Kornimate/medical-research-clean huggingface dataset:
phase ii study of irinotecan,oxaliplatin plus ts-1 in untreated metastatic colorectal cancer

Conditions: Colorecal Neoplasms; Secondary

Summary: patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and s-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. response assessment will be performed every 2 cycles of chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed unresectable or metastatic colorectal cancer, not amenable to surgery or radiation treatment for curative intent * at least one unidimensional measurable lesion * ecog performance status 0-2. * no prior chemotherapy in metastatic settings, but adjuvant or neo-adjuvant treatment for non-metastatic (m0) disease is allowed if completed at least 6 months prior to initiation of study treatment * adequate major organ functions * give written informed consent exclusion criteria: * prior systemic chemotherapy for metastatic disease * prior treatment with oxaliplatin or irinotecan * prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration * prior surgical treatment of stage iv disease is permitted * cns metastases * prior history of peripheral neuropathy ≥ nci ctc grade 1 * uncontrolled or severe cardiovascular disease * serious concurrent infection or nonmalignant illness * other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix * organ allografts requiring immunosuppressive therapy * psychiatric disorder or uncontrolled seizure that would preclude compliance * pregnant, nursing women or patients with reproductive potential without contraception * patients receiving a concomitant treatment with drugs interacting with s-1 such as flucytosine, phenytoin, or warfarin et al. * prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (dpd) deficiency * known hypersensitivity to platinum compounds or any of the components of the study medications * major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery * received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug

Keywords: colorectal neoplasms secondary combination chemotherapy s-1 irinotecan oxaliplatin
comparison of the effect of neck collar, act-as-usual, and active mobilisation early after a whiplash injury

Conditions: Whiplash Injury

Summary: background: long-lasting pain and disability, known as chronic whiplash-associated disorder (wad), may develop after forced flexion-extension trauma to the cervical spine. mechanisms behind wad are virtually unknown, as are the possible effects of early intervention. this trial was undertaken to compare the effect of three early intervention strategies for the prevention of developing chronic wad following acute whiplash injury. methods: 458 participants were randomised to one of 1) stiff neck collar, 2) advice to act-as-usual, or 3) an active mobilisation regime. participants were followed for one year and treatment effects were compared in terms of lasting neck pain, headache, disability and sick-leave.


Eligibility criteria:
inclusion criteria: * been exposed to rear-end or frontal car collision * experienced symptoms within 72 hours * 18 - 70 years exclusion criteria: * could not be enrolled within 10 days of the collision * fractures or dislocations of the cervical spine * amnesia for the accident * unconsciousness in relation to the accident * injuries other than the whiplash injury * average neck pain during the preceding 6 months exceeding 2 on a box scale 0-10, where 0= no pain and 10= worst possible pain * significant pre-existing somatic or psychiatric disease * alcohol or drug abuse * does not read or understand danish.

Keywords: whiplash injuries neck pain exercise movement techniques immobilisation
flourishing app: an evaluation with high school students

Conditions: Emotional Stress

Summary: this protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. the investigators hypothesize that this program offered in mobile application may promote well-being and reduce stress related problems in the participants. objectives: to evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of high school students. methods: sixty high school students will be recruited. the participants will be randomized in two groups of 30 participants each one, half of them in the control group (gc) and the other half to the intervention group (gi).

introduction: some very successful stress management programs are based on the principle of mindfulness. this protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. in the modern world, young people are connected to new technologies and the use of applications can be a fun way to learn how to cope with stress and promote well-being. in this sense, the investigators hypothesize that this program offered in mobile application can be considered an interesting alternative for high school students who want to reduce symptoms related to stress and also promote well-being. objectives: to evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of high school students. methods: sixty high school students will be recruited. the participants will be randomized in two groups of 30 participants each one, half of them in the control group (gc) and the other half to the intervention group (gi). the gi will participate in the flourishing app program, for eight weeks, while the gc will have access to a control app. then, after the evaluations, the gc will receive the intervention (flourishing app program), while the first group will repeat the use of the flourishing app program. questions will be applied to evaluate the levels of stress and well-being of participants before and after the program and before and after each training period.

Eligibility criteria:
inclusion criteria: * complete elementary school exclusion criteria: -

Keywords: stress well-being positive psychology
use of acupuncture for stimulation of labour

Conditions: Dystocia

Summary: hypothesis:acupuncture can be used as stimulation of labour in case of primary og secondary inertia. a randomized controlled trial including 150 pregnant women acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of the acupuncture. the women are randomized into to groups. 1. acupuncture, acu.points: ki3, ki6, sp6, bl60, li4, bl67(acupressure) 2. no treatment the women will be asked in case beginning signs of inertia, if they want to parcipitate in the trial. inclusion criteria: 1. normal pregnancy 2. in labour (orificium \< 8 cm), 37th week or thereafter 3. ruptured membranes 4. primary or secondary inertia the women will just before randomization be vaginally explored and fetal heart monitored. the meassure of effect happens two hours after randomization. the midwife who measures the effect, is blinded to the treatment or lack of, and also on the including exploration. secondary effect meassures: length of labour, use of oxytocin and number of contracions pr/min meassured twice: 1. before the randomization and again 1 hour after randomization.


Eligibility criteria:
inclusion criteria: 1. normal pregnancy 2. in labour (orificium \< 8 cm), 37th week or thereafter 3. ruptured membranes 4. primary or secondary inertia - exclusion criteria: 1. pathological pregnancy 2. pathological labour 3. medical diseases 4. women who do not speak and undrestand danish

Keywords: dystocia stimulation acupuncture oxytocin
validation of the ontological addiction scale

Conditions: Mood Disorders; Emotional Disorder

Summary: background: bypassing a reductionist view of existing diagnostic categories, ontological addiction theory (oat) is a new psychological model of human functioning and mental illness. ontological addiction is a maladaptive condition that stems from an erroneous belief in an inherently existing self or "i", which is deemed to be the root of all suffering. five experts from four different countries have created the ontological addiction scale (oas) to measure the condition and its impact on people's lives. the purpose of this study is to test this scale, evaluating levels of ontological addiction in individuals suffering from emotional or mood disorder, and assess its psychometric properties. methods: this trial will be conducted in compliance with the cosmin guidelines. the investigators will collect data from 400 individuals, aged 18 to 70, suffering from emotional or mood disorder, referred to the therapeutic center for mood and emotional disorders for an 8-week-mindfulness-based-intervention. patients will complete the oas at three time points: one month before the beginning of the therapy, within one week prior to the beginning of therapy, and one year after the end of the therapy. this scale will be completed in conjunction with other practice assessments relating to the psychotherapeutic program. the psychometric properties of the oas will be assessed. discussion: the investigators aim to validate a scale assessing a psychological dimension as the root of all mental disorders. the present study may contribute to overcoming limitations of categorical understanding of mental disorders, thus moving toward a more encompassing dimensional comprehension. the scale is responsive to current thinking in modern psychiatry, and it is envisaged that its validation will deeply impact research and care perspectives


Eligibility criteria:
inclusion criteria: an individual must fulfill all of the following criteria in order to be eligible for study enrollment: * aged between 18 and 70 years * suffering from mood disorder (bipolar or unipolar) and/or emotional disorder (subjective complaint for difficulties to regulate emotions). * being referred to the therapeutic center for mood and emotional disorders for an 8-week-mindfulness-based-intervention * subjects must be able to attend all scheduled visits and to comply with all trial procedures * subjects must be covered by public health insurance exclusion criteria * subject unable to read or/and write * psychosis * subject who are in a dependency or employment with the sponsor or the investigator
efficacy and safety of spd503 in combination with psychostimulants

Conditions: ADHD

Summary: the purpose of this study is to assess the efficacy and safety of spd503 in subjects with adhd when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of adhd with a sub-optimal, partial response to stimulants.


Eligibility criteria:
inclusion criteria: * healthy subjects with adhd currently taking a stable dose of psychostimulant for at least 4 weeks * aged 6-17 years with a sub-optimal * partial response to stimulants * subjects must be \ = 55lbs and \<= 176lbs
glutathione in mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: elderly humans have an increased risk of dementia which begins as mild defects in memory called mild cognitive impairment. glutathione (gsh), a key endogenous antioxidant has been linked to cognition. this exploratory study will investigate mechanisms linked to gsh for cognitive impairment (and improvement) by studying humans with mild cognitive impairment who will be evaluated 12-weeks after receiving either n-acetylcysteine and glycine (gsh precursors), or receiving alanine, and a further 12-weeks after stopping these supplements.

subjects with mci will be recruited by written informed consent using forms approved by the baylor irb. subjects will stop nonvitamin supplements for 4wks before screening labs (blood count, hba1c, glucose, lipid profile, liver profile, blood urea nitrogen, creatinine, thyroid stimulating hormone, free t4), and for the entire 24wks duration of the study. 60 fasted subjects will have the following measures before and after 12wks of supplementation with cysteine (as n-acetylcysteine) plus glycine vs alanine: (1) cognitive function using adcs-pacc (alzheimer's disease co-operative study-preclinical alzheimer's cognitive composite which includes free and cued selective reminding test, immediate and delayed paragraph recall score, digit-symbol substitution test, mini mental state examination; (2) red-cell concentrations of gsh, cysteine, glycine, glutamic acid; plasma malondialdehyde, f2/f3-isoprostanes, sicam, svcam, e-selectin; endothelial function; (3) mitochondrial glucose oxidation by calorimetry. measures will be repeated for washout effects 12-wks after stopping supplements.

Eligibility criteria:
inclusion criteria at study entry: (1) diagnosis of mild cognitive impairment exclusion criteria at study entry: (1) hospitalization within past 3 months; (2) known diabetes; (3) creatinine greater than or equal to 1.5 mg/dl; (4) hemoglobin concentration less than 11 g/dl; (5) known liver disease, or ast/alt greater than or equal to 2x uln; (6) history of stroke, brain tumor, or active heart failure; (7) history of psychiatric disorders; (8) untreated depression.
activation of biobank registry for bilio-pancreatic diseases

Conditions: Pancreatitis; Pancreatic Disease; Non-Neoplastic Pancreatic Disorder; Pancreatic Adenocarcinoma

Summary: the purpose of establishing the biobank is to create a collection of biological material and clinical data, with a prospective and retrospective mold, in order to investigate the role of genetic predisposition in multifactorial bilio-pancreatic diseases, so that an evaluation of the possible association in the pathogenesis of exogenous factors with endogenous factors can be allowed. multifactorial diseases are in fact an expression of genetic predisposition upon which one or more environmental stimuli act. usually the aforementioned factors are not capable individually of triggering disease but, when simultaneously present, can cause the pathological phenotype. therefore, it becomes important in the description of disease pathogenesis to identify as many risk factors for disease prevention and early diagnosis.

samples collected depending on the disease: * peripheral blood; * portal blood; * saliva; * urine; * stool; * cystic fluid; * pancreatic juice; * biopsy tissue specimens;

Eligibility criteria:
inclusion criteria: * age \>= 18 years * signed informed consent exclusion criteria: * age \< 18 years * unwilling to sign informed consent
remote resistance exercise powering survivors - gastrointestinal oncology

Conditions: Gastrointestinal Cancer

Summary: the purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * biopsy-proven upper gi cancer, stage iii-iv * ecog performance status 0-1 * treatment plan of chemotherapy with planned return to moffitt cancer center for restaging * able to read and speak english fluently * capable of providing informed consent exclusion criteria: * regular engagement in rt (2x/week targeting all major muscle groups) * screen failure for exercise safety based on physical activity readiness questionnaire (par-q) and patient-reported measurement information system (promis) screening questions * underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (new york heart association functional class iii or iv). * recent fracture or acute musculoskeletal injury that precludes ability to participate in rt * numeric pain rating scale of ≥ 7 out of 10 * myopathic or rheumatologic disease that impacts physical function

Keywords: gastrointestinal cancer remote resistance exercise gi cancer stage iii gi cancer stage iv tele-resistance training
reminerlization potential of gse gel versuscpp-acp in carious white spot lesions in post orthodontic patients

Conditions: Dental Caries

Summary: assess the effectiveness of applying grape seed extract (gse) gel versus casein phosphopeptide-amorphous calcium phosphate (mi) paste on remineralization of white spot lesion (wsls) in post orthodontic patients.

the development of wsls is a challenging problem in the track of orthodontic treatment. especially in patients wearing fixed orthodontic appliances, plaque accumulation increases around brackets and bands and the ph on dental surfaces becomes acidic. these early lesions are willing to remineralization, arrest, reharden and revert to healthy enamel condition through a remineralization process involving the diffusion of minerals into the defective tooth structure. for this purpose various remineralizing agents such as casein phosphopeptide-amorphous calcium phosphate (cpp-acp) and grape seed extract (gse) have been used. this research is conducted for early intervention and treatment of the white spot lesions by non-invasive method.

Eligibility criteria:
inclusion criteria: * presence of at least two wsls on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy. exclusion criteria: * severe or active periodontal disease. * patients had received therapeutic irradiation to the head and neck region. * patients had participated in a clinical trial within 6 months before commencement of this trial. * patients unable to return for recall appointments * presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands). * presence of restorations or cavities in any anterior teeth or enamel hypoplasia, dental fluorosis, or intrinsic and extrinsic pigmentation.
a study of the efficacy and safety of asn-002 in adult patients with low-risk nodular basal cell carcinoma

Conditions: Basal Cell Nevus Syndrome; Skin Neoplasm; Nodular Basal Cell Carcinoma of Skin

Summary: the study evaluates whether asn-002 is safe and effective in the treatment of nodular basal cell carcinoma (nbcc) in patients aged 18 years or over. the participants will receive weekly injections of asn-002 alone or in combination with 5-fu for 3 weeks and undergo surgical excision of the tumor.

the primary purpose of this study is to determine whether asn-002 alone or in combination with 5-fu is safe and effective in the treatment of nodular basal cell carcinoma (nbcc). patients aged 18 or over, who have been diagnosed with nodular basal cell carcinoma (nbcc), may be eligible to join this study. study details: asn-002 is an immunotherapeutic product that is injected into the bcc spot to be treated. it is made from modified adenovirus serotype 5 (also called ad5). adenoviruses are common in nature worldwide and can cause mild colds and respiratory infections from which people usually recover without treatment. the ad5 used in this study has been modified so that it cannot grow in the body or cause an infection. the modified ad5 in this study will deliver artificially made genetic material into the cancerous and surrounding cells. this genetic material will produce human interferon which is normally produced by the body to stimulate the immune system. it is hoped that injected asn-002 will cause the body's own cells to produce interferon and stimulate the immune system to attack the cancerous cells and reduce the size of or eliminate the nbcc. participants will attend the study centre weekly for an injection of asn-002 alone of in combination with 5-fu into the nbcc. the participants recruited will have 3 injections over 3 weeks, and then undergo surgical excision of the tumor. patient outcomes will then be assessed using a tumour sample collected during surgery and by the incidence of adverse events which occur throughout the study. it is hoped that the findings of this trial will provide information on the safety and efficacy of using asn-002 alone or in combination with 5-fu for nbcc, particularly for patients in whom the standard treatment of surgery is not possible or not recommended.

Eligibility criteria:
inclusion criteria: 1. low risk nodular basal cell carcinoma 2. biopsy of any other skin tumor 3. willingness to have injection therapy followed by surgery 4. written informed consent exclusion criteria: 1. no or only minimal symptoms 2. known or suspected metastatic disease. 3. pregnant or lactating females 4. clinically active or uncontrolled skin disease 5. immunocompromised or receiving immunomodulating agent 6. treatment with psoralen plus ultraviolet a or ultraviolet b light therapy within 6 months 7. any serious or active medical or psychiatric illness 8. recreational or therapeutic drug or alcohol use 9. taking any investigational product within 1 month of first dose of asn- 002.

Keywords: untreated nbcc low-risk
liprotamase efficacy trial in patients with cystic fibrosis-related exocrine pancreatic insufficiency

Conditions: Cystic Fibrosis; Exocrine Pancreatic Insufficiency

Summary: this is a clinical trial which will evaluate the efficacy of liprotamase treatment in cystic fibrosis (cf) patients with exocrine pancreatic insufficiency (pi).

this trial is divided into four distinct periods: 1. baseline period during which each patient is taken off pancreatic enzyme medications. 2. an open-label treatment period during which all patients will receive altu-135 (liprotamase). 3. inpatient, double blind treatment period during which half of patients will be withdrawn from treatment and will receive placebo. 4. second open-label treatment period during which all patients will resume treatment with altu-135 (liprotamase).

Eligibility criteria:
inclusion criteria: * females of childbearing potential must be willing to use birth control * diagnosis of cf based upon the following criteria: * two clinical features consistent with cf; and * either genotype with two identifiable mutations consistent with cf, or * sweat chloride \>60 meq/l by quantitative pilocarpine iontophoresis * clinically stable with no evidence of acute upper or lower respiratory tract infection * pi determined by fecal elastase \<100 µg/g stool measured at screening * able to take pancreatic enzyme supplementation in the form of capsules * able to perform the testing (e.g., stool collections) and inpatient stays required for this study, as judged by the investigator * baseline coefficient of fat absorption (cfa) less than or equal to 80% exclusion criteria: * cfa \>80% at baseline * pregnancy, breastfeeding or of childbearing potential and not willing to use birth control during the study * history of fibrosing colonopathy * history of liver transplant, lung transplant or significant surgical resection of the bowel * any acute or chronic diarrheal illness unrelated to pi * unable to discontinue enteral tube feedings during the study * known hypersensitivity to food additives * inability to consume the diet required by the study, in the judgment of the investigator * participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening * abnormal liver function (except for patients with gilbert syndrome) * signs and/or symptoms of liver cirrhosis, portal hypertension or documented liver disease unrelated to cf * distal intestinal obstruction syndrome (dios) in the last six months prior to screening * unable to discontinue the use of pancreatic enzymes * any condition that the investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient * patient is unlikely to complete the study, as determined by the investigator

Keywords: cystic fibrosis-related pancreatic insufficiency