Kornimate/medical-research-clean huggingface dataset:
family based treatment of depressed adolescents

Conditions: Depressive Disorder; Mood Disorder; Major Depression

Summary: the purpose of this project is to assess the effectiveness of a family-based therapy (attachment based family therapy-abft) for norwegian adolescents (13-17 years) referred to specialist mental heath clinics.

depression is a major public health concern among adolescents. research suggests that it not only is prevalent among adolescents (as many as 20% of adolescents have a depressive episode by the age of 18), but its effects last well into adulthood. although available studies of psychosocial and pharmacological interventions show promise, there are concerns regarding their effectiveness and possible side effects like increase in suicidal ideation. family conflict is not only an effect of depression, but also a risk factor for depression. high conflict and dysfunction, have consistently been shown to increase risk for depression. as such, family treatments that target risk and protective factors (e.g., quality of parent-child interaction, parental monitoring) for depression seem promising to reduce depression. the current study is a randomized clinical trail aimed at assessing the effectiveness of a 12-week family based intervention for depressed adolescents (attachment based family therapy- abft). adolescents referred to specialist mental health hospital in south-west norway (stavanger university hospital) will be randomized to either abft or treatment as usual (tau). therapists administering both the experimental and control group intervention are regular staff clinicians. outcome assessments would be carried out at baseline, 6, 12 and 26 weeks by raters blind to the condition of the treatment.

Eligibility criteria:
inclusion criteria: * 13-17 years * referred to specialist mental health hospital * ham-d score of \>14 * meets diagnostic criteria for major depressive disorder or depression nos * have a parent or guardian willing to participate exclusion criteria: * suicidal and require in-patient care * low intellectual abilities * current psychosis * primary caregiver unwilling to participate

Keywords: depression family therapy adolescents
maximizing outcomes in treating acute migraine

Conditions: Migraine

Summary: axs-07 is an oral, investigational medicine consisting of moseic meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. axs-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. this study is designed to evaluate the efficacy and safety of axs-07 compared to meloxicam, rizatriptan, and placebo for the treatment of a migraine attack. this is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either axs-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.


Eligibility criteria:
key inclusion criteria: * has an established diagnosis of migraine with or without aura. * has experienced an inadequate response to prior acute treatments. key exclusion criteria: * has previously received any investigational drug or device or investigational therapy within 30 days before screening. * pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

Keywords: migraine axs-07 meloxicam rizatriptan axsome axsome therapeutics moseic meloxicam
trial to assess the efficacy and safety of spm 927 (200, 400, and 600mg/day) in subjects with painful distal diabetic neuropathy

Conditions: Diabetic Neuropathies

Summary: this phase 3 trial is being conducted at approximately 80 sites in the united states (u.s.) to investigate whether lacosamide (spm 927) at different doses reduces pain in subjects with diabetic neuropathy. approximately 455 subjects will be randomized to placebo or to one of three doses of lacosamide. to qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of greater than or equal to 4 on an 11-point likert scale (0-10 scale) during the 7 day period prior to the start of treatment. to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening; and pain interference with sleep (morning) and activity (evening). use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. in addition, the safety and tolerability of the different doses of lacosamide will be investigated.


Eligibility criteria:
inclusion criteria: * diabetic neuropathy exclusion criteria: * subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial.
cayenne pepper cataplasm - effect study

Conditions: Back Pain; Low Back Pain

Summary: the beneficial analgesic effects of rubefacenciae (redden skin substances), is known since 1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. herbal cataplasms containing rubefacient substances, such as cayenne pepper, are commonly used as natural medications to treat painful or aching areas in the case of acute or chronic back pain, and rheumatisms. in vienna and lower austria, a cayenne pepper cataplasm (cpc) application containing cayenne pepper and kaolin powder in mixed proportion, is commonly used to treat musculoskeletal conditions of pain especially of the low back. therefore, the aim of the present study was to test effects of a series of ten applications of cpc prepared with 5% of pepper, investigating the resulting effect on: skin temperature, skin sensory functions, pain threshold, and proprioception. placebo control condition (0% cayenne pepper) was also tested. it was hypothesized that a series of 20-minute application of a cpc will have significant effects on the measured parameters. 40 subjects will be randomized into treatment/control group.


Eligibility criteria:
inclusion criteria: * chronic lumbar spine pain \>= 3 months * pain during activity vas \>= 4 * oswestry disabilty index \>= 20% exclusion criteria: * pregnancy * sensibility disorders (e.g. due to neurological disease) * injuries, open wounds or rash in intervention area * known hypersensitivity against the applied substances * hiv, hepatitis c and other due blood communicable infectious diseases
efficacy study of oral glecaprevir/pibrentasvir tablet in pediatric (12 years and older) and adult treatment-naive participants with chronic hepatitis c genotypes 1 to 6 and liver cirrhosis

Conditions: Hepatitis C Virus (HCV)

Summary: hepatitis c virus (hcv) infection is among the most common of all chronic liver diseases. hcv predominantly affects liver cells and causes the liver to become inflamed and damaged. this can lead to cirrhosis (scarring of the liver) and liver cancer leaving trial participants with need for liver transplant. the purpose of this study is to see how effective glecaprevir/pibrentasvir (gle/pib) is in a real world setting of participants with chronic hcv genotypes 1 to 6 and liver cirrhosis who have never received any treatment for hcv. gle/pib is a drug developed for the treatment of hcv infection. this is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with hcv genotypes 1 to 6 and compensated cirrhosis. all study participants will receive gle/pib as prescribed by their study doctor in accordance with approved local label. pediatric (12 years and older) and adult participants with a diagnosis of hcv genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in russian federation. participants will receive gle/pib tablets to be taken by mouth daily according to their physicians' prescription. the total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks. there is expected to be no additional burden for participants in this trial. all study visits will occur during routine clinical practice and participants will be followed for 12 weeks.


Eligibility criteria:
inclusion criteria: * treatment-naïve male or female with confirmed chc, genotypes 1, 2, 3, 4, 5, or 6, with compensated liver cirrhosis, receiving combination therapy with the all oral gle/pib regimen for 8 weeks according to standard of care, international guidelines and in line with the current local label. * participants may be enrolled up to 4 weeks after treatment initiation. exclusion criteria: * participating or intending to participate in a concurrent interventional therapeutic trial.

Keywords: hcv, hepatitis c virus hepatitis c liver cirrhosis gle/pib
a study to compare rosuvastatin/ezetimibe and rosuvastatin in patients with diabetes mellitus and hypercholesterolemia

Conditions: Diabetes Mellitus and Hypercholesterolemia

Summary: a study to compare rosuvastatin/ezetimibe combination and monotherapy in patients with diabetes mellitus and hypercholesterolemia.

this trial is conducted to compare the efficacy and safety between rosuvastatin/ezetimibe combination and rosuvastatin monotherapy in patients with diabetes mellitus and hypercholesterolemia for 8 weeks.

Eligibility criteria:
inclusion criteria: * subjects ≥ 19 or ≤ 75 years of age * subjects undergoing treatment for type 2 diabetes * subjects undergoing treatment of statin for hypercholesterolemia * fasting ldl-c ≤ 250mg/dl at the screening visit * fasting ldl-c ≥70mg/dl or ≤ 160mg/dl at the randomization visit * fasting tg\<500mg/dl exclusion criteria: * subjects with hypersensitivity reaction to statin and ezetimibe * subjects with severe kidney disease * subjects with hiv positive result at the screening * pregnant or breast-feeding subjects * subjects with taking any medication affecting level of ldl (fenofibrate, omega 3 fatty aicd etc.) * insulin-treated subjects * other exclusions applied
randomized controlled trial of vitamin d3 in diabetic kidney disease

Conditions: Diabetes Mellitus; Chronic Kidney Disease; Diabetic Kidney Disease

Summary: this study will assess the effects of vitamin d3 supplementation (cholecalciferol; 2000 iu daily) on serum calcium levels, circulating vitamin d levels, and markers of kidney disease and cardiovascular risk among people with diabetes mellitus and early kidney disease. eligibility criteria include type 2 diabetes and stage 1-2 chronic kidney disease, defined by a urine albumin-creatinine ratio 30-300 mg/g and an estimated glomerular filtration rate ≥ 60 ml/min. participants will be randomly assigned to treatment with vitamin d3 or placebo, each taken by mouth once daily for a study duration of one year. study medications will be added to standard treatment, including an angiotensin converting enzyme inhibitor and/or angiotensin ii receptor blocker. we hypothesize that vitamin d3, compared with placebo: (1) is well-tolerated and safe among people with diabetes and kidney disease; (2) results in adequate attained circulating vitamin d levels; and (3) positively affects markers of kidney disease and cardiovascular risk.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes mellitus * urine albumin-creatinine ratio 30-1000 mg/g * estimated glomerular filtration rate greater than or equal to 60 ml/min * treatment with angiotensin converting enzyme inhibitor and/or angiotensin ii receptor blocker for greater than or equal to 6 months, with a stable dose for greater than or equal to 3 months * blood pressure less than 140/90 (assessed while taking medications) * hemoglobin a1c less than 9% (assessed while taking medications) * 25-hydroxyvitamin d less than 30 ng/ml exclusion criteria: * prior dialysis or kidney transplantation * known cause of albuminuria other than diabetes * planning to leave the area within 12 months * life expectancy less than 12 months * participation in another clinical trial within 6 months * osteoporosis or other established indication for vitamin d therapy * vitamin d3 supplement intake greater than 400 iu/day at screening visit * history of nephrolithiasis * serum calcium greater than 10.2 mg/dl * dementia, not fluent in english, or unable to provide informed consent without proxy respondent * incontinent of urine * failure to take greater than or equal to 80% of placebo pills during study run-in

Keywords: diabetes mellitus type 2 diabetes chronic kidney disease diabetic kidney disease microalbuminuria albuminuria vitamin d cholecalciferol kidney renal cardiovascular clinical trial placebo
multicenter trial assessing an innovative vas of pain among deaf people

Conditions: Deafness; Visual Analog Pain Scale

Summary: the purpose of this study is to assess an innovative visual analogue scale of pain (pictorial vas) versus the usual vas (vas) among deaf people. the assumption of this study is that pictorial vas is more suited to deaf people than usual vas.

indeed french literature showed that 80% of deaf people are illiterate. moreover, lip-reading only allows to recognize one third of words. pictorial vas includes elements which promote understanding of deaf people: colours and 6 detailed expressive faces.

Eligibility criteria:
inclusion criteria: * people aged over 18 years old * deaf people * affiliation to the french social security system or equivalent * people who signed the consent form exclusion criteria: * hearing people * people who became deaf * pregnant or breastfeeding women * people deprived of freedom * people hospitalized without consent

Keywords: visual analog pain scale deaf persons clinical trial multicentric
prevention of pnx and haemorrhagic complications in diagnostic percutaneous lung biopsy using the mipp-kit device

Conditions: Complications in Diagnostic Percutaneous Lung Biopsy Procedures

Summary: the study will assess the safety and feasibility of a new medical device, mipp-kit, for the prevention of complications during diagnostic, ct guided ,percutaneous lung needle biopsy.


Eligibility criteria:
inclusion criteria: * clinical indication for diagnostic percutaneous lung biopsy exclusion criteria: * pregnant, or breastfeeding patient (female) * actively participating in other clinical trials in the previous 30 days * known allergies to the investigational device components * comorbidities that preclude undergoing percutaneous lung biopsy procedure * concomitant treatments that preclude undergoing percutaneous lung biopsy procedure

Keywords: lung biopsy, pneumothorax, interventional radiology
quantitative evaluation of attention to faces after orthognathic surgery with eye-tracking

Conditions: Dentofacial Deformities; Orthognathic Surgery; Social Perception; Eye Tracking

Summary: dentofacial deformities refer to morphological anomalies of the jaws. their development during growth determines the shape of the lower third of the face and the type of dental occlusion. a maxillo-mandibular dysmorphosis associates morphological modification of the face and anomaly of the occlusion. if these anomalies are most often hereditary, they also depend on acquired factors such as swallowing, breathing, sucking or phonation disorders. angle's classification defines three classes of dental occlusion: class i, when the ratio between the maxillary and mandibular first molars is normal, class ii when the upper molar is too far forward, and class iii when it is too far back. class ii and iii dysmorphoses can result in an alteration of the masticatory function, pain (tmj, headaches) or sleep apnea. at the same time, they cause patients to experience a decrease in self-esteem, anxiety and social discomfort. class ii and ii usually require orthodontic treatment and orthognathic surgery to correctly align the jaws. this surgery has a positive impact on the dental occlusion and the functions concerned, but also on the facial morphology, all of which often leads to an improvement in the patient's quality of life. standardized photographs presenting control subjects (class i) and patients (class ii and class iii) before and after surgery will be included in an approximately 10 min video sequence. naive participants will look at this sequence during which the faces of the controls and the patients - before and after surgery - will alternate, with the instruction being free visual exploration of the images. the total fixation durations in defined areas of interest (eyes, nose, mouth, chin) will be recorded with an eye tracking device and the results will be processed using a dedicated software.


Eligibility criteria:
inclusion criteria: * naïve subject with regard to dentofacial deformities and their management * subject with no known facial pathology * subject having provided an informed consent * subject \> 18 years old exclusion criteria: * subject familiar with dentofacial deformities and their management (e.g., health professionals in the relevant specialties) * subject with known facial pathology (dentofacial deformity or other) * subject under guardianship, curators or justice protection

Keywords: dentofacial deformities orthognathic surgery social perception eye tracking
escalation study to determine bioavailability of a single oral dose of decitabine in patients with myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to determine how the body absorbs decitabine when taken orally in patients with myelodysplastic syndrome (mds). safety will also be assessed for this oral dose.

cohorts are dosed sequentially, and escalation may stop before the 5th cohort is dosed. each cycle will be approximately 4 weeks in length. following cycle 1, patients may receive an additional 4 follow-up cycles of decitabine. cycles 2-5 will include a 20 mg/m\^2 1-hour iv infusion of decitabine on days 1-5 for all cohorts.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed de novo or secondary mds. 2. age greater than or equal to 18 years. 3. eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. 4. adequate renal and hepatic function (creatinine less than or equal to 2.0 mg/dl, total bilirubin less than 2.0 mg/dl, aspartate aminotransferase \[ast\] or alanine aminotransferase \[alt\] less than 3 times the upper limit of normal). 5. life expectancy of at least 6 weeks. 6. if currently receiving 5 day decitabine regimen, patient must be scheduled to receive one more cycle of 5 day decitabine. 7. recovered from all toxic effects of all prior therapy before entry into this study. 8. women of childbearing potential and all men must agree to practice a medically approved form of contraception (one of the following must be used: condoms \[male or female\] with a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, intrauterine device, hormonal contraception, abstinence) during the course of the study and up to 2 months following the last dose of decitabine. exclusion criteria: 1. candidates for up front high dose induction chemotherapy. mds patients who are scheduled to receive decitabine prior to a bone marrow transplant or stem cell transplant are allowed. 2. history of treatment failure with decitabine. 3. received any experimental agent within the preceding 30 days prior to screening. 4. uncontrolled cardiac or pulmonary disease. 5. history of intestinal surgery, pancreatic surgery, or gastric surgery. 6. any clinically relevant disease, disorder (including psychiatric disorders), or condition, in the opinion of the investigator, which may interfere with the objectives of the study, especially with the gastrointestinal (gi) absorption of the study drug, and/or with the safety of the subject in the study. 7. current active colitis of any etiology (clostridium difficile colitis, ulcerative colitis, crohn's disease, etc.) or a recent (less than 2 weeks) episode of colitis. 8. pregnant or lactating. female patients of childbearing potential must have had a negative serum pregnancy test at screening and a negative urine pregnancy test on day 1 prior to dosing. 9. known positive serology for human immunodeficiency virus (hiv). 10. active viral, fungal, or bacterial infection. no patient may enter the study unless infections have been fully treated.

Keywords: mds
long-term safety of pf-00547659 in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: subjects with ulcerative colitis who have completed an induction study with pf-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.


Eligibility criteria:
inclusion criteria: * subjects between 18 and 66 years of age. * subjects previously enrolled in study a7281009 (nct01620255) who have completed the 84 day (12 week) induction period. exclusion criteria: * subjects that have completed day 84 (week 12) of study a7281009 but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or participation in this study. * subjects who are taking any dose of azathioprine (aza), 6-mercaptopurine(6 mp) or methotrexate (mtx).

Keywords: anti-tnf refractory active ulcerative colitis immunosuppressant refractory
health values and spirituality in veterans with hiv/aids

Conditions: Quality of Life; HIV; Spirituality

Summary: we have previously shown that: 1) time tradeoff utilities for current health are high, indicating that patients have a strong will to live; 2) half of patients felt that their life was better now than before they were hiv-infected; and 3) certain non-health-related factors such as spirituality and concern and love for one�s children correlated with health values and a sense that life has improved.

background: we have previously shown that: 1) time tradeoff utilities for current health are high, indicating that patients have a strong will to live; 2) half of patients felt that their life was better now than before they were hiv-infected; and 3) certain non-health-related factors such as spirituality and concern and love for one�s children correlated with health values and a sense that life has improved. objectives: 1) to assess health values of veterans and non-veterans with hiv/aids; 2) to characterize spirituality in patients with hiv/aids; 3) to derive a power function relating health ratings to utilities; and 4) to assess whether society assigns higher values to health states for veterans than for non-veterans. methods: we interviewed 100 representative veterans with hiv/aids from the cincinnati and pittsburgh vamcs and, concurrently, 350 non-veterans with hiv/aids from cincinnati and washington, dc, twice over 12-18 months. the patient questionnaire included clinical and demographic data; health values measures; a question comparing life now with life before being infected with hiv; and measures of health status/health concerns, hiv symptoms, depressive symptoms, spirituality/religion, adherence, social support, self-esteem, and optimism. we also assessed how medical house officers rate and value the health state of a hypothetical patient with congestive heart failure, identified either as a 72-year-old veteran or merely as a 72-year-old male. status: data collection completed ahead of schedule. several manuscripts published with others to be submitted soon.

Eligibility criteria:
inclusion criteria: adults with hiv/aids exclusion criteria: