Kornimate/medical-research-clean huggingface dataset:
study of vga039 in healthy volunteers and patients with von willebrand disease (vivid)

Conditions: Von Willebrand Diseases

Summary: the vivid study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (iv) and subcutaneous (sc) vga039 in healthy volunteers and subjects with von willebrand disease (vwd) and other bleeding disorders.

this first-in-human study consists of 5 parts based on the subject population. part 1 is a randomized, double-blind, placebo-controlled, single-ascending dose (sad) evaluation of iv or sc vga039 or placebo in up to 8 cohorts in healthy volunteers. part 2 is an open-label, sad of sc or iv vga039 in up to 8 cohorts in subjects diagnosed with vwd. all participants will be enrolled, treated, and followed up for 15 weeks (iv sad) or 8 weeks(sc sad). part 3 is an open-label, phase 1b study of sc multiple doses (md) of vga039 in up to 4 cohorts. part 4 is an open-label, phase 2 study of sc single, surgical prophylaxis (sp) doses of vga039 administered prior to a minor surgical procedure in subjects diagnosed with vwd in up to 2 cohorts. part 5 is an open-label extension (ole) study of sc md of vga039 in eligible subjects diagnosed with vwd who have previously participated in a vga039 interventional trial.

Eligibility criteria:
key inclusion criteria (all subjects) * subjects, 18 to 60 years of age, inclusive for parts 1 and 2 * subjects, 12 to 60 years of age, inclusive for parts 3 and 5 * no clinically significant laboratory, ecg, or vital signs results. additional key inclusion criteria (for subjects in part 1 only) • body mass index of 18-32 kg/m2 additional key inclusion criteria (for subjects in part 2 only) * subjects with vwd who are symptomatic, defined as having a history of bleeding or bruising. * hemoglobin level ≥ 8 g/dl and platelet count ≥ 150 × 109/l at screening. exclusion key criteria (all subjects) * use of hormonal contraceptives within 56 days prior to administration of the study drug. * subjects with detection of fv leiden or prothrombin g20210a mutation, protein c or s deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at screening. * subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation. * history of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism. * evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction. additional key exclusion criterion (subjects in part 1 only) • baseline fviii activity \> 150 iu/dl. additional key exclusion criteria (subjects in parts 2, 3, 4 and 5 only) * baseline fviii activity \> 50 iu/dl. * any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.

Keywords: von willebrand disorder
the efficacy of "mindtesion"is measuring attentional and the startle response dysregulation in children and adolescents suffering from attention deficit disorder: with and without medication.

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: double blind, placebo-controlled clinical study designed to evaluate mindtension device and protocol as a diagnostic tool in children diagnosed with adhd

mindtension device measures the orbicularis muscle response to auditory stimuli, the device is backed up by an algorithm that calculate the several parameters of startle reflex such as the paired-pulse inhibition (ppi), habituation, and startle related indices. data collected by the device is used to evaluate the subject levels of attention, hyperarousal and impulsivity, by means of physiological emg signals of the startle response. evaluating baseline differences in these parameters between adhd and age matched healthy controls, and the possible improvement after psychostimulant medications.

Eligibility criteria:
inclusion criteria: (i) children with adhd according to dsm-5 criteria in a semi-structured interview by a senior psychiatrist. (ii) reaching 85 percent score on the adhd-rs scale. (iii) treated with a stimulant in the perceived optimal dosage. exclusion criteria: (i) autism spectrum disorder. (ii) chronic neurological disorders and chronic medical conditions (e.g., diabetes). (iii) schizophrenia spectrum and other psychotic disorders. (iv) substance abuse (drugs or alcohol). (v) depression. (vi) hearing loss. (vii) lack of cooperation.

Keywords: adhd attention
prospective evaluation of the preoperative lymph node staging in patients with cancer of the esophagogastric junction and stomach

Conditions: Adenocarcinoma; Stomach Cancer; Cancer of Esophagogastric Junction

Summary: this prospective study includes patients with histologically proven cancer of the esophagogastric junction (siewert type ii and iii) and the stomach. aim of the study is to evaluate the accuracy of pet-ct for the preoperative assessment of lymph node metastasis. the evaluation includes a combination with standard diagnostic tools (endoluminal ultrasound, ct and diagnostic laparoscopy prior to neoadjuvant therapy). standardized d2-lymphadenectomy is performed and individual lymph node stations (nr 1-12 according to the japanese classification) are histopathologically examined. furthermore we evaluate the role of the pet-ct for early metabolic response evaluation in patients receiving neoadjuvant chemotherapy. * trial with surgical intervention


Eligibility criteria:
inclusion criteria: * histological prove of adenocarcinoma of the stomach. exclusion criteria: * recurrent gastric carcinoma * no informed consent * previous malignancy (exception: thyroid, bladder in situ, cervix in situ)

Keywords: adenocarcinoma of the stomach and esophagogastric junction
plegridy observational program

Conditions: Relapsing Forms of Multiple Sclerosis

Summary: the primary objectives of the study are to determine the incidence of serious adverse events (saes) in participants with relapsing forms of multiple sclerosis (ms) in routine clinical practice and to assess the overall long-term clinical effectiveness of plegridy in participants with relapsing forms of ms in routine clinical practice. the secondary objectives of this study in this study population are to describe plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of plegridy in participants with relapsing forms of ms in routine clinical practice; to monitor the safety and tolerability of plegridy in routine clinical practice by assessing the incidence of adverse events (aes) of flu-like symptoms (fls), injection site reactions (isrs), and aes (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of fls on participant-reported effectiveness of, and satisfaction with, prophylactic management using a fls-visual analog scale (fls-vas); to evaluate the change in health-related quality of life (hrqol), fls, fls-vas, healthcare resource consumption, and treatment adherence over time.


Eligibility criteria:
key inclusion criteria: * patient with ms who is newly, or is currently, prescribed plegridy according to local label including patients who participated in study 105ms302 (nct01332019) or study 105ms303 (nct01939002). * patient willing and able to complete patient-reported outcomes (pro) with minimal assistance. key exclusion criteria: * concurrent enrollment in any clinical trial of an investigational product. participation in non-interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the subject's ability to comply with the protocol. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: peginterferon relapsing pegylated subcutaneous injectable multiple sclerosis
study to asses efficacy of intralymphatic immunotherapy

Conditions: Allergy

Summary: the purpose of the study is to try a new route for specific immunotherapy (sit). the current treatment form for sit is subcutaneously (scit), which is a long treatment with up to 50 injections subcutaneously in the upper arm. the investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. the trial has been performed in switzerland with significant effect of only three injections of grass-allergen into a lymph node (clinicaltrials.gov; nct00470457). the investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 sq-u). also the outcome measurements is slightly different as the patients will note their symptoms in a diary. the patients will be divided into three groups using allocation: 1 group with 6 injections of allergen 1 group with 3 injections of allergen and 3 injections of placebo 1 group with 6 injections of placebo. the trial will be double blinded.


Eligibility criteria:
inclusion criteria: * grass pollen allergy through at least 2 seasons * positive skin prick test * positive specific ige of at least 2. (cap) * signed informed consent * for females a negative pregnancy test. exclusion criteria: * out of age limits * rhinoconjunctivitis all year round. * uncontrolled seasonal asthma * patients treated with steroids continuously or beta-blockers. * pregnancy and breastfeeding * hiv, hepatitis b+c, and other immunological diseases. * psychiatric disease * treatment with scit or slit within the last 5 years * participation in other clinical trials within the last 3 months.

Keywords: grass-pollen allergy
surveillance of hospitalised pneumonia and bacterial meningitis in tône district, togo, 2010-2013

Conditions: Pneumonia, Bacterial; Pneumonia, Viral; Meningitis, Bacterial

Summary: the aim of this study is to estimate the burden of disease due to pneumococci, other bacteria and viruses in the african meningitis belt prior to pneumococcal conjugate vaccine introduction and to estimate the population impact of the vaccine after its implementation in 2014. in a defined population of a sanitary district in northern togo, during the period 2010 to 2017, investigators enroll patients of all ages with suspected pneumonia requiring hospitalization or suspected bacterial meningitis. patients are evaluated by bacteriology and molecular biology techniques on blood, cerebro-spinal fluid, nasal aspirates and by chest x-ray.


Eligibility criteria:
pneumonia surveillance: inclusion criteria: * resident of tône sanitary district - requiring hospitalisation for at least one night for clinical pneumonia syndrome * hospitalised in a study site during the study period exclusion criteria: * absence of informed consent by patient or legal tutor meningitis surveillance: inclusion criteria: * resident of tône sanitary district * presenting clinical signs of acute bacterial meningitis * hospitalised in a study site during the study period exclusion criteria: * absence of informed consent by patient or legal tutor

Keywords: surveillance study prospective observational health center-based pneumonia, bacterial pneumonia, viral meningitis, bacterial africa south of the sahara
long-term safety, tolerability, and efficacy of dtx101 (aavrh10fix) in adults with moderate/severe to severe hemophilia b

Conditions: Hemophilia B

Summary: a long-term follow-up study to evaluate the safety, tolerability, and efficacy of dtx101 in adult males with moderate/severe to severe hemophilia b.

hemophilia b is an x-linked recessive genetic bleeding disorder caused by mutations in the factor ix (fix) gene. fix is produced in the liver and is critical for fibrin clot formation. hemophilia b is characterized by frequent, spontaneous internal bleeding that can lead to chronic arthropathy (joint damage), intracranial hemorrhage, and even death. in patients with moderate/severe to severe hemophilia b, the majority of bleeding episodes occur in the joints and, if not treated, lead to debilitating damage and a decreased quality of life. study 101hemb02 is a long-term follow-up study to evaluate the safety, tolerability, and efficacy of aavrh10-mediated gene therapy of human fix in subjects with moderate/severe to severe hemophilia b. the primary objective of the study is to determine the long-term safety and efficacy of dtx101 following a single iv infusion (administered during study 101hemb01) in adults with moderate/severe to severe hemophilia b. this study was previously posted by dimension therapeutics, which has been acquired by ultragenyx.

Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent. 2. completed the week 52 visit in study 101hemb01. 3. willing to stop prophylactic treatment with recombinant fix at specified time points during the study if medically acceptable. 4. willing, able, and committed to comply with scheduled study site visits, study procedures, and requirements. exclusion criteria: 1. planned or current participation in another interventional clinical study that may confound the efficacy or safety evaluation of dtx101 during the duration of this study. 2. any clinically significant medical condition that, in the opinion of the investigator, would pose a risk to subject safety or would impede the study

Keywords: gene therapy hemophilia b
evaluating uti diagnosis in nursing homes

Conditions: Urinary Tract Infections

Summary: this prospective, multicenter, comparative cohort observational study is to determine whether the use of guidance® uti clinical pathway, a standardized infrastructure for specimen collection and result delivery, compared with current traditional pathways for urine testing reduces the proportion of uti patients with poor outcomes.

the objective of this study is to determine if prospective data, collected over 12 months from over 200 nursing homes, will show that the use of guidance® uti clinical pathway is more effective than the traditional clinical pathways for urine testing in uti diagnosis in nursing homes. guidance® uti clinical pathway provides standardized infrastructure for specimen collection, and result dissemination via assigned report point person to verify receipt of actionable data. the pathway also includes several in-services on molecular testing for uti, pooled antibiotic susceptibility testing, and polymicrobial infections to help providers better understand test methodology. standardizing a clinical care pathway for testing and reporting of clinical results approach may lead to a reduction in empiric broad spectrum antibiotic use and in turn better health-related outcomes for patients. such efficiency in clinical decision making at the time of initial presentation may lead to improved patient care by avoiding ineffective therapy due to mismanagement or incomplete lab diagnosis. the study will be observing the implementation of the guidance® uti clinical pathway and comparing it to traditional clinical care pathways from facility-level data entered into the national healthcare safety network for its ltcf (long term care facilities) component.

Eligibility criteria:
inclusion * certified skilled nursing facilities (snf) and nursing homes (nh) * nonprofit or for-profit freestanding facility certified by medicare and medicaid * currently utilizing an emr system * minimum bed size of 100 exclusion * assisted living facilities and residential care facilities * participation in another uti trial during the study period

Keywords: nursing home clostridium difficile pcr long term care facility skilled nursing facility national healthcare safety network
luteal phase support in iui moh treatment luteal phase support in iui moh treatment

Conditions: Pregnancy Related; Fertility Issues; Luteal Phase Defect; Infertility Unexplained

Summary: the lumo study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in moh/iui treatment.

participating sites consist of academic and non-academic hospitals and fertility clinics in the netherlands. there are two treatment arms (moh/iui treatment with lps vs moh/iui treatment with placebo) with a non-blinded superiority design. participants are randomly distributed across both treatment arms for the entire study-period (six months, non-crossover). eligibility criteria are: 1) couples starting iui with mild ovarian hyperstimulation (moh), with the intend to receive this treatment for at least six months. 2) indication for moh/iui treatment is in accordance with current (dutch) nvog guidelines; diagnosis of unexplained (primary or secondary) infertility with hunault \ 30%, after an expectant management period of at least 6 additional months). total mobile sperm count (vcm) \>10 million. 3) females aged \>18 years with regular menstrual cycle. (mild) ovarian stimulating treatment and insemination are according to regular treatment protocol. females assigned to the treatment group start lps, applying 3dd200mg utrogestan in vaginal capsules, on the day of iui. treatment is continued until the onset of menstruation, a negative pregnancy test, miscarriage or confirmed vital intra-uterine pregnancy at 7 weeks gestation. main outcome is pregnancy within 6 months of treatment, leading to live birth. secondary outcomes are; clinical pregnancy rate. miscarriage rate. multiple pregnancy rate. pregnancy complications. perinatal outcomes. side effects and compliance to therapy. added medication costs. budget impact. the analyses will include a cost-effectiveness analysis.

Eligibility criteria:
inclusion criteria: * couples starting iui with mild ovarian hyperstimulation (moh), with the intend to receive this treatment for at least six months. * diagnosis of unexplained (primary or secondary) infertility * hunault \ 30%, after an expectant management period of at least 6 additional months). * females aged \>18 years with regular menstrual cycle. * total mobile sperm count (vcm) \>10 million. exclusion cirteria: * cycle irregularities * male factor infertility

Keywords: progesterone cost-effective intrauterine insemination live birth luteal support ongoing pregnancy ovulation induction unexplained infertility
pharmacy-based prep for young women who sell sex in zimbabwe

Conditions: Adherence, Medication; HIV Prevention

Summary: pharmacy-based prep for young women who sell sex in zimbabwe is a cluster-randomized control trial and pilot study co-led by dr. euphemia sibanda, reader (associate professor) of global health and epidemiology at liverpool school of tropical medicine, uk and research director at the centre for sexual health and hiv research (ceshhar zimbabwe) and dr. sandra mccoy, professor of epidemiology and biostatistics at the university of california, berkeley. the goal of the proposed study is to optimize, refine and pilot a pharmacy-based prep intervention for female sex workers (fsw) in zimbabwe. despite efforts to reach the most impacted and vulnerable populations with prep, retention rates, particularly among fsw in africa, are very low. relatively high levels of uptake indicate that fsw are interested in prep and ready to initiate it, but in most cases fewer than 50% of those who initiate return for medication refills by month 4. pharmacy-based prep has the potential to address known barriers to prep retention among fsw such as stigma and access, and coupled with a small escalating incentive in the form of a gift card incentive, could also boost motivation for effective use of prep.


Eligibility criteria:
inclusion criteria: * 1) exchanged sexual intercourse for money or gifts in past 6 months * 2) age 16 or older * 3) hiv negative (via rapid test per national guidelines) at enrollment and no signs/symptoms of acute hiv infection

Keywords: hiv prep people who engage in sex work
acid-base balance, metabolism and minerals

Conditions: Acid-Base Balance Disorder; Metabolic Acidosis

Summary: metabolism is controlled by macro- and micronutrients. protein-rich diets should lead to latent acidosis at tissue level with further negative implications. food supplements with alkaline salts are available and popular pretending to prevent these changes. within a randomized double-blind placebo-controlled trial, the investigators tested the hypotheses 1) that a 4-week protein-rich diet induces a latent tissue acidosis and 2) an alkaline supplement can compensate this. acid-base balance and important metabolic parameters were determined before and after 4 weeks of supplementation by peripheral blood samples, indirect calorimetry and muscle microdialysis before and after a protein-rich test meal.


Eligibility criteria:
inclusion criteria: * slightly reduced kidney function (gfr 60-89 ml/min) * body mass index 20.0 - 29.9 kg/m2 * normal daily diet composition: 45-50, 35-40, and 15 e% from carbs, fats and proteins, respectively exclusion criteria: * sorbitol-/fructose-intolerance * intake of antacidic drugs * vegetarians, vegans * intake of any nutritional supplements * any cardiovascular, pulmonary, endocrine or metabolic diseases * any drug abuse * intake of any anticoagulant drugs

Keywords: acid-base balance energy metabolism protein-rich diet alkaline supplementation calorimetry microdialysis randomized placebo-controlled trial
clinical efficacy of moap regimen for relapsed/refractory chl as a rescue therapy after dp regimen

Conditions: Hodgkin Lymphoma

Summary: the dp regimen, low-dose decitabine combined with shr-1210, is the new treatment for relapsed or refractory classical hodgkin's lymphoma. though the cr rate of this regimen is impressively high, which is verified more than 70% in our i/ii phase study, there are also lots of patients cannot benefit from this treatment. on top of that, as the increasing utilization of mono-therapy or combination treatment with the immune checkpoint blockade (icb), the adverse reactions associated with immunotherapy make it unavailable in parts of patients. the application of moap regimen to patients, who have a progressive disease after dp regimen, can bring high cr rate. moap can be the a rescue treatment for chl resisted to dp treatment.


Eligibility criteria:
inclusion criteria: 1. subjects must have histological confirmation of relapsed or refractory hodgkin lymphoma (hl). 2. 13 to 70 years of age. 3. ecog performance of less than 2. 4. life expectancy of at least 3 months. 5. subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria. 6. subjects must have received at least two prior chemotherapy regimen and four cycle of dp regimen, and must be off therapy for at least 4 weeks prior to day 1. subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 7. subjects must have adequate marrow, live, renal and heart functions. exclusion criteria: 1. subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month . 4. prior organ allograft. 5. women who are pregnant or breastfeeding. 6. women with a positive pregnancy test on enrollment or prior to investigational product administration. 7. subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Keywords: moap; relapsed/refractory; hodgkin lymphoma; dp;