Kornimate/medical-research-clean huggingface dataset:
pilot evaluation of a walking school bus program

Conditions: Obesity; Physical Activity; Pedestrian Safety; Injury Prevention

Summary: walking to school is one of the objectives for children and adolescents in healthy people 2010 and in previous studies was associated with higher levels of overall physical activity, which has been shown to decrease obesity. therefore, more children walking to school should result in increased physical activity and presumably reduce obesity. however, increasing child pedestrian activity could increase the risk of child pedestrian injuries. walking with an adult who provides instruction in pedestrian skills and monitors the child's actual behavior may be the most important component of a successful intervention. walking with an adult reduced child pedestrian injury risk by almost 70%. a walking school bus (wsb) addresses safety concerns by providing a period of physical activity supervised by several responsible adults and teaching opportunities around pedestrian safety skills on the way to and from school. children may join the wsb at various points along the set route. despite the growing popularity of wsb programs in the united states, randomized, controlled-studies are lacking that examine the impact on children's safety, physical activity, and health. we seek to help fill this gap in the literature by piloting a wsb program in elementary schools in the houston independent school district to test feasibility. we hypothesize that a wsb program will: (1) increase the number of students walking to school and decrease the number of students driven to school by car, (2) increase students' pedestrian safety behaviors (3) increase students' physical activity, and (4) decrease students' excess weight gain.


Eligibility criteria:
inclusion criteria: * 4th grade student at a study school in the houston independent school district * must be physically able to walk to and from school exclusion criteria: * any condition that would prevent the student from walking to or from school

Keywords: obesity physical activity injury prevention pedestrian safety self efficacy school walking school bus safe routes to school
evaluation of carboplatin plus gemcitabine followed by concomitant chemoradiation for non-resectable stage iii nsclc

Conditions: Non-Small-Cell-Lung Cancer

Summary: the aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is possible to obtain optimal efficacy with minimal toxicity. patients will be treated with 3 cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic progression of disease. the induction chemotherapy is then to be followed by chemo-radiotherapy.


Eligibility criteria:
inclusion criteria: * cytological or histologically proven nsclc * unresectable stage iii nsclc * presence of at least one measurable lesion (recist criteria) * adequate haematological, renal and hepatic function * adequate lung function reserve * good condition, weight loss \ 3 months exclusion criteria: * previous chemotherapy for nsclc * distant metastasis or a pleural or pericardial effusion * treatment for malignant disease in the past or serious concomitant medical or psychiatric disease * active uncontrolled infection at time of inclusion * interstitial lung disease * auto-immune systemic disease with potential involvement of the lungs * concomitant use of amiodarone

Keywords: non-small cell lung cancer nsclc chemoradiation lung cancer induction chemotherapy chemo-radiotherapy
reduction of breast enlargement using the da vinci xi robot

Conditions: Breast Hypertrophy

Summary: breast enlargement reductions are frequent interventions. one of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove. the expected result is to achieve a reduction in breast enlargement with no visible scar using da da vinci xi robot.

breast enlargement reductions are frequent interventions. one of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove. in addition, this intervention remains subject to the vagaries of hypertrophic or even keloid scarring, especially in young women. the current research project is based on the hypothesis that the same technique could be used in the context of a reduction of breast enlargement on a smaller surface allowing the determination of a perimammary "halo" of scar retraction. the project consists in removing a breast disc at the base, thus causing a sagging skin cut of 2 to 3 cm but this time, circular. the expected result is to achieve a reduction in breast enlargement with no visible scar, using da vinci xi robot.

Eligibility criteria:
inclusion criteria: * women over the age of 18 * category 1 or 2 according to the classification of regnault * breast size cup c or more * areola "looking in front", ie a distance between point a (at noon at the top of the areola) at the mid-sternal point of about 16 cm to 24 cm * ptosis (distance between the lowest part of the breast and the furrow under the breast) to a maximum of 7cm (measurement in sitting position) * expected correction of ptosis by half with reduction of 1 to 3 cup sizes * good quality thick skin * affiliated patient or beneficiary of a social security scheme * patient requesting breast reduction * patient who signed free and informed consent exclusion criteria: * areola "look down"; point a more than 25 cm * ptose greater than and equal to 8 cm * thin skin * smoker * patient on anti-coagulant * patient participating in another clinical study * protected patient: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; * pregnant, lactating woman

Keywords: breast reduction perimammary
aesthetic analysis of gluteal deformity after weight loss and assessment the role of autologous tissue augmentation for gluteal contouring

Conditions: Body Contouring

Summary: this study aim to evaluate the role of autologous augmentation for buttock contouring and analyze different aethetic gluteal deformity

the last decades showed an increasing demand for bariatric surgery and diet dependent massive weight loss , these successful strategies for weight loss result in significant deformities in general body contour , buttock normal appearance is very important for posterior trunk aesthetic image and its severely affected after massive weight loss . aesthetically attractive buttocks required special features include adequate volume, projection, and a defined infragluteal fold.. the gluteal region in patients with massive weight loss is characterized by excessive skin and exaggerated fat loss. lower body lift procedures remove excess skin and lift sagging buttock tissue. unsatisfactory buttock shape especially v shaped buttock is considered as important indication for gluteal reshaping mendieta and cuenca-guerra and quezada have proposed novel methods of describing and analyzing gluteal aesthetics. there are a multitude of options that can be used to improve the buttock includ-ing non-surgical injections, implants, fat, excisional, liposuction and various energy devices

Eligibility criteria:
inclusion criteria: * female patients. * patients who are seeking for gluteal contouring after massive weight loss * age above 18 years and fixed weight for 6months. exclusion criteria: * male patients * patients that will refuse the procedure, * patients who thad a residual body mass index greater than 35 * patients have uncontrolled medical conditions.
long term safety of vildagliptin (100mg qd) in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with type 2 diabetes. this extension study is open to patients who have completed core study claf237a1303.


Eligibility criteria:
inclusion criteria: * diagnosis as type 2 diabetes * patients who have completed study claf237a1303 * outpatients exclusion criteria: * patients who prematurely discontinued study claf237a1303 * other protocol-defined inclusion/exclusioncriterial may apply

Keywords: type 2 diabetes vildagliptin hba1c
the implementation of the go wish game to promote advance care planning in onco- hematologic disease

Conditions: Leukemia; Multiple Mieloma; Advanced Solid Tumors; Lymphoma; Oncology; Hematologic Diseases

Summary: this is a mixed-method, device-free and drug-free multicenter interventional study. the study aims at facilitating end-of-life conversations within the doctor-patient relationship through the use of the go wish game (gwg) and supporting patients, their caregivers and healthcare professionals to complete advance care panning documentation. the gwg helps people clarify and identify their priorities, should they be affected by a chronic, disabling and potentially non-healing illness. in fact, the gwg consists of a small deck of cards, and on each card is a concrete action or situation that may be important to a person at the end of life. the "onco-hema go wish-acp" project aims to evaluate the feasibility of a go wish game-based intervention with patients with refractory lymphoma, leukemia or multiple myeloma or advanced solid tumors with prognosis \> 3 months. in terms of secondary objectives, the study aims to. * evaluate and compare the intervention with hematology and oncology patients in terms of: - other feasibility indicators; involvement in ccp pathways; quality of communication; meaning of life; impact on hope; through a series of questionnaires administered to patients and caregivers involved in the intervention * qualitatively assess the acceptability of the intervention in terms of recruitment and delivery with patients and caregivers through semi-structured interviews and with professionals through focus groups (fgs). * to analyze the clinical records of enrolled patients in terms of: values and preferences; awareness of prognosis; end-of-life choices and shared decision-making on treatment decisions.


Eligibility criteria:
inclusion criteria: * ≥ 18 years age; diagnosed with refractory lymphomas, or leukemia or multiple myeloma or advanced solid tumors and estimated prognosis \> 3 months; * able to communicate in italian and * to give written consent to the study. exclusion criteria: * patients with severe cognitive impairment or serious psychiatric condition; * refusal to participate to the study

Keywords: advance care planning go wish game medical oncology hematology oncology palliative care experimental design study mixed methods
colorectal polyp clinical decision support device study

Conditions: Polyp; Colorectal; Colonoscopy

Summary: the study objective is to establish the efficacy of the colorectal polyp clinical decision support device (cdsd) in clinical use.

prospective, single arm, multicenter study with participating endoscopists comprising a range of clinical experience. consecutive consented patients meeting the entrance criteria will undergo standard colonoscopy with the adjunctive use of cdsd. sensitivity and specificity of cdsd-unaided and cdsd-aided predictions will be compared with the ground truth of histopathology.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * willing and able to provide informed consent * subjects undergoing colonoscopy exclusion criteria: * polyposis syndromes including familial adenomatous polyposis syndrome * inflammatory bowel disease * hereditary non polyposis colorectal cancer * severe coagulopathy * subjects scoring less than 6 on the boston bowel prep score or scoring less than 2 in any colon segment. * no diminutive polyps detected during colonoscopy

Keywords: colon polyp colorectal colonoscopy ai narrow band imaging polyp prediction artificial intelligence
trial comparing three different devices for kidney stone removal during percutaneous surgery

Conditions: Kidney Stones

Summary: the investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.

large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or pnl) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. there are a number of fda approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. each technology has advantages and disadvantages. in the last few years there have been new, improved versions of these devices introduced. these improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. these include the cyberwand (cybersonics, erie, pa), a dual probe ultrasonic device, swiss lithoclast select (ems, switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by lma (gland, switzerland) called the stonebreakertm, a portable pneumatic device powered by co2 cartridges. we propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.

Eligibility criteria:
inclusion criteria: * scheduled to undergo percutaneous nephrolithotomy for at least one kidney stone measuring 2 cm or greater * stone easily visible/measurable on plain abdominal imaging (kub) or ct scan preoperatively * age 18 years or older * able to give informed consent exclusion criteria: * size of single largest stone less than 2 cm * pregnancy * active urinary tract infection * extracorporeal shockwave lithotripsy within the last three months * complex stone anticipating multiple access sites * stones that are not clearly able to be measured on kub or ct scan * inability to give informed consent * age less than 18 years

Keywords: kidney stones intracorporeal lithotriptors kidney stone removal
validation of the telematic version of the fugl-meyer scale

Conditions: Stroke

Summary: stroke is one of the most prevalent pathologies worldwide and its consequences require long-term treatment. the current situation caused by the sars-cov-2 virus has collapsed health systems and has delayed these patient's treatment. the proposed alternative is telerehabilitation: a treatment system that has already proved its effectiveness. however, the difficulty to assess the stroke patient's functional status is the great problem. for this reason, a fugl meyer assessment scale adaptation, one of the most widely used (in research and in clinic), is proposed to be carried out remotely. the objective of our study is to validate this scale in stroke patients.


Eligibility criteria:
inclusion criteria: * being older than 18-years-old * diagnosis of stroke exclusion criteria: * another neurological or orthopedic problem different than stroke that will affect functionality and balance

Keywords: stroke validation study patient outcome assessment
a phase i/ii study of the safety, tolerance, and pharmacokinetics of 9-(2-phosphonylmethoxyethyl)adenine ( pmea; adefovir ) in patients with advanced hiv disease.

Conditions: HIV Infections

Summary: to study the safety, tolerance, pharmacokinetics, and anti-hiv effects of pmea ( adefovir ) when administered daily by intravenous (iv) and/or subcutaneous (sc) injection in patients with advanced hiv disease.

patients receive a single iv or sc dose of pmea daily for 4 weeks. a maximum tolerated dose will be defined for these regimens.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * other antiretroviral therapy if on a stable dose for at least 4 weeks prior to study entry. * prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (bactrim, septra) or dapsone, and fluconazole or ketoconazole if on a stable prophylactic regimen for at least 4 weeks prior to study entry. patients must have: * hiv seropositivity. * elevated p24 antigen (\> 40 pg/ml). * mean cd4 count \<= 100 cells/mm3. * life expectancy of at least 3 months. prior medication: allowed: * other prior antiretroviral therapy. * prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (bactrim, septra) or dapsone, and fluconazole or ketoconazole. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * inadequate venous access. * active serious infection (other than hiv infection) requiring parenteral antibiotic therapy. * clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. * psychiatric disturbance or illness that may affect compliance. * malignancy other than kaposi's sarcoma. concurrent medication: excluded: * investigational agents other than stavudine (d4t). * interferon-alpha. * ganciclovir. * foscarnet. * diuretics. * amphotericin b. * aminoglycoside antibiotics. * other nephrotoxic agents. * acyclovir at doses \>= 2 g/day. prior medication: excluded within 2 weeks prior to study entry: * investigational agents other than stavudine (d4t). * interferon-alpha. * ganciclovir. * foscarnet. * diuretics. * amphotericin b. * aminoglycoside antibiotics. * other nephrotoxic agents. excluded within 4 weeks prior to study entry: * systemic therapy for kaposi's sarcoma. substance abuse.

Keywords: acquired immunodeficiency syndrome antiviral agents adenine
a randomized controlled trial of treatment of bacterial vaginosis

Conditions: Bacterial Vaginoses

Summary: this is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant women who are diagnosed with bacterial vaginosis (bv) in the late 3rd trimester (\>34 weeks). during routine clinic visit after 34 weeks, prospective patients will be counseled about the study. patients who agree to be enrolled, will sign informed consent. following enrollment, patients will be screened for bv. those patients who are bv positive by clinical diagnosis, will be randomized to receive either metronidazole 500 mg bid orally for 7 days or identically appearing placebo.


Eligibility criteria:
inclusion criteria: * pregnant women 18 to ≤50 years with the ability to give informed consent. * patients expected to have a vaginal delivery with no obstetric contraindication for vaginal delivery at time of screening. * diagnosed with bacterial bv per amsel criteria at time of screening in clinic. * gestational age ≥ 35 weeks exclusion criteria: * plan for elective cesarean delivery * allergy or contraindications to metronidazole * receipt of metronidazole or clindamycin on admission for delivery for other indications. * hemodialysis * severe liver dysfunction * patient reports bv to nurse or clinician provider at current clinic visit or has been treated for bv within the past 3 months.

Keywords: bacterial vaginoses cesarean delivery surgical site infection endometritis infection vaginitis
esketamine combined with dexmedetomidine sedation in head mri examination of children with autism spectrum disorder

Conditions: Autism Spectrum Disorder; Dexmedetomidine; Esketamine; Sedation

Summary: objective: to investigate the use of ketamine combined with dexmedetomidine for sedation in children with autism spectrum disorder, methods:aged 2-6 years,, asa grade i or ii. the children were randomly divided into three groups using a random number table method: a low-dose dexmedetomidine group (dexl group,n=100）the high-dose group of dexmedetomidine (dexh group,n=100) and the group of esketamine combined with dexmedetomidine (dexe group,n=100). the dexl group received 2.5 μ g/kg of dexmedetomidine nasal drops, the dexh group received 3 μ g/kg of dexmedetomidine nasal drops, and the dexe group received 2 μ g/kg of dexmedetomidine nasal drops plus 0.5 mg/kg of ketamine nasal drops. record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. record the vital signs of three groups of patients during the examination process, including before sedation (t0), after successful sedation (t1), after the end of the examination (t2), and upon awakening (t3).

autism spectrum disorder (asd), also known as autism spectrum disorder (asd), is a condition in which approximately 60% to 70% of autistic children have intellectual disabilities that significantly affect their ability to take care of themselves and bring immense pressure to society and families. autistic children often have neurological disorders, and therefore require head magnetic resonance imaging (mri) examinations. mri examinations can detect abnormal changes in brain structure and function, providing more objective evidence for early diagnosis and valuable treatment time for autistic patients. however, mri examinations require children to maintain a calm and quiet state, minimizing physical activity as much as possible. due to the specific interests and behaviors of autistic children, as well as their refusal to accept environmental changes, completing mri examinations often requires sedation or anesthesia. the main drugs currently used for sedation in pediatric outpatient examinations include dexmedetomidine, midazolam, ketamine, etc. this study aims to select children with asd who are scheduled to undergo head mri in outpatient settings, and explore the safety and efficacy of intranasal administration of ketamine combined with dexmedetomidine for sedation, providing reference methods and evidence for sedation in children with autism spectrum disorder.

Eligibility criteria:
inclusion criteria: clinical diagnosis of autism spectrum disorder aged 2-6 years, asa grade i or ii exclusion criteria: upper respiratory tract infections, severe respiratory system related diseases congenital heart disease liver and kidney dysfunction. contraindications for ketamine and dexmedetomidine, expected difficult airways. anesthetic or sedative drugs used in the last week.
minimizing icu neurological dysfunction with dexmedetomidine-induced sleep (mindds ii)

Conditions: Delirium

Summary: this is a pragmatic phase iii, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (iv) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.


Eligibility criteria:
inclusion criteria: * aged 60 years or older * scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass * planned postoperative admission to the intensive care unit (icu) exclusion criteria: * allergy or hypersensitivity to dexmedetomidine or the placebo study medication * preexisting diagnosis of alzheimer's disease or related dementia, severe cognitive impairment or delirium at baseline * severe liver failure (child-pugh score \> 5) * history of obstructive sleep apnea * severe deficit(s) due to structural or anoxic brain damage * undergoing a surgical procedure requiring total circulatory arrest * sars-cov-2 positive or symptomatic (e.g., fever, cough, loss of taste/smell) * blind, deaf, or unable to communicate in english * patients experiencing circumstances for which long-term follow-up might be difficult (e.g., homelessness, active psychotic disorder, or substance abuse) * co-enrollment in other interventional studies that, in the opinion of the site investigator and/or pi, might interfere with study participation, collection, or interpretation of the study data