Kornimate/medical-research-clean huggingface dataset:
improve: integrating emotion focused components into psychological therapy

Conditions: Unipolar Depression; Anxiety Disorder; Adjustment Disorder

Summary: the primary purpose of this study is to compare the efficacy of two treatment-as-usual (tau) conditions: tau with integration of emotion focused components (eft) and tau with focus on self-regulation (sr). especially the long-term efficacy is evaluated with a focus on differential effects. moreover, the mechanisms of change of both conditions are investigated.

background: "general psychotherapy" postulates an ongoing process of including all interventions and concepts relevant for a domain, be they from other approaches to psychotherapy or concepts from basic science. "psychological therapy" (pt) is a therapeutic approach largely corresponding to the ideas of general psychotherapy. it draws mainly on empirically validated interventions from cognitive behavior therapy (cbt) and is based on concepts with a strong basis in academic psychology and neighboring fields. pt is based on explicit individual case conceptualization, reference to general therapeutic factors, and an explicit prescriptive concept for building and maintaining the therapeutic relationship. however the range of emotion-related interventions commonly used in pt is limited when compared with an approach like emotion focused therapy (eft). eft appears thus as a suitable complement and enrichment to pt as commonly practiced. however, effects of integrating eft-based interventions in a way that is close to common integrative practice have not yet been studied. objective: to compare the efficacy of two treatment-as-usual (tau) conditions: tau with integration of eft components and tau with focus on self-regulation (sr). methods: in switzerland, a randomized-controlled trail will be carried out in secondary care, comparing the efficacy of tau - eft and tau - sr for adults with major depressive disorder, anxiety disorder or adjustment disorder. respondents will be followed until 36 months after end of therapy (measures will be taken at baseline, after 8 and after 16 weeks, at the end of therapy after 25 weeks, 6 months, 12 months and 36 months follow-up).

Eligibility criteria:
inclusion criteria: * major depressive disorder, anxiety disorder or adjustment disorder according to dsm-iv as main diagnosis * minimum age of 18 years * mastery of the german language for being able to undergo a psychotherapy in german * written informed consent to participate voluntary in the study exclusion criteria: * acute suicidality or immediate threats of self-harm * diagnosis or history of a psychotic disorder * mood incongruent psychotic symptoms * bipolar disorder * comorbid chronic organic disorder * substance use disorder as a main diagnosis * indication for a residential treatment
phase ii hdm-spire safety and efficacy study

Conditions: Rhinoconjunctivitis

Summary: the purpose of this study is to compare the treatment effect of three treatment regimens of hdm-spire vs placebo and to evaluates the treatment effect of hdm-spire on symptoms, rescue medication usage, quality of life and sleep quality


Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 years. * moderate to severe rhinoconjunctivitis on exposure to hdm for at least 1 years. * mean trss ≥10 * positive skin prick test to der p and der f. * dep p and der f specific ige ≥0.7 ku/l exclusion criteria: * diagnosis of asthma requiring global initiative for asthma (gina) step 3 (www.ginasthma.org)or higher treatment * fev1 \<80% of predicted. * clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period. * significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms. * clinically relevant abnormalities detected on physical examination. * history of severe drug allergy, severe angioedema or anaphylactic reaction to food.

Keywords: cat allergy rhinoconjunctivitis
efficacy and safety study of adjunctive troriluzole in obsessive compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with obsessive compulsive disorder (ocd)


Eligibility criteria:
inclusion criteria: 1. primary diagnosis of obsessive-compulsive disorder (ocd) as per diagnostic and statistical manual of mental disorders, fifth edition as confirmed by the mini at screening; the duration of the subject's illness must be ≥ 1 year 2. an inadequate response to current standard of care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by uspi labeling); an inadequate response as defined per the mgh-trq-ocd, there has been minimal or no meaningful clinical benefit as perceived by the subject 3. determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. subjects must be physically able and expected to complete the trial as designed exclusion criteria: 1. subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the mgh-trq-ocd. 2. current or prior history of: bipolar i or ii disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, tourette's disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery, deep brain stimulation (dbs) or electroconvulsive therapy (ect); or general medical condition that may confound safety and/or efficacy results 3. previous treatment in a study with troriluzole

Keywords: obsessive-compulsive disorder ocd
improving survey procedures for young men who have sex with men in web-based hiv prevention: retention study

Conditions: Healthy

Summary: the purpose of this study is to test the efficacy of alternative methods to improve survey completion.

men who have sex with men (msm) are the risk population most heavily impacted by hiv in the united states by any measure; in 2009, at least 61% of new hiv infections were estimated to have occurred in msm. msm are experiencing an increase in hiv transmission that has been occurring since at least 1990, and accelerated in multiple north american and european countries from 2000-2005. the expansion of the hiv epidemic has been proposed to be attributable, in part, to the extent to which the internet has facilitated sexual connectivity among msm. researchers have attempted to reach msm for hiv prevention research and intervention on the internet. in the past 10 years, there has been a proliferation of internet surveys and hiv research studies among men who have sex with men that utilize the internet for data collection and, in some cases, the delivery of hiv prevention content. the development of internet-based interventions has been recently identified as especially promising because of its potential for scalability. however, there are also important limitations to internet-based data collections and prevention studies. the most important of these relate to representativeness and opportunities to introduce bias to data collections and differences in access to and use of internet among different subgroups of msm. equally important, although less discussed, are the unique ethical and human research protections challenges posed by online sexual health prevention studies. the investigators will conduct an experiment to improve knowledge of how to conduct internet-based hiv prevention research with msm in ways that decrease biases in data collections. the design will consist of a randomized controlled trials of msm recruited online. a total of 1000 msm will be enrolled to determine how to best improve retention in online surveys.

Eligibility criteria:
inclusion criteria: * male * aged 18 to 34 years * have had sex with another man in the past 12 months exclusion criteria: * female or transgender * younger than 18 years of age * older than 34 years of age * have not had sex with another man in the past 12 months.
autologous cell therapy for ischemic heart failure

Conditions: Ischemic Heart Disease

Summary: the aim of this clinical study is to investigate the safety and feasibility of autologous muscle-derived cells (amdc; a preparation of a patient's own cells) as a treatment for patients with advanced heart failure caused by ischemia.


Eligibility criteria:
inclusion criteria: * age greater than 18 but less than 80 years * prior myocardial infarction * depressed left ventricular ejection fraction (lvef) ≤ 35% * nyha functional classification of ii to iv exclusion criteria: * not under stable optimal medical management * cardiac surgery or percutaneous coronary intervention within 3 months * occurrence of myocardial infarction (mi) within 6 months, in the case of first mi, or 3 months, in the case of any subsequent mi * prior cell, gene, or transmyocardial laser revascularization therapy * ventricular wall thickness in target region ≤ 5 mm * moderate to severe aortic valve stenosis or mechanical valve replacement * left ventricular aneurysm or thrombus * left ventricular dysfunction associated with a reversible cause * vascular disease preventing percutaneous vascular access * history of myopathic disease * history of neoplasia within 5 years, except for basal cell carcinoma * receiving or planning to receive anti-cancer medications * serum creatinine \> 3.0 mg/dl * pregnant, planning to become pregnant, or breastfeeding a child in the next 18 months * life expectancy of less than 1 year * morbid obesity (defined as bmi \> 35) * history of bleeding diathesis or coagulopathy * positive for hiv, hepatitis b, or hepatitis c * known hypersensitivity or contraindication to study product or treatment procedure * enrolled in another research project at the time of enrollment * unable to provide informed consent * unable or unwilling to commit to the follow-up clinical procedures

Keywords: cell therapy heart failure heart disease myocardial infarction myocardial ischemia autologous muscle-derived cell
does acl augmented with leat better controls rotational laxity than isolated acl reconstruction?

Conditions: Anterior Cruciate Ligament Injuries

Summary: it has been suggested that adding a lateral extra-articular tenodesis (leat) to anterior cruciate ligament (acl) reconstruction has the advantage of better controlling the rotational laxity. the objective of this study is to compare the the sagittal and rotational knee laxity using the porto knee testing device (pktd) - a mri-compatible arthrometer - at 2 years follow-up (side-to-side and to baseline comparison) in patients that underwent isolated acl reconstruction (isolated acl) versus acl reconstruction combined with leat (acl+leat). patient-reported outcome measures using the knee injury and osteoarthritis outcome score (koos) and graft failure (re-tear) will also be assessed at 2 years follow-up.

this study is a non-randomized clinical trial including 40 patients with anterior cruciate ligament injury who are undergoing surgery and will be allocated 1:1 to either isolated acl reconstruction (control group) or acl reconstruction combined with lateral extra-articular tenodesis (experimental group). the principal outcome of this work is the sagittal and rotational knee laxity analysis and side-to-side and 2-year improvement. the secondary outcomes include graft failure (re-tears) and the patient-reported outcome measures (koos) at 2 years follow-up.

Eligibility criteria:
inclusion criteria: * no previous knee surgeries * contralateral healthy knee * positive pivot-shift (++) exclusion criteria: * revision acl surgery * acl reconstruction using allograft or synthetic grafts * multi-ligament injury * pregnant female * other injuries or conditions that may alter the knee function (eg. severe osteoarthritis) * requiring concomitant osteotomy * requiring concomitant cartilage surgery (other than debridement)

Keywords: anterior cruciate ligament reconstruction lateral extra-articular tenodesis knee laxity porto knee testing device
patient-reported outcome after status epilepticus

Conditions: Patient Reported Outcomes; Long Term Outcomes; Status Epilepticus; Intensive Care Unit; Intensive Care Unit Syndrome

Summary: status epilepticus (se) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. se remains associated with considerable mortality and morbidity, with little progress over the last three decades. the proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory se. morbidity is more difficult to evaluate, as adverse effects of se are often difficult to differentiate from those attributed to the cause of se. our experience suggests that nearly 50% of patients may experience long-term functional impairments. the precise description of the consequences of these functional impairments and their impact on quality of life after se requiring intensive care management has been little studied. indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term post-resuscitation syndrome (pics), neuronal lesions consecutive to the se itself or to its cause could be responsible for these different functional alterations. thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress. assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. here, we propose the development of a cross-sectional collection of pros of the different constituents of pics and hr-qols, and associated with functional patient outcomes, in those who required icu management for status epilepticus.


Eligibility criteria:
inclusion criteria: * adults 18 years old or older * patients previously included in the ictal registry (status epilepticus cohort nct03457831) * survivors after icu management for status epilepticus more than 3 months and less than 5 years after icu discharge exclusion criteria: * legal guardianship * opposition to participate * unread and unwritten french language * patient not affiliated to a social security system
observational analysis of t cell responses to spires for multiple allergens in subjects with allergy in north america

Conditions: Allergy

Summary: this is a research study intending to look at the response of a specific type of allergy cells in the blood (called t cells) to a a type of immunotherapy product known as spires (synthetic peptide immuno-regulatory epitopes), across a broad range of subjects. this is a non-interventional study in which no investigational product will be administered to any subject.


Eligibility criteria:
inclusion criteria: 1. male or female, aged 18-65 years. 2. willing and able to provide written informed consent. 3. one year history of allergic rhinoconjunctivitis to one or more of cat, short ragweed, rye grass, or hdm. 4. positive skin prick test to each allergen for which a subject has a qualifying clinical history. exclusion criteria: 1. clinically relevant history of alcohol or drug abuse. 2. use of any oral or parenteral (except low dose inhaled) corticosteroids within 2 months prior to the visit or any other immunosuppressive therapy within 3 months prior to the visit. 3. vaccination/ inoculation within the 6 weeks prior to the first visit. 4. a history of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis). 5. subjects who have taken an investigational drug within 6 weeks prior to the visit or are currently participating in any other clinical study. 6. recent blood donation of an amount of \>100 ml. 7. immunotherapy within the last 5 years to any of the allergens for which a subject would otherwise be eligible on the basis of clinical history and skin prick test result.

Keywords: rye grass ragweed cat house dust mite
study evaluating 13-valent pneumococcal conjugate vaccine in healthy infants in india

Conditions: Pneumococcal Infections

Summary: the purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vpnc) compared to prevenar (7vpnc), when given concomitantly with routine paediatric vaccinations in india.


Eligibility criteria:
inclusion criteria 1. healthy infants aged 6 weeks (42-72 days) at time of enrolment 2. available for the entire study period exclusion criteria 1. previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or hib vaccines 2. a previous anaphylactic reaction to any vaccine or vaccine-related component 3. contraindication to vaccination with pneumococcal, hib, diphtheria, tetanus, pertussis, polio, hepatitis b or measles vaccines

Keywords: vaccines, pneumococcal
therapeutic evaluation of lower-level laser for treating dentinal hypersensitivity

Conditions: Dentinal Hypersensitivity

Summary: the aim of this study was to evaluate the efficacy of low energy laser for the treatment of dentinal hypersensitivity due to periodontal therapy.

we will recruit 80 adult patients with obvious symptom of hypersensitivity after periodontal therapy. they will receive low-energy laser treatment, and the area without the symptom of hypersensitivity will be served as control. changes in pain status and clinical periodontal index within six months of treatment will be recorded.

Eligibility criteria:
inclusion criteria 1.20-80 year-old with their own will and oral cleaning ability 2.patients who have been diagnosed with periodontitis and have completed periodontal treatment 3.gingival recession in at least two regions showed sensitivity of teeth (vas\> 5) 4.no systemic infection 5.no painkillers in the past two weeks 6.not pregnant or lactating exclusion criteria 1.smoking more than half a pack a day in the past month

Keywords: dentistry dentinal hypersensitivity lower-level laser therapy
fast reversal of warfarin and early surgery in patients with trochanteric hip fracture a case-control study

Conditions: Trochanteric Hip Fractures; Warfarin Medication; Early Surgery

Summary: a retrospective case-control study. to evaluate if early surgery within 24hours of troch or subtrochanteric hip fractures using intramedullary nailing is safe in patients on warfarin treatment after fast reversal of the warfarin effect


Eligibility criteria:
exclusion criteria: * pathological fracture * late presentation to the hospital * other injuries

Keywords: hip fracture surgical treatment warfarin anticoagulation treatment intramedullary nailing
a prospective cohort study to evaluate the oncotype dx® test in early stage breast cancer

Conditions: Breast Cancer

Summary: a prospective population-based cohort study is being conducted in ontario to evaluate whether the performance of oncotype dx® changes the treatment recommended and the treatment received in women or men with node negative, er positive breast cancer who are receiving (or will receive) endocrine therapy and who are candidates for chemotherapy. one thousand eligible consenting women and men will have their tumor tissue specimen sent to genomic health where the oncotype dx® assay will be performed.

the evidence supporting the adoption of oncotype dx® is relatively weak by the criteria used by the ontario health technology advisory committee (ohtac). there is only one small published prospective study that reports on oncotype dx® changing clinical management. the economic models that estimated the potential advantages of using an oncotype dx® guided treatment strategy may have overestimated the benefits because they assumed that all patients with tumors \>1cm in the absence of oncotype dx® testing would receive chemotherapy in addition to tamoxifen, and that the magnitude of benefit with chemotherapy over tamoxifen is relatively large, i.e. reduces recurrence risk by 74% and associated with an absolute benefit of 28%. (the benefit comes from one trial and is applied to all patients). it is estimated that there are about 3,300 incident cases with node negative, er positive, her2 neu negative tumors annually in ontario, it is important to evaluate the adoption of this test for decision making in ontario.

Eligibility criteria:
inclusion criteria: * women or men with histologic evidence of invasive breast cancer (ductal, lobular or mixed disease). * surgical resection including breast conserving surgery or modified radical mastectomy or simple mastectomy, within the last four months. * axillary lymph nodes assessed for tumor by: (i) sentinel node biopsy, or (ii) axillary node dissection, or (iii) both * axillary lymph node assessment negative for cancer, or positive only for micrometastases (i.e., cancer \<2mm by h\&e stain). * tumor is estrogen receptor (er) positive. * receiving or to receive adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitor). * being considered for adjuvant chemotherapy. exclusion criteria: * axillary lymph node positive for cancer. * patients with inoperable locally advanced breast cancer. * metastatic breast cancer, including local ipsilateral recurrence. * her2 neu positive. * physician/patient unwilling to comply with study protocol. * inability to provide informed consent (e.g. dementia or severe cognitive impairment).

Keywords: breast cancer oncotype dx adjuvant! online decisional conflict scale