Kornimate/medical-research-clean huggingface dataset:
a phase i, randomized, open-label, cross-over, pharmacokinetic study of genasense with and without dacarbazine

Conditions: Advanced Melanoma

Summary: this clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(dtic) when administered in combination with genasense


Eligibility criteria:
inclusion criteria: * metastatic stage iv disease, or stage iii disease that is not surgically resectable * ecog performance status of 0, 1, or 2 * life expectancy of at least 12 weeks * adequate venous access * agreement to practice effective method of birth control exclusion criteria: * less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy * significant medical disease * known hypersensitivity to phosphorothioate-containing oligonucleotides * known hypersensitivity to dtic * pregnancy/lactation

Keywords: bcl-2 cfr dtic ecog emea meddra nci ctc sae
the effect of xolair ® (omalizumab) in mastocytosis patients

Conditions: Mastocytosis

Summary: patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo, fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by mast cells. these patients have also an increased frequency of anaphylactic/anaphylactoid reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast media, local anesthetics or analgesics. in addition, there is increased osteoporosis in mastocytosis patients due to the activity of mast cell mediators on osteoblasts and osteoclasts. symptoms of mastocytosis respond poorly to treatment with antihistamines or other antiallergic drugs. there is currently no specific treatment for this disease with the exception of rare cases. there are, however, some case reports suggesting that omalizumab might decrease symptoms including hypotensive events. the aim of the study is to investigate whether patients suffering from mastocytosis benefit from a 6 month course of omalizumab with regard to symptoms and quality of life and whether the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the efficacy of omalizumab in patients with mastocytosis. * trial with medicinal product

the study will take place as double-blind placebo controlled study. after a first a run-period of 2 months for all participants randomization (1:1) in two group will take place: group a: with omalizumab treatment for 6 months; dosage and administration schedule according to body weight and total ige level (1/2 of the patients). group b: placebo (1/2 of the patients). after 4 months of treatment in both groups patients are encouraged to stop all drugs given to reduce mast cell related effects, mainly antihistaminics . in case that disturbing symptoms are reoccurring patients are allowed to restart these drugs. the evaluation will take place after 5 months of treatment. finally, a follow up visit 1 and 4 months after the study will take place.

Eligibility criteria:
inclusion criteria: * histological proven mastocytosis (cutaneous or systemic); * diagnosis made by one marrow unction and/or skin biopsy or other histological work up; * age: 18-70 years exclusion criteria * age \<18 years; * known hypersensitivity to omalizumab or any of its components; * history of cancer in previous 5 years; * patients with serious infections; * patients with active tuberculosis or undergoing anti-tb therapy; * patients currently treated with systemic immunosuppressive agents; * female patients who are pregnant or breast feeding;contraception must be performed by a save reliable and accept method such as oral or implanted contraceptives, intravaginal or male preservatives or permanent methods such as tubal ligation. * patients with known positivity for human immunodeficiency virus (hiv). hiv screening will be performed by an hiv 1/2 antibody-detection test. note: specific immunotherapy for insect sting allergy is no exclusion criteria.

Keywords: mastocytosis omalizumab
new algorithms to signal processing for speech enhancement in adult cochlear implant recipients.

Conditions: Hearing Loss

Summary: the purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for ci listeners. the master umbrella clinical investigation will be comprised of several sub-investigations, which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into ci speech processors.

this is a feasibility, prospective, multi-center, single-subject, repeated-measures clinical investigation in experienced adult cochlear implant users. the master umbrella design will enable the execution of a series of sub-investigations in the same user population, with the goal to evaluate a range of speech enhancement pre-processing algorithms in separate sub-investigations. the primary objectives for each sub-investigation will be consistent with the master umbrella investigation, with secondary and exploratory objectives selected based on the algorithm to be investigated. secondary and exploratory objectives will be described in the sub-investigation documentation.

Eligibility criteria:
inclusion criteria: * user of an approved nucleus cochlear implant. * user of the ace (advanced combination encoder) sound processing strategy. * aged 18 years or older (no upper age limit). * able to score 20% or more at +10 db snr or have an adaptive speech recognition threshold (srt) of 12 db or less ci alone on a sentence in babble test.\* * fluent speaker in the language used to assess speech perception performance, as determined by the investigator. * willing and able to provide written informed consent. * ≥3 months post cochlear implant activation exclusion criteria: * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. * additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations. * investigator site personnel directly affiliated with this study and/or the investigator's immediate families; immediate family is defined as a spouse, parent, child, or sibling. * cochlear employees or employees of contract research organizations or contractors engaged by cochlear for the purposes of this investigation. * current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a cochlear sponsored investigation and determined by the investigator or sponsor to not impact this investigation).
incidence, associated factors, and burden of post covid-19 condition in brazil

Conditions: Post-Acute COVID-19 Syndrome

Summary: this is a national retrospective cohort study with internet-based recruitment which intends to enroll 1,694 adult patients with covid-19 diagnosis during the sars-cov-2 omicron wave in brazil. participants with confirmed symptomatic covid-19 after january 2022 will be evaluated in order to assess incidence, potential risk factors and impact of post covid-19 condition according to the who definition on health-related quality of life and other relevant patient-centered outcomes.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * brazilian resident; * symptomatica covid-19 confirmed by reverse transcriptase polymerase chain reaction (rt-pcr) or antigen test for sars-cov-2 after january 2022, with diagnosis at least 90 days before recruitment. exclusion criteria: * no availability to participate in remote research appointments; * communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia) * refuse to provide informed consent
maintenance hormone therapy for postmenopausal hr positive advanced breast cancer

Conditions: Breast Cancer

Summary: this is a prospective, single arm phase ii study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal hr positive advanced breast cancer.

this is a prospective, single arm phase ii study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal hr positive advanced breast cancer. approximately 58 women who have stable disease or responded to first line chemotherapy with at least 4 and less than 8 weeks of treatment for metastatic breast cancer will be enrolled to this study and receive fulvestrant 500mg as a maintenance therapy. the treatment will continue until the objective disease progression or intolerable ae. efficacy will be determined based on tumor assessments performed by each investigator according to recist (response evaluation criteria in solid tumors ) 1.1. safety will be monitored based on the frequency and severity of adverse events (aes), as assessed by common terminology criteria (ctc) grade version 4.0. tumor assessments will be assessed by computed tomography (ct) or magnetic resonance imaging (mri) every 12 weeks for all patients until documented evidence of objective disease progression. reporting of saes (serious adverse events) to regulatory authorities will be done by the investigator in accordance with local regulations.

Eligibility criteria:
inclusion criteria: provision of informed consent histologically proven hr positive breast cancer postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria (based on the nccn definition of menopause \[national comprehensive cancer network 2008\]): prior bilateral oophorectomy age ≥60 years age \<60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle stimulating hormone and oestradiol in the postmenopausal range. patients have completed first-line chemotherapy for metastatic breast cancer the first-line chemotherapy must be given to patients with visceral disease or progressive disease requiring a fast response responded(cr or pr) or stabilized(sd\>=24 weeks) to first-line chemotherapy for metastatic breast cancer the duration of 1st line chemotherapy for advanced breast cancer had been at least 4 cycles and at most 8 cycles who performance status 0, 1 or 2- exclusion criteria: * presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present) prior hormonal treatment for metastatic breast cancer are not allowed more than one line of cytotoxic chemotherapy for metastatic breast cancer her-2 positive other malignant tumor (concurrent or previous). any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the study protocol, eg, uncontrolled cardiac disease or uncontrolled diabetes mellitus
glue sealing for patients with low-output ecfs

Conditions: Low-output External Gastrointestinal Fistula

Summary: adjuvant use of fibrin glue (fg) in the fistula tract has been shown to promote closure of low-output ecfs. the primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (prfg) and a commercially available fibrin sealant bioseal® in the management of patients with low-output volume ecfs.

* this is a prospective, randomized, single-centered study clinical, safety and economic outcome of ecfs patients. * subjects are randomized to one of 2 groups: * group 1: autologous prfg-treatment (prfg + soc) * group 2: commercial fg-treatment (bioseal® + soc) * study will include three phases: * phase 1: screening, consent and enrollment * phase 2: patients will receive either prfg, or bioseal only for 14 days * phase 3: follow up: for patients with closed fistula within 14 days, we will follow up them for 6 months. for patients whose fistulas were still open will be treated with other therapeutic option and follow up for 6 months after closure.

Eligibility criteria:
inclusion criteria: * patients with a single tubular ecf * low output volume (\<200 ml/24h) * tract length \>2cm * tract diameter \< 1cm exclusion criteria: * cancer-infiltrated fistula * abscess * foreign bodies * distal bowel obstruction * inflammatory bowel disease

Keywords: autologous platelet rich fibrin glue; enterocutaneous fistulas; single low output gi fistulas;
safety and pharmacodynamic effects of biib122 in participants with lrrk2-associated parkinson's disease (lrrk2-pd)

Conditions: Parkinson Disease

Summary: this phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an ole, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of biib122 in participants with lrrk2-pd. lrrk2-pd is defined as parkinson's disease (pd) in individuals who are heterozygous or homozygous carriers of a pathogenic lrrk2 variant that increases lrrk2 kinase activity.


Eligibility criteria:
inclusion criteria: * for heterozygous pathogenic lrrk2 mutation carriers: ≥ 30 to ≤ 80 years * for homozygous pathogenic lrrk2 mutation carriers: ≥ 30 years * have screening genetic test results verifying the presence of a pathogenic lrrk2 variant. * have a clinical diagnosis of pd meeting the movement disorder society clinical diagnostic criteria. exclusion criteria: * have a history of any clinically significant neurological disorder other than pd, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit. * have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism. * have previously participated or are currently participating in the biib122 luma study (study 283pd201). * have previously participated or are currently participating in a gene therapy study for pd. * have a history of brain surgical intervention for pd (eg, deep-brain stimulation, pallidotomy). * have any physical condition that may confound the motor assessment (mds-updrs) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability). * abnormal vitals including blood pressure, heart rate, or body temperature * have abnormal pft results at screening note: other protocol defined inclusion/exclusion criteria may apply

Keywords: lrrk2 movement disorders
vr executive training of school-aged children with asd

Conditions: Executive Function of School-aged Children With ASD

Summary: many studies support that children with autism spectrum disorder (asd) show executive dysfunction. the applicant's nsc project report also indicated that in all areas in the behavior rating inventory of executive function, the second edition (brief-2), including inhibit, self-monitor, shift, emotional control, initiate, working memory, plan/organize, task-monitor, and organization of materials, children in the typically developmental group showed better performance than children in the asd group. the results also indicated that compared to the diagnosis of asd, an executive function could be a better predictor of daily life adaptation. similarly, more and more researchers put their efforts into executive training. however, the results are mixed. a meta-analysis showed that technology-based training can effectively improve the executive function of children with asd. children with asd love game-like training as it provides friendly environments to children with asd and induces less anxiety. the applicant, therefore, plans to develop a virtual reality executive function training program in the first year based on the applicant's previous experience with executive function training. the game will include the components of visual searching, reaction time, shift, planning, and working memory. at the end of the game, the game will provide visual feedback to the children to train in self-monitoring. in the second year, the applicant will conduct a randomized controlled trial to investigate the effectiveness of the training program. i plan to include 70 children with asd and randomly assign them to either the executive training or control groups. executive function and daily life adaptation will be the indexes of the effectiveness of the study.


Eligibility criteria:
inclusion criteria: * diagnosed with asd by a qualified healthcare professional * meeting the asd criteria by using ados-2 * iq higher than 80. exclusion criteria: * not meeting the asd criteria by using ados-2. * iq lower than 80. * comorbid physical and/or motor disabilities. * comorbid mental disabilities except adhd.
a study of jr-141 in patients with mucopolysaccharidosis type ii

Conditions: Mucopolysaccharidosis II

Summary: the purpose of this study in patients with mucopolysaccharidosis type ii (mps ii) is below, * to collect the safety information of jr-141 * to evaluate the plasma pharmacokinetics of jr-141 * to explore the efficacy of jr-141 on mps ii-related central nervous system symptoms and general symptoms


Eligibility criteria:
inclusion criteria: * patients aged 6 years or older at the time of informed consent. * patients diagnosed with mps ii. * patients who have received idursulfase (0.5 mg/kg/week) continuously for at least 12 weeks until the initial dose of jr-141. exclusion criteria: * patients with a history of hematopoietic stem cell transplantation, excluding those who need enzyme replacement therapy even after hematopoietic stem cell transplantation. * patients in whom lumbar puncture cannot be performed. * patients who have developed serious drug allergy or hypersensitivity that is inappropriate for participation in the study. * patients who have received other investigational products within 4 months before enrollment in the study.
sunburst (success using neuromodulation with burst) study

Conditions: Chronic Pain

Summary: the purpose of the study is to demonstrate the safety and efficacy of the prodigy system for the treatment of chronic intractable pain of the trunk and/or limbs.


Eligibility criteria:
inclusion criteria: * subject is 22 years of age or older * subject has chronic intractable pain of the trunk and/or limbs * subject has a average score of 60 or higher for average daily overall pain on the visual analog scale (vas) 7 day pain diary * subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes * subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation * subject agrees not to add or increase pain-related medication from activation through the 24 week follow-up visit exclusion criteria: * subject is currently participating in a clinical investigation that includes an active treatment arm * subject has been implanted with a previous neurostimulation system or participated in a trial period for a neurostimulation system * subject's overall beck depression inventory ii score is \>24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit * subject has an infusion pump or any implantable neurostimulator device * subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment * subject has an existing medical condition that is likely to require repetitive magnetic resonance imaging (mri) evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor) * subject has an existing medical condition that is likely to require the use of diathermy in the future * subject's pain originates from peripheral vascular disease * subject is immunocompromised * subject has documented history of allergic response to titanium or silicone * subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection * female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test)
prolonged treatment for infected abortion after hospital discharge.

Conditions: Septic Abortion

Summary: patients with infected abortion will be treated with dilatation and curettage, intravenous antibiotics. the purpose of this study is to verify if it is necessary to keep the use of oral antibiotics after hospital discharge.

the use of 7-10 days of treatment for infected/septic abortion is not based on clinical trials. a recent evidence showed that endometritis post cesarean section needs no treatment after hospital discharge. the objective of this study is to verify if this finding also applies to infected abortions. after in hospital treatment, the patients will be randomized to the traditional treatment (metronidazole and doxycycline) or to placebo until 10 days of treatment is completed. active follow-up will be done every 2 days, and the patient will be reevaluated at the end of treatment. cure will be defined as the absence of fever, pain and bleeding. failure of treatment will be considered as the need for hospitalization or additional antibiotics.

Eligibility criteria:
inclusion criteria: * history of intrauterine manipulation with contaminated objects. * vaginal secretion with fetid odor * presence of pus flowing through the cervical uterine * presence of peritonitis * leucocytosis (\> 14,000 leucocytes/ml) * vasodilatation, bounding pulse and paradoxically warm periphery with tachycardia (heart rate\> 110 bpm) * cyanosis and/or paleness * tachypnea(\> 30mpm) * arterial hypotension (sap\< 90mmhg) * oliguria * fever (\> or = than 37,8°c) exclusion criteria: * refusal to participate in the project * prior use of antibiotics within one week * known allergy to doxycycline or metronidazole * presence of tubo-ovarian abscess

Keywords: abortion infection antibiotics treatment pregnancy complications
safety and efficacy of antidiabetic drugs in recently diagnosed patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the current study aims to investigate sitagliptin and vildagliptin efficacy and safety compared to metformin as 1st line options for t2d patients.

this is a randomized case-controlled study in which drug-naive type-2 diabetic patients were divided into 3 groups and followed up for three months.

Eligibility criteria:
inclusion criteria: * recently diagnosed type2 diabetic adult subjects who were not on an oral hypoglycemic drug (oha) at the screening visit were eligible to participate. exclusion criteria: 1. type1 diabetes or ketoacidosis 2. end-organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female) 3. liver cell failure (elevated alanine transaminase (alt ) and/or aspartate transaminase (ast) ≥ 2 folds) 4. any stage of heart failure 5. previous history of pancreatitis 6. previous history of taking medication which may alter the efficacy of either drug eg: (other oha drug, corticosteroids, and oral contraceptives) 7. pregnant or lactating females