Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of emodepside in adolescents and adults infected with hookworm

Conditions: Hookworm Infections

Summary: to compare the efficacy and safety of emodepside to that of albendazole (zentel®) in participants aged 12-60, inclusive, infected with hookworm.


Eligibility criteria:
inclusion criteria: * male or female adults aged between 12 and 60 years; * written and signed informed consent; * was examined by a study physician before treatment; * provided two stool samples at baseline; * hookworm epg \> 48 and at least two kato-katz thick smears slides with more than one hookworm eggs. exclusion criteria: * pregnant or lactating and/or planning to become pregnant within three months after drug treatment; * type 1 and/or 2 diabetes; * psychiatric disorders; * history of ophthalmological conditions; * presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment; * suffers from severe anaemia (hb \< 80 g/l); * received anthelminthic treatment within past four weeks; * attending other clinical trials during the study; * received strong cyp3a4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for cyp3a4 such as clarithromycin, erythromycin and rifampicin; * received strong p-gp inhibitors as well as concomitant treatments that are relevant substrates for p-gp such as clotrimazole and ritonavir. * participated in stage i trials of this protocol

Keywords: hookworm emodepside efficacy safety confirmatory stage soil transmitted helminth
brain and cognitive reserve

Conditions: Brain Ischemia

Summary: ischemic strokes are one of the leading causes of handicap and death in elderly people in france. cognitive reserve (cr) is an active model, defined as a function of lifetime intellectual activities and other environmental factors that explain differential susceptibility to functional impairment in the presence of pathology or other neurological insult. cr is estimated using variables for cognitive activity: years of education, professional status, socioeconomic status... furthermore, brain reverse (br) is a passive and quantitative model that depend on brain size and other quantitative aspects of the brain that explain differential susceptibility to functional impairment in the presence of pathology. firstly, volume and localization of ischemic strokes have a great impact on cr and br due to brain injury. on the other hand, cr influences the severity and the expression of cognitive diseases. the investigators realize a prospective study in order to assess the impact of cr and br on cognitive prognosis after a right middle cerebral artery ischemic stroke in elderly patients.


Eligibility criteria:
inclusion criteria: * ≥70 years old * right middle cerebral artery ischemic stroke * hospitalized in neurovascular unit of pierre wertheimer hospital between january 2015 to january 2016 exclusion criteria: * contraindication for mri * hemorrhagic stroke * aphasia

Keywords: ischemic stroke brain reserve cognitive reserve cognitive prognosis
study of personalized tumour vaccines and a pd-l1 blocker in patients with surgically resected pancreatic adenocarcino

Conditions: Pancreatic Cancer

Summary: this is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mrna tumour vaccine combined with adebrelimab (a pd-l1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.


Eligibility criteria:
inclusion criteria: 1. voluntarily signed the informed consent form and complied with protocols requirements. 2. patients with radiographically resectable primary pancreatic tumors with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (pdac) with macroscopic complete resection (r0 and r1). 3. pancreatic cancer surgical staging per ajcc 8th edition staging: t 1-3, n0-2, m0. 4. tumour specimen availability. 5. eastern cooperative oncology group (ecog) performance status of 0 or 1. 6. life expectancy ≥ 6 months. 7. surgical complications have recovered, or complications lower than clavien-dindo complication grade 3. 8. adequate marrow and organ function. 9. patients with fertility are willing to use an adequate method of contraception. exclusion criteria: 1. prior anti-pdac therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment. 2. unsuitable for immunotherapy assessed by the investigator. 3. plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment. 4. have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years. 5. active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment. 6. known or highly suspected history of interstitial pneumonia. 7. allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines. 8. prior malignancy within 5 years prior to study entry. 9. known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 10. known splenectomy history. 11. concurrent severe infection within 28 days prior to initiation of study treatment. 12. congenital or acquired immune deficiency. 13. active hepatitis b (hbv-dna≥1000iu/ml), hepatitis c (hepatitis c antibody positive, and hcv-rna higher than the lower limit of assay). 14. uncontrolled or severe cardiovascular disease. 15. other situations that are not suitable for inclusion in this study judged by investigator.
evaluation of the effectiveness of a continuing education program in community pharmacies

Conditions: Controlled Drug Dependence

Summary: preventable failures in the drug chain are related to drugs problems related use and are associated with medication errors (prescription, dispensing, administration or use by the patient or caregiver), including failures in the medication supply system (availability and quality). the controlled drugs are those that contain substances regulated by international conventions on drug control. they are important in various fields of medicine, such as pain management, obstetric emergencies, mental disorders such as the treatment of substance dependence, psychiatry and neurology. it has been defined as abuse of drugs the improper use of these for non-medical purposes, and associated with the use without medical prescription, which can produce addiction or psychic or physical dependence.

experimental study with random assignment of the staff pharmacist of pharmacies. the staff pharmacists admitted will be followed for 12 months (1 year). the study will make it possible to determine the effect of the continuing education program accompanied by information and communication technologies (ict).

Eligibility criteria:
inclusion criteria: 1. pharmacy staff working in pharmacy or drugstore, located geographically in the city of medellín and in the metropolitan area 2. that the owner works in the establishment inclusion exclusion: 1. pharmacy staff who do not agree to participate in the study

Keywords: dispensation health education pharmacovigilance pharmacists
comparing patient satisfaction of the abdomen after dieap procedure and conventional abdominoplasty

Conditions: Donor Site Complication; Satisfaction, Personal; Breast Cancer

Summary: the purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after dieap flap procedure with conventional abdominoplasty.

34 patients reconstructed with a dieap flap (dieap group) and 30 patients who had undergone a conventional abdominoplasty (ap group) were asked to complete two study-specific questionnaires. one questionnaire covered general and specific aspects concerning abdominal outcomes and morbidity. the other covered general outcomes such as satisfaction with surgery and change of body image, self-confidence, social and intimate relations. in addition, all patients performed an abdominal muscle function test.

Eligibility criteria:
inclusion criteria: * unilateral dieap flap, abdominoplasty exclusion criteria: * bilateral dieap flap, progressive cancer disease

Keywords: breast reconstruction; abdominoplasty; patient satisfaction
effect of surgery and radiation therapy on tc-99m sestamibi uptake patterns in molecular breast imaging

Conditions: Breast Cancer

Summary: the investigators hope to prove that radiation and surgical scarring does not result in changes that affect the mbi pattern 6-12 months after completion of treatment.

the study will allow us to evaluate whether surgery and radiation have persistent effects on the breast tissue with regards to whether and how such changes impact mbi images and to determine whether the inflammatory changes due to treatment resolve within 6-12 months of completing treatment.

Eligibility criteria:
inclusion criteria: * women who have planned surgical excision of a lesion or have had a baseline mbi study as part of another mbi research protocol who are within 6-12 months of completing breast surgery who are able and willing to return to mayo clinic for a follow up mbi study once the 6-12 month interval is complete. * women who plan bct for a malignant lesion or who are within 6-12 months of completing breast conserving treatment and have had a baseline mbi study as part of another mbi research protocol and are able and willing to return to mayo clinic for a follow up mbi study. exclusion criteria: * women who do not require surgical excision of a breast lesion or breast conserving treatment for breast cancer. * patients undergoing mastectomy. * women who are pregnant or lactating. * women who are taking hormonal contraception or hormone replacement therapy (vaginal estrogen is permitted), or have used these agents within the previous 3 months. * women who have received chemotherapy within the previous 6 months or receive chemotherapy as part of their cancer treatment. * men (due to the very low incidence of male breast cancer and the lack of any available data regarding the use of scintimammography or mbi in men). * women under the age of 18 years. * women unable to sit comfortably during image acquisition. * women who are unable to return to mayo clinic for a follow up mbi scan 6-12 months after surgical excision or 6-12 months after completing radiation therapy for breast conservation.

Keywords: breast mbi molecular molecular breast imaging dense breast tissue surgery radiation bct
the real clinical background of advanced colorectal cancer treatment situation survey

Conditions: Advanced Malignant Neoplasm; Colorectal Cancer

Summary: collect the real clinical background of advanced colorectal cancer c of china.

the primary objectives of this study is collect the real clinical background of advanced colorectal cancer treatment situation of china. the secondary objectives is the mutation of k-ras , targeting therapy , use present situation of cetuximab and liver metastases treatment situation of colorectal cancer patients.

Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed diagnosis of metastatic colorectal cancer. exclusion criteria: * patients with histologically or cytologically confirmed diagnosis other than metastatic colorectal cancer.

Keywords: advanced colorectal cancer targeted chemotherapy surgery radiotherapy
the effects of augmented and virtual reality gait training on patients with parkinson's disease

Conditions: Parkinson Disease

Summary: in parkinson's disease (pd) rehabilitation, the treadmill is used both in aerobic training and in gait training, as it provides more walking distance and can include body weight supported systems. it has been reported that the c-mill vr+ device, which is a treadmill system with augmented and virtual reality (vr) technology, improves gait adaptation and reduces the risk of falling in individuals with early to mid-stage pd. several publications augmented reality (ar) and vr applications in pd was focused on balance activities that do not include ambulation. in other studies in the literature, it was stated that further research are needed to better understand the effects of vr gait training on gait and balance in pd. it was also stated in these studies that the effects of vr gait training should be examined with more objective measurement methods. as a result, it is seen that there is a need for studies examining the effects of augmented and virtual reality trainings in pd with objective measurement methods. therefore, our study aimed to examine the effects of ar and vr gait training on gait and balance in individuals with early to mid-stage pd.

participants included in the study will randomly divide were randomly divided into 2 groups as intervention (ig, n=15) and control (cg, n=15). ig was given augmented and virtual reality gait training together with conventional training (ct). cg was given ct only. the training was applied 3 days per week for 6 weeks in both groups. all evaluations will be made by the same physiotherapist by meeting with participants face to face. inclusion in the research will be on a voluntary basis. as outcome measures, motor symptoms, balance, balance confidence and gait analyses were performed before and after intervention.

Eligibility criteria:
inclusion criteria: * being diagnosed with parkinson's disease by a specialist physician * being grade 1-3 on the hoehn and yahr staging scale * being 40 years or older; and * individuals agreed to be included in the study after adequate information was given about the study exclusion criteria: * people who standardised mini-mental state examination score \< 24 * having any cardiovascular, vestibular, musculoskeletal, or additional neurological disease.

Keywords: parkinson's disease exercise virtual reality balance gait
topical radial artery vasodilation

Conditions: Cardiac Catheterization; Spasm

Summary: the aim of the study is to facilitate radial artery access for cardiac catheterization. the investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery spasm. patients undergoing cardiac catheterization via the radial artery will be randomized to topical nitroglycerin + lidocaine versus placebo.

the aim of the study is to facilitate radial artery access for cardiac catheterization. the investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery spasm. patients undergoing cardiac catheterization via the radial artery will be randomized to topical nitroglycerin + lidocaine versus placebo.

Eligibility criteria:
inclusion criteria: * undergoing trans-radial cardiac catheterization exclusion criteria: * inability to receive nitroglycerin or lidocaine due to allergy or medication interactions

Keywords: radial artery spasm
developing and validating a patient-reported outcome instrument to monitor symptom management in pulmonary exacerbation in cf

Conditions: Cystic Fibrosis

Summary: the aim of this study is to develop a reliable and valid instrument to measure symptom management (experience and / or management strategies) during exacerbation episodes in cf patients. for the development a sequential exploratory two phase mixed-method study will be applied. in a first step, up to 25 cf patients will be interviewed: approximately 15 cf patients who experienced at least one episode of exacerbation in the past year and approximately cf 10 patients who are currently experiencing an exacerbation. the latter group will be interviewed up to 3 times during and after the antibiotic treatment. the instruments initial item list will be developed on basis of the interviews. up to five health professionals will rate the items' relevance. in a further step, items' clarity and relevance will be assessed by cognitive debriefing interviews with no more than 10 patients. in the last step (part iii), the instrument's preliminary construct and concurrent validity and reliability will be tested in a larger sample up to 150 patients experiencing exacerbation. patients will be asked to complete the newly developed questionnaires and a set of other questionnaires at one time point. for part iii, ethic approval will be asked at a later date (2015).


Eligibility criteria:
inclusion criteria: part i a \& ii: 1. patients with a confirmed diagnosis of cystic fibrosis 2. age ≥ 18 3. experience of at least one exacerbation during the last year requiring antibiotic treatment (oral or intravenous) part i b: 1. patients with a confirmed diagnosis of cystic fibrosis 2. age ≥ 18 3. experience of an acute exacerbation requiring antibiotic treatment (oral or intravenous) exclusion criteria: part i \& ii 1. do not speak or understand german 2. inability to verbally communicate 3. cognitive impairment

Keywords: patient reported outcome instrument
apposition assessed using optical coherence tomography of chromium stents eluting everolimus from cobalt versus platinum alloy platforms

Conditions: Coronary Artery Disease

Summary: the purpose of the trial is to directly compare the cobalt chromium platform everolimus-eluting stent, xience prime™, with the platinum chromium platform everolimus-eluting stent, promus element™, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography. hypotheses: 1. the alloy composition and strut design of a drug-eluting stent has a direct bearing on stent apposition measured using oct. 2. stent design and alloy composition have a direct influence on radial support and scaffold shrinkage.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-st elevation myocardial infarction 3. presence of one or more coronary artery stenosis \> 50% in a native coronary artery with a reference diameter ranging from 2.25 to 4.25 mm which can be covered with one or multiple stents 4. no limitation to the number of treated lesions or number of vessels according to the randomization group 5. de-novo native coronary disease with complex lesions involving: bifurcations, chronic occlusions \> 3 months, lesions \> 20mm in length or moderately/heavily calcified lesions of any length exclusion criteria: 1. known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, platinum chromium, everolimus, contrast material 2. acute st-segment elevation myocardial infarction 3. type a lesion including vessel angulation \<45 degrees 4. bypass graft 5. inability to provide informed consent 6. pregnancy 7. planned surgery within 12 months of pci unless dual antiplatelet therapy is maintained throughout the peri-surgical period 8. left ventricular ejection fraction \< 25% 9. serum creatinine \> 180mmol/l

Keywords: coronary artery disease stents optical imaging
bioequivalence and safety of vantobra and tobi in healthy subjects

Conditions: Cystic Fibrosis

Summary: this study will investigate the bioequivalence and compare the safety profiles following inhalation of vantobra to tobi nebulizer solution in healthy subjects. bioequivalence will be investigated based on the pharmacokinetic plasma profiles of vantobra nebulizer solution compared to tobi nebulizer solution.


Eligibility criteria:
inclusion criteria: * male or female healthy subjects of any ethnic origin * aged between 18 and 50 years of age * body weight of ≥50 kg and body mass index (bmi) between 18.5 and 29 kg/m2 * fev1 \> 90% of predicted * able to demonstrate correct inhaler use * written informed consent exclusion criteria: * history of clinically relevant allergies or idiosyncrasies to tobramycin or any other inactive ingredient(s) of the imp * any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis. * any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric or other diseases at screening * surgery of the gastrointestinal or respiratory tract which might interfere with drug absorption * history of malignancy within the past 5 years * history of orthostatic hypotension, faintings or blackouts * acute or chronic viral, bacterial or fungal airway infections, including laryngeal infections, mouth and throat infections, and hoarseness; * other clinically relevant chronic or acute infectious illnesses * clinical chemical, hematological or any other laboratory parameters clinically relevant outside the normal range

Keywords: bioequivalence auc cmax
pharmacogentic screening of coumarine based oral anticoagulant using next generation seguencer

Conditions: Thrombosis

Summary: as drug response is a complex trait in the majority of cases using an optimal starting dose for an individual may reduce the time taken to reach a stable inr, and reduce the risk of having either a high inr (with a risk of bleeding) or a low inr (with a risk of thrombosis)

the results of this project will benefit in (1) identification of novel features or mutation types in warfarin resistance genomes. (2) to determine whether other polymorphisms in noncoding regions or their unique haplotype combinations contribute to the variability in the maintenance dose of warfarin, and (3)personalization of the drug and deciding the correct dose from the start.

Eligibility criteria:
inclusion criteria: * patients with thrombosis and warfarin resistance exclusion criteria: * less than 18 years