Kornimate/medical-research-clean huggingface dataset:
trial evaluating a 13-valent pneumococcal conjugate vaccine given with diphtheria, tetanus, and acellular pertussis vaccine (dtap) in healthy japanese infants

Conditions: Healthy Subjects

Summary: subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: group 1: 13-valent pneumococcal conjugate vaccine (13vpnc) and diphtheria, tetanus, and acellular pertussis vaccine (dtap), group 2: 7-valent pneumococcal conjugate vaccine (7vpnc) and dtap, group 3: dtap alone. group 3 subjects will also receive catch-up doses of prevenar (commercial product of prevenar in japan) 13vpnc and 7vpnc will be blinded, and dtap will be open-label. the main purpose of the study is to determine if the immune responses to 13vpnc are comparable to the immune responses to 7vpnc and if the immune responses to 13vpnc given with dtap are comparable to those induced by dtap given alone. in addition, the study aims to evaluate the side effects (safety profile) after vaccination of 13vpnc and 7vpnc when given with dtap in healthy japanese infants.


Eligibility criteria:
inclusion criteria: * male or female subjects between 3 to 6 months of age at the enrollment. * available for the entire study period and whose parent/legal guardian can be reached by telephone. * healthy infant as determined by medical history, physical examination, and judgement of the investigator. exclusion criteria: * previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines. * a previous anaphylactic reaction to any vaccine or vaccine-related component. * bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection. * history of culture-proven invasive disease caused by s pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis). * infant who is a direct descendant (child, grandchild) of the study site personnel.

Keywords: vaccine pneumococcal conjugate
hepatitis b virus vertical transmission from hiv-hbv co-infected women

Conditions: Vertical Disease Transmission; HBV

Summary: vertical hiv transmission has been dramatically reduced by the use of combined antiretroviral therapy in hiv-infected pregnant women. among the most often used drugs, several have dual activity, against hiv and hbv: lamivudine, emtricitabine, tenofovir. studies about vertical hbv transmission from hiv-hbv co-infected pregnant women are rare in developed countries. the study hypothesis is a major reduction of the risk of hbv vertical transmission.

mother-to-child hiv transmission has been dramatically reduced by the use of combined antiretroviral therapy in hiv-infected pregnant women, both in developed and in developing countries. among the most often used drugs, several have dual activity, against hiv and hbv: lamivudine, emtricitabine, tenofovir; they can be used as a combo, as tenofovir+emtricitabine for instance. studies about vertical hbv transmission from hiv-hbv co-infected pregnant women are rare in developed countries. the study hypothesis is a major reduction of the risk of hbv vertical transmission in this context, justifying this retrospective study.

Eligibility criteria:
inclusion criteria: * children born in the maternity department from hiv-hbv co-infected women * whose mother was given a treatment with dual activity (hiv and hbv) during pregnancy exclusion criteria: * no
the combination of iguratimod and danazol as the treatment of steroid-resistant/relapse immune thrombocytopenia

Conditions: ITP; Immune Thrombocytopenia

Summary: randomized, open-label, multicenter study to compare the efficacy and safety of combination of iguratimod and danazol versus danazol for the treatment of adults with steroid-resistant/ relapse immune thrombocytopenia (itp).

the investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with steroid-resistant/ relapse itp in china. patients were randomized to iguratimod plus danazol and danazol monotherapy group. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: * primary immune thrombocytopenia (itp) confirmed by excluding other supervened causes of thrombocytopenia; * platelet count of less than 30×109/l at enrollment; * patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation; * 18 years older; exclusion criteria: * secondary immune thrombocytopenia (e.g., patients with hiv, hcv, helicobacter pylori infection or patients with systemic lupus erythematosus) * congestive heart failure * severe arrhythmia * nursing or pregnant women * aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria * creatinine or serum bilirubin levels each 1•5 times or more than the normal range * active or previous malignancy * unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
efficacy and safety study of stx209 (arbaclofen) for social withdrawal in adolescents and adults with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: to explore the efficacy, safety and tolerability of stx209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile x syndrome (fxs)


Eligibility criteria:
inclusion criteria: * molecular documentation of the full fmr1 mutation * current pharmacological treatment regimen has been stable for at least 4 weeks prior to screening. * subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics. * if the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to screening exclusion criteria: * subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. * subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. * subjects who have taken another investigational drug within the last 30 days. * subjects who are not able to take oral medications.

Keywords: fragile x syndrome autism spectrum disorder
use of continuous glucose monitors in children and adolescents with obesity

Conditions: Pediatric Obesity

Summary: to study if continuous glucose monitors are feasible for use in children and adolescents with obesity.

various cgms are approved by the u.s. food and drug administration (fda) for use in children and adults with diabetes. however, to date, little is known about how cgm technology can be integrated into weight management strategies for adolescents with obesity. no study to date has explored the effects of unblinded vs. blinded cgm use alone, without any other lifestyle modification recommendations. thus, to address this question, this is a cross-over feasibility trial of blinded vs. unblinded cgm use in youth with obesity. this study hypothesizes that cgm will be a feasible and acceptable technology for youth with obesity, without diabetes, to utilize, and that access to daily glucose trends will facilitate positive changes in eating behavior and daily activity level compared to blinded cgm use. thirty adolescents with obesity will be recruited into a six-week cross-over trial. all participants will be randomly assigned to either the blinded or unblinded group for three weeks. and then cross over to the other group for another three weeks. the primary endpoints are recruitment, retention, and adherence. while the secondary endpoints are glycemic variability, as captured on cgm, change in weight as an excess percentage of 95th percentile, sleep, dietary intake, physical activity, and eating behaviors.

Eligibility criteria:
inclusion criteria: * age 10-21 years bmi \>95th percentile exclusion criteria: * previous diagnosis of prader willi syndrome or hypothalamic obesity * intellectual disability * previous or planned bariatric surgery * hemoglobin a1c \>6.5 % * current use of medication that impacts weight
non-invasive tumor immunoglobulin gene next generation sequencing (igngs) in diffuse large b cell lymphoma (dlbcl)

Conditions: Lymphoma, Large B-Cell, Diffuse

Summary: this study will evaluate igngs at different time points in newly diagnosed dlbcl patients homogeneously treated (rchop) to address its correlation with conventional techniques (i.e., positron emission tomography/computed tomography imaging (pet/ct) and outcome.

in b-cell malignancies, every lymphocyte clone expresses a unique antigen receptor structure, therefore immunoglobulin gene rearrangements (the sequence of nucleotides at the v(d)j recombination site) serves as a specific marker for each clone. methods of analysis have changed over time to improve the sensitivity and to allow its application in clinical settings. diffuse large b-cell lymphoma (dlbcl) displays molecular heterogeneity. in this context, igngs allows for detection of tumor clonotype from plasma (ctdna) (liquid biopsy-lb) of dlbcl patients with high sensitivity and specificity. ctdna can be tracked with this methodology in the vast majority (\>90%) of patients, in contrast to ngs-methods based on genotyping for specific dlbcl mutations, which have overall low frequency. furthermore, most newly discovered neoantigens in lymphoma derive from immunoglobulin variable sequences, supporting the relevance of the analysis of this particular region in contrast to the use of specific b-cell mutations. importantly, preliminary studies on clonotype detection by igngs at the end of treatment correlate with outcome (poorer progression-free survival) and the persistence or reemergence of the tumor clonotype by ctdna studies may anticipate the clinical relapse. we propose to evaluate igngs at different time points in newly diagnosed dlbcl patients treated with rchop to address its correlation with conventional techniques (i.e., pet/ct imaging) and outcome.

Eligibility criteria:
inclusion criteria: patients diagnosed with de novo dlbcl, all ages, treated with r-chop. patients with dlbcl not otherwise specified (nos) according to world health organization classification of tumours of haematopoietic and lymphoid tissues (who) 2016 would be included. in addition, those with "high-grade b cell lymphoma (including both nos and those with myc and bcl2 and/or bcl6 alterations) will be also included. exclusion criteria: * primary mediastinal dlbcl. * transformed dlbcl * patients hiv+ * central nervous system (cns) dlbcl * all other dlbcl not included under "nos" classification, according to who 2016 (except those specifically indicated in "inclusion criteria").

Keywords: diffuse large b cell lymphoma immunoglobulin gene next generation sequencing liquid biopsy
an efficacy and safety study of fremanezumab in adults with migraine

Conditions: Migraine Prophylaxis

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (cm) or episodic migraine (em) who have responded inadequately to 2 to 4 classes of prior preventive treatments. approximately equal numbers of participants from each subgroup (cm and em) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to week 12). then all participants continue into an open-label extension of 3 months (up to week 24) during which everyone is administered sc injections of fremanezumab.


Eligibility criteria:
inclusion criteria: * the participant has a diagnosis of migraine with onset at ≤50 years of age. * body weight ≥45 kilograms. * the participant has a history of migraine for ≥12 months prior to screening. * women of childbearing potential (wocbp) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and the follow-up period and for 6.0 months after discontinuation of investigational medicinal product (imp) * men must be sterile, or if they are potentially fertile/reproductively competent (not surgically \[that is; vasectomy\] or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 6.0 months after discontinuation of the investigational medicinal product (imp). * additional criteria apply, please contact the investigator for more information. exclusion criteria: * at the time of screening visit, participant is receiving any preventive migraine medications, regardless of the medical indication for more than 5 days and expects to continue with these medications. * participant has received onabotulinumtoxina for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 3 months before screening visit. * the participant has used an intervention/device (for example; scheduled nerve blocks and transcranial magnetic stimulation) for migraine during the 2 months prior to screening. * the participant uses triptans/ergots as preventive therapies for migraine. * participant uses non-steroidal anti-inflammatory drugs (nsaids) as preventive therapy for migraine on nearly daily basis for other indications. note: low dose aspirin (for example; 81 mg) used for cardiovascular disease prevention is allowed. * additional criteria apply, please contact the investigator for more information.
treatment of sleep apnea with oral appliances

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnoea (osa) is a serious and common disorder affecting one in twenty-five men and one in fifty women over the age of 30. this breathing abnormality occurs during sleep and is characterised by snoring and episodes of sleep disturbances. the symptoms of untreated osa (e.g. excessive daytime sleepiness), can result in significant reductions in the patients' quality of life. the key treatment modalities today include continuous positive air pressure (cpap), surgery and the use of oral appliances (oas). increasingly, oas have been advocated in the treatment of the symptoms of osa since they offer a non-invasive form of treatment and also because patients often prefer this treatment to other treatment modalities. there is increasing evidence to support the effectiveness of oas in the management of osa, at least as a short term measure. what is still unclear is which types of oa are most effective and whether oas are effective in the long term management of osa. this randomized clinical trial aims to evaluate two differently designed oas in terms of their effect on patients' quality of life and on the physiological symptoms of osa (apnoea/hypopnoea index ahi). around 45 patients with osa will be recruited from a pool of patients referred to the dental hospital for treatment from the medical faculty. the treatment with oas will commence after randomization to two treatment groups; follow-up examinations will take place over a period of 12 months. the results of this study will help inform practitioners and patients of the feasibility of using oas in the long term management of osa and help determine the most appropriate type of oas for the management of osa and improvement in quality of life.


Eligibility criteria:
inclusion criteria: * aged 18 or older * ahi ≥ 10-30/h, and those who do not tolerate cpap or refused cpap if ahi \>30 * a score of \> 10 on the epworth sleepiness scale * body mass index \<35kg/m * those who are competent to give written informed consent * have adequate dental anchoring structures (\<10 periodontally healthy teeth per arch) exclusion criteria: * previous surgery to upper respiratory airway * concurrent unstable cardiovascular disease, neurological, mental or psychiatric disorders * recent major surgery in the last 6 months * pregnancy * epilepsy * temporomandibular joint (tmj) disfunction (pain during mandibular advancement or limitation of mouth opening) * untreated dental decay
comparison of biphasic insulin aspart produced by the nn2000 process to current process to in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the aim of this trial was to investigate the safety and efficacy of nn2000-mix30 produced by nn2000 process compared to that of nn-x14mix30 produced by current process in japanese subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes * subjects with insulin treatment for at least 24 weeks * current treatment with premixed biphasic human insulin preparation for at least 12 weeks * hba1c lesser than or equal to 11.0% exclusion criteria: * recurrent severe hypoglycaemia * proliferative retinopathy or maculopathy requiring acute treatment * impaired renal function * cardiac diseases * uncontrolled hypertension * subjects with known malignant tumour * total daily insulin dose greater than or equal to 100 iu
influenza vaccine to prevent adverse vascular events:pilot

Conditions: Heart Failure

Summary: a multi-centre, randomized, placebo controlled, trial. participants at high-risk for vascular events from the network of inter- chf will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.

cardiovascular disease is a major cause of morbidity and mortality. there is recent evidence that infection due to influenza may precipitate vascular events such as myocardial infarctions and strokes. there is some evidence that influenza vaccination may prevent such events but the data are inconclusive. the investigators propose a randomized controlled trial to assess whether influenza vaccination will prevent vascular illness. adults with clinical heart failure will be randomized to inactivated influenza vaccine or saline placebo. this pilot study will provide needed data to establish the feasibility of a larger study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years and nyha functional class ii, iii and iv exclusion criteria: * anaphylactic reaction to a previous dose of tiv * known ige-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock * guillain-barré syndrome within eight weeks of a previous influenza vaccine * anaphylactic reaction to neomycin * patients who have had influenza vaccine in two of the three previous years

Keywords: vascular, influenza, vaccine, heart failure
study of cryospray ablation(tm)to determine treatment effect, depth of injury, and side effects in the esophagus.

Conditions: Barrett's Esophagus; Esophageal Cancer

Summary: the purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (cryospray ablationtm, "csa" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy (egd) using surgical resection specimens from subjects undergoing esophagectomy.

the proposed study is a single center study consisting of no more than 10 subjects who are undergoing scheduled esophagectomy for reasons unrelated to the study. subjects will be divided into 2 groups in a sequential fashion based on the time of enrollment (subject 1 in group1, subject 2 in group 2, subject 3 in group1, subject 4 in group 2, etc). potential study subjects will be referred from clinical practice. after entry into the study with written informed consent, subjects will be scheduled for the egd with cryospray ablation treatment 7 days prior to the expected esophagectomy date. all subjects will receive narcotic analgesics to control symptoms. endpoints related to pathology will be assessed by two independent reviewers, one from the institution's department of pathology, and one from an independent pathology lab chosen by the sponsor. the reviewers will evaluate the pathology slides to assess maximal extent of depth of injury, side effects, and pathological changes associated with csa. all reviewers will be blinded to the treatment conditions of the specimens.

Eligibility criteria:
inclusion criteria: * age 18 years of age * esophagectomy planned based on clinical situation not related to this study. * deemed operable based on institutional criteria. exclusion criteria: * pregnant * esophageal stricture preventing passage of endoscope or catheter. * known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines. * refusal or inability to give consent. * concurrent chemotherapy. * prior or concurrent endoscopic ablation therapy within 4 cm from the csa treatment area including, but not limited to, cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation, or argon plasma coagulation. * prior radiation therapy which involved the esophagus.

Keywords: barrett's esophagus esophageal cancer esophageal dysplasia low grade dysplasia high grade dysplasia
convalescent plasma for treating patients with covid-19 pneumonia without indication of ventilatory support

Conditions: COVID-19

Summary: the covid-19 pandemic has been spreading continuously, and in brazil, until august 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. the present study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with covid-19 pneumonia without indication of ventilatory support.


Eligibility criteria:
recipient inclusion criteria: * confirmed diagnosis of covid-19 by rt-pcr; * time between symptom onset and inclusion ≤ 7 days; * chest tomography with \<50% involvement of the lung parenchyma; * no indication of ventilatory support at the time of randomization; * sign the consent form. recipient exclusion criteria: * contraindication to transfusion or history of previous reactions to blood products for transfusion; * pregnant women; * limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator. donor inclusion criteria for plasmapheresis: * convalescent plasma donation will be eligible for patients ≥ 18 years old who had previously confirmed covid-19 by rt-pcr, which met the criteria adopted by technical notes n13 and 21/2020-cgsh/daet/saes/ms; * sars-cov-2 negative rt-pcr; * asymptomatic for at least 14 days; * sars-cov-2 anti-peak titre with dilution ≥ 1: 320; * sign the consent form. donor exclusion criteria: * female gender with previous pregnancy; * absence of peripheral venous network compatible with the apheresis procedure; * positive or indeterminate result in any of the infectious screening tests; * presence of intellectual incapacity to understand the guidelines regarding the risks and benefits of participating in the study.

Keywords: convalescent plasma sars-cov-2