Kornimate/medical-research-clean huggingface dataset:
effectiveness of a short and telematic version of cognitive-behavioral treatment for borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: standard dialectical behavioral therapy (dbt)is an effective treatment for borderline personality disorder (bpd), particularly for patients with significant behavioral and affective dysregulation, including suicidality. however, dbt in its original format is delivered in 12 months, and even though currently there are shorter versions of the treatment being developed and tested, in the context of public mental health care in chile a shorter, intensive and lighter version of the treatment is likely needed to help patients seeking help for bpd symptoms. this study will test whether a 3 month, intensive and simplified version of dbt is at least equivalent to standard six months dbt with all its components (skills training, individual therapy, coaching calls, and treatment-team consulting). 120 patients diagnosed with bpd we'll be randomly assigned to receive either the short, intensive 3-month intervention or the longer standard 6-month dbt intervention. baseline measures will be taken pre-treatment, upon treatment completion, and at a 4-month follow-up. session-to-session change in bpd symptoms will also be measured throughout the treatments. primary outcomes for the study are bpd symptoms, frequency, and intensity of suicidal activity. secondary outcome measures include depression scores, quality of life, and er visits, and days in inpatient care.


Eligibility criteria:
inclusion criteria: * bpd diagnosis according to dsm-iv criteria, evaluated through a scid-ii structured interview. * history of suicide attempt or self-harm operationalized as at least two episodes of suicide or self-harm in the last 24 months * provide signed informed consent to participate in the study. * participant has not received more than 8 weeks of dbt in the past 24 months. exclusion criteria: * fulfill diagnostic criteria for psychotic disorders classified in icd-10 (f20-f29), evaluated through the mini interview. * diagnosis of antisocial personality disorder evaluated through the scid-ii. * active substance use disorder within the last 3 months, assessed by assist. * harmful use or problem dependence on alcohol assessed through audit. * meet criteria for bipolar affective disorder type i assessed through the mini mania module. * significant cognitive impairment assessed through moca (moca\> 21). * diagnosis recorded in the clinical record of intellectual-cognitive disability. * recording in the clinical record of medical or surgical problems that could imply a probable hospitalization within one year of the start of the study (for example, cancer, coronary heart disease, etc.).
evaluating bladder care™, a new non-invasive urine test, for bladder cancer detection in inconclusive cases

Conditions: Bladder Cancer; Urothelial Carcinoma Bladder

Summary: the goal of this observational study is to learn about the performance of the bladder care™ assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. the main question it aims to answer is: • does the bladder care™ assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results? participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. a medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), to document oncology-urinary-related clinical outcomes.


Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years of age at time of informed consent. 2. subject or the subject's legally authorized representative provides written informed consent. 3. subject is willing to follow all study procedures and available for the duration of the study. 4. patients with atypical cytology or equivocal cystoscopy results within 3 months before screening. 5. subject is scheduled for initial or repeat cystoscopy, with or without pathology. 6. subject is willing to provide one voided urine specimen of at least 80 ml on the same day, but prior to scheduled initial or repeat cystoscopy, with or without pathology. exclusion criteria: 1. pregnant or planning to become pregnant at the time of screening. 2. positive cystoscopy within 3 months of screening indicating presence of bladder cancer. 3. genitourinary manipulation (flexible or rigid cystoscopy, catheterization, urethral dilation, urs, ureteral stent) within 14 days before urine specimen collection. 4. history of augmentation cystoplasty. 5. history of continent cutaneous diversion or ileal conduit. 6. history of orthotopic bladder substitution or orthotopic neobladder. 7. concomitant use of an investigational drug which has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of urine specimen. 8. new or recurrent nmibc (non-muscle invasive bladder cancer) diagnosis within three months of study enrollment. 9. an active malignancy (bladder or other) diagnosis within 3 months of study enrollment. 10. patients with a history of nmibc have undergone intravesical or infusion therapy and completed treatment less than 6 weeks prior to study enrollment.

Keywords: bladder care™ bladder cancer atypical cytology equivocal cystoscopy bladder cancer detection hematuria non-invasive urine test urological urology microhematuria gross hematuria urothelial carcinoma bladder cancer biomarkers urinary biomarker urologic oncology inconclusive cystoscopy results inconclusive cytology results urine-based bladder cancer detection
changes in nasal airflow parameters after septoplasty and turbinoplasty

Conditions: Nasal Obstruction; Nasal Septum; Deviation; Nasal Mucosa Hypertrophy

Summary: pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction and are often an indication for surgery. the aim of the study is to examine nasal airflow parameters after septoplasty and turbinoplasty .

pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction and are often an indication for surgery. the aim of the study is to examine nasal airflow parameters at pre-defined intervals in patients after septoplasty and turbinoplasty .

Eligibility criteria:
inclusion criteria: * patients with nasal obstruction (nasal septal deviation, hypertrophy of nasal mucosa) * 18 to 70 years * patient capable of general anesthesia * signing of the informed consent exclusion criteria: - patient incapable of general anesthesia

Keywords: nasal obstruction septoplasty turbinoplasty nasal mucosa nasal septum
characterization of hemostatic disordres in septic shock: searching for biological markers

Conditions: Septic Shock

Summary: sepsis induces hemostatic disorders due to the exessive or inappropriate activation of inflammation, which could lead either to hypercoagulability or hypocoagulability. it is currently not possible to determine the hemostatic status of a given patient. this instability of hemostatic system is not revealed by classical tests. thus, a better characterization of hemostatic status could certainly improve patient care. this study aims at characterizing disorders of coagulation and fibrinolysis using "global" tests such as thrombin generation test or coagulolytic test. furthermore, the association with biological markers of interest (such as microparticles, neutrophil elastase or histones) will be evaluated.


Eligibility criteria:
eligibility criteria for patients with septic schock inclusion criteria: * septic shock (dellinger, 2013) * age \>18y * hospitalized patients * signature of an informed consent (emergency consent) * affiliation to a social security regimen exclusion criteria: * pregnancy or breast-feeding women * moribund patient * oral anticoagulant therapy * thrombophilia * minor patients * patients under tutelage eligibility criteria from subject without septic shock subject blood samples without septic shock are collected from a historical healthy volunteers cohort.
inspace™ system implantation in a procedure under local anesthesia

Conditions: Rotator Cuff Tear

Summary: the study objective is to assess the feasibility, efficacy and safety of the inspace™ device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.

a single arm, open-label, prospective, study to assess the feasibility, efficacy and safety of inspace™ device implantation in a procedure under local anesthesia for a treatment of subjects with massive, irreparable rotator cuff tear. subjects with radiological confirmed massive rct who are eligible per inclusion/exclusion criteria, will be enrolled for the study treatment. subjects will undergo surgical intervention under local anesthesia , fluoroscopic and/ or arthroscopic visualization of inspace™ implantation. subjects will then be followed for safety and efficacy for a 24 months following the implantation. the study objective is to assess the feasibility, efficacy and safety of the inspace™ device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder. the efficacy will be assess by using constant and ases outcome score the constant and the ases will be completed by the investigator at each study visit .the patient will complete the patient self-evaluation part of the ases at each study visit. the safety assessment will be conducted by collecting all device related aes/saes throughout the entire study period.

Eligibility criteria:
inclusion criteria: 1. age 50 or older. 2. positive diagnostic mri of the affected shoulder indicating full thickness massive irreparable rct of at least 5cm in diameter (according to cofield classification) including fatty infiltration grade iii or iv (according to classification of goutallier). 3. persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months. exclusion criteria: 1. known allergy to the balloon material 2. evidence of significant osteoarthritis or cartilage damage in the shoulder 3. evidence of gleno-humeral instability 4. evidence of major joint trauma, infection, or necrosis in the shoulder 5. major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study. 6. concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period. 7. subjects with worker's compensation claims or other litigation claims related to the shoulder being treated in the study.

Keywords: massive rotator cuff tear local anesthesia sub-acromial spacer
micro-conjunctival autografting combined with amniotic membrane transplantation treating recurrent pterygium trial

Conditions: Recurrent Pterygium; Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation

Summary: to observe the effect of micro-conjunctival autografting combined with amniotic membrane transplantation on the postoperative recurrence, complications and ocular surface symptoms among patients with recurrent pterygium.

recurrent pterygium is a common postoperative complication of pterygium surgery, the postoperative recurrence rate is about 1.44% and needs careful treatment. at present, surgical is the main and most effective treatment of recurrent pterygium. among various surgical methods, autologous conjunctival transplantation is regarded as the first choice in normal conditions. however, the scope of conjunctival transplantation is positively correlated with the degree of ocular surface damage. therefore, our research aimed to use micro conjunctival transplantation（1.5mm×3.0mm） to reconstruct limbal conjunctiva and amniotic membrane to cover the whole pterygium resection area to better protect conjunctival sac and ocular surface.

Eligibility criteria:
inclusion criteria: 1. age⩾18; 2. relapsed after pterygium surgery once; 3. invading the cornea 2.00\~5.00mm. exclusion criteria: 1. having obvious severe systemic organic diseases and mental diseases; 2. in lactation or pregnancy or planned pregnancy; 3. combined with eye diseases such as severe eyelid insufficiency, dry eye, chemical injury of cornea and conjunctiva, etc.; 4. used drugs that may affect the growth and metabolism of corneal epithelium within four weeks before inclusion in the study; 5. received pterygium surgery twice or more.

Keywords: recurrent pterygium conjunctival flap transplantation
estimating and reducing the cardiovascular risk of patients with schizophrenia drugs from lipid measures and ischemic electrocardiographic changes

Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Summary: the primary goal of this study is to examine the triglyceride/hdl ratio and the ischemic ekg changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.

the primary goal of this study is to examine the triglyceride/hdl ratio and the ischemic ekg changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder. the secondary goal is to identify those subjects in the top tertile for the highest risk of ihd as defined by tg/hdl ratios (\>\>3.5) and ischemic ekg changes with and without clinical ischemia, e.g. angina and to see if these risk factors can be reduced or reversed by a change of antipsychotic medication, dietary counseling, enrollment into available exercise groups, etc.

Eligibility criteria:
inclusion criteria to be eligible, a patient must : * be male or female, between 18-65. * have a diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder according to dsm-iv criteria * have tg/hdl ratios (\>\>3.5) and ischemic ekg changes with and without clinical ischemia, e.g. angina * be treated for a minimum of six months with one of six oral antipsychotic medications: clozapine, haloperidol, olanzapine, quetiapine, risperidone and ziprasidone * be willing to change current antipsychotic medication to that chosen by the principal investigator * have a history of compliance with the above medication * be medicaid eligible or maintain insurance covering requested lab procedures * be able to provide written informed consent. exclusion criteria a patient will be considered ineligible if he/she: * has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to dsm-iv criteria. * has a history of noncompliance with prescribed psychiatric medications * has a tg/hdl ratio \< 3.5 on current medication * is uninsured or is unable to self-pay potential costs of required lab procedures not covered by insurance. * is unable to provide written informed consent. * (females only) is pregnant, lactating or plans to become pregnant during study participation

Keywords: schizophrenia schizoaffective disorder bipolar disorder metabolic syndrome
population health management for kpnc members with newly diagnosed diabetes: a randomized trial of a proactive and augmented initial care strategy

Conditions: Type 2 Diabetes; Type 2 Diabetes Mellitus (T2DM); Type 2 Diabetes (T2D)

Summary: this study is a 2-arm randomized trial of augmented initial type 2 diabetes (t2d) care vs. usual initial t2d care among adults (18-74 years) with newly diagnosed t2d who have risk factors (defined by age and diagnosis hba1c value) for suboptimal early glycemic control. augmented initial t2d care comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team. the study team will use electronic health record (ehr) data to assess between-arm differences in diabetes-related outcomes at 6- and 12 months.


Eligibility criteria:
inclusion criteria: * age 18-74 years * newly diagnosed with type 2 diabetes * kaiser permanente northern california member receiving care in a participating service area * if age ≤45 years, then hba1c\>8% * if age\ 10% exclusion criteria: * individuals who are pregnant * individuals with likely type 1 diabetes (t1d)
study in beta-thalassaemia or myelodysplastic syndrome patients to investigate the safety and tolerability of sln124

Conditions: Non-transfusion-dependent Thalassemia; Low Risk Myelodysplastic Syndrome

Summary: the primary purpose of this study is to determine the safety and tolerability of sln124 for the treatment of non-transfusion-dependent (ntd) β-thalassaemia and low risk myelodysplastic syndrome.


Eligibility criteria:
inclusion criteria: * age ≥ 18yrs; bmi 18-35 kg/m2 * β-thalassaemia intermedia or compound heterozygous hbe/β-thalassaemia * non-transfusion dependent: ≤ 5 units red cells in last 6 months and transfusion-free for ≥8 weeks * hb between 5 \& 11 g/dl * ferritin \> 250 µg/l and /or liver iron ≥ 3mg fe/g dry weight and tsat \>40% exclusion criteria: * haemoglobin s/β-thalassaemia, homozygous β-0 thalassaemia or α thalassaemia * alt/ast \> 1.5 x upper limit normal or cirrhosis * egfr \< 60 ml/min/1.73m2 * platelets \ 1000 x 109/l * untreated b12/folate deficiency * iron chelation therapy unless stable for ≥8 weeks * daily nsaid, therapeutic dose anticoagulant, esa ≤12 weeks or stable dosing of hydroxyurea ≤ 6 months * significant cardiac disease (mi in 6 months, nyha class iii-iv heart failure, long qt) * hiv or active hepatitis b/c or malignancy within 5 year
mdx-010 antibody, mdx-1379 melanoma vaccine, or mdx-010/mdx-1379 combination treatment for patients with unresectable or metastatic melanoma

Conditions: Melanoma; Metastases

Summary: the purpose of this study is to determine the safety and efficacy of mdx-010 (ipilimumab, bms-734016) (anti-ctla4) in combination with mdx-1379 (gp100, bms-734019) in patients with previously treated, unresectable stage iii or iv melanoma. survival time will be evaluated, as well as patient responses and time to disease progression. eligible patients are those who in response to a single regimen containing interleukin-2 (il-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[pr/cr\]); 2) failed to demonstrate an objective response (pr/cr); or 3) could not tolerate such a regimen due to unacceptable toxicity. patients will be randomized into one of three groups, and will receive one of the following treatments: mdx-010 alone, mdx-1379 alone, or mdx-010 in combination with mdx-1379.

melanoma accounts for approximately 5% of all skin cancers in the united states, but it accounts for about 75% of all skin cancer deaths. in 2004, the expected prevalence of melanoma is 627,252, with about 119,178 of these cases being stage iii or iv (metastatic melanoma). first line treatments for metastatic melanoma, usually il-2, dacarbazine and/or temozolomide, are associated with significant toxicities. mdx-010 (anti-ctla4) antibodies are designed to keep the immune system running by blocking ctla-4 from down-regulating t cell activation. mdx-1379 is made up of two peptides that are pieces of a bigger melanoma protein (gp100). these peptides bind to hla-a2 which is then recognized by t cells.

Eligibility criteria:
inclusion criteria: * diagnosed with malignant melanoma * measurable unresectable stage iii or iv melanoma * hla-a\*0201 positive * previous treatment with \& failure/relapse/inability to tolerate il-2, dacarbazine and/or temozolomide * at least 4 weeks since prior treatment * negative pregnancy * life expectancy greater than 4 months * eastern cooperative oncology group (ecog) performance of 0 or 1 * required lab values * human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv) negative exclusion criteria: * prior malignancies which the patient has not been disease free for over 5 years, except treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer * ocular melanoma * active, untreated central nervous system (cns) metastasis * prior treatment with mdx-010 (anti-ctla4) antibody * prior treatment with any cancer therapeutic vaccine * active autoimmune disease or history of autoimmune disease * pregnancy or nursing * hypersensitivity to incomplete freund's adjuvant (ifa) (montanide isa-51) * underlying medical conditions deemed hazardous if treated with study drug * concomitant therapy with anti-melanoma drugs, chemotherapies, other investigational therapies, chronic use of systemic corticosteroids * unable to provide informed consent

Keywords: melanoma metastatic melanoma skin cancer
memory training in patients with amnestic mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: preview research reports evidence of cognitive plasticity among individuals with amnestic mild cognitive impairment, and small-size studies have suggest that this population can benefit from memory training. this project intends to assess the efficacy of cognitive training in persons with mci with a randomized controlled design. the hypothesis is that cognitive training can improve memory performance for persons with amnestic mild cognitive impairment and this improvement can be maintained over time.

mild cognitive impairment (mci) often represents a transitional state between healthy aging and dementia, being considered a public health problem especially due to the increase of elder population in brazil and in the world in general. yet the conclusions of studies on pharmacological treatments for this population are still controversial, making imperative to invest on new efficient therapies such as non pharmacological interventions aimed at memory improvement. one training mode that has benefited elders is the association between names and faces, which has a compelling clinical relevance considering that one of the main complains among elders is the difficulty in remembering names. however, the exact effects of this kind of training in elders (i.e. the eventual changes in cognition and in brain activation on magnetic resonance imaging) are still unclear. therefore, this study aims to verify the effects of memory training (name-face association) compared with control intervention - psychoeducation, in 30 elders with amnestic mci. we will request the participants with amnestic mci to submit to a cerebrospinal fluid (csf) in order to improve the accuracy of the diagnosis. training and psychoeducation will be conducted in 4 sessions (two per week). to assess the effects, we will use cognitive instruments and mri exams before and after the intervention. also, one and three months after the conclusion of the training patients will again be submitted to cognitive tests.

Eligibility criteria:
inclusion criteria: portuguese as native and preferred language; a minimum of 4 years of education; mri-compatible; right-handed individuals; normal corrected vision and hearing; estimated intelligence average or above (≥ 80 iq); amnestic mild cognitive impairment identified by a doctor and neuropsychological tests; able to give informed consent. exclusion criteria: history of neurological disorder; history of serious systemic disease; history of severe mental illness; current untreated alcohol or substance abuse; medical conditions that compromise in any way the central nervous system; presence of visual impairment and / or hearing to preclude cognitive testing; presence of contraindications to mri exam; findings in structural mri that can interfere with the results of the study.

Keywords: mild cognitive impairment dementia alzheimer's disease memory training cognitive training cognitive rehabilitation neuropsychological rehabilitation