Kornimate/medical-research-clean huggingface dataset:
study to assess mechanisms in peripheral tissue innervation for fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. the investigators will then use this information to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (duloxetine) and others do not. duloxetine affects certain chemicals in the brain called neurotransmitters. an abnormality in these chemicals is thought to be related to fibromyalgia. duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (snri), similar to some drugs used for the treatment of depression. duloxetine is approved for sale in the united states by the food and drug administration (fda) for the treatment of fibromyalgia.


Eligibility criteria:
inclusion criteria: * female age 18-70 * fulfill the acr criteria for fms (wide spread pain for at least 3 months and pain in at least 11 of 18 tender point sites. * vas score greater than 40mm at screening and randomization visits exclusion criteria: * history of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator * allergy to lidocaine * unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study. * women who are pregnant, breastfeeding or trying to become pregnant * active cancer within the previous two years except treated basal cell carcinoma of the skin * presence of dermatological or neurological condition that could interfere with the interpretation of the skin biopsy or qst * co-existing conditions that can produce chronic widespread pain * presence of uncontrolled or severe depression * patients with pending worker's compensation, worker's compensation, any ongoing litigation or disability claims due to fibromyalgia or any other source of pain, or currently receiving monetary compensation as a result of any of the above. * presence of uncontrolled narrow-angle glaucoma
prevention of chemotherapy induced nausea and vomiting in breast cancer patients.

Conditions: Emesis

Summary: for breast cancer patients receiving chemotherapy regimens, the use of a validated emesis (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting) control compared with "standard" anti-emetic regimen. the risk calculator has the potential to provide more individualized anti-emetic regimen by decreasing the use of toxic/costly anti-emetics in patients at low risk and possibly more importantly enhancing the appropriate anti-emetic regimen in patients at high risk.


Eligibility criteria:
inclusion criteria: newly diagnosed invasive breast cancer (stage i-iii) scheduled to receive neoadjuvant or adjuvant intravenous anthracycline with cyclophosphamide-based chemotherapy; able to consent and fill study forms exclusion criteria: received previous chemotherapy symptoms of nausea or vomiting at baseline (disease related) on chronic anti-emetic therapy on daily corticosteroids prior to initiation of chemotherapy allergic to steroids, 5ht3 or nk-1 uncontrolled diabetes medical or psychiatric illness that would interfere with patients' ability to complete the diary

Keywords: nausea vomiting
an observational study of erlotinib plus gemcitabine in patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with erlotinib plus gemcitabine. further, clinical effectiveness, efficacy and safety will be assessed. data will be collected for 12 months.


Eligibility criteria:
inclusion criteria: * adults, age \>= 18 years * patients with metastatic pancreatic cancer where investigators have decided to give combination therapy of erlotinib and gemcitabine according to summary of product characteristics (smpc) exclusion criteria: * contraindications for erlotinib according to summary of products characteristics (smpc)
valproic acid in childhood progressive brain tumors

Conditions: Pediatric Brain Tumor; Glioma; Anaplastic Astrocytoma; Medulloblastoma; Glioblastoma

Summary: the study investigates valproic acid added to radiation and temozolomide therapy (standard of care) for progressive or recurrent pediatric brain tumors.

patients with progressive or recurrent pediatric brain tumors are administered valproic acid, an hdac inhibitor, along with standard of care therapy (radiation and temozolomide) for induction therapy. thereafter, patients will be able to continue on valproic acid and temozolomide therapy as long as the combination is well tolerated and the tumor is not progressing.

Eligibility criteria:
inclusion criteria: * subject, parent, or guardian willing and able to give informed consent * recurrent or progressive pediatric brain tumor, with mri evidence of disease * age at first diagnosis of brain tumor 1-21 years old * lansky or karnofsky performance score of at least 50 at diagnosis exclusion criteria: * pregnancy * prior intolerance to valproic acid * history of use of temozolomide * use of enzyme inducing anticonvulsant medications (see appendix b) * known urea cycle disorder (e.g. ornithine transcarbamylase deficiency)

Keywords: glioma glioblastoma pediatric child brain tumor astrocytoma medulloblastoma pnet
effect of habit-ile on the body function and structures of children with cerebral palsy

Conditions: Cerebral Palsy

Summary: there is strong evidence that recent intensive interventions based on motor skill learning principles are efficient on functional and neuroplastic changes of children with cerebral palsy (cp). besides, impaired selective voluntary motor control (svmc) is one of four interrelated neuromuscular deficits in children with cp and is listed in the icf-cy (international classification of functioning, disability and health for children and youth) under body functions. additionally, impaired svmc has been shown to negatively affect the motor and functional abilities of children with cp. however, there have been little scientific investigations on the trainability of svmc according to therapeutic interventions. therefore, the study aims to evaluate the effect of hand and arm bimanual intensive therapy including lower extremities (habit-ile) on the body function and structures of children with bilateral and unilateral cerebral palsy, including svmc and brain structure.


Eligibility criteria:
inclusion criteria: * diagnosed bilateral and unilateral cerebral palsy, * macs levels from i to iv, * gmfcs levels from i to iv, * ability to follow instructions and complete testing. exclusion criteria: * orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period. * unstable seizure * severe visual or cognitive impairments likely to interfere with intervention or testing session completion

Keywords: motor skill learning body function body structure selective voluntary motor control brain structure neuroplasticity intensive therapy cerebral palsy
colistin pharmacokinetics in critically ill patients during extended dialysis

Conditions: Infection Due to Resistant Bacteria; Acute Kidney Injury

Summary: the emergence of multidrug-resistant bacteria has recently renewed interest in colistin. data on dosing in critically ill patients undergoing extended dialysis are missing. the aim of this study is to determine the pharmacokinetics of colistin during extended dialysis in critically ill patients and to provide dosing guidelines for this drug.

due to the lack of new antibiotics for the treatment of critically ill patients with multidrug-resistant bacteria, interest in "old" antibiotics like colistin re-emerged. lastly, colistin is administered more frequently especially in cases of infections due to pseudomonas aeruginosa, klebsiella pneumoniae or acinetobacter baumanii in intensive care units (icus) around the world. however, dosing of colistin in critically ill patients undergoing renal replacement therapy is based on scarce data. the aim of this study is to evaluate single and multiple-dose pharmacokinetics of both colistin and its inactive prodrug colistin-methanesulfonate (cms) in critically ill patients with acute kidney injury (aki) undergoing extended daily dialysis (edd). the investigators perform a prospective clinical pharmacokinetic single- and multiple-dose study in the medical and surgical icus of the hannover medical school. icu patients with anuric aki being treated with edd and receiving i.v. colistin are studied on day 1 and (if possible) on day 5-9 of treatment. a loading dose of 6 mio iu colistin ís administered 8 hours prior to the edd session followed by 3 mio iu every 8 hours. colistin plasma concentration levels as well as dialyzer clearance rates are measured at different time points.

Eligibility criteria:
inclusion criteria: * indication for colistin therapy * acute kidney injury akin iii with need for renal replacement therapy exclusion criteria: * participation in other studies * pregnancy * known colistin allergy or other contraindications for colistin therapy
role of transcranial direct current stimulation (tdcs) in patients with attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to determine whether transcranial direct current stimulation (tdcs) is effective in the treatment attention deficit hyperactivity disorder (adhd). randomized, double-blind controlled clinical trial subjects adults (between 18 and 59 years of age) with adhd who meet the inclusion criteria and who agree to participate in the study will recruit from advertisements and clinical referrals to a prodah active tdcs anode - right dlpfc cathode - left dlpfc electric current is 2ma - current is applied for 20 min sham tdcs same assembly is used current is applied for 30 sec both groups 5 stimulation sessions on consecutive days following tools at baseline, 1st week, 2 st week, 3st week and 4st week adult adhd self-report scale (asrs) sds - sheehan disability scale cgi - clinical global impression

randomized, double-blind controlled clinical trial subjects adults (between 18 and 59 years of age) with adhd who meet the inclusion criteria and who agree to participate in the study will recruit from advertisements and clinical referrals to a prodah active tdcs anode - right dlpfc cathode - left dlpfc electric current is 2ma - current is applied for 20 min sham tdcs same assembly is used current is applied for 30 sec both groups 5 stimulation sessions on consecutive days following tools at baseline, 1st week, 2 st week, 3st week and 4st week adult adhd self-report scale (asrs) sds - sheehan disability scale cgi - clinical global impression

Eligibility criteria:
inclusion criteria: * age between 18 to 45 years * established diagnosis of adhd according to dsm v through clinical interview and diagnostic criteria applied by trained physicians. * asrs greater than 21 in part a or b * consent form signed * ability to read and interpret the self-applicable scales exclusion criteria: * medication change in the last month * the following comorbidities: 1. depressive episode with bdi greater than 9 2. anxiety disorder with greater than 15 bai 3. bipolar disorder with depressive symptoms, manic or hypomanic in the last 6 months 4. schizophrenia and other psychotic disorders 5. autism 6. dependence of substances 7. mental retardation or dementia * epilepsy or anticonvulsant use * clinically significant medical condition * contraindications for tdcs (metallic implants, cranioencefálica important anatomical change ...) exclusion criteria retrospectively: two fouls in a row dating to stimulation or three fouls in total days.
trial for people with established type 2 diabetes during ramadan

Conditions: Type 2 Diabetes

Summary: dual therapy with metformin and liraglutide is more effective at helping people with established type 2 diabetes mellitus (t2dm) observing ramadan achieve a triple composite endpoint of weight reduction and/or maintenance and improved haemaglobina1c (hba1c) and no severe hypoglycaemic events.

participants in the control arm will essentially continue with their standard routine care and those in the intervention groups will either receive liraglutide in addition to metformin or those on dual therapy will switch from their sulphonylurea/pioglitazone to liraglutide and continue with metformin. informed consent and baseline data will be collected 4-8 weeks prior to the start of ramadan. this will allow time for a run in period for the titration of liraglutide prior to the fasting period. ramadan is followed by eid-al-fitr a 3-day islamic holiday that marks the end of this holy month. tradition includes amongst early morning prayers/celebration through feasting. therefore, participants will be invited to attend the first follow-up after this event (between weeks 2 - 4) and then at 12 weeks post ramadan. randomisation will not be revealed until after the baseline data have been collected.

Eligibility criteria:
inclusion criteria: * individuals ≥ 18 years old with established t2dm on metformin only * or dual therapy of metformin plus a sulphonylurea or pioglitazone * with a hba1c between 7 - 11 % if on monotherapy and between 6.5 - 12% if on dual therapy exclusion criteria: * are pregnant or breast feeding * suffer from terminal illness * have significant renal or liver impairment * are unable to provide informed consent * have severe and enduring mental health problems * are not primarily responsible for their own care * are receiving insulin therapy * type 1 diabetes

Keywords: diabetes liraglutide ramadan fasting
a relative bioavailability study of citalopram 40 mg tablets under fed conditions

Conditions: Healthy

Summary: the purpose of this study is to evaluate and compare the relative bioavailability, and therefore the bioequivalence of two formulations of citalopram after a single dose administration under fed conditions.

study type: interventional study design: randomized, 2-period, 2-sequence, crossover design. official title: single dose crossover comparative bioavailability study of citalopram 40 mg tablets in healthy male volunteers/fed state further study details as provided by actavis elizabeth llc: primary outcome measures: rate and extend of absorption

Eligibility criteria:
inclusion criteria: 1. availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject. 2. males aged from 18 to 50 years with a body mass index (bmi) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report. 3. clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the crf. 4. healthy according to the laboratory results and physical examination 5. normal cardiovascular function according to ecg. 6. subjects should be non- or ex-smokers. exclusion criteria: 1. significant history of hypersensitivity to citalopram or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs. 2. presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects. 3. presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease. 4. use of mao inhibitors within 14 days of day 1 of the study 5. maintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease. 6. any clinically significant illness in the previous 28 days before day 1 of this study. 7. use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.). 8. participation in another clinical trial in the previous 28 days before day 1 of this study. 9. donation of 500 ml or more of blood (canadian blood services, hema-quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study. 10. positive urine screening of drugs of abuse. 11. positive results to hiv, hbsag or anti-hcv tests 12. history of fainting upon blood sampling

Keywords: bioequivalence citalopram healthy subjects
smartphone app for cancer medication adherence

Conditions: Carcinoma; Cancer

Summary: for this current proposal, the investigator will conduct a single-center prospective non-randomized pilot interventional study in patients with any stage and type of cancer who are either taking at least one oacd or are taking at least one oral medication for chronic condition management in conjunction with any cancer treatment. primary objective: to determine the feasibility of using a medication reminder application (medisafe app) to improve medication adherence in cancer patients either receiving oral anticancer agents (oacds) or receiving oral medications for chronic disease management (non-oacds) in conjunction with non-oral cancer treatment. secondary objectives: to compare and characterize medication adherence before and after the 12-week intervention using the voils extent of adherence scale and the medisafe app. also to determine the acceptability, utility and patient engagement with the app, to evaluate changes in healthcare related quality of life before and after the intervention, and to explore behaviors, knowledge, attitudes and beliefs related to medication adherence using a semi-structured interview delivered over the telephone.

many patients with cancer experience frustration with the large number and complex scheduling of their medications. this study will help find out how much "pill burden" exists in patients with cancer, and how a smartphone app can help patients take medications as providers prescribe. results of this study may help figure out the best way to help patients manage medications in the future.

Eligibility criteria:
inclusion criteria: * any type/stage cancer * patients must be taking either: * at least one oral anti-cancer drug (oacd) or * at least one oral medication (non-oacd) for management of a chronic condition in addition to receiving non-oral cancer treatment * patients must have access to a mobile phone or tablet that can download the medisafe app. (ie apple/android) * subjects must be able to complete self-administered questionnaires in english or spanish. * co-enrollment in trials involving pharmacologic therapy is allowed. exclusion criteria: * inability to provide informed consent

Keywords: any stage
the comparative clinical performance of two daily disposable toric contact lenses

Conditions: Astigmatism

Summary: this study aimed to compare the clinical performance of two daily disposable toric contact lenses.

this was a multi-center, randomized, participant-masked, bilateral study controlled by cross-comparison. participants were assigned to either lens type in random sequence. lenses were worn on a daily disposable wear schedule. follow-up visits for each lens were performed after 1 week of wear.

Eligibility criteria:
inclusion criteria: 1. they are at least 18 years old and have the capacity to volunteer. 2. they understand their rights as a research subject and are willing and able to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they currently wear soft contact lenses or have done so in the past two years. 5. they have a spherical component of their contact lens prescription between plano to - 6.00ds (inclusive). 6. they have a cylindrical component of their contact lens prescription between -0.75dc and -2.50dc (inclusive). 7. they can be satisfactorily fitted with the study lens types. 8. at dispensing, they could attain at least 0.20 logmar distance high contrast visual acuity in each eye with the study lenses within the available power range. 9. they are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). 10. they own a wearable pair of spectacles. 11. they agree not to participate in other clinical research while enrolled on this study. exclusion criteria: 1. they have an ocular disorder which would normally contra-indicate contact lens wear. 2. they have a systemic disorder, which would normally contra-indicate contact lens wear. 3. they are using any topical medication such as eye drops or ointment. 4. they are aphakic. 5. they have had corneal refractive surgery. 6. they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. they are pregnant or breastfeeding. 8. they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 9. they have eye or health conditions including immunosuppressive or infectious diseases, which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. 10. they are currently wearing one of the study contact lenses. 11. they have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
microcirculation in spontaneous breathing trial

Conditions: Critically Ill

Summary: weaning ventilator support in critically ill patients is crucial. both delayed extubation and unexpected early reintubation are harmful to the patients. weaning parameters and spontaneous breathing trial are used to investigate the indication and predict the successful extubation. hemodynamic stability and physical reserve are important indicators as well. microcirculation parameters are known to be more sensitive to the change of hemodynamic status than macrocirculation parameters. we hypothesize that the change of sublingual microcirculation before and after spontaneous breathing trial is different between the the patients with successful extubation and the patients with failed extubation. thus, this study measures sublingual microcirculation in patients receiving spontaneous breathing trial and record the extubation status (successful or failed). the microcirculation parameters before and after spontaneous breathing trial are compared between the the patients with successful extubation and the patients with failed extubation.


Eligibility criteria:
inclusion criteria: * critically ill patients received ventilator longer than 12 hours * ready for spontaneous breathing trial * gcs coma score equal or higher than 8 exclusion criteria: * aged less than 20 years * patient with tracheostomy * patient and patients' relatives are non-native speakers

Keywords: ventilator weaning microcirculation