Kornimate/medical-research-clean huggingface dataset:
evaluate immunogenicity, safety, and reactogenicity of rotavac® in healthy infants aged between 6-8 weeks in vietnam

Conditions: Rotavirus Infections

Summary: an open label study to evaluate immunogenicity, safety, and reactogenicity of rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in vietnam.


Eligibility criteria:
inclusion criteria: * healthy infants as established by medical history and clinical examination before entering the study. * age: 6-8 weeks * weight ≥ 2.5kg at birth. * infants received epi vaccines at birth (i.e., opv, bcg and/or hep b) * parental ability and willingness to provide informed consent. * parent who intends to remain in the area with the participant during the study period. exclusion criteria: * presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion). * presence of fever (temperature ≥37.5oc) or hypothermia (temperature ≤35.5oc) on the day of enrollment (temporary exclusion). * concurrent participation in another clinical trial. * presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the infant's health or is likely to result in non-conformance to the protocol. * history of congenital abdominal disorders, intussusception, abdominal surgery * known or suspected impairment of immunological function based on medical history and physical examination. * prior receipt of rotavirus vaccine. * a known sensitivity or allergy to any components of the study medication. * major congenital or genetic defect. * participant's parents not able, available or willing to accept active follow-up by the study staff. * has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period. * history of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. infants on inhaled or topical steroids may be permitted to participate in the study. * history of any neurologic disorders or seizures. * any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.

Keywords: rotavirus rotavac vaccine vietnam
mapping the phenotype in adults with phelan-mcdermid syndrome

Conditions: Phelan-McDermid Syndrome; Autism Spectrum Disorder; Intellectual Disability

Summary: the protocol aims to comprehensively define the phenotype of phelan-mcdermid syndrome and to identify potential genetic factors, which may play a role in the variability of the disease's outcomes. the first aim involves a physical exam, a neurological exam, collection of medical history information, a clinical genetic evaluation, blood work and neuropsychological assessments. if clinically indicated, the protocol collects information from medical tests. these medical tests may include electrocardiography, echocardiography, renal ultrasonography, and renal ultrasound.

phelan-mcdermid syndrome (pms) or 22q13 deletion syndrome, caused by a loss of one copy of the shank3 gene, is characterized by global developmental delay/intellectual disability, motor skills deficits, delayed or absent speech, and autism spectrum disorder. the goal of this study is to understand more about the pms phenotypic outcomes and the biological pathways associated in the disorder, and to establish the foundation for future clinical trials in pms and in other id/asd-associated disorders that share signaling pathways with pms. individuals with pms will be asked to participate in this study if they are 22 years of age or older with pathogenic deletions or mutations of the shank3 gene at time of enrollment. both males and females will be asked to participate. additionally, to be eligible for study participation, individuals' primary communicative language must be english. parents and unaffected siblings may also be asked to consent to have blood drawn for analysis. for this study, there is only one study visit. study visit involves a physical exam, medical history questions, blood work and neuropsychological assessments. individuals who have certain clinically indicated procedures (i.e. mri, eeg, etc.) due will have them done as part of the research study

Eligibility criteria:
inclusion criteria: * participant is 22 years of age and older at the time of enrollment * participant has been diagnosed with pathogenic deletions or mutations of the shank3 gene * participant is proficient in english * participant provided consent exclusion criteria: * none

Keywords: phelan-mcdermid syndrome pms genotype phenotype mapping 22q13 deletion syndrome shank3 autism spectrum disorder asd intellectual disability id
a study to see how well and how safely different treatments work in a group of participants with non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: the objective of this study is to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable nsclc. cohort b1 is a phase ii cohort that will evaluate the safety, and efficacy of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection. cohort b2 is a phase ii cohort that will evaluate the efficacy and safety of perioperative alectinib in combination with chemotherapy in the neoadjuvant setting.


Eligibility criteria:
inclusion criteria cohort b1: * complete resection of the primary nsclc with negative margins * confirmed stage ii to select stage iiib (t3n2) nsclc of non-squamous (adenocarcinoma) histology * eastern cooperative oncology group (ecog) performance status of 0 or 1 inclusion criteria cohort b2: * evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent * pathologically and/or histologically confirmed stage ii-iiia and iiib (t3n2 only) nsclc of non-squamous (adenocarcinoma) histology inclusion criteria cohorts b1 and b2: * documented alk fusion exclusion criteria cohort b1: * nsclc of squamous or mixed histology regardless of the presence of an alk mutation * prior exposure to any systemic anti-cancer therapy exclusion criteria cohort b2: * nsclc of squamous or mixed histology regardless of the presence of an alk mutation * known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin * prior exposure to any systemic anti-cancer therapy exclusion criteria cohorts b1 and b2: * pregnancy or breastfeeding, or intention of becoming pregnant during the study
patients who underwent thyroid ultrasonography at our institution were selected for shear wave elastography of thyroid nodules, and the maximum and mean values of the modulus of elasticity of the nodules in transverse and longitudinal sections were analyzed.

Conditions: Thyroid Nodules

Summary: the objective of this observational study was to evaluate the effect of transverse and longitudinal sections on the measurement of thyroid nodule stiffness by shear wave elastography. the main questions it aims to answer are: (i) to compare the diagnostic efficacy of different section orientations of shear wave elastography for the diagnosis of benign and malignant thyroid nodules; (ii) to analyze the correlation between the two orientations of transverse and longitudinal sections of shear wave elastography; and (iii) to compare the reliability and consistency of the two orientations of transverse and longitudinal sections of shear wave elastography for the diagnosis of thyroid nodules. participants will undergo routine ultrasound examination of the thyroid gland and shear wave elastography, and the measured modulus of elasticity of the nodules in both transverse and longitudinal sections will be recorded.


Eligibility criteria:
inclusion criteria: all patients underwent preoperative shear-wave elastography ultrasonography; thyroid nodules ranged from 3 to 20 mm in size; all nodules underwent puncture biopsy or surgery to obtain pathologic results. exclusion criteria: unavailability of pathology results for various reasons; poor quality of ultrasound images; missing data.
performance and safety of the lipo-transfer cannulas in patients underlying lipofilling treatment

Conditions: Lipodystrophy; Deformities

Summary: the purpose of this post-market clinical follow up study is to assess the safety and performance of aesthetic group cannulas. the study will evaluate the outcome of the aesthetic group cannulas range over a period of 1 month after intervention.


Eligibility criteria:
inclusion criteria: * patient age ≥ 18 years at intervention * patient who will undergo a lipofilling treatment with at least one cannula of aesthetic group * patient informed of his/her participation and willing to participate in the study. * patient able to read, write and understand french. exclusion criteria: * patient deprived of freedom, under guardianship/curatorship or placed under judicial protection * patient unable to follow study procedures * patient with hematologic abnormalities, prior radiotherapy or chemotherapy * chronic use of medicines or drugs * patient with diabetes mellitus * patient with connective tissue diseases, any type of fat tissue disorder (lipodystrophy) * patient with bleeding disorders; immune deficits; heart, liver, and kidney insufficiency * patient with allergies to local anaesthetics * patient with pacemaker and serious heart rhythm disorders * pregnant and breastfeeding women

Keywords: lipofilling liposuction fat injection repair and aesthetic surgery aesthetic body contouring
active release technique and graston technique in patients with lateral epicondylitis

Conditions: Lateral Epicondylitis

Summary: this study will be a randomized control trial and will be conducted in pakistan railway hospital rawalpindi. a sample of 36 participants will be taken. patients will be divided into two groups by sealed envelop method. patients in group a will receive active release technique along with conventional therapy while patients in group b will receive instrument assisted soft tissue mobilization along with conventional therapy. the study includes intervention protocol of 4 weeks. the sessions will be given 3 times a week for 4 weeks. the outcome measures numeric pain rating scale(nprs), hand dynamometer and patient-rated tennis elbow evaluation (prtee) will be measured at baseline and at the end of 4th week. data will be analyzed by spss 25

lateral epicondylitis is an injury caused by overusing the elbow. it is characterized by tenderness and pain over the lateral epicondyle of the elbow. it is not exactly a condition involving inflammation rather a chronic degeneration of the tendon. the major symptom of lateral epicondylitis is presentation or complaint of sharp pain at the lateral side of the elbow with swelling

Eligibility criteria:
inclusion criteria: * chronic lateral epicondylitis, complaints for at least 3 months or more * pain intensity level between 3 to 6 on 0-10 point numerical pain rating scale exclusion criteria: * acute/ sub-acute lateral epicondylitis * any cervical spine or any other upper limb dysfunction * any other neurological disease, cardiovascular disease, osteoporosis * bilateral complaints

Keywords: lateral epicondylitis graston technique active release technique grip strength
personalized medicine for membranous nephropathy

Conditions: Idiopathic Membranous Nephropathy

Summary: randomized, open label, multicentre (20 sites), prospective trial comparing the efficacy of two therapeutic strategies to obtain clinical remission 1 year after diagnosis of idiopathic membranous nephropathy with nephrotic syndrome and anti-pla2r1 (phospholipase a2 receptor 1) antibodies: * gemritux protocol: 6 months of symptomatic antihypertensive and antiproteinuric therapy, and if the nephrotic syndrome persists at month-6 (urinary protein/creatinine ratio (upcr) remains \> 3.5 g/g and albuminemia \< 30 g/l), two 375 mg/m2 rituximab infusions at 1-week interval. * personalized treatment: * restricted anti-cysr activity at inclusion : 6-month symptomatic antihypertensive and antiproteinuric treatment (kdigo) * restricted anti-cysr activity after 6 months of symptomatic treatment with persisting nephrotic syndrome (upcr remains \> 3.5 g/g and albuminemia \< 30 g/l): two 375 mg/m2 rituximab infusions at 1-week interval; * anti-ctld (c-type lectin domains ) 1/7 activity at inclusion or after 6 months with persisting nephrotic syndrome (upcr remains \> 3.5 g/g and albuminemia \< 30 g/l): two 1g rituximab infusions at 2-week interval at month 0 and/or month 6.


Eligibility criteria:
inclusion criteria: * age 18 years or more * anti-pla2r1 activity detected by elisa or euroimmune immunofluorescence assay * nephrotic syndrome defined by proteinuria \> 3.5 g/24h (or upcr \> 3.5 g/g) and serum albumin \< 30 g/l at diagnosis * egfr (ckd-epi) \> 30 ml/min/1,73 m2 at diagnosis * symptomatic treatment according to kdigo guidelines: maximal tolerated dose of niat : non immunosuppressive antiproteinuric treatment (angiotensin-converting enzyme inhibitor and/or angiotensin 2 receptor blockers, diuretics and statins) * medical insurance * signed informed consent * having understood and accepted the need for long-term medical follow-up * woman of child-bearing age must be using an effective method of contraception exclusion criteria: * secondary membranous nephropathy: membranous nephropathy related to cancer, infectious, systemic lupus erythematosis, drug * anti-pla2r1 antibodies not confirmed by central analysis (in this case the patient will be replaced) * pregnancy or breastfeeding * immunosuppressive treatment in the 3 last months * cancer under treatment * patient with complicated nephrotic syndrome that would require early immunosuppressive treatment (thrombosis, acute renal failure...) * patients with active, severe infections or active hepatitis b * hypersensitivity to the active substance or to murine proteins, or to any of the other excipients * patients in a severely immunocompromised state * severe heart failure (new york heart association class iv) or severe, uncontrolled cardiac disease * patients unable to give an informed consent

Keywords: nephrotic syndrome pla2r1-antibodies epitope spreading rituximab
an open label study of cm-at for the treatment of children with autism

Conditions: Autism

Summary: this is a phase iii, open label extension study evaluating the continued safety and efficacy of cm-at in pediatric patients with autism with all levels of fecal chymotrypsin.

autism is clearly a significant cause of disability in the pediatric population. treatment is based on the observation that many children with autism do not digest protein. cm-at is a proprietary enzyme that is designed as a granulated powder taken three times daily.

Eligibility criteria:
inclusion criteria: * age between 3 and 8 years, inclusive, at the time of signing informed consent/assent in sponsor 00103 study * completion of the sponsor's 00103 study who continue to meet eligibility requirements * currently in the 00102 open label study and continue to meet eligibility requirements * subjects who initially qualified for 00103 screening, who subsequently failed baseline entrance criteria for randomization (@visit 1) baseline assessment of the abc eligibility requirement who continue to meet eligibility requirements * up to 20 subjects 9-17 years of age who directly enroll into this study, who meet the current diagnostic and statistical manual for mental disorders (dsm-iv-tr) diagnostic criteria for autistic disorder (ad), screened by the scq and confirmed by the adi-r exclusion criteria: * patient weighing \< 13kg * allergy to porcine products * previous sensitization or allergy to trypsin, pancreatin, or pancrelipase * history of severe head trauma, as defined by loss of consciousness or hospitalization, skull fracture or stroke. * seizure within the last year prior to enrollment, or the need for seizure medications either at present or in the past. * evidence or history of severe, moderate or uncontrolled systemic disease * ongoing dietary restriction for allergy or other reasons except nut allergies. lactose free is allowable but not dairy free. * inability to ingest the study drug / non-compliance with dosing schedule. * inability to follow the prescribed dosing schedule. * use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (adhd) must be discontinued 5 days prior to the initial randomized study period. * subjects taking an selective serotonin reuptake inhibitor (ssri) must be on a stable dose for a minimum of 30 days prior to entering the study. * history of premature birth \<35 weeks gestation. * prior history of stroke in utero or other in utero insult.

Keywords: autism a long-term extension study in a pediatric population of children with autism.
effects of eca on quality of life in head and neck cancer patients suffering from cetuximab-induced rhagades

Conditions: Pain

Summary: the support trial is an open-label, prospective, randomized, national multicenter intervention study to evaluate the effectiveness of ethyl-2-cyanoacrylate versus the standard treatment of each institution on the pain intensity and qol in patients with locally advanced head and neck cancer suffering from painful cetuximab-induced rhagades during radioimmunotherapy.


Eligibility criteria:
inclusion criteria: * locally advanced squamous cell carcinoma of the head and neck and participation in the hicare-phase-iv-trial * cetuximab-induced painful rhagades, i.e. supo score 2-3 (see figure 2) * compliance to the photo documentation * ability of subject to understand character and individual consequences of the clinical trial * written informed consent exclusion criteria: * cetuximab-induced rhagades without any pain, i.e. supo score 1 * cetuximab-induced rhagades, supo score 4, i.e. superinfection of the rhagades * patients not being enrolled in the hicare trial * substance misuse, psychoactive substance abuse or psychological/social conditions leading to a decreased patients' compliance with possible bad influence to the results of the study * known allergic reaction to ethyl-2-cyanoacrylate (eca)

Keywords: painful cetuximab-induced rhagades radioimmunotherapy head and neck cancer
effects of food and dose regimen on the antiviral effects of maraviroc (uk-427,857) in patients with human immunodeficiency virus

Conditions: HIV

Summary: to investigate the effects of food and dose regimen on the antiviral effects of maraviroc (uk-427,857) in patients with human immunodeficiency virus (hiv)


Eligibility criteria:
inclusion criteria: * asymptomatic hiv-1 infected male and female patients * weight between 50 and 100kg and within the permitted range for their height * patients with virus that targets ccr5 receptor exclusion criteria: * patients with a cd4 count \<250 cells/mm3 or hiv viral load \<5000 copies/ml * patients whose hiv infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion * patients with acquired immunodeficiency syndrome (aids) or a previous aids diagnosis * patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit

Keywords: hiv infections treatment naïve
neural correlates in mild alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the objective of this study was to identify neural correlates of cognitive improvement after 3 months of donepezil hydrochloride treatment using either or both of two functional magnetic resonance imaging (fmri) measures - the functional hippocampus connectivity index (hci) and cerebral blood flow (cbf) perfusion; in the medial temporal lobe (mtl) network in subjects in the early stage of alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: * men and women, aged 50 and older with mild alzheimer's disease (mmse scores of 20 to 30 are allowed). * diagnostic evidence of alzheimer's disease. * previous use of cholinesterase inhibitors (other than aricept) and memantine allowed. exclusion criteria: * prior use of aricept, pacemakers and insulin dependent diabetes are not allowed.

Keywords: functional magnetic resonance imaging examination alzheimer's disease donepezil hydrochloride aricept
a pilot study to develop a behavior-based screening protocol for early diagnosis of autism spectrum disorders

Conditions: ASD

Summary: this study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (asd) in children and adolescents through eye tracking and motion analysis.

this study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (asd) in children and adolescents through eye tracking and motion analysis.

Eligibility criteria:
inclusion criteria: * children and adolescents under the age of 19 at the time of registration * a person whose legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after receiving a detailed explanation of this study and fully understanding it exclusion criteria: * those with abnormalities in hearing and vision * those who are likely to have difficulty participating in the study according to the judgment of the clinical investigator * if the visits set out in this research plan are not followed or the patient's guardian does not cooperate due to low understanding of the patient.
safety and efficacy of usb002 for respiratory distress due to covid-19

Conditions: 2019 Novel Coronavirus Infection; COVID-19 Virus Infection; SARS Coronavirus 2 Infection; SARS-CoV-2 Infection; Respiratory Distress Syndrome, Adult; Adult Respiratory Distress Syndrome

Summary: this trial will study the use of usb002 given as an intravenous infusion in patients with respiratory distress due to infection with covid-19.


Eligibility criteria:
inclusion criteria: 1. signed informed consent from patient or legal representative; 2. age 18 or greater; 3. positive reverse transcription polymerase chain reaction (rt-pcr) for sars-cov-2 (≤10 days); 4. respiratory rate \> 20 rr; 5. spo2 \< 94% on room air, requiring supplemental oxygen, requiring invasive mechanical ventilation, or requiring ecmo; 6. chest x-ray confirming bilateral pulmonary infiltrates; 7. body mass index of ≤ 40 units/kg/m2; 8. adequate method of birth control. exclusion criteria: 1. terminally ill patients due to underlying cardiac, cancer or severe debilitating neurological disease including coma; 2. hospitalization expected to be \< 96 hours due to medical improvement; 3. interstitial lung disease; 4. correction of qtc values obtained by 12 lead ekg using fredericia's formula (qtcf) \> 450 ms; 5. history of hypotension (mean arterial blood pressure \< 65 mmhg), unrelated to covid-19 infection; 6. alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 3 times upper limit of normal; 7. participating concurrently on another clinical trial for the experimental treatment of covid-19; 8. active chemotherapy use; 9. pregnant and/or lactating women.