Kornimate/medical-research-clean huggingface dataset:
arginine therapy in sickle cell disease-voc clinical trial

Conditions: Vaso-occlusive Pain Episodes

Summary: vaso-occlusion contributes significantly to morbidity in sickle cell disease (scd). vaso-occlusive painful episodes (voe) are common and debilitating, causing the majority of emergency department visits. currently efforts to treat painful episodes with use of non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without targeting the underlying mechanisms of vaso-occlusion.investigators have found that an arginine deficiency and low no bioavailability occurs during painful events in scd. since arginine is the obligate substrate for no production, and an acute deficiency is associated with voe, investigators hypothesized that arginine supplementation may be a safe and beneficial treatment for sickle cell pain.


Eligibility criteria:
inclusion criteria: * established diagnosis of sickle cell disease(ss,sc,s-beta thal) * admitted to hospital for pain * pain requiring hospitalization for parenteral narcotics, not attributable to non-sickle cell causes * \>3 year and older exclusion criteria: * hemoglobin less than 5gm/dl or immediate need for red cell transfusion * hepatic dysfunction: increased in sgpt to \>2x normal value * renal dysfunction: increased in creatinine to \>2x normal value or \>1.5 * mental status or neurological changes * pregnancy * \>10 hospitalizations per year or history of dependance to narcotics * inability to take oral medications or allergy to arginine * inability to use a pca device * \< 3 years of age

Keywords: sickle cell disease vaso-occlusive pain episodes arginine nitric oxide
comparison of intramuscular olanzapine depot with placebo in the treatment of patients with schizophrenia

Conditions: Schizophrenia

Summary: key objectives of this clinical study are to: * determine how well intramuscular (im) olanzapine depot works compared to placebo * evaluate the safety and tolerability of im olanzapine depot compared to placebo * evaluate different doses of im olanzapine depot compared to placebo to identify the best dose(s).


Eligibility criteria:
inclusion criteria: * patients must have schizophrenia and be experiencing a psychotic episode * each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent * patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry * female patients must not be pregnant or breast-feeding * female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia exclusion criteria: * patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator * one or more seizures without a clear and resolved etiology is exclusionary. however, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered. * treatment with clozapine within 4 weeks prior to visit 1 * dsm-iv or dsm-iv-tr substance (except nicotine and caffeine) dependence within the past 30 days * treatment with remoxipride within 6 months (180 days) prior to visit 1
registry of anesthesia and perioperative medicine

Conditions: Perioperative Complication; Perioperative/Postoperative Complications; Anesthesia Morbidity; Anesthesia; Adverse Effect; Anesthesia Complication; Anesthesia; Reaction

Summary: to assess mortality and morbidity associated to anesthesia interventions

currently evidence-based medicine is one of the most important tools guiding our medical practice. part of this evidence has been generated from clinical records, which has allowed access to large databases from which relevant information has been obtained for perioperative risk stratification, searching for complications, having specific information on procedures, among others. a clear example, especially useful daily in anesthesia work, is the nsqip score, a tool that allows calculating perioperative risk according to the conditions of the patient and the surgery. nsqip score is considered to make decisions in both the american and the european guidelines for preoperative evaluation for surgery. latin-american or chilean databases are not available at the present time. chile lacks of population perioperative databases, methodology and practice of medicine outcomes records, thus making necessary the generation of a retrospective/prospective registry. the investigators expect that this registry will allow the collection of perioperative information appropriate to characterize the chilean population, observe its evolution, and detect risk factors. moreover, this registry will grant the investigators the means to design new research studies that may allow them to gather medical evidence of superior quality, thus benefiting patients with the best and safest interventions and procedures.

Eligibility criteria:
inclusion criteria: * all individuals * individuals agreeing to participate in the study by signing a consent exclusion criteria: * the subjects who had insufficient data in their files
a multidimensional behavioral intervention for those at risk for alzheimer's dementia

Conditions: Functional Aging; Subjective Cognitive Concerns; Compensation Strategies; Brain Health Activities

Summary: this intervention is designed to promote enhanced use of compensation strategies including calendar and task list use, and organization systems, as well as increased engagement with brain health activities including physical exercise, cognitive activities, and stress reduction.

the purpose of this study is to test the feasibility and efficacy of a 10-week multi-dimensional intervention for older adults with subjective cognitive concerns (scc). the goal of this intervention is to enhance compensation skills related to everyday executive and everyday memory functions through training in the systematic use of a calendar system, goal setting and task list system, and organizational strategies within the context of the individual's daily life. this multidimensional intervention program also targets engagement in healthy lifestyle activities (physical exercise, intellectual stimulation, positive emotional functioning) to further promote brain health and functional resilience. importantly, both treatment components work synergistically as the use of compensation strategies assists in building healthy activities into daily routines (e.g., scheduling exercise into one's calendar and putting it on a task list).

Eligibility criteria:
inclusion criteria: * a positive complaint in response to two questions ('do you feel like your memory or other aspects of thinking are becoming worse?'; 'does this worry you?') * normal cognitive performance corrected for age and education on a global measure of cognitive functioning * independent in all activities of daily living. * english speaking; * available informant to complete surveys; * ambulatory exclusion criteria: * known neurological condition; * severe psychiatric illness (e.g., current depression).
an observational study of carbaglu® for the treatment of mma and pa in adults and pediatrics

Conditions: Hyperammonemia; Methylmalonic Acidemia; Propionic Acidemia

Summary: to obtain short-term and long-term clinical safety information, in pediatric and adult patients with pa and mma treated with carbaglu®.

this study is being conducted to obtain short-term and long-term clinical safety information from adult and pediatric patients treated for hyperammonemia due to methylmalonic acidemia (mma) and propionic acidemia (pa). this is an observational/non-interventional study. patients will be treated per the prescribing information and routine medical practice. only available data will be collected as part of the study including developmental outcomes, details of treatment with carbaglu® and other treatments for hyperammonemia including dietary and protein management, plasma ammonia levels, pregnancy and maternal complications, adverse effects on the developing fetus and neonate, adverse effects on the infant through first year of life.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent/assent form 2. prescribed and treated with carbaglu® 3. have an established diagnosis of pa or mma defined as follows: * diagnosed with pa by semi quantitative urine organic acid analysis, defined as presence of elevated methylcitric acid and normal methylmalonic acid levels and no evidence of biotin related disorders in the organic acid analysis; or * diagnosed with mma by semi quantitative urine organic acid analysis, defined as elevation of methylmalonic acid and no evidence of vitamin b12 dependent disorder on plasma amino acid analysis (vitamin b12 dependency is defined by documented vitamin b12 responsiveness). and/or * confirmation by molecular genetic testing exclusion criteria: * none

Keywords: pa & mma
glycemic excursions in type 2 diabetic patients with vildagliptin and metformin versus vildagliptin and glimepiride

Conditions: Type 2 Diabetes; Hypoglycemia

Summary: the purpose of this study was to compare the effect of a fixed dose combination of vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in glycemic variability in patients with type 2 diabetes who have not achieved adequate control of their disease prior to treatment with metformin monotherapy in optimal doses.


Eligibility criteria:
key inclusion criteria: * hba1c between 8%-10.5% in stable metformin dose (\>1500 mg/day), four weeks prior visit 1 key exclusion criteria: * use of other antidiabetic oral therapy during the last 3 months (sulphonylurea, glitazones, glp-1 analogues, dpp-4 inhibitors), except metformin

Keywords: diabetes hypoglycemia glycemic variability vildagliptin glimepiride
latitude - lateral lymph node attitude study

Conditions: Rectal Neoplasm Malignant

Summary: patients with advanced rectal cancer can sometimes have suspected tumour affected lymph nodes outside the standard operating field. these patients often receive preoperative treatment before surgery. there is a lack of consensus on what to do if there is remaining suspicion of tumour affected lymph nodes after the preoperative treatment. removal of the lymph nodes using a broader surgical field with dissection of the lateral side-wall is often suggested, but the oncologic outcome is uncertain, and so is the patient reported outcome in terms of side effects. this study aims to study the surgical treatment of tumour affected lateral lymph nodes to understand what lymph nodes require removal, and what effect that will have on oncologic outcome and the patient's function and qol.

patients with advanced rectal cancer will receive standard care, if lateral lymph nodes exist after neoadjuvant treatment they will be operated accordingly. the focus will be to compare two groups (with and without lateral lymph node clearance) regarding function, qol and oncologic outcome. we will also aim to identify features on mri to improve diagnostic ability.

Eligibility criteria:
inclusion criteria: * 18 years or older * written informed consent * adenocarcinoma verified tumour below ≤ 8 cm from anal verge measured by rectoscopy and/or mri * clinical tumor (ct) stage ct3, ct4a or ct4b on mri or * adenocarcinoma verified tumour at any height ≤ 15 cm from anal verge measured by rectoscopy and/or mri regardless of t/n stage with visible lateral lymph node (according to definition 2.4.2) on pre-therapeutic mri or pet-ct exclusion criteria: * not biopsy confirmed rectal cancer (adenocarcinoma) * recurrent rectal cancer * age below 18 * participation in other trials in conflict with the protocol and end-points of the latitude study * no informed consent

Keywords: lateral lymph nodes quality of life local recurrence thrombosis lymph oedema lateral lymph node dissection
cd56+cd3- nk cells following allogeneic stem cell transplantation

Conditions: Haematological Malignancies; Allogeneic Stem Cell Transplant; CD56+CD3- NK Cells

Summary: the investigators propose a nonrandomized, phase i study to assess the safety of infusion of nk cells that will be selected from sibling donors and infused to patients with hematological malignancies early following allogeneic stem cell transplantation.

allogeneic hematopoietic stem cell transplantation (hsct) is a very effective treatment for a number of hematological malignancies but relapse remains a major problem, especially in patients with high risk disease. natural killer (nk) cells are immune cells that recognize and kill virally infected cells and tumor cells. nk cells are identified by the expression of the cd56 surface antigen and the lack of cd3. their ability to kill tumor cells makes them promising to evaluate as effector cells for immunotherapy.

Eligibility criteria:
inclusion criteria: 1. patients undergoing an allogeneic hsct from a sibling donor, as treatment for a hematological malignancy. the conditioning regimen, and in particular whether ablative or non ablative, will not be considered in the criteria for recruitment 2. patient and donor age \>18 years 3. patients and donors must have signed an informed consent form 4. the donor must be willing and capable of donating lymphocytes for nk selection using apheresis techniques 5. donor must be fit to undergo leukapheresis exclusion criteria: 1. life expectancy \< 3 months 2. ecog performance status 3 or 4 3. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia 4. patients will not be eligible if they receive in vivo t depletion with atg, alg or campath-1h 5. hiv-positive patients 6. psychiatric illness/social situations that would limit compliance with study requirements and ability to comprehend the investigational nature of the study and provide informed consent

Keywords: nk natural killer immunotherapy leukemia hematological malignancies stem cell transplantation adoptive therapy
a study of vitamin d in subjects with alopecia areata

Conditions: Alopecia Areata

Summary: the objective of this study is to assess the parathyroid-vitamin d-calcium axis in subjects with alopecia areata. the hypothesis behind this study is that hypovitaminosis d might contribute to the pathogenesis of alopecia areata.

alopecia areata (aa) is a t-cell mediated, non-scarring, polygenic, autoimmune disease of the hair follicle. it has been reported to be associated with other autoimmune diseases, especially autoimmune thyroid disease and vitiligo. it is more common in females. recently, vitamin d deficiency has been claimed to contribute to the pathogenesis of multiple autoimmune disease. there is a strong inverse correlation between the level of 25-hydroxyvitamin d levels and the autoimmune disease in adolescents.

Eligibility criteria:
inclusion criteria: * men and women who are at least 18 years old * subjects with newly diagnosed with alopecia areata exclusion criteria: * subjects who take supplemental vitamin d, by itself or as a part of a multivitamin

Keywords: alopecia areata vitamin d parathyroid calcium
buprenorphine as a treatment in opiate dependent pain patients

Conditions: Opiate Addiction; Refractory Pain

Summary: this study is designed to determine if different doses of buprenorphine (either tapering doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who also are addicted to opiate pain medicines.

context: some individuals have two conditions: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. it is not known how to manage these patients. in addition to other modalities for the treatment of chronic pain, combination tablets of buprenorphine/naloxone (suboxone) may be helpful. objective: the objective of this study is to determine if the addition of pharmacotherapy with suboxone to usual care would improve clinical outcome relative to usual care alone. design: randomized control trial. setting: the study will be conducted in the out-patient clinics of a tertiary-care teaching hospital. participants: the participants will be those who have: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. baseline data collected: data collected at baseline will include (with examples): demographics (age, gender, race), substance use history (type of substances used, duration of use, routes of abuse), type of pain disorder (previous traumatic injury, musculoskeletal, neuropathic), co-existing medical problems (seizures, hepatitis c), prior injuries (accidents, interpersonal violence), prior mental health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient, inpatient), socioeconomic variables (educational level, occupation, employment history), criminal history (number of arrests and convictions, total amount of time spent in jail or prison), family history (first degree relatives with substance use disorders) and scores on psychometric testing (asi). outcome data: three main outcome variables will be examined relapse to substance use (as documented by toxicology), quality of life, and successful participation in the pain management program for six months, which included the completion of the study buprenorphine treatment protocols. data analyses: outcome variables will be compared between the two groups using t-tests or chi-square tests as appropriate. a kaplan-myer survival analysis will be used to describe participant participation. predictors of poor outcomes will be identified using a case-control design in which those with poor outcomes (the "cases") will be compared to those with successful outcomes (the "controls") using multivariate techniques (logistic regression).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic refractory pain * clinical diagnosis of opiate dependency exclusion criteria: * unable to pay for medication * enrolled in a methadone maintenance program * homelessness * major mental illness * pregnant women * prisoners * terminal cancer pain

Keywords: drug dependence substance abuse substance use disorders myofascial pain syndrome neuralgia back pain
adaptation of the pediatric asthma control & communication instrument (pacci) in a pediatric emergency department

Conditions: Asthma

Summary: this study examined whether the pediatric asthma control and communication instrument for the emergency department (pacci-ed), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control. this study involved an intervention with the doctors in the emergency department of an urban pediatric hospital. the intervention was done when one of the doctors involved in the study treated a child aged 1-17 years for an asthma exacerbation. parents answered questions on the pacci-ed about their children's asthma. half of the doctors were allowed to see the pacci-ed results and half were not. the two groups of doctors were compared on their ability to correctly identify asthma control categories, whether a child's asthma was worsening or improving, whether the family was administering controller medications as often as they should, and how much burden the child's asthma was for the family.


Eligibility criteria:
inclusion criteria: * child presented to study institution emergency department during study period * child was 1 - 17 years-old * child has physician-diagnosed asthma by parent report * attending physician for child believed emergency department visit was due to asthma * attending physician for child completed informed consent and was randomized to pacci-ed or control group at beginning of study exclusion criteria: * child has major pulmonary or cardiac co-morbid illness * family of child was non-english speaking * child was triaged to the med-trauma bay for severe respiratory distress

Keywords: asthma pediatrics control medication adherence
chatbot to maximize hereditary cancer genetic risk assessment

Conditions: Gynecologic Cancer; Hereditary Cancer Syndrome

Summary: in this study, the investigators aim to compare a mobile health platform, known as a 'chatbot,' that leverages artificial intelligence and natural language processing to scale communication, to 'usual care' that patients would receive. this comparison will enable the investigators to determine if the chatbot system can improve rates of recommendation for genetic testing among patients at elevated risk of harboring a familial cancer syndrome in an all-medicaid gynecology clinic. furthermore, the investigators aim to evaluate facilitators of inequity in regard to patient access to and utilization of genetic testing services.


Eligibility criteria:
inclusion criteria: * 8 years of age or older. * scheduled for a new patient appointment in the gynecology clinic. speaks and reads in english. * access to a telephone with texting capacity. * has not had prior genetic testing for hereditary cancer syndromes. exclusion criteria: * under 18 years of age * has had previous genetic testing for hereditary cancer syndromes * does not read/speak in english * does not have access to a phone with texting capabilities