Kornimate/medical-research-clean huggingface dataset:
hematopoietic stem cell transplantation for patients with thalassemia major: a multicenter, prospective clinical study

Conditions: Thalassemia Major

Summary: the only curative therapy for thalassemia major remains the replacement of the defective erythropoiesis by allogeneic hematopoietic stem cell transplantation(allo-hsct). we conduct a prospective multicenter study to evaluate the efficacy of allo-hsct in the treatment of thalassemia major.

allogeneic hematopoietic stem cell transplantation (allo-hsct) is one of the established curative option for thalassemia major (tm). previous study has predicted that more than 90% of tm patients can survive after allo-hsct with a thalassemia-free survival (tfs) in around 80% of them.the purpose of this study is to evaluate the efficacy of allo-hsct in the treatment of thalassemia major.

Eligibility criteria:
inclusion criteria: 1. diagnosed with thalassemia major. 2. indication of hematopoietic stem cell transplantation. 3. a cardiac ejection fraction of \>50%; normal pulmonary function tests and pulmonary examination results; and normal kidney function. exclusion criteria: 1. aspartate aminotransferase levels \> 4-fold the upper limit of the normal range for our institution's lab criteria; 2. uncontrolled bacterial, viral or fungal infections; 3. any other restriction for transplantation.

Keywords: thalassemia major hematopoietic stem cell transplantation
chronic pain after scoliosis and thoracic surgery in children

Conditions: Thoracic Surgery; Scoliosis; Adolescence; Pediatric ALL; Chronic Pain

Summary: the aim of this epidemiologic prospective study is to determine the prevalence of cpsp defined as pain occurring 4 months after scoliosis and thoracic surgery and rated \> 3 on a 10 point visual analogue scale or flacc scale, in children aged from 6 to 18 years. the main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant thoracic surgery in children aged 6 to 18 years. the secondary objectives: the intensity of chronic post surgical pain, the prevalence of neuropathic syndrome and the predictive risk factors.


Eligibility criteria:
inclusion criteria: * children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric bordeaux hospital. exclusion criteria: * patients who not willing to participate, with children and/or parental insufficient understanding of the questionnaires.
observational analysis of palbociclib treatment in patients with first line therapy for locally advanced and/or metastatic breast cancer

Conditions: Breast Cancer

Summary: hormone therapy is the primary treatment option for patients with hr+ her2- breast cancer. despite its activity, hormone therapy is associated with initial, or more frequently acquired, resistance after exposure to one or more treatment lines. the combination of palbociclib with hormone therapy significantly increases progression free survival (pfs) compared with hormone therapy in first and second treatment line of hr+ her2- advanced breast cancer. these results lead to palbociclib approval by the food and drug administration (fda) in february 2015, and european medicines agency (ema) approval in november 2016 for first-line treatment of patients with metastatic hr+/her2-breast cancer in combination with an aromatase inhibitor, and for patients who had previously received hormone therapy in combination with fulvestrant. in spain, palbociclib was launched last november 1st, 2017. during this period, approximately 3500 patients have received treatment with palbociclib, and approximately a half of them in first-line treatment in combination with hormone therapy. the collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest.


Eligibility criteria:
inclusion criteria: * 1. documented histologically confirmed breast cancer with er and/or pgr positive and her2 negative status. * 2. locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy * 3. hr+/her2- 1. hr+: er+ or pr+ test before or up to 60 days after mbc diagnosis 2. her2-: any her2 negative test and the absence of a positive test (ihc positive 3+, fish positive/amplified, positive nos) before or up to 60 days after mbc diagnosis * 4. female or male patients \> 18 years * 5. have received at least one dose of palbociclib * 6. at least 2 document clinical visits * 7. treatment with palbociclib should have started from november 2017 to november 2019 * 8. data from the clinical records should be available. * 9. patients must be able to understand and sign informed consent if alive. exclusion criteria: * 1. previous treatment with hormonal therapy, targeted therapy or chemotherapy for metastatic disease. previous anticancer treatment for early breast cancer are allowed. * 2. treatment with palbociclib in clinical trial or compassionate use programs * 3. her2 + (ihc 3+ or fish +) tumors in the most recent or previous biopsies * 4. hr negative tumors in the most recent biopsy

Keywords: breast cancer. real-world data. palbociclib
exercises with electromyographic biofeedback in conservative treatment of massive rotator cuff tears

Conditions: Rotator Cuff Tears

Summary: there are very few studies in the literature about conservative treatment of massive rotator cuff (rc) tears. whether the treatment of massive rc tears is conservative or surgical is decided according to the age, activity level, expectation and additional pathologies of the patient. the aim of conservative treatment is to make the patient functionally independent and to reduce pain. in recent years, there are different opinions in the literature about the effectiveness of conservative treatment of massive rc tears. however, in recent biomechanical studies, it has been reported that the rc and the deltoid, which remain intact in massive rc tears, can function well together. the hypothesis of this study is that the deltoid-focused physiotherapy program, where strengthening exercises are performed with emg biofeedback, will give more positive results in terms of range of motion (rom), functional status, muscle strength, pain and patients satisfaction. aim of our study is to investigate the efficacy of electromyographic biofeedback (emg-bf) device which was added to deltoid focused conservative treatment program in massive rc tears.


Eligibility criteria:
inclusion criteria: * unilateral, non-traumatic massive rotator cuff tears according to deorio and cofield classification * age older than 50 years and attend 1-year follow-up assessment exclusion criteria: * patients with symptomatic lesions in the contralateral shoulder * cuff tear arthropathy * glenohumeral osteoarthritis * pseudoparalytic shoulder * grade 3-4 fatty degeneration according to goutallier classification * history of involved shoulder surgery * major systemic conditions that disallowing exercise

Keywords: massive rotator cuff tear deltoid electromyographic biofeedback rehabilitation nonoperative management
mr fingerprinting for vestibular schwannomas

Conditions: Vestibular Schwannoma

Summary: mr fingerprinting (mrf) will be performed in patients who will be treated with gamma knife radio surgery for a vestibular schwannoma before the intervention. fifty patients will be included with a vestibular schwannoma of minimum 1cm in size. during follow-up, response of the tumor to radiosurgery will be evaluated for each patient with mri. the aim of the study is to find patterns of vestibular schwannomas in mrf data which correlate with the type of response to radio surgery, i.e. tumor control after radiosurgery, further tumor growth despite radiosurgery, cystic transformation after radiosurgery.


Eligibility criteria:
inclusion criteria: planned gamma knife radiosurgery for vestibular schwannoma of minimum 1cm in size - exclusion criteria: vestibular schwannoma of less than 1cm in size. other a priori treatment than gamma knife radiosurgery -
magnetoencephalographic (meg) localization of ramelteon's effects on brain function and cortical arousal in insomnia

Conditions: Insomnia

Summary: the present protocol will utilize simultaneous recording of brain activity during attention and memory tasks in insomnia participants after ramelteon vs. zolpidem vs. placebo administration. the investigators hypothesize that amplitudes of associated with memory will be unchanged by ramelteon, whereas zolpidem will significantly reduce brain activity associated with stimulus processing as evidenced by abnormal reduction in the amplitude of specific brain regions relative to placebo.

the proposed research has two specific aims: 1) demonstrate that ramelteon has no effect on event related potential components that reflect basic sensory processes (p1 and n1), and will not impair attention and memory processes, whereas the benzodiazepine receptor agonist zolpidem will significantly reduce (relative to placebo) the amplitude of these event related potential components throughout the cerebral cortex and 2) show that ramelteon reduces the abnormal hyperarousal in insomnia as reflected through a reduction in the contingent negative variation component of the event related potential across frontal and parietal brain regions.

Eligibility criteria:
inclusion criteria: * healthy individuals with no secondary condition to insomnia. exclusion criteria: * healthy individuals with no insomnia.
comparison of the hologic genius digital diagnostics system with the thinprep imaging system

Conditions: Cervical Cancer Screening

Summary: quality assurance of the laboratory examinations. retrospective non-interventional study with thinprep slides collected as part of the german co-screening program for routine diagnostic. these slides will retrospectively be used to validate the hologic genius digital cytology (dc) system vs. the thinprep imaging system (tis).

the cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (hpv). cytology has been the gold standard for cervical screening since the introduction of routine screening with the pap test in the 1950s due to its effect on mortality in regions with screening programs. since that time, there have been several technological advances (lbc, imaging) to improve and automate cervical cytology, resulting in increased disease detection and efficiency. the hologic's genius digital diagnostics system is a ce-ivd (ce-marked in vitro diagnostic device) marked digital cytology platform. for quality assurance and to retrospectively validate the hologic genius digital cytology (dc) system selected slides earlier measured with tis will be additionally reviewed with the genius digital diagnostic system in order to demonstrate clinical performance and efficiency. hologic's digital image analysis algorithm uses ai to identify diagnostically relevant objects of interest.only anonymized results will be evaluated.

Eligibility criteria:
inclusion criteria: * lbc thinprep® samples are collected by gynaecologists and sent routinely to cytology laboratory cytomol as part of the german cervical cancer screening program.
lifestyle modification for weight loss in schizophrenia

Conditions: Obesity; Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to find out how effective lifestyle modification group therapy is on reducing body weight when compared to usual care in individuals with schizophrenia and/or schizoaffective disorder.


Eligibility criteria:
inclusion criteria: 1. subjects will be between 18 and 65 years of age. 2. have a bmi of 28 or greater. 3. meet dsm-iv criteria for schizophrenia or schizoaffective disorder. 4. be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the clinical team and investigator. exclusion criteria: 1. a history of dementia or mental retardation. 2. not capable of giving informed consent for participation in this study. 3. ongoing pregnancy. 4. living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.

Keywords: obesity schizophrenia schizoaffective disorder weight loss
rouxbe pilot for ms

Conditions: Multiple Sclerosis

Summary: the purpose of this protocol is to collect data from approximately 15 multiple sclerosis (ms) patients who are participating in a pilot cooking course. this online cooking training program is currently available to general public through the company "rouxbe" for a fee. data gathered from this cooking course will be used to develop novel ways of promoting healthy eating habits in people with ms. the investigators will use the data from blood tests, questionnaires, and demographics to assess the feasibility and effectiveness of this program. this is an outpatient program designed for people with ms that would occur regardless of whether participant data is collected. this pilot cooking course will run for approximately four weeks. the investigators intend start to the training course in mid-march 2015. subjects will be followed prior to course initiation for baseline data gathering, at four weeks from baseline, twelve weeks from baseline, and twenty-four weeks from baseline.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ms * willingness to comply with the diet and values set forth in the course

Keywords: diet cooking multiple sclerosis fatigue
single dose study of tulisokibart (mk-7240) in healthy chinese participants (mk-7240-002)

Conditions: Colitis, Ulcerative

Summary: the goal of this study is to learn about the safety of tulisokibart in healthy participants and what happens to tulisokibart over time when participants receive treatment intravenously versus subcutaneously.


Eligibility criteria:
inclusion criteria: inclusion criteria include, but are not limited to: * be in good health * has a body mass index (bmi) ≥18 and ≤28 kg/m\^2 and weight ≥40.0 kg * continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the dosing of study drug exclusion criteria: exclusion criteria include, but are not limited to: * history of cancer (malignancy) * has positive serum test for human immunodeficiency virus (hiv), hepatitis c or hepatitis b virus infection
a multicenter, relapse prevention study with levomilnacipran extended release (er) in participants with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: this study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (er) compared with placebo in the prevention of depression relapse in major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria * currently meet the dms-5 (diagnostic and statistical manual of mental disorders, 5th edition) criteria for major depressive disorder (mdd) * the participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months * the participant must have at least 3 lifetime episodes of mdd (including the current episode) exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control * participants who are considered a suicide risk * history of non-response to 2 or more antidepressants (after adequate treatment) * participants who have a history of meeting dms-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder * panic disorder

Keywords: fetzima relapse-prevention placebo-controlled
evaluation of udp-glucose as a urinary biomarker for early detection of cardiac surgery-associated pediatric acute kidney injury

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) is common in children after cardiac surgery with a reported incidence of 20-40%. pediatric aki has been found to be associated with important short and long-term adverse outcomes. a major challenge to management of aki after cardiac surgery and cardiopulmonary bypass is the lack of early diagnostic markers. current diagnostic criteria for aki in children relies exclusively on elevation of serum creatinine concentration and oliguria. both of these markers lack sensitivity and specificity, and result in delayed detection of kidney injury. this study aims to determine if udp-glucose can be used as a urinary biomarker to detect subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary bypass.


Eligibility criteria:
inclusion criteria: * less than or equal to 8 years of age * scheduled for cardiac surgery exclusion criteria: * severe pre-existing renal insufficiency
evaluation of prognosis and prognostic scores in geriatric patients with acute pancreatitis

Conditions: Acute Pancreatitis

Summary: * to compare the prognosis of acute pancreatitis between geriatric and other adult patients * to evaluate the efficacy of various prognostic scores in geriatric patients with acute pancreatitis


Eligibility criteria:
inclusion criteria: acute pancreatitis hospitalisation adult patients exclusion criteria: * recurrent pancreatitis * chronic pancreatitis * outpatient follow up * loss of follow up within 3 months of discharge

Keywords: elderly prognosis
xl119 versus 5-fluorouracil (5-fu) plus leucovorin (lv) in subjects with advanced biliary tumors

Conditions: Biliary Tract Cancer

Summary: the main purpose of this study is to determine if xl119 is more effective than the combination of 5-fluorouracil (5fu) and leucovorin (lv) in prolonging the survival of subjects with advanced biliary tumors.


Eligibility criteria:
inclusion criteria: * male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach * 18 years or older * life expectancy of at least 12 weeks * eastern cooperative oncology group (ecog) performance status score less than 3 * willing and able to sign informed consent * sexually active men and women must use an accepted and effective method of contraception (including barrier contraception with spermicide) * women of child-bearing age must have a negative pregnancy test * laboratory criteria exclusion criteria: * prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study) * unstable angina, or class iii or iv new york heart association heart disease * central nervous system metastases * uncontrolled diabetes mellitus * uncontrolled seizure disorder * major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment * need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation * pregnant or breast-feeding * a known history of human immunodeficiency virus (hiv) infection

Keywords: advanced biliary cancer cholangiocarcinoma gall bladder tumor gall bladder cancer bile duct tumor tumor of biliary tree
coronary bypass grafting with minimal extracorporeal circulation system versus off-pump coronary surgery

Conditions: Coronary Artery Disease

Summary: the investigators aimed to evaluate the clinical results and the inflammatory response of the minimal extracorporeal circulation system (mecc) compared with off-pump coronary revascularization (opcabg). this is a randomized and prospective study in 230 patients with indications for coronary surgery, with 113 patients in the opcabg group and 117 in the mecc group. the endpoints were the clinical and biochemical results, intra-operative outcomes and the determination of 19 inflammatory circulating markers, 17 of them for the first time analyzed comparing both techniques.


Eligibility criteria:
inclusion criteria: * indication for coronary surgery established on the basis of current published guidelines exclusion criteria: * documented preoperative systemic proinflammatory status and/or steroid administration within 6 months before surgery. * coexistence of a cardiomyopathy different than coronary artery disease that precise surgical treatment. * left ventricle ejection fraction of 40% or less. * treatment with erythropoietin (epo) three months before the intervention * hematocrit less than 35% the day prior to the procedure * redo surgery

Keywords: off-pump bypass graft surgery mini extracorporeal circulation bypass surgery
modulation of an experimental prolonged pain model using high definition transcranial direct current stimulation

Conditions: Pain, Muscle; Healthy

Summary: the purpose of this double-blinded, parallel group randomized controlled trial is to investigate the effects of high definition transcranial direct current stimulation (hd-tdcs) on an experimental prolonged pain model in healthy subjects.

the purpose of this double-blinded, parallel group randomized controlled trial is to investigate the effects of high definition transcranial direct current stimulation (hd-tdcs) on an experimental prolonged pain model in healthy subjects. forty healthy participants are administered the compound nerve growth factor (ngf) in the right first dorsal interosseous muscle (fdi), which produced prolonged muscle soreness and hyperalgesia. the forty participants are randomly allocated to either the control group receiving a sham-tdcs paradigm, or the intervention group receiving three consecutive days of multimodal hd-tdcs targeting primary motor cortex (m1) and dorsolateral prefrontal cortex (dlpfc) simultaneously. the somatosensory profile is assessed at baseline, before administration of ngf as well as prior and post each hd-tdcs session using standardised quantitative sensory testing. it is hypothesised that the active hd-tdcs will modulate the neurological changes induced by the experimental pain condition, which will alleviate the hyperalgesia and hypersensitivity.

Eligibility criteria:
inclusion criteria: * healthy men and women. * able to speak, read and understand english or danish. exclusion criteria: * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * current use of opioids, antipsychotics, benzodiazepines * previous or current neurological, musculoskeletal, rheumatic, malignant, inflammatory or mental illnesses * current or prior chronic pain conditions * lack of ability to cooperate
predictors of exposure success in public speaking anxiety

Conditions: Performance Anxiety

Summary: anxiety disorders are common and impairing. although exposure therapy is one of the most effective treatments for anxiety, some individuals do not fully respond to treatment, and these individual differences are not well understood. exposure therapy involves repeated, deliberate, safe engagement with a feared stimulus without the feared outcome occurring. this treatment is thought to work through a type of emotional learning called fear extinction. this study aims to look at links between fear extinction learning and exposure success, with the overall goal of better understanding who is likely to respond best to exposure therapy and why.


Eligibility criteria:
inclusion criteria: * score of at least 20 on the prcs * age 18-55 * english fluency exclusion criteria: * psychotropic medication use in the past 4 weeks * past experience with exposure based therapy * history of bipolar disorder, psychotic disorder, or substance dependence * current major depressive disorder of greater than moderate severity (defined as a score on the 9 item patient health questionnaire of greater than 14) * clinically significant suicidal or homicidal ideation * non-removable ferrous metal * current significant neurological conditions * history of loss of consciousness greater than 5 minutes duration * pregnant * claustrophobic