Kornimate/medical-research-clean huggingface dataset:
feasibility study of an online self-management program for chronic non-cancer pain

Conditions: Chronic Pain

Summary: based on a mixed-methods design, the objective of this trial is to assess the feasibility and acceptability of the "agir pour moi" program, an 8-week online self-management program for chronic non-cancer pain (cncp). the investigators will also explore its potential effects on self-efficacy, pain interference, pain severity, anxiety, depression, catastrophizing, and global impression of change in adults with cncp awaiting services from a chronic pain multidisciplinary treatment center.

the mixed-methods sequential explanatory design combines a quantitative questionnaire-based study with a subsequent in depth qualitative approach.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * live with cncp for more than 3 months; * read and understand french easily; * have access to a computer and high-speed internet; * be available to take part in the project for 6 to 8 months; * not having started a new treatment for pain within the last month; * agree to notify the team before starting a new treatment; * be able to give informed consent. exclusion criteria: * be supported by a multidisciplinary treatment center or be likely to be in the short term; * having participated in a cncp self-management program within the last year; * be awaiting scheduled surgical treatment within six months.
pyridoxal kinase activity in tardive dyskinesia

Conditions: Tardive Dyskinesia

Summary: objectives: the mechanisms of tardive dyskinesia (td) remain unclear, although pathophysiologic theories have proposed mechanisms such as dopamine receptor supersensitivity, the degeneration of cholinergic striatal interneurons, γ-aminobutyric acid (gaba) depletion, and an excess of free radicals. prior development of second generation antipsychotic agents, tardive movement disorders were widespread among neuroleptics treated patients. there were great expectations of the new novel drugs. unfortunately, reports about tardive movement disturbances induced by these medications became more and more frequent, although it has been in use for less than two decades. a recent study demonstrated that schizophrenic and schizoaffective patients suffering from td had the mean level of pyridoxal 5'-phosphate (plp) below lower limit of normal range, while those patients without td had normal values. at the same time, some open and double-blind placebo-controlled, randomized clinical studies showed that vitamin b6 was very effective in treatment of td. pyridoxal kinase is a key enzyme for the biosynthesis of plp, the biologically active form of vitamin b6. some publications reported that the finding of high vitamin b6 levels is consistent with recent reports of low levels of plp and low activity of pyridoxal kinase. it may explain the functional need for high-dose vitamin b6 supplementation in subjects with td. methods: a multicenter study including 300 schizophrenia and schizoaffective subjects will be performed. the trial will be consisted of 2 parts: the first part a single comparison pyridoxal kinase plasma activity in patients with and without td; in the second part only td schizophrenia and schizoaffective patients will continue. it will be a 12-week, randomized, double-blind placebo-controlled trial. vitamin b6 (1200 mg/day) or placebo capsules will be added to the stable ongoing antipsychotic treatment of 150 schizophrenia patients. participants will be assessed at baseline and after every 2 weeks of treatment till week 12. pyridoxal kinase activity will be compared between patients who positively respond to vitamin b6 versus non responders. in addition, plp levels will be monitored at baseline and at the end of the study. a battery of research tools will be used for assessment of movement disorders, psychopathology, and side effects. the study will be performed along a period of 2 years.


Eligibility criteria:
inclusion criteria: * inpatients * dsm-iv diagnosis of schizophrenia or schizoaffective disorder with and without tardive dyskinesia (td) * total esrs score should be more than 20 in subjects with td * ability to provide a written informed consent exclusion criteria: * patients with concurrent medical illness or any movement disorder resemble td * patients who received any vitamin medication * evidence of substance or alcohol abuse or a family history of movement disorder. * pregnancy and/or lactation.

Keywords: schizophrenia pyridoxal kinase activity plasma pyridoxal level
procedural outcomes in endobronchial ultrasound - transbronchial needle aspiration (ebus-tbna) with and without rapid on-site evaluation (rose)

Conditions: ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION; Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy

Summary: the objective of this study is comparing the attributable procedural time of endobronchial ultrasound - transbronchial needle aspiration (ebus-tbna) when sampling mediastinal and hilar lymph nodes with or without rapid on-site evaluation (rose). the primary outcome will be the time elapsed from ebus bronchoscope insertion to bronchoscope withdrawal. secondary outcomes will include total number of sampled lymph nodes, average number of needle aspirations per lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.


Eligibility criteria:
inclusion criteria: 1. subject provides informed consent 2. subject is \>18 years of age 3. subject is scheduled to undergo flexible bronchoscopy with ebus-tbna of suspected enlarged mediastinal or hilar lymph nodes as part of their standard medical care 4. a negative pregnancy test in women of child-bearing potential 5. subject is mentally capable of following study directions exclusion criteria: 1. study subject has any disease or condition that interferes with safe completion of initial or follow-up assessments 2. concurrent participation in another study involving investigational drugs or investigational medical devices 3. inability to read and understand the necessary study documents

Keywords: enlarged mediastinal nodes enlarged hilar lymph nodes
single dose, dose escalation healthy volunteers study of pf-05105679

Conditions: Healthy Volunteers

Summary: this is a two part study. the purpose of the first part (part a) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of pf-05105679. the second part (part b) of this study will focus on the exploratory pharmacodynamics of pf-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. the doses selected in part b will have been administered previously in the part a of the study.


Eligibility criteria:
inclusion criteria: healthy volunteers exclusion criteria: standard healthy volunteers

Keywords: pharmacokinetics safety tolerability pharmacodynamics
online stress management and coping skills training for women with breast cancer

Conditions: Breast Cancer

Summary: stress management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer. this study will evaluate an online version of a stress management intervention for women with early stage breast cancer. each chapter of the 10-week intervention include self-assessment and targeted feedback, education, interactive learning exercises -- all tailored to the needs of women with early stage breast cancer. in addition, guided writing exercises will promote emotional expression and a discussion board will encourage group support. the web-based intervention is being evaluated in a randomized clinical trial with a sample of 120 women with early stage breast cancer. women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone.

stress management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer. this study will evaluate an online version of a stress management intervention for women with early stage breast cancer. each chapter of the 10-week intervention include self-assessment and targeted feedback, education, interactive learning exercises -- all tailored to the needs of women with early stage breast cancer. in addition, guided writing exercises will promote emotional expression and a discussion board will encourage group support. the web-based intervention is being evaluated in a randomized clinical trial with a sample of 120 women with early stage breast cancer. women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone.

Eligibility criteria:
inclusion criteria: * diagnosis of stage 0, i, ii or iii breast cancer within past 18 months * elevated stress, distress or negative mood * access at least 1.5 - 2 hours per week to a computer with audio capabilities that is connected to the internet * ability to read, write, and speak english at a sixth grade level * access to a telephone and an active e-mail account exclusion criteria: * cancer diagnosis is a recurrence * diagnosis of schizophrenia * use of anti-psychotic medication * diagnosis of bipolar disorder without use of mood stabilizing medication

Keywords: stress depression anxiety web internet coping
international pms study - kogenate bayer

Conditions: Hemophilia A

Summary: to evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of kogenate bayer in home treatment either on prophylaxis or on demand. to evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.


Eligibility criteria:
inclusion criteria: * patients with severe haemophilia a (\<2% fviii baseline plasma levels) treated with kogenate bayer as their only source of recombinant fviii exclusion criteria: * exclusion criteria must be read in conjunction with the product information (smpc)

Keywords: hemophilia a recombinant factor viii
positron emission tomography assessment of ketamine binding of the serotonin transporter

Conditions: Depression; Ketamine

Summary: the study at hand is the first to investigate ketamine's sert binding in humans, by utilizing the highly selective sert radioligand \[11c\]dasb and positron emission tomography.

intravenous application of ketamine is currently dramatically gaining in significance as a rapid and highly effective antidepressant treatment option. ketamine modulates various neurotransmitter systems, though the mechanisms responsible for its antidepressant effects remain unkownn. however, the serotonin transporter (sert) presents a target of high interest due to the sert's fundamental role in depression's pathophysiology as well as in antidepressant response. the study at hand is the first to investigate ketamine's sert binding in humans, by utilizing the highly selective sert radioligand \[11c\]dasb and positron emission tomography. further, investigation of severely depressed patients provides the unique opportunity to establish the relationship between ketamine's sert binding and its antidepressant efficacy.

Eligibility criteria:
inclusion criteria: * 18-55 years * somatic health * severe unipolar depression according to dsm-iv (scid) und ham-d (for patients) * capable of giving informed consent * negative pregnancy test (females) exclusion criteria: * severe somatic illness * psychiatric disorder (for healthy controls) * an axis i comorbidity other than mdd , other than anxiety symptoms (for patients) * clinically relevant alterations in blood draw, ecg, and somatic testing * substance dependency disorder * intake of psychopharmacological medication in last 6 months * first degree relative with axis 1 disorder (for pilot i study)
a new method for treatment of deep venous insufficiency: early results of vein restoration treatment(vrt)

Conditions: Primary Varicose Veins

Summary: to present the 9. months clinical results of percutaneous ven restoration therapy (vrt), a new method in the treatment of primary femoral vein insufficiency.twenty four patients diagnosed with isolated primary femoral vein insufficiency between january 2020 and december 2020 were included in the study. before the procedure, junctional femoral vein diameters and reflux times were measured. ceap classification and venous clinical severity scores (vcss) were recorded. chronic venous insufficiency questionnaire (civiq-20) were also recorded. then, vrt was applied percutaneously to the anterior and posterior of the femoral veins of the patients, and the diameter of the femoral vein was narrowed and valve coaptation was achieved. after the procedure, vein diameters and reflux times were measured again. all parameters were reevaluated by calling patients for control at 1.,3., 6. and 9. months.


Eligibility criteria:
inclusion criteria: * patients with isolated deep venous insufficiency, without accompanying superficial venous insufficiency, * volunteering to take part in the study were included exclusion criteria: * post-thrombotic or congenital deep venous insufficiency * venous reflux disease in the gsv diagnosed by clinical symptoms * local or systemic infection

Keywords: deep venous insufficiency,
therapeutic adherence of multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: the goal of this study is to assess the role of sociocognitive and interpersonal factors in the therapeutic adherence of multiple sclerosis patients. this study will provide a better understanding of the socio-psychological issues associated with different types of non-adherence to treatment, and identify the risk factors and vulnerability of each patient.

multiple sclerosis is a chronic and progressive disease that affects young adults (between 20 and 40 years old), impacting significantly the patients quality of life. the adherence to therapy affects the long-term functional clinical course (lower risk of relapses, reduction in disability progression and quality of life). the non-adherence rate to therapy in multiple sclerosis is estimated at 40%. the main identified causes of non-adherence are: forgetting to take treatment and adverse effects of drugs. sociocognitive models as the theory of planned behaviour (tpb) have been developed to help to understand and predict health-related behaviours. this model postulates that the intention to adopt a behaviour is one of the major determinants in the context of health. this intention comes from three independent elements : * personal positive or negative attitudes towards the behaviour, * social expectations or entourage perception (subjective norms), * difficulty in accomplishing this behaviour (perceived control) multiple sclerosis adherence to therapy studies have mainly focused on somatic variables (physical disability, illness duration, type of treatment) and some clinical variables (cognitive impairment, fatigue, depression). the few studies that have examined the multiple sclerosis therapeutic adherence determinants have mainly taken a one-dimensional perspective, such as perceived control. in the felsa-sep study, the role of sociocognitive factors (norms and beliefs, perceived threat to disease and health behaviours) and interpersonal factors (social support, patient-doctor relationship) will be explored.

Eligibility criteria:
inclusion criteria: * multiple sclerosis defined according to mcdonald criteria; * already undergone or beginning substantive treatment (self-managed, excluding treatment administered in hospital) * aged ≥ 18 years; * given the informed consent form. exclusion criteria: * severe cognitive impairment (score below the 5th percentile); * any associated neurological pathology or serious or chronic somatic disease (cancer); * being under a legal protection measure.

Keywords: theory of planned behaviour therapeutic adherence sociocognitive and interpersonal factors
respiratory stability and vegetative coupling during neonatal skin-to-skin care

Conditions: Premature Infant

Summary: the main purpose of this study is to identify and to determine the involvement of cardio-respiratory coordination mechanisms during ssc between the preterm infant and his (her) parent.

the skin to skin care (ssc) is a technique that proceeds by laying the neonate ventrally on the parent's chest. many positive effects are recognized as due to ssc i.e, maintaining the infant's body temperature, better sleep organization, neurocognitive development and cardio-respiratory stability, more strength in parent-infant affective relations, reduction in neonatal and parental stress, more success in feeding with breast milk. nowadays, ssc is generalized in modern neonatal intensive care units as part of developmental care. however, the mechanisms involved in ssc are not totally understood. the hypothesis in this study is that the cardio-respiratory stability results partially from the intervention of the coordination between cardiac and respiratory activities. these suppose the involvement of complex mechanisms of cardio-respiratory coordination including neuro-autonomous loops with chemoreceptors and baroreceptors, bulbar vasomotor and respiratory regulatory centers, ortho-parasympathetic neuronal and chemical pathways and cardiac, vascular and lung effectors. in this study the identification of these characteristics will be performed by processing signals of ecg, sao2 (arterial oxygen saturation), respiratory movements, perfusion index, cutaneous and ambient temperature extracted from the clinical monitoring systems. each preterm infant included in the study will be explored twice, 5-10 days apart. the explorations will be carried out on 3 steps: before (at least 30 minutes), during (at least 60 minutes) and after (≥ 60 minutes) the ssc session. each patient will participate in the study for 10 days at maximum. inclusions in the study will last for a total period of 18 months and 10 days. the cardio-respiratory coordination will be assessed using coordigram technique, corresponding to the proportion of time with \> 0.7 amplitude on spectral density.

Eligibility criteria:
inclusion criteria: * premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age * at least 72 hours postnatal age * benefiting skin-to-skin care exclusion criteria: * severe congenital malformation and nervous system dysfunction (e.g., ondine sd) * septic shock * mechanical ventilation support * severe pulmonary arterial hypertension * analgesia morphinics at high dosage and curare
a clinical trial to study the effects of grc 17536 in patients with painful diabetic neuropathy (painful extremities due to peripheral nerve damage in diabetic patients)

Conditions: Painful Diabetic Neuropathy

Summary: diabetic peripheral neuropathy (dpn) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (qol), morbidity, and costs from a public health perspective. painful diabetic neuropathy affects 16% of patients with diabetes. pharmacological agents used in the management of painful dpn mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioids, and anti epileptic drugs. however, only two drugs (duloxetine and pregabalin) have been formally approved by the emea and the us fda for the treatment of painful dpn. generally, the available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. hence newer therapies are required for the treatment of dpn. this is randomized, double-blind, placebo-controlled, parallel group study. the study will include patients with type 1 or type 2 diabetes mellitus with history of pain attributed to dpn for least 6 months and no greater than 5 years. patients will be recruited after providing written informed consent.


Eligibility criteria:
inclusion criteria: 1. patients willing to provide voluntary written informed consent 2. male and female (women of non child-bearing potential) patients ≥18 yrs and ≤ 75 yrs 3. patients with diabetes mellitus with painful peripheral neuropathy for at least 6 months 4. a baseline 24-hour average daily pain intensity score ≥5 5. women must be of non child-bearing potential, defined as post menopausal or surgically sterile. exclusion criteria: 1. other chronic pain conditions not associated with dpn, that may confound the assessment of neuropathic pain 2. other causes of neuropathy or lower extremity pain 3. complex regional pain syndrome or trigeminal neuralgia 4. lower extremity amputations other than toes 5. participation in another study with an investigational compound within the previous 90 days prior to study medication administration, or concurrent participation in another clinical study 6. major depression. 7. presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. 8. patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that according to investigator's medical judgment: could interfere with the accurate assessment of safety or efficacy, or, could potentially affect a patient's safety or study outcome
the role of endogenous gip in glycosis metabolism during fasting

Conditions: Obesity

Summary: this research project aims to investigate the role of endogenous gip during fasting. with the infusion of a gip receptor antagonist (gip\[3-30\]nh2), is it possible to selectively remove the effect of endogenous gip, and thus describe its effects by comparing it with what happens during a saline infusion.

this research project investigates the effects endogenous gip has in the body of healthy, overweight people. two trial days will be held. the participant will receive intravenous infusion of either gip\[3-30\]nh2 (800 pmol/kg/min) or placebo (saline) in a randomized order. after 20 minutes, gip\[3-30\]nh2 is expected to have maximum effect. on time of 180 minutes, an ad libitum meal is served, which is consumed during continued infusion. when the participant is comfortably full, the infusion is turned off and the trial day ends. during the day, the participant assesses and notes on standardized vas schedules current appetite, satiety, nausea, fatigue, malaise and thirst. blood pressure and heart rate are measured every 30 minutes throughout the trial day and blood samples are taken. in total, there will be drawn ten blood samples between intervals of 15 to 30 min. three times along the way, the activity in the brown adipose tissue is measured with a thermal camera (temperature measurements over the skin on the chest) and the resting metabolic rate is determined with indirect calorimetry (inhaled and exhaled air is captured by breathing under a large plastic bell).

Eligibility criteria:
inclusion criteria: * 18-70 years * bmi \> 30 kg/m2 * body fat percentage \> 25 % for men og \> 35 % for women exclusion criteria: * type 1 diabetes and/or type 2 diabetes diagnosis * other chronic condition * treatment with medications or supplements that cannot be paused for 12 hours * \> 14 units of alcohol weekly or drug abuse * circulating liver enzymes (alanine aminotransferase (alat) and/or aspartate aminotransferase (asat)) ≥ 2 × normal value * renal impairment (egfr \< 90 or creatinine level above the reference range) * uncontrolled high resting blood pressure (above 140/90 mmhg) * low blood percentage (hemoglobin \< reference range (different for women and men)) * special diet or planned weight change within the trial period * any disease/condition that investigators believe will interfere with study participation