwelling vascular catheters liquid skin barrier film wound dressing
postpartum pain experience and attitudes about opioid prescribing

Conditions: Postpartum Pain; Pain Management; Opioid Prescribing

Summary: this is a prospective qualitative study of obstetric clinicians examining factors which influence their approach to postpartum pain management, their perspectives and preferences of interventions aimed at reducing opioid use, and the biases which may contribute disparities in this setting.

opioid misuse has been declared a national emergency in the united states. more than half of hospitalized patients receive an opioid during their hospitalization. as birth is the most common reason for hospitalization, reproductive-aged individuals are particularly vulnerable to opioid exposure and are an important population for addressing the opioid epidemic. indeed, data have demonstrated the high frequency of postpartum inpatient and outpatient opioid use, the wide variation in postpartum pain management, the lack of alignment of opioid prescribing with patient reports of pain, and the contributions of obstetric clinicians to opioid prescribing. the opioid epidemic has a differential impact by race/ethnicity; individuals of minority race/ethnicity are less likely to receive an opioid for pain management than non-hispanic white individuals. notably, data show that, despite reporting higher levels of pain postpartum, minority race/ethnicity birthing individuals receive less opioid treatment as inpatients and are less frequently prescribed an opioid upon hospital discharge. a complete understanding and, ultimately improvement, of these experiences and reduction in disparities requires a deeper delve into influences which guide clinicians in their management of postpartum pain. this investigation aims to fill an unmet need for a systematic, in-depth, and unbiased evaluation of obstetric clinicians' experience of postpartum pain management. this is a prospective qualitative study of obstetric clinicians, examining factors which influence their approach to postpartum pain management, biases which may contribute to disparities, and their perspectives and preferences of interventions to reduce opioids and improve pain control. investigators will conduct in-depth semi-structured interviews with up to 50 obstetric clinicians, including physicians, advanced practitioners, and nurses. aim 1 will evaluate beliefs and factors which influence clinicians' management of postpartum pain, including potential clinician-level biases which may contribute to disparities. using the consolidated framework for implementation science, aim 2 will evaluate clinicians' perspectives and preferences of interventions to reducing postpartum opioid prescribing and improving pain control, in order to optimize the implementation of future interventions.

Eligibility criteria:
inclusion criteria: * practicing health care provider in obstetrics/gynecology at northwestern medicine exclusion criteria: * below the age of 18 years old
phase iii study of 5lgr to treat tic disorder

Conditions: Tic Disorder; Tourette Syndrome; Chronic Tic Disorder

Summary: the purpose of this study is to evaluate the effective and safety of 5lgr in pediatric patients with tic disorders.

5lgr is a kind of traditional chinese medicine(tcm) which under the direction of tcm theory.the aim of this study is prove the effective and safety of 5lgr in children and adolescence of tic syndrome sub-population with specific tcm syndrome differentiation, when compared with tiapride and placebo.

Eligibility criteria:
inclusion criteria: * \>1 year history of diagnosed tic disorder; * age:5-18 yrs; * ygtss score\>=30 at baseline. exclusion criteria: * diagnosed with hyperactivity disorder,epilepsy,chorea,autism,obsessive-compulsive disorder,mental retardation,athetosis,wilson's disease. * any indefinite tic disorder or tic disorders caused by medication. * participation to other studies. * patients with loose stool.

Keywords: tic disorder pediatric
dpbrn longitudinal study of repaired or replaced dental restorations

Conditions: Dental Caries

Summary: the purpose of this study is to assess the quality and expected lifespan of fillings recorded in the dpbrn "reasons for replacement and repair of dental restorations" study, and the factors affecting how long the fillings last.

the study is an observational follow-up of previously placed dental restorations (fillings)and is conducted during routing dental care visits.

Eligibility criteria:
inclusion criteria: * participant in the dpbrn "reasons for replacement or repair of dental restorations" study

Keywords: dental caries assessment dental materials
feasibility of using the gatorade sports science institute (gssi) labs app for hydration related outcomes

Conditions: Hydration

Summary: this remote study will evaluate the feasibility of using the gatorade sports science institute (gssi) labs app for remotely collecting hydration related outcomes.

the primary objective is to understand user engagement and feasibility of remotely collecting subjective and self-reported markers of hydration status as well as markers of hydration using transdermal optical imaging (toi) within the gatorade sports science institute (gssi) branded mobile application (adherence and dropout rates, and differences between demographics). the secondary objective is to understand the within subject variability of toi features before and after acute fluid ingestion during remote data collection. tertiary objectives are to compare self-reported measures of hydration status against the toi hydration model prediction before and after acute fluid ingestion during remote data collection. an outside service was contracted for recruiting. please do not contact the investigator to express interest.

Eligibility criteria:
inclusion criteria: * 18-65 years of age, inclusive * male or female. if female, subject is not pregnant, planning to get pregnant, or currently breast feeding * able to speak, write, and read english * provision of written consent to participate * owns and wears an activity tracker daily, including during sleep, except when submerged underwater (i.e., swimming, bathing) and is willing to connect their device to the app, per gssi labs app requirements (oura, whoop, apple watch, garmin, polar, withings, or fitbit). * owns a bathroom scale * able to drink 600ml (600 ml = 20 oz = 2 ½ cups) of water as directed. * willing to avoid alcohol consumption 24 hours prior to study session(s) exclusion criteria: * subject is currently enrolled in a clinical trial or has participated in a clinical trial within the past 30 days. * subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any gatorade product. if subject is unsure if a company would be considered a competitor to gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.

Keywords: transdermal optical imaging toi app user engagement
a phase 2 study to evaluate the safety, tolerability, pk and pd of elx-02 in cystic fibrosis patients with g542x allele

Conditions: Cystic Fibrosis

Summary: this is a phase 2 open-label, dose-escalation study to evaluate the safety, tolerability, pk, and pd of multiple dose levels of sc administered elx-02 with and without ivacaftor in patients with cf with at least one g542x allele. in total, up to 16 patients will be enrolled in the trial; up to 4 patients will be homozygotes for g542x, and the remaining patients will be compound heterozygotes with one g542x or phenotypically similar nonsense allele and any class 1 or class 2 mutation. each patient will receive up to 5 escalating doses as follows: * elx-02 0.3 mg/kg per day sc * elx-02 0.75 mg/kg per day sc * elx-02 1.5 mg/kg per day sc * an individualized dose of elx-02, as high as 3.0 mg/kg per day sc, based on the patients observed safety and tolerability, pk at previous doses and the results of laboratory tests. * elx-02 1.5 mg/kg per day sc plus 150 mg ivacaftor every 12 bid


Eligibility criteria:
inclusion criteria: 1. males and females age 18 years and above 2. a confirmed diagnosis of nmcf with a documented g542x mutation, homozygote, or compound heterozygote with one of the specified mutations. for heterozygotes, one mutation has to be g542x or phenotypically similar nonsense allele, and the second mutation has to be any class 1 or class 2 mutation. patients with one g542x allele or phenotypically similar nonsense allele and a second allele that is not a class 1 or class 2 mutation may be potentially allowed but only after discussion on a case by case basis with and written approval from the sponsor. 3. documented scc ≥60 meq 4. fev1 ≥40% predicted normal for age, gender and height at screening (knudson equation) 5. body mass index (bmi) of 19.0 to 30.0 kg/m2 (inclusive). patients with a lower bmi may be entered into the study at the discretion of the investigator following consultation with the sponsor. exclusion criteria: 1. participation in clinical study including administration of any investigational drug or device in the last 30 days or 5 half-lives (whichever is longer) prior to investigational product dosing in the current study 2. history of any organ transplantation 3. major surgery within 180 days (6 months) of screening 4. patients without documented prior aminoglycoside exposure who have a mitochondrial mutation that has been shown to increase sensitivity to aminoglycosides 5. known allergy to any aminoglycoside 6. patients with any abnormality at ent screening, that indicates the presence of a vestibular toxicity associated with prior exposure to aminoglycosides. 7. dizziness handicap inventory (dhi)-h score at screening must be \>16. 8. patients receiving cftr modulators within 2 months of study treatment

Keywords: cystic fibrosis elx-02 g542x allele eukaryotic ribosomal selective glycoside
the effect of environmental factors on colorectal cancer based on macrogenomes

Conditions: Colon Cancer; Rectal Cancer

Summary: the aim of this study is to investigate the effects of environmental factors, such as air pollution, on the occurrence, development and prognosis of colorectal cancer; to identify metabolic markers specific to colorectal cancer patients, which will provide a basis for early diagnosis, early intervention and individualized treatment; and to comprehensively understand the mechanism of the occurrence and development of colorectal cancer by integrating the data of environmental factors and the macro-genome, and to develop new predictive and therapeutic strategies.


Eligibility criteria:
inclusion criteria: * age ≥18 years old; * patients diagnosed with colorectal cancer by pathologic biopsy before surgery; * patients did not undergo chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment; * willing to participate in the study and sign an informed consent form. complete clinical data. exclusion criteria: * concurrent primary malignant tumor other than colorectal cancer; * patients with severe cardiopulmonary insufficiency or other systemic diseases that affect the choice of treatment plan; * inappropriate for enrollment as assessed by the investigator; * incomplete clinical data.

Keywords: colorectal cancer macrogenome environmental pollution air pollution
clinical and biochemical presentation of polycystic ovary syndrome in different age group

Conditions: Polycystic Ovary Syndrome

Summary: to study the clinical and biochemical characteristics women with polycystic ovary syndrome (pcos) in different aged groups.

polycystic ovarian syndrome (pcos) is the most frequent endocrine disorder of reproductive age women, affecting an estimated 9-18% of all women in this age group. to diagnose of pcos in early life is especially important because it is now thought to increase metabolic and cardiovascular risks. investigating pcos is crucial as it is now considered to increase metabolic and cardiovascular risk, thereby impacting the health of women to a much greater extent than previously thought. we are plan using retrospective analysis to evaluate the clinical and biochemical presentation of pcos in different aged groups.

Eligibility criteria:
inclusion criteria: * reproductive age women with sufficient data exclusion criteria: * disorders of uterus (e.g. asherman's syndrome, mullerian agenesis) and chromosomal anomalies (e.g. turner syndrome) * women who had had menarche at less than 3 years of age, day 3 fsh \> 15, or who were older than 46 * women with inadequate clinical/biochemical records * and women who had had ovarian cysts or ovarian tumors in ultrasonography examination * pregnancy women

Keywords: polycystic ovarian syndrome (pcos)
study of tolerability and efficacy of bvs857 in severe burn subjects

Conditions: Hypercatabolic Status Related to Severe Burn

Summary: study of tolerability and efficacy of bvs857 in severe burn subjects over 8 weeks and 15 weeks

no formal analysis was performed as study was terminated due to low enrollment issues. (n=1 patient was enrolled)

Eligibility criteria:
inclusion criteria: * burn injury comprising 2nd degree deep partial thickness and/or 3rd degree full thickness burns, ≥20% total body surface area with expected need for surgical intervention and not exceeding the sum of age plus burn size of 100 (baux score) * dosing must occur within 8-12 days post-burn * subjects must weigh at least 45kgs (for group 1 with doses of 0.03mg/kg) and be under 100 kg to participate in the study exclusion criteria: * spinal cord injury * hypoxic brain injury (glasgow coma scale (gcs) \<8) at screening * true conductive electric burn with suspected neurologic injury * uncontrolled diabetes with hba1c \> 10% at screening, or known history of hypoglycemia, * history of or active peripheral neuropathy or seizure disorder * systemic corticosteroids : \> 10mg/d of prednisone or equivalent, other investigational treatments (excluding investigational dressings), medications for weight loss including megestrol acetate, androgens or oral beta agonists

Keywords: burn, severe burn, lean body mass, cachexia, hypermetabolism, catabolism, wound healing
magnetic resonance imaging (mri) solely for liver stereotactic body radiation therapy (sbrt)

Conditions: Primary Liver Cancer; Metastatic Liver Cancer From Any Cancer Site

Summary: this study is a research and development initiative established to explore the use of magnetic resonance imaging (mri) as a tool for managing organ motion of the liver in cancer patients planning procedures for stereotactic body radiation therapy (sbrt).

there is a potential role to systematically implement mri to establish appropriate workflow of the implementation for tumor motion management in liver sbrt. compared to ct, mri has many significant advantages for radiotherapy planning, including superior tumor and soft-tissue contrast, flexible imaging orientation, freedom from radiation exposure and real-time imaging. mri solely based liver sbrt will allow for more precise delineation of target volume, less uncertainties in treatment planning, better motion management, and potentially better treatment outcome

Eligibility criteria:
inclusion criteria: * age ≥ 21 * patients with primary stage i, ii, iii liver cancer or metastatic tumor in the liver from any cancer site * signed, specific informed consent prior to study entry * women of child bearing potential must have a negative serum pregnancy test exclusion criteria: * any condition for which a mri procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- mri compatible surgical clips, shrapnel. * pregnant or breast-feeding women are excluded. * subjects who have difficulty lying flat on their back for extended periods of time
vertebroplasty versus conservative treatment in acute non osteoporotic vertebral fractures

Conditions: Vertebral Compression Fracture; Spinal Trauma

Summary: the purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering from acute non osteoporotic vertebral compression fracture. vertebroplasty consists in the injection of cement (pmma) in the damaged vertebral body to prevent further collapse. our study will compare vertebroplasty versus conservative therapy (brace).

the study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (vcf) type a according magerl classification

Eligibility criteria:
inclusion criteria: * 18 - 70 year old * volunteers * vertebral compression fractures magerl type a * acute trauma (less than 15 days) * between t5 and l5 * patient able to undergo both vertebroplasty and conservative treatment * consent form obtained exclusion criteria: * neural arch fracture * c1 to t4 fracture * neurologic symptoms caused by the fracture * encephalic trauma with glasgow coma scale less than 15 * ongoing cancer * routine painkillers intake * local or systemic infection * coagulation's disorder * pregnancy * involvement in an another clinical trial

Keywords: trauma vertebral compression fracture spinal acute vertebroplasty conservative treatment
autoantibody specificity and response to ivig in itp

Conditions: Immune Thrombocytopenia (ITP)

Summary: the objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to ivig treatment.

immune thrombocytopenia (itp) is a common autoimmune bleeding disorder, in which platelet surface gpiib/iiia and gpib/ix are the two most frequently targeted autoantigens. our previous studies in animal models of itp demonstrated that intravenous immunoglobulin g (ivig) could protect against anti-gpiib/iiia-mediated thrombocytopenia but failed to ameliorate itp induced by most anti-gpib/ix antibodies. the objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to ivig treatment.

Eligibility criteria:
inclusion criteria: * (1) the diagnosis of itp was based on the presence of isolated thrombocytopenia and the absence of any obvious initiating and/or underlying cause of the thrombocytopenia in accordance with the recently released international consensus guidelines,(2) a diagnosis was established during the 4 weeks prior to initiation of ivig treatment, (3) age ≥ 18 years, (4) a platelet count of ≤ 20 × 109/l, and (5) a bleeding score ≥ 9 at the time of admission according to the clinical scoring system described by khellaf et al. to assess the severity of hemorrhage. exclusion criteria: * a history of any itp-specific treatment administered prior to or concomitantly with the ivig
determinants of insulin-induced weight gain in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Weight Gain

Summary: the purpose of this study is to find determinants of insulin-induced weight gain in type 2 diabetes mellitus primary objective: to find an association between weight gain after start of insulin therapy and physical activity levels.

insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes mellitus (t2dm), but often at the expense of weight gain. insulin-induced weight gain is obviously undesirable in an already overweight population and may negatively affect blood pressure, lipid levels, inflammatory and fibrinolytic parameters, adipocytokines and also deter further optimization of insulin therapy. it is unknown what determinants predict insulin-induced weight gain in type 2 diabetes mellitus. the aim of this study therefore, is to assess determinants of insulin-induced weight gain in type 2 diabetes mellitus. in a retrospective and cross-sectional study (jansen hj et al., submitted) two extreme subgroups were identified (subjects with a weight gain above 80th percentile) and subgroup non-weight gainers (subjects with a weight gain below the 20th percentile). it was found that the gainers had less energy expenditure after initiation of insulin therapy than non-weight gainers. therefore, the primary aim of this study is to detect an association between energy expenditure and weight gain

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus * age 18-85 years * hba1c at baseline \< 12.0% * written informed consent exclusion criteria: * clinical evidence of psychiatric, renal, cardiovascular or liver or other diseases which may influence study results regarding glucose and weight * patients with hormonal disorders which may influence weight (i.e. thyroid diseases), even if properly treated with stable hormonal levels * excessive alcohol consumption (\>20 g/day), and drug abuse * use of thiazolidinedione derivatives (tzds) * pregnancy or intention to become pregnant during the study

Keywords: insulin