Kornimate/medical-research-clean huggingface dataset:
motivational interviewing for hcv elimination

Conditions: Hepatitis C

Summary: this study addresses a difficult barrier to hepatitis c elimination, specifically development and maintenance of a productive relationship between the health care provider and patient to ensure both treatment success and engagement in harm reduction services. improvements in these domains may be observed through the use of a technique called "motivational interviewing" (mi). the aim of this study is to determine whether a customized motivational interviewing curriculum by general primary care and addictions medicine primary care providers changes rates of curative hepatitis c therapy completion.


Eligibility criteria:
patient inclusion criteria: * willingness to participate and provide informed consent * positive hcv rna result * ≥18 years of age patient exclusion criteria: * unwilling or unable to provide consent health care provider inclusion criteria: * willingness to participate and provide informed consent * has a hepatitis c care experience health care provider exclusion criteria: * unwilling or unable to provide consent

Keywords: motivational interviewing healthcare delivery
assessment of an exhaled breath test to detect bronchiectasis

Conditions: Bronchiectasis

Summary: to investigate whether the breath test is able to detect bronchiectasis using breathomics. this study was conducted with a prospective specimen collection, evaluator-blinded, case-controlled clinical study designed to evaluate the accuracy of breathomics to diagnosis of bronchiectasis in adults.

bronchiectasis is a chronic airway inflammation with irreversible expansion of bronchial walls, which is characteristic by chronic cough, mucinous sputum, dyspnea and wheezing. high resolution ct (hrct) combined with clinical manifestations is the main diagnostic method of bronchiectasis, but hrct is expensive and radioactive. therefore, it is urgent to develop a new technology to diagnose bronchiectasis. exhaled breath may be a better tool for bronchiectasis detection because of its noninvasive nature. many efforts have been made to develop breath tests for lung cancer, asthma and helicobacter pylori infection. however, little studies pay attention to bronchiectasis. high-pressure photon ionization time-of-flight mass spectrometry (hppi-tofms) is a promising tool for breath testing, because it is highly sensitive, does not require pretreatment of exhaled breath, and holds great tolerance for humidity. in our case-control diagnostic study, we investigated whether a breath test combining hppi-tofms and a support vector machine (svm) algorithm was able to distinguish patients with bronchiectasis from control individuals.

Eligibility criteria:
inclusion criteria: be patients were recruited according to the following inclusion criteria: (1) age\>18 years; (2) the diagnosis of be was according to european respiratory society guidelines for the management of adult bronchiectasis; (3) willing to join in and sign the informed consent form. healthy control subjects were recruited according to the following inclusion criteria:(1) age\>18 years; (2) no history of any lung disease (according to pulmonary imaging and physical examinations); (3) willing to join in and sign the informed consent form. unhealthy control subjects were recruited according to the following inclusion criteria: (1) age\>18 years; (2) the diagnosis of ild was according to hrct and clinical symptoms by two experts' consensus; (3) the diagnosis of sarcoidosis (sa) was according to american thoracic society clinical practice guideline;(4) willing to join in and sign the informed consent form. exclusion criteria: (1) patients combined with serious comorbidities (chronic renal failure, hepatic disease, etc.); (2) patients who are diagnosed with asthma, pneumonia, malignant tumor, and copd; (3) women who are pregnant or preparing for pregnancy or breastfeeding; (4) participated in other clinical trials within three months; (5) refused to join in and sign the informed consent form.

Keywords: bronchiectasis breathomics exhaled breath
a phase 2 efficacy and safety study of the tolvaptan tablets in patients with non-hypovolemic non-acute hyponatremia

Conditions: Hypovolemic Hyponatremia

Summary: this is a randomized, double-blind, multicenter, placebo-controlled (standard therapy + placebo), phase 2 efficacy and safety study of the tolvaptan tablets in treatment of patients with non-hypovolemic non-acute hyponatremia arising from a variety of etiologies. 240 (120 in each group) patients are to be enrolled randomly into tolvaptan group or placebo group. subjects in tolvaptan group will receive standard therapy + tolvaptan (15-60mg/day), while those in control group receiving standard therapy + placebo. the starting dose of tolvaptan is 15mg and it could be titrated up to 30mg and then,if necessary, to the maximum of 60mg according to a certain titration scheme based on patients' response of serum sodium level. the study includes a 2-day screening period from day -2 to day -1, 7-day inpatient study treatment (day 1 to day 7 ). after study treatment, subjects will be followed-up on safety events on day 14 - 16. the primary efficacy variable is the change of serum sodium from baseline. for patients with congestive heart failure (chf) or hepatic cirrhosis, change of body weight, fluid balance and symptoms improvement of chf and hepatic edema will be assessed as secondary efficacy variables.


Eligibility criteria:
inclusion criteria: 1. informed consent. 2. age:18～75 (when informed consent is obtained)，male or female. 3. non-hypovolemic and non acute hyponatremia with a serum sodium \< 135meq/l before randomization. (main underlying diseases include chf, hepatic cirrhosis with edema, siadh and others) 4. in-patient subjects.

Keywords: hyponatremia non-acute and non hypovolemic hyponatremia
does surgical-approach affect outcome after fixation of intra-articular fractures of distal humerus?

Conditions: Distal Humerus Fracture

Summary: observational study at tertiary care hospital and level 1 trauma centre aiming to evaluate the difference between two common surgical approaches to distal humerus fracture fixation.

fractures around the distal humerus fractures make up to 2% of all fractures. complex intra-articular distal humerus fractures present as challenge to restore of painless, stable and mobile elbow joint. surgical exposure to all critical structures is of paramount importance to achieve anatomic reduction. conflict still persists regarding the choice of ideal approach between triceps-sparing approach compared with olecranon osteotomy approach. in this study investigators compare the effect of surgical approach triceps lifting vs olecranon osteotomy on the functional outcome after fixation of distal humerus intra-articular fractures. investigators conducted a non-funded, non-commercial, retrospective cohort study on participants with closed distal humerus intra-articular fractures between 2010 and 2015 at our tertiary care level-1 trauma and university hospital. participants \>18 years of age with closed complex intra-articular distal humerus fracture were operated using two different surgical approaches, either triceps lifting approach (group1) or with olecranon osteotomy (group 2). functional evaluation of the participant is carried out with quick dash scores at the final 1 year follow-up. investigators concluded that triceps lifting approach can be used equally efficiently for exposure of these complex distal humerus injuries with no comprise in visibility of articular fragments.

Eligibility criteria:
inclusion criteria: * all patients \>18 years of age with closed complex intra-articular distal humerus fracture (intercondylar fracture riseborough radin classification type lll and lv) were included. exclusion criteria: * patients with cva (cerebero-vascular accident), dementia and associated with neurovascular injuries which may impede with rehabilitation are excluded

Keywords: intra-articular fractures; distal humerus; osteotomy; elbow joint
premature infant exposure to noise generated by respiratory support

Conditions: Premature Birth of Newborn

Summary: infants in neonatal intensive care units are increasing exposed to non-invasive ventilatory support modes (nasal continuous positive airway pressure - ncpap and high flow nasal cannula: \>1 l/min flow - hfnc). while there have been small descriptive studies of noise exposure in infants on ncpap, there have been no comparative trials done comparing noise exposure in infants undergoing both ncpap and hfnc. objective: using a cross-over model determine noise exposure levels in infants exposed to similar levels of respiratory support provided by ncpap and hfnc.

infants born \ 7 days postnatal that were maintained on either on ncpap or hfnc to maintain sao2 in a range of 88 - 92 %. study infants had decibel measurements obtained every 15 seconds for 30 minutes using a noise dosimeter (noisepro dlx-1). the microphone for the dosimeter was suspended from the inside of the incubator such that it hung 1 foot above the infants nose and mouth. the exhalation port for ncpap was placed outside of the incubator. repeated measurement periods on the same mode of support were made within a 72 hour period. each infant the acted as their own control and was switched within 7 days to the alternative respiratory support method that maintained similar sao2 goals and repeat measurements were obtained. comparisons of mean decibel levels during recording were compared using paired t-tests.

Eligibility criteria:
inclusion criteria: * premature infant born \< 32 weeks and 0 days post-conceptional age; * seven or more days of age and not in acute respiratory distress; * need for nasal continuous positive airway pressure or high-flow nasal cannula for ventilation or supplemental oxygen delivery; * in a neutral-thermal environment (i.e. isolette) exclusion criteria: * oro-facial congenital anomalies; * congenital heart disease (except for patent ductus arteriosus and/or patent foramen ovale); * unstable respiratory status as deemed by the attending physician * patients under isolation for infectious disease

Keywords: continuous positive airway pressure high flow nasal cannula hearing outcomes noise exposure preterm infants
helicobacter pylori genome project (hpgp)

Conditions: Gastric Cancer; Non-Atrophic Gastritis; Intestinal Metaplasia

Summary: helicobacter pylori is a common bacterial infection. it can lead to severe stomach problems, including stomach cancer. researchers want to look at samples of the bacteria. these h. pylori strains will be taken from chronically infected people. they want to identify the genetic and epigenetic differences in h. pylori strains. this could help predict which people who get infected with the bacteria will get stomach cancer. this could lead to the cancer being detected earlier. it could also mean less people get stomach cancer. objectives: to study genetic variations of h. pylori strains based on samples from chronically infected people. to identify the features of strains that might lead to severe stomach problems or stomach cancer. eligibility: people ages 30-70 years who need an upper endoscopy or who were recently diagnosed with stomach cancer design: participants will be screened by the doctor who does their procedure and a study nurse. participants who have endoscopy will have \~6 biopsies removed. these are tissue samples. they are about the size of a grain of rice. participants will allow the study team to access reports from their stomach exam. participants with stomach cancer will donate some of the tissue that will be removed during their clinical care. they will allow the study team to access reports of their surgery. they will also allow them to access the microscope slides of their stomach.

helicobacter pylori, a gram-negative bacterium associated with a spectrum of benign and malignant gastric conditions, is one of the most genetically variable pathogens. variations in a few genes have been associated with risk of inflammation and carcinogenesis, but to date no systematic study has evaluated the entire bacterial genome. we propose a multicountry study to establish and analyze an informative international collection of h. pylori clinical isolates from residents of defined geographic areas. molecular characterization will be conducted at the nci/dceg. our hypothesis is that genetic and epigenetic variations in h. pylori strains among chronically infected individuals may affect risk of progression to gastric cancer. findings from this study may help to characterize the differential virulence among h. pylori isolates and suggest predictive biomarkers for early diagnosis of cancer. the bacterial isolates and databases from this study will also provide a foundation for further elucidation of h. pylori pathogenesis.

Eligibility criteria:
inclusion criteria: h. pylori strains collected from: 1. adult aged 30 to 70 years old. 2. patients who need upper endoscopy (examination of the lining of their stomach with a flexible tube). 3. patients with stomach cancer.

Keywords: gastric cancer bacterial risk factors dna methylation dna sequencing biobank helicobacter pylori smrt/pacbio
evaluating the symbicort turbuhaler (formoterol/budesonide) maintenance and reliever therapy for asthma in daily practice

Conditions: Asthma

Summary: we want to evaluate efficacy of symbicort® turbuhaler® (formoterol/budesonide) therapy for asthma in real life conditions. for this purpose we will include both patients that are treated with symbicort® turbuhaler® the "classical" maintenance only treatment approach as well as those treated with the smart approach.


Eligibility criteria:
inclusion criteria: * patients diagnosed with persistent asthma treated with symbicort® turbuhaler® in line with its label * non-pregnant females * existing maintenance only treatment with symbicort® turbuhaler® 80 μg/4,5 μg, 160 μg/4,5 μg or 320 μg/9 μg for at least 1 month * existing smart treatment with symbicort® turbuhaler® 80 μg/4,5 μg or 160 μg /4,5 μg for at least 1 month exclusion criteria: * patients not being treated with symbicort® turbuhaler® * patients treated with symbicort® turbuhaler® for copd

Keywords: asthma smart symbicort turbuhaler asthma control
long-term safety and tolerability of my008211a tablets in patients with paroxysmal nocturnal hemoglobinuria

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: this is a multicenter, single-arm, open-label study to characterize long-term safety and tolerability of my008211a tablets and to provide access to my008211a tablets to patients with pnh who have completed phase 2 or 3 studies with my008211a tablets.

the purpose of this open-label, single arm, multicenter study is to evaluate the long-term safety, tolerability and efficacy of my008211a tablets in patients with pnh and to provide access to patients who have completed (without tapering down) phase 2 and phase 3 trials and derived benefit from my008211a treatment.

Eligibility criteria:
inclusion criteria: 1. patients who have previously received and completed my008211a study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of my008211a. 2. prior vaccinations against neisseria meningitidis, streptococcus pneumoniae and haemophilus influenzae infections. exclusion criteria: 1. history of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus. 2. known or suspected hereditary complement deficiency. 3. any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the investigator, could put the subject at increased risk or potentially confound study data.
formation of antibodies and subsequent prediction of clinical response in patients with rheumatoid arthritis treated with four tnf blocking agents

Conditions: Rheumatoid Arthritis (RA)

Summary: the rationale for this study is to further explore if development of antibodies against tnf-α blocking agents is associated with reduced clinical effect/worsened clinical outcome. an important aspect of the study is to carry out an exploratory analysis of the immunogenicity of the 4 recommended tnf-α blockers in the treatment of ra in denmark, using the same cell-based assay.

no sampling

Eligibility criteria:
inclusion criteria: * subject fulfils criteria for rheumatoid arthritis (ra) according to acr or eular criteria. * subjects who are planned to start treatment with ada, eta, cer or ifx * subjects taking a minimum weekly dose of 7.5 mg of methotrexate exclusion criteria: * patients with compliance problems * patients who have difficulties in reading and understanding local language * patients with juvenile idiopathic arthritis (jia) * azathioprine or cyclophosphamide treatment within 6 months before entering into the study
intra-operative application of hemopatch to the pancreatic stump to prevent post-operative pancreatic fistula following distal pancreatectomy

Conditions: Pancreas Cancer; Pancreas Disease; Pancreas Adenocarcinoma; Pancreas; Fistula; Surgery; Surgery--Complications; Surgery Site Fistula

Summary: despite improvements and advances in pancreas surgery, about 30-35% of patients who have pancreas surgery develop a type of complication called a pancreatic fistula. a pancreatic fistula occurs when fluid produced by the pancreas leaks into the abdomen after pancreas surgery. patients who develop a pancreatic fistula can have poor short-term and long-term consequences.we are studying the effect of a medical device named hemopatch on the development and seriousness of pancreatic fistulas. hemopatch is a thin, flexible bovine protein-based pad that may improve tissue sealing where it is applied during surgery. some small studies called case studies of between 2 and 7 patients, and two clinical trials have shown that hemopatch is effective at stopping bleeding and reducing drain output after some types of surgery. however, there have been no completed clinical trials using hemopatch to prevent or reduce pancreatic fistulas in patients having pancreas surgery, so we don't know if it works in this setting. health canada has approved the use of hemopatch as a device to stop bleeding or seal other bodily fluids for procedures in which the control of bleeding or leakage of other body fluids or air by standard surgical techniques are either ineffective or impractical.


Eligibility criteria:
inclusion criteria: * scheduled to undergo distal pancreatectomy surgery that is open or laparoscopic, with or without splenectomy * age ≥ 18 years * able and willing to comply with study procedures and follow-up examinations contained within the written consent form exclusion criteria: * contraindication to placement of hemopatch tissue sealant including: 1) known hypersensitivity to bovine proteins; 2) known hypersensitivity to brilliant blue \[fd\&c blue no.1 (blue 1)\]; 3) presence of an active infection; and 4) known pregnancy or lactation (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation) * participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor)

Keywords: hemopatch
a phase 2 evaluation of trc105 in combination with bevacizumab in patients with glioblastoma

Conditions: Glioblastoma; Glioblastoma Multiforme

Summary: the purpose of this study is to evaluate the safety and efficacy of trc105 in patients with recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-vegf therapy)

angiogenesis plays a central role in the progression of solid cancer. trc105 is an antibody to cd105, an important non-vegf angiogenic target on proliferating endothelial cells. trc105 inhibits angiogenesis, tumor growth and metastases in preclinical models. trc105 has been well tolerated in patients with glioblastoma (gbm) as a single agent. the combination of trc105 in combination with bevacizumab has demonstrated activity in bevacizumab refractory cancer patients. we hypothesize that trc105 when administered with bevacizumab will have activity in gbm patients who progress on bevacizumab. by targeting a non-vegf pathway, trc105 has the potential to complement vegf inhibition by bevacizumab, which could represent a major advance in gbm therapy.

Eligibility criteria:
inclusion criteria: 1. patients with histologically confirmed glioblastoma, recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy. 2. patients with documented radiographic progression following bevacizumab therapy for treatment of glioblastoma. 3. patients with up to 3 prior recurrences are allowed. 4. karnofsky performance status ≥ 70%. 5. age ≥ 18 years old. 6. normal organ function exclusion criteria: * patients who have had previous treatment with trc105. * patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury * patients with cirrhosis, or active viral or nonviral hepatitis. * patients with active bleeding or pathologic conditions that carry a high risk of bleeding,(i.e. hereditary hemorrhagic telangiectasia). * patients who are currently receiving anticoagulation treatment * patients unwilling or unable to comply with the protocol
safety study of conventional versus micropulse transscleral cyclophotocoagulation in treating end-stage glaucoma

Conditions: Advanced Glaucoma; Refractory Glaucoma

Summary: the aim of this study is to compare the safety and efficacy of conventional and micropulse transscleral diode laser in the treatment of end-stage glaucoma.

end-stage glaucoma is difficult to treat, and it may sometimes be unresponsive to surgery or medications. a common treatment is the conventional transscleral cyclophotocoagulaion, but it has various side effects. this study specifically aims to compare the intraocular pressure (iop) lowering effects and the incidence of complications such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage, in conventional and the newer micropulse transscleral cyclophotocoagulation.the hypothesis is that the micropulse transscleral cyclophotocoagulation will be as good or better than the conventional transscleral cyclophotocoagulation, with less complications.

Eligibility criteria:
inclusion criteria: * · more than 21 years old * advanced glaucoma refractory to maximum tolerated medical and surgical treatment * visual acuity worse than 6/60 * poor candidates for additional filtration surgery exclusion criteria: * · any eye surgery done within 2 months of enrolment * any ocular infection or inflammation * unable to give informed consent

Keywords: advanced glaucoma refractory glaucoma cyclophotocoagulation transscleral cyclophotocoagulation micropulse transscleral cyclophotocoagulation