Kornimate/medical-research-clean huggingface dataset:
implementation of a prehabilitation program for surgical patients

Conditions: Prehabilitation; Oncology; Surgical Oncology

Summary: frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. prehabilitation programs can help mitigate the negative outcomes associated with frailty. the investigators hope to implement a newly developed prehabilitation pilot program in the maine medical center surgical oncology clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.

frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. prehabilitation programs can help mitigate the negative outcomes associated with frailty. the investigators hope to implement a newly developed prehabilitation pilot program in the maine medical center surgical oncology clinic to initially evaluate adherence, self-efficacy, and health-related quality of life. the investigators now hope to implement this prehabilitation program in the clinics at maine medical center. our long term goal is the introduce this program in all surgical specialties; but first, the investigators plan to assess adherence, patient self-efficacy, frailty and health-related quality of life through a pilot study in the surgical oncology clinic.

Eligibility criteria:
inclusion criteria: 1. subjects ≥18 years old 2. evaluated at maine medical center by surgical oncology service 3. planned surgical intervention for gastrointestinal oncologic condition 4. score ≥40 on risk analysis index frailty screening 5. physically able to participate in prehabilitation exercises 6. home internet access and established email account 7. able to understand the english language exclusion criteria: 1. patients unable to participate in exercises included in prehabilitation program 2. patients with impaired decision making capacity 3. those in a high risk community: prisoners and pregnant women 4. those who do not meet the above inclusion criteria
online parent-report evaluation of the effects of processed music

Conditions: Sensory Disorders; Sensory Processing Disorder; Autism Spectrum Disorder; Eating Disorders; Gastro-Intestinal Disorder; Swallowing Disorder; Anxiety

Summary: the study aims to examine effectiveness of the safe and sound protocol (ssp) on sensory, digestive, and eating behaviors in children currently receiving therapy.

the ssp consists of listening to a computer altered sequence of vocal music that has been processed to "exercise" the neural regulation of the middle ear muscles. low and high frequencies are dynamically filtered and presented monaurally to both ears. the intervention stimuli are delivered through headphones or speakers. the protocol consists of 60 minutes of listening on five sequential days and is delivered via a music player device in a quiet room without major distractors. for this study, parents or legal guardians of children already enrolled to complete the ssp intervention at children's therapy of woodinville will complete a series of surveys. the ssp is used as a component of therapy across multiple diagnostic categories including autism spectrum disorders and sensory processing disorder. no specific diagnoses will be targeted in this design. parents will be recruited for the study if their child is already enrolled to receive the therapy. participating parents will be asked to complete online questionnaires using a survey link at three intervals: before the start of therapy, one week after completion, and 1 month after completion.

Eligibility criteria:
inclusion criteria: * parent or legal guardian of child who is receiving the safe and sound protocol at children's therapy of woodinville (in woodinville, wa) * parent must be 18 years or older exclusion criteria: -
efficacy study to evaluate the effect of new antiviral drugs on hcv infection.

Conditions: Chronic Hepatitis, C Virus

Summary: the purpose of this study is to determinate the amh levels before and after antiviral therapy with ombitasvir-paritaprevir-ritonavir and dasabuvir in comparison with age-matched hcv-positive women not undergoing antiviral treatment.

the study is interventional, controlled randomized (block 2:1 case: controls) in open label.

Eligibility criteria:
inclusion criteria: * female between 18 and 35 years of age at the time of screening * childbearing potential and sexually active with male partner(s) currently using at least one effective method of birth control at the time of screening and two effective methods of birth control while receiving study drugs, starting with study day 1 and for 7 months after stopping study drug. * females must have negative results for pregnancy tests * chronic hcv-infection prior to study enrollment * screening laboratory result indicating hcv gt 1b or gt 1a or gt 4 infection. * must be able to voluntarily sign and date an informed consent form * liver biopsy within 24 months prior to or during screening demonstrating a metavir score of 2 or less or an ishak score of 3 or less or screening fibroscan® result of ≤ 9.6 kpa; exclusion criteria: * women who are pregnant or breastfeeding * positive test result for hbsag and hiv ab * recent history of drug or alcohol * hcv genotype performed during screening indicates more than 1 subtype or co-infection with any other genotype. * use of medications contraindicated * use of known strong inducers of cytochrome p450 3a (cyp3a) or strong inducers of cytochrome p450 2c8 (cyp2c8) or strong inhibitors of cyp2c8 * history of solid organ transplant. * confirmed presence of hepatocellular carcinoma * current use of any investigational or commercially available anti-hcv agents * screening laboratory analyses showing any of the following abnormal laboratory results
mdr - pmcf study for ringloc bipolar acetabular cup

Conditions: Hip Arthritis; Hip Disease; Hip Fractures; Hip Injuries; Hip Pain Chronic

Summary: the objective of this retrospective enrollment/prospective follow-up consecutive series pmcf study is to collect data confirming safety, performance, and clinical benefits of the ringloc bipolar acetabular cup when used for hip hemiarthroplasty (implants and instrumentation).

the objective of this retrospective enrollment/prospective follow-up consecutive series pmcf study is to collect data confirming safety, performance, and clinical benefits of the ringloc bipolar acetabular cup when used for hip hemiarthroplasty (implants and instrumentation). the primary objective of this study is the assessment of safety by analyzing implant survivorship at the longest follow-up timepoint available, greater than or equal to eight years post-implantation. this will be established by recording the incidence and frequency of revisions, complications, and adverse events. relationship of the events to implant, instrumentation and/or procedure should be specified. the secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (proms).

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older and skeletally mature * patient must be willing and able to sign irb approved informed consent * non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * rheumatoid arthritis * correction of functional deformity * treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * revision procedures where other treatment or devices have failed exclusion criteria: * off-label use * uncooperative patient or patient with neurological disorders who are incapable of following directions * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy, or neuromuscular disease * infection * sepsis * osteomyelitis * patient is known to be pregnant or nursing * patient is a prisoner * patient is a known alcohol or drug abuser * patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent * patient is unwilling to sign an informed consent
development of a response signature to neoadjuvant chemotherapy for breast cancer

Conditions: Breast Cancer

Summary: breast cancer is the most frequent cancer in women. it is often treated with neoadjuvant chemotherapy, administered before surgical resection. unfortunately, many patients do not respond to this treatment, or only respond partially. clinicians therefore need predictive biomarkers of treatment response. thanks to an innovative technique, called cats, this study aims at identifying blood and tissue biomarkers which are predictive of response to chemotherapy.

breast cancer is the most frequent cancer in women. it is often treated with neoadjuvant chemotherapy, administered before surgical resection. unfortunately, many patients do not respond to this treatment, or only respond partially. clinicians therefore need predictive biomarkers of treatment response. thanks to an innovative technique, called cats, this study aims at identifying blood and tissue biomarkers which are predictive of response to chemotherapy. the objective of this study is to develop molecular signatures predictive of response to neoadjuvant chemotherapy which would be able to discriminate between patient groups based on their epithelio-mesenchymal transition (emt) status and their immune status. as these two parameters are known to be responsible for incomplete responses to chemotherapy, investigators hypothesize that these signatures will be predictive of response to neoadjuvant chemotherapy. in a second step, researchers will evaluate the ability of these signatures to predict treatment response in breast cancer patients treated with neoadjuvant chemotherapy. the investigators will investigate two types of signatures: a tissue signature and a circulating signature. the former is based on the level of expression of several mrna and mirna assessed by cats-rnaseq in the biopsy. the circulating signature will be based on the expression level of several mirna by the same technique. given that the expression level of tumoral mirna is affected by the emt and immunological status, and given that tumors secrete mirna in the circulation, investigators expect the mirna plasma content to reflect the emt and immunological status of the tumor. the circulating signature will have the additional advantage of being independent of tumor heterogeneity.

Eligibility criteria:
inclusion criteria: * women and men with breast cancer * treated with neoadjuvant chemotherapy exclusion criteria: * none
treatment of mild to moderate depression symptoms in patients with spinal cord injury

Conditions: Spinal Cord Injury

Summary: this study was initially designed to test the efficacy of venlafaxine hcl in reducing incidence of the onset of major depression after a new spinal cord injury (sci). after several protocol modifications, the purpose of the study is to test the effectiveness of a sub-therapeutic dose of venlafaxine hcl to reduce mild to moderate symptoms in persons with sci.

the successes of psychological and pharmacological modes of intervention in treating depression, both alone and combined, are well documented in the literature. while a great deal of research has identified specific clinical indications for many antidepressants currently available in the general population, little is known about the clinical indications of these agents in sci. this study is proposed to test the benefits of venlafaxine hci (effexor xr) for reducing mild to moderate symptoms of depression among people with sci. the intervention will last 12 weeks and there will be 13 assessments and data collection points. data will be collected at 26 weeks also. eight face to face contacts are anticipated. because of the change in protocol to reducing mild to moderate symptoms and substantially lower enrollment than anticipated (1/6th of what we anticipated), we deleted a number of study outcomes listed in the 2011 posting of this study. most of these were not part of the original posting in 2008, and those that were deleted were no longer relevant to new protocol's focus on reducing mild to moderate depression. the two outcomes reported here were most relevant to the revised protocol.

Eligibility criteria:
inclusion criteria: * having sustained an sci at least six months prior to enrollment. * neurological impairment asia grades a-d. * mild to moderate depressive symptoms. * english speaker * age 18 years or older * able to communicate with study personnel exclusion criteria: * no neurological impairment due to sci. * presence of cognitive deficits precluding and giving informed consent and completion of survey based assessment tools. * psychiatric contraindications (suicidal ideation, history of suicidal attempts, alcohol and drug dependency, other psychiatric diagnosis including bipolar disorder). * medical contraindications (terminal illness or unstable medical condition as determined by medical history and/or examination). * pregnant or unwilling to use birth control if female and sexually active. * presence of glaucoma. * prior use of study drug without success or being treated with another antidepressant medication and being unwilling to taper off to take the stud drug. * willing to travel to ann arbor michigan. * expecting to take or currently taking another experimental study within 30 days * major surgery scheduled within 12 weeks

Keywords: sci
study of a geriatric assessment to plan a treatment approach for older people with various blood disorders

Conditions: Myelodysplastic Syndrome; Myeloproliferative Neoplasms; Chronic Myelomonocytic Leukemia; Atypical Chronic Myeloid Leukemia; Myelodysplastic/Myeloproliferative Overlapping Syndrome

Summary: this study will evaluate whether a geriatric assessment can lead to better treatment outcomes in older patients (age 60+) with a myeloid malignancy including acute myeloid leukemia, ,myelodysplastic syndromes, myeloproliferative neoplasms, or related blood disorders who are going to receive chemotherapy or another treatment to prepare the body for an allogeneic hematopoietic stem cell transplant (allo-hct). the geriatric assessment includes looking at patients' cognitive function (thinking processes), physical function, mobility (ability to move the body), mood, nutrition, and current medications to help decide the type of treatment they'll receive. another purpose of this study is to see whether use of the geriatric assessment improves participants' quality of life. we will evaluate participants' quality of life through questionnaires.

this is a prospective, phase ii study evaluating the efficacy of a risk-adapted, personalized allo-hct strategy based on geriatric vulnerabilities identified by pre-transplant ga. the less vulnerable/fit older patients are recommended to receive ma conditioning and the more vulnerable older patients are recommended to receive ric/nma conditioning. 1. hct-ci/age ≤4 and no iadl impairment (less vulnerable/fit) -\> ma regimen 2. hct-ci/age \>4 and/or any iadl impairment (more vulnerable) -\> ric/nma regimen * chemotherapies: busulfan, fludarabine, melphalan, cyclophosphamide, thiotepa, clofarabine * radiation therapy: total body irradiation (tbi) * other therapy: anti-thymocyte globulin (atg)

Eligibility criteria:
inclusion criteria: * are 60 years or older * have a pathologically confirmed myeloid malignancies including acute myeloid leukemia, ,myelodysplastic syndrome, myeloproliferative neoplasms, or related blood disorders including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, and myelodysplastic/myeloproliferative overlapping syndrome * have \<10% blasts in bone marrow prior to transplant * have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor * meet institutional standard criteria for allogeneic transplantation as determined by the primary transplant physician * undergoes transplantation using the allocated conditioning regimen intensity defined by the protocol-specified criteria below: * hct-ci/age \<5 and iadl normal = myeloablative regimen * hct-ci/age ≥5 and/or iadl impairment = ric/nma regimen exclusion criteria: * prior hematopoietic cell transplantation * cord blood donors * persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant

Keywords: blood disorders allogeneic hematopoietic cell transplant 20-522
pepita study: an observational study of tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this observational study will evaluate the efficacy and safety of tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (nsclc) after failure of first line platinum-based chemotherapy. eligible patients will be followed for 12 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically or cytologically confirmed advanced (stage iiib) or metastatic (stage iv) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy * patients for whom the treating physician has decided to initiate treatment with tarceva exclusion criteria: * mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component * current participation in a clinical trial evaluating an anticancer treatment
prosthesis and implant survival in immediately loaded temporary full arch restorations

Conditions: Completely Edentulous Patients

Summary: in immediate loading of implants of completely edentulous patients, the most common post-surgical complication following the surgery noted in the dental literature is fracture of the provisional restoration with rates ranging from 4.17% to 41%. most of these fractures occur because polymethyl methacrylate (pmma) materials are inadequate and have low rigidity to withstand extended periods of heavy occlusal use. fractures of full arch provisional restorations during healing are concerning, because they eliminate cross-arch stabilization and disrupt stress distribution patterns which might jeopardize implant osseointegration affecting the survival rates for implants. therefore, it is important to look for another material that has higher rigidity than pmma and can withstand masticatory forces for extended periods without fractures or load concentration on the implants during the osseointegration period.


Eligibility criteria:
inclusion criteria: * completely edentulous patients. * patients with proper amount of attached gingiva (≥2 mm) exclusion criteria: * patients having a medical condition that absolutely contraindicates implant placement. * patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (hba1c). (greater than 6.4 percent) * potentially uncooperative patients who are not willing to go through the proposed interventions. * moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day). * patients with history of bruxism * if insertion torque for the implants is less than 35 ncm
study of hypothalamic metabolism in spontaneous cluster headache attacks

Conditions: Cluster Headache

Summary: cluster headache is characterized by unilateral excruciating head pain and autonomic dysfunction. hypothalamic overactivity was observed in nitrate-induced cluster-headache and in only one case of spontaneous cluster headache 'sprenger et al, 2004). this prompted the application of hypothalamic deep brain stimulation. the aim of this data is to precise the localisation of the hypothalamic activation.


Eligibility criteria:
inclusion criteria: * cluster headache in crisis * no serious illnesses in progress as cancer, autoimmune disease, liver disease * patient without chronic psychiatric disease excluding moderate and reactional depression * no demential disease * no anxious or depressive disease * no contraindication to pet scan (pregnancy and breast-feeding) * social security cover * written informed consent exclusion criteria: * no effective contraception taken * unable to realize a decubitus of 15 minutes long

Keywords: comparison of a spontaneous acute cluster headache attack and rest (no pain) in ten patients with cluster headache defined with ihs criteria
intraoperative imaging with icg registry

Conditions: Lung Nodule, Breast, Kidney,Parathyroid, Mediastinal, Skin Mass, Soft Tissue, Prostate, Stomach Pleural, Head and Neck, and Are at Risk of Recurrence

Summary: the purpose of this registry is to monitor the rate of recurrence in patients who undergo cancer surgery.

our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. the registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance. in this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. also, we will monitor any side effects or potential toxicities that may occur. this data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Eligibility criteria:
inclusion criteria: inclkusion criteria * adult patients \>= 18 years of age * patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence. * good operative candidate as determined by the treating physician and/or multidisciplinary team * subject capable of giving informed consent and participating in the process of consent. exclusion criteria none