Kornimate/medical-research-clean huggingface dataset:
a study evaluating the safety of vx-152 combination therapy in adults with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is a phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of vx-152 in triple combination (tc) with tezacaftor (tez; vx-661) and ivacaftor (iva; vx-770) in subjects with cystic fibrosis (cf) who are heterozygous for the f508del mutation and a minimal function (mf) cftr mutation not likely to respond to tez and/or iva therapy (f508del/mf), or who are homozygous for the f508del mutation of the cf transmembrane conductance regulator (cftr) gene (f508del/f508del).


Eligibility criteria:
inclusion criteria: * willing and able to comply with scheduled visits, treatment pan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures. * body weight ≥35 kg. * sweat chloride value ≥ 60 mmol/l from test results obtained during screening. * subjects must have an eligible cftr genotype: * cohorts 1a, 1b, 1c: heterozygous for f508del and a minimal function mutation known or predicted not to respond to tez and/or iva. * cohorts 2a, 2b: homozygous for f508del. * subjects must have an fev1 ≥40% and ≤90% of predicted normal for age, sex, and height at the screening visit. * stable cf disease as judged by the investigator. * willing to remain on a stable cf medication regimen through the planned end of treatment or if applicable the safety follow-up visit. exclusion criteria: * history of any comorbidity that in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject. * history of cirrhosis with portal hypertension. * risk factors for torsade de pointes. * history of hemolysis. * glucose-6-phosphate dehydrogenase (g6pd) deficiency assessed at screening. * clinically significant abnormal laboratory values at screening. * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before the first dose of study drug. * lung infection with organisms associated with a more rapid decline in pulmonary status. * an acute illness not related to cf within 14 days before the first dose of study drug. * a standard digital ecg demonstrating qtc \>450 msec at screening. * history of solid organ or hematological transplantation. * history or evidence of cataract or lens opacity determined to be clinically significant by the ophthalmologist or optometrist, based on the ophthalmologic examination during the screening period. * history of alcohol or drug abuse in the past year, including but not limited to, cannabis, cocaine, and opiates, as deemed by the investigator. * ongoing or prior participation in an investigational drug study with certain exceptions. * use of commercially available cftr modulator within 14 days before screening (applies only to cohorts 1a, 1b, and 1c). * pregnant or nursing females: females of childbearing potential must have a negative pregnancy test at screening and day 1.
comparison of woodcast vs traditional cast in distal radius fracture

Conditions: Bone Fracture

Summary: the investigators project is a randomised controlled trial that will compare the efficacy of the traditional casting method against the woodcast splint in distal radial fracture. after the investigators have taken consent and the patients have agreed to be a part of the project, the investigators will randomly divide the participants into two groups. one with the traditional cast and one with the wood cast. the difference will be measured by using the eq-5d-y tool alongside the use of the dash score and our own questionnaire. the study will take place over the following year with the sheffield children's hospital being the only site involved. woodcast products have the ce declaration of conformity which is covered for the use in children, and apart from the type of cast the child is given, the course of treatment is the same for both group

distal radial fractures are a very common fracture. without good plaster immobilisation these fractures are prone to slipping. as a result, patients may end up with surgical treatment which would otherwise not be needed if the plaster were to hold the fracture position adequately. if one was shown to be better compared to the other, then all hospitals could start to use a more effective treatment. with traditional casting, some of the details of the fracture are missed due to the shadowing on the x-ray. the woodcast aims to reduce this shadowing, allowing a more detailed image of the fracture and hopefully a better outcome. problems may arise with the plaster cast, at one or two week scans, in which the cast may need to be removed for imaging, this could lead to displacement of the fracture effecting the outcome. woodcast would potentially not need to be removed or is easily removed due to the fact that it is not a complete cast and so would hopefully improve the outcomes for the patient.

Eligibility criteria:
inclusion criteria: * children between the ages of 3 and 16 that present with a distal radial fracture. exclusion criteria: * patients with underlying physical and learning disabilities. * patients with significant co-morbidities that would put the patient at risk of extra distress. * pathological fractures for instance osteogenesis imperfecta, metabolic bone diseases etc... * patients who aren't fluent in english as we only have questionnaires available in english.
acp simulation-based communication training program for nurses discussing acp with chronic kidney disease patients

Conditions: Chronic Kidney Diseases

Summary: this study was to evaluate the effects of acp simulation-based communication training program (acp-sct program) for nurses to discuss acp with chronic kidney disease patients

the acp-sct program was including three stages, as follows stage i: to discuss acp knowledge and law objective: opportunity to share experiences, and develop a mutual understanding of the the challenge of acpdiscussing with ckd patients. stage ii: communication skills section and feedback section objective: 1. to provide a structured approach to managing acp discussions. 2. opportunity to practice communication skills in a safe environment 3. opportunity to discuss their experiences of the training program, and reflect future on their own practice and experience.

Eligibility criteria:
inclusion criteria: * participants were nephrology nurses and worked at least one year exclusion criteria: * non-nephrology nurses
colorectal cancer screening in a community health setting

Conditions: Cancer of the Colon

Summary: this randomized controlled pilot study at the health annex, family practice \& counseling network (fpcn), a community clinic in southwest philadelphia, aimed at providing data on the feasibility of a mailed fit approach to crc screening in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

this is a single-center rct at the family practice \& counseling network (fpcn), a community clinic in southwest philadelphia with 320 eligible subjects between the ages of 50-74 randomized to two study arms: 1. text messaging outreach (text) 2. text messaging outreach with lottery for 1/5 chance to win a financial incentive (text + lottery). findings will provide data on the feasibility of this mailed fit approach in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

Eligibility criteria:
inclusion criteria: 1. between 50 and 74 years old 2. has active medical insurance 3. has had had at least one visit at health annex in the prior 12 months (at time of chart review) 4. due for crc screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year) 5. asymptomatic for crc exclusion criteria: 1. has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fobt/fit within twelve months of the chart review (we will exclude patients who self-report undergoing any of the above procedures) 2. has a history of crc 3. has a history of other gi cancer 4. has history of confirmed inflammatory bowel disease (ibd) (e.g. crohns disease, ulcerative colitis) 5. has a history of colon polyps 6. has had a colectomy 7. has a first-degree relative that has been diagnosed with crc 8. has been diagnosed with lynch syndrome (i.e. hnpcc) 9. has been diagnosed with familial adenomatous polyposis (fap). 10. has iron deficiency anemia 11. has recent history of lower gi bleeding 12. has metastatic (stage iv) blood or solid tumor cancer 13. has end stage renal disease 14. has had congestive heart failure 15. has dementia 16. has liver cirrhosis 17. has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study 18. does not use a mobile phone enabled to send and receive text messages

Keywords: colorectal neoplasms colonic neoplasms gastrointestinal neoplasms digestive system neoplasms neoplasms digestive system diseases gastrointestinal diseases colonic diseases rectal diseases
thermocool® smarttouch™ catheter for the treatment of symptomatic paroxysmal atrial fibrillation continued access

Conditions: Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Summary: this is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the thermocool® smarttouch™ catheter.

the device is currently under investigation with ide #g110030. this continued access study will enroll subjects that have participated in the smart-af ide study. subjects with drug refractory symptomatic paroxysmal atrial fibrillation (paf) will be considered for this study. effectiveness and safety endpoints have been defined and will be evaluated post treatment.

Eligibility criteria:
inclusion criteria: * have had at least 3 atrial fibrillation episodes within 6 months of this study * have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes * 18 years of age or older exclusion criteria including, but not limited to: * have had previous ablation for atrial fibrillation * have take amiodarone within 6 months of this study * have had any heart surgery within the last 60 days * have had a heart attack within the last 60 days * females who are pregnant or breast feeding

Keywords: drug refractory atrial fibrillation antiarrhythmic drug failure atrial tachyarrhythmias
based-virtual reality diagnosis for neuropsychiatric diseases and sleep/wake disorders

Conditions: Aging; Addiction; Attention Deficit Disorder With Hyperactivity; Sleep Disorders; Anxiety; Depression; Attention Deficit

Summary: the objective of this research is to develop original virtual reality scenarios and/or new virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies interfering with sleep/wake disorders.

nature of the trial: without direct individual benefit study conducted in healthy volunteers, patients with attention disorders : adhd (attention deficit disorder / hyperactivity) and cognitive aging, addictive disorders, anxiety disorders, depressive disorders or pathologies that interfere with sleep/wake cycle. the duration of the study is 8 years. type of trial: comparison of two parallel groups of healthy volunteers and patients with attention disorders, addictive, anxious, depressive or interfering with sleep/wake cycle. study design: * standardized clinical interview with a sleep specialist, psychiatrist, or psychologist and rating scales, * a virtual reality task. the primary outcome is to evaluate the diagnosis accuracy and the acceptability of the virtual tool to the referent standard (clinical interview and scales). the secondary outcomes are: * the comparison of healthy subjects and patients performances * tolerance, acceptability to exposure to virtual scenarios.

Eligibility criteria:
inclusion criteria: * being aged between 7 and 75 years * having signed written informed consent exclusion criteria: * having participated to a clinical trial in the previous 3 months
comparing inflammatory markers in patients with and without depression with chronic periodontitis

Conditions: Chronic Periodontitis; Depression

Summary: this study will evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease.

the primary purpose of this study is to evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease. this study will also investigate the link between oral and systemic inflammation in patients diagnosed with depression and periodontal disease. researcher will collect gingival crevicular fluid, plaque, tissue and blood serum samples to evaluate the link between these two diseases. the collection of gingival crevicular fluid, plaque and blood serum is relatively non-invasive, elicits minimal discomfort and does not require use of any anesthesia. the soft tissue sample will be collected as part of an otherwise planned periodontal surgical procedure under local anesthesia. in periodontal therapy (surgical procedures i.e. gum surgery, tooth extraction and or dental implant surgery) there is enough availability of remnant tissue for the collection of samples, which is otherwise discarded.

Eligibility criteria:
inclusion criteria: * at least 18 years old * must be a patient of the uab dental school * able to read and understand informed consent document * good general health as evidenced by medical history * minimum of 18 teeth, excluding third molars * having moderate to severe periodontal disease according to aap definition (teeth ≥5 mm pd and ≥3 mm cal) * having \>30 percent bleeding sites upon probing * patients taking depression medication with chronic periodontitis * patients without depression with chronic periodontitis * patients who have not had a dental cleaning in the past 3 months prior to procedure * patients scheduled for surgical procedures (i.e. gum surgery, tooth extraction, or dental implants) exclusion criteria: * non-english speaking * less than 18 years old * smokers/tobacco users (\>10 cigarettes/day) * any dental condition that requires immediate treatment, such as emergency care * chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti-inflammatory drugs, steroids). low-dose aspirin (less than 325 mg daily) * immunocompromised subjects * any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as uncontrolled diabetes, nifedipine, phenytoin (dilantin), subjects with arthritis and morbidly obese (bmi ≥ 40)
the clinical outcome and the exploration of related biomarkers of target therapy in metastasis colorectal cancer

Conditions: Neoplasms, Therapy-Associated

Summary: through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer and explore some biomarkers that relate to target therapy.

1. establish a clinical database of patients who are diagnosed with metastasis colorectal cancer in tongji hospital. 2. build a biological specimen banks of metastasis colorectal cancer through collecting blood samples from those patients who have reached an agreement with us. 3. through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer. 4. to extract dna from the blood and explore some biomarkers that related to target therapy in metastasis colorectal cancer.

Eligibility criteria:
inclusion criteria: 1. metastasis colorectal cancer confirmed by histologically and radiography 2. receive target therapy over half a year 3. have a measurable lesions exclusion criteria: 1. a history of other malignant tumors in five years

Keywords: molecular targeted therapy metastasis colorectal cancer biomarker
traditional chinese medicine or low-dose dexamethasone in covid-19 pneumonia

Conditions: COVID-19 Pneumonia

Summary: the goal of this type of clinical trial is to learn about symptomatic patients with post-covid-19 parenchymal lung abnormalities. the main questions it aims to answer are: the efficacy and safety of low-dose dexamethasone or traditional chinese medicine in symptomatic patients with post-covid-19 parenchymal lung abnormalities. participants will be divided into three parallel groups：controlled group with conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc. dexamethasone group: dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine. chinese medicine group: strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of covid-19 pneumonia； * 3 to 8 weeks after the onset of the first symptoms of covid-19 infection; * modified medical research council (mmrc) score ⩾2 or hypoxemia; * imaging severity assessment of pneumonia: ct severity scores (ctss):≥5； * signed the informed consent. exclusion criteria: * participants still admitted to intensive care unit at the time of enrollment; * known prior structural lung disease, including pulmonary fibrosis, severe copd, severe bronchiectasis, and lung destruction; * taking glucocorticoids or immunosuppressants because of other chronic diseases; * contraindications of glucocorticoid; * heart failure(nyha iii or iv); * participants with renal replacement therapy; * psychiatric disorders or cognitive impairments; * the expected survival time is less than six months due to diseases other than covid-19 pneumonia.
the effect of losartan on the recoverability of renal function in anuric and oliguric patients with unilateral obstructed kidney

Conditions: Losartan Adverse Reaction; Uropathy; Uropathy Obstructive

Summary: previous experimental studies concluded that angiotensin receptor blockers can ameliorate the harmful inflammatory and histological changes after relief of obstruction. nevertheless, these witnessed effects have not been yet translated into the clinical practice.


Eligibility criteria:
inclusion criteria: * anuric and oliguric patients * calculuar ureteral obstruction exclusion criteria: * anomalous kidney * bilateral obstructed kidney * history of recent use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors * asa score of \>3
a study to evaluate efficacy and safety of vx-864 in participants with the pizz genotype

Conditions: Alpha-1 Antitrypsin Deficiency

Summary: the purpose of this study is to evaluate the efficacy and safety of vx-864 in participants with the pizz genotype over 48 weeks.


Eligibility criteria:
key inclusion criteria: * participants must have a pizz genotype confirmed at screening * plasma aat levels indicating severe deficiency at screening key exclusion criteria: * history of a medical condition that could negatively impact the ability to complete the study * solid organ, or hematological transplantation or is currently on a transplant list * history of use of gene therapy or ribonucleic acid interference (rnai) therapy at any time previously * participants for whom discontinuation of augmentation therapy is not considered to be in their best interest, based on the clinical judgement of the treating physician other protocol defined inclusion/exclusion criteria may apply.
interrupting prolonged sitting with periodic interval exercise: effect on postprandial lipemia

Conditions: Sedentary Behavior; Hypertriglyceridemia

Summary: investigating the effects of interrupting various lengths of prolonged sitting with bike sprints on post prandial lipemia the next day. we will conduct three trials, one control, one with two-hour sitting intervals (total of 4 bouts of bike sprints) and one with 6-hour sitting intervals i total of two bouts of bike sprints). a milkshake high fat tolerance test will be conducted the next day and whole body fat oxidation as well as triglyceride area under the curve will be measured every hour for the duration of the 6-hour test.


Eligibility criteria:
inclusion criteria: * inactive or recreational healthy adults aged 18-65 years old. exclusion criteria: * lactose intolerance, cardiovascular or metabolic diagnoses, medications for cardiovascular or metabolic diagnoses, orthopedic issues barring cycling.
improving medication prescribing-related outcomes for vulnerable elderly in transitions

Conditions: Patient Discharge; Drug-Related Side Effects and Adverse Reactions; Aged; Health Care Costs

Summary: medication safety is a crucial health issue for every older canadian since many of the medications causing serious harm are those which also have life-saving or important symptom-relieving benefits. very few specialists can accurately advise seniors which medications provide more benefit than harm for them personally, and make changes safely as this requires a very large breadth and depth of knowledge about the patient, the conditions they have and their therapies. now that telemedicine is compatible with smart phones, this extends the ability of scarce specialists to 'see' any patient in canada in a way that is more convenient for the patient and may be less expensive than current care. this project will find out whether a unique clinical pharmacology specialist team in hamilton, ontario can improve medication safety (stop medications no longer needed, reduce doses where appropriate, change to safer medications) for a high risk group of older hospitalized canadians taking many medications. the hospital where this pilot study will take place was the first to install the world's leading electronic health record and set it up to facilitate and support high quality research. patients who volunteer will be assigned to their usual care, or to the intervention which is the clinical pharmacology specialist team approach starting in hospital and following up with the patient at home using telemedicine and detailed communication with them, their caregiver, family physician, community pharmacist and other specialists. the investigators will study whether the intervention is effective and cost-effective at reducing harmful medication burden, reducing the need to return to hospital, or improving the patient's ratings of their care coordination. the results will determine whether a subsequent large trial is worthwhile.


Eligibility criteria:
inclusion criteria: * adults over the age of 65 years. * admitted to medicine or surgery services for more than 2 days. * high cost users (defined as): * have at least one other hospitalization within the previous year. * taking 5 or more chronic medications including at least one triim-med. * provide informed consent. exclusion criteria: * patients with "do not approach status". * patient or caregiver not fluent in english. * patients who do not provide informed consent. * patients admitted for \< 2 days. * patients \< 65 years of age. * not a high cost user (as defined above).

Keywords: polypharmacy