Kornimate/medical-research-clean huggingface dataset:
radical prostatectomy and perioperative fluid therapy

Conditions: Prostate Cancer

Summary: the optimal amount of fluid a patient need under surgery is not clear. both to much and to little fluid can damage the organ functions. a strategy called "goal directed therapy", where the fluid amount a patient need is guided by the stroke volume, has shown to minimize post-operative nausea and vomiting. the investigators intend to investigate if patients treated after these standards, has a better outcome then patients treated after normal regimes, regarding post-operative orthostatic-intolerance.


Eligibility criteria:
inclusion criteria: * patients with cancer in there prostate exclusion criteria: * patients who don't understand the information * asa \> iii * patients that are under treatment with the drug triazolam * patients with af known renal decease * patients with a psychiatric decease * alcohol abuse * severe haemorrhagic decease * cancer in the mouth,pharynx, larynx or oesophagus

Keywords: patients with cancer in the prostate
research study to compare the addition of topaz micro debridement to the standard of care surgery

Conditions: Greater Trochanteric Pain Syndrome; Hip Pain Chronic

Summary: compare the surgical use of topaz with the standard of care in the treatment of greater trochanteric pain syndrome (a type of hip pain). the hypothesis is that there is a difference between the two treatment groups.


Eligibility criteria:
inclusion criteria: 1. female or male aged between 40-70 years old, females and males are eligible 2. a history of \> 6 months of conservative care treatment for lateral hip pain, including but not limited to local anaesthetic and steroid injections into the trochanteric bursa 3. pre-operative mri and ultrasound with evidence of gtps within the previous 24 weeks 4. willing to comply with the protocol and follow-up visits 5. signed the independent ethics committee (iec) approved informed consent form exclusion criteria: 1. previous surgery to the hip such as hip replacement, fracture neck of femur fixation, or repair of gluteal tendons 2. subjects with sero-positive or sero-negative arthropathy 3. long term steroid use \> 6 weeks 4. allergy to drugs to be used in the procedure 5. medical co-morbidities that preclude surgical intervention 6. inability to understand or respond to the study questionnaires 7. females who are pregnant, or pregnancy is suspected or planned within the clinical investigation timeframe 8. subjects who are simultaneously participating in another device or pharmaceutical investigation intra-operative exclusion: 1. abductor tears 2. severe tendinopathy

Keywords: iliotibial band release trochanteric bursectomy micro debridement
pilot indocyanine green imaging for mapping of arm draining lymphatics & nodes in breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if indocyanine green (ic-green) is comparable to isosulfan blue (is-blue) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.

it is the objective of the current study to test indocyanine green (ic-green) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (is-blue) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. all participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers.

Eligibility criteria:
inclusion criteria: * ability to understand and the willingness to sign a written informed consent document. * signed written informed consent. * women undergoing sentinel lymph node biopsy. * women with breast cancer with known or suspected lymph node involvement. * women undergoing sentinel node identification and completion axillary lymph node dissection. * women of 18 years of age or older. * eastern cooperative oncology group (ecog) or karnofsky performance status 0,1,2. * complete blood count (cbc) and basic metabolic panel within 6 months exclusion criteria: * history of liver or kidney failure will not be eligible. * allergies to iodine containing products will not be eligible. * women who are pregnant will not be eligible. * psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
efficacy study to treat subjects with severe hypertriglyceridemia

Conditions: Severe Hypertriglyceridemia

Summary: the primary objective is to determine the efficacy of akr963 compared to placebo and active comparator in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 1500 mg/dl.

increases in triglyceride concentrations have been correlated with increased risk for pancreatitis as well as for coronary heart disease (ginsberg 2001, 2002). the incidence rates for major coronary events in the munster heart study increased from 4.4% among subjects with baseline tg concentrations under 200 mg/dl to 9.3% among subjects with tg concentrations in the 200-399 mg/dl range, and up to 13.2% in subjects with tg levels ranging from 400-799 mg/dl (assmann 1996).

Eligibility criteria:
inclusion criteria: * men and women, ages 18-79 * fasting triglyceride ≥500 mg/dl and ≤1500 mg/dl * provide written informed consent and authorization for protected health information disclosure exclusion criteria: * women who are pregnant or lactating, or planning to become pregnant * use of non-statin lipid-altering drugs which cannot be stopped or other supplements with potential lipid-altering effects * history of pancreatitis * history of bariatric surgery or currently on weight loss drugs or in weight loss programs * treatment with any agent that may affect lipid levels or hepatic function * consumption of more than 3 alcoholic beverages per day * history of cancer within last 2 years * participation in another clinical trial involving an investigational agent in the last 30 days * other parameters will be assessed at the study center to ensure eligibility for this study
efficacy and safety of oxycodone/naloxone (targin®) in persistent moderate to severe low back pain following nsaids treatment

Conditions: Low Back Pain

Summary: the purpose of this study is to evaluate the efficacy of the study drug (targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled\* by nsaids.


Eligibility criteria:
inclusion criteria: 1. korean patients age ≥ 19 years old 2. patients having moderate to severe low back pain (nrs pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with nsaids 3. patients showing average nrs pain score ≥4 over the last 1 week at screening point 4. in case of previous opioids medication history, opioids wash-out period \> 30 days before enrolment 5. patients who is willing to voluntarily sign informed consent exclusion criteria: 1. patients with any history of hypersensitivity to oxycodone, naloxone or related products 2. low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause 3. pregnant or lactating women
evaluation of the immunogenicity and safety of glaxosmithkline biologicals' hpv vaccine in young males.

Conditions: Infections, Papillomavirus

Summary: the main aim of this vaccine is to prevent cervical cancer in women. however, it could also be relevant to vaccinate selected groups of males. therefore, this study is designed to evaluate the safety and immunogenicity of the hpv vaccine in pre-teen and adolescent male subjects aged 10-18 years.


Eligibility criteria:
inclusion criteria: * a male between, and including, 10 and 18 years of age at the time of the first vaccination. * written informed consent obtained from the subject prior to enrolment * for subjects below the legal age of consent, a written informed consent must be obtained from the subject's parent/guardian. in addition, a written informed assent must be obtained from the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * free of obvious health problems as established by medical history and clinical examination before entering into the study. exclusion criteria: * previous vaccination against human papillomavirus (hpv). * previous vaccination against hepatitis b, known clinical history of hepatitis b infection. * cancer or autoimmune disease under treatment.
what information is remembered by parents following the ingestion of foreign body by their child?

Conditions: Information Remembered by Parents Following the Ingestion of Foreign Body by Their Child

Summary: foreign body (fb) ingestion is a very common domestic accident in children. the prevention of the recurrence by securing child's environment is mandatory. the study will study whether the advices of follow-up at home and recurrence prophylaxis were given to parents after a foreign ingestion by their child.

foreign body ingestion (fb) is a very common domestic accident in children. when the fb is not dangerous or it is inaccessible after crossing the pylorus, the child should be monitored. in all cases, recurrence should be prevented by securing the environment of the swallowing child. the information on monitoring and securing the environment should be communicated during hospital care. this prospective study will analyze whether advices were correctly given to the families concerning the follow-up at home and the prophylaxis of fb ingestion.

Eligibility criteria:
inclusion criteria: * children under 18 years * foreign body ingestion exclusion criteria: * refusal to participate in the study * non-french speaking parents
adherence with iron sprinkles among high-risk infants

Conditions: Anemia; Iron Deficiency

Summary: compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.

iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. it is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. previous studies suggest adherence with iron containing drops is low. adherence to iron sprinkles among children as tested in studies in less developed countries appears high. comparison: children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.

Eligibility criteria:
inclusion criteria: * healthy infants * age 5-7 months * presenting for 6 months well-child care * caregiver speaks english or spanish exclusion criteria: * pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and hiv infection) * inability to speak english or spanish * use of vitamin or iron supplements in the previous three months

Keywords: adherence supplements iron iron deficiency anemia vitamins minerals
psychosocial interventions in the treatment of youth with type 1 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: primary objective is to evaluate the influence of psychosocial interventions in the treatment of children and adolescents with type 1 diabetes mellitus by measuring the connection between these interventions to quality of life and to metabolic control. secondary objective is to provide an opportunity, through quality of life (qol) questionnaires, for enhanced communication between the patient, family and diabetes care team and also an opportunity to resolve negative issues.


Eligibility criteria:
inclusion criteria: * all children and adolescents with type 1 diabetes mellitus attending assaf harofeh pediatric diabetes clinic will be eligible for inclusion in the study.

Keywords: diabetes mellitus psychosocial metabolic control quality of life questionnaires children adolescents
clinical and radiological outcomes following insertion of a novel removable percutaneous interspinous process spacer: an initial experience.

Conditions: Degenerative Lumbar Spinal Stenosis; Neurologic Intermittent Claudication

Summary: purpose to evaluate clinical and radiologic outcome of a series of patients treated with a removable percutaneous interspinous process spacer (ips) (lobsterproject® techlamed®) for symptomatic degenerative lumbar spinal stenosis (dlss). methods all patients treated in the two considered centres with this ips during 2019 were retrospectively reviewed. patients with incomplete clinical or radiological documentation were not included. procedures were performed under deep sedation or general anaesthesia by two interventional radiologists. patients were clinically evaluated before intervention and at 3-month follow-up with visual analog scale for pain (vas), oswestry disability index (odi) and radiologically with mri or ct scans. neural foramina were independently measured for each patient on pre- and post-procedural ct scans by two radiologists.


Eligibility criteria:
inclusion criteria: * removable percutaneous ips treatment * attended interventional radiology outpatient consultations for back pain and nic, refractory to medical treatment exclusion criteria: * ps positioning included cauda equina syndrome * permanent motor deficit, * previous spine surgery, * spondylolisthesis greater than meyerding grade i, * local or systemic infection and severe osteoarthritis with pronounced osteophytosis or bone bridges
a study of the effect on oro-dental complications of intensity modulated radiotherapy (imrt) versus conventional radiotherapy in patients with cancer of the head or neck

Conditions: Cancer: Head or Neck

Summary: study to investigate the effect of two types of radiotherapy on saliva: imrt versus conventional radiotherapy. in each group, one part will receive normal dental preventive treatment. the other part will use products for treatment of dry mouth (biotene gamma). both anorganic and organic components of the saliva will be studied at different time points, combined with bacterial swabs.


Eligibility criteria:
inclusion criteria: * \> 18 years old * cancer of head or neck exclusion criteria: -
a multicenter, randomized, controlled trial of sch 619734 for the treatment of chemotherapy-induced nausea and vomiting (study p04351am2)(completed)

Conditions: Nausea; Vomiting

Summary: this is a phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of sch 619734 in subjects receiving cisplatin-based chemotherapy. ondansetron and dexamethasone will be concurrently administered with sch 619734 before initiation of chemotherapy on day 1. subjects will record nausea and vomiting in the spnv subject diary through day 6. the quality of life assessment as measured by the functional living index-emesis questionnaire (flie) will be used to measure the effect of chemotherapy-induced nausea and vomiting (cinv) on daily life. blood samples for sch 619734 pharmacokinetic assessments will be collected. the study is to be conducted in conformance with good clinical practice.


Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older. * subject has never been treated with cisplatin and is to receive first course of cisplatin-based chemotherapy (\>=70 mg/m\^2). * subject has a karnofsky performance score of \>=60. * subject has a predicted life expectancy of \>=3 months. * subject has adequate bone marrow, kidney, and liver function as evidenced by: * absolute neutrophil count \>=1,500/mm3 and white blood cell count \>=3,000/mm3. * platelet count \>=100,000/mm3. * aspartate aminotransferase (ast) \<=2.5 x upper limit of normal (uln) range. * alanine aminotransferase (alt) \<=2.5 x uln. * bilirubin \<=1.5 x uln, except for subjects with gilbert's syndrome. * creatinine \<=1.5 x uln. * subject is able to read, understand, and complete the questionnaires. exclusion criteria: * any current treatment or medical history (eg, subject is mentally incapacitated or has a psychiatric disorder) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject. * subject has contraindication to the administration of cisplatin, ondansetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, hearing impairment, or systemic fungal infection. * subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (hesketh scale) from day -2 through day 6. * subject is scheduled to receive any radiation therapy to the abdomen or pelvis within 5 days prior to and/or during days 1 through 5 following cisplatin infusion. * subject has symptomatic primary or metastatic central nervous system (cns) disease. * subject has ongoing vomiting caused by any etiology or has a history of anticipatory nausea and vomiting.
intervening with haitian immigrants in the u.s. to improve hiv outcomes

Conditions: HIV Infection Primary

Summary: the goal of this clinical trial is to test a culturally tailored engagement and retention intervention for haitian immigrants living with hiv (hilwh). the main questions it aims to answer are: * does this intervention result in measurable engagement and retention in care? * does this intervention result in measurable viral suppression within 6 months? participants will * participate in a pilot health intervention entailing 4 individual meetings, approximately once monthly over a six-month period and completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment. * six participants who have completed the pilot intervention and agree to take part, will participate in the photovoice portion of the study. this activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and take and display photographs.

research design: the proposed study will test a culturally tailored engagement and retention intervention for haitian immigrants living with hiv (hilwh). this is sequential mixed-methods formative pilot research that is designed to examine engagement and retention in care, and viral suppression (vs) for hilwh and adapt a promising intervention that will result in viral suppression between baseline and a 6 month follow-up assessment. the pilot will be conducted as a prospective, quasi-experimental single arm with a sample of newly diagnosed or nonvirally suppressed hiwlh adults drawn from 2 federally qualified health centers (fqhc) sites in miami. procedures to be used: aim 1 mixed methods (quantitative and qualitative) data collection on barriers and facilitators to viral suppression among hilwh. quantitative questionnaires will be completed by health care service providers and hilwh who will also participate in a focus group. a sample of hilwh will participate in individual in-depth interviews. aim 2 consists of a pilot health intervention entailing completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment. in addition, participants will have 4 individual meetings, approximately once monthly over a six month period. aim 3 photovoice participants will be 6 participants who have completed the pilot intervention (aim 2) and agree to participate in the photovoice portion of the study. this activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and taking photographs. this activity is expected to take approximately 8 additional hours over 2 and a half months. for these six participants, the total amount of time will be approximately 20 hours over 8 and 1/2 months.

Eligibility criteria:
inclusion criteria: 1. seropositive for hiv 2. either a recent hiv diagnosis (within the last 2 months) or non-virally suppressed. 3. migrated to the us from haiti exclusion criteria: 1. virally suppressed

Keywords: viral suppression
human mesenchymal stem cells in the synovial fluid of the hip

Conditions: Osteonecrosis

Summary: previous studies have shown an increase in the concentration of mesenchymal stem cells (msc's) in the setting of osteoarthritis of the knee and its correlation to severity. researchers have shown that as there is an increase in the severity of the disease, the concentration of stem cells also increases. the purpose of this study is to determine if there is the same increase in stem cell concentration in patients with osteonecrosis (on) of the femoral head.

since the treatment of osteonecrosis is related to the severity of disease, namely articular cartilage collapse, the purpose of this study is to determine if the msc concentration in synovial fluid can be correlated to disease stage. in order to do this the investigators will: milestone #1: determine the concentration of msc's in the synovial fluid in patients with osteonecrosis. this work will be carried out utilizing facs-based technique to synovial fluid stem cell sub-population. milestone #2: compare concentrations of msc's in patients with pre collapse, post collapse osteonecrosis and "normal" hips. patient-derived msc will be quantified at the different stages of disease and assays will be performed in order to assess their viability. a control group will be selected in patients undergoing hip arthroscopy for femoral/acetabular impingement (fai). since fai does not affect the intraarticular environment of the hip, theoretically these patients would have a "normal" concentration of synovial stem cells.

Eligibility criteria:
inclusion criteria: * patients consented to undergo a tha (post-collapse osteonecrosis), hip arthroscopy or minimally invasive core decompression * preoperative radiographic diagnosis of on or fai (femoral/acetabular impingement) exclusion criteria: * pregnant females * active infection, hiv, hepatitis c or b, syphilis immunodeficiency * patients receiving hematopoetic growth factors or anti-angiogenesis products
insight (insight into nephrotic syndrome)

Conditions: Nephrotic Syndrome

Summary: insight is a longitudinal study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression.

insight is a longitudinal observational study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression. this is a large multiethnic cohort to test hypotheses of gene and environmental risk factors and disease progression. participants are recruited from toronto, ontario and surrounding regions. additional sites will be added on in the future.

Eligibility criteria:
inclusion criteria: 1. diagnosis of nephrotic syndrome 2. signed informed consent and assent appropriate for age 3. ages 6 months -18 years old and 4. ability to complete questionnaires exclusion criteria: 1. congenital nephrotic syndrome (less than age 1) 2. syndromic disease with multiple organ involvement 3. inability to provide consent by primary care providers 4. conditions such as systemic lupus erythematous.

Keywords: pediatric kidney disease minimal change disease focal segmental glomerulosclerosis nephrotic syndrome