Kornimate/medical-research-clean huggingface dataset:
incidence of h1n1v influenza-like illness and risk factors for serious influenza forms in hiv infected patients

Conditions: HIV Infections; Influenza

Summary: to estimate the incidence of h1n1v influenza-like illness and to study the risk factors for serious influenza forms during pandemic period in french hiv infected patients. * definitions: * influenza like illness is defined as fever\> 37°8c and cough or pharyngalgia. (centers for disease control definition). * serious forms of influenza-like illness is defined by hospitalization within 14 days onset of symptoms or death attributed to influenza like illness. * design: * survey sampling for estimating h1n1v influenza-like illness incidence. * out of approximately 50 000 patients under follow-up in one of the 40 anrs centres, a sub-group will be selected by random sampling. sampling will be stratified by centre and sampling fraction per site will vary in order to select 60 to 80 patients for this study per site. a total of 2500 to 3000 patients will be selected to allow for estimating the incidence of h1n1v influenza-like illness with an adequate precision. selected patients will be asked to contact the clinical staff on site as soon as any influenza like symptoms appear. in the case of influenza like illness patients are requested to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for diagnosis of a(h1n1)v infection. nested case-control study for the determination of risk factors for serious forms: * cases: serious forms (see definition above) identified by any clinical site or hospitalisation unit. * controls: patients of the randomly selected sample (see survey sampling above), presenting with influenza-like illness without any criterion for severity. exhaustivity check: the exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * able to give written consent * covered by french social security * hiv-infected (infection attested by the patient's chart) * pregnant women * control and sample to estimate incidence * patients followed for their hiv-infection in an anrs center * serious form * hospitalization whatever is the service in 14 days consecutive to a h1n1v influenza syndrome such as defined, or death consecutive to a h1n1v influenza syndrome such as defined. exclusion criteria: * patients for whom a h1n1v influenza syndrome can be informed at the beginning of the study. * under protection(saving) of justice
quality of life study breakthrough cancer pain treated in medical oncology services (cavidiom)

Conditions: Breakthrough Pain

Summary: in cancer patients, pain is one of the most common symptoms. the range of reported prevalence of pain varies from 33% to 64% including different stages of cancer, during or after anticancer treatment. moreover, despite the optimal management of basal chronic pain, 66% of these patients have reported breakthrough pain which has a severe impact on quality of life. there is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in medical oncology services according to routine clinical practice. for this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain in medical oncology services as well as other factors that can affect quality of life. this post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in medical oncology services in spanish hospitals.


Eligibility criteria:
inclusion criteria: * patients \> 18 years * patients with histologically confirmed neoplasia * patients attended in medical oncology consultations * life expectancy \> 3 months * patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by davies algorithm * written informed consent exclusion criteria: * untreated patients with opioids for baseline pain * patients who are not opioid tolerant * serious psychiatric disorder or any disease or condition that prevents the collection of data * patients with evidence of opioid addiction or history of drug or alcohol abuse

Keywords: breakthrough cancer pain quality of life medical oncology
medico-economic evaluation of sublingual pca (zalviso) versus oxycodone-pca in the management of postoperative pain.

Conditions: Analgesia

Summary: more than 230 million surgical operations are been realized all over the world every year. a surgical intervention can cause postoperative acute pain. the management of postoperative acute pain is multimodal and the use of patient-controlled analgesia (pca) is often a part of this pain-management. intravenous pca has established itself as a therapeutic concept and constitutes the reference treatment for the management of postoperative acute pain for the first 48 hours. the pca offers patients autonomy in managing their pain with the intravenous delivery of morphine on demand. since 2017 pca zalviso is marketed. it allows the sublingual administration of sufentanil and it does not require venous access. it seems interesting to allow the early rehabilitation of patients who are no longer limited in their movements by an infusion. however, its acquisition cost appears to be higher than that of the intravenous pca. in order to verify this hypothesis, the investigators propose to compare the set of costs associated with the use of sublingual pca with those of intravenous pca in the management of acute postoperative pain (less than 72 hours) in the context of patients benefiting from the placement of a total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * adults * patients able to express consent * signed written informed consent form * patient covered by national health insurance * patient undergoing total knee arthroplasty and requiring postoperative analgesia with the use of a pca (patient controlled analgesia) exclusion criteria: * minors * obstruction to participate * patient non covered by national health insurance * patient requiring a stay in intensive care immediately after the surgery * patient unable to use a pca a assessed by the investigator

Keywords: sublingual patient controlled analgesia (pca) intravenous patient controlled analgesia (pca) patient controlled analgesia (pca)
non-interventional european study of trabectedin + pld in the treatment of relapsed ovarian cancer (roc) patients

Conditions: Relapsed Ovarian Cancer

Summary: non-interventional, multicenter, prospective, european study to describe the effectiveness of trabectedin + pld in the treatment of relapsed ovarian cancer (roc) patients according to smpc regardless of previous use of an antiangiogenic drug


Eligibility criteria:
inclusion criteria: * women aged 18 years or older. * presence of platinum-sensitive relapsed ovarian cancer. * treatment and treated indication according to local label smpc and reimbursement for trabectedin and pld treatment. * prior treatment with a minimum of 1 cycle of trabectedin + pld according to smpc before inclusion in the study, and no more than 3 previous treatment lines. * written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study. exclusion criteria: * none
signs of central sensitization in tension-type headache

Conditions: Tension-Type Headache

Summary: the goal of this observational study is to assess the pain sensitivity in tension-type headache patients. the main question it aims to answer is: - are signs of central sensitization present in tension-type headache? participants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing). researchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group.


Eligibility criteria:
inclusion criteria: 1. diagnosis of tension headache according to globally recognized criteria (ichd-3) or verified by a physician 2. diagnosis of tension headache confirmed by a questionnaire (headache screening questionnaire) 3. not pregnant or given birth in the past year since a change in hormone levels can affect pain experience 4. adults between the ages of 18 and 65 5. proficient in the dutch language exclusion criteria: 1. other diagnosis of headache or a mixed form 2. other existing condition involving central nervous system sensitivity 3. other structural neurological syndromes 4. any condition involving the brain in the past 5. procedure on the head, neck, or shoulder in the past 3 years 6. currently suffering from a psychiatric condition 7. athletes competing at a competitive level 8. not proficient in the dutch language 9. currently pregnant.
analysis of the impact of the undernutrition on the cerebral infarct in thrombolized patients

Conditions: Thrombosis

Summary: many clinical trials show that 30 to 50 % of the hospitalized patients are undernourished in various degrees. this prevalence didn't change since 15-20 years the fact is that the present undernutrition in the admission deteriorates during the hospitalization. besides, the cerebral vascular accident (avc) complicates the first days, in at least 50 % of the cases, the disorders of the gulp, which are a risk factor of acquired undernutrition. the nutrition holds an important place in the therapeutic coverage of the avc. nevertheless, the link between the undernutrition the entrance and the evolution of the avc is at the moment only little known. the purpose is to study the impact of the undernutrition in the entrance to the hospital (undernutrition previous to the avc), on the gravity and the evolution


Eligibility criteria:
inclusion criteria: * patient admitted in hospital for vascular cerebral accident in 2015 * thrombolytic treatment exclusion criteria: * no thrombolytic treatment * transcient ischaemic attack
short term treatment with bi 201335, peginterferon-alpha 2a and ribavirin in hepatitis c virus genotype-1 treatment-naïve patients (silen-c3)

Conditions: Hepatitis C

Summary: to compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of bi 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (pegifn) plus ribavirin (rbv), in treatment-naïve patients infected with hepatitis c virus (hcv) genotype 1


Eligibility criteria:
inclusion criteria: 1. chronic hepatitis c infection of genotype 1 2. therapy-naïve to interferon, pegylated interferon, and ribavirin 3. hcv viral load \> 100.000 iu/ml at screening 4. liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis 5. normal retinal finding on fundoscopy within 6 months prior to day 1 6. age 18 to 70 years exclusion criteria: 1. hcv of mixed genotype (1/2, 1/3, and 1/4) . 2. patients who have been previously treated with at least one dose of any protease inhibitor 3. evidence of liver disease due to causes other than chronic hcv infection 4. positive for hiv-1 or hiv-2 antibodies 5. hepatitis b virus (hbv) infection 6. decompensated liver disease, or history of decompensated liver disease 7. active malignancy or history of malignancy within the last 5 years 8. history of alcohol or drug abuse (except cannabis) within the past 12 months. 9. body mass index \ 35 kg/m2. 10. usage of any investigational drugs within 30 days prior to enrolment 11. alpha fetoprotein value \>100ng/ml at screening; 12. total bilirubin \> 1.5 x uln with ratio of direct/indirect \> 1. 13. alt or ast level \> 10 x uln
efficacy of zinc supplementation in maintaining sustained remission in children with steroid-sensitive nephrotic syndrome

Conditions: Steroid-Sensitive Nephrotic Syndrome

Summary: this study aims to fill the gaps by determining the efficacy of zinc supplementation in maintaining sustained remission in children with steroid sensitive nephrotic syndrome (ssns).

there is a need to ascertain the efficacy of zinc supplementation in maintaining sustained remission in children with ssns, thereby lowering the number of relapses and disease morbidity. the findings of this study could pave the way for reasonable evidence about the role of zinc supplementation is sustained remission in children with ssns.

Eligibility criteria:
inclusion criteria: * both genders * aged 2-12 years * with steroid-sensitive nephrotic syndrome, with frequent relapses exclusion criteria: * children with steroid-resistant nephrotic syndrome * with a history of chronic systemic illness (cardiac, metabolic, malignancy, pulmonary, neurologic, or rheumatologic) * with a history of kidney disease like polycystic kidney disease
safety study of ap24534 to treat chronic myelogenous leukemia (cml) and other hematological malignancies

Conditions: Chronic Myelogenous Leukemia; Hematologic Malignancies

Summary: the purpose of this study is to determine the maximum tolerated dose or a recommended dose of oral ap24534 in a defined schedule in patients with refractory or advanced chronic myelogenous leukemia and other refractory hematologic malignancies.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years old * diagnosed hematologic malignancy (other than lymphoma) that has relapsed or is refractory to standard care or for which no standard care is available or acceptable * able to give written informed consent * ecog performance status ≤ 2 * bsa ≥ 1.5 m² (first cohort only) * minimum life expectancy of 3 months or more * adequate renal function defined as serum creatinine \<1.5× upper limit of normal (uln) for institution * adequate hepatic function (defined as: total bilirubin \<1.5 × uln for institution; alt and ast \<2.5 × uln for institution \[\<5 x uln if liver involvement with leukemia\]; prothrombin time \<1.5 × uln) * ability to comply with study procedures in the investigator's opinion * adequate cardiac function defined as ejection fraction (ef) \>40% by any method of the investigator's choice * normal qtcf interval on screening ecg evaluation, defined as qtcf of \<450 ms. * for females of childbearing potential, a negative pregnancy test must be documented prior to enrollment * female patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners throughout participation in this study exclusion criteria: * have had cytotoxic chemotherapy or radiotherapy within 21 days prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 28 days earlier with the exception of alopecia * received any other investigational agents or have received an investigational agent within 14 days of starting ponatinib * malabsorption syndrome or other illness which could affect oral absorption * significant uncontrolled cardiac disease * patients taking medicinal products that are known to be associated with prolongation of the qt interval on the electrocardiogram. * uncontrolled hypertension (diastolic bp \>100 mmhg; systolic \>150 mmhg) * uncontrolled intercurrent illness * pregnant * known infection with hiv * autologous or allogeneic stem cell transplant \< 3 months prior to enrollment; any evidence of ongoing graft versus host disease (gvhd), or gvhd requiring immunosuppressive therapy * another primary malignancy within the past 3 years * any condition or illness which, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the safety of the drug * patients taking medicinal products that are known to be associated with prolongation of the qt interval on the electrocardiogram * major surgery (with the exception of intravenous catheter placement or bone marrow biopsy) within 14 days prior to initiating ponatinib therapy
short-term effects of oxytocin nasal spray on chronic tinnitus

Conditions: Chronic Tinnitus

Summary: the study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition.


Eligibility criteria:
inclusion criteria: * chronic tinnitus with a duration \> 6 months * medical examination by an ent specialist * sufficient knowledge of the portuguese language to follow the instructions and answer the questionnaires * vas score \>4 points exclusion criteria: * vascular tinnitus * muscular tinnitus * conductive hearing loss * previous experience with oxytocin nasal spray * additional medications during the intervention
a study of shr-a1811 in subjects with gynaecologic oncology

Conditions: Gynaecological Malignancies

Summary: this is an open-label, two-part study to evaluate the safety and efficacy of shr-a1811 for injection in subjects with a gynaecological malignancies.


Eligibility criteria:
inclusion criteria: 1. the subjects voluntarily joined the study and signed the icf. 2. measurable disease, as defined by recist v1.1. 3. the eastern cancer cooperative group (ecog) performance status of 0 or 1. 4. life expectancy ≥ 12 weeks. 5. subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer. exclusion criteria: 1. symptomatic, untreated or active central nervous system metastases. 2. previously received antibo-conjugated drugs with the following characteristics: topoisomerase i inhibition in the composition preparations, such as enhertu (ds-8201a), u3-1402, etc.. 3. have uncontrolled or severe cardiovascular disease. 4. with any active autoimmune disease or history of autoimmune disease. 5. patients with active hepatitis b or hepatitis c. 6. severe infections within 28 days prior to initiation of study treatment. 7. active tuberculosis within one year prior to initiation of study treatment.
an individualized exergame training solution for people with major neurocognitive disorder: a usability study

Conditions: Major Neurocognitive Disorder; Physical Activity; Dementia

Summary: the aim of this study is to investigate the usability of a newly designed and developed user-centered exergame in older adults with major neurocognitive disorder (dementia).

the aim of this study is to investigate the usability of a newly designed and developed user-centered exergame in older adults with major neurocognitive disorder (dementia). on one appointment, the participants will perform a user-centered exergame for about 30 minutes. the exergame will include specific cognitive and motor functions. as the difficulty of the training game is user-centered, the participants will always be challenged on an appropriate level. stepping exercises will be used to control the video game scenario. the video game scenario will include different cognitive functions. the body movements will include different physical aspects including balance, strength and pelvic floor muscle training (pfmt). during the exergame performance, different qualitative assessments will be performed to determine usability of the exergame including acceptance and game experience protocol (think aloud method). after the exergame performance, the participant will answer individual and guideline-based interview questions about usability including their individual experiences (duration about 20 min). this study contributes to fundamental research investigating how user-centered exergame training can be applied in older adults with individual needs.

Eligibility criteria:
inclusion criteria: * aged 60+ years * live in long-term care facility "de wingerd" * being diagnosed with major neurocognitive disorder by a specialist doctor * standing straight for minimal 10 minutes without aids * visual acuity with correction sufficient to work on a tv screen exclusion criteria: * mobility impairments that don't allow to play the exergame * severe acute or uncontrolled health problems (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension) * orthopaedic or neurological diseases that inhibit exergame training * rapidly progressive or terminal illness
alterations in coagulation factor levels in patients with end stage liver disease

Conditions: Liver Cirrhosis; Hemophilia; Hemophilia A; Hemophilia B; Liver Transplant Disorder; Liver Failure; Coagulation Factor Deficiency

Summary: the goal of this observational study is to learn about the changes in coagulation factor viii and ix levels in patients undergoing liver transplantation to help guide future management of coagulation factor replacement in patients with hemophilia and liver disease. the question we aim to answer is: should the recommendations for factor replacement in patients with hereditary bleeding disorders be altered in the setting of end stage liver cirrhosis? participants will be asked to provide two blood samples, one at the beginning of their liver transplant, and one after their liver transplant.

current guidelines for management of hemophilia b suggest replacement of factor ix to 100% prior to major abdominal surgery. however, in patients with concurrent liver cirrhosis where the liver does not produce factor ix, is it worth considering adjusting the factor replacement strategy? we recently had a case of a patient with hemophilia b and end-stage liver disease (esld) who underwent orthotopic liver transplantation and received the standard pre-operative recombinant factor ix replacement. his case was complicated by intra-cardiac thrombus and hypotension. we conduct a small study to assess the pre-operative thromboelastography (teg) and factor levels in esld patient which we hope will help guide clinical decision making in future hemophilia b patients with cirrhosis.

Eligibility criteria:
inclusion criteria: * participants who have end stage liver disease who are listed for liver transplantation and have an accepted organ offer * age \> 18+ * meld \> 25 exclusion criteria: * undergoing multi-organ transplant * tumor meld exception points * has hereditary coagulation disease * currently on therapeutic blood thinner or anti-platelet medication (ie. aspirin, plavix, warfarin, heparin)

Keywords: liver transplant hemophilia coagulation thrombosis bleeding cirrhosis
efficacy and safety of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis

Conditions: Osteoporosis

Summary: the intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. zoledronic acid (aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). this study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.


Eligibility criteria:
inclusion criteria: * long duration treatment with corticosteroids (started or ongoing) exclusion criteria: * history of osteogenesis imperfecta, multiple myeloma or paget's disease * history of hyperparathyroidism, hyperthyroidism * history of osteomalacia other protocol-defined inclusion/exclusion criteria may apply.

Keywords: corticosteroid induced osteoporosis prevention treatment zoledronic acid