Kornimate/medical-research-clean huggingface dataset:
reliability and responsiveness of one questionnaire used on a low back pain population

Conditions: Low Back Pain

Summary: the purpose of this study is to determine the reliability and responsiveness of the pain self-efficacy questionnaire (pseq) in a chronic low back pain (clbp) population referred to the danish rheumatism associations´ rehabilitation centre sano aarhus.

chronic low back pain (clbp) is a highly prevalent health condition, and the leading cause of years lived with disability both globally and in denmark. in the majority of patients with clbp, no underlying pathology or cause can be identified and clbp is acknowledged to be multifactorial. clbp is defined by symptoms lasting for a period longer than three months. the high prevalence of clbp causes a substantial impact on patients and their families, communities and health-care systems, as well as a financial burden. besides pain and disability people with clbp often experience psychosocial consequences with signs of anxiety and depression and effects on social, leisure, and work life. an important component in rehabilitation is documentation of treatment outcomes. this demands that a change over time can be measured. to determine effect, the measurement tool must detect real or important change over time. this requires the measurement tool is reliable, and therefore will show no real or important change in periods where the patient is stable. if the measurement tool shows real or important change, in periods where there is no change in the patient state, the results can not be predicted as an effect from an intervention, but due to uncertainty of measurement tool. the measurement tool is selected by the recommendation of literature and involvement of clinicians and patients at sano, and examines patient with clbp. it is found necessary to determine the reliability and responsiveness of the pseq on the clbp population referred to sano aarhus. data will be electronically entered in, stored in and collected from sanos internal database (sanobasen).

Eligibility criteria:
inclusion criteria: • referred to the danish rheumatism associations' rehabilitation centre sano exclusion criteria: * a rated physical status of \> 3 according to the american society of anesthesiologists physical status classification system * axial spondyloarthritis * spinal fracture within the last 3 months * severe osteoporosis * active cancer * active psychiatric pathology assessed by general practitioner before referral * pregnancy * low danish language skills * no e-mail address
clinical study of titrating peep of different methods on right heart function

Conditions: ARDS, Human

Summary: to observe the influence of different methods titrating peep on right heart function and pulmonary artery pressure in ards patients .

30 patients who diagnosed as ards were included in this study.then set peep with respectively ards net 、eit and esophageal pressure in breathing machine . recorded diameter of right and left ventricular tam tapse pulmonary artery pressure.objective to evaluate the correlation between the level of peep in three methods and the right heart function and pulmonary artery pressure in ards patients .

Eligibility criteria:
inclusion criteria: * patients admitted to icu diagnosed of modecate to severe ards (berlin criteria) * patients age between 18 years old and 80 years exclusion criteria: * patients with chronic respiratory diseases such as copd. * ventilated because of oesophageal surgery in the previous 12months. * patients who cannot obtain clear ultrasound images due to thoracic surgery ,massive pleural effusion. * oesophageal bleeding in previous 30 days history of oesophageal varices. * facial trauma and surgery.
phase i study of combined immune cell therapy in patients with stage 4 colorectal cancer with metastatic lesion who failed prior standard of care

Conditions: Colorectal Cancer Stage IV; Metastatic Colorectal Cancer

Summary: to evaluate the safety, immune response, and potential efficacy of combined immune cell therapy in patients with stage 4 colorectal cancer who have failed standard treatment and have unresectable lesions or metastatic lesions.

the combined immune cell therapy has a strong potential to improve treatment outcomes in several cancers, but problems related to manufacturing complexity, immunocompatibility, and poteintial toxicity may also arise. this clinical study was designed to address these challenges and to establish the safety and potential efficacy of combined immune cell therapy for unresectable colorectal cancer. this is a phase i study to evaluate the safety and potential efficacy of combined immune cell theapy, and obtain the recommended dose and infusion plan.

Eligibility criteria:
inclusion criteria: * those who have been histologically or cytologically confirmed as adenocarcinoma among colorectal cancers * those with at least one measurable or evaliable lesion by recist v1.1 * those who fail standard treatment for metastatic colorectal cancer (failure of treatment is defined as failure of not only progression of the disease or recurrence after treatment, but also unacceptable side effects or maintenance of the treatment process) * ecog performance status 0 or 1 person * a person who can draw about 100 cc of whole blood for the manufacture of immune cells * weight: more than 50 kg for men and more than 45 kg for women * hb: 9.0 g/dl or higher (registerable if hemoglobin levels recover to 10.0 g/dl or higher during the screening period); however, transfusions within 7 days prior to screening to meet this standard are not allowed) * appropriate contraceptive regimen up to 2 months after clinical research drug administration * a person who voluntarily decides to participate after receiving a sufficient explanation for this clinical study and agrees in writing exclusion criteria: * brain metastasis patients who have symptoms or need treatment \[however, patients with stable brain metastasis who have no symptoms and do not need treatment (excluding anticonvulsants in maintenance therapy) can register\] * a person with a systemic disease that is inappropriate to administer anticancer drugs according to the researcher's judgment * those with the following cardio-cerebrovascular diseases as of the time of screening * a person who is hiv-positive * those determined that the researcher was not suitable for participation in this clinical study as a result of the active infection (hbv, hcv) test * a person with acute or severe infection * those who have autoimmune diseases or have a history of chronic or recurrent autoimmune diseases * those with a history of organ transplants * a hematopoietic stem cell transplant patient

Keywords: immune cell therapy colorectal cancer dendritic cell natural killer cell cytotoxic t cell
a pilot study to evaluate the role of high-dose ranibizumab (2.0mg) in the management of amd in patients with persistent/recurrent macular fluid less than 30 days following treatment with intravitreal anti-vegf therapy (the last study)

Conditions: Age Related Macular Degeneration

Summary: this is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-vegf therapy. patients will be masked to their treatment assignment. the study duration is anticipated to be 12 months and will enroll 30 subjects . patients will be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.


Eligibility criteria:
inclusion criteria: subjects will be eligible if the following criteria are met: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 50 years * subfoveal neovascularization secondary to amd * best corrected visual acuity in the study eye between 20/30 to 20/400 using an etdrs chart * documentation of the presence of subretinal fluid and/or cystoid macular edema on sd-oct less than 30 days following at least six months of anti-vegf therapy * presence of fibrosis, hemorrhage, or other hypofluorescent lesions should not obscure greater than 50% of the cnv lesion exclusion criteria: subjects who meet any of the following criteria will be excluded from this study: * pregnancy (positive pregnancy test) or lactation * premenopausal women not using adequate contraception. the following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an iud, or contraceptive hormone implant or patch. * participation in another simultaneous medical investigation or trial * prior treatment with anti-vegf therapy in the study eye within 30 days of bsl * prior treatment with triamcinolone in the study eye within 6 months of bsl. * prior treatment with dexamethasone in the study eye within 30 days prior to bsl * past treatment with pdt or thermal laser in the study eye * intraocular surgery (including cataract surgery) in the study eye within 2 months preceding bsl * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd in the study eye * active intraocular inflammation (grade trace or above) in the study eye * current vitreous hemorrhage in the study eye * history of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye * active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * uncontrolled glaucoma in the study eye (defined as iop ≥ 30 mmhg despite treatment with anti-glaucoma medication) * history of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment. * history of allergy to fluorescein, not amenable to treatment
effect of sms reminder and free eye drops on follow-up adherence after trabeculectomy surgery in rural china

Conditions: Glaucoma; Adherence

Summary: the purpose of the study is to use a randomized controlled design to determine the impact of a sms messaging associated with free eye drops intervention on the following outcomes among patients after trabeculectomy surgery in rural china.

sms message reminder is a system which can sent re-visit information to remind the patient about the revisit time and address. the investigators can use the sms system to find out if it is a useful to reduce the not-attended rate of the revisit appointment among the rural patients.

Eligibility criteria:
inclusion criteria: * all the patients after trabeculectomy surgery in 4 cooperated rural hospitals exclusion criteria: * both the patient and his/her caretakers don't have cellphone or the one who has cellphone but don't know how to use the sms function.
the effects of apple derived flavanols on cardiovascular disease risk (flavascular study)

Conditions: Blood Pressure

Summary: fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease (cvd). the protective effect may be ascribed to compounds contained within these foods, called flavonoids. flavanols (epicatechin and procyanidins) are a particular group of flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine. there is evidence to suggest that ingestion of flavanol rich foods and beverages beneficially alter 'markers' of cvd risk (e.g. blood pressure). the aim of this study is to determine the acute and chronic effects of apple derived flavanols on some risk markers for cvd.

this study is a single arm randomized, 4-phase crossover design.

Eligibility criteria:
inclusion criteria: * men and women ≥ 50 years of age * systolic blood pressure 130 - 159 mmhg exclusion criteria: * history of cardiovascular events such as stroke, myocardial infarction trans- ischaemic attacks or peripheral vascular disease * kidney or liver disease/problems * diabetes * asthmatics (unless no medication taken for 1 year - occasional use will be assessed on an individual basis) * prescribed anti-hypertensive medication * hrt (unless the participant has used the therapy for ≥ 6 months) * lipid lowering therapies e.g. statins * other medications that may affect any of the study outcome measures e.g. vasodilators (this will be assessed on a case by case basis) * current smoker (or stopped for less than 3 months) * throat surgery or neck injury * allergy to apples * consumption of fish oil supplements unless willing to discontinue them up for 4 weeks preceding the start of the study and for the duration of the study. (all other supplements will be assessed on a case by case basis) * gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated). * parallel participation in another research project which involves dietary intervention * participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 ml. * has donated or intends to donate blood within 16 weeks prior to or during the study period. * depressed or elevated blood pressure measurements (\ 160/100 (mmhg)) during the course of the trial.

Keywords: blood pressure flavanols cardiovascular disease
the effect of probiotics on the clearance of the human papillomavirus and on cytological lesions caused by the virus

Conditions: HPV-related Cytological Abnormalities on PAP Smear (LSIL)

Summary: aim: in this project proposition the investigators would like to examine the effect of immune modulation by probiotics on the clearance of hpv-infections. this study provides a model for viral infection but also for cancer precursors. this would be an excellent model (and the only possible short-term model) to examine an effect on cancer precursors. cancer precursors (cytological abnormalities such as l-sil) are a scientifically accepted surrogate endpoint for cervical cancer, for example in hpv-vaccine studies. research question: does daily intake of probiotics lead to a better immune-response in hpv-infected women, i.e. does it facilitate clearance of the virus and/or regression of cytological lesions?


Eligibility criteria:
inclusion criteria: * women with a new lsil diagnosis an hpv positivity on pap smear exclusion criteria: * women over 65 * immunocompromised patients (because of disease or drugs)
minimal invasive volar plating versus cast immobilization for treatment of stable non-displaced distal radial fractures.

Conditions: Radius Fracture Distal

Summary: nondisplaced distal radial fractures are nowadays treated by plaster cast immobilization. in this study, the investigators challenge this classical standard treatment with a surgical solution: minimal invasive volar plating with pronatus quadratus sparing approach. potential benefits of this surgical treatment are higher cost effectiveness, economical benefit, earlier recuperation of professional and recreational activities, earlier functional recuperation by faster clinical recovery (range of motion, grip strength) and decreased risk of secondary fracture displacement. potential drawbacks are surgical risks and complications.

randomized controlled trial number still to be determined by power analysis on economical outcome measurement similar study number = 90 randomization by computer. rz tienen, dr goorens level 4 hand surgeon inclusion criteria: * stable distal radial fractures (volar tilt \<10° dorsal tilt, \<2mm impaction, \<2mm articular depression) * 18 - 65 years, professional active exclusion criteria: * associated lesions, open fractures, unstable, displaced fractures * neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist treatment 1. cast treatment: 6 weeks with 1 plaster exchange of after 2 weeks 2. minimal invasive plating: no cast followup 2 weeks, 6 weeks, 3 months, 6 months, 1 year primary prom: * cost effectiveness: qaly sf-36 * direct costs: surgery, hospitalisation, follow-up consultations, imaging, medication, wound care, nurse cost, physiotherapy cost * indirect costs: loss of productivity (sf-hlq) * health insurances costs * confounding factors * independent vs servant * insurance? * work type? * age, sex, dominance * work absence, professional recuperation * recreational sport resumption secondary prom * rom (f/e/rd/ud/p/s) * grip strength (jamar) * pain (vas) * dash scare, prwe score * satisfaction (vas), would you do it again? * rx ulna variance, radial tilt * complications

Eligibility criteria:
inclusion criteria: * stable distal radial fractures (volar tilt \<10° dorsal tilt, \<2mm impaction, \<2mm articular depression) * 18 - 65 years, professional active exclusion criteria: * associated lesions, open fractures, unstable, displaced fractures * neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist

Keywords: minimal invasive osteosynthesis conservative treatment cost effectiveness
aripiprazole lauroxil for preventing psychotic relapse after an initial schizophrenia episode

Conditions: Schizophrenia; Schizoaffective Disorder, Depressive Type; Schizophreniform Disorder

Summary: this 12-month study will evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia.

this is a single-site 12-month open-label randomized study comparing the efficacy of the fda-approved long-acting formulation of aripiprazole lauroxil to the efficacy of oral aripiprazole among patients with a recent onset of schizophrenia, schizophreniform, or schizoaffective (depressed) disorder. all assessments and treatment will take place at the ucla aftercare research program (300 ucla medical plaza, los angeles, ca 90095), which is a program that specializes in the treatment and study of individuals with a recent onset of schizophrenia. the primary goal is to evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia. all patients on oral medications will, at least initially, be treated with oral aripiprazole.

Eligibility criteria:
inclusion criteria: 1. is between 18 and 45 years of age, inclusive, at screening. 2. has a diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder, depressed type. 3. has a first episode of a psychotic illness that occurred within the 24 months before entry. 4. fluency (oral and written) in the english language. 5. exhibits tolerability to ari oral during the stabilization period. 6. resides within commuting distance of the ucla aftercare research program in a stable living situation where the patient can be located. 7. agrees to abide by the contraceptive requirements of the protocol. 8. additional criteria may apply exclusion criteria: 1. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury. 2. premorbid iq less than 70. 3. is currently pregnant or breastfeeding, or is planning to become pregnant during the study. 4. is currently on a long-acting injectable antipsychotic medication and it is clinically contra-indicated to switch to oral aripiprazole. 5. history of poor or inadequate response to an adequate trial of oral or injectable aripiprazole. 6. has received al-lai or im depot aripiprazole within two months prior to randomization. 7. has alcohol or substance abuse as a prominent clinical problem or makes the primary diagnosis not possible to confirm. 8. is currently being treated with clozapine. 9. has participated in a clinical drug trial involving any drug within the past two months. 10. has a current dsm-5 diagnosis of bipolar disorder, or schizoaffective disorder, bipolar type, based on the screening scid. 11. patient is an imminent danger to himself/herself. 12. history of neuroleptic malignant syndrome, malignant hyperthermia, or clinically significant tardive dyskinesia. 13. additional criteria may apply.
retrospective study in patients who have had a difficult intubation.

Conditions: Aspiration; Pneumonia

Summary: the investigator wants to investigate if there is an increased risk of postoperative pulmonary problems in patients who have had an intubation where there was need for more than a laryngoscope.

a difficult intubation is defined as an intubation in which more than a laryngoscope was needed. afterwards patient data retrieved from the clinical work station: age, type of operation and time, date, type of anaesthesia, de tools needed for intubation, time needed for intubation and anaesthesia. in the clinical work station of the hospital the investigator will search for the following data in these selected patients: preoperative comorbidities, home medication, type of postoperative pulmonary problems and the treatment that was given, time of hospital stay and which department the patient stayed. patients with a difficult intubation will be linked to a patient with a corresponding medical history and type of operation but without a difficult intubation. the investigator will look for the same parameters of these patients in the clinical work station. by means of an odds-ratio the relative risk of a pulmonary complication after a difficult intubation in connection with an easy intubation with different variables can be calculated.

Eligibility criteria:
inclusion criteria: * every patient who had an intubation where another device than a laryngoscope was necessary exclusion criteria: * n/a

Keywords: risk on aspiration postoperative difficult intubation