Kornimate/medical-research-clean huggingface dataset:
customized foot orthoses on muscle activity during standing and gait in plantar heel pain

Conditions: Foot Orthoses; Fasciitis, Plantar

Summary: the present study will use a randomized controlled trial (rct) to determine the effectiveness of customized foot orthosis (cfo) for the treatment of patients with php. three treatment groups including the cfo without wedge, the cfo with wedge type 1 (w1), and the cfo with wedge type 2 (w2) will be randomly assigned to each participant by a computer-generated randomization. the opaque-sealed envelopes will be used to allocate the groups of participant.

participants will be allocated to the control (cfo without wedge) or experimental (cfo with w1 or w2) groups according to the seal-envelop randomization technique. then, they will be assessed all outcomes for the baseline including pain intensity, foot function, lower-extremity muscle activity during gait and standing by the 2nd physical therapist. and the participants will receive the assigned treatment by the 1st physical therapist. all participants will be asked to use the cfo in daily life during weight-bearing activities, and logbook, chat line, or phone call will be used to monitor the participants during the treatment program. they will be asked about activity they done in daily and a number of hour they used cfo per day in diary book. at least 4 hours per day of wearing cfo will be required to each participant. after 3 months of the cfo use, all outcomes will be re-assessed by the 2nd physical therapist. and such outcomes will be then statistically analyzed.

Eligibility criteria:
inclusion criteria: * reaching the specific criteria of php including * a complaint of tenderness from the palpation of the medial calcaneal tubercle and the medial aspect of the proximal portion of the plantar fascia, or pain along the plantar fascia at medial longitudinal arch side * the presence of heel pain immediately during the first few steps of walking in the morning or after a prolonged period of inactivity; and gradually decreased throughout the day with ordinary walking, and worsened with prolonged activity * having the symptom of heel pain for at least 6 weeks, indicates the chronic condition * having the maximum level of pain intensity during last week using the visual analog scale (vas) at least 3 out of a full 10 scores exclusion criteria: * having positive sciatica test, indicating the l5-s1 nerve root irritation * having a history of lower extremity fracture * having a history of lower extremity surgery * having been diagnosed with gout, diabetic neuropathy, rheumatoid arthritis, systemic lupus erythematosus (sle), cancer, infectious disease, and tumor
measurement of critical closing pressure (pcrit) during drug-induced sleep endoscopy (dise)

Conditions: Obstructive Sleep Apnea

Summary: this study intends to test the feasibility of measurement of the critical closing pressure (pcrit) during drug-induced sleep endoscopy (dise) for use in future studies, which are aimed at finding an alternative method for patient selection and response prediction before implementation of non-cpap therapies.twenty patients diagnosed with osa and eligible for non-cpap treatments are going to be included into this study and undergo these measurements. drug-induced sleep endoscopy (dise) is part of the standard clinical care for osa patients that are eligible for non-cpap therapies. we aim to expand this procedure with measurement of pcrit, oesophageal pressure, airflow, eeg, eog, respiratory effort, spo2 and chin emg during this study.

patients from the ent department will be recruited and informed about the study. after obtaining informed consent, the patients will undergo dise according to the normal clinical care.the study will be performed during this clinical dise, using a standard polysomnographic set-up (alice 6 ldx, philips respironics) expanded with pressure and flow measurements. after measurements and evaluations are done, the most suitable treatment option based on the dise and psg findings, as defined in the standard clinical care, will be advised to the patient. the treatment and its further choice are not part of the current study protocol.

Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosis with osa (ahi ≥15/hour sleep) * eligible for dise as the next step in the clinical path for osa. * capable of giving informed consent exclusion criteria: * medication use related to sleeping disorders. * central sleep apnea syndrome. * medical history of known causes of tiredness or severe sleep disruption other than osa (insomnia, plms, narcolepsy). * seizure disorder. * known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient). * inability to provide informed consent. * simultaneous use of other treatment modalities to treat osa * esophageal ulceration, tumors, diverticulitis, bleeding varices, sinusitis, epistaxis, recent nasopharyngeal surgery * pregnancy or willing to become pregnant * excessive alcohol or drug use (\> 20 alcohol units/week or any use of hard drugs)
real-time feedback (rtfb) to improve colonoscopy

Conditions: Colorectal Cancer

Summary: to test whether real-time feedback will improve quality of endoscopic examination.


Eligibility criteria:
inclusion criteria: - any endoscopist willing to parcipate and performing routine colonscopy exclusion criteria: - no exclusion criteria
left atrial appendage occlusion guided by 3d printing

Conditions: Atrial Fibrillation

Summary: left atrial appendage closure (laac) was approved by the esc guidelines as a stroke prevention alternative to warfarin for patients with nonvalvular atrial fibrillation in patients at high risk of bleeding (iibb). although the overall laac benefice, in term of prevention of stroke or embolisme and decresing the anticoagulant-related risk of bleeding is already demonstrated, however the procedure success and safety, critically depends on understanding laa anatomy and adequate pre-procedure planning. 3d-printed patient-specific adaptive and flexible la models have demonstrated in a previous study an improving in laao device sizing, a better pre-procedural planning of the optimal trans-septal puncture site, by incorporating all anatomical variations and an improuving patient outcomes by reducing procedure time and number of prostheses employed per patient. this technique is now used in several surgical centers in france and large prospective evaluation of the practice is necessary.

the 3d printing has modified the laac practices with a preoperative time allowing an optimal preparation of the prosthesis. this technique is now used in several surgical centers and prospective evaluation of the practice is necessary. the objective of our research is to demonstrate the reduction of the operating time and number of prosthesis used per procedure when prior laac simulation testing and sizing is made on a 3d printed model. it is therefore a longitudinal research to monitor professional practices for the evaluation of a new preoperative approach. procedures guided by 3dprinted models will be compared (intention to treat population) in term of procedural parameters (procedure time, success rate, number of prosthesis per procedure) and procedural complication with prior watchman study: post-fda approval us experience and national registries data. a second analysis (per protocol population) will be performed to compare patients with an informative utilization guided by 3d printed to those of the post-fda approval us experience and national registries.

Eligibility criteria:
inclusion criteria: * non valvular af * adressed for laac procedure exclusion criteria: * opposition from patients

Keywords: laac 3d printing procedure success procedure-related complications
clinical application of 68ga-dota-nt-20.3 in the early diagnosis of pancreatic ductal adenocarcinoma

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68ga-dota-nt-20.3 in patient with pancreatic ductal adenocarcinoma (pdac).

this study is design to prospectively investigate the safety and efficacy of 68ga-dota-nt-20.3 in the early diagnosis of pancreatic ductal adenocarcinoma (pdac). the specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68ga-dota-nt-20.3 in patient with pdac. neurotensin receptor 1 (ntr-1) is the high affinity receptor of neurotensin (nt), which was found abnormal expression in the early stages of pdac malignant cell transformation. 68ga-dota-nt-20.3 as a new ntr-1 targeted probe was prepared and showed good uptake on pdac cell line and animal studies. the study intends to recruit 6 pdac volunteers to participate in the experiment. patients were evaluated with 18f-fluorodeoxyglucose (18f-fdg). and then all patients underwent a single-injection with 68ga-dota-nt-20.3, dual-modality imaging protocol consisting of a pet/ct and subsequent pet/mr scan. the follow-up period was followed up to assess safety and effectiveness.

Eligibility criteria:
inclusion criteria: * patient with pathohistologically proven localized or metastatic pdac; * patient aged 18 or older, male or female, who can provide written informed consent for this study; * patient with complete clinical data. exclusion criteria: * patient age \< 18 years; * patient with other active cancer; * patient with pdac under the treatment blocking nt receptors; * pregnant or lactating women; * patient who cannot stay on pet/ct camera for app. 90 minutes; * patient who cannot stand mri; * patient simultaneously participating in another clinical trial; * patient with hiv, hcv, hvb infection or other serious chronic infection * patient with serious mental, neurological, cardiovascular, respiratory and other system diseases; * patient with liver and kidney function (gfr less than 50 ml/min) disease; * patient with severe severe refractory mental disorder.
forxiga ckd japan post-marketing surveillance (pms)

Conditions: Chronic Kidney Disease

Summary: to capture safety when forxige is administrated to ckd patients in the real world setting

the purpose of the study is to review the following points during use of forxiga tablets (hereinafter referred to as forxiga) in the real world setting after launch for treatment of ckd. 1. adrs which are unexpected from the precautions for use in our jpi 2. understanding of incidence of adrs during use of forxiga in the real world setting 3. factors (ie demography, treatment) possibly having an impact on the safety.

Eligibility criteria:
inclusion criteria: * patients with ckd except for dialysis and/or renal failure chronic exclusion criteria: * none
cd19+targeted car-t cell therapy for relapsed/refractory cd19+ b cell leukemia and lymphoma

Conditions: Leukemia; Lymphoma, Large B-Cell, Diffuse; Leukemia, B-cell; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Summary: this is a single arm study to evaluate the efficacy and safety of cd19-targeted car-t cells therapy for patients with relapsed/refractory cd19+ b cell leukemia and lymphoma.

there are limited options for treatment of relapse/refractory b cell leukemia and lymphoma.cd19 is expressed on most b cell leukemia and lymphoma cells so it is an ideal target for car-t. in this study, investigators will evaluate the safety and efficacy of car-t targeting cd19 in patients with elapsed/refractory cd19+ b cell leukemia and lymphoma. the primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent； 2. diagnose as relapsed/refractory b cell leukemia and lymphoma, and meet one of the following conditions: 1. failed to standard chemotherapy regimens; 2. relapse after complete remission, high-risk and / or refractory patients ; 3. relapse after hematopoietic stem cell transplantation; 3. for patients with ph + all, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after tki treatment or have relapsed after remission (cannot tolerate tki treatment or have contraindications to tki treatment or the presence of tki class) except for drug resistant patients)； 4. evidence for cell membrane cd19 expression； 5. all genders ，ages: 2 to 75 years； 6. the expect time of survive is above 3 months; 7. kps\>60； 8. no serious mental disorders ; 9. left ventricular ejection fraction ≥50% 10. sufficient hepatic function defined by alt/ast≤3 x uln and bilirubin≤2 x uln; 11. sufficient renal function defined by creatinine clearance≤2 x uln; 12. sufficient pulmonary function defined by indoor oxygen saturation≥92%; 13. with single or venous blood collection standards, and no other cell collection contraindications; 14. ability and willingness to adhere to the study visit schedule and all protocol requirements. exclusion criteria: 1. previous history of other malignancy; 2. presence of uncontrolled active infection; 3. evidence of disorder that need the treatment by glucocorticoids; 4. active or chronic gvhd； 5. the patients treatment by inhibitor of t cell； 6. pregnant or breasting-feeding women; 7. any situation that investigators regard not suitable for attending in this study (e.g. hiv , hcvinfection or intravenous drug addiction) or may affect the data analysis.

Keywords: leukemia lymphoma
safety and efficacy of nnc-0156-0000-0009 after long-term exposure in patients with haemophilia b: an extension to trials nn7999-3747 and nn7999-3773

Conditions: Congenital Bleeding Disorder; Haemophilia B

Summary: this trial is conducted in asia, europe, japan, north america and south africa. the aim is to evaluate the safety and efficacy of nonacog beta pegol (nnc-0156-0000-0009) after long-term exposure in patients with haemophilia b. this trial is an extension to trials nn7999-3747 (nct01333111/paradigm™ 2) and nn7999-3773 (nct01386528/paradigm™ 3).


Eligibility criteria:
inclusion criteria: * previous participation in nn7999-3747 (nct01333111) and/or nn7999-3773 exclusion criteria: * known history of fix inhibitors based on existing medical records, laboratory report reviews and patient and lar (legal acceptable representative) interviews * current fix inhibitors above or equal to 0.6 bu (bethesda units) * congenital or acquired coagulation disorders other than haemophilia b * previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records) * any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the investigator's (trial physician) judgement, could imply a potential hazard to the patient, interfere with trial participation, or interfere with trial outcome
plasma of argon cleaning on implant abutments: 5-year results of a randomized clinical trial

Conditions: Endosseous Dental Implant Failure; Alveolar Bone Loss

Summary: contamination of implant abutments could potentially influence the peri-implant tissue inflammatory response. the aim of the present study was to assess the radiographic bone changes around customized, platform switched, abutments placed according to the "one-abutment-one-time" protocol, with and without plasma of argon cleaning treatment.

after technical procedures, presence of contaminants (mostly titanium wear micro-particles, carbon and aluminum traces due to lubricant used during customization) on the whole abutment surface, the internal connection and the screw can be found, even after the usually cleaning steps (steaming). such debris, present at titanium/connective-bone tissues interface (gingival portion of the abutment), could directly or indirectly deleteriously influence the inflammatory response on the peri-implant tissues. plasma of argon cleaning treatment was demonstrated to have a double effect on titanium abutments: removal of pollutions following customization and increase of cell adhesion. additionally, plasma of argon demonstrated very potent anti-biofilm activity. this prospective, match paired, triple-blinded randomized controlled trial was aimed to test if plasma treatment of customized abutments can affect radiographic peri-implant marginal bone level changes after 5 years of prosthetic loading.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older, previously treated for periodontal disease according to a comprehensive treatment strategy,25 requiring a single implant-supported restoration in the anterior maxilla or premolar region with the presence of mesial and distal tooth. * bone crest allowing the insertion of a 4 mm platform implant without further bone augmentation procedures and with thin (≤ 1 mm) gingival biotype, measured by previously reported protocol. exclusion criteria: * no relevant medical conditions; * non-smoker or smoking ≤ 10 cigarettes/day; * plaque index and bleeding on probing ≤ 25 %; * impossibility of follow-up for 5 years after prosthetic loading; * pregnant and lactating patients; * patients with a history of bisphosphonate therapy; * presence of sites with acute infections.
improving antibiotic stewardship for children with respiratory illness presenting to village health workers in uganda

Conditions: Respiratory Infections in Children

Summary: this is a stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care c-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with acute respiratory illness in the bugoye sub-county of the kasese district in southwestern uganda. the purpose of this study is to assess the impact of the algorithm on antibiotic use.


Eligibility criteria:
inclusion criteria: * age 2 months-5 years * evaluated by a study vhw in one of the participating villages in bugoye sub-county for acute respiratory illness defined as the following: fever (documented (temperature \> 38°c) or subjective fever in the last seven days) and fast breathing (respiratory rate \> 30) or cough exclusion criteria: * age \> 5 years or \< 2 months at time of presentation * guardian not present to provide consent

Keywords: community health workers c-reactive protein
different dose of methotrexate for the treatment of meningeal carcinomatosis

Conditions: Meningeal Carcinomatosis

Summary: the main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis.


Eligibility criteria:
inclusion criteria: * age 14 or more * a history of solid tumor * a new clinical neurological signs and symptoms * a typical ct(computerized tomography,ct) or mri(magnetic resonance imaging,mri) imaging findings * tumor cells in cerebrospinal fluid exclusion criteria: * kps score \<60 * the tumor patients with organ failure * bacteria, fungi or viral meningitis

Keywords: intrathecal chemotherapy
efficacy of polypodium leucotomos extract decreasing uva premutagenic and photoaging markers

Conditions: Aging; Skin Abnormalities

Summary: with this study, the investigators will like to determine if taking a dose of the study medication, called polypodium leucotomos (pl), prevents some of the changes in the skin caused by the adverse effects of uva, a type of ultraviolet light.


Eligibility criteria:
inclusion criteria: * healthy subjects, * 18 years of age or older, * with fitzpatrick skin types ii and iii. exclusion criteria: * pregnancy * personal history of skin cancer * history of abnormal photosensitivity * smokers * patients with history or being exposed to other forms of radiation (other than sunlight) * history or current exposure to asbestos * patients taking any drug that might alter the response of skin to uvr (including, but are not limited to, doxycycline, sulfas, psoralens, and amiodarone) * patients unable to undergo skin biopsies * history of abnormal scarring * history of adverse reaction to local anesthesia

Keywords: polypodium leucotomos, ultraviolet rays, heliocare, calaguala, anapsos skin aging and damage
left ventricular dysfunction in critically ill patients

Conditions: Left Ventricular Dysfunction; Critically Ill; Acute Coronary Syndrome; Cardiomyopathies; Takotsubo Cardiomyopathy

Summary: left ventricular dysfunction is common in the critically ill. the aim of this study is to assess the incidence and prognosis of left ventricular dysfunction in critically ill patients.

left ventricular dysfunction is common in the critically ill. a number of conditions can cause left ventricular dysfunction including myocardial infarction, septic cardiomyopathy, post resuscitation syndrome, takotsubo syndrome etc. a number of studies have assessed cardiac dysfunction in specific conditions (e.g. sepsis, cardiac arrest) but only a few studies have assessed cardiac dysfunction in a general icu-population. the study will focus on diagnostics of the different types of cardiomyopathy and differentiating between ischemic and non-ischemic left ventricular dysfunction in a general icu population. the aim of this study is to assess the incidence and prognosis of the different types of left ventricular dysfunction in critically ill patients. our hypothesis is that left ventricular dysfunction is common in the critically ill and is associated with an increased risk of short-term death.

Eligibility criteria:
inclusion criteria: * admitted within 24 hours to the icu * dysfunction of at least one organ system, defined as at least +1 point in sofa-score. exclusion criteria -
predictability of osa with a subjective screening scale (osasss1)

Conditions: Obstructive Sleep Apnea; OSA

Summary: the study aims to evaluate the accuracy correlation between subjective perception of the air flow through airways from patients and survey and/or polysomnography they spent, using a brief clinical protocol they answered with a manual therapist

the subjects in the study are 18 to 77 years old and present the following conditions: * polysomnography and sleep survey realized at the center for sleep medicine andré renard, without any informations of the results for the experience group * sleep survey with no sleep trouble found for the control group

Eligibility criteria:
inclusion criteria: * female or male subjects aged 18 to 77 years old * subjects who have performed a psg at the sleep medicine center andré renard for the study group * subjects with no sleep disorder on sleep survey for the control group * subjects who agree to comply with the requirements of the study. * subjects who are of age (and know how to read and write) who have given their informed, explicit consent in advance to any procedure related to the trial, the study or the investigation conducted on human beings, with the objective of developing knowledge specific to the exercise of health care professions, as set out in royal decree no. 78 of 10 november 1967 on the practice of the health care professions (act of 27 december 2005) exclusion criteria: * subjects with acute infections * subjects with trauma within the last 72 hours * subjects who already benefit from osa treatment * subjects with known perceptual disorders, for example post-stroke * subjects with current or recent chemotherapy and radiotherapy treatment * pregnant women * criteria related to prior or concurrent treatments: treatment with antipsychotics, anxiolytics, soporifics or muscle relaxants started within the two months preceding the study. treatment with intraoral implants during the study or in the two months preceding the study

Keywords: obstructive sleep apnea osa obstructive sleep apnea syndrome sleep disorder upper airways resistance syndrome uars subjective scale of air flow