Kornimate/medical-research-clean huggingface dataset:
neurophysiology and pharmacology of cough reflex hypersensitivity

Conditions: Chronic Cough

Summary: a cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult non-smoking population. chronic cough has many associated complications including incontinence, muscular chest pains, blackouts and depression. current treatment is often ineffective in these patients. to develop new medications the investigators need to understand more about the mechanisms that can lead to excessive coughing. this study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic cough. the investigators hypothesise that that chronic cough patients have a more sensitive cough reflex as a result central nervous system hyper-excitability (central sensitisation). the investigators will measure cough reflex sensitivity before and after administration of ketamine, a medication that blocks an important receptor in the central nervous system.


Eligibility criteria:
inclusion criteria: healthy volunteers: * over 18 years old * measurable cough reflex sensitivity * no current or past history of chronic cough or chronic respiratory disease. * no symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip. chronic cough patients * over 18 years old * chronic persistent cough (\> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post nasal drip and gastro-oesophageal reflux disease. * normal cxr * normal lung function * measurable cough reflex sensitivity exclusion criteria: * recent upper respiratory tract infection (4 weeks) * pregnancy/breast feeding * current smokers or ex-smokers with \ 10 packyears * diabetes mellitus * opiate or ace inhibitor use. * any centrally acting medication which has the potential to alter cough reflex sensitivity. * significant and ongoing chronic respiratory, cardiovascular (in particular hypertension), gastro-intestinal, haematological (porphyria), neurological or psychiatric illness. * drug or alcohol abuse * history of allergy or reaction to ketamine of other nmda receptor antagonists.

Keywords: cough cough reflex nmda receptor central sensitisation
transfusion of pathogen reduced cryoprecipitated fibrinogen to expedite product availability in perioperative bleeding

Conditions: Hypofibrinogenemia; Bleeding

Summary: the goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. the investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided. participants will be given one of the two fda-approved blood products.

immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. the product that is primarily used for fibrinogen replacement in the us, cryoprecipitate (cryo), must be stored frozen and expires six hours after thawing, resulting in a delay in transfusion of approximately 50 minutes from the time it is ordered, as well as unnecessary transfusion of more readily available but not indicated blood components that are transfused while the patients waits for cryo . a modified version of the product, pathogen reduced (pr) cryo, is now fda approved and can be thawed and stored for 5 days, allowing the product to be available immediately when needed. in this quality improvement study, the investigators will compare the effect that readily available, pre-thawed pr cryo has on transfusion practice in cardiovascular and liver transplant patients who receive pr cryo versus those who receive traditional cryo by randomizing cryo transfusions in the blood bank by month to all cryo or all pr cryo. all clinical decisions, including the need for cryo, and laboratory testing will occur per standard of care.

Eligibility criteria:
inclusion criteria: 1. adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period. 2. cardiovascular surgery includes the following procedures: 1. coronary artery bypass grafting 2. valve repair or replacement 3. open thoracic aortic and thoracoabdominal aortic surgery 4. atrial or ventricular septal defects 5. ventricular assist device implantation or revision 6. or any combination of the above. exclusion criteria: 1. patients who do not receive any cryo product in the or 2. patients who are not cardiovascular surgery or liver transplant patients 3. cardiac transplantation surgery 4. patients who receive a product in error within either the cryo time period or the pr cryo time period. for example, pr cryo during a cryo month or cryo during a pr cryo time month. 5. patients who receive less than 1 pool (5 units) of cryo 6. pediatric patients (less than 18 years of age). 7. patients who received both pr cryo and traditional cryo 8. pregnant women

Keywords: cryoprecipitate pathogen reduced cryoprecipitate
early intervention for impairments identified during comprehensive geriatric assessment in patients with bladder cancer

Conditions: Bladder Cancer

Summary: a comprehensive geriatric assessment (cga) is a set of tests used to evaluate a patient's medical, social, and functional status, and can identify impairments in these domains that may not be noticed otherwise. prior studies have shown that a cga can accurately predict which patients are more likely to have serious side effects from cancer treatment. however, it is unknown whether interventions can be done to address the impairments found during a cga in order to reduce the risk of these side effects. this pilot study will test the feasibility of targeted interventions for deficits identified during a cga in patients 65 years or older with bladder cancer that have not yet started treatment.

this study will enroll patients with muscle-invasive bladder cancer that have not yet started systemic cancer treatment. the participants will complete a cga and patient-reported outcome (pro) measures at baseline. based on any impairments found during the cga, participants will be referred to specialists to help address these difficulties. participants will complete the cga and pro measures again at 3 months and 1 year after the initial assessment. the goal of this study is to see if patients with advanced bladder cancer are interested in referrals to specialists to address their impairments, and whether participants attend those appointments.

Eligibility criteria:
inclusion criteria: * age 65 years or older * confirmed diagnosis of muscle-invasive bladder cancer * plan to undergo systemic treatment but have not yet started therapy exclusion criteria: * must be able to read english

Keywords: geriatric oncology comprehensive geriatric assessment patient-reported outcomes muscle-invasive bladder cancer
improvement of knowledge about the arthrogenic muscle inhibition in the aftermath of knee trauma.

Conditions: Anterior Cruciate Ligament Rupture

Summary: arthrogenic muscle inhibition (ami) is one of the classic complications occurring in the aftermath of knee trauma; ami is grossly defined as a lack of extension due to quadriceps inhibition and hamstring contracture. however, its origins remains unknown with a strong suspicion for a central brain origin. it could be the missing link explaining this lack of extension following an anterior cruciate ligament (acl) rupture. the primary hypothesis of this study is that a difference in activation of motor brain areas exists in patients with an acl rupture, between those with ami or without. the second hypothesis is that this difference could be seen on brain functional mri.

ami leads to quadriceps atrophy, persistent knee pain, dynamic instability, and a higher rate of osteoarthritis. a recent literature review suggests that the ami phenomenon is multifactorial, but not widely known and poorly understood. known mechanisms include impaired motor function at rest, impaired transmission of information from joint sensory receptors, impaired excitability of the spinal reflex and impaired cortical activity. several studies have suggested a link between acl rupture and central nervous system reorganization. among the neurophysiological investigations explored are the evoked somesthesic potentials, electroencephalography, and transcranial magnetic stimulation (tms). however, these mechanisms alone do not explain the phenomenon in its entirety, suggesting that there are other mechanisms. furthermore, no study has used functional brain mri to assess the existence of similar changes in ami. this study plans to compare two groups of patients with an acl rupture: a group with ami, and a group without ami. both groups will undergo a functional brain mri in order to analyse any modification of the sensory-motor network connectivity that could occur.

Eligibility criteria:
inclusion criteria: * male patient, right-handed, * with a severe right knee sprain in the event of acl rupture, * occurrence of trauma within 4 weeks prior to inclusion, * with a score of ≥ 8/10 on the edinburgh manual laterality questionnaire, -affiliated or benefiting from public health services. exclusion criteria: * person presenting any of these conditions : professional player / athlete, -contraindication to the mri examination (claustrophobic patient, patient with a metallic element), * patient already operated on with ligament damage to the knee other than acl, * patient with iterative acl rupture, * patient who has undergone contralateral ligament reconstruction, * patient with multi-ligamentary knee injury, * patient refusing to be informed of any abnormality detected on brain mri, -protected patient (adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision).

Keywords: arthrogenic muscle inhibition anterior cruciate ligament functional brain mri central nervous system knee trauma
relapse prevention study of desvenlafaxine succinate sustained release in outpatients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with major depressive disorder, using a randomized withdrawal design. randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. subjects will not know to which group they have been assigned. the study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. subjects assigned to placebo will receive a blinded placebo taper. following taper, subjects will be evaluated for one additional week to monitor safety.


Eligibility criteria:
inclusion criteria: * adult, outpatient with primary diagnosis of major depressive disorder (depressive symptoms for at least 30 days prior to screening) * hamilton psychiatric rating scale for depression (ham-d 17) total score of \>= 20 * clinical global impressions scale-severity (cgi-s) score of \>= 4. exclusion criteria: * significant risk of suicide as assessed by clinician judgment, ham-d17 and columbia suicide-severity rating scale scores. * past treatment with desvenlafaxine succinate sustained release. * other eligibility criteria also apply.

Keywords: major depressive disorder
glucose and fructose stimulated brain activity in obese subjects before and after bariatric surgery

Conditions: Exploratory Behavior

Summary: the objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional mri before and after bariatric surgery. administration of glucose as well as fructose is followed by functional brain mri, and findings are correlated with serum glucagon-like peptide 1 (glp-1) levels as an endogenous satiety signal in obese humans.


Eligibility criteria:
inclusion criteria: * right-handed * morbidly obese patients * scheduled for bariatric surgery exclusion criteria: * diabetes mellitus * cardiovascular disease * neurologic or psychiatric disorder
prognostic and predictive biomarkers in ovarian cancers

Conditions: Ovarian Cancer

Summary: the investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, vaginal smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in oc prior to treatment and adaptation following treatment contribute to chemotherapy resistance. in addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo dna repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.


Eligibility criteria:
inclusion criteria: 1. new patient with a diagnosis of oc, or 2. previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to ct guided biopsy of relapsed disease, or 3. previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease. 4. signed informed consent 5. age ≥ 18 6. patient affiliated to a social security regimen or beneficiary of the same exclusion criteria: 1. patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment; 2. coagulation abnormalities that contra-indicates the biopsy
blood flow analysis of the human mucosa after vestibuloplasty procedures

Conditions: Mucogingival Defect

Summary: apply the lsci for follow-up the postoperative microcirculation after surgical procedures to enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes during wound healing in human subjects.

vestibuloplasty is the common name of those procedures designed to widen the zone of attached gingiva. the apically repositioned split thickness flap with a xenogeneic collagen matrix or with a combination of strip gingival graft and a xenogeneic collagen matrix are frequently used surgical techniques, however no data are available, how these graft tissues affect the microcirculation of the healing gingiva. lsci is a non-invasive, two dimensional method to evaluate microcirculation of different tissues. this new method let us monitor the entire surgical area real-time during the healing period. the aim of the present study is to define blood flow patterns, which might characterize the wound healing of such surgical procedures during the first 6 months of healing in order to facilitate treatment.

Eligibility criteria:
ages eligible for study: 18 years to 45 years genders eligible for study: both accepts healthy volunteers: yes inclusion criteria: • clinical diagnosis of inadequate width of keratinized gingiva at the mandibular front region exclusion criteria: * pregnancy * heavy smoking * general diseases * taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, anti-inflammatory drugs) * taking any other medications in the last three months (except contraceptives)

Keywords: mandibular vestibuloplasty wound healing microcirculation laser speckle contrast imager mucograft strip gingival graft
study to assess the safety and tolerability of a parp inhibitor in combination with carboplatin and/or paclitaxel

Conditions: Triple Negative Metastatic Breast Cancer; Advanced Ovarian Cancer; Carboplatin; Paclitaxel

Summary: the purpose of this study is to identify a safe and tolerable dose of the drug ku-0059436 that can be given in combination with carboplatin and/or paclitaxel chemotherapy.


Eligibility criteria:
inclusion criteria: * male or female patients with a histologically or cytologically diagnosed malignant solid tumour * adequate bone marrow, hepatic and renal function * performance status of no more than 2 ( ecog scale). exclusion criteria: * any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry * major surgery with 4 weeks of entering the study and must have recovered from effects of the major surgery * more than two previous courses of platinum-containing chemotherapy * heavily pre-treated patients(\> 2 courses of previous chemotherapy and/or extensive irradiation leading to bone marrow deficiency) will be excluded from the study

Keywords: malignant solid tumours poly(adp ribose) polymerases
gemcitabine in treating patients with persistent or recurrent cancer of the cervix

Conditions: Cervical Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of gemcitabine in treating patients who have persistent or recurrent cancer of the cervix.

objectives: * determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols. * determine the toxicity of this regimen in these patients. outline: this is a multicenter study. patients receive gemcitabine iv over 30 minutes weekly for 3 weeks. courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: approximately 15-37 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable * eligible subtypes: * adenocarcinoma * adenosquamous carcinoma * undifferentiated carcinoma * must have documented disease progression * histologic confirmation of original primary tumor required * bidimensionally measurable disease * ineligible for higher priority gog protocol patient characteristics: age: * 18 and over performance status: * gog 0-2 life expectancy: * not specified hematopoietic: * platelet count at least 100,000/mm\^3 * granulocyte count at least 1,500/mm\^3 hepatic: * bilirubin no greater than 1.5 times normal * sgot and alkaline phosphatase no greater than 3 times normal renal: * creatinine no greater than 1.5 mg/dl other: * no significant infection * not pregnant * fertile patients must use effective contraception * no other invasive malignancy within the past 5 years except nonmelanomatous skin cancer prior concurrent therapy: biologic therapy: * no concurrent filgrastim (g-csf) chemotherapy: * no prior gemcitabine * at least 3 weeks since other prior chemotherapy for cervical cancer and recovered * no more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy) endocrine therapy: * not specified radiotherapy: * at least 3 weeks since prior radiotherapy for cervical cancer and recovered surgery: * at least 3 weeks since prior surgery for cervical cancer and recovered other: * no prior cancer treatment that would preclude study

Keywords: recurrent cervical cancer cervical adenocarcinoma cervical adenosquamous cell carcinoma
social and monetary incentives for smoking cessation at large employers

Conditions: Tobacco Use Disorder

Summary: the investigators will conduct a cluster randomized controlled trial of several behavioral interventions for smoking cessation among a sample of employees at large workplaces in the bangkok metropolitan area. the study aims to test the impacts of different incentive structures for smoking cessation on take-up, effectiveness, and cost-effectiveness. the interventions are designed to elucidate certain principles from the field of behavioral economics.


Eligibility criteria:
inclusion criteria: * current full-time employee of a participating company * smoker of 100+ cigarettes during lifetime * smoker of 10+ cigarettes per week * individual is aged 18+ years old * smoker wants to quit within the next 6 months exclusion criteria: * expects to leave company within the next 12 months * is currently pregnant * are unable to provide informed consent

Keywords: smoking cessation incentives health behavior smoking work-site
lowdose nivolumab in combination with avd as front line therapy for classic hodgkin's lymphoma

Conditions: Safety Issues; Efficacy, Self

Summary: this study aims to prove the efficacy and safety of low dose nivolumab (40mg as the lowest available presentation) in combination with avd (adriamycin,vinblastine sulfate and dacarbazine) as frontline treatment for classic hodgkin's lymphoma.

the main objective of this project is to prove the efficacy and safety of nivolumab used as an standard dose of 40mg ( as the lowest available presentation) in combination with avd as frontline therapy for hodgkin's lymphoma. patients classification. we will categorize patients in three groups as follows: 1. early stages by ann-arbor classification (i,ii) with no risk factors (as stablished by nccn's guidelines criteria). 2. early stages by ann.arbor classification (i,ii) with risk factors ( as stablished by nccn's guidelines criteria). 3. advanced stages by ann-arbor classification (iii,iv). methodology: * patients will receive two initial cycles of navd therapy ( each with two applications in day 1 and 15) and then will be evaluated with an interim pet/ct after completing cycle 2. * according to the pet c/t results, patients will be categorized as fast responsers (patients who achieve deauville 1-3 classification) and low responsers ( patients who achieve deauville 4-5). * fast responsers will receive following cycles without nivolumab (2 extra cycles for patients categorized as early stage with no risk factors, 4 extra cycles for patients categorized as early stages with risk factors and for advanced stages). * patients will receive medical evaluation at first meeting, during their treatment and after conclusion of the treatment with physical examination and laboratory tests according to medical criteria. * adverse effects will be recorded and managed following the guidelines for immunotherapy and chemotherapy indications.

Eligibility criteria:
inclusion criteria: * patients with recent diagnosis of classic hodgkin's lymphoma demonstrated by incisional or excisional biopsy of adenopathy. * treatment naive patients. * any stage * any functional status. exclusion criteria: * patients with refractory or relapsed disease. * patients with non classical variety. * patients with chronic or active infections at the moment of recruiting. * patients younger than 16 years old. * pregnancy

Keywords: nivolumab lowdose nivolumab navd hodgkin's lymphoma