Kornimate/medical-research-clean huggingface dataset:
hydroxyurea in the emergency room to lessen pain in sickle cell crisis

Conditions: Anemia, Sickle Cell; Anemia; Sickle-Cell, With Crisis

Summary: this study will investigate the safety, tolerability and potential for the use of up to three daily doses of 30-40 mg/kg hu (daily) upon hospitalization for painful vaso-occlusive crises .

sickle cell anemia (sca) is a hereditary hemoglobinopathy; complications of the disease include, spleen enlargement, acute chest syndrome, pulmonary hypertension, stroke and cumulative damage to multiple organs, and painful vaso-occlusive crises (voc). in brazil, about 3,500 children are born each year with df, and the number of individuals with sickle cell disease (df) in the country is estimated between 25,000 and 30,000 (anvisa 2012; brazil, 2012). hydroxyurea (hu, or hydroxycarbamide) is the only drug approved to date by the american fda for use in adults with sickle cell disease. the drug modifies the disease process, improving hematological parameters and the hospitalization time of patients, as well as the frequency of vaso-occlusive crises.in addition to its proven effects during chronic use, experimental data indicate that hu has immediate anti-inflammatory effects. in addition to its proven effects during chronic use, experimental data indicate that hu has immediate anti-inflammatory effects. this study will investigate the safety, tolerability and potential for the use of up to three daily doses of 30-40 mg/kg hu (daily) upon hospitalization for voc.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of homozygous sickle cell anemia (hbss). * hospitalization due to onset of uncomplicated vaso-occlusive crisis (with pain scale≥6 within the last 24 h), confirmed by clinical evaluation. * documented and written informed consent exclusion criteria: * confirmed or suspected pregnancy. * initiation of painful crisis\> 72h. * blood transfusion during the last 8 weeks. * admission to emergency room due to pain in the last 4 weeks. * neutrophil count \<2.5 x 109/l or platelet count \<95.0 x 109 / l or hb \<4.5 g / dl * weight \ 95 kg. * interval longer than 8h since arrival at center. * non-consent to participate in the study.
investigation of microbiome-based prognostical biomarkers in patients with morbid obesity and bariatric surgery

Conditions: Obesity, Morbid; Bariatric Surgery Candidate; NAFLD; Microbiome

Summary: morbid obesity leads to non-alcoholic fatty liver disease (nafld), and not all nafld cases benefit from weight loss e.g. after bariatric surgery. our aim is to find out, which intrahepatic factors and / or biomarkers might be beneficial or can be identified as prognostic factors for remission of nafld after weight loss. as other factors such as the microbiome or muscle and fatty tissue also influence the development of obesity and liver diseases, it is planned to examine these parameters before and after bariatric surgery as well. tissue biopsies will therefore be taken during the surgery, and blood as well as stool samples will be collected and compared for suitable biomarkers before and after the intervention.


Eligibility criteria:
inclusion criteria: * bmi above 40 kg/sqm or * bmi above 35 kg/sqm and comorbidities related to morbid obesity (e.g. type 2 diabetes, hypertension, coronary heart disease, dyslipoproteinemia, sleep apnea, and others exclusion criteria: * bmi below 35 kg/sqm * no informed consent * patient not suitable for bariatric surgery (severe psychological disorder, pregnancy, drug abuse, active malignant or other consuming disease
a pilot study for systematic neonatal screening for lysosomal storage diseases using tandem mass spectrometry

Conditions: Neonatal Screening; Lysosomal Storage Diseases

Summary: the study will include all newborns in normandie region for 3 years (about 105,000 births) for whom signed consent by one (or two) parents will be collected. based on our previous pilot study (2011) assessing mcad and pku using tandem mass spectrometry-based method in normandie region in which informed consents have been signed for all newborns (43,000) but we are expecting a great willingness to participate to this project. thus, we are aiming to include 100,000 newborns, and the study will be continued until we reach at least this target. the primary objective is to evaluate the epidemiology of mps1 and pompe disease using dried blood samples in the first cohort of neonates tested in france (normandie region).


Eligibility criteria:
inclusion criteria: * newborn in a normandy maternity hospital * newborn participating in the national neonatal screening program * holder(s) of parental authority having read and understood the information letter and signed the informed consent form exclusion criteria: there are no criteria for non-inclusion in this study. participation in the study, such as participation in the national neonatal screening program, is not mandatory.
the use of sugammadex in the critically ill

Conditions: Critical Illness

Summary: moderate and deep neuromuscular blockade (rocuronium administered to a train of four count 0 and post-tetanic count of 1-2) in critically ill patients needing intubation or procedures can be reversed immediately and effectively by sugammadex avoiding unnecessary paralysis in an already weakened population

the critically ill is a special population needing immediate and aggressive treatments and interventions. neuromuscular blockade is frequently used to secure an airway, optimize ventilation/oxygenation in ards, aid in maintaining hypothermia in patients post-cardiac arrest. muscle relaxants can also contribute to neuromuscular weakness in the critically ill which can be a devastating condition. appropriate depth of neuromuscular blockade is important but unnecessary paralysis need to be avoided. rocuronium is one of the most popular neuromuscular blockade agents used in the critically ill (1). sugammadex is a modified γ-cyclodextrin that reverses the effect of the steroidal nondepolarizing neuromuscular blocking agents rocuronium and vecuronium (2). sugammadex results in rapid, predictable recovery from moderate and deep neuromuscular blockade. sugammadex has been mostly studied and used in the surgical population but its use outside the operating room is still very relevant. the investigators set up to evaluate the potential benefit that may result from the reversal of nmb with sugammadex compared to neostigmine. objectives in critically ill patients undergoing intubation receiving appropriate depth of nmb (moderate and deep blockade) the investigators will assess: primary objective: 1. to determine if choice of reversal agent affects time from intubation to return of a train of four (tof) count of 1, and, separately, to return of a tof ratio \>0.9 secondary objectives: 1. to document the ability of 1.0 mg/kg rocuronium (maximum 100 mg) to achieve satisfactory intubation conditions in the icu, based on measurement of the number of intubation attempts and intubation grades in the entire cohort 2. to document general adverse effects: hemodynamic instability, need for vasopressors etc

Eligibility criteria:
inclusion criteria: * adult patients requiring intubation in the intensive care unit exclusion criteria: * patients younger than 18 yr, to have known or suspected neuromuscular disease, allergies to medications to be used during intubation, a (family) history of malignant hyperthermia or severe renal insufficiency (glomerular filtration rate \<30 ml/h) will not be eligible.

Keywords: sugammadex rocuronium critically ill
effect of aromatherapy on pain, anxiety and satisfaction in cannulation

Conditions: Hemodialysis Patients

Summary: the most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety.


Eligibility criteria:
inclusion criteria: * those who are over 18 years of age, * able to answer questions and communicate, * no hearing, vision or speech impairments, * regularly undergoing hemodialysis three times a week, * having arterio-venous fistula for at least 3 months, * having pain during needle cannulation and scoring at least two or more points on the visual analogue scale (vas), * having been on hemodialysis for at least three months, * agreeing to participate in the study with their own consent, * patients who are not allergic to clove oil will be included in the study. exclusion criteria: * having neuropathic pain, * patients with arterio-venous fistula and loss of sensation of more than 50% in the extremity, * patients with infection in the arterio-venous fistula line, * patients with aneurysm or pseudoaneurysm in arterio-venous fistula, * patients who have used analgesic medication/s in the last 6 hours, * patients who have used sedative agent(s) in the last 6 hours, * patients who used local anesthetic agents before needle intervention will not be included in the study.

Keywords: clove oil arteriovenous fistula pain anxiety satisfaction hemodialysis
the pah disability and bothersomeness questionnaire

Conditions: Pulmonary Arterial Hypertension (PAH)

Summary: to develop a patient-reported questionnaire to investigate the impact of pah (pulmonary arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.

a 3-steps study protocol was initiated in 2011 to develop a patient reported outcome measure (prom) in pah.the first two steps have been completed (qualitative study and delphi consensus study) leading to the development of a provisional 37-items questionnaire. a reduction of items in this provisional questionnaire and the validation of the final questionnaire are the goals of the current study.

Eligibility criteria:
inclusion criteria: * patients with idiopathic and heritable pah; * patients over 18; * male and female; * nyha functional class i, ii, iii \& iv; * written consent signed * patients with a good understanding of the french - language * patient affiliated with a social security scheme exclusion criteria: * patients under 18 years of age * patients with other pathologies associated with pah (group 1) * patients with other forms of pulmonary hypertension (groups 2, 3, 4 and 5) * non-consenting patients * patients who do not have a good understanding of the french language

Keywords: questionnaire disability assessment bothersomeness pulmonary arterial hypertension patient-reported outcome measure new york heart association (nyha) functional class
v.a.c. veraflo™ instillation therapy vs v.a.c. ulta™ therapy on biofilm in chronically infected wounds

Conditions: Lower Extremity Wound Infected; Venous Stasis Ulcers

Summary: this study would like to determine if using negative pressure wound therapy with an instillation of .125% dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds.


Eligibility criteria:
inclusion criteria: * the patient is of 18 years or older. * males and females - provided they are not pregnant and if of reproductive age are using contraception. * patient with ulcers that: 1. have an ulcer area of at least 4 cm2 confirmed via counting squares on an wound tracing 2. have been present for at least 4 weeks 3. are confirmed to have a colony forming unit per gram of wound tissue greater than or equal to 10 to the 5th cfu 4. are full thicknesses through to dermal or subcutaneous tissue but not extending to muscle or bone. 5. the patient has an abi of greater or equal to 0.8 and lower than 1.3 or has a suitable peripheral vascular resistance (pvr) and doppler assessment which confirms venous disease \& therefore treatment with profore is deemed acceptable by the clinician. 6. the patient has one or more clinical signs of infection (edema, malodor, local/periwound erythema, spontaneous pain between dressing changes, increased exudate, discoloration of granulation tissue, increased temperature at wound, non progression of wound, purulent exudate and friable granulation tissue) 7. the patient is able to understand the evaluation and is willing to consent to the evaluation. 8. patients with a suitable wound on a different limb to any other wounds previously eligible. exclusion criteria: 1. patients undergoing chemotherapy 2. patients being treated with immunosuppressive drugs or corticosteroids 3. patients with an autoimmune disease 4. patients who have participated in an experimental drug or device study within the last 15 days 5. patients that have been entered in this evaluation previously as an evaluable patient.

Keywords: infected wounds npwti vac instill biofilm
free fat flap in recurrent neurogenic thoracic outlet syndrome surgical treatment

Conditions: Neurogenic Thoracic Outlet Syndrome

Summary: the thoraco-brachial outlet syndrome (t-bos) corresponds to the entirety of clinical manifestations related to the compression of the branches of the brachial plexus and/or the subclavian vessels during their passage through the cervico-thoracic region. following surgery, a recurrence of symptoms occurs in 5% to 30% of operated patients. the treatment of these recurrences primarily relies on conservative therapies, and in case of failure, surgical intervention, particularly neurolysis of the brachial plexus. in order to prevent a new recurrence, it is desirable to cover the neurolyzed brachial plexus with a flap, providing better local vascularization. however, fatty perforating flaps, by avoiding muscle harvesting, reduce donor site sequelae. we aim to investigate, through validated and recommended questionnaires, the impact of covering the neurolyzed brachial plexus with a free fatty flap after neurolysis in the context of recurrent neurological thoraco-brachial outlet syndrome.


Eligibility criteria:
inclusion criteria: * patients underwent brachial plexus neurolysis and free fat flap coverage in the context of recurrence of neurological thoraco-brachial outlet syndrome exclusion criteria: * patients were unable to express their non-opposition to participating in the study. * patients under guardianship or trusteeship. * patients whose mother tongue is not french. * patients who cannot read and/or write.

Keywords: recurrent neurogenic thoracic outlet syndrome free fat flap
observational of pnh type cells in korean patients with bone marrow failure syndrome and having hemolytic pnh

Conditions: PNH

Summary: patients who are positive of pnh-type cells are followed up for the percentage of pnh-type cells regularly for examining how it change.


Eligibility criteria:
inclusion criteria: * patients with commbs' test - negative * any patients meeting any of idiopathic aa/mds/patients who had pnh clone size \<10% exclusion criteria:
dexa bone density analysis of the corehip® prosthesis system

Conditions: Primary Osteoarthritis; Cartilage Degeneration; Osteoarthritis, Hip; Inflammatory Arthritis; Osteonecrosis of Femoral Head; Traumatic Disorder

Summary: the goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (gruen zones 3 and 4) within 24 months postoperative in patients treated with corehip® primary cementless stem. the dexa bone density analysis is used.

additional diagnostic examination: dexa-analysis. a dexa scan is an imaging test that measures bone density (strength). the results can provide helpful details about risk for osteoporosis (bone loss) and fractures. furthermore we would like to find out more about stress shielding processes around our prosthesis.

Eligibility criteria:
inclusion criteria: * unilateral hip osteoarthritis * indication for corehip standard hip stem according to preoperative planning * written informed consent * age 35-85 years * according to the assessment of the study doctor, the patient is therapy compliant and able to attend the follow-up visits exclusion criteria: * femoral neck fractures * pregnancy * bmi \> 35 * history of femoral fracture or previous surgery on the same hip * metabolic bone disease, use of steroids or other drugs affecting bone metabolism * intraoperative bone cracks * severe osteoarthritis of the contralateral hip * tha of the contralateral side or other event leading to restricted weight bearing during the study period

Keywords: total hip arthroplasty dexa bone density analysis
a study of prt-201 administered immediately after radiocephalic arteriovenous fistula(avf) creation in patients with chronic kidney disease (ckd) (patency-1)

Conditions: Chronic Kidney Disease

Summary: this research study is designed to assess the safety and effectiveness of an experimental drug called prt-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. prt-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (avf). the purpose of this study is to determine whether prt-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your avf.


Eligibility criteria:
inclusion criteria: 1. age of at least 18 years. 2. life expectancy of at least 6 months. 3. diagnosis of chronic kidney disease (ckd). 4. planned creation of a new radiocephalic arteriovenous fistula (avf)-revision of an existing avf is not eligible. 5. ability to understand and comply with the requirements of the entire study and to communicate with the study team. 6. written informed consent using a document that has been approved by the institutional review board (irb). 7. if female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (visit 1) and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. acceptable methods of birth control include abstinence, barrier methods, hormones, or intra uterine device. exclusion criteria: 1. malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ. 2. presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study. 3. previous treatment with prt 201. 4. treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.

Keywords: radiocephalic arteriovenous fistula avf hemodialysis prt-201 vascular access kidney renal vonapanitase patency-1
the effect of n-acetyl-l-cysteine, on inflammatory and oxidative stress markers in pulmonary sarcoidosis

Conditions: Pulmonary Sarcoidosis

Summary: this is a pilot study investigating the effect of an antioxidant, n-acetyl-l-cysteine (nac), on inflammation and oxidative stress in sarcoidosis.

sarcoidosis is a granulomatous lung disease predominantly affecting the lungs. reactive oxidative species are produced secondary to oxidative stress and inflammation and can affect key cellular processes. the investigators have shown a role for oxidative stress in chronic beryllium disease (cbd), a granulomatous disease that resembles sarcoidosis, and have also shown that antioxidant therapy reduces inflammation in cbd. oxidative stress also plays a role in sarcoidosis but the exact mechanism and potential effect of antioxidant therapy on sarcoidosis is unknown. the investigators propose conducting a pilot study investigating the effect of an antioxidant, n-acetyl-l-cysteine (nac), on inflammation and oxidative stress in sarcoidosis. the investigators will measure and compare markers of inflammation and oxidative stress in the lungs of sarcoidosis patients before and after treatment with nac. the results of this study will prepare the investigators for a larger study investigating the role of nac as a therapy for sarcoidosis with changes in lung function and x-ray as our primary outcome. this will provide the investigators with a new non-toxic therapy for sarcoidosis that can be used on its own or to supplement other therapies minimizing their toxicity.

Eligibility criteria:
inclusion criteria: * biopsy proven sarcoidosis. * pulmonary parenchymal involvement with a scadding chest x-ray stage ii, iii or iv. * abnormal spirometry and/or dlco (\< 80% of predicted). * consenting adults : age 18 years and above exclusion criteria: * positive lung washing or biopsy cultures for fungi or mycobacterial disease; * presence of other co-morbid conditions that may affect the patient's outcome. * patient inability to undergo venipuncture and bal procedures. * current use of tobacco (smoking or otherwise) in the past 6 months * treatment with immunosuppressive therapy within the past 6 months. * on oral anti-oxidant supplements. * active peptic ulcer disease.

Keywords: sarcoidosis oxidative stress anti-oxidant
comparison of intramuscular olanzapine and intramuscular haloperidol in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to compare intramuscular olanzapine and intramuscular haloperidol in changing of agitation in patients with schizophrenia


Eligibility criteria:
inclusion criteria: * male or female patients, between the ages of 18 and 65 * patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in dsm-iv * patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with im medication. investigator must believe that it is safe to administer im olanzapine and im comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of olanzapine im or the comparator agent) * subjects' illness must not, in the opinion of the investigator, be caused by substance abuse * patient must be hospitalized during the study exclusion criteria: * previous participation (treatment with study drug) in a lilly sponsored intra-muscular olanzapine clinical trial * serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months * have a known diagnosis of dementia of any type, as defined in the dsm-iv or dsm-iv-tr * documented history of allergic reaction to study medication(s) * treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration