Kornimate/medical-research-clean huggingface dataset:
pet/ct to image hypoxia in head and neck tumours

Conditions: Head and Neck Cancer

Summary: patients with head and neck cancer will be imaged with pet scan and ct scan in order to determine areas of the tumour that are hypoxic. it is hypothesized that pet /ct will provide information on hypoxia of the tumors and tumor regions in head and neck cancer patients.

patients with head and neck cancer greater than 3 cm will imaged with pet scan and ct scan in order to determine areas of the tumour that are hypoxic. following surgical removal, samples of the tumour will be evaluated for the expression of hypoxia genes. the preoperative imaging will be compared to the "gold standard" measures of hypoxic response at the level of gene transcription and a new hypoxia marker with the hypoxyprobe detection system (pimonidazole). hypothesis: fdg/pet visualization of glycolysis combined with ct visualization of blood flow will correlate with cellular response to hypoxic stress in head and neck tumors and intra-tumor regions. measurement of relative levels of mrnas encoding hypoxia response genes will be performed in cells microdissected from the surgical samples. good correlation between imaging signals and direct molecular measures of hypoxic response in primary human tumors will provide information necessary to develop treatment strategies that employ targeted, increased radiation to hypoxic tumors. pimonidazole is an exogenous nitro-imidazole marker, which can be detected through immunohistochemical analysis of frozen sections. it detects cellular hypoxia upon becoming reduced in cells with low oxygen tension, a property that can be detected through antibody mediated detection of the reduced form. it has also shown to reliably and specifically stain hypoxic regions within the tumor, and to correlate well with patient prognosis and treatment outcome.

Eligibility criteria:
inclusion criteria: * all patients with head and neck tumours (\>3cm diameter) without bone involvement. exclusion criteria: * known allergy to contrast agents * poor kidney function (serum creatinine level \> 2.0 mg/dl or 177 mmol/l) * pregnancy * breast-feeding * unable to lie supine * patient who were biopsied or operated upon within the past month. * patient who were treated with chemotherapy or radiation within the past month. * tumors that were obscured by artifacts (e.g. tooth fillings) in ct scans.

Keywords: cancer hypoxia pet scan ct scan
safety, false-positive reactions and sensitizing properties of leishmania tropica skin test antigen

Conditions: Cutaneous Leishmaniasis

Summary: the efficacy of ltsta as a skin test antigen depends upon the sensitivity and specificity of the product. this study has been designed to measure the skin test responses to 15, 30, or 50µg doses of ltsta. the measurements of non-specific reactivity due to components of the antigen solution and the product's ability to sensitize lymphocytes of leishmania naïve persons when administered intradermally. the presence or absence of a local inflammatory response to the first skin test with each of three doses of ltsta will provide insight on the specificity of the antigen in a naïve population. the local inflammatory response to ltsta following the first and second repeat skin tests will indicate if the antigen is sensitizing after intradermal administration.


Eligibility criteria:
inclusion criteria: * male or female in good health; * age 18 - 60 years; * no past history of leishmaniasis or prior participation in a leishmania study; * no prior skin test with a leishmania antigen; * no occupational, residential, or travel exposure to leishmania; * positive candin® or trichophyton skin test (\>= 5 mm induration). exclusion criteria: * history of adult atopic dermatitis, contact dermatitis to multiple agents, unexplained urticaria, or asthma; * active allergic rhinitis or conjunctivitis; * history of allergy or reactions to phenol, polysorbate 80, or glycerol; * medications: currently taking (within the last month) antihistamines or recent history of taking (within the last 1 year) corticosteroids, immunosuppressants; * splenectomy; * active medical disease\*; \*active medical disease: any active physical or psychiatric condition that may increase the risks associated with participation in the study or interferes with the interpretation of study results. included chronic medical illnesses are cardiovascular disease, renal insufficiency, chronic respiratory illness, cirrhosis, chronic hepatitis, chronic pancreatitis, chronic diarrhea, malnutrition, malignancy, autoimmune disease, and asthma. * pregnancy or lactating; * immunization within 4 weeks; * history of leishmaniasis; * occupational exposure to leishmania; * prior participation in a leishmania study; * prior skin test with leishmania antigen; * travel history to leishmania endemic areas; * abnormal screening lab results; * keloid scar formation

Keywords: leishmaniasis delayed-type hypersensitivity (dth) skin test conversion prior exposure to leishmania major
impact of the type of interface in neuromuscular patients treated with nocturnal noninvasive ventilation

Conditions: Neuromuscular Diseases; Alveolar Hypoventilation

Summary: nocturnal non invasive ventilation (niv) is the reference treatment for chronic alveolar hypoventilation in patients with neuro-muscular diseases. niv can be provided by using different types of interfaces: nasal masks are the most frequent type of interface used at home but oronasal masks are used by at least 25% of neuro-muscular patients mainly because of persistent unintentional mouth leaks. however, oronasal mask may cause persistent upper airway obstructive respiratory events because of the mechanical constraint on the chin induced by the traction of the straps that may push the mandible posteriorly during sleep. no randomized study has specifically addressed the question of the impact of type of interface in patients with neuromuscular diseases treated by nocturnal niv. the investigators hypothesize that: 1. the application of oronasal mask may jeopardize the pharyngeal patency in patients already proned to upper airway obstruction; 2. the use of a nasal mask may improve upper airway stability and niv efficacy while reducing side effects. authors objective will be to compare the impact of nasal mask versus oronasal mask on niv efficacy and side-effects. eligible patients are those with nocturnal niv and neuromuscular disease. after a scheduled hospital visit, patients willing to participate will undergo in random order 2 unattended nocturnal polygraphies under niv at home: one polygraphy with nasal mask; one with an oronasal mask. each polygraphy ans side effects assessment will be performed after one week of familiarization with each mask.


Eligibility criteria:
inclusion criteria: * adult patients (\>18 years old) * affected by slowly progressive neuro-muscular diseases (becker muscular dystrophy, facio-scapulo-humeral dystrophy, limb-girdle dystrophy, myotonic dystrophy...) or relatively rapid progression (duchenne muscular dystrophy). * treated with nocturnal non-invasive ventilation (\<15 hours/day) * in stable state (no cardiorespiratory or ear-nose-throat event for at least 1 month before inclusion) exclusion criteria: * rapidly progressive neuro-muscular diseases (such as als) * severe nasal obstruction, maxillofacial deformities or previous upper airway surgery preventing the usage of one type of mask (nasal or oronasal), or, at the discretion of investigator, any other contraindication for using the other type of mask * niv daily use \>15h/day * unwillingness or inability to provide consent to participation * curatorship * subject in exclusion period of another study * vulnerable person or legally protected adult.

Keywords: neuromuscular diseases non-invasive ventilation nasal mask oronasal mask alveolar hypoventilation leaks sleep disorder breathing side effects
aspirin in asymmetrically intrauterine growth

Conditions: Intrauterine Growth Restriction Asymmetrical

Summary: intrauterine growth restriction refers to a fetus that has failed to get a specific measures by a gestational age. asymmetric type of intrauterine growth restriction is known by normal sized head with smaller abdomen.it is important to recognize the growth restricted fetuses, because these fetuses may have fetal or neonatal complications. when blood flow is increased, the oxygen and nutrients will deliver good to the fetus. the role of low-dose aspirin therapy in management of intrauterine growth restriction is controversial. it has been used, in many studies, in prevention of intrauterine growth restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid syndrome.


Eligibility criteria:
inclusion criteria: * the pregnant women * 28-30 weeks * idiopathic asymmetrically intrauterine growth restriction * middle aged women (20-35 years) * women with abnormal umbilical artery doppler flow indices ( \> +2 standard deviation above mean for gestational age) exclusion criteria: * women less than 20 and more than 35 years * hypertensive or diabetic women * any type of smoking * multiple pregnancies * amniotic fluid index \<5 cm * premature pre-labor rupture of membranes * abnormal placenta * any fetal congenital malformations. * women had absent diastolic flow or reversed flow in umbilical artery at the time of recruitment.
radiofrequency ablation of uterine fibroids

Conditions: Uterine Fibroids

Summary: this research study is being conducted to evaluate the safety and effectiveness of ablation (destruction) of uterine leiomyomas (fibroids) using electrocautery heating guided by ultrasound. we are doing this to look for a less invasive method of treatment for patients with uterine fibroids. one method that is being used in other areas of the body to treat masses is radiofrequency electrocautery. this method may be performed for the treatment of uterine fibroids by placing a small diameter needle through the wall of the vagina into the fibroid guided by an ultrasound probe. an optional approach is to place the needle through the skin of the abdomen into the fibroid guided by an ultrasound probe. once the needle is in the fibroid, the electrocautery current is applied and the fibroid is destroyed by heating. this would be done before hysterectomy (removal of the uterus). we are trying to test to see if this type of treatment can be applied to uterine fibroids. we are trying to develop radiofrequency electrocautery as one of the methods to treat fibroids without surgery.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosed with uterine leiomyomas (fibroids) * patient will undergo surgical hysterectomy * patient is willing to sign informed consent form exclusion criteria: * patients with acute infection * patients with bleeding disorders * patients who are not candidates for surgery or general anesthesia

Keywords: uterine fibroids
a short period of proactive community case management (proccm) to improve early care-seeking for fever in sierra leone

Conditions: Health Services Research

Summary: this is a three arm cluster randomized control trial to determine if proactive community case management (proccm) conducted over a short period of time improves care-seeking indicators for febrile illnesses in children in hard to reach (htr) areas of sierra leone compared to integrated community case management (iccm). the three arms include: 1. optimized standard of care for ccm plus proccm - proccm will be implemented for two months near the start of the transmission season, and the existing program will be supplemented to ensure that htr chws have all commodities needed for malaria testing and treatment and are adequately trained on sbcc messages to ensure activities are implemented as designed. 2. optimized standard of care- as in arm 1 without proccm 3. routine implementation (control) - no changes (business as usual) to iccm, sbcc and stock management.


Eligibility criteria:
inclusion criteria: * household lives within the study cluster * head of household or a household member over the age of 18 provides verbal consent for the htr chw visit * all available household members at the time of the htr chw visits are eligible to receive services exclusion criteria: * household does not live within the study cluster * household does not provide consent for the study visit
prospective pilot study andprecise

Conditions: Breast Cancer

Summary: this study aims at providing first evidence that axillary clearance by using an operation technique including the precise ligasure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited.

axillary clearance in breast cancer is usually performed by using a drain to prevent seroma formation and to support obliteration of the dead space in the axillary carry out. the hypothesis made in this protocol is that axillary clearance by using an operation technique including the use of the precise ligasure instrument and closure of dead space can be done without using a postoperative drain. the and precise protocol aims at providing first evidence that axillary clearance by using an operation technique including the precise ligasure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited patients undergoing axillary clearance necessary for achieving reasonable control in invasive breast cancer and participating in the and precise protocol will undergo the operation by using a technique including the use of the precise ligasure instrument and closure of dead space. postoperatively, the numbers of seroma punctions and the amount of seroma will be recorded prospectively. patients will be asked to record on a daily basis their experience of pain by a visual analog scale of pain. the main study parameter is the percent of cases which successfully did not need seroma punctions after the intervention. potential disadvantages for the patient are risk for more seroma formation and discomfort. patients will be asked to record on a daily basis their experience of pain by a visual analog scale of pain.

Eligibility criteria:
inclusion criteria: * indications for axillary clearance can be a tumor positive sentinel node or tumor positive lymph nodes proven by ultrasound or fine needle aspiration cytology. * for this pilot, only patients undergoing breast conserving surgery are eligible. * axillary clearance can be performed after previous sentinel node procedure, at the same operation, and after neo-adjuvant chemo therapy, and as secondary procedure in case of axillary relapse after previous treatment for breast cancer. exclusion criteria: * patients undergoing a modified radical mastectomy including an axillary clearance. * preoperative preexisting seroma.
a study to investigate vx-787 given to adult volunteers inoculated with live influenza virus

Conditions: Influenza Virus

Summary: the purpose of this study is to determine the antiviral activity and safety of vx-787 given to healthy adult volunteers that have been inoculated with the influenza virus.


Eligibility criteria:
inclusion criteria: * negative human immunodeficiency virus (hiv), hepatitis b (hbv) and hepatitis c(hcv) antibody screen * have not been vaccinated for influenza virus since 2006 or had a known influenza-like illness in the current season (as determined in the medical history), defined as in the last 12 months before screening exclusion criteria: * subjects who are pregnant or nursing, or who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period (from at least 14 days before the first dose until 90 days of the last dose of study drug) * presence of any significant acute or chronic, uncontrolled medical or psychiatric illness * abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry * health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral inoculation * intending to travel(to countries for which vaccinations are recommended or where high risk of infections exists) * subjects with a history of asthma, copd, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any etiology; any history during adulthood of asthma of any etiology, copd, or any use of a bronchodilator or other asthma medication during adulthood * regular daily smokers * history or evidence of autoimmune disease or known impaired immune responsiveness * history of heart failure or any other severe cardiac abnormality including clinically significant arrhythmia * receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine, medication, or experimental respiratory viral challenge delivered directly to the respiratory tract within 1 year before viral inoculation * previous exposure to study drug or similar substance(s)
inflammation and infection in trauma, role in posttraumatic complications

Conditions: Trauma

Summary: the purpose of this study is to investigate the relationship between trauma, the immune system, biochemical changes in the first 24 h and subsequent complications and mortality

the immune system plays a role in the development of complications after severe trauma, but we do not know how. equally, biochemical changes measured in the blood after trauma (eg. bloodglucose, gc-globulin, coagulation parameters etc.) may predict the prognosis and the degree of complcations. two significant complications are infection and organ failure, which may prolong hospitalisation and increase mortality. in the study we collected samples from blood and body surfaces to determine changes in cytokines, biochemistry, bacterial flora, and subsequent complications. we compare the changes in between groups of the cohort.

Eligibility criteria:
inclusion criteria: * clinical suspicion of multiple trauma * age \>/= 18 years * direct referral from scene of accident exclusion criteria: * major burn injury * hiv positiv * pregnancy
study to determine the best way to measure how quickly the drug can give relief from sudden diarrhea

Conditions: Diarrhea

Summary: for six hours following drug administration, subjects will rate the severity of specific symptoms. at the end of the six hour study, subjects will rate the overall effectiveness of the product.

a six-hour study to evaluate multiple early efficacy endpoints in loperamide-simethicone therapy to help identify speed of onset of symptomatic treatment of acute nonspecific diarrhea (ansd).

Eligibility criteria:
inclusion criteria: * diagnosis of acute diarrhea with gas-related abdominal discomfort, meeting specific criteria * willing to follow the protocol requirements and comply with protocol restrictions, including use of contraception * able to understand the informed consent process and sign the form * cooperative, reliable and willing to comply with the protocol requirements and schedule, and able to record efficacy and safety assessments. exclusion criteria: * female subjects who are pregnant, lactating or experiencing perimenstrual abdominal or pelvic discomfort * illness requires hospitalization, iv fluids or antibiotics * has taken antibiotics in the past 7 days or a symptomatic antidiarrheal compound in the past 12 hours or any analgesic in the past 6 hours * history of significant underlying enteric, pulmonary, hepatic, cardiac, renal disease, seizure disorder, ibd, cancer, uncontrolled diabetes, or any other unstable medical condition * history of hypersensitivity to loperamide or simethicone * has previously participated in this study or received an investigational drug within the 30 day period before screening

Keywords: pilot study outcome measures
advanced mr imaging of osteoarthritis

Conditions: Osteoarthritis

Summary: the utility of conventional imaging in the development of new treatments for osteoarthritis (oa) is hindered by: 1. difficulty in non-invasively evaluating the initial response to potential new treatment options. oa typically develops over a long time period, so evaluating the efficacy of new treatment options over a timeframe relevant to experimental medicine studies is difficult. 2. inadequate methods of disease quantification and stratification. oa is a heterogeneous condition and identifying which subgroups of patients are most likely to benefit from new treatments is crucial. novel magnetic resonance (mr) imaging acquisition and analysis techniques have the potential to solve these problems. however, their reliability needs to be fully established and knowledge of likely effect sizes is required to inform sample size considerations for further longitudinal/interventional studies. this study aims to help address these issues by: 1. calculating effect sizes for mr measurements to inform sample size calculations for future studies. 2. assessing the reliability of a multiparametric mr protocol for assessment of the knee joint. the investigators will examine a single knee of an initial 15 participants with mr. participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with clinical and x-ray features of oa and (2) 5 control subjects (matched to cases for age, sex and body mass index in a 1:2 ratio) who do not have clinical features of oa. participants will undergo an initial (baseline) mr examination, followed by repeat mr examinations at approximately 1 month and 1 year following the baseline examination. this will allow us to assess both the reliability of our mr measurements and the expected progression in our mr measurements in oa subjects in the absence of any disease-modifying intervention.


Eligibility criteria:
group 1 inclusion criteria: * meets american college of rheumatology (acr) criteria for oa * kellgren-lawrence grade 2-3 oa on knee radiograph * medial compartment predominant disease * neutral alignment * aged 40-60 * body mass index (bmi) \< 35 kg per square meter * ambulatory and in good general health group 2 inclusion criteria: * no current symptoms of knee pain or stiffness or other clinical features of oa * aged 40-60 * bmi \< 35 kg per square meter * ambulatory and in good general health exclusion criteria (both groups): * history of ipsilateral lower limb fracture * history of ipsilateral lower limb surgery (including arthroscopy) * metabolic bone disease * inflammatory arthritis * haematological malignancy * paget's disease * bone metastases * contraindication to mr imaging (e.g. pacemaker, severe claustrophobia) * contraindication to intravenous gadolinium based contrast medium administration (see 'ethical considerations' section) * unable to consent