Kornimate/medical-research-clean huggingface dataset:
back pain and posttraumaticstressdisorder. a randomized clinical trial

Conditions: Low Back Pain; PTSD

Summary: aim the aim is to test whether a short psychotherapeutic intervention targeting post traumatic stress disorder (ptsd) symptoms will have an additional positive effect on the outcomes of the standard multidisciplinary program (smp) against chronic back pain development.

focus patients with back pain often demonstrate symptoms of ptsd measured via the harvard trauma questionnaire scale (htq). it has been found that ptsd and pain may maintain each other. methods thousand consecutive patients with low back pain (lbp) referred to the spine center are screened for ptsd. it is expected that 100 patients will meet the inclusion criteria and be randomized to smp or to smp plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'somatic experiencing'. conclusion the project started in 2013, so there have not yet been any results. currently total reached 65 back pain patients; 34 patients in the smp + sessions intervention arm. effect parameters are: pain, daily function, euroqol and (htq), anxiety and depression, fear avoidance (tampa scale for kinesiophobia) on entry, and at 6/12 months. this "nested randomized trial in a cohort design" is one of the very first studies targeting both ptsd and chronic pain-related symptomatology.

Eligibility criteria:
inclusion criteria: * back pain: from 1/2 y duration or longer * trauma according to htq exclusion criteria: -
safety, tolerability, pharmacokinetics and pharmacodynamics study of pf-06291874 as oral monotherapy to treat adults with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type II

Summary: this study is going to assess the safety and tolerability of pf-06291874 in adults with type 2 diabetes mellitus as monotherapy, to evaluate the significance of overall glycemic control in these subjects.


Eligibility criteria:
inclusion criteria: * male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old. * body mass index of 18.0 to 45.4 kg/m2; and a total body weight of \>50 kg * hba1c value at the screening visit meeting once of the following criteria: * currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5% * not currently taking any oral antiglycemic drug therapy within 7 to 10.5% * fasting plasma glucose concentrations\<270mg/dl at the screening and run-in visit, confirmed by a single repeat, if deemed necessary. * subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate. exclusion criteria: * history of type 1 diabetes mellitus or secondary forms of diabetes * one or more self-reported hypoglycemic episodes of sever intensity within 3 months of screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within the previous 6 months. * history of myocardial infarction, unstable angina, arterial revascularization, stroke, new york heart association functional class ii-iv heart failure, or transient ischemic attach within 6 months of screening. * history or evidence of diabetic complications with significant end organ damage, such as * proliferative retinopathy and/or macular edema; * diabetic neuropathy complicated by neuropathic ulcers; * screening seated systolic blood pressure \>160 mm hg and/or diastolic blood pressure \>100 mm hg after at least a 5 minute seated rest. if the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility; * male subjects with partners currently pregnant; or male subjects capable of conceiving children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
improving upper extremity function and trunk stability after cervical spinal cord injury (sci)

Conditions: Cervical Spinal Cord Injury

Summary: ninety-nine individuals meeting the study's inclusion/exclusion criteria will be enrolled in this study. the objective of this study is to evaluate three different therapeutic approaches to synergistically retrain functional movement patterns of the upper extremities in combination with trunk stabilization to promote neurologic and functional recovery after sci. each subject will complete 40 sessions of intervention. subjects will also complete a baseline evaluation (week 0), re-evaluation (week 4), post treatment evaluation (week 8), and a follow-up evaluation (week 12).


Eligibility criteria:
inclusion criteria: * history of traumatic sci * less than 5months post sci * sci injury level c1-c8 * sci categorized as ais b-d * currently receiving inpatient rehabilitation at craig hospital * passive range of motion (rom) within functional limits at wrists, shoulders, and elbows * demonstrate motor response to electrical stimulation in majority of ue muscle groups below level of injury (tested during screening) * no complicating physical or cognitive conditions (as determined by their physician) that would preclude safe use of electrical stimulation * able to complete study as an outpatient if discharged from inpatient rehabilitation before completing 40 sessions of training exclusion criteria: * unstable chronic cardiac or respiratory complaints * current or history of ue contracture or skin pressure injuries that might interfere with intervention * received botox injections within the last 3 months * pregnant * implanted devices including: pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intra-thecal pump.
exactdna-003 / nsabp b-64: study of molecular residual disease detection in breast cancer (mrd)

Conditions: Breast Cancer

Summary: the exactdna-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk, early breast cancer, who are willing to provide tissue and blood specimens for circulating tumor dna (ctdna) analysis. participants will be followed for up to 5.5 years.


Eligibility criteria:
inclusion criteria: 1. the participant or a legally authorized representative must provide study-specific informed consent prior to study entry. 2. the participant must be ≥ 18 years of age. 3. ecog performance status 0 or 1. 4. histologically confirmed invasive carcinoma of the breast. 5. planned neoadjuvant therapy which includes cytotoxic chemotherapy. 6. tumor size ≥ 2.1 cm in greatest diameter. 7. unifocal or multifocal cancer documented to be the same histologic clinical subtype. 8. clinically node positive or if node negative, any one of the following: 1. tnbc or her2+ subtype 2. hr+/her2-negative with at least one of the following: i. high tumor grade (g3) ii. ki67 index of 20% or higher iii. high genomic risk (oncotype dx® (odx) breast recurrence score of \> 25, mammaprint® high, etc.) 9. willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 tablespoons) of blood for each research blood draw. 10. available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctdna assay. exclusion criteria: 1. definitive clinical or radiologic evidence of metastatic disease. 2. initiated neoadjuvant therapy for current breast cancer diagnosis. 3. synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers. 4. completed all therapy (including endocrine therapy) \<5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment. 5. completed all therapy for any previous hematologic malignancy \< 5 years ago. 6. multicentric or contralateral invasive breast cancers. 7. known pregnancy at time of enrollment. 8. prior solid organ transplant. 9. prior allogeneic hematopoietic stem cell transplant.

Keywords: breast cancer ctdna
autologous bone marrow stem cell transplantation for osteonecrosis in sickle cell disease

Conditions: Avascular Necrosis of Bone; Sickle Cell Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cells in sickle cell disease patients with osteonecrosis

the aim of this study is to evaluate autologous bone marrow stem cells transplantation as a safe and potentially beneficial treatment for sickle cell disease patients with osteonecrosis.

Eligibility criteria:
inclusion criteria: * stable sickle cell disease patients * ficat classification of osteonecrosis, inclusive of stage ii. * diagnosis will be based on x-ray and magnetic resonance imaging (mri). * no infection in affected bones at the time of surgery. * patient competent to give informed consent. * scoring at least 20 points on the pain and daily life activities questionnaire. exclusion criteria: * ficat stage iii or more * patients with a history of corticosteroids or on active therapy * bone infection at the limb affected by necrosis * recurrent painful crises, * immunosuppressive drug therapy, * pregnancy, * presence of neoplastic disease or any other clinical concurrent condition other than sickle cell disease that predisposed them to the development of osteonecrosis of the femoral head

Keywords: cell therapy sickle cell disease hip osteonecrosis autologous implantation mesenchymal stromal cell humeral osteonecrosis knee osteonecrosis ankle osteonecrosis
validation of the har score for prioritization of patients calling the emergency medical service for chest pain by emergency call dispatcher

Conditions: Chest Pain

Summary: the lifetime prevalence of chest pain in the general population is 20-40%. the etiologies to be evoked from the outset of management are those of cardiovascular origin, such as acute coronary syndrome (acs) and pulmonary embolism. acs is responsible for almost 20% of deaths. delay in treatment is a major prognostic factor, given the importance of coronary reperfusion. in france, one of the first contacts with the healthcare system is the medical regulation assistant (mra) at the centre 15. his or her role is to prioritize the call according to the identification of immediate signs of seriousness, and if necessary, to decide autonomously to send a rescue team before medical regulation. depending on the reason for the call and any signs of seriousness, it prioritizes the call according to the expected response time. in line with current recommendations, all calls for chest pain should be answered by an emergency medical dispatcher (emr) within 5 minutes. however, 60-90% of chest pain calls are not of cardiovascular origin. their prioritization could therefore be re-qualified for longer response times. given the frequency of this type of call, a more efficient mra referral strategy is needed. to achieve this, decision-support tools would be essential. the performance of the har (history, age and risk factors) score has been recently explored, derived from the heart score, in a previous single-center prospective study in 2019. it stratifies the risk of a major cardiovascular event (mce) into low (0 or 1 point), intermediate (2 or 3 points) or high (4, 5 or 6 points). investigator's hypothesis is that the har score could be entrusted to mra, to enable them to optimize the prioritization of patients calling with non-traumatic chest pain, by qualifying low-risk chest pain calls on the one hand, which could be prioritized in p2 snp, and high-risk calls on the other, making it possible to anticipate the dispatch of an emergency service.


Eligibility criteria:
inclusion criteria: * patient of legal age (≥ 18 years) * calling center 15 from 49, 72 or 37 * expressing non-traumatic chest pain, even if this is not the main reason for seeking help. exclusion criteria: * treatment in departments other than 49, 72 and 37 * taken in charge in an emergency department of a private facility in the 49, 72 and 37 départements * poor understanding of the french language * non-affiliated or non-beneficiary of a social security scheme * person deprived of liberty by judicial or administrative decision * person under forced psychiatric care * person subject to a legal protection measure * person unable to express his/her non-opposition. * follow-up at day 30 impossible for any reason * person having expressed his/her opposition to the collection of his/her data.

Keywords: chestpain har score emergency call
staphylococcal acute post-operative pji treated with 'dair' and impact of rifampin

Conditions: Bone and Joint Infection; Antibiotic Resistant Staphylococcus Aureus Infection

Summary: s. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for pji (prosthetic joint infection). the aim of this study is to describe the use of rifampicin.


Eligibility criteria:
inclusion criteria: patients having had acute pji (i.e. \<1 month following the implantation), dair with exchange of removal components) due to s. aureus and coagulase-negative staphylococci (2011-2016) exclusion criteria: none
continuation of oral onc201 in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor

Summary: this phase i trial studies the long-term side effects of the continuation of oral onc201 in treating patients with solid tumors that have spread to other places in the body who have previously benefited from receiving this drug. oral onc201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

primary objectives: i. to evaluate the long-term safety and tolerability of onc201 (oral onc201) administered orally in patients with advanced cancers. secondary objectives: i. to characterize pharmacokinetics of onc201. ii. to assess serum biomarkers of therapeutic response to onc201. iii. to assess preliminary antitumor activity of onc201 as a single agent in advanced solid tumors. outline: patients receive oral onc201 orally (po) on day 1. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up for 4 weeks.

Eligibility criteria:
inclusion criteria: * patient has completed participation in one of the onc201 protocols, has not shown tumor progression while on study treatment, and has tolerated the study drug without unacceptable toxicities * patient has not met criteria for withdrawal from the base protocol * patient is willing to comply with protocol requirements and procedures, and keep scheduled study visits * patient agrees to practice effective contraception during the entire study period unless documentation of infertility exists * patient is able to understand and is willing to sign the informed consent form exclusion criteria: * patient is receiving concomitant standard and/or investigational anticancer therapy; local palliative radiotherapy is permissible upon discussion with the principal investigator * patient has alcohol or substance abuse which, in the opinion of the investigator, would interfere with compliance or safety * patient has any condition or laboratory abnormality which, in the opinion of the investigator, would pose additional risk in administering the study drug to the patient

Keywords: protocol specific