Kornimate/medical-research-clean huggingface dataset:
new oxymetry indices in critical limb ischemia

Conditions: Critical Limb Ischemia

Summary: transcutaneous oxygen tension (tcpo2) at rest, sensitized by oxygen inhalation tests, is widely applied for the evaluation of chronic critical limb ischemia (cli). if foot tcpo2 measurements are good prognostic factors of the risk of amputation or the probability of wound healing without amputation, they have never proven their hability to estimate the risk of death in patients with critical limb ischemia. on the one hand, studies have considered only the response observed on legs without considered the thoracic variations. on the other hand, the variability of the tcpo2 signal has never been analyzed as a prognostic factor. the objective of the novice study is therefore to assess, first, whether the variability of resting tcpo2 values at thoracic probe as well as at affected limb probe is a morbidity-mortality prognostic factor and secondly, to evaluate during the oxygen tests, if the measurement of the amplitude of the distal responses in ischemic zone compared to the response observed in thoracic probe is a prognostic factor of morbi-mortality.

this is an ambispective (both retrospective and prospective) cohort study in which any major patient, referred for resting (transcutyaneous oxygen pressure = tcpo2) for suspicion of critical limb ischemia, is included retrospectively and prospectively from november 2018 to october 2020. tcpo2 recording are analysed to determine specific parameters (signal variability and response top oxygen). a morbidity-mortality follow-up is carried out between 12 and 15 months after the tcpo2 measurement. a kaplan mayer study of these indices against male (major adverse lower limb events ) and mace(major adverse cardiovascular events) will be carried out.

Eligibility criteria:
inclusion criteria: * suspicion of critical limb ischemia * reffered for tcpo2 absence of rebuttal to the use of the data by the patients exclusion criteria: * no available tcpo2 recording * rejection of the follow up by the patients

Keywords: transcutaneous oximetry oxygen peripheral artery disease follow-up
a journey to balance: development and validation of individualized life balance intervention for depression

Conditions: Depression Disorders

Summary: the goal of this clinical intervention study is to enhance life balance in community-dwelling individuals with depression. the main question it aims to answer is: can an individualized life balance intervention, combining group sessions and telephone support, effectively improve life balance, time management, functional roles, quality of life, and reduce depression severity in individuals with depression? participants will: complete baseline assessments including demographics, illness-related information, and the canadian occupational performance measure (copm). participate in four weekly, two-hour group sessions tailored to their individual needs identified through the copm assessment. receive telephone support 1-3 days before each group session. complete post-intervention assessments immediately after the four-week program and again one month later.


Eligibility criteria:
inclusion criteria: * diagnosed with depression by a psychiatrist. * assessed by a psychiatrist to be in a non-acute phase, approximately 4-8 weeks or more post-onset. * adults aged 20 or above with independent behavioral capacity. * literate, with basic cognitive function. exclusion criteria: * diagnosis of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, substance-related and addictive disorders, neurodevelopmental disorders, neurocognitive disorders, or substance/medication-induced depressive disorders. * significant physical illnesses requiring active and long-term treatment, such as cancer, cerebrovascular disease (stroke), spinal cord injury, congenital or genetic diseases, chronic renal failure, systemic autoimmune diseases, or burns. * lack of willingness to participate in the study.

Keywords: depression life balance individualized intervention
soft tissue outcomes of badly broken-down teeth treated with surgical extrusion compared with immediate implant placement

Conditions: Broken Teeth

Summary: many patients suffer from badly decayed anterior teeth mostly in young age, causing esthetics and functional issues. this may be due to more than cause as fights, contact sports, accidents and falls. however; implant placement might not be the treatment of choice in some situations such as: medically compromised patients with absolute contraindications for implant placement or requiring extensive augmentation procedures, growing patients, patients with financial limitations, in addition to patients living in rural areas with no access for cbct machines. moreover, clinicians must be aware of cost-to-benefit ratios when attempting to recommend a specific treatment modality, especially in patients having financial limitations. regarding the aforementioned conditions, surgical extrusion might be considered a cost-effective 'often overlooked' alternative compared to immediate single-tooth implant placement. regarding healing time, cost, soft and hard tissue outcomes, surgical extrusion may be a good alternative yielding better soft tissue results as we preserve the natural tooth with the whole periodontium.


Eligibility criteria:
inclusion criteria: 1. patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients) 2. single rooted teeth; should be single with adjacent intact or restored neighboring teeth. more than one tooth may be included in the same arch. 3. more than 1:1 crown root ratio, so that the crown to root ratio is 1:1 after extrusion and restoration exclusion criteria: 1. badly broken-down teeth with active signs of infection. 2. teeth with vertical root fracture. 3. teeth with severely tapered root. 4. diabetic patients, assessed by measuring glycosylated hemoglobin (hba1c). patients with an hba1c level greater than 8 will be excluded. 5. potentially uncooperative patients who are not willing to go through the proposed interventions. 6. moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day). 9 7. history of radiation therapy and/or chemotherapy to the head and neck, or bone augmentation to implant site. 8. labial cortical bone fenestration diagnosed from cbct. 9. patients with systemic disease that may affect normal healing. 10. psychiatric problems, emotional instability, and unrealistic esthetic demands. 11. bruxism.
endosleeve in adolescents

Conditions: Obesity, Childhood

Summary: in this study, the investigators assess the safety and efficacy of endoscopic sleeve gastroplasty in adolescents with obesity.

endoscopic bariatric therapy (ebt) is an emerging, rapidly evolving field that aims to serve as a middle ground between safe, albeit poorly effective medical weight loss strategies and drastic but effective bariatric surgery. endoscopic sleeve gastroplasty (esg) is a procedure that restricts the stomach to a sleeve-like configuration by utilizing full-thickness sutures that plicate the greater curvature of the stomach. emerging data from adult populations shows an acceptable safety, tolerability and efficacy profile. based on analysis that confirmed the safety and efficacy of esg in adult patients who undergo the procedure under a standardized protocol and clinical care pathway, the investigators planned to study its effects on adolescents in a specialized center that offers surgical, endoscopic, and medical management of obesity under a standardized protocol and care pathway.

Eligibility criteria:
inclusion criteria: * bmi that is \>120% of the 95th percentile for age and gender * written informed assent/consent, with concomitant parental consent for patients aged ≤17 years exclusion criteria: * age \<10 years * age \>21 years * presence of large hiatal hernia * previous gastric surgery * cognitive impairment
does fluoxetine have an effect on the cns crf systems in women abused in childhood?

Conditions: Major Depressive Disorder

Summary: the primary objective of this project is to determine whether treatment with the ssri, fluoxetine versus placebo reverses alterations in the central crf system induced by early life stress experiences (i.e. childhood sexual and/or physical abuse) in cases with and without major depression. we also evaluate whether neuroendocrine changes after ssri treatment correlate with clinical improvement.

we compare indices of central crf activity (i.e. acth and cortisol response to crf stimulation test) before and after 8 weeks of treatment with either fluoxetine or placebo between women with a history of childhood abuse (early life stress, els) and current major depression (els/mdd), women with a history of childhood abuse without major depression (els/non-mdd), and women without a history of childhood abuse and major depression (non-els/mdd). changes in neuroendocrine responses to crf are correlated with psychological outcome measures. we hypothesize that treatment with fluoxetine will normalize altered neuroendocrine responsiveness in cases with els and that this normalization will be correlated with improvement of symptoms of depression and anxiety.

Eligibility criteria:
inclusion criteria: 1. for all subjects female gender; 2. for subjects assigned to the mdd groups, current dsm-iv diagnosis of mdd; 3. for subjects assigned to the early-life stress group, repeated (once per month or more for at least year) sexual or physical abuse before the age of 12 years by a perpetrator at least 5 years older at the time; 4. for all subjects, age of 18 to 45 years; 5. regular menstrual cycle and assessment in the early follicular phase as verified by sex steroid measures. exclusion criteria: 1. for all subjects, gender identity disorders; 2. for all subjects assigned to non-mdd groups, dsm-iv diagnosis of current mdd; 3. for all subjects assigned to the group without early-life stress, major stress experiences before the age of 12 years, such as separation from parents, neglect, parental loss, accidents, severe illness or natural disaster; 4. for all subjects, significant medical illness, such as gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease, organic brain disease, or cancer as determined by history, physical examination, ecg, and laboratory tests; 5. pregnancy or nursing; 6. for all subjects, past or current presence of psychotic symptoms or bipolar disorder; 7. for all subjects, current presence of psychoactive substance abuse/dependency or eating disorders; 8. for all subjects, hormonal medication; 9. for all subjects, psychotropic medication in the four weeks prior to study entry; 10. for all subjects, inability to provide informed consent.

Keywords: early life stress hpa-axis crf
acceptability of the somnomat casa for the treatment of parkinson's disease

Conditions: Parkinson Disease

Summary: this pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (vs) applied by a rocking bed (somnomat casa) for two months in patients with parkinson's disease.

twelve pd patients will receive overnight vs in their familiar home environment for two months via the rocking bed. participants will be given questionnaires to obtain feedback on the acceptability of the nocturnal intervention device. effects on sleep, motor and non-motor symptoms, and quality of life will be assessed using the appropriate validated scales and questionnaires. the corresponding assessments will be performed before, during, and two month after the intervention. unobtrusive pressure-sensitive textiles and bioradar will be used to record physiological variables such as body position, movements, breathing rate, and heart rate to correlate them to the clinical assessments as well as to markers obtained from actigraphy devices that the patients will be wearing throughout the study. the primary feasibility outcomes include rate of accrual and retention, adherence to the protocol, acceptability and satisfaction with intervention using rocking bed specific questionnaires, semi-structured interviews, and data collected automatically from the bed. to assess the preliminary effectiveness of the intervention the secondary outcomes are the change in subjective sleep quality, daytime sleepiness, pd related sleep disorders, mentation, behaviour, mood, activities of daily living, motor performance, and quality of life.

Eligibility criteria:
inclusion criteria: * informed consent signed by the subject * pd according to the mds clinical diagnostic criteria for parkinson's disease * suffering from reduced sleep quality as defined by pathological cut-off (score of \> 5) on the pittsburgh sleep quality index (psqi) * patients with stable antiparkinsonian, antidepressant, and sleep medications for six weeks before intervention and maintained on stable medication during the intervention period * treatment without bilateral deep brain stimulation * fluent in german exclusion criteria: * brain disease other than parkinson's disease (e.g. atypical parkinsonism, alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.). * dementia as defined by a moca score lower than 24/30 * weight \> 150kg * depression with acute suicidal ideation * presence of major ongoing psychiatric illness such as acute non-controlled psychosis * poor general health (e.g. non-controlled diabetes, uncontrolled arterial hypertension, therapy for malignancy) * inability to follow the procedures of the study, e.g. filling out patient questionnaires due to language problems, psychological disorders, dementia, etc. of the participant * participation in another interventional trial within the 30 days preceding and during the present study * participants with psqi score lower or equal 5

Keywords: vestibular stimulation sleep quality rocking bed feasibility
impact of crisp on self-efficacy, loneliness, and depression

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to examine the effects of an innovative program, entitled crisp (community integration for socially isolated patients), on improving self-efficacy and assessing whether improved self-efficacy helps to reduce depression and loneliness of people with ms.

whether crisp increases self-efficacy while decreasing loneliness and depression

Eligibility criteria:
inclusion criteria: * age 18 to 65 years old. * must have a definitive diagnosis of ms by a physician. * must understand english at 6th grade level since the crisp program requires participants to comprehend the educational information presented in english. * agree to participate in 12 group sessions over 12 weeks; * must have the ability to complete questionnaires in english since the outcome measures used for the study are in english. * must be able to commute to the site destinations exclusion criteria: * have an actively psychotic axis i disorder. * have a significant axis ii disorder of borderline personality disorder or schizoid personality disorder. * have a diagnosis of another neurological condition aside from ms. * inability to comply with study requirements/visits.
efficacy and safety study of botulinum toxin type-a (dysport®) in continent female subjects suffering from idiopathic overactive bladder

Conditions: Overactive Bladder

Summary: the purpose of this study is to determine the optimal dose of botulinum toxin type a injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.


Eligibility criteria:
inclusion criteria: * the subject has a diagnosis of idiopathic overactive bladder, without incontinence. * the subject has ≥ 3 urgency episodes over the course of the 3 days immediately preceding the baseline visit. * the subject has ≥ 24 episodes of micturition over the course of the 3 days immediately preceding the baseline visit. exclusion criteria: * bladder outlet obstruction (on urodynamic assessment). * post-micturition residual volume \> 150 ml (ultrasound assessment). * evidence of a urinary tract infection at screening or baseline in the study. * active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney stones.
effect of different injection speeds for spinal anaesthesia in caesarean section

Conditions: Pregnancy; Effects of; Anesthesia, Spinal and Epidural; in Pregnancy

Summary: the purpose of this study is to investigate if prolonging the speed of injection during spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements thereby making it safer for the mother and foetus.

we plan to investigate if by varying the speed of injection during spinal anaesthesia, will there be a difference in the incidence of hypotension. hypotension is a common complication especially for pregnant women undergoing caesarean section. a high speed of injection can theoretically cause a higher spread of anaesthetic, which may increase the incidence of hypotension. we want to know if by prolonging the injection time, will this lead to a reduction in a rate of hypotension.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * singleton term pregnancy * american society of anesthesiologists (asa) class i-ii exclusion criteria: * severe pre-eclampsia * contraindications to spinal anaesthesia * height \ 180cm * weight ≥100kg * baseline systolic bp \<90 mmhg * baseline systolic bp \>150mmhg * category 1 urgency for delivery

Keywords: lower segmental caesarean section (lscs) speed of injection spinal anaesthesia anesthesia
colchicine randomized double-blind controlled crossover study in behcet's disease

Conditions: Behcet's Syndrome

Summary: colchicine was first used in behcet's disease (bd), in 1977. there are controversial reports of the efficacy of colchicine in bd. for some experts the unresponsiveness of some patients could be explained by genetic difference between the silk road bd and sporadic bd from other parts of the world. to test this hypothesis (the inefficacy of colchicine in the silk road bd), we designed a randomized double-blind controlled crossover study in iran, which is in the middle of the silk road, and has the second highest prevalence of bd in the world.

patients: they were selected as consecutive patients. the entry criteria was: age between 14 and 60 years, confirmed diagnosis of behcet's disease, absence of major organ involvement (eye, brain, lung, and cardio-vascular involvement), having at least one active symptom, and no treatment for at least one month. patients were explained the study design and they gave a signed written consent. during the two phases of study, if a major organ involvement appeared, the patient was moved out of the study. all patients fulfilled the new international criteria for behcet's disease. method: patients were randomized at the study entry to take either colchicine or placebo. at 4 months, they were crossed over. those who were taking colchicine went on placebo and those on placebo went on colchicine. each patient tried therefore, both colchicine and placebo. the primary outcome was the effect of colchicine on the disease activity index, the ibddam (16-17). to calculate the overall ibddam of the baseline, the ibddam of the last 12 months (prior to the study) of each manifestation was calculated and added together. the overall disease activity index was then divided to the number of months (12 months) to have the mean activity index per month. ibddam was then measured every 2 months (in the middle and at the end, in each arm of the study). the total ibbdam of the 4 months was then divided by 4 to have the mean activity index per month. the secondary outcome was to see how the individual symptoms responded to colchicine (ibddam of each manifestation). statistical analysis: the analysis was done by the intention to treat method. as the difference between ibddam before and after treatment had normal distribution student t test for paired samples were used to evaluate the outcome in the colchicine and the placebo group. as the levene's test showed the homogeneity of variance, anova (one way) was used to test the effect of treatment (colchicine and placebo) and gender on patients' outcome. the dependent variable was the difference between ibddam (before and after the treatment). the independent variables were the treatment, and the gender. spss 15 was used for all statistical calculations.

Eligibility criteria:
inclusion criteria: * patient's who fulfilled the international criteria for behcet's disease. exclusion criteria: * major organ involvement * hypersensitivity reaction

Keywords: oral aphthosis genital aphthosis psuedofolliculitis erythem nodusom joint manifestations colchicine
open-label extension (ole) study of plecanatide for chronic idiopathic constipation (cic)

Conditions: Chronic Idiopathic Constipation

Summary: this is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with chronic idiopathic constipation (cic).

this is an open-label extension study of plecanatide in the treatment of patients with cic who previously completed synergy protocols sp304-20210 and sp304203-00 (the cic3 study). the planned duration of each patient's study participation is up to 411 days, including up to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks after the last dose of study drug.

Eligibility criteria:
inclusion criteria: * patient completed a previous double-blind plecanatide study and was compliant with the study requirements. * patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study. exclusion criteria: * patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of day 1. * patient has a medical history of hepatitis b, hepatitis c or human immunodeficiency virus (hiv) infection. * patient has taken a protocol-prohibited drug without the appropriate washout period.

Keywords: plecantaide chronic idiopathic constipation chronic idiopathic constipation synergy cic cic study cic ole cic ole study ole ole cic ole cic3 open label open label study long term long term study extension extension study