Kornimate/medical-research-clean huggingface dataset:
flossing protocol and manual therapy in young subjects with recurrent ankle sprains

Conditions: Young People

Summary: the most frequent lateral ankle sprain mechanism consists of talocrural plantarflexion added to a subtalar inversion. the anterior talofibular ligament, in plantar flexion, suffers maximum stress, being very sensitive to injury mechanisms with inversion of the foot, being the cause of up to 70% of sprains. the risk of injury recurrence must be taken into account. in sports practice, this percentage of recurrence is especially relevant. randomized clinical study. participants will be randomized to a control or experimental group. the dependent variable will be the range of motion in ankle dorsiflexion. secondary variables will be pressure pain threshold, and stability of the foot and ankle. three evaluations will be carried out: before the start of the study (t0), after the intervention (t1) and after a 4-week follow-up period (t2). all evaluations will be performed by one evaluator, blinded to player assignment the intervention consists of the application of a treatment protocol based on an initial active warm-up consisting of 3 active exercises, walking for 1 minute performing slow and controlled movement of the ankle, raising the heels, 15 repetitions, dorsiflexion of the ankle in the standing position. gentleman, 15 reps. subsequently, the floss band will be placed, performing again the 3 active warm-up exercises with the band on. after this, the passive manual techniques will be carried out for the remaining time, removing the flossing at the end of the latter, and actively mobilizing again.


Eligibility criteria:
inclusion criteria: * young people between 18 and 22 years old * who have suffered a previous sprain * no chronic or degenerative musculoskeletal pathologies of the ankle or knee * that they do physical activity regularly. exclusion criteria: * have suffered a sprain in the last 6 months * being receiving another physiotherapy treatment at the time of the study * not signing the informed consent document.
virtual reality to reduce periprocedural anxiety during invasive coronary angiography

Conditions: Anxiety; Anxiety State

Summary: introduction patients undergoing invasive coronary angiography experience anxiety due to various factors. this can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. benzodiazepines are commonly used to reduce periprocedural anxiety, although the effect is modest. vr is an promising nonpharmacological intervention that can be used to reduce anxiety in patients undergoing an invasive coronary angiography. methods and analysis a single-center open-label randomized controlled trial was performed to assess the effectiveness of add-on vr therapy on anxiety in 100 patients undergoing invasive coronary angiography and experiencing anxiety in periprocedural setting. the primary outcome is the nrs anxiety score measured just before obtaining arterial access. secondary outcomes are physiological measures of anxiety and the state-trait anxiety inventory, perceived stress scale, and igroup presence questionnaire. the nrs anxiety level and physiological measurements will be taken at five scheduled times between pre procedural, peri and post procedural. the state-trait anxiety inventory and perceived stress scale will be performed prior to coronary angiography and the state-trait anxiety inventory (state form) and the igroup presence questionnaire will be performed post-intervention.


Eligibility criteria:
inclusion criteria: * patient ≥16 years undergoing elective cardiac catheterisation * patient is willing and able to comply with the study protocol * nrs anxiety score ≥ 4 exclusion criteria: * history of dementia * severe hearing/visual impairment not corrected * depression or anxiety disorder

Keywords: virtual reality therapy procedural anxiety invasive coronary angiography nonpharmacological anxiolysis
double-blind, randomised study of a3384 in bam/bad

Conditions: Bile Acid Malabsorption

Summary: the purpose of this trial is to determine the efficacy and safety of a3384 administered to patients with bile acid malabsorption (bam)/bile acid diarrhoea (bad).


Eligibility criteria:
inclusion criteria: * patient meets protocol specified criteria for bile acid malabsorption/bile acid diarrhoea * patient has successfully completed study requirements with no clinically relevant findings for physical exam, ecg, laboratory tests as applicable exclusion criteria: * medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study * patient needs medications prohibited as specified in the protocol
short-term effects of pt on physical activity

Conditions: Low Back Pain; Motor Activity; Chronic Pain

Summary: the primary purpose is to examine the impact that physical therapy (pt) interventions, including manipulations, have on physical activity levels outside of the clinical environment in persons with low back pain (lbp) as measured both objectively with an accelerometer and subjectively with questionnaires. the secondary purpose is to determine if a relationship exists between objective physical activity, self-perceived disability pain catastrophizing thoughts, bmi, age, six-minute walk distance, lower extremity muscle endurance. the tertiary purpose is to assess the predictive value that a standing manual lumbar unloading technique has for relief of pain following manipulation

at session 1: participants are screened for eligibility. baseline outcome measures are conducted (self-report questionnaires and physical performance tests). accelerometer which is an instrument to measure physical activity is issued. at session 2 (to occur at least one-week later): accelerometer data is retrieved and downloaded to a computer. participant numerically rates low back pain level at rest and in most painful position. participant receives a manual distraction procedure. participant rates pain level again. participant starts the physical therapy intervention (manipulation of the spine, muscular strengthening and cardiovascular exercise, education). accelerometer is reissued again. at session 3 (at least one-week later): accelerometer is collected and data is retrieved. participant continues with the intervention (manipulation, exercise, education).

Eligibility criteria:
inclusion criteria: * 1. patient referred to outpatient pt with a lbp related diagnosis 2. lbp without radiating pain distally to the knee \> 3 months in duration 3. ability to read and write in english or spanish 4. age between 18 and 70 years 5. able to ambulate independently without assistive devices 6. access to a computer or cell phone with an email address and/or the ability to receive short text messages exclusion criteria: * 1. no previous diagnosis, radiological evidence, or clinical signs and symptoms of instability, spondylolysis, spondylolisthesis, fracture, tumor or metastases to the spine 2. no clinical indication of nerve root pathology such as: straight leg raise less than 45 degrees, asymmetric lower extremity deep tendon reflexes, lower extremity muscle strength deficits or radiating pain, numbness or tingling below the knee 3. no surgical or biological fusion to the spine 4. no previous spinal surgery 5. no known diagnosis of osteoporosis or rheumatoid arthritis 6. no use of oral steroids within the past 6 months 7. no epidural injection over the previous 4-weeks to the lumbar spine region 8. no current litigation, workman's compensation or disability claim for a low back injury 9. no known pregnancy
smartphone mindfulness meditation for patients with rheumatic diseases

Conditions: Inflammatory Arthritis; Scleroderma; Myositis; Sjogren's Syndrome; Systemic Lupus Erythematosus; Vasculitis

Summary: this study will assess the effect of a mindfulness meditation program administered via a smartphone application on health-related quality of life for patients with rheumatic disease.

after obtaining written consent, participants will be asked to download and use the calm meditation smartphone application everyday for a 30-day period. participant demographics and clinical information will be collected at baseline. participants will additionally be asked to complete questionnaires concerning health-related quality of life (hrqol) as well as mental health, stress, and self-efficacy at baseline and at the end of the 30 day study period. a brief check-in via telephone will be conducted on day 15. participants using the calm app will be compared to participants receiving usual care who will be asked to complete identical sets of questionnaires. the participant may choose whether they join the calm application vs usual care (questionnaires only) group on a voluntary basis; there is no pre-assignment. the calm application is a publicly available program that is available to any patient independent of this study.

Eligibility criteria:
inclusion criteria: established patients of the johns hopkins (jh) rheumatology division will be eligible for participation. * participants must have one of the following jh rheumatologist-diagnosed and/or confirmed diseases: inflammatory arthritis, scleroderma, myositis, sjogren's syndrome, systemic lupus erythematosus, and vasculitis. * participants must be at least 18 years of age to participate; there is no upper-bound age limit * participants must have access to a smartphone or computer to access the calm app (or webpage) as well as redcap (which requires an email address) to access the questionnaires exclusion criteria: * none
safety and efficacy of iqp- ak-102 in reducing body weight

Conditions: Weight Loss

Summary: the individual ingredients in iqp-ak-102 have been widely used. backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation.

appetite regulation plays an important role in determining the food intake, which is a complex process influenced by biological, behavioral and environmental stimuli. satiation (intrameal satiety) is defined as the process of feeling full and subsequently stopping food consumption during eating, it therefore reduces hunger and limits the energy consumptions during meals. on the other hand, satiety or more precisely intermeal satiety, delays the onset and possibly reduces the consumption of the next meal. high viscosity and bulking food components such as dietary fibre are expected to elicit stronger satiation/satiety than macronutrients or clear liquid. due to its unique physicochemical properties, dietary fibre has been recognized as a potential ingredient that helps to enhance the sensation of satiety in the upper gut by increasing gastric distension and delaying gastric emptying, which subsequently reduces the food intake, and eventually leading on to weight loss. the investigational product is formulated from iqp-ak-102, a proprietary, patent pending combination of three soluble fibres. in-vitro studies showed synergistic properties for the fibres in iqp-ak-102. when consumed orally, iqp-ak-102 capsules dissolve in the stomach to release the fibres. once hydrated, the fibres swell to form a thick, viscous and indigestible gel structure in the stomach. this physical structure results in increased gastric distension and delays the gastric emptying that induces satiety and fullness. however the unique composition of iqp-ak-102 had not been evaluated in human clinical studies. the objective of this placebo controlled, double blind study was to confirm the benefit of iqp-ak-102 in weight loss through promoting satiety and managing appetite. in this study, 120 overweight and obese subjects (60 per study arm) were tested to investigate if iqp-ak-102 is effective in reducing body weight over a period of 12 weeks.

Eligibility criteria:
inclusion criteria: * age 18 to 65 years * 25≤bmi≤35 * expressed desire for weight loss * accustomed to 3 main meals/day * generally in good health * consistent and stable body weight 3 months prior to study enrolment * consistent regular physical activity * commitment to avoid the use of other weight loss products during study * commitment to adhere to diet and lifestyle recommended for the study exclusion criteria: * known sensitivity to the ingredients of the device * presence of any active gastrointestinal disease * malabsorption disorders * pancreatitis * stenosis in the gi tract * bariatric surgery * any other reason deemed suitable for exclusion, per investigator's judgement
study evaluating kesimpta® treatment effects in patients with relapsing multiple sclerosis transitioning from other therapies

Conditions: Multiple Sclerosis

Summary: kairos is a prospective, multicenter, non-interventional study (nis) in germany. prospective, primary data will be collected via questionnaires and an electronic case report form (ecrf) over a period of one year (max. 1.5 years) of treatment. additionally, medical history of participants will be collected including disease duration, edss, mri parameters and relapses.

the decision for ofatumumab as routine medical treatment must be taken independently of and prior to the study start. during the observation phase of the study, data will be collected according to standard of care as recommended by kknms (competence network multiple sclerosis in germany). the prospective observational period per patient will be up to approx. one year from the time of consent (1 year ± 2 months visit window + potentially 6 months follow-up to confirm disability worsening in patients who showed increase in edss within 6 months prior to eos). the observational period will not be dictated by the protocol. the follow-up documentation will take place at a frequency defined as per investigator's discretion. the diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care, can be performed as telemedicine visits and will take place as per investigator's discretion.

Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained before participating in the study 2. diagnosis of rms per mcdonald criteria (2017) (thompson, banwell et al. 2018) 3. prior treatment with eu approved dmt for ms other than ofatumumab 4. decision for treatment initiation of ofatumumab (kesimpta®) prior to study participation and planned initiation of ofatumumab after respective wash-out period of prior dmt (if applicable) or performed initiation of ofatumumab within the last 14 days 5. ofatumumab treatment in line with the german label exclusion criteria: 1. use of investigational drugs during the study, or within 3 months before ofatumumab initiation, or within 5 half-lives of investigational drug before ofatumumab initiation, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer 2. subjects who are not able to provide consent due to incapable judgement 3. simultaneous participation in any investigational trial or simultaneous participation in another novartis-sponsored non-interventional study with ofatumumab

Keywords: multiple sclerosis ms kesimpta ofatumumab
the perceive study

Conditions: Amputation; Peripheral Artery Disease; Diabetes Mellitus

Summary: the perceive (prediction of risk and communication of outcome following major lower limb amputation - a collaborative study) study aims to explore how decisions about major lower limb amputations are made by patients and healthcare professionals.

this study will look in detail at major lower limb amputation risk perception, communication and decision-making, both from a patient/family and a surgeon/clinician point of view. the investigators will audio-record 10-15 consultations between surgeons and patients, examining the communication and decision-making process, and conduct individual interviews with 10-15 patients and 10-15 healthcare professionals. patients will be interviewed at two time points: firstly as soon as possible after they discuss the possibility of leg amputation with a surgeon, and secondly around six months later. the investigators will identify what is important to patients, what information they need to make an informed decision and how best to communicate that information. interviews with surgeons, anaesthetists and specialist physiotherapists will explore how they estimate risks and outcomes of amputation surgery, and how they communicate this to patients. finally, the investigators will combine all this information together and discuss our findings with groups of patients and healthcare professionals, to identify key areas around amputation decision-making that can be improved and how best to further examine those areas.

Eligibility criteria:
inclusion criteria: * any patient aged 18 years old or over with chronic limb threatening ischaemia or diabetic foot disease for whom major lower limb amputation is considered or discussed * vascular surgeons / anaesthetists / specialist physiotherapists involved in, or supporting major lower limb amputation decision making exclusion criteria: * patients under 18 years old * patients undergoing major lower limb amputation for other causes (e.g. trauma or cancer) * any patient/healthcare professional unable or unwilling to provide informed consent. some patients undergoing emergency major lower limb amputation will have insufficient time to give informed consent * potential participants with an insufficient understanding of english or welsh to be able to provide informed consent * potential participants unable to complete an interview in english

Keywords: major lower limb amputation risk perception shared decision making
psychometric measurements of three nociception assessments methods in intubated brain injured critical care patients

Conditions: Intubated Brain Injured

Summary: nociception in intensive care unit is frequently evaluated with some tools such as bps (behavioral pain scale) and ncs (nociception coma scale). these scales were not validated in intubated and brain injured icu patients. the investigators propose to validate the ncs adapted for intubated patients (ncs-i) in comparison with the recommended scale (bps) and the pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

nociception in intensive care unit is frequently evaluated with some tools such as bps (behavioral pain scale) and ncs (nociception coma scale). these scales were not validated in intubated and brain injured icu patients. the investigators propose to validate the ncs adapted for intubated patients (ncs-i) in comparison with the recommended scale (bps) and the pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

Eligibility criteria:
inclusion criteria: * adult, \> or equal to 18-yr * admission to intensive care unit * brain injured and intubated patient * signs of awakening after the interruption of sedation * impossibility to self-report pain intensity exclusion criteria: * eye injuries (glaucoma, keratitis, conjunctivis, cataract) * neurodegenerative attack * brainstem damage * pregnancy

Keywords: intensive care unit neuro-icu pain intubation critical care patients
comparison between clear aligners and traditional fixed appliances in the treatment of four-premolar-extraction cases

Conditions: Malocclusion, Angle Class I; Malocclusion; Displaced or Missing Teeth; Crowding

Summary: patients who have severe crowding that require four premolars extraction will be treated in this study. the efficacy of the clear aligners and vestibular fixed appliances will be assessed. the treatment result of these two different methods will be explored using the peer assessment rating (par) in two different times (t0: before treatment, t1: after treatment) and the american board of orthodontics objective grading system (abo-ogs) after treatment (t1). there are two groups: first group (experimental): the patients in this group will be treated using clear aligners. second group (control): the patients in this group will be treated using fixed appliances.

for years, orthodontists and dentists have used removable appliances for orthodontic treatment. today, with the cad/cam technology, clear aligners treat a broader range of cases with greater precision. they consist of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

Eligibility criteria:
inclusion criteria: * class i malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy). * good oral hygiene and periodontal health. * no severe skeletal discrepancy. * normal proclination for the upper and lower incisors. * no congenitally missing or extracted teeth (except for the third molars). * no history of previous trauma to the maxillofacial region or surgical interventions. exclusion criteria: * bimaxillary dentoalveolar severe protrusion. * previous orthodontic treatment. * subject with psychological abnormalities. * subject with systemic diseases. * subject has known allergy to latex and plastic
intra and postoperative outcomes with 3 injectors

Conditions: Cataract

Summary: this randomized clinical trial compares subjective performance during intraocular lens (iol) implantation, as well as incision enlargement and anterior segment morphology on oct when iol implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision using one of three injectors : manual screw type (monarch iii), manual plunger type (royale) and motorised injector (autosert). further, the investigators also looked at incision integrity by comparing ingress of trypan blue from the ocular surface into the anterior chamber.

in this randomized, clinical trial, three types of injectors were compared : 1. manual, screw type injector (monarch iii) 2. manual, plunger type injector (royale, asico) 3. motorized injector (autosert, alcon) having performed a phacoemulsification through 2.2mm incision, iol implantation was performed using a d cartridge and one of three injectors which was decided in a randomized fashion. the investigators evaluated incision enlargement at following points : at the end of phacoemulsification, and then, at the end of iol implantation the investigators also looked at trypan blue ingress into the anterior chamber from the ocular surface. at 1 day, 1 week, and 1 month after surgery anterior segment oct morphology was also studied. further, the surgeon was asked to subjectively grade the ease of implantation with each injector

Eligibility criteria:
inclusion criteria: * patients undergoing phacoemulsification for age-related uncomplicated cataracts through a 2.2mm incision. * nuclear or corticonuclear of grade 2 to 4 according to the lens opacities classification system (locs iii) exclusion criteria: * glaucoma, * uveitis, * shallow anterior chamber (depth \<2.1mm), * prior ocular trauma or surgery, * maximal pupillary dilatation \<6mm, * high myopia (axial length \>25mm), * posterior polar cataracts, * dense cataracts, and * an iol power \ 25.0 d

Keywords: intraocular lens implantation