Kornimate/medical-research-clean huggingface dataset:
free radical level in scc of tongue patients tumor, serum and saliva

Conditions: Squamous Cell Carcinoma

Summary: study comparing level of free radicals in tumor tissue, blood serum and saliva in patients with squamous cell carcinoma of tongue and mouth floor. patients with benign fibroma of oral cavity and normal gingiva around extracted lower wisdom tooth are used for control


Eligibility criteria:
inclusion criteria: 1. older than 18 years of age. 2. mentally healthy 3. scc of tongue or mouth floor 4. benign fibroma of oral cavity 5. lower wisdom tooth extraction - exclusion criteria: 1. younger than 18 years of age 2. mentally incapacitated

Keywords: squamous cell carcinoma of tongue and mouth floor
a comparison of methods of discontinuing nasal cpap in premature infants <30 weeks gestation

Conditions: Apnea of Prematurity; Respiratory Distress Syndrome

Summary: the purpose of this study is to determine if among infants \<30 weeks gestational age on nasal continuous positive airway pressure (ncpap), whether discontinuing cpap after gradual reduction in continuous positive airway pressure (cpap) pressure leads to successful weaning off cpap when compared to discontinuing cpap without weaning pressure.


Eligibility criteria:
inclusion criteria: * all infants \< 30 weeks by dates, on ncpap therapy, on caffeine 10mg/kg daily * meet cpap stability criteria for ≥ 12hours (cpap 6 cm water (h2o), fio2 \</=0.25 and stable (to maintain sats 85-95%), respiratory rate consistently less than 60, mild to no subcostal/intercostal retractions, no apnea or bradycardia event that requires bag mask ventilation, less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, tolerated time off cpap during routine cpap care (\~15 min) exclusion criteria: * major congenital anomalies including congenital heart disease * anomalies that prevent discontinuation of ncpap * undergoing current evaluation for and/or treatment of sepsis
a clinical study, to evaluate the safety and tolerability of intradermal imm-101 in adult melanoma cancer patients

Conditions: Melanoma

Summary: to evaluate the safety and tolerability of intradermal injections of imm-101 (heat-killed mycobacterium obuense) in melanoma cancer patients.

the proposed study is a first-in-man, placebo-controlled, dose escalation trial to evaluate the safety and tolerability of three different doses of imm-101 administered intradermally to melanoma patients. additionally, the study aims to characterize local responses to this vaccine in order to delineate unexpected / unacceptable local reactions from those indicative of appropriate immunological response in this patient group.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of disease free stage iii or stage iv melanoma (with or without metastases) or stable disease (if with metastases) and receiving no other treatment * willing to use effective contraception for the duration of the study * able to comply with the requirement to complete a diary card exclusion criteria: * pregnant or lactating females * major surgery within the 14 days preceding the screening visit * suspicion of a previous infection with mycobacteria including previous tuberculosis (tb) prophylaxis * treatment with another investigational medicinal product within the last 30 days prior to the screening visit * previous treatment with m. vaccae * exposure to bacille calmette guérin vaccine (bcg) within the last 12 months * concurrent uses of drugs likely to reduce inflammation at the local injection site or dampen/modulate the immune system * depot injection of corticosteroids within 6 weeks of the screening visit or chronic systemic corticosteroids in the 2 weeks prior to the screening visit * ongoing treatment with radiotherapy, cytotoxic chemotherapy or chemotherapy in the last 30 days prior to the screening visit
effects of repeated transcranial magnetic stimulation (rtms) on the treatment of cocaine addicted patients

Conditions: Cocaine Addiction; Treatment; Transcranial Magnetic Stimilation

Summary: cocaine addiction is a serious disease. nowadays we still have no efficient method reducing craving and extending the abstinence period of this patients during treatment. the aim of this study is to evaluate reduction if craving and other parameters related to addiction within this group of patients through a treatment with transcranial magnetic stimulation.

patients are going to submitted do a course of rtms of one month, each session up to 15 minutes. after the rtms they are going to be offered cognitive therapy to prevent relapse. the area stimulated is the dorso-lateral prefrontal cortex. this technique was employed in previous studies and the risks are insignificant.

Eligibility criteria:
inclusion criteria: * minimum age of 18 * maximum age of 40 * diagnostic of cocaine addiction * willingly participate the study exclusion criteria: * metallic cerebral implant * history of severe brain trauma or injury * organic brain disease * severe somatic disease * history of other actual or past psychiatric diagnostics
advagraf/prograf conversion trial

Conditions: Renal Transplant; Kidney Pancreas Transplant

Summary: renal and kidney pancreas transplant patients will be randomized to once daily advagraf or twice daily prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.


Eligibility criteria:
inclusion criteria: * renal transplant or renal pancreas patients who are \> 12 months post transplant * stable allograft function defined as egfr \> 30-60ml/min * renal patients who have a stable tacrolimus trough level of 5-8ng/ml in prior 3 months; renal pancreas patients who have a stable tacrolimus trough level of 3-10 mg/ml in prior 3 months * receiving concomitant therapy with mycophenolate mofetil in a dose of 500-1000mg bid or equivalent exclusion criteria: * any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study. * history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. * treated rejection within 3 months of randomization. * increased serum creatinine \> 20% within 3 months of randomization. * subject is pregnant or breastfeeding * subject has significant co-morbid disease (eg. malignancy or uncontrolled infection) or disability (e.g. cognitive deficit) which prevents understanding of, or adherence to, the protocol

Keywords: renal kidney/pancreas transplant conversion bioequivalence mycophenolate acid
toilet training and adults with learning disabilities

Conditions: Urinary Incontinence

Summary: incontinence is common in adults with learning disabilities (lds). behavioural toilet training in conjunction with toilet alarms is recommended for people with lds, but there is a paucity of research, thus evidence-based practise, on behavioural toilet training for adults with lds. the aim of this study is to assess the toileting needs and issues of 30 adults with lds with incontinence, and determine whether a 12-week individualised positive behavioural support training intervention, with the use of toilet alarms, promotes continence.

adults with learning disabilities with incontinence are being invited to participate in a 12-week personalised, positive toilet training plan, following assessment of their toileting needs. primary outcome measures will be: number of incidences of incontinence, and number of instances of successful voiding in a toilet. toilet alarms will be used to encourage prompted voiding in a toilet.

Eligibility criteria:
inclusion criteria: - adults with learning disabilities with incontince across all levels of learning disabilities (mild to profound) exclusion criteria: * cannot sit on a toilet for up to 3 minutes

Keywords: incontinence learning disabilities
safety, galenic acceptability and efficacy of gv-328 lozenges in children with oral aphthosis

Conditions: Aphthous Stomatitis

Summary: the aim of the study was to assess the safety, acceptability, and efficacy of product gv-328 for the treatment of childhood oral aphthous lesion.

prospective study carried out in the pediatric dentistry department of the international university of catalonia. the sample was made up of children between 3 and 13 years old. baseline pain status, functional limitation, edema and lesion diameter were evaluated. the treatment lasted 4 days. the parents recorded the intensity of the pain and the number of pills provided daily. statistical significance was accepted with p≤0.05 and a 95% confidence interval. a total sample of 33 patients, 11 boys (33 %) and 22 girls (67 %) was obtained. the average age of the children was 7.8 years (sd: 1.41). numerical variables referring to pain, inflammation and edema presented statistically significant improvements (p-value \<0.05). healing efficacy was demonstrated in 13 cases (39 %) and only 3 cases (9 %) reported poor taste acceptability.

Eligibility criteria:
inclusion criteria: * patients aged 3-13 years. * children who presented canker sores. exclusion criteria: * patients who presented canker sores with 48 h of evolution. * patients with diabetic disorders.

Keywords: aphthous lesion hyaluronic acid
clinical effects of upper cervical translatoric mobilization in patients with headache

Conditions: Headache

Summary: frequently, headache is associated with disorders of the cervical spine, specially on the upper cervical spine. therefore, restoration of the upper cervical mobility is considered fundamental for the treatment of headache. manual therapy interventions seek to restore upper cervical mobility through a wide range of therapeutic procedures, including mobilization or manipulation techniques. previous systematic reviews reported preliminary evidence for the application of upper cervical manual therapy techniques for the management of headache. the objective of this study is to study the effects of upper cervical translatoric spinal mobilization (uc-tsm) on headache intensity, cervical mobility and pressure pain threshold in subjects with headache. for this purpose, the investigators will conduct a randomized controlled trial. volunteers with headache will participate in the study and will be randomly divided into control or treatment group. treatment group will receive uc-tsm and the control group will receive no treatment. headache intensity, cervical mobility, temporomandibular mobility and pressure pain thresholds (ppt) will be measured before and immediately after each treatment session (3 treatment sessions in one week period) and after one month follow-up. at this moment, global perceived effect will be assessed.


Eligibility criteria:
inclusion criteria: * present a history of headache. exclusion criteria: * receive cervical treatment in the previous month. * present red flags for headache. * present any contraindications to manual therapy. * current involvement in compensations.

Keywords: physiotherapy manual therapy
hypofractionated radiotherapy for nonmelanoma skin cancer

Conditions: Non-melanoma Skin Cancer

Summary: radiotherapy is a treatment considered standard for non melanoma skin cancer. this institution uses schemes of 4 to 6 weeks of treatment. the objective of the study is to perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion.

delineation of radiation field * gross tumor volume (gtv): disease clinically visible / palpable * clinical target volume (ctv): equal to gtv * planned treatment volume (ptv): * tumors ≤ 2 cm in diameter, with 5-10 mm ctv margin * tumors\> 2-5 cm in diameter, with 15-20 mm ctv margin * marking the gtv and ptv pen back projection * photograph of the treatment area * protections of the normal structures with blocks of lead, if necessary technical * distance focus-skin tube: 35 cm locator: 30 and 40 cm * sizes tube: 2, 3 and 4 cm in diameter finder: 6x8 cm, 8x10 cm * energy: 80 kv 140 kv * filter 80 kv, 2 mm al 140 kv, 0.5 mm copper * current draw: 20 ma dose * tumors ≤ 2 cm in diameter: 5 fractions of 600 cgy, once a day, five times a week - tdf: 89 * tumors \> 2-5 cm in diameter: 10 fractions of 400 cgy, once a day, five times a week - tdf: 96 clinical revisions every 5 weekly sessions, or a weekly and at the end of treatment.

Eligibility criteria:
inclusion criteria: * cosmesis not important * basal cell carcinoma (bcc) or squamous cell carcinoma (scc) of any differentiation * clinical stage i and ii * location on the thorax, abdomen, pelvis (except perineum), arm, thigh, cheek * patient with up to 3 injuries eligible for the study * karnofsky performance status (kps) ≥ 70% * age \> 18 years * informed consent signed by the patient consenting to undergo the study exclusion criteria: * indian race * prior treatment for their skin cancer * more than three synchronous lesions to treatment with rt * basal syndrome, xeroderma, vitiligo and albinism * immunosuppression * prior burn at the tumor site * tumor \> 5 cm * age \<18 years * carrier mental incapacity * people in a relationship of dependence as prisoners, soldiers, students, staff, etc..

Keywords: non-melanoma skin cancer, radiotherapy, orthovoltage
a study in chinese mild to moderate hypertensive patients comparing the efficacy of co-diovan with diovan.

Conditions: Hypertension

Summary: valsartan, an orally active angiotensin ii receptor blocker, is registered in most countries worldwide for the treatment of hypertension. in china the usual recommended starting and maintenance dose is 80 mg o.d. the combination of hctz 12.5 mg with valsartan 80 mg has been shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected patients6. this fixed combination is registered in most countries worldwide. the potential benefits of these combinations should be evaluated in patients not adequately controlled by valsartan 80 mg monotherapy. this study will compare the efficacy, safety and tolerability of adding hctz 12.5 mg to valsartan 80 mg in those hypertensive patients. this study is not recruiting in the us.


Eligibility criteria:
inclusion criteria: * - male or female outpatients 18 years and older. * patients with hypertension defined as the following: * newly diagnosed hypertensive patients should have a msdbp \> 95 mmhg and \ 95 mmhg and \< 110 mmhg at visit 2 * for entrance into the double-blind treatment period (visit 3), all patients should have a msdbp of \> 90 mmhg and \< 110 mmhg * patients must have given written informed consent to participate and be willing to participate in the entire study exclusion criteria: -

Keywords: hypertension angiotensin ii receptor blocker fixed combination diuretics
effects of two supervised training programs for the rehabilitation of ankle sprains

Conditions: Ankle Sprains

Summary: the purpose of this study was to determine the effects of supervised balance and proprioceptive neuromuscular facilitation (pnf) training for the rehabilitation of ankle sprains

supervised proprioceptive training has been recommended by recently published guidelines for the rehabilitation of ankle sprains. however, research evidence on the efficacy of this type of training is still weak, mainly owing to the methodological limitations of relevant studies. in addition, there is paucity of evidence concerning the effects of such training for the outcomes of functional performance, pain, ankle range of motion, and contradictory results have been reported for postural control. this study aimed to substantiate the benefits of supervised training for the rehabilitation of ankle sprains, and elucidate the effects of two different proprioceptive protocols on the above-mentioned outcomes.

Eligibility criteria:
inclusion criteria: * individuals with a symptomatic, conventionally treated, post acute (after 14 days) lateral ankle sprain, grade i-ii exclusion criteria: * individuals with lateral ankle sprains grade iii * individuals with ankle sprain to the medial ligaments * individuals with ankle sprain to the interosseous (syndesmotic) ligament * individuals with concurrent fracture * individuals with chronic ankle instability * individuals with history of surgery to the ankles * individuals with history of lower limb nerve injuries * individuals with history of further ankle injuries, after the sprain * individuals with any injuries that hindered training participation
dsaek/dmek and cystoid macular edema - the role for topical nsaids (nepafenac) (dmec)

Conditions: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK); Descemet Membrane Endothelial Keratoplasty (DMEK)

Summary: the dmec trial is a randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical nsaids and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (dsaek or dmek).


Eligibility criteria:
inclusion criteria: * patients must be 18 years and older at the time of the signing of the informed consent. there is no upper age limit. * scheduled for dsaek or dmek * ability to cooperate fairly well during the examinations * willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (icf) and in this protocol. exclusion criteria: * contraindications for use of any medication (as listed in the approved spc, e.g. allergy, pregnancy, breastfeeding) * pregnancy or possible pregnancy during the study period * preoperative macular edema and/or ongoing treatment for macular edema * re-transplantation * in-operated glaucoma shunt / valve (e.g. ahmed glaucoma valve) * aphakic eyes (eyes without a biological or artificial intraocular lens) * loss of central vision (expected visual acuity potential after surgery below 0.1 snellen)
low-dose radiation therapy for severe covid-19 pneumonia

Conditions: COVID-19 Pneumonia

Summary: this phase ii trial studies low-dose radiation therapy as a treatment for patients with severe covid-19 pneumonia to improve clinical status.

primary objective: i. to compare treatment of severe covid-19 pneumonia between supportive care and standard of care drug therapies versus supportive care and standard of care drug therapies plus low-dose, whole-lung radiation therapy outline: patients undergo 1.5gy of single low-dose radiation therapy. after completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.

Eligibility criteria:
inclusion criteria: 1. have had a positive test confirming the diagnosis of covid-19; 2. have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment); 3. have visible consolidations/ground glass opacities on chest x-ray or computed tomography; 4. have been on ventilator support for no longer than 5 calendar days prior to the schedule date of delivery of low-dose radiation therapy; 5. they voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form. exclusion criteria: 1. have received chest radiotherapy before 2. bacteria, fungi and other infections other than novel coronavirus infection; 3. combined with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic and endocrine system or immune system diseases (the upper limit of liver function alt and ast\> normal reference value, the upper limit of scr\> normal reference value, poor blood glucose control); 4. mental retardation, mental disorders; 5. planned pregnancy, pregnancy, lactation women and during the trial; 6. allergy constitution or allergy to the drug ingredients and excipients of this test; 7. participated in other clinical trials in the recent 1 month; 8. the investigator does not considered appropriate to participate in this clinical trial.

Keywords: covid-19 radiation therapy pneumonia
implementation of an analgesia-sedation algorithm in the pediatric icu to reduce benzodiazepine use

Conditions: Mechanical Ventilation; Sedation

Summary: the purpose of the study is to develop and implement an evidence-based analgesia-sedation algorithm in the pediatric intensive care unit (picu) using quality improvement and implementation science methodology. the analgesia-sedation protocol will be implemented for patients admitted to the pediatric icu who require mechanical ventilation for greater than 24 hours. specifically, we will examine the impact of this implementation on total benzodiazepine usage, icu length of stay, and ventilator free days, using a pre- and post- algorithm implementation comparative design.

study design and exposures: 1. development of an evidence-based analgesia-sedation algorithm for mechanically ventilated children using an iterative, multidisciplinary collaborative effort. 2. exposure: implementation of the analgesia-sedation algorithm using standard quality improvement (qi) methodology. this will include education, awareness, wash-in phases followed by actual implementation with support. we will use a before-after comparison design. patients will be eligible if they are admitted to the medical and multidisciplinary (medical/surgical) icus at boston children's hospital and require mechanical ventilatory support for greater than 24 hours. study period: eligible patients who are admitted to the icus between august 1st 2017 - february 28th 2018 (pre-implementation) and august 1st 2019 - february 28th 2020 (post-implementation) will be enrolled. data collection: retrospective chart review, with manual data entry in redcap. pre-intervention data will be collected starting july 2019. after the intervention begins in july 2019, data collection will occur monthly with the intent of collecting compliance data through analyzing usage of a new electronic medical record order set designed specifically for this intervention and feeding that back to staff members via electronic communication and meeting presentations in order to assess barriers to implementation of the new algorithm. prospective post-intervention data collection will begin in september 2019 and end in march 2020.

Eligibility criteria:
inclusion criteria: * admitted to the pediatric icu between august 1st 2017 - february 28th 2018 and august 1st 2019 - february 28th 2020 * intubated for greater than 24 hours will be eligible exclusion criteria: * ventilated via a tracheostomy at the time of admission * pre-admission documentation of dexmedetomidine allergy * receiving a midazolam infusion for greater than 4 hours at the time of admission * admitted to the icu for initiation of the rapid-escalation midazolam protocol for status epilepticus

Keywords: analgesia sedation dexmedetomidine mechanical ventilation delirium