Kornimate/medical-research-clean huggingface dataset:
study of the psychological profile of type 2 diabetic patients with foot wounds, compared to diabetic patients without foot wounds

Conditions: Type 2 Diabetes; Foot Wound

Summary: several studies have highlighted the value of analyzing a patient's psychological profile with the bortner scale questionnaire (defined as type a or b personality). this analysis helps to better understand and anticipate patients' behaviour, stress and compliance with their disease and its progression. the type a personality profile combines hyperactivity, competitiveness and exaggerated ambition, while the b profile is characterized by lower sensitivity to stress and reduced competitiveness. it has been shown that the type b psychological profile in patients with type 2 diabetes is an independent risk factor for inflammation and that, in type 1 diabetes, the type a psychological profile is associated with a decrease in the expression of the pro-inflammatory cfos gene. thus, the psychological profile appears to have an impact not only on the patient's behaviour but also on his or her biology. it has never been determined whether the type a or b psychological profile assessed by bortner's self-administered questionnaire can influence the development of foot wounds in patients with type 2 diabetes who often have a medically unfavourable prognosis and socio-economic difficulties. we would therefore like to study the psychological profile of these individuals in order to make comparisons with the data obtained in a previous study that included patients with type 2 diabetes who did not have a foot wound.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * patient \> 18 years old * with a diabetic foot wound * person who has expressed non-opposiyion to participation in the study exclusion criteria: * a person who is not affiliated to national health insurance * person subject to legal protection (curatorship, guardianship) * person under limited judicial protection * pregnant, parturient or breastfeeding woman * adult unable to consent * minor
efficacy of tai chi versus cbt-i in treating chronic insomnia in older adults

Conditions: Chronic Insomnia

Summary: insomnia is common in the older population, over 50% of older adults have sleep complaints, and 20-40% are reported to have insomnia. in hk, 38% of adults have reported insomnia. insomnia is associated with increased mortality and morbidity. as the worldwide population continues to age, insomnia in older adults will increasingly cause substantial economic burdens on healthcare systems and society. cognitive behavioral therapy for insomnia (cbt-i) is currently the first-line clinically recommended non-pharmacological treatment for insomnia in older persons. our group has been actively studying the health-enhancing effects of tai chi. tai chi has various health benefits including fall prevention, osteoarthritis management, cardiorespiratory fitness and improvement of sleep. in the present study, the investigators want to validate the clinical effectiveness of tai chi on improving insomnia in older adults. this study aims to exam whether three months of cbt-i or three months of tai chi have similar robust effects in treating insomnia in older adults. the investigators want to validate the clinical effectiveness of tai chi on improving insomnia in older adults. the cbt-i and tai chi classes will be held twice a week with each lasting for 60 mins. the treatment is three months with 12-month follow-up. the primary outcome of this study is the insomnia severity index (isi) score at post-intervention measure, which examining sleep-onset and sleep maintenance difficulties, satisfaction with current sleep pattern, inference with daily functioning.


Eligibility criteria:
inclusion criteria: 1. 50 years or older, 2. ethnic chinese who can communicate by cantonese or mandarin, and 3. fulfill the dsm-5 criteria for chronic insomnia including difficulty in initiating sleep, maintaining sleep or non-restorative sleep, with complaints of impaired daytime functioning, sleep difficulty occurring at least three nights per week present for at least 3 months. exclusion criteria: 1. cannot walk without assistive device (e.g., cane), 2. somatic conditions that limit exercise participation (e.g., limb loss), 3. regular aerobic exercise or mind-body training such as tai chi, yoga, qigong or meditation (\>3 times weekly for \>60 minutes per session), 4. serious chronic diseases known to affect sleep (e.g., cancer and autoimmune diseases), 5. dementia or use of anti-dementia medication, 6. under treatment for serious diseases known to affect sleep (e.g., cancer chemotherapy), 7. any chronic pain disorders known to affect sleep, 8. untreated sleep disorder including obstructive sleep apnea, periodic leg movement disorder and narcolepsy (screened by questionnaire followed by polysomnographic confirmation in our co-i's sleep lab, if needed), 9. having current or past cbt-i, 10. shift-worker.

Keywords: clinical efficacy, chronic insomnia, tai chi, cbt-i
a study of bemarituzumab (fpa144) combined with modified folfox6 (mfolfox6) in gastric/gastroesophageal junction cancer

Conditions: Gastric Cancer

Summary: the main objective of the phase 2 part of the study is to evaluate the efficacy of bemarituzumab (fpa144), a targeted antibody, in combination with modified folfox6 compared to placebo in combination with modified folfox6 in participants with advanced gastrointestinal cancer.

study fpa144-004 is a phase 1/2, multicenter, global, double-blind, randomized, controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (pk) of bemarituzumab in combination with mfolfox6, compared with placebo in combination with mfolfox6, in adults with unresectable, locally advanced, or metastatic gastric cancer including cancer of the gastroesophageal junction (gej). this study includes a phase 1 safety run-in portion and a phase 2 portion. the phase 1 safety run-in is an open-label dose-escalation of bemarituzumab + mfolfox6 in patients with gi tumors (not fgfr2 selected) that is reported separately (nct03343301). the phase 2 portion of the study (to follow the phase 1 safety run-in) is described in this record.

Eligibility criteria:
key inclusion criteria: * histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy) * eastern cooperative oncology group (ecog) performance status of 0 to 1 * adequate hematological, liver and kidney function. measurable or non-measurable, but evaluable disease using recist v1.1 * fibroblast growth factor receptor 2b (fgfr2b) overexpression as determined by a centrally performed immunohistochemistry tissue test and/or fgfr2 gene amplification as determined by a centrally performed circulating tumor deoxyribonucleic acid (ctdna) blood based assay * candidate for mfolfox6 chemotherapy key exclusion criteria: * untreated or symptomatic central nervous system (cns) metastases * clinically significant cardiac disease, * peripheral sensory neuropathy \>/= common terminology criteria for adverse events (ctcae) grade 2 * active infection requiring systemic treatment * known human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids)-related illness, or known active or chronic hepatitis b or c infection * prior treatment with any selective inhibitor of the fibroblast growth factor (fgf)-fgfr pathway * known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer * known positivity for human epidermal growth factor receptor 2 (her2) * women who are pregnant or breastfeeding note: other protocol defined inclusion/exclusion criteria may apply
as oct evaluation for perforated punctual plugs

Conditions: Punctal Stenosis

Summary: evaluation of the perforated punctal plugs after implantation in cases of punctal stenosis regarding position and patency in the early postoperative period (during the first operative weak)

prospective non randomized case series study included 50 eyes. the study is conducted on patients attending to the oculoplastic unit of ophthalmology department of minia university hospital. informed consents were obtained from the participants in this study. the study was adherent to the tenets of declaration of heleniski. anterior segment optical coherence tomography(as-oct) was performed for the included patients after perforated plug implantation (during the first operative weak)

Eligibility criteria:
inclusion criteria: * patients with punctal stenosis who will be treated by implantation of perorated punctal plugs exclusion criteria: * patients who are not willing to participate in the study

Keywords: punctual stenosis perforated lacrimal punctal plugs as-oct
a study of tislelizumab (bgb-a317) plus chemoradiotherapy followed by tislelizumab monotherapy in newly diagnosed, stage iii subjects with locally advanced, unresectable non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (ccrt) followed by tislelizumab monotherapy versus ccrt alone, and tislelizumab given sequentially after ccrt versus ccrt alone, in newly diagnosed stage iii subjects with locally advanced, unresectable non-small cell lung cancer (nsclc). the primary endpoint is centrally-assessed progression free survival (pfs) in the intent-to-treat (itt) population. .


Eligibility criteria:
inclusion criteria: 1. newly diagnosed, histologically confirmed, locally advanced, stage iii unresectable non small cell lung cancer (nsclc). staging will be confirmed at screening by positron emission tomography-computed tomography (pet/ct) and brain imaging by magnetic resonance imaging (mri) or computed tomography (ct) with contrast. 2. eastern cooperative oncology group (ecog) performance status ≤ 1. 3. epidermal growth factor receptor (egfr) mutation and anaplastic lymphoma kinase (alk) gene translocation status available prior to randomization. 4. provision of fresh or archival tumor tissue or discussion with sponsor. 5. adequate hematologic and end-organ function. exclusion criteria: 1. prior therapies including those targeting pd-1 or pd-l1 or chemotherapy, radiation, targeted therapy, biologic therapy, immunotherapy or investigational agent used to control non-small cell lung cancer (nsclc). 2. history of severe hypersensitivity reactions to other monoclonal antibodies or any contraindication to the planned chemotherapy regimen. 3. history of, or ongoing, interstitial lung disease; pneumonitis requiring steroids; or clinically significant pericardial effusion. 4. any active malignancy less than or equal to 2 years before randomization, with the exception of non-small cell lung cancer (nsclc) and any locally recurring cancer that has been treated curatively. 5. severe chronic or active infections including those requiring systemic antibacterial, antifungal or antiviral therapy; known human immunodeficiency virus (hiv) infection; untreated chronic hepatitis b or chronic hepatitis b virus carries or active hepatitis c; or active autoimmune disease. 6. prior allogeneic stem cell transplantation or organ transplantation. 7. significant cardiovascular disease or other condition which places the patient at risk.

Keywords: locally advanced, unresectable non-small cell lung cancer non-small cell lung cancer nsclc randomized bgb-a317 tislelizumab pd-1
intravenous pertussis immune globulin in patients with severe childhood pertussis infection

Conditions: Pertussis; Whooping Cough

Summary: objectives: assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children.

protocol outline: this is a randomized, multicenter study. patients are randomized to receive an infusion of either pertussis immune globulin or placebo (0.9% saline). patients are followed every 2 weeks for up to 6 months. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
* documented infection with bordetella pertussis

Keywords: bacterial infection immunologic disorders and infectious disorders pertussis rare disease
nasopharyngeal streptococcus pneumoniae carriage

Conditions: Streptococcus Pneumoniae Infections

Summary: primary objective: evaluation of the - carriage rate of streptococcus pneumoniae in the nasopharynx of children secondary objective: * carriage rate and distribution of streptococcus pneumoniae serotypes * estimation of prevalence rate of antibiotic-resistant streptococcus pneumoniae strains * distribution of staphylococcus aureus strain * the influence of risk factors in the streptococcus pneumoniae carriage rate in children


Eligibility criteria:
inclusion criteria: 1. children aged between 2 months and 5 years attending pediatric clinics in hospitals, day care centers or kindergartens. 2. informed consent obtained from parents or legal guardian. exclusion criteria: 1. children younger than 2 months of age. 2. children with following serious diseases: immunological disease, neoplastic disease, renal, cardiac or hematological disease, bronchodysplasia, down's syndrome.

Keywords: streptococcus pneumoniae nasopharyngeal carriage
analysis of implant placement in patients with distal radius fractures in western brittany (redira)

Conditions: Distal Radius Fracture

Summary: the purpose of this study was to determine the impact of design on plate position at the level of the distal radius. six anterior wrist plates design were analyzed relative to the watershed line using the soong classification. a total of 2723 anterior locking plate fixation cases were analyzed and divided into six groups: zimmer biomet, newclip technics, stryker, synthes, medartis and medartis footprint. the number of plates recorded as soong grade 0+1 was determined for each design, then compared using the marascuilo procedure. the zimmer biomet and newclip plates were proximal to the watershed line significantly more often than those by synthes and medartis footprint. plate position with the medartis design was significantly more proximal to the watershed line compared to its companion design, the medartis footprint plate. plate design is a deciding factor when treating distal radial fractures, to avoid impingement when implant removal is not routinely planned.

this is a retrospective multicenter study involving several orthopedic surgeons with a trauma surgery practice within the public hospital centers of the department of finistère. these include the chu de brest - brest university hospital center (la cavale blanche), the hia clermont-tonnerre military hospital (hôpital d'instruction des armées - armed forces teaching hospital), the ch des pays de morlaix, the ch de landerneau ferdinand grall, the ch de carhaix and the ch de cornouaille quimper concarneau. this study was approved by the local ethics committee. among the cited hospital centers, the chu de brest is a level 1 trauma center, the ch des pays de morlaix, the hia military hospital and the ch de cornouaille are level 2 trauma centers and the ch de landerneau and carhaix are level 3 trauma centers.

Eligibility criteria:
to be included, patients had to have a digital radiographic file that could be used for the soong classification. among the volar plate fixation cases retrieved from the databases, we excluded patients that were not treated with a locking plate and those with a lateral x-ray that could not be interpreted. the inclusion criteria for lateral radiographs were alignment of the radius, lunate, capitate and third metacarpal bones, combined with radial-ulnar overlap (the ulnar styloid process projecting into the middle of the ulnar head). exclusion criteria: patient refusal no postoperative radiograph n=40 poor quality radiograph n=214

Keywords: distal radius fracture volar plate plate design watershed line plate positioning
nurse-led proactive telephone follow-up with patients after completion of primary cancer treatment

Conditions: Breast Cancer; Colorectal Cancer; Prostate Cancer

Summary: the goal of this randomized study is to test and evaluate nurse-led telephone follow-up intervention in patients primarily curatively treated for breast cancer, colorectal cancer, and prostate cancer. the main question aims to answer: does this nurse-led telephone follow-up improve patients' quality of life? participants in both groups will be asked to fill in questionnaires regularly. the intervention group will get a telephone follow-up at predetermined intervals, while the control group will get the care as usual.the investigators will compare intervention and control groups to see if predetermined regular nurse-led telephone follow-up improves quality of life.

the hypothesis is that nurse-led telephone follow-up will improve the quality of life in patients primarily curatively treated for breast cancer, colorectal cancer, and prostate cancer. participants in both groups will respond to a survey regularly during one year from inclusion. the intervention group will get a telephone follow-up at predetermined intervals (1, 3, 6, 9, 12 months) while the control group will get the care as usual. the usual care means that no proactive support is offered to patients from health care while they wait for follow-up, but patients are of course allowed to contact health care if they needed. participants in both groups are asked to respond on a survey concerning their quality of life, feelings of anxiety and depression, perception of illness, and experienced symptoms and discomfort regarding to cancer. additionally, the number of visits at the health care during the waiting for follow-up will be collected from both group.

Eligibility criteria:
inclusion criteria: * being primarily curatively treated for breast, colorectal-, or prostate cancer exclusion criteria: * no adjuvant treatment * no cognitive impairment * no known alcohol or other misuse
placebo versus antibiotics in acute exacerbations of chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the role of antibiotic therapy in patients with copd remains controversial. while the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. in this study the efficacy of doxycycline is compared to placebo. all concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized. the investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.


Eligibility criteria:
inclusion criteria: * acute exacerbation of copd type i or ii according to gold * ability to perform lung function tests * ability to take oral medication exclusion criteria: * pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception. * pretreatment ( \> 24 hours) with an antibiotic for the present exacerbation. * pretreatment with corticosteroids (\>30 mg for more than 4 days) for the present exacerbation. * progression or new radiographic abnormalities on the chest x-ray. * severe exacerbation that required mechanical ventilation. * history of bronchiectasis * recent or unresolved lung malignancy. * other disease likely to require antibiotic therapy. * significant gastrointestinal or other conditions that may affect study drug absorption. * class iii or iv congestive heart failure or stroke. * immunodeficiency disorders such as aids, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (\>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks). * cystic fibrosis * tuberculosis. * impaired renal function (creatinine clearance \< 20 ml/min).

Keywords: acute bronchitis antibiotics
clinical benefits of a blood glucose monitoring system in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: clinical benefits of the onetouch® ultra®2 bgms versus standard bgms during 52 weeks of use.


Eligibility criteria:
inclusion criteria:· * current diagnosis of type 2 diabetes * diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study * stable regimen (i.e., no changes in therapeutic regimen) for the past three months * baseline hba1c of 7.0 to 8.9%, inclusive exclusion criteria: * using insulin * using oral agents that target post-prandial hyperglycemia (note: these medications may be added during the study) * known history of anemia or disorders associated with anemia * has previously used the devices being tested in the study
the prevent trial: a pragmatic cluster randomized controlled trial of a multifaceted fracture prevention model for long-term care

Conditions: Fracture; Fractures, Hip; Osteoporosis

Summary: hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. to address this problem the prevent (person-centered routine fracture prevention in ltc) program was designed for use in long-term care homes. prevent uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. the program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. the healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. the study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the prevent program (intervention group) and some homes to usual care (control group) and comparing the results.


Eligibility criteria:
inclusion criteria: * both profit and non-profit long-term care homes in ontario and alberta. * homes must have a minimum of 70 occupied beds to participate; there is no maximum home size for participation. * for both control and intervention homes, resident eligibility (and study cohorts) will be determined via the rai-mds 2.0 database. exclusion criteria: * residents identified as having end-stage disease, who are comatose, receiving hospice or respite care and who have an expected short stay (90 days or less).

Keywords: long-term care fracture risk falls knowledge translation
cognition and health in adolescents, mindfulness as prevention of stress.

Conditions: Stress; Complete Psychological Check Up; Sleep; Cognition - Other; Personality

Summary: the purpose of this study is to determine whether mindfulness is useful as primary prevention for psychological health in highschool students, primarily related to stress, and whether mindfulness can improve cognitive function.

there is a general suspicion that stress and stress-related psychological disorders is growing in highschool students in sweden. mindfulness is a well researched therapeutical method for treating stress-related disorders. this study will first collect data on stress-related psychological symptoms by several well-validated surveys. the surveys will be made twice with 8 weeks in between to examine variability. after the second survey the population of highschool students will be randomly assigned to web-based mindfulness intervention, music relaxation intervention or control group. a third survey will be conducted after eight weeks of intervention and before and after an external stressor.

Eligibility criteria:
inclusion criteria: * high school student from designated school exclusion criteria: * none swedish-speaking

Keywords: mindfulness stress cognition psychological health primary prevention