Kornimate/medical-research-clean huggingface dataset:
modified melanoma vaccine for high risk or low residual disease patients

Conditions: High Risk HLA-A2+ Melanoma; Metastatic Disease

Summary: this study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease. ongoing clinical trials in the hadassah hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival. in this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. the vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.


Eligibility criteria:
inclusion criteria: 1. patients included in this protocol must carry one or more of the following tissue typing alleles: hla-a2, -a24, -a33, -b35, -b49, -cw04/12(04/08). we estimate that 50% of melanoma patients will be eligible. 2. cutaneous malignant melanoma ajcc stage iib (over 4 mm) or iic (ulcerated melanoma over 4mm). 3. metastatic melanoma ajcc stage iii (nodal involvement, n1-3a,b) post surgical removal of lymph nodes. 4. metastatic melanoma ajcc stage iv, completely resected. 5. non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma. 6. melanoma can be of either mutant or wild-type b-raf. 7. karnofsky performance status over 80 (normal activity with effort). 8. no active cardio-respiratory disease. 9. hematocrit over 25% and wbc over 3000. 10. informed consent of the patient. exclusion criteria: 1. administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration. 2. active brain metastases requiring cortico-steroids. 3. concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer). 4. active serious infection. 5. allergy to penicillin. 6. patient's wish to withdraw from the study at any stage.

Keywords: melanoma vaccine resectable ajcc stage iv ajcc stages iib-c, iii patients with low-burden failed respond one treatment line
total knee arthroplasty comparing cementless to cemented fixation

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.

out comes measures were to determine: 1. whether the knee and function scores and the radiographic results of the knees with a nexgen cemented knee prosthesis would be better than those with an nexgen cementless prosthesis. 2. whether the patients with a nexgen cemented knee prosthesis would have a better range of knee motion than those with an nexgen cementless prosthesis. 3. whether patient satisfaction and preference would be better in the patients having a nexgen cemented knee prosthesis than those of patients having an nexgen cementless knee prosthesis 4. whether complication rate would be less in the knees with a nexgen cemented knee prosthesis than in the knees with an nexgen cementless prosthesis.

Eligibility criteria:
inclusion criteria: * end-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease exclusion criteria: * inflammatory disease * patient with other lower extremity disease which may affect functional outcome * neurologic disease effecting patients lower extremity * revision surgery * patient not medically cleared for bilateral surgery

Keywords: total knee arthroplasty cemented cementless fixation posterior stabilized cruciate retaining
transcranial magnetic stimulation in the rehabilitation of postoperative motor dysfunction.

Conditions: Glioma; Postoperative Motor Deficit

Summary: this study focused on glioma patients with postoperative motor deficits, especially for patients with supplementary motor area syndrome. the investigators want to investigate whether the recovery of motor function will be accelerated by using transcranial magnetic stimulation to stimulate primary motor area and supplementary motor area on the lesional hemisphere.


Eligibility criteria:
inclusion criteria: 1. patient underwent awake craniotomy and motor functional identification during tumor resection; 2. patients with postoperative motor deficit (muscle strength of limbs is weaker than preoperative status) exclusion criteria: 1. patients with contraindication of transcranial magnetic stimulation; 2. patients without data of the pre- and postoperative resting state mri and diffusion tensor image.
review of surgical site infection registration routine at surgery departments in sweden and validation of one of the used routines

Conditions: Surgical Site Infections

Summary: this study explores the routines of registration of surgical site infections (ssi) at different surgical centers in sweden. it explores the sensitivity and specificity of the registration routines of ssi are at halmstad county hospital, sweden.


Eligibility criteria:
inclusion criteria: * surgical clinics in sweden that report tho the swedish national register for colorectal cancer. exclusion criteria: * clinics that dosen´t report.
linguistic characteristics of suicidal patients in the emergency department

Conditions: Suicide

Summary: the purpose of this study is to determine whether patients who have a high risk for serious suicide behavior will demonstrate a speech pattern that has a relationship to language patterns found in suicide notes.

in an average week the cchmc emergency department (ed) evaluates 40 patients with suicidal behavior. currently, there is no systematic method for assessment of suicide risk in these patients and often, emergency department staff are required to make judgments about the disposition of these patients without a full understanding of the patient's risk for another serious suicide attempt. this pilot project involves experts in child psychiatry, biomedical informatics, and emergency medicine to collect pilot data for developing a method to estimate the risk of serious suicidal behavior based on computational linguistics.

Eligibility criteria:
inclusion criteria for suicidal subjects: * subjects age 13 years 0 months to 17 years, 11 months old * admission to cchmc ed, psychiatric units, or medical units with suicidal behavior or attempt * the patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. the legal guardian must give written informed consent and the youth, written assent. * english is spoken as the primary language in the home inclusion criteria for non-suicidal subjects: * subjects age 13 years 0 months to 17 years, 11 months old * admission to cchmc ed with no current or no history of suicide ideation/attempt/gesture * no past or current history of a major mood disorder * no history of death by suicide in first-degree relatives * the patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. the legal guardian must give written informed consent and the youth, written assent. * english is spoken as the primary language in the home exclusion criteria for suicidal subjects: * any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol * level of consciousness precludes consent and research assessments * unable to assent because of severe mental retardation or incapacitating psychosis exclusion criteria for non-suicidal subjects: * any current or past suicide attempts * any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol.
pnt2258 for treatment of patients with richter's transformation (brighton)

Conditions: Richter's Transformation

Summary: this study is sponsored by sierra oncology, inc. formerly pronai therapeutics, inc. it is a multi-center, single-arm, 2-stage, open-label phase ii investigation of pnt2258 to characterize anti-tumor activity and collect safety data on patients with richter's transformation.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed richter's transformation (rt) from chronic lymphocytic leukemia/small lymphocytic lymphoma (cll/sll). 2. availability of fresh or archived tumor tissue. 3. fdg pet-ct (disease) positive baseline scan with measurable disease. 4. ecog performance status of 0-1. 5. evidence of disease progression at study entry. 6. discontinuation of prior anticancer therapy for ≥ 7 days prior to c1d1 and recovered to ≤ ctcae grade 2 (or baseline) from any acute or chronic toxicity associated with prior therapy. 7. must have previously received at least one prior chemotherapeutic regimen for rt. - previously untreated rt patients deemed ineligible for, or that refuse, intensive chemotherapy are eligible. 8. adequate bone marrow, renal, and hepatic function. 9. normal coagulation profile. 10. agreement to use acceptable methods of contraception during the study and for ≥ 120 days after the last dose of pnt2258 if sexually active and able to bear or beget children. 11. ability to participate in the clinical study for a minimum of at least 2 cycles (6 weeks). exclusion criteria: 1. concurrent non-hematologic malignancies requiring treatment. 2. no more than 2 prior regimens for dlbcl. 3. hodgkin's variant of richter's lymphoma, accelerated cll, composite lymphoma, interdigitating dendritic cell sarcoma, sarcoma, ebv-associated lymphoma or prolymphocytic transformation. 4. ongoing risk of bleeding. 5. cns or leptomeningeal involvement of lymphoma 6. concurrent clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram or laboratory finding that, in the opinion of the investigator, could adversely affect the safety of the subject or impair the assessment of the study results. 7. pregnancy or breast-feeding. 8. previous exposure to pnt2258.

Keywords: pnt2258 richter's transformation nhl non-hodgkin's lymphoma lymphoma dlbcl diffuse large b-cell lymphoma lymphoma, large b-cell, diffuse lymphoma, non-hodgkin lymphoma, b-cell
impact of respiratory rehabilitation on quality of life in patients with hyperventilation syndrome

Conditions: Hyperventilation Syndrome

Summary: the hyperventilation syndrome is a quite frequent pathology, affecting up to 10% of the general population and 40% of the asthmatic population. its physiopathology is still badly known and even if it is a benign affection, its associated comorbidities and symptomatology greatly decrease the patients' quality of life. yet, no medicinal treatments have been proved useful, but prescribers noticed improvements after physiotherapy. given that the physiotherapy impact on hyperventilation syndrome is not well described in the literature, this study aims to scientifically ascertain physiotherapy benefits on quality of life and symptomatology in hyperventilation syndrome-suffering patients.


Eligibility criteria:
inclusion criteria: * positive hyperventilation syndrome diagnosis * having a social security insurance * being at least 18 years old * having given their written consent exclusion criteria: * being put under guardianship or curatorship * having seen a physiotherapist for a respiratory rehabilitation in the last three months * suffering from a chronic and degenerative pathology (chronic obstructive pulmonary disease, parkinson's disease, idiopathic fibrosis, ...) * not being able to receive the respiratory rehabilitation from our care providers * already having received a rehabilitation for hyperventilation syndrome * not speaking french or not being unable to complete the questionnaires

Keywords: hyperventilation syndrome respiratory rehabilitation quality of life
pierre robin sequence outcome assessment multi institutional study

Conditions: Pierre Robin Sequence

Summary: the purpose of this prospective, multi-center, longitudinal study is to assess clinical outcomes related to the surgical treatment of prs ( pierre robin sequence) by mdo (mandibular distraction osteogenesis). this study aims to develop a scoring system to determine success and complication rate pre and post mdo.

the recruitment phase of this trial is 3 years. duration of the trial is 19 years. all study patients who undergo mandibular distraction will be indicated for surgery following published and accepted protocols of care for mandibular distraction in this specific patient population. there will be no experimental/treatment arms in this study. all patients will undergo standard of care interventions and assessments that would not change if the patient were not to participate in this study. the purpose of this study is to follow multiple surgical outcomes following these standard of care practices. the methods and procedures detailed below follow published and accepted standards of care.

Eligibility criteria:
inclusion criteria: 1. signed informed consent/assent form 2. all patients with prs as defined by mandibular hypoplasia, glossoptosis causing airway obstruction, who undergo mdo prior to the age of 6 months, will be included in the study. this will include all infants regardless of syndromic diagnosis, other organ system abnormalities, cleft palate diagnosis or the presence of other concurrent craniofacial anomalies. exclusion criteria: 1. infants over the age of 6 months 2. patients who undergo mandibular distraction for conditions other than pierre robin sequence. 3. patient who refuse to be included in this study
efficacy of web-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome

Summary: the aim of this study is to determine the efficacy of fitnet (web-based cognitive behavioural treatment) for adolescents with chronic fatigue syndrome (cfs) in the netherlands. the second goal of the study is to establish predictors of outcome. it is very important to know the characteristics of patients who will benefit from cognitive behavioural treatment (cbt) and who will not. possible predictors of outcome are: age, depression, anxiety, fatigue of the mother, parental bonding, self-efficacy, body consciousness of child and mother, physical activity (actometer).

all participants will be randomized to one of the two treatment arms: 1. intervention with web-based cognitive behavioral treatment 2. usual care the duration of the cognitive behavioural program is limited to 6 months. the adolescents who have been assigned to the usual care will get the opportunity to attend the program after these 6 months. the total follow-up time is 12 months after the start of the web-based program. the web-based program is developed for both the adolescents and the parents. the program consists of two parts, a psycho-educational part and a cognitive behavioural part consisting of 21 treatment modules. the therapist activates one or more treatment modules per week, dependent on the progress of the participant. within a treatment module the participant will keep several journals, answer questions and do several assignments. all answers are sent to the therapist, with whom a weekly email contact will be realized. efficacy of the web-based program will be determined after 6 months. there will be a follow-up measurement at 12 months.

Eligibility criteria:
inclusion criteria: * adolescents (12 - 18 years) with chronic fatigue syndrome exclusion criteria: * score greater than or equal to 44 on the stait-trait anxiety inventory for children * score greater than or equal to 20 on the children's depression inventory * no availability of computer and/or internet * risk of suicide * mental retardation

Keywords: chronic fatigue syndrome (cfs) adolescence cognitive behaviour therapy (cbt) web-based internet efficacy
fabrication of naso-alveolar molding (nam) appliance in cleft lip and palate (clp) from digital magnetic resonance imaging (mri) face scan

Conditions: Cleft Lip and Palate

Summary: the purpose of this study is to fabricate a nasoalveolar molding (nam) appliance that is digitally fabricated and 3 dimensionally printed utilizing an mri face scan and to assess the fit of the nam in new borns with cleft lip and palate.


Eligibility criteria:
inclusion criteria: * new born babies with cleft lip and/or palate * will undergo treatment with ut pediatric dental clinic with a nam appliance exclusion criteria: * patients without cleft lip and/or palate * patients that cannot tolerate an intraoral appliance * patients that are not able to be discharged from the hospital 2-3 days after birth.

Keywords: nasoalveloar molding 3d printing mri
woest ( what is the optimal antiplatelet & anticoagulant therapy in patients with oral anticoagulation and coronary stenting)

Conditions: Anticoagulants; Platelet Aggregation Inhibitors; Stents; Atrial Fibrillation

Summary: the study will assess the hypothesis that the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect to bleeding complications while equally safe with respect to the prevention of thrombotic complications in patients with both indications for warfarin use and dual antiplatelet (clopidogrel 75mg/day + aspirin 80mg/day) treatment.

chronic oral antithrombotic treatment is necessary in patients with mechanical heart valves and in the majority of patients with atrial fibrillation. when these patients have to undergo percutaneous coronary intervention (pci) with stenting, there is also an indication for treatment with aspirin and clopidogrel. however, triple therapy is known to augment the risk for bleeding complications.unfortunately, no prospective data are available to solve this issue. nevertheless, it all comes down to finding the ideal therapy in patients with both atrial fibrillation and percutaneous intervention to prevent thrombotic complications (e.g. stent thrombosis) without increasing the risk of bleeding. this prospective randomised study will assess the hypothesis that in patients on warfarin therapy and indication for elective percutaneous intervention, the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy treatment in reducing the risk of bleeds while equally safe with respect to the prevention of thrombotic complications

Eligibility criteria:
inclusion criteria: * patients is on oral anticoagulation therapy and this will be continued throughout the period of 1 year-and deployment of at least 1 coronary stent (bare metal stent (bms) or drug eluting stent (des)). -age of more than 18 years exclusion criteria: * cardiogenic shock, * contra-indication for aspirin or clopidogrel * allergy to aspirin or clopidogrel, * documented peptic ulcer disease within the previous six months, * pregnancy and * previous intracerebral haemorrhage or * significant thrombocytopenia (platelet count \< 50x10 9/l). * major bleeding according to timi criteria within the past 12 months * age \> 80 years

Keywords: atrial fibrillation percutaneous coronary stenting bleeding complications triple therapy
outcomes of mentalization-based treatment for borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: the effects of a psychological treatment, mentalization-based treatment, was studied using a research protocol with patients with mood swings and impulsive behavior (borderline personality disorder).

background: mentalization-based treatment (mbt) in borderline personality disorder (bpd) has a growing evidence base, but there is a lack of effectiveness and moderator studies. the present study examined the effectiveness of mbt in a naturalistic setting and explored psychiatric and psychological moderators of outcome. method: borderline and general psychiatric symptoms, suicidality, self-harm, alexithymia and self-image were measured in a group of bpd patients (n=75) receiving mbt; assessments were made at baseline, and subsequently after 6, 12 and 18 months (when treatment ended). borderline symptoms were the primary outcome variable.

Eligibility criteria:
inclusion criteria: * to be included, bpd diagnosis was confirmed by scid-ii interview and the zanarini rating scale for borderline personality disorder (zan-bpd) interview, together with a consensus discussion between mbt therapists using dsm-iv and icd-10 criteria. all patients referred between 2007-02-01 and 2012-05-30 were eligible for inclusion. exclusion criteria: * exclusion criteria were: iq\<85, psychotic disorder other than schizotypal personality disorder, acute/temporary psychosis, previously diagnosed autism-spectrum disorder, bipolar disorder type i and severe eating or substance use disorder.

Keywords: borderline personality disorder psychotherapy treatment outcome pragmatic clinical trials as topic mentalization-based treatment alexithymia
lipitor and biguanide to androgen delay trial

Conditions: Prostate Cancer

Summary: this study is a randomized trial examining the administration of a combination of biguanide metformin and atorvastatin ("lipitor") to men who are experiencing rising prostate-specific antigen (psa) levels, despite having undergone radical therapy (surgery and/or radiation).


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * histologically confirmed adenocarcinoma of the prostate * history of radical therapy (i.e., radical prostatectomy, radiotherapy, brachytherapy or prostatectomy with salvage radiotherapy) * serum testosterone levels 8.0 nmol/l (230 ng/dl) or greater * not currently undergoing treatment for hyperlipidemia or diabetes mellitus * ldl-cholesterol levels 5 mmol/l or lower * hga1c 6.5% or lower * psa levels between 2 and 5 ng/ml exclusion criteria: * subjects that have been treated for prostate cancer with any of the following: i. cytotoxic chemotherapy; ii. hormonal therapy within past 3 years; iii. oral glucocorticoids; iv. gonadotropin-releasing hormone (gnrh) analogues (e.g., leuprolide, goserelin, degarelix) * past treatment with the 5-α reductase inhibitors finasteride and dutasteride within past 5 years * past treatment with drugs with antiandrogenic properties (e.g., flutamide, bicalutamide, ketoconazole, progestational agents) within 6 months prior to screening * use of metformin or statins within past 2 years * planned or concurrent use of metformin, sulfonylureas, thiazolidinediones or insulin for any reason * known hypersensitivity or intolerance to metformin or atorvastatin * any clinically significant laboratory abnormalities (e.g., severe renal or hepatic impairment) which in the judgment of the investigator would affect the patient's health or the outcome of the trial * any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as new york heart association (nyha) class iii or iv, history of any type of acidosis, habitual intake of 4 or more alcoholic beverages per day) * abnormal liver function test * abnormal organ and marrow function

Keywords: metformin atorvastatin prostate-specific antigen biochemical recurrence