Kornimate/medical-research-clean huggingface dataset:
pilot study of a new medical food in the management of ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the goal of this clinical trial is to determine at how well a new medical food works in managing inflammation associated with ulcerative colitis in children. the main question it aims to answer is: 1) how well does the new medical food lower an inflammatory biomarker known as fecal calprotectin (fcal) in ulcerative colitis as compared to the historical active therapy levels of fcal? participants will take a specified dose of the medical food in water each day for 12 weeks. the level of fcal will be measured through a stool sample at baseline, one during the 12 weeks, at the end of 12 weeks, and once more at 16 weeks. the levels of fcal will be compared across the 16 weeks and compared with levels before the new medical food was taken.

the objective of this clinical trial is to assess the physiological response to a biologic food substance in maintenance therapy for ulcerative colitis in children. this will be measured through the measurement of fecal calprotectin (fcal) levels across the study period as well as in comparison to historical active therapy levels. secondary endpoints will include a variety of biologic markers (inflammatory, microbial, metabolic) as well as clinical scores including patient reported outcomes and serum-based biomarkers such as ferritin and hemoglobin. the aim is to evaluate the effectiveness of the medical food as a safe and well-tolerated non-pharmacologic approach for reducing dependence on drug therapies and their associated side effects in the treatment of ulcerative colitis.

Eligibility criteria:
inclusion criteria: pediatric patients with a confirmed diagnosis of ulcerative colitis on stable maintenance therapy. exclusion criteria: pediatric patients with a confirmed diagnosis of ulcerative colitis who utilize oral or topical corticosteroids in maintenance therapy.
clinical study of epoetin beta to chemotherapy-induced anemia (cia) patients

Conditions: Anemia

Summary: this is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 iu compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.


Eligibility criteria:
inclusion criteria: * lung cancer or gynecologic cancer patients * undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (epo) or placebo administration * 8.0 g/dl ≦ hemoglobin concentration (hb) ≦ 10.0 g/dl * 20 - 79 years old * performance status: 0 - 2 * no iron deficiency anemia exclusion criteria: * red blood cell transfusion within 4 weeks before treatment * erythropoietin therapy within 8 weeks before treatment

Keywords: cancer patients with chemotherapy induced anemia
european trial of immunosuppression in spk tx

Conditions: Diabetes Mellitus, Type 1; Diabetic Nephropathy

Summary: 1. to determine and compare the efficacy of tacrolimus/rapa versus tacrolimus/mmf-based immunosuppression (in conjunction with initial short-term steroids and polyclonal antibody administration) in type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation. 2. to evaluate the safety of tacrolimus/rapa versus tacrolimus/mmf in terms of drug-related complications and overimmunosuppression-associated complications, particularly under monitoring of the pharmacokinetic profile of all drugs administered.

this will be a controlled, randomised study, to be performed in 15-20 pancreas transplantation centers throughout europe. patients will be randomised into one of two treatment groups. group 1 will receive tacrolimus and mycophenolate mofetil (= best group in eurospk001 trial). group 2 will receive tacrolimus and sirolimus. both groups will receive in association short-term corticosteroids and polyclonal antibody preparation. patients will be randomly assigned to one of the 2 treatment groups in a 1:1 ratio before transplantation. the study will last 3 years, with a first interim analysis of the data at 6 months and a complete analysis at 1 year.

Eligibility criteria:
inclusion criteria: 1. male or female patients, of 18 to 55 years of age, with end-stage, c-peptide-negative, type 1-diabetic nephropathy. 2. female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years). 3. patient must have signed the patient informed consent form. 4. patient must receive a primary simultaneous pancreas/kidney (spk) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages. exclusion criteria: 1. patient is pregnant or breastfeeding. 2. patient is allergic or intolerant to mycophenolate mofetil, sirolimus, tacrolimus or other macrolides, or any compounds structurally related to these compounds. 3. patient has a positive t-cell crossmatch on the most recent serum specimen. 4. patient is known for active liver disease or has significant liver disease, defined by asat and alat serum levels greater than 3 times the upper limit of normal. 5. patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence. 6. patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation. 7. patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication. 8. patient receives a spk transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone. 9. pancreatic duct occlusion technique . 10. donor is older than 55 years of age. -

Keywords: simultaneous pancreas/kidney transplantation immunosuppression
change in the phase iii slope of the volumetric capnography by prone positioning in acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome; Ventilation Perfusion Mismatch; Respiratory Failure

Summary: this study evaluates the effects of prone positioning on homogenization of ventilation.

after initiation of mechanical ventilation and assessing the eligibility of the patient, informed consent will be taken from the closest kin. if eligible, following steps will be performed which are part of standard ards patient care. 1. low-flow pressure volume curve and assessment of airway opening pressure 2. calculation of recruitment to inflation ratio 3. optimizing positive end-expiratory pressure afterwards, phase iii slope of the patient will be recorded at four timepoints: supine 1 (immediately before turning to prone position) prone 1 (immediately after prone position) prone 2 (at the end of the 16-24 hour prone cycle) supine 2 (immediately after turning to supine position)

Eligibility criteria:
inclusion criteria: * ards criteria met * intubated and mechanically ventilated as a result of respiratory failure * pao2/fio2 \<200 exclusion criteria: * age older than 18 * chronic pulmonary disease, pneumothoraces, intraabdominal hypertension (\> 12 mmhg), pregnancy, not expected to survive \>24 hours, hemodynamic instability

Keywords: acute respiratory distress syndrome volumetric capnography phase iii slope prone
long-term efficacy and safety of ct-p10 in patients with ra

Conditions: Rheumatoid Arthritis

Summary: this is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the phase 1 study ct-p10 1.1. this study is designed to assess the long-term efficacy and safety of ct-p10 co-administered with mtx and folic acid in patients with ra who have completed the scheduled visits in study ct-p10 1.1


Eligibility criteria:
inclusion criteria: * patient has disease improvement (moderate or good response) according to disease activity score using 28 joint counts (das28) during the last course of treatment in study ct-p10 1.1. * patient has completed all of the scheduled visits in the study ct-p10 1.1 main study period, including the core study period and/or extension study period. exclusion criteria: * patient has been withdrawn from study ct-p10 1.1 for any reason. * patient has, at the time of providing informed consent, any current medical issues such as serious adverse events (saes) or current or previous intolerance issues that mean continuation in this maintenance study could be detrimental to their health, in the opinion of the investigator.
the effect of 2-dent oral topical powder on minor recurrent aphthous ulcer

Conditions: Minor Recurrent Aphthous Stomatitis Lesions

Summary: this is a prospective, randomized, blinded, placebo-controlled, crossover clinical trial to evaluate the efficacy of 2-dent oral topical powder in the treatment of recurrent aphthous stomatitis (ras). to be included in the study, subjects must have had minor ras ulcers of less than 48 hours duration. it was randomly determined which powder was used first; all subjects used both the 2-dent powder and the placebo powder. subjects applied the powder twice daily and maintained a daily log recording the size of the ulcer, its erythema score, and their level of pain. the subjects continued applying the 2-dent powder until the ulcer was resolved.


Eligibility criteria:
inclusion criteria: * a history of minor recurrent aphthous stomatitis (ras) lesions occurring at least 3-4 time/ year, and usually requiring 5 or more days to resolve * presence of an active ulcer of less than 48 hours duration on either the buccal or labial mucosa (making them more easily accessible for powder application) * willing and able to give informed consent exclusion criteria: * pregnant or lactating * if ulcers were manifestations of a systemic disease process such as ulcerative colitis, crohn's disease, behcet's syndrome, or anemia; * concurrent clinical conditions that could either pose a health risk to the patient by being involved in the study or potentially influence the outcome of the study * hypersensitivity to dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, karaya gum, or zinc oxide * having used corticosteroids, oral retinoids, or other immunomodulatory agents within one month of participation in the study; non-steroidal anti-inflammatory agents (e.g., aspirin, ibuprofen, etc.), acetaminophen, or oral antihistamines chronically within one month of participation in the study or any use within five days of participation in the study; topical medication (including steroids, retinoids, and anti-microbial drugs) within two weeks of participation in the study, systemic antibiotics within two weeks of participation in the study; any preparation or medication (otc or prescription) applied to the ulcer within 48 hours of participation in the study * history of drug or alcohol abuse * having had any dental work within 2 weeks of study entry * having had any orthodontic or oral appliances (that could cause oral trauma) within 1 cm of the ulcer or any recollection of trauma in the area of the ulcer * participating in any other study involving investigational or marketed products within 1 month of study entry or plans to participate in such an investigation during this study.
pilot study: effect of dexamethasone vs vicodin in reducing post-operative pain

Conditions: Oral Surgery

Summary: the main objective of the pilot study is to investigate the process that includes recruitment (to estimate the rate of enrollment), feasibility, protocol refinement, and willingness of the subject to be randomized. to provide a sample estimate of the population parameter which is the true value in the target population to be used in the planning of a larger confirmatory study. secondary objectives include: to examine the efficacy of pre/post-operational administration of dexamethasone vs vicodin (acetaminophen and hydrocodone) for post-operative pain control following periodontal surgery at the henry m. goldman school of dental medicine. to examine how bmi alters the response to dexamethasone and hydrocodone following periodontal surgery since obese patients have shown higher pain scores and increased pain sensitivity in previous experimental models of pain.


Eligibility criteria:
inclusion criteria: * must be scheduled for periodontal surgery * subjects must be aged 21 years old and above * able and willing to provide informed consent * 20 non-obese patients with bmi less than 30kg/m2 * 20 obese patients with bmi greater than or equal to 30kg/m2 * diabetic and hypertensive patients included exclusion criteria: * patients allergic to any formulations used in the study * patients with chronic use of nonsteroidal anti-inflammatory drugs or chronic use of narcotics; chronic defined as frequent use or misuse/ abuse so much as once a month * pregnant or lactating female patients; pregnancy test will be performed alongside the medical history * patients with kidney dysfunction * patients at risk for infective endocarditis determined by the medical history or past medical records

Keywords: dexamethasone vicodin pain management
a safety/tolerability and pharmakokinetic study of sargramostim administrated in the gingiva

Conditions: Periodontitis

Summary: this exploratory study is the first study in a clinical program where the overall objective is to develop a novel pharmaceutical therapy comprising local administration of gm-csf for the treatment of periodontitis. the project hypothesis is based on gm-csf's antibacterial and putative bone regeneration properties. periodontitis is the major cause of tooth loss in people over 35 years of age. an effective pharmacological treatment is today lacking and the actual therapy would represent a new treatment option for the large patient group suffering from the disease.

it is suggested that local administration of gm-csf in the gingival tissue next to the periodontal destruction may reduce the infectious condition by an antibacterial effect via stimulation of neutrophil phagocytosis of bacteria, enhanced functional activities of monocytes and granulocytes, as well as stimulation of bone tissue recalcification.

Eligibility criteria:
inclusion criteria: * healthy individuals (male or female) referred to dept of oral \& maxillofacial surgery to have a lower wisdom tooth surgically extracted * ≥ 20 and ≤ 40 years of age * analysis results of blood status within normal reference ranges * ability to attend the scheduled visits for evaluation procedures * women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study * signed informed consent exclusion criteria: * any significant disease (acute or chronic) or any medication with concomitant oral manifestations that in the opinion of the investigator would interfere with safety evaluation of leukine. * an active osseous infection or periodontal infection, any active mucosal lesions or a history of acute necrotizing ulcerative gingivitis. * current use of anti-coagulant therapy or within 10 days from baseline * current use of immunomodulating medication * current use of corticosteroids (amendment 1: topical use permitted). * current use of lithium. * use of tobacco products or nicotine replacement therapy * alcohol or drug abuse * hiv or hepatitis infection * pregnancy or lactation * participation in another clinical study on medicinal products at the time of inclusion * lack of suitability for participation in the trial, for any reason, as judged by the investigator.
harnessing the healthy gut microbiota to cure patients with recurrent c. difficile infection

Conditions: Clostridium Difficile Infection

Summary: cdi (clostridium difficile infection) causes diarrheal illness and can cause colitis which may be fatal. a patient being treated for cdi has a 10-25% chance of developing relapse. recurrent cdi is on the rise. there are few options available to treat recurrent cdi. "stool transplant" (infusing donor stool into the intestine of the recipient), is not very palatable to either patient or medical personnel. the investigators will isolate intestinal bacteria from donor stool and use this purified mixture of donor bacteria instead of stool transplant. the investigators hypothesize that this cleaner mixture of purely isolated intestinal bacteria from a healthy donor would be equally effective as conventional fecal bacteriotherapy, which uses donor stool. the use of this prepared mixture of aerobic and anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora reconstitution. however our approach would provide a more controlled, reproducible, cleaner and more aesthetically acceptable method of administration, and from a patient safety perspective, would also be a safer strategy than using freshly defecated donor fecal matter.


Eligibility criteria:
inclusion criteria: * patients with recurrent cdi that have failed standard therapy exclusion criteria: * critically ill patients

Keywords: clostridium difficile recurrent infection
copley ii: long-term outcome follow-up study of osteoporotic women who underwent a local osteo-enhancement procedure (loep) in the proximal femur

Conditions: Osteopenic Women; Proximal Femur Fracture

Summary: to evaluate longer-term (5-7 years) outcomes of the twelve (12) subjects treated with agn1 femoral loep in the clinical study "a prospective pilot evaluation of percutaneous osteo-supplementation in the proximal femur of osteoporotic patients". performance will be evaluated via medical history evaluation, x-ray, dxa, ct and mobility testing. the study will look at the extent to which the benefits demonstrated in the initial, baseline study were sustained over time. in this manner, it may be possible to determine the rate of change in bmd following the treatment; thereby allowing prediction of the total benefit period. in addition, this longer period of observation allows for further evaluation of the safety profile of the material in osteoporosis patients.

this observational single arm study will be broken into two parts: 1. a retrospective component which will evaluate the original frax score along with any events or medications received after the end of the original study. 2. a prospective component which will evaluate longer term outcomes following the use of the agn1 synthetic bone graft material in a local osteoenhancement procedure through evaluation of mobility and imaging. in the original study, subjects completed a twenty-four (24) month follow-up visit after receiving a unilateral hip injection with the device. the contralateral hip acted as the control. the purpose of the study was to determine the safety of the injection as well as the initial improvement in femoral bone density in a twenty-four (24) month period. in this follow-up study the subjects, after signing the informed consent form, will complete a short medical history (focused on their osteoporosis management) and a mobility test. subjects will also undergo a dxa, x-ray and ct scans of both hips.

Eligibility criteria:
inclusion criteria: * participated in the original study and signed the consent form * received treatment with agn1 femoral loep * completed the study. exclusion criteria: * there is no exclusion criteria for this study.

Keywords: loep osteoporosis femur fracture
usage of skeletal muscle relaxants survey among egyptian dental practitioners

Conditions: Temporomandibular Joint Disorders; Bruxism

Summary: pharmacists may also logistically serve as ideal health-care destinations to implement and deliver prevention, early intervention, and referral of oral health services to reduce the incidence of potentially preventable oral conditions including tooth decay, gum disease, and oral cancer. interprofessional teamwork between pharmacist and dentistry may help to encourage pharmacists to take a more active role in promoting oral health. by providing information and assistance for self-care and the use of over the counter (otc) products for minor problems on oral health, it can provide better patient care in the malaysian health-care system

skeletal muscle relaxants (smr) are a diverse group of medications that are not chemically related like other drug classes and work through a variety of mechanisms. the term "muscle relaxant" is used to refer to two major therapeutic groups: neuromuscular blockers and spasmolytic. some of them are working mainly through the central nervous system; they have many adverse effects such as sedation and dizziness that may limit their use. pharmacists may also logistically serve as ideal health-care destinations to implement and deliver prevention, early intervention, and referral of oral health services to reduce the incidence of potentially preventable oral conditions including tooth decay, gum disease, and oral cancer. interprofessional teamwork between pharmacist and dentistry may help to encourage pharmacists to take a more active role in promoting oral health. by providing information and assistance for self-care and the use of over the counter (otc) products for minor problems on oral health, it can provide better patient care in the malaysian health-care system

Eligibility criteria:
inclusion criteria: * academic dental practitioners in egypt * nonacademic dental practitioners in egypt exclusion criteria: * age less than 20 or more than 60 * non-dental
upper limb-based movement priming for lower limb neuroplasticity & motor recovery in stroke

Conditions: Stroke

Summary: the goal of this clinical trial is to to determine the effect of movement-based priming using the upper limbs on lower limb neuroplasticity and behaviors in chronic stroke. the main questions we aim to answer are: 1. what are the acute effect of ul-priming on lower limb neuroplasticity and motor behaviors in persons with stroke compared to other priming modalities? 2. what are the time effects of ul-priming on neuroplasticity and motor behavior in individuals with stroke? in this cross over study, participants will be involved in three priming sessions involving - ul-priming using rhythmic, symmetric, bilateral priming involving the movement of at least one major joint in the upper limbs. and - sham priming using auditory stimulation (1 hz metronome). and - lower-limb movement-based priming using rhythmic, symmetric, dorsiflexion and plantarflexion movements. researchers will compare outcome measures between the different priming sessions.


Eligibility criteria:
inclusion criteria: * single, monohemispheric stroke * chronic stroke (\> 6 months prior) * residual hemiparetic gait deficits (e.g., abnormal gait pattern) * minimum score of stage 2 on the chedoke arm impairment scale which includes stage 2, task 3 (facilitated elbow flexion) as one of the stage 2 tasks. exclusion criteria: * use of anti-spasticity medications * existence of other neurological disorders * have brainstem or cerebellar lesions. * score of ≥2 on the modified ashworth scale. * mmse score of \<21, to ensure they will follow instructions. * non-english-speaking individuals * bone, joint or soft tissue injury * uncontrolled medical conditions (such as uncontrolled hypertension, untreated cardiac disease, or untreated pulmonary disease) * no motor evoked potentials (meps) during tms tms exclusion criteria * previous adverse reaction to tms * skull abnormalities or fractures * concussion within the prior 6 months * unexplained, recurring headaches * implanted cardiac pacemaker * metal implants in the head or face * history of seizures or epilepsy * use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants) * current pregnancy