Kornimate/medical-research-clean huggingface dataset:
ankle instability treatment in patients with chronic ankle instability

Conditions: Ankle Injuries

Summary: ankle joint self mobilization.

the intervention would consist in the administration of self mobilization with movement techniques in patients with chronic ankle instability in addition to an exercise program

Eligibility criteria:
inclusion criteria: * ankle range of motion limitation respect the contralateral ankle. * at least two episodes of giving way on the affected ankle. * scores of at least 24 in the cumberland ankle instability tool. exclusion criteria: * recent fractures of the involved limb. * vestibular or balance dysfunction. * acute ankle sprain.
evaluation of halitosis after treatment with photodynamic therapy

Conditions: Halitosis

Summary: halitosis is the term used to define an unpleasant odor emanating from the mouth. some lung diseases, such as bronchiectasis, are among the extra-oral causes of this condition. however, no studies have evaluated the reasons and treatment of halitosis in the population of adults with bronchiectasis. methods and analysis: a randomized, controlled trial is proposed. halitosis will be evaluated based on the measurement of volatile sulfur compounds (vsc) using gas chromatography. the participants (n=40) with halitosis and bronchiectasis will be randomized into two groups: g1-treatment with photodynamic therapy (n = 20) or g2-cleaning of the tongue with a tongue scraper (n = 20). after the treatments, a second evaluation will be performed, along with a microbiological analysis (qpcr) for the identification of the bacteria p. gingivalis and t. denticola. if the halitosis persists, the participants will receive periodontal treatment. the evaluation of halitosis and the microbiological analysis will be repeated. if the halitosis is solved, the participants will return after three months for an additional evaluation. this protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in healthy older adults and those with bronchiectasis.

a single-center, randomized, controlled, single-blind clinical trial was designed in accordance with the criteria recommended for interventional trials in the spirit statement. the project for the proposed study received approval from the human research ethics committee o fnove de julho university(certificate number: 1057901). selection of individuals - characterization of sample - two groups will be composed of adults in treatment at the dental clinic of nove de julho university. after verbal and written explanations of the study, those who agree to participate will sign a statement of informed consent approved by the human research ethics committee of nove de julho university. the study will be conducted in compliance with the precepts stipulated in the declaration of helsinki (revised in fortaleza, brazil, 2013).

Eligibility criteria:
inclusion criteria: * every age in both genders * with diagnosis of bronchiectasis (experimental group) * patients clinically stable (compensated) (control group) * have more than 10 teeth * do not have any changes in the anatomy of the back of the tongue (geographical or fissured tongue) * with positive halitosis, sh2 level \>112 ppb exclusion criteria: * smokers or ex-smokers for less than 5 years * patients diagnosed with cystic fibrosis * patients with hypersensitivity to the photosensitizer

Keywords: bronchiectasis: photodynamic therapy periodontal disease randomized controlled clinical study
efficacy and safety of bi 1356 in combination with metformin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the current study is to investigate the efficacy, safety and tolerability of bi 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control


Eligibility criteria:
inclusion criteria: 1. male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug 2. glycosylated haemoglobin (hba1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug 3. hba1c 6.5 - 10.0% at screening for patients treated with metformin alone 4. hba1c 6.5 - 10.0% at beginning of the placebo run-in phase exclusion criteria: 1. myocardial infarction, stroke or transient ischemic attack (tia) 2. impaired hepatic function 3. renal failure or renal impairment 4. treatment with rosiglitazone or pioglitazone within 6 months prior to screening 5. treatment with insulin or glucagon-like peptide 1 (glp-1) analogue/antagonists within 3 months prior to screening
study of lee011 with fulvestrant and byl719 or bkm120 in advanced breast cancer

Conditions: Breast Cancer

Summary: the purpose of this trial is to explore the clinical utility of the three investigational agents in hr+, her2- breast cancer. lee011 (cdk4/6 inhibitor), bkm120 (pi3k-pan class i-inhibitor) and byl719 (pi3k-alpha specific class i inhibitor) in combination with fulvestrant. this is a multi-center, open-label phase ib/ii study. the phase ib portion of the study is a dose escalation to estimate the mtd and/or rp2d for three regimens: lee011 with fulvestrant; lee011 and bkm120 with fulvestrant; lee011and byl719 with fulvestrant. the phase ii portion of the study was planned to be a randomized study to assess the anti-tumor activity as well as safety and tolerability of lee011 with fulvestrant to lee011 and bkm120 with fulvestrant, and lee011 and byl719 with fulvestrant in patients with er+/her2- locally advanced or metastatic breast cancer. approximately 216 adult women with er+/her2- locally advanced or metastatic breast cancer were planned to be enrolled.

on 31-may-2016 novartis's made the decision decision to not open the phase ii portion of the study, for business reasons. sufficient data had already been collected and no additional data for the triplet combinations was needed. as a result, the phase ii portion of the trial was not opened.

Eligibility criteria:
inclusion criteria: * postmenopausal, hormone receptor positive (hr+), her2 negative breast cancer * unlimited number of lines of endocrine therapy and up to two lines of cytotoxic chemotherapy in the metastatic setting (phase ib) * unlimited number of lines of endocrine therapy and one line of cytotoxic chemotherapy in the metastatic setting (phase ii) exclusion criteria: * her2-overexpression in the patient's tumor tissue * inadequate bone marrow function or evidence of end-organ damage * severe or uncontrolled medical issues * diabetes mellitus other protocol-defined inclusion/exclusion criteria may apply

Keywords: hormone receptor positive, her2 negative
efficacy of exenatide-lar and dapagliflozin in overweight/obese, insulin treated patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to see what the effects of using one or two additional diabetes drugs (dapagliflozin and exenatide-lar) are on blood sugar levels in patients who are taking insulin. this research study is being done to investigate which of these commonly-used medications, medication combinations or increasing insulin dose is better.

this is a single center prospective, randomized, placebo-controlled trial in overweight/obese patients with insulin treated uncontrolled type 2 diabetes eligible subjects willing to participate in the study will be randomized to one of 3 treatment groups: group 1: insulin titration + behavioral therapy basal insulin titration upto 12 weeks with 2 u increment every 3 days (fasting glucose goal \<110) based on self-monitored blood glucose. after 12 weeks, patients with hba1c \>8% will switch to a basal bolus regimen. group 2: exenatide-lar 2mg q week x 24 weeks + dapagliflozin placebo x 52 weeks + titrated basal insulin +behavioral therapy. group 3: exenatide-lar 2mg q week x 24 weeks plus dapagliflozin 5mg qd x 2 weeks followed by 10mg qd x22 weeks +titrated basal insulin + behavioral therapy. behavioral therapy will be delivered by registered dietitians and will include the bmiq program -a web based medical weight loss program.

Eligibility criteria:
inclusion criteria * diagnosis of type 2 diabetes * bmi ≥27kg/m\^2 * hemoglobin a1c 8-12% * english speaking * provided written consent * on a stable dose of metformin and/or glitazone and/or alpha-glucosidase inhibitors for ≥ to 8 weeks exclusion criteria: * history of type 1 diabetes * fasting c-peptide \<.8 ng/ml * egfr \<60 ml/min/1.73 m\^2 * urine albumin-to-creatinine ratio greater or equal to 300 mg/g * ast/alt greater or equal to 2.5 upper limits of normal * history of infectious liver disease (hbv, hcv) * creatine kinase greater or equal to 3 times the upper limits of normal * unstable or serious cardiovascular, renal, or hepatic disease * symptoms of severely uncontrolled diabetes * history of more than 1 episode of severe/major hypoglycemia within 6 months, active/history of bladder cancer * female patients who are pregnant or intending to become pregnant * women who are breastfeeding * personal/family history of medullary thyroid cancer or men2 * fasting triglyceride levels \> 500 mg/dl * history of confirmed pancreatitis * known hypersensitivity or allergy to exenatide or dapagliflozin * are currently enrolled in or discontinued within last 30 days from another study * have any other condition that precludes the patient from following and completing the protocol * history of diabetic ketoacidosis * anti-diabetes medication other than those listed in the inclusion criteria within 8 weeks of screening * history of previous bariatric surgery or planned bariatric surgery during the course of the study * clinically significant abnormal free t4/tsh requiring initiation or adjustment of thyroid treatment

Keywords: obesity
evaluation of rheumatoid arthritis disease education literature

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis is an inflammatory disease that results in joint inflammation, pain and swelling. it may progress to advance stages that render patients unable to carry out their daily activities. it also results in joints deformity and is a leading cause of disability globally. patient education plays an important role in the management of disease. adequate patient knowledge and awareness about disease may help in incorporating the ailment in daily life. the purpose of this study is to evaluate the benefit of a disease education literature in urdu language and with culturally relevant illustration for rheumatoid arthritis patients.


Eligibility criteria:
inclusion criteria: 1. out-patients with established diagnosis of rheumatoid arthritis over 3 months. 2. participants who are willing to participate in the study. exclusion criteria: 1. patients with no rheumatoid arthritis. 2. patients currently undergoing surgery or had previous history of surgery. 3. patients who are not willing to participate. 4. in-patients.

Keywords: patient education rheumatoid arthritis knowledge attitudes practice
effect of addition of aromatase inhibitor to ovarian stimulation therapy in ivf treatment

Conditions: Infertility

Summary: this project seeks to determine whether estradiol suppression achieved with adjuvant treatment with an aromatase inhibitor improves end-follicular and midluteal phase parameters during ivf. 128 patients will be randomized to either placebo or active treatment.

the aim of the study is to investigate whether the detrimental effects of ovarian stimulation on outcomes in fresh embryo transfer cycles be ameliorated by co-treatment with aromatase inhibitors? the research questions are: 1. can the impact of ovarian stimulation on late follicular phase sex steroid levels (and hence endometrial receptivity) be mitigated by co-treatment with aromatase inhibitors during ovarian stimulation? 2. does co-treatment with aromatase inhibitors 'normalize' the endocrinology of the midluteal phase

Eligibility criteria:
inclusion criteria * indication for ivf/icsi treatment * eligible for ivf/icsi treatment according to local criteria * regular cycles 21-35 days (both included) * age \< 40 * amh 8- 32 (both included) * written consent exclusion criteria * any contraindication for ivf/icsi treatment according to local criteria * previous stimulation for ivf/icsi with \< 4 oocytes obtained * pcos * undergoing ivf/icsi for the purpose of fertility preservation * allergy towards study drug
a retrospective study to evaluate the safety and efficacy of a nucleoside-sparing regimen of darunavir, ritonavir, and dolutegravir

Conditions: HIV-1-infection

Summary: a retrospective study to evaluate the safety and efficacy of a nucleoside-sparing regimen of darunavir, ritonavir, and dolutegravir


Eligibility criteria:
inclusion criteria: * ≥18 years old * received a regimen of darunavir 800 mg/ritonavir 100 mg in combination with dolutegravir 50 mg qd for ≥24 weeks as documented in emr * laboratory reports (cd4, viral load, srcr) available at time points +/- 4 6 weeks from 12, 24, 36, 48 weeks from start of regimen * resistance data (if applicable) exclusion criteria: * received a regimen of darunavir/ritonavir in combination with dolutegravir for \<24 weeks duration * patients receiving darunavir/ritonavir + dtg+nrti's * missing laboratory data in ≥2 study time points * patients missing more than five doses over two weeks prior study visit
prospective and retrospective breast cancer database

Conditions: Breast Cancer

Summary: in order to accelerate border crossing between basic research and clinical research in breast cancer, it is necessary to easily use clinical and biological data. that is the reason why it is very important to create a clinical, biological and pathologic beast cancer database, mainly prospective but also retrospective. all data are from patients treated in toulouse centre. the scientific community will easily have access to clinical and biological informations through a centralized, structured database , leading to optimize patients with breast cancer treatment.


Eligibility criteria:
inclusion criteria: * female patient * histologically confirmed breast cancer of any stage * affiliated to a social security system in france * who signed the informed consent exclusion criteria: * any psychiatric or medical condition that would make the patient unable to give a signed informed consent

Keywords: breast cancer database
study in pediatric subjects with epilepsy

Conditions: Epilepsy

Summary: this is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or lennos-gastaut syndrome.


Eligibility criteria:
inclusion criteria: * between 12 and 18 years of age. * diagnosis of uncontrolled partial onset seizures (with or without secondarily generalized seizures) or lennox-gastaut syndrome. * taking between one and three antiepileptic drugs. * able to swallow tablets. * females must be of : (1) non-childbearing potential or (2) child-bearing potential and agrees to use acceptable contraception. exclusion criteria: * epilepsy secondary to progressive cerebral disease, tumor or any progressive neurodegenerative disease. * history of status epilepticus in the last six months. * currently treated with felbamate or has been treated with vigabatrin within the past 6 months. * following the ketogenic diet. * suicidal intent or history of suicide attempt in the last 2 years. * elevated liver enzymes or abnormal kidney function. * current disturbance of micturition or known urinary obstructions. * history of vesicoureteric reflux. * abnormal post-void residual bladder ultrasound. * urinary retention and/or required urinary catheterization in the preceding 6 months. * abnormal urine sample at screening/.baseline. * abnormal blood sample at screening. * clinically significant arrhythmias. * abnormal ecg at screening. * bmi lower than the 10th percentile for age and gender or subject weighs less than 30kg.
evaluation of the phagetech virus bioresistor

Conditions: Bladder Cancer

Summary: to evaluate the effectiveness of the phagetech virus bioresistor to detect bladder cancer biomarkers.

this study will sample urine provided by bladder cancer patients as part of their normal routine surveillance screening. no additional effort will be required from the patients and only modest additional effort from the study staff. some de-identified patient medical information may also be requested, including concominant medications, relevant current or previous diseases, prior bladder cancer interventions and other relevant information to ensure there are no interfering substances or other confounders that could affect study results. there is no risk to patients as the normal diagnostics for bladder cancer will be followed.

Eligibility criteria:
inclusion criteria: 1. male and female patients ≥ 18 years 2. previous bladder cancer diagnosis; any stage and histological type, undergoing cystoscopy 3. patients with suspected bladder tumor undergoing surveillance cystoscopy 4. patients must provide written informed consent. exclusion criteria: 1. patients unable or unwilling to sign the informed consent 2. age \< 18 years 3. known hiv/hcv/hbv (information from clinical history).
the puri-hf (air purifiers on heart failure) trial

Conditions: Heart Failure

Summary: indoor air pollution and fine mode particulate matter with an aerodynamic diameter smaller than 2.5 micrometers (pm2.5) is a major contributor to global morbidity and mortality, particularly due to cardiovascular disease. this project aims to demonstrate the efficacy, feasibility and effectiveness of portable air filters in improving indoor pm2.5 levels and improving functional capacity of heart failure patients with reduced ejection fraction in india. the findings from the project will add to existing knowledge of innovative and scalable strategies to improve environmental and cardiovascular health worldwide. the overall objective of this study is to demonstrate the efficacy, feasibility, and effectiveness of portable air filters in improving indoor pm2.5 levels and improving functional capacity of heart failure patients with reduced ejection fraction in india.


Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age diagnosed with hf with a reduced ejection fraction of ≤ 40% within the last six months in nyha class ii-iv. exclusion criteria: * listed for a cardiac transplant * history of crt device implantation in last 3 months * on oxygen therapy * with severe pulmonary disease * participants unable to ambulate

Keywords: indoor air purifier
bone mineral density changes under two tibial components in total knee arthroplasty

Conditions: Unilateral Primary Osteoarthritis of Knee

Summary: osteoarthritis is a progressive disease afflicting to two thirds of americans. today, an estimated 43 million individuals have arthritis. by 2020, more than 59.4 million americans will be affected by the disease. despite the relative good track record of total knee replacement, it remains a biomedical device that can fail over time. a recent study looking at the current mechanisms of total knee replacement failures, listed polyethylene wear and osteolysis around implants. the material used for polyethylene insert as well as the conformity of articular surface of implants has been modified to decrease wear. while introducing modularity, the usage of metal backing in tibial base plates became obvious as it offered better stress distribution to the proximal tibial bone. however, it introduced other modes of failures. micromotion has been demonstrated between the metal backing and the tibial liner, and produced backside polyethylene wear in 44% of implants at retrieval for revision. factor influencing the surgeon's choice of implant include: reproductibility and longevity of results, technical difficulty of implantation, cost, and impact on bone stock. the modulus of elasticity of the tibial base plate has a direct effect on periprosthetic bone biology. studies have described a significant decrease in postoperative bone mineral density (bmd), adjacent to the implants, after total knee replacement. no study, to our knowledge, has looked at bmd in vivo after total knee replacement comparing different tibial base plate designs. direct effect of changes in design on overall implant survival can be studied with randomized clinical trials isolating specific variables. no randomized clinical trial has looked at tibial insert stiffness and modularity, and it effect on bone density changes, synovitis, osteolysis or survivorship. in order to isolate stiffness and modularity as study variables, one would aim at randomizing an homogenous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial insert modularity and stiffness.

number of patients: 80 ages: 55 - 75 years old sex: male and female race: all

Eligibility criteria:
inclusion criteria: * tri-compartmental knee arthrosis * 55 to 75 years of age * stable health condition exclusion criteria: * inflammatory arthritis * osteonecrosis * infection * amputation (ak or bk) * biphosphonates * metal in the proximal tibia (25cm) * history of fracture or osteotomy * ligament instability

Keywords: total knee arthroplasty trabecular metal bone mineral density
can genetic markers predict weight loss after gastric by-pass surgery

Conditions: Obesity

Summary: there is a variability in weight loss after gastric bypass surgery for obesity despite a standardised surgical procedure. this study aims to investigate if genetic markers can predict outcome after gastric by-pass surgery in treatment of obesity. the investigators will also study if adenovirus infection can influence the outcome after surgery. in a subgroup of patients, hormonal changes after gastric by-pass surgery will be assessed. lipid and protein patterns will be assessed in plasma and tissues. omental and subcutaneous fat as well as liver biopsies and whole blood are stored in a biobank. the same tissues will be collected from non-obese controls undergoing gallbladder surgery.


Eligibility criteria:
inclusion criteria: * laparoscopic gastric by-pass with bmi greater than 35 exclusion criteria: * unable to understand swedish