Kornimate/medical-research-clean huggingface dataset:
cost-effectiveness of eswt plus rehabilitation vs rehabilitation alone in post-burn scars

Conditions: Hypertrophic Scar

Summary: this randomized controlled trial (rct) will evaluate the cost-effectiveness of combining extracorporeal shock wave therapy (eswt) with standard rehabilitation versus standard rehabilitation alone for the management of hypertrophic post-burn scars in adults. the study will assess clinical outcomes-such as pain intensity, pruritus, and scar quality-alongside economic outcomes including cost per quality-adjusted life year (qaly) gained, direct medical costs, and indirect costs (e.g., absenteeism and reduced productivity). results will inform health policy and resource allocation decisions for advanced burn rehabilitation interventions.

post-burn hypertrophic scars can cause significant pain and pruritus, substantially affecting quality of life and functionality. although eswt has been recently associated with enhanced scar maturation and symptom reduction (yang et al., 2022), its implementation into standard care is limited by a lack of economic evaluation. this trial is a prospective, randomized controlled study with an integrated cost-effectiveness analysis. adult patients (aged 18-65) with hypertrophic scars at least 6 months post-burn injury will be recruited and stratified by scar severity. participants will be randomized into one of two arms: arm 1 (experimental): eswt combined with standardized rehabilitation therapy. arm 2 (active comparator): standard rehabilitation therapy alone. primary clinical outcomes will include changes in pain intensity (measured on a visual analog scale \[vas\]), pruritus intensity (using the itch man scale), and scar quality (assessed through the vancouver scar scale \[vss\]). economic outcomes will be determined by calculating the cost per qaly gained along with an assessment of both direct (therapy sessions, equipment use, hospital visits) and indirect costs (absenteeism, lost productivity). data will be collected at baseline and at follow-up visits at 1, 3, and 6 months post-intervention.

Eligibility criteria:
inclusion criteria: adults aged 18-65 years. documented hypertrophic scars following a burn injury, with scars present and stable for at least 6 months. moderate to severe scar severity as measured by a standardized clinical assessment. experiencing significant pain and/or pruritus related to the scar, with a baseline vas score of ≥4. able to provide informed consent and comply with study procedures. employed or engaged in daily activities such that indirect costs (absenteeism/reduced productivity) can be recorded. exclusion criteria: pregnant or lactating women. individuals with previous surgical scar revision or other invasive scar treatments within the last 6 months. patients with comorbid conditions (e.g., severe cardiovascular disease, uncontrolled diabetes) that could interfere with rehabilitation or eswt. active skin infection in the area of the scar. use of concurrent investigational therapies for scar management.
effect on postoperative sore throat of lidocaine jelly application over the endotracheal tube of tapered-shaped cuff

Conditions: Sore Throat

Summary: postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. the investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.


Eligibility criteria:
inclusion criteria: * asa i-iii * patients scheduled for general anesthesia with endotracheal intubation * patients scheduled for surgery which duration is expected to less than 3 hr exclusion criteria: * difficult airway * rapid sequence induction * recent sore throat * recent upper respiratory infection * asthma * chronic obstructive pulmonary disease * chronic cough * pregnancy * allergy to lidocaine * friable teeth * history of head and neck surgery * multiple intubation attempts * regional anesthetic agents * gastric tube * dexamethasone
fluid balance in children undergoing fontan surgery

Conditions: Heart Defects, Congenital; Hypoplastic Left Heart Syndrome

Summary: this project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, the fontan procedure. surgery will make the child end up with a univentricular heart with one-chamber circulation ( fontan circulation). this project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. the project will also investigate if the edema formation seen during cardiac surgery with the use of cardio-pulmonary bypass (cpb) and hypothermia is caused by capillary leakage of plasma protein. the study hypothesis are 1. edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane. 2. the degree of micro vascular leakage in open-heart surgery is related to duration of cpb and hypothermia. 3. fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.


Eligibility criteria:
inclusion criteria: diagnosis of congenital heart defect in need of fontan procedure - exclusion criteria: no parental consent -
effectiveness of qualia magnesium+® supplementation on rbc magnesium levels

Conditions: Magnesium Deficiency

Summary: this is a randomized, double-blind, placebo-controlled parallel trial designed to evaluate the effectiveness of qualia magnesium+® supplementation on red blood cell (rbc) magnesium levels in adults aged 21 and older. approximately 100 participants with baseline rbc magnesium levels below 6.0 mg/dl will be randomly assigned to receive either qualia magnesium+ or a placebo. participants will take 2 capsules daily in the evening, with or without food, for a duration of 12 weeks. the primary outcome is the between-group change in rbc magnesium levels from baseline to week 12. secondary outcomes include assessments of sleep quality, perceived stress, magnesium status, and safety and tolerability. data collection will occur through lab bloodwork and electronic questionnaires.


Eligibility criteria:
inclusion criteria: * provide voluntary, written, informed consent to participate in the study * agree to provide a valid cell phone number and are willing to receive communications through text * can read and write english * willing to complete questionnaires, records, and diaries associated with the study. * male and female participants aged 21 years and older * willing and able to visit a local blood draw facility for required blood sample collections * live within 20 miles of a suitable blood draw facility (such as quest) * rbc magnesium levels below 6.0 mg/dl * willing to not consume any supplements containing magnesium starting about 2 weeks prior to the baseline magnesium blood test and continuing through the intervention period. * willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly with the exception of those containing magnesium exclusion criteria: * women who are pregnant, breastfeeding, or planning to become pregnant during the trial * known food intolerances/allergy to any ingredients in the product * having any of the following conditions: psychiatric conditions, neurologic disorders, endocrine disorders, cancer * having had a significant cardiovascular event in the past 6 months * taking mao inhibitors, ssris, or any other psychiatric or neurological medicines * on immunosuppressive therapy * individuals who were deemed incompatible with the test protocol * adults lacking capacity to consent

Keywords: magnesium supplementation magnesium
evaluation of a locoregional anesthesia protocol by pudendal block in reconstructive surgery clitoral

Conditions: Reduction in Pain Within 24 Hours of Surgery

Summary: reconstructive surgery of the clitoris is part of the care offered during a process of care of women victims of msf. it consists in reconstituting a clitoral neogland after removal of the vulvar excisional scar and recovery of the remaining clitoris. studies that have monitoring the implementation of this surgery show that it improves the well-being of the patients, brings benefits anatomically, sexual health, personal development, and in the long term decreases chronic pain. currently the standard method used in the usual care of the patient is: general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco the pudendal block that the investigators want to evaluate in this research, is a technique that has made proven in several types of surgery, associated with very few complications and easily reproducible.

reconstructive surgery of the clitoris is part of the care offered during a process of care of women victims of msf. it consists in reconstituting a clitoral neogland after removal of the vulvar excisional scar and recovery of the remaining clitoris. studies that have monitoring the implementation of this surgery show that it improves the well-being of the patients, brings benefits anatomically, sexual health, personal development, and in the long term decreases chronic pain. currently the standard method used in the usual care of the patient is: general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco the pudendal block that the investigators want to evaluate in this research, is a technique that has made proven in several types of surgery, associated with very few complications and easily reproducible. the human clitoris is the most sensitive organ in the human body, with over 8000 endings nervous. all these endings come from the pudendal nerve, itself most often of nerve roots s3. the main hypothesis is that a bilateral anesthetic block of this nerve would reduce postoperative pain in clitoral surgery

Eligibility criteria:
inclusion criteria: * major patient, * with the indication of a clitoral repair surgery * having expressed their free and informed written consent * affiliated with a social security scheme exclusion criteria: - contraindication to the pudendal block technique: notably : * blood crass disorder * allergy to naropein * infection at the injection site - poor understanding of the interest of the practice proposed experimental

Keywords: excision reconstructive surgery of the clitoris sexual health chronic pain, the pudendal block nerve endings. postoperative pain in clitoral surgery
clinical assessment of a daily disposable soft silicone hydrogel contact lens

Conditions: Refractive Errors

Summary: the purpose of this study is to assess the clinical performance of dailies total1® spherical soft contact lenses over approximately 1 week of daily wear.

subjects will be expected to attend 2 visits (visit 1 screen/baseline/ dispense; and visit 2 week 1 follow-up/ exit). the total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).

Eligibility criteria:
key inclusion criteria: * current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day; * manifest cylinder less than or equal to 0.75 diopter (d) in each eye; * best corrected distance visual acuity better than or equal to 20/25 (snellen) in each eye. key exclusion criteria: * current or prior habitual dailies total1 soft contact lens wear in the past 3 months prior to consent; * monovision contact lens wear; * wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.

Keywords: contact lenses
effects of a common cold treatment on cognitive function

Conditions: Common Cold

Summary: a reduction in alertness and lower levels of performance are commonly associated with the common cold. paracetamol has been shown to be more effective than placebo in treating symptoms associated with upper respiratory tract infection; caffeine has been shown to increase levels of alertness and improve performance of people suffering from colds. this study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering from the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.


Eligibility criteria:
inclusion criteria: * present with symptoms of the common cold of no more than 96 hours duration * score of "2" or more on a self-rating for malaise and at least 4 other cold symptoms exclusion criteria: * pregnancy or lactation * hypersensitivity to drugs * have taken caffeine in the last 12 hours or treated their cold

Keywords: paracetomol caffeine common cold
effect of vitamin e ointment on incisional ssi in colorectal surgery

Conditions: Surgical Site Infection

Summary: a prospective, randomized study was performed. the patients were randomized into 2 groups: those patients undergoing subcutaneous vitamin e ointment application (group 1) and those patients who not (group 2). incisional surgical site infection (ssi), microbiological cultures from the infected surgical wounds, postoperative pain and acute phase reactants were investigated.

a prospective, randomized study was performed. the patients were randomized into 2 groups: those patients undergoing a subcutaneous sterile vitamin e acetate ointment application (group 1) and those patients who did not receive this vitamin e ointment application (group 2). before the skin stapling and after the subcutaneous irrigation with normal saline, sterile vitamin e acetate ointment (filmeoft, hulka srl, rovigo, italy) was applied in the subcutaneous tissue; 2 ml were applied in the suprapubic incision and 0.5 ml in the rest of port sites. incisional ssi, microbiological cultures from the infected surgical wounds, postoperative pain was evaluated 24 hours after surgery by means of a visual analogic scale (vas), ranging from 0 mm (complete absence of pain) to 100 mm (unbearable pain) and acute phase reactants (white cell count (wbc), fibrinogen and c reactive protein) 48 hours after surgery were investigated.

Eligibility criteria:
inclusion criteria: * diagnosis of colorectal neoplasms and plans to undergo an elective laparoscopic surgery with curative aims exclusion criteria: * open surgical approach or conversion to laparotomy * performance of a stoma * immunodepression status * anastomotic leak
oral glucocorticoids effect on post endodontic pain

Conditions: Pulpitis

Summary: the aim of this single-center randomized, double-blind, placebo-controlled clinical trial is to assess the effect of preoperative, single, oral dose of prednisolone on postoperative pain and medication intake in patients with symptomatic, irreversible pulpitis in mandibular molars.

patients receive 40 mg prednisolone (two tablets prednisolone 20 mg, aventis intercontinental, paris, france); and group b (control), where patients received two placebo tablets. all patients receive the assigned premedication 30 minutes before the administration of local anesthesia

Eligibility criteria:
inclusion criteria: * systemically healthy patients, aged between 18-35 years, with mandibular molars with symptomatic irreversible pulpitis, radiographically-normal periapical area and no pain on biting or percussion. exclusion criteria: * pregnant patients, patients with any known sensitivity or adverse reactions to any of the medications or materials used in this study, those who had used any analgesic medication during the preceding 6 hours before the treatment, those with unrestorable teeth or teeth with severe periodontal disease. patients with active sites of pathosis in the area of injection were, also, excluded.

Keywords: symptomatic irreversible
computer assisted relaxation learning for dental offices

Conditions: Dental Anxiety

Summary: this is a randomized study in which two groups will be used to compare the effectiveness of a computerized psychological therapy compared to an information only control group (pamphlet) for reducing fear of dental injections.

this is a randomized study in which two groups will be used to compare the effectiveness of a computerized psychological therapy compared to an information only control group (pamphlet) for reducing fear of dental injections. all patients (96 people with high fear of dental injections) will be tested to assess pre-existing dental fear levels prior to being assigned to study condition. subsequently, patients in the active treatment group will complete computerized psychological therapy in 1 to 9 weekly 45-minute sessions. subjects in the control condition will meet with a dental assistant once for approximately 15 minutes to go over a pamphlet. the pamphlet is based on written information developed by a commercial dental web site development company. following the intervention or control procedures, patients will be reassessed for dental fear using computerized questionnaires. they will also be scheduled to receive a dental injection. subjects' willingness to complete the dental injection and fear levels during the dental injection will be assessed.

Eligibility criteria:
inclusion criteria: * high dental injection fear * age 18 and over * healthy with no untreated systemic conditions * able to read and write english exclusion criteria: * heart murmur * known allergies to lidocaine or benzocaine * under 18 year old * untreated systemic conditions * currently receiving medication for anxiety

Keywords: dental anxiety dental phobia odontophobia
aripiprazole in the treatment of patients with schizophrenia and symptoms of obsessive compulsive disorder (ocd)

Conditions: Schizophrenia OCD; Obsessive Compulsive Disorder

Summary: to evaluate the effectiveness of flexible doses (15-30mg) of aripiprazole in the treatment of patients with schizophrenia and co-morbid symptoms of ocd in the outpatient setting. the overall effectiveness of aripiprazole will be evaluated by use of the brief psychiatric rating scale(bprs), yale-brown ocd scale and clinical global impression-improvement(cgi-i) scale.

symptoms of ocd is a rather common co-morbid condition in patients with schizophrenia. some studies suggest that obsessive-compulsive symptoms may be present in 7.8-46% of schizophrenic patients and who seem to be poorly responsive to drug therapy. the serotonergic medications in combination with cognitive-behavioral therapy stil remain the preferred treatment for ocd symptoms. there are controversial data regarding effect of neuroleptics on symptoms of ocd. it was noted that the use of risperdone, quatiapine and clozapine might aggravate ocd symptoms. serotonin antagonism of these neuroleptics is believed to exacerbate obsessive-compulsive symptoms in schizophrenia. on the other hand, pourovsky m. at(2000) reported three cases of schizophrenia with symptoms of ocd successfully treated with olanzapine.one of our patients with schizophrenia and co-morbid symptoms of ocd who was unsuccessfully treated with various neuroleptics in combination with anti-obsessive agents,demonstrated significant improvement in both schizophrenic and obsessive compulsive symptoms after she was switched to aripiprazole. this result encouraged us to initiate pilot study of effectiveness of aripiprazole in the treatment of specific population of schizophrenic patients with symptoms of ocd.

Eligibility criteria:
inclusion criteria: * man and women 18-65 years of age. * patients who are capable of giving informed consent and fluent in english. * patients who have dsm iv -diagnosis of schizophrenia with co-morbid ocd symptoms and bprs score averaging from mild to moderate (3-4). * patients whose obsessive symptoms are not optimally controlled and require a change of treatment.ybocs score of more than 16. exclusion criteria: * outside the age range of 18-65 years. * patients with current evidence(past three months) of substance abuse. * women of child bearing age who are unwilling to use acceptable methods of contraception. * patients who have had recent treatment with long-acting antipsychotic. * patients who are suicidal or who have history of recent suicidal attempt. * history of significant medical condition e.g. seizures, cardiovascular, endocrine,gastrointestinal,renal or respiratory diseases.

Keywords: schizophrenia with ocd schizophrenia with-comorbid symptoms of obsessive compulsive disorder(ocd)
florida center for brain tumor research

Conditions: Brain Tumors

Summary: the purpose of this research study is to collect and store brain tumor tissue samples for future research. the samples will become part of the university of florida brain tumor tissue bank/florida center for brain tumor research. the goal is to find improved treatments and cures for brain tumors.

the mission of the florida center for brain tumor research is to discover cures for brain tumors and develop innovative brain tumor treatment modalities by providing a central repository for brain tumor biopsies and clinical information from individuals throughout the state of florida, improving brain tumor biomedical research programs within the state of florida, facilitating funding opportunities, fostering collaboration with brain tumor research organizations and other institutions, and fostering improved technology transfer of brain tumor research findings into clinical trials and widespread public use. the florida center for brain tumor research will collect and store left-over tissue that is not needed for medical care or diagnosis in a tissue bank in the evelyn f. and william l. mcknight brain institute at the university of florida. tissue, medical information, cerebrospinal fluid, blood and answers to quality of life questionnaires will be stored and made available to researchers. although developed for florida, tumor tissue from all other states would be accepted.

Eligibility criteria:
inclusion criteria: * children and adults scheduled to undergo brain surgery to remove tumor tissue.

Keywords: brain neoplasms central nervous system diseases central nervous system neoplasms brain diseases nervous system neoplasms
a study of xeloda (capecitabine) plus radiation therapy in children with newly diagnosed gliomas

Conditions: Glioma

Summary: this single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. post-radiation therapy with xeloda will continue after a 2 week break. the anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.


Eligibility criteria:
inclusion criteria: * patients \>=3 and \<=21 years of age; * newly diagnosed non-disseminated brainstem glioma or non-disseminated high grade glioma; * karnofsky (if \>16 years) or lansky (if \ =50%; * adequate organ function. exclusion criteria: * previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant; * uncontrolled infection; * known dpd deficiency.