Kornimate/medical-research-clean huggingface dataset:
vibe-assisted deb registry

Conditions: Coronary Artery Disease

Summary: viber aims at assessing angiographic outcome of drug-eluting balloon angioplasty assisted by the vascular imaging balloon catheter (vibe, volcano, san diego, ca) device, which integrates a predilation catheter with electronic intravascular ultrasound capabilities.


Eligibility criteria:
inclusion criteria: * age \>18 years * de novo native vessel lesion * rvd 2.5 - 4 mm limited compliance with \>3 month dapt exclusion criteria: * lmca
modified relaxation (mr) technique for treating hypertension in postmenopausal women

Conditions: Postmenopausal Syndrome; Hypertension

Summary: the purpose of this study is to demonstrate better effectiveness of modified relaxation (mr) technique over no mr for treating hypertension in thai postmenopausal women.

medical treatment of hypertension (htn) in postmenopausal women is not very effective, as it requires co-operation and long-term commitment from the patients and their families. the medication itself may cause bothersome side effects and it can pose economic burden to the patients and the society. in contrast, lifestyle modifications, particularly relaxation technique, are less costly and relatively free of any side effects. once the patients master the techniques, they can practice by themselves at home and at any time that is convenient to them. there is evidence from at least one rct that the techniques are effective in reducing the systolic blood pressure (sbp) and diastolic blood pressure (dbp), even after a short practice of only two months. in this study, the investigators propose a randomized control trial to examine the effectiveness of modified relaxation (mr) technique to control htn in thai postmenopausal women against a control group who practice no mr. such a study in thai population has not been done before. in addition, the investigators will extend the period of observation up to 16 weeks, to assess longer-term patients' compliance, and the effects of mr on bp.

Eligibility criteria:
inclusion criteria: * stage 1 essential hypertension, defined as a systolic blood pressure of 140-159 and/or dbp of 90-99 mmhg on two occasions at least 30 minutes apart. * women who are able to attend follow visits as advised. exclusion criteria: * women with systolic blood pressure (sbp) \>160 mmhg or diastolic blood pressure (dbp) \>100 mmhg. * women who have other known causes of hypertension, such as renal diseases * women who are using sedatives or tranquilizer,or antidepressant, or antihypertensive medication during the past 2 months prior to the study. * have language or geographical barrier. * do not give their informed consent. * women who need to be prescribed hrt.

Keywords: postmenopause hypertension relaxation sbp 140-159 mmhg dbp 90-99 mmhg stage 1 or mild hypertension
a prospective study to evaluate the conformis itotal® (ps) knee replacement system

Conditions: Osteoarthritis, Knee

Summary: this is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.

the study is prospective. subjects will be implanted with an itotal® ps knee replacement system. the study will include a minimum of 100 subjects across up to 10 sites. the patients enrolled in this study may represent the first cases of the itotal ps krs implanted at a particular site; data collected for the first 15 patients at each site will be analyzed separately from the rest of the enrolled population. this will provide visibility towards determining if there exists a learning curve in the implantation process of the itotal ps krs. the study sites will be located in the united states.

Eligibility criteria:
inclusion criteria: * clinical condition included in the approved indications for use for the itotal® ps * osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a tkr procedure. disease status is assessed by clinical and radiographic assessment. * willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits * \> 18 years of age exclusion criteria: * simultaneous bilateral procedure required * bmi \> 40 * active malignancy (defined as a history of any invasive malignancy - except non- melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years * poorly controlled diabetes * neuromuscular conditions which prevent patient from participating in study activities * active local or systemic infection * immunocompromised * fibromyalgia or other general body pain related condition * rheumatoid arthritis or other forms of inflammatory joint disease * loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified * diagnosed with or receiving treatment for osteoporosis * other physical disability affecting the hips, spine, or contralateral knee * severe instability due to advanced loss of osteochondral structure * prior arthroplasty of the affected knee, including high tibial osteotomy (hto) * unwilling or unable to comply with study requirements * participation in another clinical study which would confound results * allergy to any of the implant materials

Keywords: osteoarthritis patient-specific knee replacement tka knee arthroplasty total knee replacement posterior stabilized
evaluation of the effect of the "cr500 single-dose gel" medical device in patients with knee osteoarthritis (koa)

Conditions: Knee Osteoarthritis

Summary: single arm clinical investigation, post-market confirmatory interventional to assess performance, safety and tolerability of "cr500 single-dose gel" medical device in patients with knee osteoarthritis (koa).

subjects 26-83 years old will receive cr500 single-dose gel given for the treatment of osteoarthritis of the knee over a 4-week time period. the primary objective of the study is to evaluate the effect of cr500 single-dose gel in the treatment of koa.

Eligibility criteria:
inclusion criteria 1. male or female, aged ≥18 years at the time of the signature of icf (informed consent form). 2. patients with a diagnosis of primary or secondary koa affecting only one knee (monolateral koa) of "mild" (score 1 - 4) or "moderate" (score 5 - 7) severity according to the lki score. 3. willing to follow all study procedures, including attending all site visits, tests and examinations. 4. willing to participate in the study and sign the icf. exclusion criteria 1. osteoarthritis (oa) in both knees (bilateral koa). 2. other - different - clinical conditions of the knee. 3. infective or inflammatory processes near the area of treatment. 4. damaged skin in the area of treatment. 5. ongoing cutaneous allergies. 6. serious and chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy. 7. allergy to device components (sodium hyaluronate; synthetic human (sh)-polypeptide-85; sh-polypeptide-93; glycerin; propylene glycol; ethylhexylglycerin; panthenol; polyethylene glycol (peg)-40 hydrogenated castor oil; sodium hydroxide; xanthan gum; phenoxyethanol; benzoic acid; carbomer; dehydroacetic acid; disodium edta). 8. any other systemic or local therapy for the treatment of koa. 9. any other systemic or local therapy (e.g. nsaids, corticosteroids) for the treatment of other inflammatory diseases (e.g. dermatitis, acute or chronic bronchitis, gastroenteritis, etc.) or painful states (e.g. headache, dental abscess, etc.) that may interfere with the clinical course of koa under treatment with the medical device cr500. 10. immune system illnesses. 11. uncontrolled systemic diseases. 12. known drug and/or alcohol abuse. 13. mental incapacity that precludes adequate understanding or cooperation. 14. participation in another investigational study. 15. pregnancy\* or breastfeeding.

Keywords: knee osteoarthritis; hyaluronic acid peptides synovial fluid algofunctional scores biochemical markers macrophages infiltration
impact of diverticular disease on the detection of colon adenomas

Conditions: Colon Adenoma; Diverticulosis

Summary: benign adenomas of the colon have the potential to degenerate and become malignant. therefore adenomatous polyps should be detected and resected during colonoscopy. factors like advanced age and male gender are associated with the detection of adenomas. the same epidemiological pattern can be found with regard to colon diverticula. furthermore, western world countries report higher incidences of both colorectal carcinoma as well as diverticular disease. it is not known whether a correlation exists between both entities. some recent data have postulated higher adenoma detection rates in patients with concomitant diverticular disease (rondagh ej et al. eur j gastroenterol hepatol. 2011; 23:1050-5. kieff bj et al. am j gastroenterol 2004; 99: 2007-11). if a positive correlation could be found this would possibly affect recommendations regarding colonoscopy surveillance intervals for patients with and without diverticular disease. the investigators therefore plan to conduct the following trial.


Eligibility criteria:
inclusion criteria: * indication for colonoscopy * age \>= 18 years exclusion criteria: * pregnant women * patients denying written consent * indication for colonoscopy: familial adenomatous polypose * indication for colonoscopy: inflammatory bowel disease * indication for colonoscopy: previously known colon polyp/adenoma/carcinoma * history of colon surgery * contraindication for resection of polyps * american society of anesthesiologists (asa) class iv, v or vi

Keywords: adenoma diverticular disease diverticulosis colorectal carcinoma polyp
amino acid-based oral rehydration solution in children with short bowel syndrome

Conditions: Short Bowel Syndrome

Summary: this study will assess the tolerability and palatability of an amino acid based oral rehydration solution (enterade®) compared to current oral rehydration solution among children with short bowel syndrome .

patients with short bowel syndrome (sbs) have a critical reduction of the gut mass/function that is below the minimum needed to absorb nutrients and fluids required for adequate homeostasis. there are limited data regarding the optimal choice for oral rehydration in the setting of sbs that can maximize fluid absorption in the setting of diarrhea with limited intestinal absorptive surface area. the investigators propose a preliminary open label single center study assessing tolerability and palatability of enterade® ( an amino acid (aa) based oral rehydrating solution (ors)) and compare to baseline. eligible patients with sbs will participate in a 14-day trial monitoring and measuring tolerability and palatability of an aa-ors, enterade®, in addition to their regular diet.

Eligibility criteria:
inclusion criteria: * male and female patients with a diagnosis of short bowel syndrome (as defined by surgical therapy for congenital or acquired gastrointestinal disease) between the ages of 1-17 * patients who are in intestinal continuity or with diverting ileostomy, jejunostomy * patients must be on a stable enteral nutrition regimen with oral rehydration fluids that are taken orally. * stable gi medication regimen (e.g., loperamide, cholestyramine, small bowel bacterial overgrowth (sbbo) regimen) exclusion criteria: * patients receiving iv antibiotics within the previous 72h. * patients with a primary diagnosis of a motility disorder (e.g., chronic intestinal pseudo-obstruction) or epithelial cell disorder (e.g., microvillus inclusion disease) * malnourished (as defined by weight/height z-score (whz) \<-2)

Keywords: oral rehydration solutions
bt-011 pharmacokinetics of botulism antitoxin heptavalent in pediatric patients

Conditions: Botulism

Summary: the purpose of this study is to verify the pediatric dosing recommendations for bat product in pediatric patients that are treated with bat product due to a confirmed or suspected case of botulism. a minimum of one serum sample should be collected but whenever feasible additional serum samples (up to three per enrolled participant) may be collected from the participant or obtained from surplus standard of care samples, if available, within 32 hours after bat product administration. safety of the bat product will also be evaluated. emergent will follow-up with the physician by telephone after 30 days post-bat product administration to collect aes, saes, and unanticipated events.

primary objective: to collect blood from pediatric participants to analyze the pharmacokinetics (pk) of bat product to verify the current us fda-approved pediatric dosing recommendations for bat product. safety objective: to evaluate the safety of bat product in pediatric participants. protocol design: this is a single arm, multi-site pk study in pediatric patients treated with bat product. pharmacokinetic parameters: the serum concentrations of bat product obtained will be modeled using a population pk approach based on a previously developed model for bat serotypes a through g in healthy adult human participants. safety endpoints: the incidence of adverse events (aes), serious adverse events (saes), and adverse events of special interest (aesi) that occur within 30 days after bat product administration. in this study hypersensitivity/allergic reactions including serum sickness, febrile reactions, and hemodynamic instability and bradycardia, as well as reports of an infectious disease transmission will be included as aesi.

Eligibility criteria:
inclusion criteria: 1. legally authorized representative is able and willing to voluntarily provide informed consent and patients to provide assent, if applicable. 2. pediatric participants (age groups: birth to \<two years, two to \<six years, and six to \<12 years). 3. treatment with bat product (initial dose only). 4. blood sample can be collected (or standard of care sample scavenged) within 32 hours of completion of bat product infusion. exclusion criteria: 1. if the 5 ml blood sample volume is deemed, at the discretion of the investigator, to be unsafe based on patient weight or condition of health. 2. history of treatment with babybig or other botulism antitoxin within the past 90 days.

Keywords: pharmacokinetics bat pediatric
ultrasound of the diaphragm in icu patients

Conditions: Critically Ill

Summary: diaphragmatic dysfunction is an important complication of mechanical ventilation. critically ill patients admitted in a teaching hospital intensive care unit will be evaluated with diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical course of these patients. vascular surgery patients (aortic abdominal surgery) might also be included and assessed with diaphragm ultrasound before and after surgery irrespectively of the need of intensive care unit. on december 2014 the etical committee approved an amendment to include the possibility to study elective aortic abdominal surgery patient to assess the relationship between surgery related diaphragmatic dysfunction and postoperative respiratory complications.


Eligibility criteria:
inclusion criteria: * adult plus admitted in icu plus invasive or non-invasive mechanical ventilation or * adults aortic vascular surgery exclusion criteria: * \< 18 years

Keywords: ultrasound diaphragm intensive care critical care
an ophthalmic safety study in patients with breast cancer

Conditions: Ophthalmic Safety in Patients With Breast Cancer

Summary: to assess ophthalmic health in parallel cohorts of patients with breast cancer

this is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. the study will include two cohorts of at least 60 individuals each. to be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. the duration of the study assessment period will be approximately 12 months. longer duration of the study would result in additional patient burden.

Eligibility criteria:
inclusion criteria: 1. signed informed consent in the qualifying study. 2. signed informed consent in the ophthalmic study prior to any ophthalmic study specific assessments and procedures. 3. completed the baseline ophthalmic examination for this study before the first dose in the qualifying study. 4. meets all the eligibility criteria in the qualifying study exclusion criteria: 1. patients not randomized and not receiving study assigned treatment in a qualifying study. 2. patients with contraindications to any ophthalmic procedure required by the study or sensitivity/allergy to pupil dilating agents. 3. judgement by the investigator that the patient should not participate in the ophthalmic study if the patient is unlikely to comply with study procedures, restrictions, and requirements

Keywords: ophthalmic safety assessment
effectiveness of shockwave treatment for proximal fifth metatarsal stress fracture in soccer players

Conditions: Stress Fracture Metatarsal

Summary: fifth metatarsal stress fracture is a failure of a healthy metatarsal bone subject to repetitive microdamages. it has a high prevalence in soccer players and is classified as a high-risk stress fracture. based on torg classification, the treatment options may be conservative or surgical. the recent increase of evidences about shock wave treatment in different bone pathologies, including stress fractures, suggests the possibility to use this conservative intervention option also in patients candidate for surgery. this randomized clinical trial included 18 soccer players diagnosed of proximal fifth metatarsal stress fracture, randomly matched in surgery group and shock wave group. patients of surgery group were treated with intramedullary screw fixation; patients of shock wave group received 3 weekly sessions of focused shock wave treatment (f-eswt), using an electrohydraulic device set to an energy flux density (efd) of 0.21 mj/mm2 and 2000 impulses. patients of both groups were followed monthly until their return to play (rtp) using radiography, visual analogue scale (vas), tegner activity level scale and aofas score.


Eligibility criteria:
inclusion criteria: * male soccer players, aged over 18 years. * diagnosis of proximal fifth metatarsal stress fracture, according to clinical signs and symptoms and to radiologic findings * fracture occurred during soccer practice * informed consent signed exclusion criteria: * to be under 18 years old * traumatic fracture * fracture occurred out of soccer practice * patients with metatarsal shaft, neck or head fracture * patients with contraindication to receive surgical treatment * patients with contraindication to receive shock wave treatment * patients that refuse the informed consent
a study of mrna-1010 seasonal influenza vaccine in adults

Conditions: Seasonal Influenza

Summary: the primary objectives of this study are to evaluate the humoral immunogenicity of mrna-1010 relative to that of an active comparator against vaccine-matched influenza a and b strains at day 29, and to evaluate the safety and reactogenicity of mrna-1010.


Eligibility criteria:
inclusion criteria: * investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow-up, including all procedures. * for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to day 1, and agreement to continue adequate contraception through 90 days following vaccine administration. exclusion criteria: * participant has had close contact to someone with sars-cov-2 infection or covid-19 as defined by the united states (us) cdc or has had a positive sars-cov-2 test in the past 10 days prior to the screening visit. * participant is acutely ill or febrile (temperature ≥38.0℃ \[100.4°f\]) 72 hours prior to or at the screening visit or day 1. participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number. * participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. * reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mrna or influenza vaccines or any components of the mrna or influenza vaccines, including egg protein. * participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 180 days prior to the screening visit (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. inhaled, nasal, and topical steroids are allowed. * participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study injection (day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study injection. * participant is not aware whether they have received an influenza vaccine in the past 12 months or has received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to day 1. * participant has tested positive for influenza by local health authority-approved testing methods within 180 days prior to the screening visit. * participant has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study. note: other inclusion and exclusion criteria may apply.
lung cancer symptom assessment and management intervention

Conditions: Lung Cancer

Summary: the purpose of this study is to develop and test the usability of a computerized symptom assessment and management intervention system in a laboratory setting (phase i) and its feasibility in a clinical setting in a group randomized trial (phase ii).


Eligibility criteria:
inclusion criteria: * hcps: attending physician, thoracic medical oncologist, expected to work in the setting for at least 2 years. * patients: 21 years of age or older; diagnosis of stage iiia, iiib, iv non-small cell lung cancer or limited or extensive stage small cell lung cancer; receiving care in the out-patient setting; receiving treatment with chemotherapy +/- additional therapies; english speaking. exclusion criteria: * patients: any patient who needs emergent care, routine visits scheduled less than once a month

Keywords: sami symptom assessment and management intervention program