Kornimate/medical-research-clean huggingface dataset:
long term follow up study of long-acting hgh (mod-4023) in growth hormone deficient children

Conditions: Growth Hormone Deficiency (GHD)

Summary: protocol cp-4-004-ole (open label extension) is designed as a long-term, open-label extension using single patient use, multi-dose, disposable pre-filled pen.


Eligibility criteria:
inclusion criteria: patients who completed the first year of treatment in the main study are allowed to enter the (long term) open label extension (ole) study. exclusion criteria: 1. children with past or present intracranial tumor growth as confirmed by an mri scan (with contrast). 2. history of radiation therapy or chemotherapy. 3. malnourished children defined as: 1. serum albumin below the lower limit of normal (lln) according to the reference ranges of central laboratory; 2. serum iron below the lower limit of normal (lln) according to the reference ranges of central laboratory; 3. bmi \< -2 standard deviation for age and sex; 4. children with psychosocial dwarfism. 5. children born small for gestational age (sga - birth weight and/or birth length \< -2 sd for gestational age). 6. presence of anti-hgh antibodies at screening. 7. any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to, chronic diseases like renal insufficiency, spinal cord irradiation, etc. 8. patients with diabetes mellitus. 9. patients with impaired fasting sugar (based on who; fasting blood sugar \>110 mg/dl or 6.1 mmol/l) after repeated blood analysis. 10. chromosomal abnormalities and medical "syndromes" (turner's syndrome, laron syndrome, noonan syndrome, prader-willi syndrome, russell-silver syndrome, short stature homeobox-containing gene (shox) mutations/deletions and skeletal dysplasias), with the exception of septo-optic dysplasia. 11. closed epiphyses. 12. concomitant administration of other treatments that may have an effect on growth such as anabolic steroids and methylphenidate for attention deficit hyperactivity disorder (adhd), with the exception of hormone replacement therapies (thyroxine, hydrocortisone, desmopressin (ddavp)) 13. children requiring glucocorticoid therapy (e.g. asthma) who are taking a dose of greater than 400 µg/d of inhaled budesonide or equivalents for longer than 1 month during a calendar year. 14. major medical conditions and/or presence of contraindication to r-hgh treatment. 15. known or suspected hiv-positive patient, or patient with advanced diseases such as aids or tuberculosis. 16. drug, substance, or alcohol abuse. 17. known hypersensitivity to the components of study medication. 18. other causes of short stature such as coeliac disease, hypothyroidism and rickets. 19. the patient and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct. 20. participation in any other trial of an investigational agent within 30 days prior to screening.

Keywords: growth hormone deficiency (ghd) r-hgh long-acting
constipation and gut transit in dmd patients

Conditions: Constipation; DMD

Summary: in this research study the investigators want to screen duchenne muscular dystrophy (dmd) patients for signs and symptoms of constipation in patients over 18. the investigators hypothesized: * dmd patients have a high prevalence of constipation than in the general population. * prevalence of constipation will increase with age and with worsening functional status.

the following procedures will take place during the study. constipation assessment: * the patient will be asked to complete a questionnaire about any symptoms of constipation. * a physician from the study team will perform an abdominal physical exam * the patient will have routine x-rays that monitor for spine compression fractures. these films will also be used to assess stool content. clinical information the following information will also be collected during the clinic visit ; * age at diagnosis and genetic mutation * age at loss of ambulation if applicable * medications * functional status

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of duchenne muscular dystrophy (based on clinical presentation and verified by compatible muscle biopsy or known dystrophin gene mutation). * age greater than or equal to 18 years old exclusion criteria: * none
acp-104 in acutely psychotic subjects with schizophrenia

Conditions: Schizophrenia

Summary: this is a randomized, double-blind, placebo-controlled parallel-group, 6-week study, evaluating two dose levels of acp-104 or placebo twice a day in patients with schizophrenia who are experiencing an acute psychotic episode.


Eligibility criteria:
inclusion criteria: * male or female; 18-60 years of age * the subject is physically healthy and medically stable. * the subject is able to provide informed consent * the subject has been diagnosed with schizophrenia for at least 1 year * currently experiencing an acute episode of psychosis * the subject is willing to comply with all study-related events including in-patient hospitalization for at least 3 weeks. * the subject has a caregiver who is willing and able to support the subject to ensure compliance with treatment and outpatient visits. * if the subject is female, subject must be of non-childbearing potential - or- if she is capable of becoming pregnant, agrees to commit to use one of the approved methods of contraception, as defined by the protocol. exclusion criteria: * if the subject is a pregnant or lactating (breast-feeding) female. * the subject has a significant risk of suicide, homicide, and/or harm to self or others. * subject's psychotic symptoms have not improved with a therapeutic dose of antipsychotic treatment over the last 2 years. * the subject is experiencing his/her first episode of schizophrenia. * the subject has another psychotic disorder or has a history of autistic disorder or other pervasive developmental disorder (for example, mental retardation). * the subject has been prescribed or exposed to clozapine before. * the subject has donated blood or plasma within 56 days prior to the screening visit. * the subject has participated in any clinical study within 30 days prior to the screening visit. in addition to the criteria described above, subjects will be evaluated at screening to ensure that all criteria for study participation are met. these evaluations will include specific measures of the subject's health, including psychosis (mental health -the extent to which subject is unable to think clearly), heart condition, and pregnancy status. patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline condition does not meet all protocol-specified entry criteria).

Keywords: schizophrenia, psychotic disorders
evaluation of intra-operative neuro-monitoring alarm during complex spine surgery

Conditions: Spine Injuries and Disorders

Summary: iatrogenic spinal cord injury is the most feared complication of complex spine surgery. the incidence of neurological complications for spinal deformity surgery has been estimated by the scoliosis research society as 1%, except when a combined approach is used, where the rate increases to 1.87% \[1\]. intraoperative neuromonitoring (ionm) techniques are usually implemented during spine surgery to avoid nefarious abuse of the nervous system, which can cause postoperative problem \[2\]. in 1992 a scoliosis research society study concluded that the use of intraoperative spinal cord neurophysiological monitoring during operative procedures including instrumentation should be considered ''a viable alternative as well as an adjunct to the use of the wake-up test during spinal surgery'' \[5\]. the benefit of using neuromonitoring has been validated by numerous studies involving scoliosis correction, revision surgeries and vertebral osteotomies.

the trend in ionm usage in the current literature, which may be a direct consequence of improved efficacy of the procedure, and the development of optimized treatment algorithm \[6\]. nevertheless, it is well known that the use of somatosensory evoked potentials (seps) alone may be ineffective in detecting a motor tract deficit \[7, 8\]. as a result, various methods for monitoring the motor tract of the spinal cord have been developed. the most commonly used stimulation technique is transcranial electric stimulation (tes) of the primary motor cortex by corkscrew electrodes placed in the scalp, to produce myogenic motor evoked potential\[9\]. the combination of seps and tes-meps provides global monitoring coverage of spinal cord function \[10\]. based on the available evidence, it is recommended that the use of multimodality neuromonitoring be considered in complex spine surgery where the spinal cord or nerve roots are deemed to be at risk \[11\].

Eligibility criteria:
inclusion criteria: * patient with spine deformities * patient with sever cervical and lumbar degenerative diseases * patient with combined cervical and lumbar diseases * patient with spine tumours exclusion criteria: • cases with mild to moderate degenerative diseases simple spine procedures
maternal acupuncture for substance abuse

Conditions: Substance Addiction

Summary: to determine the efficacy of daily maternal acupuncture treatments in reducing the frequency and severity of neonatal abstinence syndrome among infants born to substance-using women..

potential study subjects will be recruited from the chemical dependency unit by a trial coordinator. after obtaining written informed consent, the coordinator will take a sequentially numbered opaque envelope from a box on the unit. this envelope will contain a card indicating the treatment group to which the woman is allocated. women participating in the treatment group of our study will have access to a quiet room furnished with comfortable reclining chairs. the acupuncturist will swab the ears with alcohol and insert sterile, disposable needles. following the treatment, which is 45-minutes in length, participants will remove the needles themselves and place them in protective sharps boxes. a sham acupuncture procedure will not be used. chinese traditional medicine does not include the concept of a placebo. those who argue that auricular acupuncture stimulates the vagus nerve, which innervates the ear concha state that needles placed anywhere in the concha should produce the same effects. 58 studies utilizing sham procedures have failed to show a difference between the control and active experimental conditions. in this unit, morphine is prescribed for the neonate by pediatricians (11 in total) if there is a constellation of symptoms unresponsive to environmental control including: 1) convulsions, 2) inconsolability or crying continuously for 3 hours, 3) persistent tremors or jitteriness when undisturbed, 4) continuous central nervous system irritability including hyperactive moro reflex, tremors, jitteriness, increased muscle tone and unprovoked muscle jerks, 5) persistent vomiting or projectile vomiting over a 12 hour period; or 6) explosive diarrhea for 2-3 consecutive episodes. additional clinical signs such as tachycardia, tachypnea, watery stools, fever, or weight loss \> 10% may justify use of morphine after consideration of differential diagnoses. morphine 1mg/ml is started at a rate of 0.03 mg/kg/dose every 3 hours. the dose is reviewed daily and titrated based on daily weights and ongoing symptoms.

Eligibility criteria:
inclusion criteria: women admitted to the chemical dependency unit at bc women's hospital, vancouver, b.c. exclusion criteria: * women who neither read nor write english * having a pacemaker or any other electrical implants * bleeding disorder or on anti-coagulants * conditions putting someone at particular risk for infection including damaged heart valves or prior heart valve surgery, history of myocardiopathy, diabetes requiring insulin, history of knee or hip replacements, immunosuppressive drug therapy, open wounds.

Keywords: rct intervention study addiction substance use pregnancy
real-world study of vivity intraocular lenses (iols)

Conditions: Aphakia; Presbyopia

Summary: the primary objective of this clinical study is to assess the clinical performance of the acrysof iq vivity extended vision iol in a chinese population.

in this clinical study, subjects will be implanted with the acrysof iq vivity extended vision iol in both eyes. the second eye surgery will occur 7-28 days after the first eye. a total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. the total expected duration of the subject's participation will be about 13 months. this study will be conducted in china.

Eligibility criteria:
key inclusion criteria: * able to understand and sign an approved informed consent; * willing and able to attend all scheduled study visits as required per protocol; * diagnosed with cataracts in both eyes; * pre-operative regular corneal astigmatism less than 1.0 diopter (d); * planned bilateral cataract removal by phacoemulsification. * other protocol-specified inclusion criteria may apply. key exclusion criteria: * glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve; * clinically significant corneal diseases; * clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion; * previous intraocular surgery history; * pregnancy or lactation during study or planning to be pregnant/lactating; * systemic medications that, in the opinion of the investigator, may confound the outcome or increase the risk to the subject; * other planned ocular surgical procedures; * patients who can only undergo cataract surgery in one eye. * other protocol-specified exclusion criteria may apply.

Keywords: cataract intraocular lens
the efficacy of prp combined with exercise to treat knee osteoarthritisq

Conditions: Platelet-rich Plasma; Physical Exercise; Knee Osteoarthritis

Summary: objective. in this study, the investigators aimed to investigate the efficacy of combined a single platelet-rich plasma (prp) and physical exercise (leg swing and quadriceps strengthening exercise) versus prp and hyaluronic acid (ha) combination therapy. methods. one hundred and six patients with grade ⅱ-ⅲ knee osteoarthritis (koa) according to the kellgren-lawrence classification were randomly divided into intra-articular injection of prp combined with leg swing and quadriceps strengthening exercise (group a) and intra-articular combination injections of prp and ha (group b). patients in group a received twice intra-articular injection of prp (2 ml, 2 weeks apart) and regular leg swing and quadriceps strengthening exercise for 3 months. patients in group b received twice intra-articular combination injections of prp (2 ml) and ha (2 ml) every 2 weeks. the primary outcome measures were visual analogue scale (vas) and western ontario and mcmaster universities (womac) score. the second outcomes included single leg stance test (sls) and functional activity by 2 minutes walking test (2mwt) and time up and go test (tugt). all outcomes were evaluated at baseline and after 1,3,6, and 12 months.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 45 years old; * koa was diagnosed according to the american college of rheumatology classification criteria; * patients with the kellgren-lawrence grade (k-l grade) for koa of ⅰ-ⅲ; * a history of symptoms more than three month, and patients with independent mobility. exclusion criteria: * lower limb axial deviation large than 5° (valgus and varus knee); * patients with diabetes mellitus, sever cardiovascular disease, immunosuppressive status, mental illness or other diseases than might affect the results; * injections or other invasive treatments into the lower extremities were used in the past three months; * patients willing to follow the doctor's recommendation for exercise training; * patients with previous knee fracture or malignancy; * patients with a previous history of hip or knee joint surgery; * patients participating in hip or knee muscle strengthening in the past 3 months; * patients did not complete the intervention strategies or regular follow-up.
study of durvalumab + tremelimumab with chemotherapy or durvalumab with chemotherapy or chemotherapy alone for patients with lung cancer (poseidon).

Conditions: Non Small Cell Lung Cancer NSCLC

Summary: this is a randomized, open-label, multi-center, global, phase iii study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + standard of care (soc) chemotherapy or durvalumab monotherapy + soc chemotherapy versus soc chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (nsclc) with tumors that lack activating epidermal growth factor receptor (egfr) mutations and anaplastic lymphoma kinase (alk) fusions.

adult patients with a histologically or cytologically documented metastatic nsclc, with tumors that lack activating egfr mutations and alk fusions, are eligible for enrollment. patients will be randomized in a 1:1:1 ratio to receive treatment with durvalumab + tremelimumab combination therapy + soc chemotherapy, durvalumab monotherapy + soc chemotherapy, or soc chemotherapy alone. tumor evaluation scans will be performed until objective disease progression as efficacy assessment. all patients will be followed for survival until the end of the study. an independent data monitoring committee (idmc) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

Eligibility criteria:
inclusion criteria: for inclusion in the study, patients should fulfill the following criteria: 1. aged at least 18 years. 2. histologically or cytologically documented stage iv nsclc. 3. confirmed tumor pd-l1 status prior to randomization. 4. patients must have tumors that lack activating egfr mutations and alk fusions. 5. no prior chemotherapy or any other systemic therapy for metastatic nsclc. 6. world health organization (who)/eastern cooperative oncology group (ecog) performance status of 0 or 1. 7. no prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines. exclusion criteria: patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. mixed small-cell lung cancer and nsclc histology, sarcomatoid variant. 2. active or prior documented autoimmune or inflammatory disorders. 3. brain metastases or spinal cord compression unless the patient's condition is stable and off steroids. 4. active infection including tuberculosis, hepatitis b, hepatitis c, or human immunodeficiency virus.

Keywords: nsclc programmed cell death ligand 1 (pd-l1) durvalumab tremelimumab progression-free survival (pfs) overall survival (os)
online dance versus therapeutic exercise for parkinson disease.

Conditions: Parkinson Disease

Summary: this is a randomized clinical trial in an online format, which will only include people with pd randomly divided into two groups: group 1 - social telerehabilitation with dance and music group 2 - social telerehabilitation with multimodal therapeutic exercise and music


Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic pd according to the clinical criteria of the london brain bank criteria (2006); * age between 40-90 years; * a minimum score of 18 in the montreal cognitive assessment; * drug therapy/exercise stable for at least four weeks before the study starts; * agreement to participate in the study according to the informed consent form. exclusion criteria: * auditory and/or visual disturbances that compromise understanding simple commands; * access to the internet and a device to access online classes; * a house member and/or caregiver at home for supervision during the entire experiment, including evaluations and interventions. for patients scoring less than 2.5 points on the modified hoehn and yahr scale (indicating mild disease impairment, independence in daily living activities, and no risk of falls), the requirement for household member supervision may be waived.

Keywords: parkinson disease dance physiotherapy telehealth telerehabilitation
a study to assess the efficacy and safety of the vegfr-fgfr inhibitor, lucitanib, given to patients with advanced/metastatic lung cancer and fgf, vegf, or pdgf related genetic alterations

Conditions: Non-Small Cell Lung Cancer; Squamous Non-Small Cell Lung Cancer; NSCLC; Small Cell Lung Cancer; SCLC; Lung Cancer; Advanced Lung Cancer; Metastatic Lung Cancer; Stage IV Lung Cancer

Summary: the purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (fgf), vascular endothelial growth factor receptor (vegf), or platelet derived growth factor (pdgf) related genetic alterations.

lucitanib is an oral inhibitor of the tyrosine kinase activity of fgfr 1-3, vegfr 1-3, and pdgfr α/β. lucitanib has demonstrated potent anti-tumor and anti-angiogenic activity in vitro proliferation assays and in vivo using human tumor xenograft models, with a trend for stronger efficacy in those with genomic aberrancies of fgf or pdgf. abnormalities in the fgf, vegf, and pdgf-related genes are observed across lung cancer histologies. the first in human trial of lucitanib demonstrated that daily lucitanib is clinically active in patients with advanced solid tumors. specifically, patients with fgfr1-amplification appeared to derive particular benefit from lucitanib. based on these results, this study is designed to explore the safety and anti-tumor activity of daily lucitanib in lung cancer patients with fgf, vegf, and pdgf genetic alterations.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced/metastatic sclc or nsclc * any of the following tumor tissue based genetic alterations: fgfr1, fgfr2, fgfr3, vegfa, or pdgfrα amplification; any fgfr1, fgfr2, or fgfr3 gene fusion; fgfr1, fgfr2, or fgfr3 activating mutation * availability of tumor tissue sample suitable for the central confirmation of the genetic alteration and exploratory analyses * eastern cooperative oncology group (ecog) of 0 or 1 * measurable disease per recist 1.1 * documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting exclusion criteria: * tumors that are invading a major vessel; nsclc tumors abutting to a major vessel * uncontrolled hypertension, defined as sbp ≥ 140 mmhg and/or dbp ≥ 90 mmhg with optimized anti-hypertensive therapy * uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (tsh) higher than 5 miu/ml while receiving appropriate thyroid hormone therapy * symptomatic and/or untreated central nervous system metastases * presence of another active cancer * ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies * pregnant or breastfeeding women

Keywords: fgfr1 amplification fgf alteration vegf alteration pdgf alteration tyrosine kinase inhibitor vegfr inhibitor fgfr inhibitor pdgfr inhibitor vegfr-fgfr inhibitor