Kornimate/medical-research-clean huggingface dataset:
evaluation of a psychoeducation group program for mild/moderate depression

Conditions: Depressive Disorders

Summary: the purpose of this study is to compare the effectiveness and efficiency of doing a psychoeducational group program and the conventional treatment versus individual conventional care in patients with a mild/moderate depression disorder,in urban primary healthcare centers in barcelona city.

nowadays, the depression is one of the public health major issues, this is because of its prevalence and its economic and social repercussions. it is fundamental for the primary care to assume the management of these health problems. design:a randomised controlled trial of two groups (intervention and control), longitudinal and prospective. population of study: the subjects of the study are patients of 20 to 65 years old attended in 8 urban primary healthcare centers of barcelona city, identified by the general practitioners and nurses with diagnosis of mild/moderate depression disorder according to the bdi scale. the intervention group receive weekly a psychoeducational group program during 12 weeks run by 2 nurses. the program have a structured content where patient is educated about the illness, pharmacological treatment, the adherence to treatment, diet and physical exercise, problem solving, and cognitive-behavioral therapy. in the control group the depression in treated as usual with the conventional care. measure's tool: the evolution of patients will be monitoring up to 1 year after the inclusion by a individual interview (the first visit and 3,6 and 9 months).the beck depression inventory (bdi) is a self-administered questionnaire that measure the symptomatology and severity of the depression. the analysis variables are: patient's quality of life (euroqol-5d scale) ,clinical variables of the patient, pharmacological prescription, anxiolytics and antidepressants consumption , sociodemographic, number of visits to primary healthcare center, number of days of labour lost and cost.

Eligibility criteria:
inclusion criteria: * beck depression inventory(bdi)\>10 and \<30. * diagnosis of mild/moderate depressive disorders. * signed the informed consent. exclusion criteria: * patients diagnosed of severe mental psychiatric disorder, * patients diagnosed of a major depressive disorders, * patients with acute illness or near-terminal medical illness, * using secondary mental health services, * suicidal ideation or intentions, * don't speak and understand spanish or/and catalan language, * sensory or cognitive disabilities, * illiteracy, * does not know or not give consent to participate in the study, * temporary residents.

Keywords: depressive disorders; primary health care; nurses; health education.
an efficiency/safety study of surgical tissue glue to treat inguinal hernias

Conditions: Inguinal Hernia

Summary: prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. the objective is to determine the prevalence of chronic pain at 1 year.


Eligibility criteria:
inclusion criteria: * patient is older than 18 years. * written informed consent is obtained from patient. * patient is able to complete the eq-5d questionnaire. * patient has a primary unilateral or primary bilateral inguinal hernia- mesh fixation is established with solely surgical tissue glue (ifbond™). exclusion criteria: * patient has a recurrent inguinal hernia. * patient is treated using the lichtenstein technique. * mesh fixation with sutures, tacks, absorbable tacks or clips. * patient is allergic to components of surgical tissue glue (ifbond™). * patient has a life expectancy of less than 1 year.

Keywords: inguinal hernia laparoscopy surgical tissue glue
the effects of electronic cigarettes on the microcirculation of the hand

Conditions: Hand Injuries; Elective Hand Surgery

Summary: cigarette smoking is associated with poor wound healing and worse results after hand surgery. nicotine and cigarette smoke has been shown to affect blood flow in blood vessels in the hand. patients are increasingly using electronic cigarettes (e-cigarettes) as a method of quitting smoking. e-cigarettes consist of a replaceable nicotine cartridge, a heating element and a battery source. they are able to deliver vaporised nicotine in the absence of other ingredients found in normal cigarettes such as tar and carbon monoxide. although e-cigarettes lack a lot of the harmful ingredients of regular cigarettes, nicotine still has toxic effects on the body. nicotine causes the release of chemicals within the body that act to reduce blood flow in small blood vessels of the hand. e-cigarettes remain a controversial topic among healthcare professionals due to the lack of research surrounding them. a recently published literature review identified only three significant studies into the effects of smoking e-cigarettes. all of these studies showed the harmful effects of e-cigarettes on the lungs but to date, there is no published research investigating the effects of e-cigarettes on the blood flow within the small blood vessels of the hand. currently, we advise patients to quit smoking after they sustain a hand injury to improve healing and recent research suggests that patients should be advised to quit smoking 4 weeks before routine hand surgery. however, there is no guidance on whether we should also advice patients to refrain from using e-cigarettes for this time period. our aims are to answer the following questions: 1. do electronic cigarettes have any effect on the blood flow in the hand? 2. do we need to give cessation advice to patients with hand injuries who smoke electronic cigarettes?


Eligibility criteria:
inclusion criteria: * volunteers between 18-65yrs * volunteers with no co-morbidities * volunteers with no history of oral infections exclusion criteria: * volunteers with ongoing co-morbidities requiring medical treatment * volunteers with a history of oral infections e.g herpes simplex virus * volunteers who lack capacity to consent to the study * volunteers who are currently on nicotine replacement therapy * volunteers who have had use of a cigarette or nicotine containing product within 4 hours of beginning the study * volunteers who have previously quit smoking
evaluation of side effects and relative activity of two chemotherapy regimens in the treatment soft tissue sarcoma

Conditions: Sarcoma, Soft Tissue

Summary: the purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

the purpose of this study is to explore the relative activity and toxicity of a newer combination of chemotherapy drugs, gemcitabine and docetaxel, as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin. ifosfamide and doxorubicin, given in combination, are recognized as a standard of care for some types of sarcoma. both gemcitabine and docetaxel are approved by the us food and drug administration (fda) for the treatment of some cancers (cancers of the pancreas, lung) because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms. however, neither gemcitabine or docetaxel is approved for sarcoma, but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma.

Eligibility criteria:
inclusion criteria: * no evidence of metastasis * soft tissue sarcoma * intermediate or high histologic grade * greater than 5 cm * zubrod performance status 1 or better * age 10 or older exclusion criteria: * clear cell, alveolar soft part, ewing's rhabdosarcoma, undifferentiated small cell or kaposi's * prior chemotherapy * nephrectomy * active unstable angina pectoris * concurrent therapy
prospective evaluation of the quality of life of elderly patients undergoing transfemoral percutanous aortic valve replacement (tavi) for the treatment of severe aortic stenosis.

Conditions: Quality of Life; Aortic Valve Replacement; Transfemoral Approach

Summary: in order to overcome the shortcomings of the assessment questionnaires currently available on the assessment of overall quality of life, the "toronto aortic stenosis quality of life questionnaire" (tasq) was developed as a specific assessment tool for the impact of severe aortic stenosis in elderly patients, through 16 questions covering 5 domains: symptoms and physical limitations, emotional impact and expectations following tavi, as well as social limitations incurred. a better knowledge and understanding of the clinical outcomes and quality of life of elderly patients with severe symptomatic aortic stenosis at 12 months of follow-up of a tavi procedure would further optimize the clinical decision-making process and patient selection who will benefit the most from this intervention in the long term.


Eligibility criteria:
inclusion criteria: * male, female, over 18 years old, * all patients who will have transfemoral percutaneous aortic valve replacement (tavi) with implantation of a valve delivered on a balloon, * patient able to understand the study, and answer the tasq questionnaire, * affiliation to a social security scheme or beneficiary of such a scheme, * patient having signed the free and informed consent. exclusion criteria: * minor, * disorder of comprehension and/or expression, * patients unable to answer questions due to an underlying cognitive deficit or physical disability, * patients treated with a self-expanding valve, * refusal to participate in the study, * protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision, * pregnant, parturient, or breast-feeding patient.
measurement of beta cell death in individuals with cystic fibrosis

Conditions: Cystic Fibrosis-related Diabetes

Summary: this study evaluates the feasibility of using differentially methylated insulin dna, a biomarker of beta cell death, in determining the time course of beta cell death and development of diabetes in people with cystic fibrosis. study participants with cystic fibrosis and healthy control participants will have a blood sample drawn in order to measure the levels of differentially methylated insulin dna.

cystic fibrosis related diabetes (cfrd) causes increased morbidity and mortality in people with cystic fibrosis (cf). the prevalence of cfrd increases with age. while cfrd is diagnosed in only 2 percent of children under 10 year sof age, it is present in 19 percent of adolescents and up to 50 percent of adults with cf. although cfrd is uncommon in children, recent animal and human studies have shown that milder glycemic abnormalities are common in infants and young children with cf. one of the proposed mechanisms for early glucose dysregulation in cf is related to ongoing beta cell death that may start at a very early age. the assay to be used in this study measures differentially methylated insulin dna, released exclusively by beta cells, to determine levels of beta cell death. this assay has been shown to detect beta cell death in individuals at risk of developing type 1 diabetes. if this assay successfully detects beta cell death in individuals with cf, the investigators can identify critical time points of beta cell loss in people with cf. understanding how and when glycemic dysregulation occurs in cf will lead to better treatment of cfrd in the future.

Eligibility criteria:
inclusion criteria for cystic fibrosis subjects: * age 0 - 21 years * diagnosis of cf by two cf-causing mutations or elevated sweat chloride test * normal glucose tolerance, impaired glucose tolerance, indeterminate glucose tolerance or cfrd * pancreatic insufficiency exclusion criteria for cystic fibrosis subjects: * age \> 21 years * diagnosis of type 1 or type 2 diabetes * pregnancy * oral or iv steroid use in the past 2 weeks * pulmonary exacerbation requiring hospital admission in the past 2 weeks. * initiation of cftr corrector or potentiator medication within 6 months inclusion criteria for healthy, age-matched controls: * age 0 - 21 years exclusion criteria for healthy, age-matched controls: * age \> 21 years * diagnosis of type 1 or type 2 diabetes or pre-diabetes * disorders impacting pancreatic exocrine function * pregnancy * oral or iv steroid use in the past 2 weeks
surgical pleth index (spi) guided analgesia during sevoflurane anesthesia

Conditions: Balanced Anesthesia

Summary: the aim of the present study was to compare spi guided analgesia with standard clinical practise during general anesthesia using a balanced setting of sevoflurane and sufentanil anesthesia. it was to be tested whether spi guided analgesia leads to more cardiovascular stability, less use of analgetics and shorter recovery from anesthesia.

general anesthesia can be considered as a combination of hypnosis, antinociception, and immobility. the monitoring of hypnosis and immobility has been established in clinical practise, however for the evaluation of antinociception a valid monitoring is missing. the surgical pleth index (spi; former named surgical stress index-ssi) is a multivariate index derived non invasively from finger plethysmographic signal. it has been demonstrated to correlate with surgical stress intensity. in the setting of total intravenous anesthesia tiva our group could show beneficial effects of spi guided analgesia in terms of remifentanil consumption, hemodynamic stability and incidence of unwanted events. therefore, we wanted examine whether these beneficial effects of spi guided anesthesia can be transferred to a setting of balanced anesthesia using a volatile anesthetic sevoflurane and the opioid sufentanil. the following hypotheses have been made: 1. spi guided analgesia will result in less sufentanil consumption 2. spi guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia, and less opioid use in post operative period

Eligibility criteria:
inclusion criteria: * age between 18 - 65 years * asa physical status i or ii * elective surgery under general anesthesia of 1-2 hours * written informed consent exclusion criteria: * pregnancy * history of cardiac arrhythmia * presence of any neuromuscular opr neurologic disease * use of cns active medication or alcohol/illicit drug abuse -

Keywords: anesthesia general anesthetics inhalation diagnostic techniques and procedures
metabolomic analysis of exhaled breath condensate in asthmatics

Conditions: Asthma

Summary: asthma is a chronic inflammatory airway disease. significant heterogeneity exists in the clinical manifestations and treatment responses in these patients. metabolomics is a large-scale approach to monitoring as many as possible of the compounds involved in cellular processes in a single assay to derive metabolic profiles. compared with genomics or proteomics, metabolomics reflects changes in phenotype and therefore function. up to now, few studies have evaluated the role of metabolomic analysis in the diagnosis and prognostic evaluation of airway disorders. collection of exhaled breath condensate (ebc) is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the alveolar lining fluid. this study will apply metabolomics to examine the biomarkers in the ebcs, serum and urine specimens in adult asthmatics.

the aims of this study are: 1. metabolomic profiling of the exhaled breath condensate (ebc), serum and urine specimens in adult asthmatics; 2. correlation between metabolomic profiles of these specimens with the severity and control of asthma; 3. comparing metabolomic profiles in asthmatics with different phenotypes and endotypes; 4.comparing metabolomic profiles obtained from asthmatics during stable and acute exacerbation periods; 5. comparing metabolomic profiles in asthmatics before and after inhaled corticosteroid therapy.

Eligibility criteria:
inclusion criteria: 1. 20-90 years 2. diagnosis of asthma based on the gina guideline exclusion criteria: 1. patient with cancer 2. patient with long-term ventilator use

Keywords: asthma metabolomics exhaled breath condensate
longitudinal assessment of autonomic and sensory nervous system in als

Conditions: Amyotrophic Lateral Sclerosis

Summary: the goal of this interventional non-pharmacological study is to evaluate, using a multimodal approach, the progression of autonomic and sensory involvement in in amyotrophic lateral sclerosis (als) patients enrolled within 18 months from motor onset and its relationship with the progression of overall clinical disability. the main questions it aims to answer are: * is autonomic dysfunction at diagnosis associated with disease progression and survival in patients with amyotrophic lateral sclerosis ? * can we identify in the skin biomarkers to be used as reliable measures of disease progression and to apply in future clinical trials for patient stratification and to assess response to drug treatment ? participants at time 0 will receive a full clinical and instrumental examination and a blood sample testing to check inclusion and exclusion criteria, genetic screening for the most common genes associated with als (sod1, fus, tardbp and c9orf72), questionnaires about clinical characteristics, quality of life, pain and a multidomain battery of neuropsychological tests, multimodal assessment of the autonomic nervous system including skin biopsy for morphological study. at follow-up we'll perform clinical scales and skin biopsy. researchers will compare results from als patients with data obtained from a population of age and sex matched healthy subjects.


Eligibility criteria:
inclusion criteria: * als patients will be recruited within 18 months from the motor symptoms onset exclusion criteria: * glucose intolerance or conditions potentially affecting the peripheral nervous system

Keywords: autonomic nervous system skin biopsy biomarkers cutaneous sensory an autonomic innervation
a phase 2 study of mm-141 plus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to determine whether the combination of mm-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on progression free survival (pfs) in front-line metastatic pancreatic cancer patients with high serum levels of free igf-1.

this is a randomized, double-blind, placebo-controlled phase 2 study of mm-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer. all patients will be initially screened for free igf-1 status. eligible patients with high free igf-1 will be randomized to receive mm-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients. patients with low free igf-1 or patients who have high free igf-1 but are not otherwise eligible will be followed in an observational group.

Eligibility criteria:
inclusion criteria: * metastatic adenocarcinoma of the pancreas. patients with islet cell neoplasms are not eligible. * patient must have received no prior radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease. * blood sample sent for free igf-1 testing * ecog performance status (ps) of 0 or 1 exclusion criteria: * patients who only present with localized disease * patients with cns malignancies (primary or metastatic) * clinically significant cardiac disease

Keywords: pancreatic cancer front-line pancreatic cancer metastatic pancreatic cancer gemcitabine nab-paclitaxel abraxane free igf-1 heregulin
intracutaneous delivery of varied dose volumes of saline

Conditions: Influenza

Summary: this study will evaluate intracutaneous delivery of 0.1, 0.25 and 0.5 milliliter volumes of saline from the flugen 101.2 investigational microneedle-based device.

an intracutaneous delivery device will be evaluated for ability to inject various volumes of saline into subjects skin.

Eligibility criteria:
inclusion criteria: * able to read and/or understand and sign the informed consent form exclusion criteria: * medical history of acute or chronic skin disease * active skin allergy or acute skin infection, presence of tattoo(s), scars, sunburn or skin abnormalities at any prospective injection site * hirsute at any prospective injection site * diabetes * high levels of anxiety or depression or history of psychosis * abuse of alcohol or use of other drugs of abuse including tobacco * pregnant or breastfeeding women * any medical condition that may interfere with study protocol adherence including completion of study activities * foreseeable inability to complete the study as scheduled.

Keywords: microneedle-based delivery hollow microneedle intracutaneous drug delivery
efficacy of mycobiotic® in children and adults with abdominal symptoms.

Conditions: Abdominal Symptoms; Stool Culture Positive for Candida Species

Summary: this is a prospective, randomised, double blind, placebo controlled, parallel arm, cross-over, multicentre study conducted in a population of children and adults with abdominal symptoms observed at outpatient primary health care centres.


Eligibility criteria:
inclusion criteria 1. children and adults age \>3 up to ≤ 75 years old. boys and girls aged 3-15 years 2. presence of abdominal symptoms 3. informed consent for participation in the study signed by children' parents/ legal caregivers and child above 13 years old, all adults patients. exclusion criteria: 1. chronic intestinal disease, immunodeficiency or immunosuppressive treatment. 2. chronic or acute diarrheal disease. 3. use of laxatives or antydiarrhoeal treatment within the week before inclusion in the study. 4. antibiotic treatment for the last four weeks before inclusion in the study. 5. intake of probiotic products for the last two weeks before inclusion in the study 6. known hypersensitivity to any of the ingredients in the probiotic product or the placebo (corn starch, magnesium stearate ± bacterial culture).

Keywords: stool culture candida sp. probiotic abdominal symptoms