Kornimate/medical-research-clean huggingface dataset:
study with modafinil in patients treated with docetaxel-based chemotherapy for metastatic breast or prostate cancer (motif)

Conditions: Prostatic Neoplasms; Breast Cancer

Summary: the primary objective is: * to determine the efficacy of modafinil in the reduction of fatigue in patients with metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy the secondary objectives are: * to determine the effect of modafinil on quality of life (qol) during docetaxel-based chemotherapy * to determine the effect of modafinil on patients physical activity level, functional status, number of chemotherapy cycles tolerated, sleep disturbance and depression, during docetaxel-based chemotherapy * to investigate the impact of tumour type, patient physical activity level, functional status, sleep disturbance and depression on the efficacy of modafinil at improving fatigue and quality of life during docetaxel-based chemotherapy. * to determine the safety and tolerability of modafinil during docetaxel-based chemotherapy


Eligibility criteria:
inclusion criteria: * treatment with q3w (every three weeks) docetaxel-based chemotherapy for metastatic breast or prostate cancer at a minimum dose of 50 mg/m2 * completed at least two cycles of chemotherapy and intention to treat the patient with at least two further cycles of docetaxel-based chemotherapy * fatigue \> or = to 4 on the md anderson symptom inventory fatigue assessment scale during the previous docetaxel chemotherapy cycle * sphere somatic (soma) subscale score \> or = to 3 * worsening of fatigue after commencement of docetaxel chemotherapy * haemoglobin (hb)\> or = to 10 g/dl within two weeks before randomisation exclusion criteria: * unable to complete the md anderson symptom inventory fatigue assessment scale or functional assessment of chronic illness therapy-fatigue quality of life survey * require docetaxel chemotherapy dose reduction to less than 50 mg/m2 * history of chronic fatigue condition * uncontrolled hypertension (blood pressure \> or = to 150/90 mm hg * known hypersensitivity / intolerance to modafinil or any of the excipients * pregnant women * psychological, familial, sociological, or geographical conditions that do not permit treatment or medical follow-up and / or prohibit compliance with the study protocol * any serious concomitant illness that, in the opinion of the investigator, would preclude a patient from participating in the study * non-english speaking the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
novel triple-dose tuberculosis retreatment regimens: how to overcome resistance without creating more

Conditions: Tuberculosis, Pulmonary

Summary: drug-resistance is a major challenge for tuberculosis (tb) care programs. the new who guideline recommends adding levofloxacin in previously treated patients with isoniazid-resistant rifampicin-susceptible tb. the investigators believe that such a retreatment regimen may result in acquired resistance to fluoroquinolone, the core drug of multidrug-resistant tb (mdr-tb) regimen, and thus threaten the effectiveness of the fluoroquinolone-based mdr-tb treatment regimen. therefore the investigators propose to study if regimens strengthened by using high-dose first-line drugs, either a triple dose of isoniazid or a triple dose of rifampicin, are non-inferior to the who recommended levofloxacin-strengthened regimen. if one of both high-dose regimens would be non-inferior, it could replace the levofloxacin-strengthened regimen.


Eligibility criteria:
inclusion criteria: * all newly registered patients with smear-positive recurrent pulmonary tb * adults as well as children (no age limit) * able and willing to provide written informed consent exclusion criteria: * patients transferred to a health facility not supported by damien foundation will be excluded. this includes patients diagnosed with hiv/tb-coinfection.
peripheral artery disease (pad) : its effects on bone

Conditions: Bone; Peripheral Artery Disease

Summary: prevalence of pad and osteoporosis (op) both get higher with age. clinical and epidemiologic evidence have showed an increased cardiovascular risk in op and bone loss and fragility fractures in patient with cardiovascular disease. this study will examine the relationship between vascular disease in legs and sbmd and vbmd at trabecular and cortical sites and bone microarchitecture.

the primary goal of our study is to determinate if presence of pad is associated with lower sbmd and vbmd values at the tibias, assuming that bmd should be more alterate in the predominant vascular impairement site. our secondary objectives are to : * determine if severity of pad quantified by ankle brachial index abi is associated to a decrease of bmd values defined by t-score at the left hip, spine and legs, but also with volumetric values, assessed by hrpqct at the non dominant radius and at both tibias. * determine the prevalence of osteoporosis in our population * to evaluate the relationships between ; * lipids and bone parameters * vit d and parathormone with pad severity * levels of physical activity and both vascular and bone impairments

Eligibility criteria:
inclusion criteria: * pad patients defined by an ankle brachial index \< 0.9 * written consent * patient affiliated with a social security organism exclusion criteria: * age \< 18 years * pregnancy or risk of pregnancy * patients under guardianship * patient with known pad who had been previously treated by surgery or endovascular pathway

Keywords: bone osteoporosis peripheral artery disease hrpqct
evaluation of the parent centre's positive parenting skills training.

Conditions: Parenting Behaviour; Child Behaviour Problems

Summary: the purpose of this study is to determine whether the parent centre's positive parenting skills training (ppst), a parenting programme being delivered in south africa, is effective in improving parenting, and child behaviour related outcomes.

the evaluation of the ppst will assess both the fidelity of the intervention's implementation, as well as the outcomes of the programme in a randomised controlled trial. programme facilitators and intervention group participants will provide data for the former. for the outcome evaluation, two types of participants will be recruited who will provide self-report data: primary caregivers (n = 80) and where possible another adult living in the home with this primary caregiver and their selected child (n = 60). this "other adult" data will serve to verify the primary caregivers' self-report data. both participants will provide demographic information, and report on parenting behaviour and child behaviour. their data will be analysed separately in intention to treat analyses and secondary analyses which consider moderators of programme effectiveness.

Eligibility criteria:
this study will include two types of participants: (1) primary caregivers and (2) another adult. both have separate eligibility criteria. inclusion criteria: 1. primary caregivers (the person most responsible for the well-being of a child) * has a child between the ages of 5-12 years * looks after this child for a minimum of four nights a week * indicated interest in the programme and expressed willingness to enrol in the study 2. another adult in the household (if available) * lives with the index child (selected by the formerly mentioned caregiver) for at least four nights a week exclusion criteria: (1) primary caregiver - has already participated in the parent centre's positive parenting skills training or the parenting and leadership training

Keywords: parenting programme randomised controlled trial south africa positive parenting child behaviour problems implementation fidelity low- and middle-income country
the effect of weight loss on psoriasis area severity index in adult psoriasis patients

Conditions: Psoriasis; Obesity

Summary: the purpose of this study is to evaluate the effect that weight loss has on the severity of psoriasis in obese subjects. fifty obese (bmi equal to or greater than 30) patients with moderate to severe plaque psoriasis will be enrolled in a weight loss intervention program. the severity of their psoriasis will be reevaluated at month 3 and month 6 of the program to determine what effect weight loss has had on their psoriasis. serum tnf-alpha will be measured at month 0 and month 6. the hypothesis that will be tested is that weight loss will lead to a significant improvement in the severity of psoriasis and a reduction in tnf-alpha levels.


Eligibility criteria:
inclusion criteria: * \>18 years of age * a body mass index (bmi) \>/= 30 * subject has plaque psoriasis * a psoriasis area severity index (pasi) score \>/= 10 or a total body surface area (bsa) affected by psoriasis \>/= 10% * capable of reading, understanding, and signing a consent form * females of childbearing potential must have negative urine pregnancy test on day 0, and agree to a medically effective method of birth control (as determined by the investigator) exclusion criteria: * already participating in a study for weight loss or a study of other psoriasis treatments * if they are on systemic therapy for their psoriasis * female subjects who are pregnant or planning to become pregnant * patients with a history of anorexia nervosa, bulimia, or other diseases that would make a weight loss program a risk to their health * subjects unable to comply with study protocol

Keywords: psoriasis obesity
u-poem vs co2-poem

Conditions: Esophageal Motility Disorders

Summary: multicenter randomized trial comparing post-procedural pain intensity after per-oral endoscopic myotomy (poem) between two types of standard of care insufflation methods (co2 vs underwater). poem is routinely performed under carbon dioxide insufflation (co2-poem) as this gas is more rapidly absorbed than air, which has been shown to reduce gas-related complications. water immersion for luminal distension of the gi tract as opposed to carbon dioxide insufflation has been shown to be associated with improved patient satisfaction, safety profile and even higher detection of polyps during colonoscopy in randomized trials aim 1. the primary aim is to compare post-procedural pain following u-poem vs. co2-poem. aim 2. compare the proportion of patients that require post-procedural admission for pain management. aim 3. compare the need for analgesic medications for pain control in patients undergoing u-poem vs. co2-poem. aim 4. compare technical and clinical success between u-poem vs. co2-poem. technical success is defined as successful completion of the procedure whereas clinical success will be defined as an eckardt score ≤ 3 at the time of follow-up. aim 5. compare and evaluate procedural characteristics between the two groups. 1. compare procedural time between u-poem and co2-poem. 2. compare the mean number of coagulations with hemostatic forceps for active intraprocedural bleeding and the mean number of times in which a device besides an electrosurgical knife was required for prophylactic ablation of vessels. 3. adverse event rate (i.e. bleeding, perforation).


Eligibility criteria:
inclusion criteria: * age 18 years or older * ability to provide informed consent * patient scheduled to undergo poem procedure for esophageal dysmotility exclusion criteria: * inability to provide informed consent * any contraindication to poem as per the endoscopist at the time of endoscopic evaluation (example: esophageal stricture, malignancy). * any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy

Keywords: poem u-poem co2-poem esophageal motility
laparoscopic nissen versus anterior partial fundoplication

Conditions: Gastroesophageal Reflux

Summary: the most widely used operative technique for gastroesophageal reflux is total fundoplication where the gastric fundus is sutured around the distal esophagus like a wrap. this operation effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related to over-competence of the gastroesophageal junction. 40% of the operated patients experience increased flatulence and 20% dysphagia. anterior fundoplication is an alternative technique where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of the front wall of the esophagus is covered with fundus. an anterior fundoplication is un attempt to create a more physiologic reflux control and less functional problems postoperatively. the aim with this study is to compare the results postoperatively, both short time and long time results.

aim: to establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques. the secondary aims are to establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications. method: all patients operated on for reflux disease in lund, malmö,trollättan and kalmar are randomised between the two operations. postoperatively, telephone interview is performed weekly the first two months. one year and ten years postoperatively. the patients are investigated with endoscopy, esophageal manometry, 24 hour ph-monitoring and symptom evaluation.

Eligibility criteria:
inclusion criteria: * age:18-65 years. * good results of ppi treatment (\<3 months) resulting in reduced heart burn and acid regurgitations. * gastroesophageal reflux disease as evidence by gastroscopy and ph-monitoring. exclusion criteria: * previous surgery on the stomach * patients with ibs (criteria rom ii) * severe disease, for example diabetes mellitus, cardiopulmonary disease or renal disease, that would influence outcome measurement * patients with active ulcer disease * paraesophageal hernia * patient that are incapable to understand the study information (for example mentally disorder, drug abuse)

Keywords: gastroesophageal reflux fundoplication surgical procedures
mycompass in a swedish context - an automated self-help intervention targeting mental health problems

Conditions: Mild Depression; Anxiety State; Sleep Disturbance; Stress, Psychological

Summary: the study present findings from the implementation of mycompass, a fully automated self-help intervention of australian origin for mild to moderate anxiety and depression, in a swedish context. the study also investigates the usage of a specially designed research platform aimed at handling informed consent and online surveys.


Eligibility criteria:
inclusion criteria: * swedish resident * valid e-mail address * 18 years old or older * phq-9 score of 5-20 * gad-7 score of 5-15 exclusion criteria: * suicidal thoughts
medical economics of urinary pca3 test for prostate cancer diagnosis

Conditions: Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination

Summary: the ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis of prostate cancer, the first human cancer and second leading cause of cancer death. overall, in more than half of cases, prostate biopsies performed in search of a prostate cancer are negative. in this population, there is no consensus recommendation on how to care, leading to repeated invasive biopsies, potential sources of complications. the pca3 urine test (progensatm, genprobe) is an innovative diagnostic tool to predict the positivity of prostate biopsies, especially in patients who had at least one negative biopsy. proposed in clinical practice in france as a commercial kit, it is expensive and is not covered by health insurance. it is therefore essential to assess the medical and economic impact of its introduction into medical practice. the investigators propose to set up a study of high standard of proof, multicenter, based on recruitment of patients treated in hospitals. this working hypothesis is that the availability of the pca3 test results would reduce the number of invasive biopsies performed incorrectly in patients already had at least one negative biopsy, thus improving the diagnostic strategy of prostate cancer.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 year-old * patients who undergo prostate biopsy for increased serum psa and/or abnormal digital rectal examination * patients who gave informed consent exclusion criteria: * no informed consent * medical history of or current significant prostate cancer * medical history of or current extra-prostatic cancer * high risk of loss of follow-up * clinically obvious prostate cancer (clinical stage ≥ t3, psa ≥ 50 ng/ml, lymph node involvement, osteolytic bone metastases)

Keywords: diagnosis prostate cancer urine medical economics
cohort of children with severe cerebral palsy

Conditions: Orthopedic Complications in Cerebral Palsy

Summary: " cohort cp " is a multicentre cohort study, initiated by the hospices civils de lyon in september 2009. population targeted are children with bilateral cerebral palsy, level gmfcs iv or v, aged from 2 to 10 years at inclusion. they are followed-up during 10 years, at the rhythm of 1 visit per year. at each visit are collected clinical, orthopaedic, radiological and environmental data. the primary objective is to establish the incidence of orthopaedic complications (scoliosis and hip joint) depending on patients' age. secondary objectives are to describe the sequences over time of these complications and the related pain, to explore the impact of nutrition, surgery, asymmetric postures and environmental factors, and to describe the medical and rehabilitative follow-up of these patients. 385 patients are expected by the end of 2020. we expect of this long-term follow-up to gain tools that permit to improve patient's care and patient's quality of life, by putting in place preventing actions and adapted treatments related to their own pathologies.


Eligibility criteria:
inclusion criteria: * children aged from 2 to 10 years at inclusion, * with bilateral cerebral palsy, * grade iv or v of the gmfcs. * affiliated with the french healthcare system. * oral consent of the parents obtained. exclusion criteria: - progressive pathology.

Keywords: cohort cerebral palsy children pain orthopedic complications epidemiology
a 2-year study of patients with schizophrenia who are treated with long-acting injectable risperidone.

Conditions: Schizophrenia

Summary: the purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.

controlled clinical trials for treating schizophrenia often involve selected patients with common characteristics. it is recognized that schizophrenia are much more diverse than those in the clinical setting, and that physician's prescribing practices may vary. the objective of the study is to examine treatment practices for adult schizophrenic patients by their own physicians, and to assess patient outcomes when treated with long-acting risperidone injection. this is a 2-year, prospective, multi-center, longitudinal, observational study in adults with schizophrenia. physicians will determine the appropriate treatment for their patients, according to their usual practice. patients starting treatment with long-acting risperidone injections and meeting all the study criteria may enroll in the study. patients will continue their treatment according to usual care by their physicians. patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (e.g., emergency room visits, hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. safety will be monitored throughout the study. a dose of 25, 37.5 or 50 mg of risperidone, administered every 2 weeks by intramuscular injection.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia * long-term use of antipsychotic medication and taking any oral antipsychotic for 4 weeks before the study * stable with respect to disease symptoms and other medical conditions * if female, using birth control. exclusion criteria: * at risk to self or others * use of injectable antipsychotics within the past 6 months, of clozapine, or of investigational drugs within 30 days * considered to be resistant to treatment * pregnant or breast-feeding * not using birth control.

Keywords: schizophrenia acceptance motivational enhancement therapy long-acting risperidone intramuscular injection treatment guidebook gain acceptance approach
tumor antigen-sensitized dc vaccine for colorectal cancer liver metastases

Conditions: Carcinoma; Colorectal Cancer

Summary: the aim of this study is to explore the safety and efficacy of tumor antigen-sensitized dc vaccine in postoperative adjuvant treatment of r0 excision colorectal cancer liver metastases.


Eligibility criteria:
inclusion criteria: pathologically confirmed diagnosis of colorectal cancer； karnofsky performance status 0-1; patients with tumors identified by pathologic immunohistochemistry as pmmr or by genetic testing as mss/msi-l; imaging diagnosis of stage iv, resection of both primary and metastatic tumors and had ned status after surgery; with a high risk of recurrence, such as liver metastasis crs score \>3 or successful conversion therapy; multiple peritoneal metastases after cc0; function of the main organs is normal; edition patient's written informed consent exclusion criteria: tumor emergencies; abnormal coagulation function; contagious diseases, such as hiv, hbv, hcv infection; mental disorders; concomitant tumors; immunological co-morbidities
the impact of chokeberry bioproducts on metabolic parameters and antioxidant potential

Conditions: Diet, Healthy; Diabetes Mellitus; Hypertension; Obesity; Hypercholesterolemia

Summary: chokeberry can be used both in the prevention and treatment of various metabolic disorders due to its high antioxidant properties. the study assessed for the first time the synergistic effect of chokeberry juice and chokeberry fiber on selected metabolic and anthropometric parameters. 102 people (67 women and 35 men) took part in the intervention study. after 8 weeks of intervention with chokeberry juice and another 4 weeks of intervention with chokeberry juice and fiber, a change in waist circumference, blood pressure, glucose, glycated hemoglobin, ldl cholesterol, aspartate transaminase (ast) and the level of antioxidant potential was observed.


Eligibility criteria:
inclusion criteria: * age 30-65 years, * low or moderate physical activity. exclusion criteria: * age \ 65 years, * high physical activity, * obesity (class ii), * diabetes (all types), * gastric ulcer, * acute or chronic gastritis, * intestinal diseases, including inflammatory bowel diseases and functional intestinal disorders, * taking hypoglycemic, lipid-lowering, immunosuppressive, anticoagulant and antihypertensive drugs, use of steroid therapy, * high physical activity, * pregnancy, * breastfeeding.

Keywords: chokeberry juice fiber diet intervention diabetes obesity hypertension hypercholesterolemia