Kornimate/medical-research-clean huggingface dataset:
reflect scoliosis system post approval study

Conditions: Idiopathic Scoliosis

Summary: the purpose of this multi-center, prospective, single-arm registry post-approval study (pas) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the reflect™ scoliosis correction system, as a condition of hde approval

the reflect™ scoliosis correction system is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials. reflect™ uses a growth modulation technique in which growth of the patient is used to achieve progressive scoliosis correction. the reflect™ scoliosis correction system is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. patients should have failed bracing and/or are intolerant to brace wear. a total of 100 patients will be prospectively enrolled and treated at a minimum of 5 u.s. sites, with a maximum of 20 subjects at any one site, with sequential enrollment from each site. patients will be followed for 5 years with evaluations at the following timepoints: preoperative, intraoperative, immediate postoperative (first erect), 6 weeks, 6 months, 12 months, 24 months, and 60 months. primary and secondary outcomes from 100 patients enrolled and treated with reflect™ will be summarized.

Eligibility criteria:
inclusion criteria: * diagnosis of progressive idiopathic scoliosis * preoperative major cobb angle 30°-65° * preoperative flexibility to ≤30° on side bending radiograph (left or right) * skeletally immature at the time of surgery with risser sign \<5 or sanders score \<8 * osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging * failed or intolerant to bracing * signed informed consent and/or assent forms specific to this study exclusion criteria: * prior spinal surgery at the level(s) to be treated * documented poor bone quality, defined as a t-score of -1.5 or less * presence of any systemic infection, local infection, or skin compromise at the surgical site * any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions * unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and informed consent * active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study
tissue sectioning by electro-dissociation

Conditions: Thin Sections; Fresh Unfixed Tissues; Fresh Unfrozen Tissues

Summary: currently there is no technique to produce thin (0.004-0.01 mm) serial sections of large fresh tissue specimens that are suitable for high-resolution in situ protein/gene expression studies without ice artifact or fixation-induced molecular damage. traditional frozen sectioning preserves protein and nucleic acid structure, but the inherent ice artifact precludes reconstruction of protein and mrna expression patterns in 3-dimensions. since the limitations of the existing sectioning techniques result from the fact that they rely on mechanical cutting which in turn require the tissue to be stiff, we suggest a new approach to cut tissue via an electro erosion process that utilizes focus radio frequency (rf).


Eligibility criteria:
inclusion criteria: * fresh tissue * unfrozen tissue * unfixed tissue exclusion criteria: * unfresh tissue * frozen tissue * fixed tissue

Keywords: histology immunohistochemical gene expression tissue sectioning
overweight and obesity in relation to type ll diabetes melitus

Conditions: Diabetes Mellitus, Type 2; Overweight and Obesity

Summary: the aim of the study is to evaluate the efficacy of local zambian food in improving metabolic profiles of overweight/obese type ll diabetic patients in kitwe district


Eligibility criteria:
inclusion criteria: * diabetic patients attending kitwe teaching hospital * 18 years and above * body mass index of 25 and above * willing to follow the diet plan and eat food provided * not enrolled in other clinical studies exclusion criteria: * eating disorder or any psychosocial or scheduling factors that could impede study outcomes * have renal or liver problem * pregnant women * breast feeding women * hiv positive individuals
screening for colonization with resistant enterobacterales in neutropenic patients with hematologic malignancies

Conditions: Hematologic Malignancy; Leukemia, Acute; Neutropenia; Bloodstream Infection

Summary: this is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies and hematopoietic cell transplant (hct) recipients are colonized with fluoroquinolone-resistant enterobacterales (fqre) and the clinical impact of fqre colonization.

this is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies and hematopoietic cell transplant (hct) recipients are colonized with fluoroquinolone-resistant enterobacterales (fqre) and the clinical impact of fqre colonization. the investigator will collect perianal swabs from patients receiving induction chemotherapy for acute leukemia or undergoing hematopoietic stem cell transplantation (hct), and who are receiving fluoroquinolone (fq) prophylaxis. fqre colonization will be assessed by culture, and the investigator will correlate fqre colonization with the risk of gram-negative bacteremia during neutropenia. population: 410 adults with acute leukemia who are receiving induction chemotherapy and hct recipients who are receiving fq prophylaxis during neutropenia. results of this study will be combined with a portion of subject data from an identically-designed r01-funded study of fqre colonization. the combined data will be used for study analysis and reporting.

Eligibility criteria:
inclusion criteria: 1. ability to provide informed consent 2. male or female ≥18 years of age 3. receiving intensive induction chemotherapy for acute leukemia or undergoing hct 4. receive fluoroquinolone prophylaxis during neutropenia exclusion criteria: 1. expected to have \<7 days of neutropenia (absolute neutrophil count ≤500 cells/μl) after receipt of chemotherapy (a) (acute leukemia cohort only) 2. first swab collected ≥5 days after onset of chemotherapy 3. first swab collected after the day of transplant (hct cohort only) 4. acute promyelocytic leukemia 5. receiving chimeric antigen receptor (car)-t-cell therapy 6. pregnant women as determined by clinician

Keywords: fqre fluoroquinolone-resistant enterobacterales hematopoietic stem cell transplantation hct induction chemotherapy hematologic malignancy acute leukemia neutropenia bloodstream infection perianal swab gram-negative bacteremia
a study on the long-term efficacy of nebivolol after withdrawal of therapy

Conditions: Hypertension

Summary: this study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.


Eligibility criteria:
inclusion criteria: * male and female outpatients 18 to 79 years of age * females must be post-menopausal, or not pregnant and using an approved contraceptive regimen * meet criteria for stage i or ii hypertension * currently not treated, or being treated with no more than two anti-hypertensive medications exclusion criteria: * type 1 or type 2 diabetes * secondary hypertension * evidence of other concurrent disease or conditions that might interfere with the conduct of the study * treatment with any investigational study drug within 30 days of screening (visit 1) * have a history of hypersensitivity to nebivolol or other β-blockers

Keywords: nebivolol bystolic® hypertension blood pressure withdrawal
randomized clinical trial comparing rehabilitation robotic versus conventional after breast cancer surgery

Conditions: Breast Cancer

Summary: the aim of this study is to evaluate the effects of rehabilitation robotics in upper limb functionality involved in the surgical treatment of breast cancer. the study will be conducted following the delineation of randomized clinical trial. it will be assessed 108 women aged between 30 and 60 years, submitted to surgical treatment of breast cancer and axillary dissection.

breast cancer is one of the most common neoplasia types, with greater involvement in the female population, showing a high mortality rate in brazil, due to diagnosis in advanced stages. with the increased survival of women treated for breast cancer, the evaluation of the effect of therapeutic resources for the morbidities resulting from surgical treatment of breast cancer are essential. the aim of this study is to evaluate the effects of rehabilitation robotics in upper limb functionality involved in the surgical treatment of breast cancer. the study will be conducted following the delineation of randomized clinical trial. it will be assessed 108 women aged between 30 and 60 years submitted to surgical treatment of breast cancer and axillary dissection, divided between two equal groups: control group (gc) - composed of women who had undergone conventional rehabilitation and experimental group (ge) - composed of women who had undergone rehabilitation robotics. the data obtained in the study aim to improve the forms of intervention against the functional alterations resulting from surgical treatment.

Eligibility criteria:
inclusion criteria: * women submitted to quadrantectomy, simple mastectomy, radical mastectomy or modified radical mastectomy with complete axillary dissection. * women from 30 to 60 years old. * postoperatory range from 20 to 80 days. exclusion criteria: * bilateral surgery * radiotherapy treatment in progress * upper limb metastasis

Keywords: breast cancer rehabilitation robotics
avandamet versus metformin and sulphonylurea in people with poorly controlled type 2 diabetes

Conditions: Non-Insulin-Dependent Diabetes Mellitus

Summary: this study compares the effects of avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * body mass index \> or = to 25 kg/m2. * hba1c \> or =7% and \< or =10% at screening. * fpg \> or = 7.0mmol/l (126mg/dl) at visit 2. * receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a. * female subjects must be postmenopausal or using effective contraceptive measures. exclusion criteria: * use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening. * subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment. * subjects with a history of severe hypoglycaemia. * renal disease or renal dysfunction. * presence of clinically significant hepatic disease. * presence of unstable or severe angina or known nyha grade i-iv congestive heart failure. * subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.

Keywords: type 2 diabetes overweight avandamet metformin sulphonylurea
effects of discharge readiness on success following discharge from sub-acute rehab

Conditions: Discharge From Sub-acute Rehabilitation Facility

Summary: study's purpose is to determine if a patient's perception of readiness for discharge from sub-acute rehabilitation, as measured by readiness for hospital discharge scale patient self-reports form, correlates with the patient's success after discharge, measured by patient reported number of falls, emergency room visits and hospitalizations 30 days post discharge.

all sub-acute rehabilitation patients will be approached for study participation one day prior to discharge day from the facility. patients will be approached in their private room within the facility to obtain consent. consent will be reviewed with patient by investigators. patients will be asked to demonstrate understanding of the study and what consent will imply utilizing the teach back method. if patient is able to demonstrate understanding and gives consent the moca will be administered. if moca scores falls between 22-30 they will be included in study. if moca score falls below 22 they will not be included in study and that will be explained to them at that time. moca scores will be included in patient medical record. patient name and assigned id number, phone number, second contact and consent will be recorded on the confidential roster sheet and stored in a locked file cabinet located in director's office at peconic landing. the day of discharge patients will complete the rhds survey. investigators will complete the study data sheet including id number, moca score, rhds score, length of stay, discharge date, and recommended discharge therapy- home care, outpatient, none. thirty to thirty-seven days after discharge investigators will call patient and ask 3 questions from scripted form. "how many falls have you had since discharge home:, "how many visits to the emergency room have you had since your discharge home","how many admissions to the hospital have you had since your discharge home." following completion of telephone questions, confidential roster sheet and consent form will be shredded.

Eligibility criteria:
inclusion criteria: montreal cognitive assessment score 22 or greater * consent with observed teach back confirmation * discharge from sub-acute rehabilitation exclusion criteria: * montreal cognitive assessment score less than 22 * inability to "teach back" during consent process * non english speaking
the ibd-fitt study - moderate-intensity exercise for ibd patients with moderate disease activity

Conditions: Inflammatory Bowel Diseases

Summary: the investigators aim to investigate whether exercise therapy during 12 weeks including a lesson on general healthy lifestyle in adult patients with a moderately active disease is more effective, compared to control patients only receiving a lesson on general healthy lifestyle recommendations. the three main categories of outcomes are 1) health-related quality of life, 2) general health status of the patients 3) explorative outcomes. the primary outcome is health-related quality of life, the secondary outcome is general health status measured by waist circumference, disease activity scores, blood pressure, and blood lipids, and the third outcome are explorative outcomes (none-disease specific quality of life scores, biomarkers of c-reactive protein, fecal calprotectin and immunology markers including interleukins).

the investigators will apply a superior trial design in this randomized clinical trial with two arms, intervention and comparison. in both the intervention and comparison arm, the patients will receive the proper and usual medical treatment decided by their responsible physician and changes in the medical treatment is allowed at all times.

Eligibility criteria:
inclusion criteria: * patients with moderately active crohn's disease or ulcerative colitis are defined by fulfilling all the following five criteria: 1. well-characterized crohn's disease or ulcerative colitis (physician assessment) i. fulfilling standard clinical, endoscopic, radiologic, and histological criteria 2. a minimum of one-year disease duration from the time of diagnosis of crohn's disease or ulcerative colitis to inclusion into the trial 3. any of the following pharmacological treatments in a period of three months prior to inclusion: i. usage of 5-aminosalicylic acid (5-asa) ii. usage of corticosteroids iii. immunomodulators usage: azathioprine (aza), 6-mercaptopurine (6-mp), methotrexate (mtx) iv. biologics usage: anti-tnfα (infliximab, adalimumab, golimumab), ustekinumab or anti-integrin (vedolizumab) 4. disease activity defined by clinical disease score: i. harvey bradshaw index (hbi) 27 \> 5 ii. simple clinical colitis activity index (sccai) 29 \> 5 5. marker for gastrointestinal inflammation: i. fecal calprotectin (fc) \> 200 mg/g exclusion criteria: * 1. a language barrier that prohibits the exercise instructors/supervisors to give sufficient or safe instructions during the intervention or at the general health lesson. 2. known heart condition that prevents them to actively participate safely in the exercise intervention. 3. known pregnancy or planned pregnancy. 4. disabling musculoskeletal injuries that prevent them to actively participate in the exercise intervention. 5. severe disease activity manifested clinically and with the need for urgent change in treatment evaluated by the responsible physician.

Keywords: exercise
bioequivalence study for terbinafine 250 mg

Conditions: Mycoses

Summary: the objective of this study was to confirm if two formulations of terbinafine (tablets) are bioequivalent. test product was xilatril® 250 mg (laboratorios dermatológicos darier) and reference product lamisil® 250 mg (novartis). one tablet was the single dosage. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. the population was composed of 30 healthy volunteers, both genders, adults between 18-50 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: inclusion criteria: males 18-50 years. healthy based on comprehensive medical history, lab tests, chest x-ray, electrocardiogram, negative tests for hepatitis b and c, and hiv. negative urine doping test. bmi 19-26.5 kg/m2. lab test in normal range +/- 10%. blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °c. non-smoking at least for 10 hrs before study. written informed consent. - exclusion criteria: hypersensitivity to study medication or other related drug. history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition. requiring any drug interfering with minocycline pharmacokinetics. exposed to inducers or inhibitors of hepatic enzymes. intake of possible toxic drugs 30 days before study. intake of any drug 14 days or 7 half-lives before study. hospitalization or severe disease 60 days before study. receiving investigational drug out of study center 30 days before study. blood loss or blood donation =\>450 ml 60 days before study. recent history of drug abuse including alcohol. intake of xanthine containing products 10 hrs before study. intake of grapefruit juice or hot-spice 10 hrs before study. -

Keywords: mexico terbinafine mycoses pharmacokinetics
a open label study in previously studied, sbc-103 treatment naïve mps iiib subjects to investigate the safety, pharmacokinetics, and pharmacodynamics/efficacy of sbc-103 administered intravenously

Conditions: Mucopolysaccharidosis III, Type B (MPS IIIB); Sanfilippo B

Summary: this study evaluated the safety and tolerability of intravenous (iv) administration of sbc-103 in previously studied, sbc-103 treatment naïve patients with mucopolysaccharidosis iii, type b (mps iiib, sanfilippo b) who participated in the nglu-cl01 study. the nglu-cl01 study was a non-interventional study that evaluated structural brain abnormalities and blood brain barrier (bbb) integrity by magnetic resonance imaging (mri) and cerebrospinal fluid/serum albumin index.


Eligibility criteria:
participants from ngu-cl01 study were enrolled into the nglu-cl01-t study. subjects who met all of the inclusion criteria and none of the exclusion criteria were eligible to participate in this study.
journey to better health

Conditions: Weight Loss

Summary: this study is being conducted in 8 rural counties in alabama and mississippi (4 per state). approximately 400 overweight or obese african american women living in the selected counties will participate in a 2-year weight loss study.

using a cluster-randomized study design, 400 overweight or obese african american women living in 8 rural counties in alabama and mississippi associated with the deep south network for cancer control will be assigned to either a weight loss only or weight loss plus community strategies condition for 2 years. weight loss only condition: in year 1, participants will attend weekly in-person group sessions (1.5 hours each) aimed at behavioral changes for weight loss (diet and physical activity) for 6 months followed by twice a month meetings for 3 months, then monthly meetings for 3 months. in year 2, monthly phone calls will be used to encourage continued behavior change or weight maintenance. in-person group meetings will be facilitated by a trained lay staff and community health advisors. monthly phone calls will be conducted by the community health advisor. weight loss plus community strategies condition: participants will receive the same weight loss program as the weight loss only condition. in addition, a community-based organization or other non-profit group in the targeted community will receive funds and technical assistance to implement community-wide efforts to increase access to healthy affordable food and safe and convenient opportunities for physical activity (e.g., increase farmer's markets, develop walking trails). over the course of the study, participants will complete four full assessments to include measurement of height and weight (to calculate bmi), waist circumference, blood pressure, finger-stick blood draw for lipid and glucose testing, dietary recall, and questionnaires concerning participation in physical activity, self-efficacy for eating and exercise behaviors, depressive symptoms, perceived stress, social support, and demographic information (e.g., age, marital status, education, employment, household income).

Eligibility criteria:
inclusion criteria: * african american female * live or work in target county * bmi \>= 25 kg/m2 exclusion criteria: * pregnant or planning to become pregnant in the next year * known major medical or psychological condition known to influence body weight * uncontrolled hypertension (bp \> 160 mmhg systolic or \>100 mmhg diastolic) * cardiovascular event in the preceding 12 months * history of gastric bypass surgery * history of psychiatric hospitalization in past 2 years * history of substance abuse or eating disorder * any other condition by which a medical professional has suggested diet modification * physical activity and/or weight reduction would be contraindicated