Kornimate/medical-research-clean huggingface dataset:
a study comparing the acceptability of pentasa® sachets versus pentasa® tablets in children with crohn´s disease

Conditions: Crohn's Disease

Summary: the primary objective of the clinical trial is the assessment of the acceptability of the new pentasa formulation - pentasar sachets in comparison with the reference pentasar tablets 500 mg in children with crohn's disease. after the screening period (which includes medical history, physical examination, basic haematology, serum chemistry , urine analysis and stool microbiology , pcd activity index )patients will receive (visit i) pentasa sachets 1g or pentasa tablets 500mg for next 4 weeks according to the randomisation scheme in common dose 2× 1 g of pentasar sachets 1 g or pentasar tablets 500 mg. the formulation of pentasa will be switched at visit 2, patients will receive the medication for next 4 weeks. patients will record the acceptability of the both forms of the medication. in 6 patients from each group (selected by the randomization), stool and urine will be taken to assess concentrations of mesalazine and n-acetylmesalazine during visit 2 and visit 3. adverse events will be recorded during the whole course of the treatment period.


Eligibility criteria:
inclusion criteria: * established diagnose of crohn's disease * age 8-18 years, both sexes * weight above 40 kg * oral maintenance treatment with 5-asa and any concomitant antinflammatory medication (maintained at the same dose during the study) before inclusion is permitted, * written informed consent obtained (patient and his/her guardian) exclusion criteria: * patients with a history of allergy to salicylates * patients with known significant hepatic or renal function abnormalities * positive enteric pathogens in stool (salmonella, shigella, yersinia, campylobacter) * pregnant or lactating women * patients with a known history of disease, including mental/emotional disorder, that would interfere with their participation in the study, * patients who participated in another clinical study in the last 3 months, * patients who are unable to comply with the requirements of the protocol * patients who are unable to fill in the diary cards
evaluation of a nutritional product for people with type 2 diabetes

Conditions: Diabetes

Summary: the objective of this trial is to evaluate a nutritional product for people with diabetes.


Eligibility criteria:
inclusion criteria: * subjects will be eligible for the study if they meet all of the following inclusion criteria: 1. diagnosis of type 2 diabetes. 2. age between 18 and 75 years. 3. hba1c \> 6.0 but ≤ 8.5 4. if female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration. 5. bmi is \> 18.5 kg/m2 and \< 40.0 kg/m2. 6. chronic medication dosage must be stable for at least two months prior to screening visit. 7. subject states that they are a habitual consumer of a morning meal. exclusion criteria: * subjects will be excluded from the study if they meet any of the following criteria: 1. use of exogenous insulin or glp-1 agonists for glucose control. 2. diagnosis of type 1 diabetes. 3. history of diabetic ketoacidosis. 4. current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks. 5. active malignancy. 6. significant cardiovascular event \< 12 weeks prior to study entry. 7. end stage organ failure or status post organ transplant. 8. active metabolic, hepatic, or gastrointestinal disease. 9. chronic, contagious, infectious disease. 10. currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose. 11. history of fainting or other adverse reactions in response to blood collection. 12. clotting or bleeding disorders. 13. allergy or intolerance to study product ingredient.
pesticides and parkinson´s disease

Conditions: Pesticide-Induced Parkinsonism

Summary: the aim of this project is to study whether people exposed to pesticides have a higher risk of developing pd. we will perform an epidemiological study determining the presence of pesticides in urine and comparing signs traditionally associated with pd in early forms.

within different risk factors, pesticide exposure increases the risk of developing parkinson's disease (pd) through epigenetic mechanisms by modifying the expression of genes related to pd and secondary mitochondrial dysfunction.we will conduct a cross-sectional prevalence study with cases (exposed to pesticides) and controls (not exposed to pesticides), randomly selecting 130 individuals in each group. pesticide exposure will be determined through questionnaires.we will study the prevalence of preclinical and prodromal pd based on pesticide exposure, stratified by age and gender in the exposed, and non-exposed groups. preclinical and prodromal pd will be assessed using: biological biomarkers and prodromal pd signs. multivariate analyses will be employed to determine the risk of presenting early pd, adjusting for different clinical covariates. the results of this study will allow us to understand the early mechanisms associated with neurodegeneration and pesticides exposure.

Eligibility criteria:
inclusion criteria: * farmers exposed to pesticides for cases * no work exposure to pesticides for controls exclusion criteria: * subjects without signed consent form * neurological significant conditions
a 2 week, crossover trial of dietary nitrate in htn

Conditions: Hypertension

Summary: acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations including newly diagnosed, untreated hypertensives. the additional effect in hypertensives on blood pressure lowering medications is uncertain.

acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations including newly diagnosed, untreated hypertensives. the additional effect in hypertensives on blood pressure lowering medications is uncertain. the investigators hypothesize that chronic nitrate consumption might decrease blood pressure in hypertensives who are suboptimally controlled on at least one blood pressure medication compared to a placebo beetroot juice. this study is a randomized, double-blind placebo-controlled, crossover trial. at baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics and blood draw. after baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 7 consecutive days when assessments will be repeated followed by 7 days of placebo and endpoint assessments or the converse.

Eligibility criteria:
inclusion criteria: * clinically stable, * uncontrolled hypertension exclusion criteria: * pulmonary hypertension * active cvd * taking vasodilators * diabetes mellitus
oculomotor assessment of traumatic brain injury (tbi)

Conditions: Traumatic Brain Injury

Summary: the purpose of the proposed study is to compare the sensitivity and specificity of three oculomotor test devices in normal subjects versus subjects with history of tbi. the study is designed as a prospective research project in which a group of 120 normal controls without a history of tbi will be compared to another group of 120 participants (total of 240) who have a confirmed history of tbi. each participant will complete the tbi assessment protocol for each of three separate devices (neuro kinetics, syncthink, and oculogica). the order of the devices will be counter-balanced across participants. participants will also be screened for vestibular migraine and visual vertigo, which are two conditions that influence oculo-vestibular perception in normal and tbi patients and might influence the results from the three oculomotor devices. data from each device will be utilized to perform auc analyses to determine the respective sensitivity and specificity for each.


Eligibility criteria:
all participants must be deers eligible, no exceptions! inclusion criteria: * must be between 18 and 45 at time of screening (upper age restriction is to prevent confounding with age-related physiological changes). * must be able to provide written informed consent. * must be able to read and understand questionnaires and consent forms. * must have corrected binocular acuity of at least 20/40 for near distance with or without single-power corrective lenses or contacts and absent of ocular injury or disease. control group - no history of tbi or any history of severe or penetrating tbi tbi group - must have a documented history of a tbi occurring within the last 10 years. exclusion criteria: * current or previous neurological disease, including: stroke, congenital brain malformation, degenerative illness such as multiple sclerosis, epilepsy or seizure (other than febrile seizure). * current or previous ocular disease/injury, including: glaucoma or increased pressure in the eyes, structural damage to ocular tract and ocular cortex, etc. * history of vestibular disorder (e.g., with symptoms of clinical vertigo) * binocular vision not correctable to 20/40 for near distance * use of tobacco or caffeinated products less than four hours before test session * consumption of alcohol within past 24 hours

Keywords: oculomotor testing
oropharyngeal administration of mother's milk in preterm infants and gastrointestinal motility

Conditions: Preterm Infant; Feeding Disorder Neonatal; Gastrointestinal Motility Disorder

Summary: mother's milk does not come in contact with the oropharyngeal pouch of preterm infants during gavage feeding. we hypothesized that stimulation of the oropharyngeal pouch using small amount of the mother's milk 5 minutes before initiation of regular gavage feeding will increase the level of git hormones.

feeding preterm infants continues to challenge health care providers because of difficulty to provide adequate volume of milk that maintains optimum nutrition without increasing the risk of feeding intolerance. preterm, vlbw, infants are at increased risk of feeding intolerance as they have shorter git with lower digestive, absorptive, and motility capabilities than those of full-term infants. intolerance to enteral feeding has been associated with abdominal distention, initiation of inflammatory cascade, edema of the bowel, and subsequent development of necrotizing enterocolitis. oral feeding is the best physiologic method for enteral nutrition of preterm infants. however, because of immaturity of suckling reflex and poor coordination between suckling and swallowing, gavage feeding (oro-gastric or naso-gastric tube feeding) has been used an alternative method of enteral nutrition in preterm infants. during breastfeeding, mother's milk comes in contact with mouth and oro-pharyngeal pouch which, theoretically, stimulates both oro-pharyngeal receptors that improves the motility, secretory, and absorptive ability of the git. furthermore, anti-inflammatory and pro-inflammatory cytokines, which are present abundantly in mother's colostrum and milk, may exert an immuno-protective effect when they come in contact with oro-pharyngeal as well as git mucosa. preterm, vlbw, infant in the nicu receives enteral feedings by a naso-gastric or oro-gastric gavage tube. thus, mother's milk does not typically come into contact with oro-pharyngeal pouch which delays the maturation of oral suckling and swallowing skills in preterm infants. oral stimulation has been shown to improve oral feeding performance, attain early oral feeding, improve weight gain and shorten the length of hospital stay. investigators aimed to study the effect of oro-pharyngeal administration of mother's milk before regular gavage feeding on gastrointestinal movement in preterm infants.

Eligibility criteria:
inclusion criteria: * preterm infants delivered at less than 32 weeks gestation and less than 1500 grams birth weight will be included in the study exclusion criteria: 1. preterm infants \> 32 weeks gestation unable to be fed on own mother's colostrum or milk. 2. preterm infants with major congenital anomalies or chromosomal abnormalities. 3. preterm infants delivered to mothers with confirmed chorioamnionitis. 4. preterm infants with confirmed early onset sepsis.
high dose ascorbic acid treatment of cmt1a

Conditions: Charcot-Marie-Tooth Disease, Type Ia

Summary: this study will look at the impact of ascorbic acid (vitamin c) on the progression of disease in people with cmt1a as compared to volunteers receiving a placebo. this study will assess whether is it futile to proceed with a larger, longer-term, placebo-controlled study.

charcot marie tooth disease (cmt), or inherited peripheral neuropathies, are among the most frequent heritable disorders, affecting approximately 1 in 2500 people. the most frequent genetic form of cmt is cmt1a. cmt1a is caused by a 1.4 mb duplication within chromosome 17p11.2 in the region containing the pmp22 gene. most subjects with cmt1a have a "typical" phenotype characterized by onset in childhood or early adulthood, distal weakness, sensory loss, foot deformities and absent reflexes. how increased expression of pmp22 causes these disabilities is unknown but is currently being investigated in both animal and tissue culture systems. in this study, researchers will evaluate whether ascorbic acid (vitamin c), administered orally, slows clinical progression of cmt1a and affects the pmp22 mrna levels of myelinated peripheral nerve fibers obtained from biopsies of glabrous skin.

Eligibility criteria:
inclusion criteria: * the subject has cmt1a, defined by the duplication on chromosome 17p11.2 performed by either pulse field gel electrophoresis or fluorescence in situ hybridization (fish) by a clia certified laboratory, or the subject has a first or second degree relative with a documented duplication performed by the above methods and the subject has uniform motor conduction slowing of the median or ulnar nerve between 16 and 30 m/s. * the subject is between 13 and 70 years of age. * the subject, if 18 years or older, has signed the informed consent form and agrees to follow the stipulations of the protocol. * if the subject is less than 18, his or her parents or guardians have signed the informed consent form and agree to follow the stipulations of the protocol. the subject has also signed a written assent form. exclusion criteria: * a known neuropathy from another source (for example, diabetes, drug induced, alcohol, etc.) * the subject has ever received vincristine. * the subject has a known allergy to ascorbic acid. * the subject has ever had kidney stones. * the subject has a known history of g6pd deficit. * the subject has a history of hemochromatosis. * the subject suffers from a serious illness or medical condition that is not stabilized or that could require hospitalization. * the subject has a high ascorbic acid level at screening. * the subject is pregnant or nursing. * the subject, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason. * the subject participates to another clinical trial or is still within a washout period of a previous clinical trial. * the subject is taking neurotoxic medications.

Keywords: ascorbic acid vitamin c charcot marie tooth cmt cmt1a
comparative study of nonintubated anesthesia versus intubated general anesthesia in single port thoracoscopic bullectomy

Conditions: Primary Spontaneous Pneumothorax

Summary: investigators compared the patients' subjective postoperative symptoms and complications between the double lumen endotracheal intubated patients under general anesthesia and non-intubated patients under sedation and local anesthesia including 1. postoperative visual scale of pain 2. postoperative sore throat/voice change 3. postoperative nausea/vomiting 4. intraoperative arterial blood gas analysis 5. cost for anesthesia 6. morbidity

thoracoscopic bullectomy for primary spontaneous pneumothorax is relatively simple and short procedure compared to other thoracic surgery. however, in the anesthetic preparation, complicated technique and procedures are needed including a double lumen endotracheal intubation, auscultation, and flexible bronchoscopic confirmation of the tube location, even during lateral decubitus position. the double lumen endotracheal tube has a bigger outer diameter. and postoperative sore throat and voice change can develop after the intubation procedure. recently, single lumen intubation using carbon dioxide gas instillation under general anesthesia during thoracoscopic surgery is reported. however, if safety and efficacy are warranted, thoracoscopic surgery using nonintubated and self-ventilated anesthesia will be a best solution for above mentioned postoperative discomforts. investigators designed the comparative study of nonintubated local anesthesia under sedation and intubated general anesthesia in thoracoscopic bullectomy through the single port. investigators will investigate postoperative pain, sore throat, voice change, nausea, vomiting, and intraoperative arterial blood gas analysis. this study will be performed at korea university ansan hospital. a total of 40 patients will be enrolled (20 patients in each arm).

Eligibility criteria:
inclusion criteria: 1. primary spontaneous pneumothorax 2. age between 13 and 30 3. asa score 1,2 4. written informed consent exclusion criteria: 1. a history of previous bullectomy or ipsilateral thoracic operation 2. pregnant or lactation female 3. a cognition or mental dysfunction 4. consumption of oral sedatives 5. a present sore throat or hoarseness 6. asa score greater than 3
a study of focal salvage high-dose-rate brachytherapy for prostate gland only recurrence

Conditions: Prostate Cancer; HDR

Summary: the purpose of this study is to learn more about what effects the use of high-dose-rate (hdr) brachytherapy on prostate cancer recurrence, seen by axumin pet scan, has on prostate cancer.

in this study the investigator would like to better understand the use of high-dose rate (hdr) brachytherapy to target only recurrent prostate cancer that can be seen by axumin pet scan. the use of hdr brachytherapy for prostate cancer is not new, but it is a more recent advancement to use it to treat only what can be seen instead of the whole prostate.

Eligibility criteria:
inclusion criteria: history of histologically confirmed, clinically localized adenocarcinoma of the prostate treated with external beam radiation, brachytherapy, or combination of external beam radiation and brachytherapy, with curative intent completed at least 24 months ago f-18 fluciclovine (axumin) pet scan within 90 days prior to registration demonstrating recurrent lesion within the prostate gland biopsy confirmation of disease recurrence within the prostate gland age ≥ 18 kps ≥ 70% suitable candidate for brachytherapy based on established criteria ipss score \<16 no pelvic arch interference no rectal fistula/fissure fit for general or spinal anesthesia no history of urethral stricture ability to understand, and willingness to sign the written informed consent exclusion criteria: evidence of metastatic or nodal disease outside of the prostate gland on axumin pet scan within 90 days prior to enrollment patient unable to have mri patients with neuroendocrine or small cell carcinoma of the prostate turp within 6 months prior to enrollment history of crohn's disease, ulcerative colitis, or known radiation proctitis inability to understand spoken and written english

Keywords: brachytherapy prostate cancer high-dose-rate (hdr)
biofeedback with cycling exercise in oa knee patients

Conditions: Exercise Therapy; Osteoarthritis Of Knee; Biofeedback

Summary: osteoarthritis (oa) is one of the most common joint diseases causing pain, muscle weakness and disability in older population. quadriceps muscle weakness is one of the recognized risk factors for the development and the progression of the disease. increasing the muscle strength could actually bring many benefits to the knee oa patients. the purposes of this study are 1) to investigate the effects of combining the emg biofeedback technique into a stationary cycling exercise on the activities of vastus medialis (vm) in people with medial compartment knee oa; 2) to investigate the efficiency of a 6-week cycling exercise program on improving of quadriceps muscle strength and endurance, physical functions and pain in these patients and compare between the conditions of with or without emg biofeedback; 3) to determine the relationships between the muscle activities and the kinematics of the knee joint during this cycling exercise program; and therefore to find the mechanism of the improvement on muscle activities in the intervention of cycling combining emg biofeedback. in this study, we will enroll the knee oa patients from our hospital, and they will be randomly assigned either to the control group, who will cycle without biofeedback, or the biofeedback group, who will cycle with a real-time visual emg biofeedback, during the six-week training program. the exercise program consisted of a 5-minute warm-up with low-resistance cycling, 30-minute moderate-resistance cycling exercise, and 5-minute cool down session. . the knee adduction angle, quadriceps strength and endurance, koos chinese version, vas scale will also be measured at baseline and after six weeks of intervention. mixed-model repeated measure analysis of variance (anova) will be used to determine if there are any differences in the kinematic, myoelectric, muscle strength and endurance. it is hoped that the results of this study could provide information regarding the proper and efficient training strategy for the oa knee patients, and deliver the concepts of proper exercise technique to enhance health in the community.


Eligibility criteria:
inclusion criteria: * the oa knee patients are those who had medial compartment tibiofemoral osteoarthritis in either one or both of their knees, had at least a grade 2 on the kellgren-lawrence score, which was verified with radiographs and a diagnosis by a physician exclusion criteria: * if the participant had been diagnosed with oa in the hip or ankle joints, had a lower extremity joint replacement, had knee joint arthroscopic surgery or intra-articular injections within 3 months prior to testing, had systemic inflammatory arthritis such as rheumatoid or psoriatic arthritis, had lower back pain that referred to the lower limbs, or those who had cardiovascular disease or other risk factor which precluded participation in aerobic exercise