Kornimate/medical-research-clean huggingface dataset:
study of calcium metabolism in teenage girls with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the proposed pilot study will enroll 33 adolescent females with type 1 diabetes for the assessment of whole body calcium metabolism using dual stable calcium isotopes. this is the state of the art technique for assessing calcium metabolism in the body and has been used in both healthy and diseased pediatric populations.


Eligibility criteria:
inclusion criteria: * diagnosis of t1d of at least three years duration * female sex * age between 9-18 years * parental/guardian consent and participant assent * bmi \<99th percentile exclusion criteria: * history of metabolic bone disease, chronic renal disease, hepatic disease, celiac, or other malabsorptive disease * history of any proton-pump inhibitor use within a 6 month period prior to enrollment * history of oral or inhaled corticosteroid use for ≥ 5 consecutive days within a 6 month period prior to enrollment * pregnant or lactating females * parents/guardians or participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
restoring glutathione synthesis with tecfidera: an in vivo h-mrs single-arm study at 7t in patients with rr ms

Conditions: Multiple Sclerosis

Summary: the primary objective is to directly estimate brain glutathione concentrations in vivo using h-mrs at 7t before and after initiation of tecfidera in established multiple sclerosis (ms) patients considering switching therapy or being treatment-naive (first line).


Eligibility criteria:
inclusion criteria: * male or female adult patients * 18-60 years of age * diagnosis of multiple sclerosis, in accordance with the revised mcdonald criteria (2010) * patients naive to ms therapy or patients switching from an fda-approved ms therapy, including ifn-b formulations, cop-1, teriflunomide, and fingolimod to bg-12 * expanded disability status scale (edss) score 0 to 5.5 inclusive exclusion criteria: * primary progressive multiple sclerosis patients * patients with previous exposure or known allergies to fumarates * ms patients switching from natalizumab, cyclophosphamide, or mitoxantrone to bg-12 * contraindications for mri/mrs * known presence of other neurological disorders that may mimic multiple sclerosis * pregnancy or lactation * requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * history of or currently active primary or secondary immunodeficiency * active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis b or c, hiv, syphilis, tuberculosis_ * history of progressive multifocal leukoencephalopathy * contraindications to or intolerance of oral or intravenous (iv) corticosteroids
safety and efficacy study of nbi-98854 in children and adolescents with tourette syndrome

Conditions: Tourette Syndrome

Summary: phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of nbi-98854 administered once daily (qd) for a total of 6 weeks of treatment. this study will enroll approximately 90 male and female pediatric subjects clinically diagnosed with tourette syndrome.


Eligibility criteria:
inclusion criteria: 1. have a clinical diagnosis of tourette syndrome (ts) 2. have at least moderate tic severity 3. have ts symptoms that impair school, occupational, and/or social function 4. if using maintenance medication(s) for ts or ts spectrum diagnoses (e.g. obsessive-compulsive disorder \[ocd\], attention-deficit hyperactivity disorder \[adhd\]), be on stable doses 5. be in good general health 6. adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen 7. subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study exclusion criteria: 1. have an active, clinically significant unstable medical condition within 1 month prior to screening 2. have a known history of long qt syndrome or cardiac arrhythmia 3. have a known history of neuroleptic malignant syndrome 4. have a cancer diagnosis within 3 years prior to screening (some exceptions allowed) 5. have an allergy, hypersensitivity, or intolerance to vmat2 inhibitors 6. have a blood loss ≥250 ml or donated blood within 30 days prior to screening 7. have a known history of substance dependence, substance (drug) or alcohol abuse 8. have a significant risk of suicidal or violent behavior 9. have initiated comprehensive behavioral intervention for tics (cbit) during the screening period or at baseline or plan to initiate cbit during the study 10. have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than nbi-98854) during the study
effects of dapagliflozin therapy on myocardial perfusion reserve in prediabetic patients with stable coronary artery disease

Conditions: Coronary Artery Disease; Prediabetic State

Summary: the purpose of this study is to investigate the effects of dapagliflozin therapy on myocardial perfusion reserve (mpr) using dynamic spect examination in prediabetic patients with stable cad. dapagliflozin therapy versus lifestyle modification improves myocardial perfusion reserve in prediabetic patients with stable cad.


Eligibility criteria:
inclusion criteria: 1. men or women at least 18 years of age 2. prediabetes by ada criteria (fasting glucose 100-125mg/dl, or hba1c 5.7-6.4%) 3. stable coronary artery disease 4. global myocardial perfusion reserve (mpr) index \< 2.0 5. the patient or guardian agrees to the study protocol and the schedule of clinical and dynamic spect follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site. exclusion criteria: 1. contraindications to dapagliflozin 2. significant renal disease manifested by egfr\<30 ml/min/1.73m² 3. unstable or rapidly progressing renal disease 4. acute coronary syndrome, or any other major cardiovascular events within the previous 6 months 5. stent placement, or coronary artery bypass graft surgery within the previous 6 months 6. planned revascularization within 6 months 7. significant disease (diameter stenosis \>70% by coronary ct angiography) in major epicardial coronary arteries 8. heart failure requiring loop diuretics 9. hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alt or ast \> 3 times upper limit of normal). 10. contraindication to adenosine stress test 11. current treatment for the active cancer 12. women of child bearing potential who are not willing to use a medically accepted method of contraception. patient's pregnancy confirmed by positive pregnancy test, or breast-feeding. 13. expected life expectancy \< 1 year 14. any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests which, in the judgment of the investigator, would preclude safe completion of the study. 15. unwillingness or inability to comply with the procedures described in this protocol.

Keywords: dapagliflozin lifestyle modification myocardial perfusion reserve
erythropoietin in the treatment of anemia after autologous hematopoietic stem cell transplantation

Conditions: Anemia; Lymphoma; Hematopoietic Stem Cell Transplantation

Summary: this is an randomized trial to evaluate the potential benefit of erythropoietin in the treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell transplantation.

lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin group or control group. potential benefit of erythropoietin will be evaluatedon day +60 post-transplant.

Eligibility criteria:
inclusion criteria: * confirmed lymphoma * first autologous hematopoietic stem cell transplantation * hemoglobin level less than 100 g/l on day +15 post-transplant * written informed consent given by patient or his/her guardian if of minor age. exclusion criteria: * hiv positive * known allergy to recombinant human erythropoietin * uncontrolled infection

Keywords: anemia lymphoma hematopoietic stem cell transplantation erythropoietin
exercise interventions for improving eye control post strabismus surgery

Conditions: Strabismus

Summary: the purpose of this study will be focused on the following issue: 1. the aim of this study is to determine therapeutic effect of postoperative eye exercises on improving eye control after the strabismus surgery. hypotheses: it will be hypothesized that: • eye exercises have a positive effect on improving eye control post strabismus surgery. research question:" • do postoperative eye exercises improve eye control post strabismus surgery?

therapeutic procedures: * patient will be informed about measurement and treatment procedure before beginning of the treatment. * patient will be asked to follow physician instructions. * patients will be asked to avoid participation in any rehabilitation program prior to the study which may affect the result of the study. * measurement procedures will be applied for each patient. * they will start the treatment program after 2 weeks of the surgery. the subjects will be divided into two groups (experimental group and control group) with equal numbers of patients in each group: control group participants within the control group will receive traditional care and medication following strabismus surgery. experimental group participants within the experimental group will receive physiotherapy exercises beside traditional care and medication after strabismus surgery. physical therapy exercises will apply in the office and home. office exercises will involve palming exercise, pencil push-ups, brock string exercise, thumb exercise (near-distance jump), balance board exercise, proprioceptors neuromuscular facilitating (pnf) exercise, occlusive therapy, eye hand coordination and computer therapy. office exercises will be done two sessions per week for three months. each session will be about 1 hour. exercises will also perform at home from the first session including eye exercises in all directions, pencil push-ups, thumb exercise (near-distance jump),brock string exercise, and dominant eye occlusion for 1 hour daily.

Eligibility criteria:
inclusion criteria: * criteria of selecting the patients include the following: * patients are both males and females. * their age will range from (5-15) years. * patients received strabismus operation. * they will be selected from outpatient clinic of research institute of ophthalmology. * patients will begin the training program after 2 weeks of operation. * all types of strabismus surgery will be included. exclusion criteria: the subjects will be excluded from the study if they meet one of the following criteria; * muscular disorders that will impair performance during training. * any organic lesion in the eye. * neurological disorders. * malignant conditions. * psychiatric illness, severe behavior or cognitive disorders. * children who can't understand the therapist's instructions and orders.
commit hiv trial nepal

Conditions: Hiv

Summary: community healthcare workers (chws), who live in the communities they serve, have the potential to reach patients who poorly engage in their care. motivational interviewing (mi) is a special type of interactional approach that focuses on improving the person's motivation to engage in healthy behaviors, such as keeping their clinic appointments and regularly taking medications. in this study, we will develop a mobile health tool that will assist chws in two tasks while they utilize mi to assist patients' engagement in care: 1) follow prompts on the mobile device to deliver mi; and 2) record consented conversations between chws and patients so that mi specialists can review the audiotape and provide feedback to maintain the mi skills.


Eligibility criteria:
inclusion criteria: 1. inclusion criteria for patient population: 1) having a documented hiv diagnosis, 2) living in the community health worker catchment area at the nepal research site and , 3) having poor adherence (missed a clinic visit by more than 2 weeks, \<95% adherence from visual analogue scale and/ or failed to refill their antiretroviral medications 1 week past the expected date) 2. inclusion criteria for community health worker or a community health worker supervisor: living/working at the nepal research site who has received motivational interviewing training as part of the intervention, and are involved directly in program implementation process. exclusion criteria: 1. exclusion criteria for patient population: includes decision from the patient to not receive care delivered by care provider at the nepal research site or not to participate in the study 2. exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.

Keywords: low- and middle-income countries mhealth human-centered design and engineering digital tools nepal motivational interviewing non-physician healthcare workers community health workers hiv
the impact of bariatric surgery on non-alcoholic fatty liver disease

Conditions: Obesity; NAFLD

Summary: up to 300 million people have a bmi over 30kg/m2. obesity is the cause of many serious diseases, such as type 2 diabetes, hypertension and nafld. bariatric surgery is the only effective method of achieving weight loss in patients with morbid obesity. the aim of the study is to assess the impact of bariatric surgery on non-alcoholic fatty liver disease in patients operated on due to morbid obesity.

investigators include 20 patients qualified for the bariatric procedure with bmi \> 40 kg/m2 or a bmi \> 35kg/m2 with the presence of comorbidities. the average body weight in the group was 143.85kg with an average bmi of 49.16kg/m2. before the procedure, investigators evaluated the severity of the non-alcoholic fatty liver disease in each patient using the sherif saadeh ultrasound scale. investigators also evaluated the levels of the liver enzymes. follow up was performed twelve months after surgery.

Eligibility criteria:
inclusion criteria: patients at the age of 18-60, meeting the criteria of qualification for the surgical treatment of obesity, i.e. bmi \> 40 kg/m2 or bmi \> 35 kg/m2 together with accompanying diseases. exclusion criteria: * chronic mental diseases * addictions * earlier bariatric procedures

Keywords: obesity bariatric surgery non-alcoholic fatty liver disease
analgesic efficacy of smoked cannabis

Conditions: Pain; Hyperalgesia

Summary: the purpose of this study is to determine whether or not inhaled marijuana displays any pain-relieving properties on experimentally-induced pain.

it is important to evaluate the effects of the cannabinoids on facilitated pain as conditions of hyperalgesia more closely approximates the clinical situation. there are limited clinical studies on the effect of the cannabinoids on facilitated pain states. noyes et al evaluated the analgesic effects of delta-9-thc in 34 cancer patients with pain. they concluded that 20mg of oral delta-9-thc was similar to 120mg of codeine (noyes et al, 1975). jain et al concluded that 1.5-3mg of intramuscular levonantradol resulted in significant pain relief as compared to placebo in 56 patients with acute postoperative pain (jain et al, 1981). comparison(s): three different doses of smoked cannabis will be compared to placebo for the reduction of experimentally induced pain.

Eligibility criteria:
inclusion criteria: * age 18-90 * male or female * subject smoked cannabis within the last six months exclusion criteria: * active opportunistic infections or opportunistic malignancies requiring acute treatment * active substance abuse (alcohol or injection drug) * pulmonary complications (e.g., tuberculosis, asthma) * current use of cannabis (e.g., within 30 days of randomization) * pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test before any cannabis or placebo consumption condition * personal or familial history of psychiatric disorder

Keywords: pain cannabis analgesic
a phase 1, dose-escalation study of medi-551 in japanese adult patients with relapsed or refractory advanced b-cell malignancies

Conditions: Blood Cancer; Advanced B Cell Malignancies

Summary: the primary objective of this study is to evaluate the safety and tolerability of medi-551 in japanese patients with relapsed or refractory advanced b-cell malignancies.


Eligibility criteria:
inclusion criteria: * japanese men or women at least 20 years of age * histologically confirmed cll (excluding small lymphocytic lymphoma (sll)), dlbcl, fl, or mm. * karnofsky performance status ≥70; * life expectancy of ≥12 weeks exclusion criteria: * any available standard line of therapy known to be life-prolonging or life-saving * any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer * previous therapy directed against cd19, such as monoclonal antibodies or mab conjugates

Keywords: phase i advanced b cell malignancies dose escalation cd19 japanese
the effect of cinnamon extract on insulin resistance parameters in polycystic ovary syndrome: a pilot study

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to determine whether oral cinnamon extract are effective in reducing insulin resistance parameters in women with polycystic ovary syndrome.

polycystic ovary syndrome (pcos) is a very common condition found in women of childbearing age. pcos patients often have irregular periods, extra hair growth, or difficulty becoming pregnant. the syndrome can also be associated with more serious conditions such as heart disease, diabetes, or cancer of the uterus. although no one knows the cause of the syndrome, scientific studies showed that having too much insulin can be one of the reasons. in fact, almost every overweight woman with pcos has been found to have high insulin levels. medications that lower the body's insulin level used to treat people with diabetes mellitus have also been used very successfully to treat some of the symptoms of pcos such as irregular periods. recently studies using rats and mice have shown that a commonly used spice, cinnamon, may also reduce the body's insulin level. another study showed that daily use of cinnamon for forty days lowered the blood sugar level in patients with diabetes. the purpose of this study is to see if cinnamon can lower the insulin level in women with pcos. if so, it can also be used as a treatment for irregular periods as well. half of the patients in the study will take premade cinnamon extract pills twice a day while the other half will take placebo pills (pills with no cinnamon extract) twice a day for eight weeks. blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the eight weeks of medication. a total of three separate visits will be needed to finish the study. at the end of the study, we will then compare the blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.

Eligibility criteria:
inclusion criteria: * polycystic ovary syndrome exclusion criteria: * diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension

Keywords: polycystic ovary syndrome insulin resistance cinnamon
control cohort ctrl coh

Conditions: Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis

Summary: autoimmune encephalitis (ae) and paraneoplastic neurological syndromes (pns) are rare disease that could be difficult to diagnose. so it necessary to obtain numerous sample from different disease to develop more specific diagnosis kit it could be possible through the characterisation of new genetic biomarkers.


Eligibility criteria:
inclusion criteria: * patient with consent * patient with following disease: parkinson's disease, amyotrophic lateral sclerosis, glioblastoma, cancer without neurological disease (pulmonary cancer, breast cancer, ovarian cancer, melanoma, thymoma), rheumatoid arthritis. exclusion criteria: * refusal consent * patient with neurological disorder compatible with paraneoplastic neurological syndrome or auto-immune encephalitis * patient under guardianship

Keywords: biological collection, control cohort,, new biomarkers
hospital-acquired pneumonia in intensive care unit

Conditions: Hospital Acquired Pneumonia; Ventilator-Associated Pneumonia; Sepsis; Pneumonia

Summary: hospital-acquired pneumonia are a common disease in intensive care unit. the prevention, the diagnosis and the treatment of hospital acquired pneumonia are a frequent challenge. nevertheless it seems that there are great differences in standard of care between hospitals. the investigators hypothesized that medical education and implementation of evidence-base guidelines can reduce the duration of mechanical ventilation in patients presenting of hospital acquired pneumonia

the before period (phase 1) will consist of all consecutive patients admitted to the participating icus before the national guidelines publication concerning healthcare associated pneumonia. the second period (phase 2) will consist of all consecutive patients admitted to the participating icus after the publication of the national guidelines publication concerning healthcare associated pneumonia. afterward, an interphase will occur during which all physicians, residents, physiotherapists and nurses will receive a formal training for the processes and procedures related to the new guidelines published in september 2017. in the intervention group, on top of the standard training, the centers receive an analysis of the evolution of the practices of their center and the future of their patients between phases 1 and 2, as well as these same values for the data set. the centers are then called to conduct a meeting to determine their priority improvement points based on this audit. the third and final period (phase 3) will consist of all consecutive patients admitted to the participating icus after the formal training.

Eligibility criteria:
inclusion criteria: * age \> 18 years ; igs-ii score \> 15 ; hospital stay \>= 3 days exclusion criteria: * community-acquired pneumonia, pregnant women, refusal to participate

Keywords: intensive care unit pneumonia ventilator associated hospital acquired pneumonia guidelines
a study of complete molecular response for chronic myeloid leukemia in chronic phase patients, treated with dasatinib

Conditions: Chronic Myeloid Leukemia

Summary: the purpose of this study is to evaluate complete molecular response of dasatinib in patients for philadelphia chromosome-positive chronic myeloid leukemia


Eligibility criteria:
inclusion criteria: * chronic myeloid leukemia in the chronic phase * 20 years old over * ecog performance status (ps) score 0-2 * patients for major molecular response (mmr) with no cmr * adequate organ function (hepatic, renal and lung) * signed written informed consent exclusion criteria: * a case with the double cancer of the activity * women who are pregnant or breastfeeding * the case of pleural effusion clearly * patients with complications or a history of severe or uncontrolled cardiovascular failure following * have a myocardial infarction within 6 months * have an angina within 3 months * have a congestive heart failure within 3 months * have a suspected congenital qt syndrome * have a qtc interval of more than 450msec at baseline * a serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy * prior treatment with dasatinib * subjects with t315i, f317l and v299l bcr-abl point mutations

Keywords: chronic myeloid leukemia dasatinib complete molecular response