Kornimate/medical-research-clean huggingface dataset:
inspiratory muscle training in hfpef

Conditions: Heart Failure

Summary: this study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.


Eligibility criteria:
inclusion criteria: * ≥18 yrs of age * receiving sglt2 inhibitors and spironolactone (and beta-blocker use for hfpef patients with hypertension) for \>3 months * nyha symptoms i-iii * body mass index ≤40 kg/m2 * currently non-smokers with \<20 pack year history * able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise) exclusion criteria: * sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1 * second or third degree heart block * body mass index \>40 kg/m2 * current smokers and/or smoking history \>20 pack years * pregnant women (testing will be done by research team if requested) * glomerular filtration rate of \<30 ml/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on visit 1) * individuals who are not able to engage in exercise * uremia, history of allergy to iodides * peripheral artery disease * alanine transaminase and/or aspartate transaminase greater than 2 times the upper limit of normal (via clinical record within the past 6 months) * asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea * ruptured eardrum or any other condition of the ear * history of spontaneous pneumothorax or osteoporosis with a history of rib fractures * history of lidocaine allergy. for individuals agreeing to undergo dual energy x-ray absorptiometry (dexa) scanning for measurement of body composition as part of their study visit, additional exclusion criteria apply: recently administered gastrointestinal contrast or radionuclides; severe degenerative changes or fracture deformity in measurement areas; or inability to attain correct position and/or remain motionless for the measurement period.
the effectiveness of heat treatment on knee pain in patients with osteoarthritis - an international, multicenter clinical investigation

Conditions: Pain Management; Osteoarthritis

Summary: this post-market clinical follow-up, open-label, multicenter clinical investigation is designed to investigate the effectiveness, safety and tolerability of thermacare® knee heatwraps in the painful knee joint due to osteoarthritis. approximately 80 patients, 19-69 years old inclusive, with moderate knee osteoarthritis (without acute flares or inflammation) will be enrolled. the overall duration of the investigation is expected to be 11 days, including screening days. the maximum treatment duration for each patient is 7 days (8h/d).


Eligibility criteria:
inclusion criteria: * signed written informed consent before inclusion in the investigation. * any gender, any ethnic origin, 19-69 years old inclusive. * body mass index 18.5-40 kg/m2 inclusive. * full comprehension: ability to comprehend the full nature and purpose of the clinical investigation. * patient with diagnosis of mono or bilateral moderate knee osteoarthritis with knee pain intensity \> 40 mm on a 0-100 mm vas, able to independently ambulate without walking aid. * availability of a radiography of the selected knee not older than 6 months. * patient is either not of childbearing potential or must agree not to start a pregnancy from the signature of the informed consent up to the final visit exclusion criteria: * clinically significant abnormal physical findings which could interfere with the objectives of the investigation * history of anaphylaxis to drugs or allergic reactions in general, which could affect the outcome of the clinical investigation. * significant history of diseases that may interfere with the aim of the clinical investigation. * history of (in the last 6 months) or ongoing intra-articular injection involving the selected knee. history of ongoing physical therapy involving the selected knee. * presence of flares, inflammation, effusion and swelling at the selected knee. * any skin injury, wound, irritation, rash, bump, sore and/or discoloration at the application area. * surgery at the selected knee in the 12 months preceding the clinical investigation. * any medication that could interfere with the investigation procedures or investigation outcome. * use of other hot or cold therapies for the selected knee. * positive pregnancy test at screening; pregnant or breastfeeding women * history of (within the past 12 months) or current drugs or alcohol abuse * individuals unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response.

Keywords: pain osteoarthritis thermacare® medical device
a study evaluating the french version of the ciqol-35 quality of life questionnaire in adult cochlear implant use.

Conditions: PROM; Cochlear Hearing Loss; Hearing Loss; Quality of Life

Summary: the cochlear implant - quality of life (ciqol) prom is a quality-of-life assessment questionnaire for adults with cochlear implants. the ciqol responds to an important need for a questionnaire that captures the benefits of cochlear implantation as perceived by patients and that can be used in clinical practice.

the ciqol-35 has been translated and adapted from english to french in accordance with the guidelines of hall and colleagues. the purpose of the current study is to describe the measurement properties of the french ciqol-35 questionnaire. hall et al recommend that at least 8 patients participate in any qualitative testing of the translation (n=13 in the previous study) and that at least 50 patients participate in a measurement property evaluation (n=50 in the present study). the aim of this study is not to assess the performance of the device or compare the performance of different devices/brands but to correlate quality of life scores with speech understanding in patients with cochlear implants. the main objective of the study is to validate the translation of the questionnaire, the correlation is a secondary criterion.

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years) user of at least one cochlear implant system, * duration of cochlear experience ≥ 6 months (period from cochlear implant activation to study enrolment), * psychological/literacy ability to read, understand, and complete the questionnaire. exclusion criteria: * patient who participated in initial validation of the french ciqol-35 (ciqol project part 1), * patient with a psychological or linguistic inability to understand the information sheet or the questionnaire, * patient under legal protection or deprived of liberty, * unwillingness or inability to comply with all investigational requirements.
a study to evaluate the long-term safety and tolerability of faricimab in participants with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (ivt) injection at a personalized treatment interval (pti) to participants who enrolled in and completed one of the two phase iii studies, gr40349 (nct03622580) or gr40398 (nct03622593), also referred to as the parent studies.


Eligibility criteria:
inclusion criteria: * previous enrollment in and completion of study gr40349 (nct03622580) or gr40398 (nct03622593), without study or study drug discontinuation * ability to comply with the study protocol, in the investigator's judgment * for women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment exclusion criteria: * pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final intravitreal injection of faricimab * presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications * presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications * history of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study * requirement for continuous use of any medications or treatments indicated as prohibited therapy
evaluation of remote fitting in adult and pediatric users of the hiresolution bionic ear system

Conditions: Hearing Loss; Ear Diseases; Hearing Disorders; Otolaryngological Disease

Summary: this is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a hiresolution bionic ear system.

the overall goal of this clinical study is to demonstrate the safety and efficacy of the remote fitting option. hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet is no worse with remote fitting than in an in-office setting.

Eligibility criteria:
inclusion criteria all subjects * ability to provide informed consent/assent * 13 years of age or older * unilateral or bilateral user of a hiresolutiontm bionic ear system (hires 90ktm, hires 90ktm advantage, hirestm ultra, hirestm ultra 3d) * minimum of 6 months of ci experience with a minimum of 1 month experience with a naída ci or sky ci sound processor * at least moderate open-set speech recognition abilities (defined as speech in quiet score ≥ 60% as assessed at visit 1) * minimum average score ≥ 3 on the mobile device proficiency questionnaire (mdpq-16) * english language proficiency as determined by the investigator * willingness to use a bte sound processor for the duration of the study inclusion criteria specific to aidable residual hearing group * residual low frequency hearing sensitivity (pure tone average of \< 70 db hl for 125, 250, and 500 hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 db hl for 1,000, 2,000, 3000, 4,000, and 8,000 hz) in the implanted ear for unilaterally implanted subjects and in both ears for bilaterally implanted subjects * willingness to use an in-canal acoustic earhook for the duration of the study exclusion criteria: * clinical presentation indicative of potential implanted device malfunction * unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator * unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator
comparing mta pulpotomy to root canal treatment in management of permanent molars with irreversible pulpitis in children

Conditions: Irreversible Pulpitis

Summary: dental caries, highly prevalent amongst children, can cause pulpitis. coronal pulpotomy provides an easier, cost-effective, conservative and biologically-driven treatment option compared to endodontic treatment in mature permanent teeth with irreversible pulpitis. the aim of the current study is to evaluate postoperative pain, clinical and radiographic outcomes of mta pulpotomy compared to root canal treatment in children's first permanent molars suffering from irreversible pulpitis.

in this randomized controlled trial, patients aged 10-14 years suffering from irreversible pulpitis in the first permanent molar with closed apex will be randomly divided into two groups. the first group will receive complete coronal mta pulpotomy, while the second group will receive endodontic treatment.

Eligibility criteria:
inclusion criteria: * healthy male and female children, aged 10 to 14 years * signs and symptoms of irreversible pulpitis in carious first permanent molar. exclusion criteria: * molars with immature roots * non-restorable molars, with abnormal mobility or increased probing pocket depth (normal range = 1-3 mm) * any indication of pulpal necrosis, such as sinus tract or swelling or no bleeding from orifices after access opening. * any signs of periapical or furcal rarefaction.

Keywords: endodontic treatment, vital pulp therapy
efficacy and safety of insulin glargine versus. neutral protamine hagedorn (nph) insulin in children with type 1 diabetes above 6 years old.

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: 6 to assess the efficacy of insulin glargine given once daily (qd) on glycosylated hemoglobin (hba1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (t1dm) aged at least 6 years to less than 18 years. secondary objectives: * to assess the effects of insulin glargine compared to nph insulin over 24 weeks on: * percentage of patients reaching international society of pediatric and adolescent diabetes (ispad) recommended target of hba1c \< 7.5%, * fasting blood glucose (fbg), * nocturnal blood glucose (bg), * 24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (smbg) values, * daily total insulin dose and basal insulin dose, * rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia. * to assess the safety and tolerability of insulin glargine versus nph insulin based on the occurrence of treatment-emergent adverse events (teaes). * to assess anti-insulin and anti-glargine antibody development in both groups. * to assess insulin glargine pharmacokinetic(pk) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing

the study duration for each patient is 28 weeks +/- 7 day broken down as follows: * screening phase: up to 2 weeks * run-in phase: 1 week * treatment phase: 24 weeks * follow-up: 1 week

Eligibility criteria:
inclusion criteria: - paediatric patients diagnosed with t1dm aged at least 6 years to less than 18 years at screening. exclusion criteria: * treatment with oral or parenteral glucose-lowering medications other than insulin. * hba1c \ 12 % at screening. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
complete revascularization versus culprit lesion only pci in nstemi

Conditions: Non-ST-elevation Myocardial Infarction; Multivessel Coronary Artery Disease

Summary: prospective, randomized, controlled, multicenter, open-label trial to study whether multivessel percutaneous coronary intervention (pci) is superior over culprit-lesion only pci in patients with non-st-segment elevation myocardial infarction (nstemi) and multivessel coronary artery disease.

the complete revascularization versus culprit lesion only pci in nstemi (complete-nstemi) trial aims to investigate whether multivessel complete pci is superior over culprit-lesion only pci in patients with nstemi and multivessel coronary artery disease.

Eligibility criteria:
inclusion criteria: * nstemi as suggested by high-sensitivity troponin algorithms * multivessel coronary artery disease * identifiable culprit lesion * informed consent exclusion criteria: * age \<18 years * cardiogenic shock * sustained ventricular tachycardia (vt) or ventricular fibrillation (vf) * contraindication for coronary revascularization * prior coronary artery bypass graft * indication for coronary artery bypass graft surgery * non-culprit lesion located in the left main coronary artery * co-morbidity with life expectancy less than 6 months * type 2 myocardial infarction * pregnancy and breast feeding period

Keywords: nstemi multivessel coronary artery disease culprit-lesion only pci multivessel percutaneous coronary intervention
a study of ipn10200 for the treatment of cervical dystonia in adults

Conditions: Cervical Dystonia

Summary: the purpose of this study is to evaluate the efficacy and safety of the study drug, ipn10200, and to assess how well it works when compared with placebo in treating cervical dystonia (cd) in adults. cd can cause a series of abnormalities and symptoms in the head and neck that can lead to neck pain and stiffness, and headaches. cd is believed to involve deep parts within the brain that control movement, but genetic factors, environmental factors, and abnormalities in the brain may also play a role. the usual treatment for cd includes injecting bont into the affected muscles, but the treatment only lasts about 3 months. ipn10200 is designed to last for a longer period. the study will consist of two periods: 1. a screening period of up to 4 weeks (28 days) to assess whether a participant can take part in the study and requires at least one visit. 2. a treatment period of 36 weeks. on day 1 of the treatment period, participants will receive either ipn10200 dose a or dose b (additional participants may receive ipn10200 dose c) of the study drug, or placebo distributed into different muscles in the head, neck and shoulders. participants may continue some other medications, but details need to be recorded. there will be 10 visits to the clinic in person and one remote visits (phone call) (12 visits to the clinic for participants who receive dose c). participants will undergo blood samplings, urine collections, physical/neurological examinations, and clinical evaluations. participants will also need to complete questionnaires throughout the study. the total study duration for a participant will be up to 40 weeks (approximately 9 months).


Eligibility criteria:
inclusion criteria: 1. a clinical diagnosis of isolated cervical dystonia (cd) (idiopathic) characterized by dystonic symptoms localised to the head, neck, and shoulder areas with at least moderate severity at screening and baseline (day 1) defined as: * (a) toronto western spasmodic torticollis rating scale (twstrs)-total score ≥20 * (b) twstrs-severity subscale score ≥15 * (c) twstrs-disability subscale score ≥3 * (d) twstrs-pain subscale score ≥ 1 2. treatment naïve or non-naïve to bont therapy for cd exclusion criteria: 1. participants presenting with a swallowing disorder of any origin which might be exacerbated by bont treatment, such as: * (a) grade 3 or 4 on the dysphagia severity scale (severe dysphagia) with swallowing difficulties and requiring a change in diet. 2. predominant anterocollis. 3. predominant retrocollis. 4. traumatic torticollis or tardive torticollis. 5. marked limitation on passive range of motion that suggests cervical contractures or structural abnormality.
electrohaemodynamic activity in epileptic children : combined video-eeg and near-infrared spectroscopy (nirs) analysis

Conditions: Epilepsy

Summary: evaluate the contribution of multimodal high-resolution eeg-nirs electrical and local haemodynamic analysis to spatial localization of epileptogenic foci

this study is designed to evaluate the contribution of multimodal high-resolution eeg-nirs electrical and local haemodynamic analysis (hr-eeg, hr-nirs) to spatial localization of epileptogenic foci in order to perform multimodal mapping and localization of interictal spikes (by hr-eeg source reconstruction) with the clinical prospects of guiding the seeg electrode implantation strategy prior to surgery in children with drug-refractory partial epilepsy.

Eligibility criteria:
inclusion criteria: * children between the ages of 6 and 18 years * with drug-refractory partial epilepsy, presenting interictal spikes on standard eeg recordings. exclusion criteria: * children with a serious congenital malformation. * refusal from one of the parents or the child. * children with generalized epilepsy or diffuse interictal spikes. * children with severely impaired general status and vital functions. * children with dermatosis of the face or scalp. * children under the age of 6 years or adults over the age of 18 years.

Keywords: video-eeg near-infrared spectroscopy (nirs)
endoscopic resection of non-ampullary duodenal adenomas: endoscopic mucosal resection (emr) vs. endoscopic full-thickness resection with the 'duodenal full-thickness resection device' (dftrd)

Conditions: Duodenal Adenoma

Summary: prospective, randomized multi-center trial. comparison of endoscopic mucosal resection (emr) versus endoscopic full-thickness resection with the duodenal full-thickness resection device (dftrd) of non-ampullary duodenal adenomas.

prospective, randomized multi-center trial. comparison of endoscopic mucosal resection (emr) versus endoscopic full-thickness resection with the duodenal full-thickness resection device (dftrd) of non-ampullary duodenal adenomas.

Eligibility criteria:
inclusion criteria: * duodenal adenoma * age 18 or older * written informed consent exclusion criteria: * duodenal adenomas with a size \> 25 mm * duodenal adenomas with 20 mm or less distance to the major and/or minor duodenal papilla * presence of two or more duodenal adenomas * suspected or histologically confirmed malignancy * tumor disease (exception: after successful curative treatment) * conditions/diseases of the upper gi-tract that impair advancing of the devices into the duodenum * moribund patient * pregnancy and breastfeeding * patients that cannot give informed consent (e.g. psychiatric disorders, language barrier,...) * other contraindications for duodenal resections

Keywords: duodenal adenoma ftrd dftrd emr endoscopic mucosal resection
study on curative effect and mechanism of acupuncture on neuropathic pain in dry eye disease

Conditions: Dry Eye

Summary: this project is designed as a prospective, randomized, open, controlled clinical trial. for the first time, acupuncture was applied to the treatment of dry ocular neuropathic pain. its mechanism was discussed by comparing the efficacy between acupuncture and artificial tears.


Eligibility criteria:
inclusion criteria: * according to the dews diagnostic criteria, the osdi score ≥ 13, with positive signs of dry eye (sit ≤ 10mm/5min or tbut ≤ 10s) or cfs positive; * vas\>0; * signed informed consent. exclusion criteria: * patients with dry eye who have had irritants directly irritating the ocular surface in the past 3 days; * eyeball infections, allergies, deformities, abnormal movements * any history of eye surgery * have had eye trauma or fundus laser treatment within 3 months * used drugs that affect tear production such as antihistamines, antidepressants, etc. within 30 days * suffer from systemic diseases that affect tear production, including sjogren's syndrome, diabetes, mental illness, malignant tumors, etc.

Keywords: dry eye pain acupuncture