Kornimate/medical-research-clean huggingface dataset:
bowel preparation may lead to a higher feasibility of intestinal infection

Conditions: Healthy

Summary: an adequate bowel preparation is essential for a high quality of colonscopy. nowdays, polyethyleneglyco is considered the most safe drug for bowel preparation, and is widely used around the world. however, previous study illustrated that bowel preparation by polyethyleneglyco could lead to qualitative changes in the intestinal microbiota both in mice and human. this study is aimed to investigate wether the changes in the intestinal microbiota could lead to a higher rate of intestinal infection.


Eligibility criteria:
inclusion criteria: * patients who agree to participant in the study exclusion criteria: * patients who couldn't stand polyethyleneglycol or inulin patients couldn't provide informed consent patients who are suffering from sever heart disease, pulmonary disease or renal dysfunction.
safety and dosage of a computerized cognitive training program for cognitive dysfunction after covid-19

Conditions: Post-Acute COVID-19; Post Acute COVID-19 Syndrome; Cognitive Dysfunction; Cognitive Impairment

Summary: the goal of this phase i/ii clinical trial is to assess the safety and maximum tolerated training time of a self-administered computerized cognitive training (cct) in individuals with cognitive dysfunction as a consequence of covid-19 infection.

a phase i/ii protocol is designed to determine the safety of a computerized cognitive training (cct) aimed at ameliorating the cognitive dysfunction often observed in persons with post-acute sequelae of covid-19 (pasc). the phase i/ii trial also aims at establishing the maximum tolerated training time per session of the cct and to explore the feasibility of such intervention. in phase i, through a 3+3 design, a dose-escalation trial will be set. participants will be tested across subsequent training blocks of 15 minutes each, reporting on the experienced fatigue or adverse effects after every block. the safe training dose will be set to a block before extreme fatigue or a notable adverse effect has been reported by two or more participants. once a safety training time has been established, a group of participants will engage in a 15-day training effectiveness assessment. after an initial thorough pre-test assessment, the intervention protocol will start. an evaluation day and a training day will be interspersed so that participants will complete a total of 8 training sessions (days 1, 3, 5, 7, 9, 11, 13 and 15). after the final day of intervention, a post-test assessment session will be carried out.

Eligibility criteria:
inclusion criteria: * adults between 25 and 55 years old. * history of infection with covid-19 at least 3 months prior to expression of interest with a valid diagnostic or antibody test. * presence of self-perceived cognitive dysfunction associated with post-acute sequelae of covid-19 (concentration problems or brain fog). exclusion criteria: * suicidal traits. * poor digital skills. * not having access to a mobile phone or tablet with internet connection during the time of the intervention (only for phase ii). * not having 60 spare minutes per day to complete the intervention (only for phase ii).

Keywords: post-acute sequelae of covid-19 pasc cognitive dysfunction computerized cognitive training brain training
efficacy of surgical treatment of osteomyelitis in diabetic foot ulcers

Conditions: Osteomyelitis; Diabetic Foot; Diabetic Foot Ulcers

Summary: hypothesis:surgical treatment of osteomyelitis in diabetic foot is more effective that medical treatment through antibiotherapy and leads wound healing in ulcers complicated with bone infection.material and methods: randomized clinical trials which include two groups of patients (n=88), one receives medical treatment through antibiotherapy during 90 days and the other group receive conservative surgical treatment and antibiotics during 7 days after surgery. it will be studied differences between both groups in healing time, recidives, present and relationship of adverse events and outflow of quality of life related health .


Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus type 1 or 2. * patients with diabetic foot ulcers. * patients with clinical suspects of osteomyelitis. * patients with positive probe to bone test. * patients with signs of osteolysis in the bone located adjacent to the ulcer in x-ray * patients with transcutaneous oxygen oxygenation above 30 mmhg. * acceptance to participate in the study through prior informed consent. exclusion criteria: * patients with osteomyelitis associated with necrotizing soft tissue infections. * presence of necrotic tissue in the wound bed, edges or margins of the lesion. * hbac1 \> 10. * presence of systemic toxicity such as fever, tachycardia, confusion, disorientation, vomiting or other signs usually related to systemic infection. * patients with bone exposure through the ulcer. * patients with absent pulses, ankle/brachial index (abi) \<0.8 and tcpo2 \<30 mmhg. * pregnancy. * allergies to antibiotics. * any degree of renal impairment that contraindicated the administration of antibiotics proposed. * hepatic insufficiency. * mental illnesses that prevent the understanding by the patient's proposed treatment, or for any other reason associated with your mental health, to recommend their inclusion.

Keywords: diabetic foot osteomyelitis diabetic foot ulcers foot infections
eye soft surgery for facial sinkynesis

Conditions: Facial Paralysis; Sinkynesis

Summary: facial synkinesis (fs) is a distressing sequela of facial palsy (fp) characterized by involuntary, simultaneous movements of facial muscles occurring during voluntary facial expressions. treatment of synkinesis is challenging, and preventive methods are needed. this study evaluates the efficacy of physical facial nerve rehabilitation (pfnr) therapy alone versus pnfr with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis. 25 outpatients are randomized to receive either pfnr alone (neuromuscular retraining and kabat proprioceptive neuromuscular facilitation) or pnfr and early (90 days after fp onset) eyelid surgery (involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion). comprehensive otolaryngological assessments and magnetic resonance imaging (mri) will be conducted. synkinesis progression was measured using another disease scale (ads) at baseline, 3 months 6 months, 12 months, and 24-months post-treatment. the data were analyzed with anova, t-test, chi-square analyses.


Eligibility criteria:
inclusion criteria: * people over 18 years old * willingness to participate * acute/new onset of fp (less than 15 days) exclusion criteria: * neuro-inflammatory diseases (e.g., multiple sclerosis) * fp from systemic disorders (e.g., guillain-barré syndrome, lyme disease, encephalitis) * fp from middle ear infections or untreated cholesteatoma * severe cognitive or psychological disorders * non-consent to participate in the study
study to evaluate the effect of isis gcgrrx on hepatic lipid and glycogen content in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the effect of isis 449884 (isis-gcgrrx) on hepatic lipid and glycogen content in patients with type 2 diabetes being treated with metformin.


Eligibility criteria:
inclusion criteria: * male or female, age 18 to 75 * bmi ≥ 25.0 kg/m2 \< 36.0 kg/m2 * hba1c ≥ 7.5% and ≤ 10.5% * type 2 diabetes mellitus and on stable dose of metformin. patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to screening evaluation and will be required to continue their stable dose of metformin throughout the study. patients on a stable dose of metformin plus a sulfonylurea (su) or metformin plus a dipeptidyl peptidase-iv (dppiv) inhibitor for a minimum of 3 months prior to screening evaluation may be allowed * agree to conduct home-based (fasted) blood glucose testing as directed exclusion criteria: * clinically significant abnormalities in medical history or physical exam * show evidence of uncorrected hypothyroidism or hyperthyroidism * history of liver transplantation or renal dialysis * history of liver disease * history of greater than 3 episodes of severe hypoglycemia within 6 months of screening * treatment with any other antidiabetic drug(s) other than metformin, su or dppiv within 3 months of screening * history of diabetic ketoacidosis * any other significant illness or condition that may interfere with the patient participating or completing the study * inability or unwillingness to comply with protocol or study procedures -
evaluating novel healthcare approaches to nurturing and caring for hospitalized elders

Conditions: Delirium; Neurocognitive Disorders; Mild Cognitive Impairment; Alzheimer Disease; Aging; Family Support; Family Members; Caregiver Burden; Implementation Science; Patient Satisfaction

Summary: the goal of this clinical trial is to compare the hospital elder life program (help) with a family-augmented version of help (fam-help), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. the main objectives of the trial are the following: 1. to compare the effectiveness of fam-help and help in reducing both the incidence of delirium and its severity. 2. to compare the effectiveness of fam-help and help in improving patient- and family-reported outcomes. 3. to explore the implementation context, process, and outcomes of the fam-help program in diverse hospital settings.

delirium is a common complication of hospitalization and major surgery for older adults, and it can lead to loss of independence and substantial healthcare costs. one approach to preventing delirium is through the hospital elder life program (help). help personnel work to prevent delirium by providing orienting communication, assisting patients with walking and exercise, providing help with nutrition and fluids, implementing sleep protocols, and helping patients with vision and hearing aids. however, it is unknown whether involving family members in these activities along with help staff (i.e., "fam-help") might be more effective with preventing delirium. the objective of this clinical trial is thus to compare the traditional help program with a family-augmented version of help (fam-help) to determine which program is more effective with preventing delirium and related complications in older, hospitalized patients.

Eligibility criteria:
inclusion criteria: * provision of informed consent * at least 70 years of age * anticipated length of hospital stay at least 72 hours * family member or care partner available to be on-site in the hospital * at least one delirium risk factor (e.g., cognitive or functional impairment, dehydration, vision or hearing impairment) * evaluable cognitive function at baseline (i.e., ability to complete baseline cognitive function assessment) exclusion criteria: * delirium on admission * unable to communicate verbally (e.g., coma, mechanical ventilation) * unable to participate fully in interventions (e.g., terminal condition, advanced dementia) * staff safety concerns (e.g., violent behavior) * cardiac or intracranial surgery (due to competing causes of delirium)

Keywords: delirium clinical trial comparative effectiveness research implementation science
a trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of nnc0215-0384 administered to subjects with moderate to severe rheumatoid arthritis

Conditions: Inflammation; Rheumatoid Arthritis

Summary: this trial is conducted in europe. the aim of the trial is to investigate the safety, tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of nnc0215-0384 administered to subjects with moderate to severe rheumatoid arthritis (ra) concomitantly treated with methotrexate (mtx).


Eligibility criteria:
inclusion criteria: * male or female, age between 18 and 75 years (both years inclusive), for russia only: age between 18-65 years (both years inclusive) * moderate to severe ra, confirmed by a disease activity score based on 28 joints and c-reactive protein (das28 (crp)) equal to or above 4.5 and a minimum of five tender and five swollen joints based on a 28 joint count (a joint can score as both tender and swollen) * mtx (10-25 mg/week both inclusive) for at least 16 weeks, with an unchanged dose for at least 6 weeks prior to screening and until randomisation * females who are not of child-bearing potential must have been post-menopausal for at least 1 year confirmed by follicle-stimulating hormone (fsh) equal to or above 26.7 u/l or be surgically sterile exclusion criteria: * past or current inflammatory joint disease other than ra (e.g. gout \[crystal proven\], psoriatic arthritis, juvenile idiopathic arthritis, reactive arthritis or lyme disease * any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) within 4 weeks prior to randomisation * clinically significant cardiac or cardiovascular disease * past or current malignancy * evaluation of tuberculosis screening indicative of latent or active tuberculosis (tb)
ultrasound guided activated and non activated platelet rich plasma injection versus hydro dissection by steroids.

Conditions: Carpal Tunnel Syndrome; Compare Steroids Versus PRP in Dissection of Median Nerve by Ultrasound

Summary: prp represents a promising, nonsurgical option for patients with carpal tunnel syndrome (cts) with improvement in symptoms compared to placebo, conservative treatment, and local corticosteroid injections at 3-months postintervention. however, the lack of significant long-term results in pain and function demands the presence of future studies to further determine the long-term effect on a large group of homogeneous patients. more over to determine the clinical indications, effect on differing cts severities, and the effects of preparation, concentration of the platelets and methods of activation of prp

1. the patients are blinded to the type of drug and the researchers are blinded to the randomization. randomization will be done using a research randomization program (http://www.randomizer.org) 2. patients will be randomly divided into three groups; each consists of 30 patients. group 1 will include patients subjected to ultrasound guided activated prp injection, group 2 will include patients subjected to ultrasound guided non-activated prp injection, and group 3 patients will be subjected to ultrasound guided hydro dissection using a combination of steroid (triamcinolone 40mg), la (local anesthesia) and dextrose.

Eligibility criteria:
inclusion criteria: * patients with mild to moderate idiopathic carpal tunnel syndrome with clinical manifestations, diagnosed by electrophysiological study and ultrasound. cts grading will be performed on basis of an electrophysiological study following stevens classification (stevens; 1997). * early cts: abnormal findings only in both comparative studies (≥0.5ms difference in peak latency) * mild cts: abnormal median sensory study (peak latency ≥3.5ms) * moderate cts: abnormal median sensory study and prolonged median distal motor latency (onset latency ≥4.5ms) * sever cts: any of the above mentioned abnormalities together with the evidence of axonal loss either by absent median sensory response, low amplitude, or absent median motor response (\<2µv) exclusion criteria: * • patients suffering from diabetes, hypothyroidism, rheumatoid arthritis, , cervical radiculopathy, polyneuropathy, brachial plexopathy, traumatic nerve injury, thoracic outlet syndrome, coagulopathy * pregnancy * previous corticosteroid injection into the carpal tunnel. * previous carpal tunnel decompressive surgery.

Keywords: prp, cts
vis-rx post-market evaluation

Conditions: Coronary Artery Disease

Summary: post-market clinical evaluation of the gentuity high-frequency optical coherence tomography (hf-oct) system and the vis-rx micro-imaging catheter for use in percutaneous coronary intervention (pci) procedures.

prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the gentuity hf-oct system and the vis-rx micro-imaging catheter for use in pci procedures. objectives are to evaluate the clinical and technical performance in the target patient population.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * willing and able to provide written informed consent to participate * transluminal interventional procedure for their coronary arteries general exclusion criteria: * bacteremia or sepsis * major coagulation system abnormalities * severe hemodynamic instability or shock * acute renal failure * disqualified for coronary artery bypass graft (cabg) surgery * disqualified for pci procedure * currently enrolled in another study to evaluate an investigational device or medication lesion-specific exclusion criteria: * total occlusion * coronary artery spasm * large thrombus (visible under angiography) * any target vessel which has undergone a bypass procedure
hypertonic saline inhalation in acute bronchiolitis

Conditions: Acute Bronchiolitis

Summary: acute bronchiolitis is a viral infection that occurs in children most commonly in the first 2 years of life and is characterized by respiratory symptoms, resulting in wheezing and/or crackles upon auscultation. it is usually a self limiting illness. however, this condition may be associated with several severe complications, such as apnea,respiratory failure, or secondary bacterial infection

acute bronchiolitis is a viral infection that occurs in children most commonly in the first 2 years of life and is characterized by respiratory symptoms, resulting in wheezing and/or crackles upon auscultation. it is usually a self limiting illness. however, this condition may be associated with several severe complications, such as apnea,respiratory failure, or secondary bacterial infection. bronchiolitis is a significant cause of respiratory disease worldwide. according to the world health organization bullet in, an estimated 150 million new cases occur annually; 11-20 million (7-13%) of these cases are severe enough to require hospital admission. worldwide, 95% of all cases occur in developing countries. typically, initial clinical manifestations include upper respiratory tract symptoms such as cough, nasal congestion, and low-grade fever lasting 1 to 3 days, followed by expiratory wheezing, nasal flaring, fine crackles, oxygen saturation on presentation\<94%, tachypnea, increased work of breathing, use of accessory muscles, and retractions in some patients. the need for hospitalization depends on the presence of respiratory symptoms (degree of retractions, increased respiratory effort, decreased oxygen saturation), cyanosis, restlessness or lethargy, and underlying disease states, including apnea. since no definitive antiviral therapy exists for most causes of bronchiolitis, management of these infants should be directed toward symptomatic relief and maintenance of hydration and oxygenation. one medication that has demonstrated promising results in the management of acute bronchiolitis is nebulized hypertonic saline , its hyperosmolarity helps to absorb water from the mucosal and submucosal space, thereby increasing mucociliary function by clearing fluids accumulated in the airway and mucus plugs in the lungs. hypertonic saline can also induce cough to help enhance mucus clearance. the american academy of pediatrics guidelines recommend administration of hypertonic saline in hospitalized bronchiolitis patients. the most common dosage studied is hypertonic saline 3% 4 ml per dose inhaled by nebulizer every 4 to 6 hours, which may take ≥24 hours to work and is typically continued while the child is hospitalized.

Eligibility criteria:
inclusion criteria: * infants less than 24 months of age with adiagnosis of acute bronchiolitis exclusion criteria: * other infants and children above 24 months of age * patients with other diseases than acute bronchiolitis
treatment of tnfa naive patients with poor prognosis rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine how well rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells. this will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (ra) patients.


Eligibility criteria:
inclusion criteria: * patients with documented rheumatoid arthritis by acr criteria * disease duration \< 5 years * may have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single dmard or in combination * tender joint count \>= 6, swollen joint count \>= 6, and one must be a knee * corticosteroids \<= 10 mg per day permitted on stable doses for at least 4 weeks * patients must consent to 2 arthroscopic synovial biopsy procedures exclusion criteria: * history of severe allergic or anaphylactic reactions to monoclonal antibodies * previous treatment with rituximab * previous treatment with arava * injected with steroids within 4 weeks of day 1 of study * treatment with any investigational agent within 4 weeks of day of study * any severe or significant medical condition or disease or known active infection * pregnancy or nursing at present
the valentx endo bypass system in obese subjects

Conditions: Obesity

Summary: the purpose of this study is to collect clinical data to support the use of the valentx endo bypass system to improve weight loss and the resolution of comorbidities in obese subjects.

* single-arm, non-randomized, open-label, multi-center trial conducted in up to 70 subjects to assess the safety and efficacy of the valentx endo bypass system over implant duration of up to 36 months. * body weight, adverse events and device function in implanted subjects will be monitored at monthly visits for the first year after implant, at quarterly visits during the second year, and biannually during the third year. * additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic assessments of the condition of the implanted device, and a quality of life questionnaire. * all subjects will be followed for 12 months after device removal with scheduled visits at 1, 6 and 12 months after explant. * subject participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis based on the condition of the implanted device.

Eligibility criteria:
inclusion criteria 1. between 18- 60 years old. 2. bmi of 40-50 kg/m2 with or without comorbidities, bmi of 35-40 kg/m2 with one or more obesity related comorbidities, or bmi of 30-35 with type 2 diabetes 3. willing to give informed consent, and able to understand what this means. 4. documented failure with non-surgical weight loss methods. 5. willing to follow the study procedures and comply with the visits schedule. 6. live within a reasonable distance of the research center and be able to attend routine follow up visits. exclusion criteria 1. pregnancy or intention to become pregnant during the course of the study. 2. abnormal screening esophagogastroduodenoscopy findings 3. prior esophageal, gastric or bariatric surgery. 4. known allergies to any of the device materials. 5. use of weight loss drugs, stimulants and/or herbal weight loss supplements. 6. recent or ongoing health conditions that contraindicate undergoing an elective weight loss procedure involving a device implanted within the lumen of the esophagus, stomach and proximal small intestine. 7. participation in another clinical trial within 60 days of the implant. 8. presence of psychiatric conditions that would impair the ability to provide informed consent or to comply with study procedures.

Keywords: obesity weight loss