Kornimate/medical-research-clean huggingface dataset:
improving walking after a lower limb injury using a custom motorized orthosis

Conditions: Lower Limb Injury

Summary: the purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (afo) brace, in adults who have had a lower limb injury.

the long-term goal of this project is to improve the outcomes of robot-assisted exercise interventions for patients with reconstructed lower limb following high-energy lower extremity traumas using novel machine learning methods to enable individualized ankle foot orthosis (afo) designs and self-adaptive afo assistance. the main hypothesis predicts greater comfort and lower pain levels when using the new afo as well as improvements in gait mechanics, which will outperform those induced by patients' daily-use afos. the main goal is this adaptive assistance will encourage the wearer's active engagement in ragt thereby promoting patient self-efficacy/satisfaction and leading to improvements in ambulation after a 6-week rehabilitation program.

Eligibility criteria:
inclusion criteria: * have a lower limb injury greater than a year ago. * be 18-80 years old. * be able to stand for 30 minutes. * have enough range of motion in my ankle to comfortably wear the afo. * be able to follow directions and commands. * be willing and able to give informed consent. * be able and willing to comply with study procedures, verbal instructions, and follow-up requirements. exclusion criteria: * have any joint or muscle tightness that would limit my movement while walking with the afo. * have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity). * have any medical issues that affect my unaffected side. * have skin issues that would prevent wearing the device. * have a pre-existing condition that caused exercise intolerance. (documented uncontrolled hypertension, coronary artery disease, abnormal heart rate or rhythm, or congestive heart failure). * have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study. * have nervous system issues that affect my movement (for example parkinson's disease, multiple sclerosis). * have additional orthopedic issues that interfere with my walking or limit my range of motion in my legs. * have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the device.
digital intervention for depression and anxiety in adolescents

Conditions: Depression; Anxiety

Summary: the goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. the main question it aims to answer is: can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? the trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy. participants will be asked to engage with the digital intervention platform for a period of two months.


Eligibility criteria:
inclusion criteria: * the mini international neuropsychiatric interview for children and adolescents (mini-kid) will be used to assess participants' eligibility based on the diagnostic criteria for depression outlined in the dsm-5(the diagnostic and statistical manual of mental disorders, fifth edition). * having a hamd(hamilton depression scale) score upon enrollment * demonstrate normal cognitive function. * voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent. exclusion criteria: * with severe consciousness disorders and a history of psychiatric illness, traumatic brain injury, substance dependence, or acute poisoning * with concurrent psychiatric disorders (as determined by clinical assessment) * with concurrent psychiatric disorders (as determined by the assessing clinician) * at high risk of suicide
comparing site specific mouth disinfection with commercial oral mouth rinse with traditional oral maouth disinfection

Conditions: Oral Odor (Halitosis); The Study Want to Know if Site Specific Mouth Rinsing With Oral Mouth Disinfectants Can be Better Than Paonoral Mouth Rinsing

Summary: objectives: to determine whether site-specific mouth rinsing with oral disinfectants can improve oral odor beyond the traditional panoral mouth disinfection with mouth rinses by targeting specifically oral malodor implicate anaerobic bacteria. methods: twenty healthy fasting subjects volunteered for a blinded prospective, descriptive correlational crossover cross-section clinical trial conduct during the month of ramadan in the lunar hajri year 1434 ah (10 july 2013-8 august 2013) in albaha province in saudi arabia involving the application of listerine® cool mint® mouth rinse by either the traditional panoral rinsing method or a site-specific disinfection method targeting the subgingival and supragingival plaque and the posterior third of the tongue dorsum while avoiding the remaining locations within the oral cavity. the viable anaerobic and aerobic bacterial counts, volatile sulfur compounds (vscs) levels, organoleptic assessment of oral odor and the tongue-coating index were compared at baseline, 1, 5 and 9 hours after the treatment.


Eligibility criteria:
inclusion criteria: 1. saudi arabia volunteers to be recruited from albaha province of saudi arabia via an online invitation on the e-learning blog www.alqumber.wordpress.com 2. no antibiotic usage and no antiseptic mouth rinse use for the last 3 months and one week preceding the commencement of the study, respectively. 3. must be dentate healthy saudi males aged 17-65 years, who adhere to the ritual of fasting. 4. provided informed consent form. exclusion criteria: 1. receiving any professional periodontal treatments (prophylactic scaling, root planning, and periodontal surgery) or professional advice during the previous year. 2. prior to the inception of the study.
long-term outcomes of endoscopic papillary balloon dilation for 8-12mm bile duct stones: a prospective study

Conditions: Endoscopic Papillary Balloon Dilation; Bile Duct Stones; Endoscopic Sphincterotomy; Stone Recurrence

Summary: the investigators prospectively evaluated long-term outcomes of elbpd+est for cbd stones up to 8-12mm. epbd+est in patients with cbd stones up to 8-12mm appears to be associated with a very low (\<3%) rate of long-term stone recurrence. the efficacy of epbd for 8-12mm stones warrants further exploration in randomized trials.

consecutive patients with cbd stones up to 8-12mm successfully treated by epbd+est from september 2018 to august 2020 were prospectively followed for at least 12 months. cbd stone recurrence was defined as recurrent stones confirmed by ercp during the follow-up period. the maximum diameter of the balloon used was 15mm. overall, 72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple cbd stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous est. the mean cbd diameter was 11.6±1mm, whereas a tapered duct was noted in 7 (9.7%). post-procedural bleeding occurred in one case, treated successfully a with a fully covered metal stent. mild cholangitis occurred in two cases. no cases with perforation or pep were observed. during a mean follow-up of 22.4±6.2 months (range 13-36), cbd stones recurred in 2/72 (2.7%). epbd+est in patients with cbd stones up to 8-12mm appears to be associated with a very low (\<3%) rate of long-term stone recurrence. the efficacy of epbd for 8-12mm stones warrants further exploration in randomized trials.

Eligibility criteria:
inclusion criteria:patients with elbpd+est for cbd stones up to 8-12mm from september 2018 to august 2020 - exclusion criteria: patients with bile duct stones less than 8mm or more than 12mm. -

Keywords: endoscopic papillary balloon dilation stone recurrence
a study of mt-303 in adults with advanced or metastatic gpc3-expressing cancers, including hcc

Conditions: Hepatocellular Carcinoma

Summary: this is a multicenter, open-label, phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability and define the rp2d of mt-303 in participants with advanced hepatocellular carcinoma expressing gpc3.

mt-303 will be administered intravenously with treatment provided until lack of tolerability or progression. participants will be enrolled in sequential dose escalation cohorts with determination of dose limiting toxicities with the goal of establishing the (maximum tolerated dose) mtd and (recommended phase 2 dose) rp2d.

Eligibility criteria:
inclusion criteria * aged 18 years or older * histological diagnosis of advanced/recurrent or metastatic and/or unresectable hcc. \[note: participants with other tumor types expressing gpc3 may be eligible pending a discussion with the medical monitor\] * measurable lesion per recist 1.1 criteria * eastern cooperative oncology group (ecog) performance status grade of 0 or 1 * child-pugh score: class a * adequate organ function exclusion criteria * known active central nervous system (cns) metastasis and/or carcinomatous meningitis. * any acute illness including active infection * history of liver transplantation or on waiting list * participants with untreated or incompletely treated varices with bleeding or high risk for bleeding * uncontrolled pleural effusion, pericardial effusion, or ascites * history of symptomatic congestive heart failure * history of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.

Keywords: liver cancer hepatocellular carcinoma (hcc) glypican-3 chimeric antigen receptor car-m
correction study of r744 in renal anemia patients on hemodialysis

Conditions: Hemodialysis Patients

Summary: this study will assess the efficacy and safety of intravenous r744 in renal anemia patients on hemodialysis.


Eligibility criteria:
inclusion criteria: * patients who have been receiving hemodialysis more than 1 time a week * patients aged ≥ 20 years at the time of obtaining consent * after starting of hemodialysis, patients who have not received rhuepo preparation * after starting of hemodialysis, patients whose value of hb concentrations determined before the first hemodialysis during the last week prior to the registration has been \< 10.0 g/dl exclusion criteria: * patients with hardly controllable hypertension (patients whose diastolic blood pressure has been ≥ 100 mmhg on more than 1/3 of the determining occasions after starting of hemodialysis during the last week before registration) * patients with congestive cardiac failure (≥ class iii in nyha cardiac function classification) * female patients who are pregnant, lactating, possibly pregnant or not willing to take a contraceptive measure during the period from the day of starting the treatment with the study drug to 90 days after the day of the last dose of the study drug * patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction) * patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom) * patients hypersensitive to a rhuepo preparation * patients with malignant tumor (including hemic malignant tumor), severe infection, systemic hemic disease (osteomyelodysplasia syndrome, hemoglobinopathy, etc.), hemolytic anemia or apparent hemorrhagic lesion such as digestive tract hemorrhage * patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration * patients who have received another investigational drug within 12 weeks before registration * patients who have received r744 before registration * patients whose ast(got) value ≥ 100 iu/l or alt(gpt) value ≥ 100 iu/l before registration * patients who have received erythrocyte transfusion within 16 weeks before registration * patients for whom a surgical operation involved with heavy bleeding is planned during the study period * in addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator
cannabis oil for chronic non-cancer pain treatment

Conditions: Chronic Non-cancer Pain

Summary: cannabis is being prescribed medically for chronic non-cancer pain despite limited evidence whether or not it works to reduce average pain in patients with chronic non-cancer pain. the cannabis plant (cannabis sativa, cannabis indica) consists of several hundred compounds of which, approximately 70 of which are thought to be active. the two active cannabinoids of interest in this trial are tetrahydrocannabinol (δ9-thc) and cannabidiol (cbd). the goal of this trial is to determine whether cbd or cbd+thc reduces the average pain in participants with chronic non-cancer pain. the investigators also aim to determine whether cbd or cbd+thc is associated with a reduction in pain severity, pain interference, anxiety, depression, insomnia, opioids and use of benzodiazepines, analgesics, antidepressants, anxiolytics, or hypnotics amongst chronic non-cancer pain patients or an increase in physical functioning, physical health related role limitations, social functioning, mental functioning.


Eligibility criteria:
inclusion criteria: * age \>25 * average pain score in past week of ≥ 4/10. exclusion criteria: * personal history of bipolar disorder * personal or family history (first degree relative - parent of sibling) of psychotic disorders (e.g., schizophrenia) * active cancer (an individual undergoing active cancer chemotherapy, radiation or surgical treatment and is deemed to not be in remission as per an oncologist's report) * intention to travel internationally during the trial * uncontrolled diabetes (a1c \> 11) * cannabis use in the past 4 weeks (recreational or medicinal) * current use of illicit drugs (e.g., cocaine) * current use of non-prescription opioids * unable to read and write in english * women who are currently pregnant or breast-feeding; or women of child-bearing age who plan to become pregnant during the trial period.
hunger/satiety's physiopathologic study in morbidly obese patients

Conditions: Morbid Obesity

Summary: the mechanisms that regulate appetite in the morbidly obese are multifactorial and not well-known. different peripheral signals (such as ghrelin or cholecystokinin) play an important role in the central regulation of appetite and hunger. postprandial ghrelin and cholecystokinin (cck) response has also an effect on gastric emptying that, in turn, has an effect on satiety sensation. on the other hand, bariatric surgery is supposed to affect hunger and satiety in and also promotes changes in gastric emptying which are not clearly defined. aim: to better understand the physiologic mechanisms involved in the regulation of hunger and satiety in morbidly obese individuals, especially those related with gallbladder and gastric emptying, as well as those related with the response of the gastrointestinal hormones ghrelin, cck and glucagon-like peptide-1 (glp-1), before and after bariatric surgery (sleeve gastrectomy). methodology: three groups of individuals will be studied and compared: group a) non obese healthy subjects, group b) morbidly obese subjects and group c) morbidly obese subjects who had had a previous sleeve gastrectomy. in all subjects a standard meal test after a fasting night will be administered and appetite, satiety and hormonal response (ghrelin, cck, glp-1 and insulin) during 4 hours post-ingestion assessed, as well as postprandial gallbladder and gastric emptying by means of ultrasonography and the paracetamol absorption technique.


Eligibility criteria:
inclusion criteria: group a: non obese individuals (body mass index; bmi \< 30 kg/m2) group b: fulfilling the national health institute (nhi) criteria for bariatric surgery (bmi higher than 40 kg/m2 or 35 kg/m2 when related comorbidities) group c: previous morbidly obese individuals who had had a sleeve gastrectomy at least 6 months ago. exclusion criteria: group a: previous gastric surgery or gallbladder removal. group b: previous gastric surgery or gallbladder removal. group c: previous gallbladder removal.
etiology of orphan community-based meningitis and meningo-encephalitis.

Conditions: Community-based Meningitis; Meningo-encephalitis

Summary: the primary purpose of this study is to assess the contribution of a non-invasive sampling (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.

community-based meningitis and meningo-encephalitis are defined by the presence of more than 10 leukocytes per ml of cerebrospinal fluid (csf), eventually reported to the number of red blood cells. they can be associated with encephalitis, defined by cerebral or cerebellar dysfunction in the case of the transmission. the evolution includes death, what makes the seriousness of this clinical situation. however the diagnostic performance of meningitis and meningo-encephalitis in a patient without contact with a care structure is less than 25% resulting in empirical support in half of the patients. indeed, the microbiological diagnosis of meningitis and transmission target currently only five pathogens including hiv positive resulted in a significant change to support the patient in three areas, decision of hospitalization, decision of isolation and antibiotic or antiviral treatment decision. a weekly epidemiological monitoring of the microbiological diagnosis of meningitis and meningo-encephalitis has enabled us to see a mismatch between a curve of requests for analyses and a flat curve of produced diagnoses. this discrepancy is interpreted as indicating a community outbreak of meningitis or meningo-encephalitis non-diagnosed by routine methods, called orphan meningitis or orphan meningo-encephalitis. on this observation, our research project is to improve the performance of the etiological diagnosis of community-based meningitis or meningo-encephalitis. to do this, we will evaluate the diagnostic performance of an advanced technique, using a non-invasive sample, the pharyngeal swab from the patient, to find micro-organisms that are not part of the commensal flora of the pharynx and who are responsible for undetected in routine meningitis. indeed the main pathogens and meningitis (enterovirus, pneumococcus, meningococcus) transmission give a pharyngeal carriage before being responsible for meningitis or meningo-encephalitis. these bacteria are coxiella burnetii, bartonella spp., tropheryma whipplei, leptospira spp. and borrelia spp.

Eligibility criteria:
inclusion criteria: * patient is aged more than 18 years old. * patient with clinical meningitis or meningo-encephalitis with community transmission. * patient with a prescription of microbiological diagnosis of meningitis or meningo-encephalitis. * patient who do not declined to have his medical records reviewed for research * patient with health insurance exclusion criteria: * minor patient (age \<18 years) * pregnant woman, parturient or breastfeeding * adult patient under guardianship * patient deprived of liberty under court order * patient vital in emergency.
a global phase 3 safety study of 120 mcg rlp2086 vaccine in adolescents and young adults aged 10 to 25 years

Conditions: Meningitis, Meningococcal

Summary: a multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rlp2086 vaccine in a 0, 2, 6 month schedule or control. the control group will receive havrix vaccine at month 0 and 6 and saline at month 2. all subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.


Eligibility criteria:
inclusion criteria: * healthy subjects aged 10 to 25 years. exclusion criteria: * previous vaccination with hepatitis a virus vaccine * previous vaccination with investigational meningococcal b vaccine * history of culture-proven n. meningitidis serogroup b disease * any neuroinflammatory or autoimmune condition * any immune defect that would prevent an effective response to the study vaccine

Keywords: phase 3 safety study 5700 healthy subjects 3 vaccine doses at month 0 2 and 6 control hav/saline/hav
dose-finding of multiple dose of bt061 in patients with active rheumatoid arthritis incompletely controlled on stable methotrexate (mtx)

Conditions: Rheumatoid Arthritis

Summary: the study is conducted in order to find out if repeated doses of the monoclonal (artificially manufactured) antibody bt061 can help arthritis patients whose disease does not sufficiently respond to a treatment with methotrexate (mtx).

patients showing active rheumatoid arthritis according to acr criteria despite at least 6 months of treatment with methotrexate fulfilling all other inclusion criteria including written informed consent and none of the exclusion criteria (see below) have the opportunity to be randomised to either treatment with bt061 or placebo, both given subcutaneously in a double-blind set-up.

Eligibility criteria:
inclusion criteria: * patients with active rheumatoid arthritis (ra) according to 1987 revised acr criteria with functional class ii-iii * disease activity at screening and baseline (more than 6 swollen joint count; more than 6 tender joint count; elevat. of crp or esr) * duration of ra more than 12 month * history of at least one disease-modifying anti-rheumatic drug (dmard) with an inadequate response despite more than 3 month of treatment * mtx treatment at least 6 month with a stable dose at least 15mg mtx * patients could continue at more than daily 7,5mg of prednisone or equivalent stable dose at least 6 weeks prior baseline * written informed consent exclusion criteria: * treatment with traditional dmards apart from mtx 12 weeks prior to baseline and dmard leflunomide 24 weeks * treatment with any biologics other than tnf-α inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra) * treatment with any tnf-α inhibitor within 5 elimination half-lives prior baseline and during the study * clinical non-response to more than one of tnf-α inhibitor exceeding adequate treatment duration

Keywords: rheumatoid arthritis
esketamine combined with prf of drg for postherpetic neuralgia

Conditions: Postherpetic Neuralgia

Summary: this trial's primary objective is to compare the analgesic efficacy of esketamine in combination with pulsed radiofrequency (prf) of dorsal root ganglion(drg) against that of prf monotherapy in patients with postherpetic neuralgia(phn).

this study aims to determine whether the addition of esketamine to the prf of drg regimen can relieve pain in phn patients. by doing so, the research endeavors to identify a rapid, effective, and safe treatment approach for refractory phn patients

Eligibility criteria:
inclusion criteria: 1. ages more than 18 years; 2. pain persisting for over three months following the onset of the herpes zoster skin rash; 3. lesions located in in the unilateral cervical, thoracic, and lumbosacral segments; 4. having an average pain score of at least 4 on a numeric rating scale (nrs, 0 = no pain, 10= worst possible pain)； planned to perform ct-guided prf treatment of the dorsal root ganglion（drg） exclusion criteria: 1. obstructive sleep apnoea syndrome; 2. those who receive other more invasive treatments, such as radiofrequency thermocoagulation (rft) of drg. 3. a history of systemic immune diseases, organ transplantation, or cancers; 4. a history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder; 5. a history of schizophrenia, epilepsy, or myasthenia gravis, delirium; 6. comorbid hyperthyroidism or phaeochromocytoma; 7. recent history of drug abuse; 8. having contraindications to esketamine; 9. communication difficulties. 10. women who are preparing for pregnancy, in the pregnancy or lactation period.

Keywords: postherpetic neuralgia esketamine