Kornimate/medical-research-clean huggingface dataset:
treatment of chronic post-traumatic headache with onabotulinumtoxina

Conditions: Chronic Post Traumatic Headache

Summary: this study will provide evidence on whether the use of an fda-approved drug therapy for the treatment of chronic migraine (onabotulinumtoxina) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (tbi) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.

headaches caused by trauma are called post-traumatic headaches (pth). the center for disease control estimates that between 1.4 and 1.8 million civilians in the us sustain a traumatic brain injury (tbi) each year. the objectives of the study will be evaluated in a civilian population which has sustained a mild traumatic brain injury (mtbi). research has found that the total cost due to headache in the us workforce is $20 billion per year, most of which is in the form of reduce productivity while at work. for patients with tbi who are already struggling with cognitive and health challenges in an effort to be productive, it seems reasonable to suspect that chronic pth may slow rehabilitation efforts and successful re-entry into the work force and societal responsibility. results from this study have the potential to contribute to recommendations for treatment of chronic pth.

Eligibility criteria:
inclusion criteria: * diagnosis of mild traumatic brain injury (mtbi) within the past 15 months * suffer at least fifteen total headache days per month * ability to speak and read english exclusion criteria: * subject with hypersensitivity reactions or other intolerance to onabotulinumtoxina * previous use of onabotulinumtoxina for treatment of headache * any medications commonly used as headache preventives started less than 3 months prior to enrollment * prior or current diagnosis of major psychiatric disorder or other central nervous system disorder * less than 80% compliance (recorded for less than 24 days) in the 30 day screening headache diary * subjects who are pregnant or trying to become pregnant within the timeframe of the study

Keywords: mild traumatic brain injury concussion post concussive headache
effects of cyclosporine a on pancreatic insulin secretion

Conditions: Chronic Renal Failure

Summary: our primary aim is to investigate if cyclosporine a reduces insulin secretion.

our primary aim is to investigate if cyclosporine a may reduce insulin secretion by 20% or more. in order to get cyclosporine a naïve patients we will perform this investigation in dialysis patients on the waiting list for a renal transplantation. in addition we will investigate if also the peripheral insulin sensitivity and endothelia function is affected by cyclosporine a treatment in these patients. since these patients will be treated with cyclosporine a we will also measure cyclosporine pharmacokinetics at the time of investigation and repeat this investigation at the time of the first week following transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in predefining the dose to be used at the time of transplantation.

Eligibility criteria:
inclusion criteria: * renal failure patients on dialysis which is planned to receive a renal transplant exclusion criteria: * age below 18 years or above 75 years * pregnancy * breast feeding mothers * diabetes mellitus /who criteria) * dialysis treatment less than 2 months * serious coronary heart disease * unstable angina pectoris * recent acute infarction (less than 3 months) * non-compensated heart failure * simultaneous treatment with glucocorticosteroids (e.g. prednisolone, dexamethasone), diltiazem, verapamil, erythromycin, clarithromycin, telithromycin, rifampicin, fluconazole, itraconazole, ketoconazole, voriconazole, indinavir, nelfinavir, ritonavir, nefazodone, bosentan, carbamazepine, st. john's worth, grapefruit.

Keywords: glucose intolerance insulin microvascular function genotyping cyp3a5 pharmacokinetics renal transplantation
a study to test mk-0941 in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin (mk-0941-017)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to test the effect of mk-0941 as add-on therapy for participants taking metformin for type 2 diabetes.


Eligibility criteria:
inclusion criteria: * patient has type 2 diabetes mellitus * between the ages of 18 and 70 exclusion criteria: * patient has a history of type 1 diabetes mellitus or ketoacidosis. * patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication. * patient has had surgery within 30 days of starting the study or has planned major surgery during the study
edema control in patients with breast cancer-comparison of manual lymph drainage and epidermis fascia taping

Conditions: Breast Cancer

Summary: the ultrasound imaging could be used to examine the thickness of dermis and the space between dermis and subcutaneous tissue. whether the measurement of ultrasound imaging correlate to other measurement of edema is unknown. the purpose of this study is to investigate 1. the reliability of measurement of edema using ultrasound imaging, and the correlation of measurement of ultrasound with other measurement tools. 2. the different effect of edema control by manual lymph drainage technique and epidermis taping technique, and the cost-effective assessment. our hypothesis : 1. the measurement of edema with ultrasound imaging is a reliable method and correlate with other edema measurement with moderate correlation. 2. ultrasound measurement could demonstrate different effect of manual lymph drainage and epidermis taping, and different cost-effectiveness analysis.


Eligibility criteria:
inclusion criteria: 1. age:20\~80 y/o 2. female patients with unilateral breast cancer after surgery 3. unilateral lymph edema ( circumference of affected side 2cm bigger than sound side） 4. do not receive any treatment of lymph edema exclusion criteria 1. skin problems on affected side 2. neurological sign involved affected side, ex:stroke, brachial plexus impairment 3. involved other diseases may cause extremity edema, ex: heart failure or chronic kidney disease (stage one to stage five) 4. have medicine which may cause extremity edema 5. pregnant

Keywords: edema,taping,ultrasound
non invasive detection of idh1/2 mutation in gliomas

Conditions: Glioma; IDH1/IDH2 Mutation

Summary: this trial develops a non invasive diagnostic approach of idh1 mutated gliomas combining mutation detection from free plasmatic dna, d-2hg dosage in urine samples, and d-2hg detection by brain spectro mri. in group 1 (25 patients), patients with presumed grade ii-iii gliomas candidate to surgery will undergo spectro mri, plasma, urine dosages. results will then be confronted to tumor mutational status and d-2hg. in group 2 (15 patients), patients with known idh1 mutation will undergo spectro mri, plasma, urine dosages overtime in order to correlate results with the response to treatment.

the aim of this trial is to develop and validate a non invasive diagnostic approach of idh1 mutated gliomas. it will evaluate the specificity and sensitivity of d-2hg detection by brain spectro mri. this approach will be coupled with mutation detection from free plasmatic dna and d-2hg dosage in urine samples. the primary end-point is the quantification of d-2hg by spectro-mri, and the correlation with the dosage of d-2hg in the tumor fragment, and the mutational status (group 1: 25 patients). the secondary endpoints include: 1. longitudinal analysis spectro-mri overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients) 2. differentiation of tumor recurrence from radiation induced changes 3. confrontation of spectro-mri, d-2hg dosages and idh mutation detection from plasma dna, and elaboration of a combined score of prediction

Eligibility criteria:
inclusion criteria 1. affiliation to a social security system 2. patient≥ 18 years old 3. written informed consent 4. one of the two situations: * presumed grade ii-iii glioma candidate to surgery (group 1) * idh1/idh2 mutated grade ii-iii gliomas, candidate to chemotherapy or radiotherapy treatment, or simple follow-up (group 2) 5. evaluable tumoral mass min diameter \>2 cm (flair) 6. pkps \> 60 exclusion criteria 1. contra-indication to mri 2. patient unable to give an written informed consent 3. patient under guardianship or deprived of freedom 4. for group 2: patient already included in group 1

Keywords: glioma idh1/idh2 mutation spectroscopy mri d-2-hydroxyglutarate free circulating dna
a study to measure relationship between antimüllerian hormone and initial dose of menopur®

Conditions: Infertility

Summary: ame is a non-interventional, prospective, longitudinal and multicenter study. this study aims to measure the relationship between antimüllerian hormone serum level (amh), as measured by a fully automated assay and the initial dose of menopur® hp-hmg 600 iu/ml prescribed for infertile women undergoing their first ivf/icsi cycle in the current practice.


Eligibility criteria:
inclusion criteria: * women aged between \[18-42\] years. * both ovaries present. * regular menstrual cycles presumed to be ovulatory. * primary or secondary infertility of any origin for more than 12 months. * patient with at least one result of antimüllerian hormone (amh) measured by a fully automated assay available before inclusion, and performed in the past 12 months before inclusion. * candidates eligible to a first ivf/icsi cycle and for whom menopur® hp-hmg 600 iu/ml has been prescribed. * having received oral and written information on the study, without any objections for the use of his/her anonymized data, and having signed a written informed consent form. exclusion criteria: * major uterine or ovarian morphological abnormalities or past ovarian surgery. * endometriosis stage iii/iv. * polycystic ovarian syndrome. * major endocrine or metabolic abnormalities without treatment. * patient included in an interventional study assessing treatment for infertility.
effectiveness of a physical activity intervention for pre-frail older adults with chronic pain.

Conditions: Frailty; Chronic Pain; Old Age; Debility

Summary: the purpose of this investigation is to evaluate the effectiveness of a multicomponent structured physical exercise program for adults aged 65 years or more, classified as pre-frail and with chronic pain to improve the perceived health related quality of life, compared with usual care.

design: randomized controlled, pragmatic clinical trial with two groups and 3 months follow-up. unit of randomization: patient. unit of analysis: patient. setting: a primary health care center in the spanish autonomous community of madrid. population: pre-frail patients aged 65 years or more with chronic pain. intervention: multicomponent structured physical exercise program. control group: usual care. variables: perceived health related quality of life (euroqol 5d-5l), pain intensity (visual analogue scale), frailty (share-frailty index), physical performance (short physical performance battery, sppb), depression (yesavage). analysis: mean change differences after 3 months in eq5d dimensions between groups with ci 95%. mean differences or proportion differences will be calculated according to variable characteristics between groups with appropriate statistical test.

Eligibility criteria:
inclusion criteria: * clinical record of chronic pain by international classification of primary care (icpc) code a01. * being classified as pre-frail by share-fi questionnaire. * informed consent exclusion criteria: * housebound patients * institutionalized patients * not living in the area of the investigation * dependence for badl * not being fluent in spanish * severe mental illness or cognitive disorder

Keywords: primary health care nursing intervention physical activity
functional mr lung imaging using hyperpolarised 129xe

Conditions: COPD; IPF

Summary: the aim of this study is to investigate the potential value of a novel imaging technique (hyperpolarized 129xe lung imaging) in the diagnosis and assessment of lung disease in patients with copd and ipf.


Eligibility criteria:
general inclusion criteria * male or female aged over 18 years. * capacity to give informed consent * normal blood pressure (systolic bp \> 100 mmhg and diastolic bp \> 70 mmhg) * resting heart rate \> 50 bpm * for women, negative urinary β-hcg at the screening and subsequent visits * subject able to hold breath for 10 seconds * subject able to fit into 129xe chest coil used for mri * subject able to understand the requirements of the study and to cooperate with the study procedures inclusion criteria healthy volunteers • no significant respiratory disease within the last year patients copd * evidence of airflow obstruction (fev/fvc \<0.7) and fev1 \<80% predicted post bronchodilator * minimum fvc 1.5l exclusion criteria healthy volunteers * unsuitable for mri scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire) * acute respiratory illness within 30 days of mri * subject has received an imp (not including hyperpolarized 129xe) within 30 days of mri and administration of 129xe deemed inappropriate in context of other study * subject deemed unlikely to comply with instructions during imaging * do not meet the inclusion criteria above * subject not deemed fit enough to tolerate procedure * subject deemed unsuitable by clinical investigator for other reasons patients * unsuitable for mri scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire) * acute respiratory illness within 30 days of mri * subject has received an imp (not including hyperpolarized 129xe) within 30 days of mri and administration of 129xe deemed inappropriate in context of other study * subject deemed unlikely to comply with instructions during imaging * do not meet the inclusion criteria above * subject not deemed fit enough to tolerate procedure * subject deemed unsuitable by clinical investigator for other reasons
pharmacogenetics for pain management in joint replacement patients

Conditions: Arthroplasty Complications

Summary: the purpose of this study is to determine the ability to use pharmacogenetic testing in a joint replacement practice to prescribe the most effective pain medicine for a specific patient.


Eligibility criteria:
inclusion criteria: * primary total hip or total knee arthroplasty cases exclusion criteria: * history of narcotic dependence
anti-inflammatory h1 antihistamines allergic rhinitis

Conditions: Allergic Rhinitis

Summary: the main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and patients' quality of life and prevent the development of asthma. therapeutic strategies also target a reduction of pro-inflammatory mediators released from activated cells, including mast cells and epithelial cells. the presence of allergic inflammation in nasal mucosa may increase the risk of asthma occurrence, especially in patients with persistent allergic rhinitis. h1 antihistamines are widely recommended in all types of allergic rhinitis, regardless of symptom severity or persistence. they control all of the symptoms, but to a lesser extent nasal congestion. new generation agents, such as levocetirizine and desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.

allergic rhinitis is characterized by a chronic inflammation of nasal mucosa and represents a risk factor for asthma occurrence. h1 antihistamines reduce the rhinitis' symptoms, but some compounds may have anti-inflammatory properties. we evaluated the plasmatic level of some cytokines in patients with persistent allergic rhinitis (par) and their evolution after 4-week treatment with h1 antihistamines and the risk of asthma after 1.5 year. eighty-five patients with par and 30 healthy volunteers were included in the study. the patients with par were randomly divided into 2 groups: 41 patients treated with desloratadine 5 mg/day and 44 patients under levocetirizine 5 mg/day for 4 weeks. the clinical evaluation include the presence and severity of allergic rhinitis' symptoms: rhinorrhea, nasal congestion, sneezing, nasal and ocular itching and duration of the disease. each symptom was evaluated on scale from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe) and after that we calculated the total symptoms score (tss). a tss\ 6 represented a moderate severe one. the patients were clinically evaluated after 1.5 year to determine the possible onset of bronchial asthma. the biological evaluation means determination of total ige and plasmatic level of il-1 beta, il-6, il-8 and tnf alpha. clinical and biological evaluation were performed before and after treatment

Eligibility criteria:
inclusion criteria: * persistent allergic rhinitis exclusion criteria: * the presence of asthma or nasal polyps, * acute and chronic upper respiratory infections, * administration of intranasal or systemic corticosteroids or h1 antihistamines in the past 30 days.

Keywords: cytokines persistent allergic rhinitis h1 antihistamines
energy turnover in patients with anorexia nervosa

Conditions: Anorexia Nervosa

Summary: pilot study to assess energy turnover at end of inpatient treatment in 10 patients with anorexia nervosa.


Eligibility criteria:
inclusion criteria: * anorexia nervosa * anabolic metabolism * high compliance * end of inpatient treatment exclusion criteria: * any further disease than eating disorder * smokers

Keywords: energy metabolism
duloxetine for phn

Conditions: Postherpetic Neuralgia

Summary: in this study, the investigators aim to investigate the preventive efficacy of prophylactic oral duloxetine during acute herpes zoster on postherpetic neuralgia and its safety.

postherpetic neuralgia is a common complication of herpes zoster. several interventions have been investigated for the treatment of postherpetic neuralgia, however, there is a lack of preventive intervention on postherpetic neuralgia. a recent retrospective study revealed that the administration of gabapentin during the acute herpes zoster period significantly decreased the incidence of postherpetic neuralgia. in the present study, the investigators aim to conduct a prospective, randomized, open-label, endpoint blinded study to investigate the preventive efficacy of prophylactic use of duloxetine on postherpetic neuralgia.

Eligibility criteria:
inclusion criteria: * ages more than 50 years; * diagnosed with uncomplicated acute herpes zoster; * presents with vesicles within 72 hours; * has an average pain score of at least 40/100 mm on a visual analog scale (vas, 0 = no pain, 100 = worst possible pain, at opposite ends of a 100-mm line). exclusion criteria: * refuses to participate or to provide written informed consent; * zung self-rating depression scale raw score of more than 50 points; * herpes zoster that involves with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system; * has hemorrhagic or necrotizing lesions, satellite lesions, abnormal vesicles or acute retinal necrosis; * has been on immunosuppressive therapy or mono- or multi-pharmacotherapy that involves any tricyclic antidepressant, valacyclovir, duloxetine or cytotoxic medications before acute hz onset; * has been diagnosed with hepatic, renal or immune dysfunction; * during pregnancy or breastfeeding at the time; * hypersensitivity to the study drugs; * has contraindications to valacyclovir or duloxetine; * hz vaccinated.

Keywords: postherpetic neuralgia, duloxetine
effect of gos supplementation on amoxicillin-treated gut microbiota from healthy adults

Conditions: Colonic Diseases [C06.405.469.158]

Summary: prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea because of their ability to stimulate beneficial bacteria. in-vitro results showed a promising recovery of bifidobacteria combined with an increase of short chain fatty acids (scfa) upon galacto-oligosaccharides (gos) supplementation to amoxicillin-treated microbiota. as the microbiota is nowadays considered as a key factor in human health, a further understanding of the gut microbiota functioning in-vivo is essential. this understanding of the use of specific prebiotics may possibly be beneficial in the prevention or recovery of antibiotic-disturbed microbiota. as the effects of gos supplementation on the microbiota composition and activity from healthy adults receiving amoxicillin have never been tested in-vivo, the investigators propose the current study as a proof of principle. objective: to explore whether the promising effects of gos supplementation on the composition and activity of gut microbiota from healthy adults as found by in-vitro, can also be observed in-vivo. study population: 10 healthy men and women volunteers, 18 - 40 yr old


Eligibility criteria:
inclusion criteria: * age: 18-40 \* * bmi: 18.5-25 kg/m2 * stable weight over the last 6 months * western diet * availability of information about birth by caesarean section and breast-feeding * regular defecation (\~1day) * healthy as judge by the participant himself * having signed the informed consent form exclusion criteria: * smoking or drug use * pregnant (include planning to be or gave birth in the last 6 months) or lactating woman * using contraceptive pill * gastro-intestinal diseases (e.g. irritable bowel syndrome, inflammatory bowel disease) * traveling to an asian, african or south american country \< 6 months before the study * hypersensitivity or food allergy for products used in this study (e.g. lactose, penicillin) * having hepatic disease and renal failure * using medication other than paracetamol, acetylsalicylic acid (aspirin), hay fever, asthma * not willing to have the family doctor be informed about participation to the study. * antibiotic use \< 3 months before the study * more than 3 antibiotic treatments in the last 2 years. * probiotic or prebiotic use \< 1 month before the study\*

Keywords: intestinal microbiota composition intestinal microbiota activity gastro-intestinal complains
a 6-week study of pf-05175157 in type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of oral doses of pf-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * subjects who have been diagnosed with type 2 diabetes mellitus by a medical professional according to the american diabetes association guidelines. * hemoglobin a1c of ≥7 and ≤10.0% in subjects who are metformin-naive or have not taken metformin for 2 months or hemoglobin a1c of ≥6.5 and ≤9.5% in subjects who are metformin-naïve and are taking su or dpp-ivi which is washed off or taking metformin and are willing to discontinue metformin in a 8-week washout period. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine (other than t2dm and hypothyroidism), gastrointestinal, cardiovascular, pulmonary, hepatic, psychiatric or neurologic disease. * a waist circumference which makes fitting imto the bore of the mr scanner impossible. subjects with history of dry eye, known ocular or systemic disease that affect the sclera or cornea.

Keywords: type 2 diabetes mellitus pharmacodynamics safety & tolerability