Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of two dose levels of ono-4578 with opdivo®, in combination with mfolfox6 and bevacizumab versus standard of care in participants with non-msi-h/dmmr, pd-l1 positive advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of two dose levels of ono-4578 with opdivo® when added to mfolfox6 and bevacizumab versus soc as first-line treatment for advanced crc.

potential participants will be consented and screened for study eligibility. eligible participants will be randomized in a 1:1:1 ratio to one of the three study intervention arms. study intervention will be administered in 28-day treatment cycles and continued until disease progression, intolerable toxicity, investigator decision or withdrawal of consent by the participant, or termination of the study by the sponsor.

Eligibility criteria:
inclusion criteria: * histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection * ecog performance status of 0-1 * no prior systemic treatment for advanced local or mcrc * participants whose tumor is positive for pd-l1 expression as determined at a central laboratory exclusion criteria: * participants with high microsatellite instability (msi-high), or mismatch repair deficient (dmmr) tumor * participants with braf v600e mutation * unable to swallow tablets. * participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis * participants with an active, known or suspected autoimmune disease. * prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2, or anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways. other protocol-defined inclusion/exclusion criteria apply
genetics of obsessive-compulsive disorder

Conditions: Obsessive Compulsive Disorder

Summary: the purpose of this study is to identify genes that affect susceptibility to obsessive-compulsive disorder (ocd). by identifying genes that increase or decrease the risk of ocd, researchers can better understand how the condition develops and ultimately improve treatment for people with ocd. ocd is a severe, familial condition that affects approximately 2% of the population. the way ocd is inherited is not clearly understood, but researchers believe it is complex and involves multiple genes. this study will detect and localize genes that increase or decrease susceptibility to ocd. the data collected from this study will be combined with data from other research studies to determine gene linkage and association.

obsessive-compulsive disorder (ocd) is a severe, heritable condition with a lifetime prevalence of about two percent of the population. the mode of inheritance is poorly understood but is likely complex, involving multiple loci of small to major effect. since 1995, the nimh-irp has been active in a multi-center family study of ocd, led by dr. gerald nestadt of johns hopkins university, which was approved via a competitive nimh extramural application (mh 502140). an expanded consortium of sites (including new sites at brown and harvard universities) anticipates adding 300 new affected sib-pair families over the next three years. this sample will be used for linkage and association analyses. data will be shared within this consortium of investigators studying ocd, and will eventually be combined with data obtained from a second consortium.

Eligibility criteria:
* inclusion criteria: must have a diagnosis of obsessive-compulsive disorder, or be a family member (usually a parent or sibling) of someone with obsessive-compulsive disorder. certain disorders are considered part of ocd "spectrum" disorders and often include family members with ocd. these include tourette's syndrome, other individuals with tics, and trichotillomania (severe hair pulling), and other forms of repetitive behaviors. persons with primary behavioral difficulties who do not fit with the current definitions of "ocd and ocd spectrum disorders" may not be eligible. these include compulsive shopping, gambling, or compulsive sexual behaviors.

Keywords: genetic psychiatric disorder affected sib pairs obsessions compulsions family study ocd spectrum disorders trichotillomania tourette's syndrome
energetics and glutamate in schizophrenia

Conditions: Schizophrenia

Summary: the goal of this case-control study is to compare brain glutamate, glucose utilisation, lactate production and brain activity in healthy volunteers and people with a diagnosis of schizophrenia. it investigates the following main questions: whether, compared to healthy volunteers, participants with schizophrenia show: 1. reduction in brain glucose utilisation 2. increased brain lactate 3. greater variability in brain glutamate participants will be asked to have a screening visit, a mri brain scan and a pet-mri brain scan.


Eligibility criteria:
inclusion criteria: healthy volunteer group: 1. no history of psychiatric illness, as assessed on the mini neuropsychiatric interview (mini). treatment responsive schizophrenia group: 1. meeting icd-11 criteria for schizophrenia (f20) 2. meeting symptomatic consensus criteria for remission, defined as scores of mild or less on items p1, p2, p3, n1, n4, n6, g5 and g9 of the panss and no history of symptomatic relapse in the past 6 months. 3. currently receiving one or more of the following antipsychotic medications: olanzapine; risperidone; quetiapine; amisulpride; aripiprazole; paliperidone. 4. antipsychotic adherent, defined as having a score of \>=moderate adherence on the kemp scale. treatment-resistant schizophrenia group: 1. meeting icd-11 criteria for schizophrenia (f20) 2. meeting modified consensus criteria for treatment resistance, including history of at least two antipsychotic treatment trials each lasting ≥6 weeks at a dose of ≥400mg chlorpromazine equivalents. 3. total panss total score \> 70 4. moderate functional impairment (\<60 on the sofas) 5. currently receiving one or more of the following antipsychotic medications: clozapine; olanzapine; risperidone; quetiapine; amisulpride; aripiprazole; paliperidone. 6. antipsychotic adherent, defined as having a score of \>=moderate adherence on the kemp scale. exclusion criteria: all participants: 1. pregnancy or breastfeeding 2. lacking in mental capacity to provide informed consent to study participation. 2. diabetes or history of taking an antidiabetic medication 3. presence of contraindication to mri at 7 tesla, including metallic or electronic implants and dental wires. 4. severe claustrophobia prohibiting participation on pet or mri 5. body size above the comfortable limits for the mri scanner. 6. previous participation in research or clinical procedure/s involving ionising radiation, which, including the current study, would result in total radiation exposure \>=10msv within 12 months 7. history of head injury resulting in loss of consciousness for \> 5 minutes 8. meeting icd-11 criteria for organic mental disorder (f00-f09) 9. meeting icd-11 criteria for mental and behavioural disorders due to psychoactive substance use (f10-f19) 10. with exclusion of nicotine or cannabis, meeting icd-11 criteria for psychoactive substance dependence 11. participation in clinical trial investigating any pharmacological agent other than a licensed antipsychotic compound in the last month.
buffered local anesthetic

Conditions: Dental Pain

Summary: the purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). two types of local anesthetic will be used--one will be buffered (by adding a salt solution to make it less acidic), while the other will be plain, without anything added. previous studies have shown that the addition of the buffer solution can improve comfort during a dental injection.


Eligibility criteria:
inclusion criteria: * healthy children or children with mild controlled systemic illness * treatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administration exclusion criteria: * children present with any illness or symptoms that can alter pain perception such as pain in head and neck area due to tmj disorders, arthritis, autoimmune diseases * antibiotic premedication requirement * history of taking medications (nsaids, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessment * has signs of dental pain, odontogenic abscess or facial cellulitis * allergy to local anesthetics or sulfites

Keywords: dental surgery deep sedation
local anesthesia before arterial puncture for blood gas analysis

Conditions: Indication of Blood Gas Analysis by Radial Artery Blood Sampling

Summary: the aim of the study is to evaluate the interest of local anesthesia (lidocaïne/prilocaïne versus placebo)before arterial puncture for blood gas analysis. the pain is measured with a numeric pain intensity for all patients included.

in an approach of continuous improvement of the quality of the care, this project joins logically after a reflection on the treatment of pain generated by the care in the department of pneumology 1 / septic thoracic and vascular cardiac surgery. the arterial puncture for blood gas analysis is an act with aim diagnosis which allows to study gases of the arterial blood to watch the hematosis of the patient. this act appears at the top of the anticipated care as painful by the nursing teams. in the literature, we find no study carried out with the eutectic mixture lidocaïne prilocaïne. other local anesthetics and other local ways of administration were estimated and the results diverge as for the efficiency of a local anesthetic for the arterial blood sample at the level radial nerve. finally authors showed a correlation between certain factors(mailmen) and the painful character of the arterial blood sample, without defining really of population. in this context, it is necessary to estimate the interest of a local anesthetic before arterial sampling of blood by a study randomized in insu double and versus placebo.

Eligibility criteria:
inclusion criteria: * patients aged more than 18 years old, having signed an enlightened consent, who have an indication of gazometry by taking radial nerve * patients capable of estimating the pain felt with numeric pain intensity scale * patients with numeric pain intensity scale = 0 before sample of blood * patients with no contraindication or no allergy of an anesthetic such as lidocaine exclusion criteria: * patients aged less than 18 years old * patients incapable of estimating the pain felt with numeric pain intensity scale * patients with numeric pain intensity scale \> 0 before sample of blood * patients for whom the arterial taking is impossible for the level radial nerve * hypersensibility to local anesthetics of the amide-type or other component of lidocaïne/prilocaïne cream * porphyries known * pregnant woman

Keywords: blood gas analysis arterial puncture local anesthesia eutectic mixture lidocaïne/prilocaïne cream (5%) placebo pain intensity scale numerical rating scale
risk of hepatitis b virus reactivation in patients undergoing allografting

Conditions: Hepatitis B Virus; Allograft; Hematological Malignancies

Summary: the purpose of this study is to evaluate the risk of hepatitis b reactivation in patients undergoing allografting.


Eligibility criteria:
inclusion criteria: * all patients undergoing an allograft for hematological malignancies

Keywords: incidence of hepatitis b after allografting risk of hepatitis b reactivation lamivudine prophylaxis
intratissue percutaneous electrolysis vs dry needling in myofascial pain syndrome of shoulder pain

Conditions: Shoulder Pain; Myofascial Pain Syndrome

Summary: this is a parallel-group randomised clinical trial: primary purpose: to analyse the clinical changes produced by two different physiotherapy treatments (intratissue percutaneous electrolysis and dry needling) for myofascial trigger points in the infraspinatus muscle in subjects with non-specific shoulder pain. hypothesis: a physiotherapy treatment including intratissue percutaneous electrolysis therapy present greater benefits in terms of pain reduction and increased mobility and functionality rather than dry needling treatment in subjects with non-specific shoulder pain. the intervention consisted of 3 treatment sessions, different according to the group, once a week. seven evaluation points were performed, two pre-intervention evaluations one week apart and after the second one the first treatment session was performed. the third and fourth assessments were prior to the second and third treatment sessions, one week apart. the fifth, sixth and seventh assessments were conducted one week, one month and two months after the last treatment session in each group.


Eligibility criteria:
inclusion criteria: * both male and female patients suffering from shoulder pain during at least three months before intervention protocol starts. * patients with free passive range of movement and at least 15 degrees active external rotation in the affected shoulder. * patients willing to participate in the study and return for all scheduled follow-up visits. * patient is capable of giving, and has given, written informed consent. exclusion criteria: * patients with a previous medical diagnosis (tendon rupture, bursitis, etc.) or a traumatic history that justifies shoulder pain. * patients with unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias. * patients allergic to metal or those who have needle phobia. * patient that has participated in any other shoulder pain treatment research study within 30 days prior. * patients that had prior shoulder surgery. * patients that are currently being treated with a narcotic or nsaids and/or has used analgesics or nsaids within the 72 hours prior. * patients that has a known bleeding disorder or that are currently being treated with anticoagulant therapy. * pregnant women.

Keywords: intratissue percutaneous electrolysis dry needling myofascial trigger points infraspinatus muscle non-specific shoulder pain
safety and efficacy of two dosages of inhaled tpi asm8 compared to placebo in mild to moderate asthmatic patients

Conditions: Asthma

Summary: this study will evaluate the efficacy, safety and tolerability of two dosages of a new drug tpi asm8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged between 18-65, non-smokers . the study will also look at the nature and quantity of inflammatory white cells in the lung secretions and in the blood, and some additional inflammation markers.

see above

Eligibility criteria:
inclusion criteria: * age 18-65 y. old, non or ex-smokers for \> 6 months * mild to moderate asthmatic in general good health * on either low-dose inhaled corticosteroid or steroid naive * no other asthma medication * regular sputum producer * eos more than 3% at randomization, * fev1 \> 70% exclusion criteria: * respiratory infection within last 4 weeks * any condition that may affect the conduct of the study as per the investigators

Keywords: high eosinophils level in sputum
frailty in patients with cirrhosis: prognostic value of the phase angle in hospitalized patients and effect of multifactorial intervention

Conditions: Cirrhosis of the Liver; Sarcopenia; Frailty Syndrome

Summary: this study evaluate frailty syndrome (fs) as a common syndrome in patients with cirrhosis and it is an independent predictor of hospitalizations, falls and mortality. identifying, treating and preventing fs can improve the prognosis and quality of life of these patients and reduce health costs.

substudy i. the phase angle (pa) determined by electrical bioimpedance is an index of fs with prognostic value in outpatients with cirrhosis, but its usefulness in hospitalized patients has not been studied. objective: to analyze the prognostic value of pa in hospitalized patients with cirrhosis. patients and methods: 100 hospitalized patients with cirrhosis will be consecutively included and pa will be determined by bioimpedance at admission. the correlation between pa and liver function and frailty markers, and the evolution during hospitalization, as well as the incidence of falls, hospitalizations and mortality during follow-up will be analyzed. substudy ii. given the multidimensional nature of the fs, we propose a multifactorial non-pharmacological intervention based on evidence from previous studies that could be implemented in daily clinical practice. objective: to evaluate if a multifactorial intervention can improve the fs and decrease the related events (hospitalizations, falls and mortality) in patients with cirrhosis. patients and methods: 150 outpatients with cirrhosis will be included and evaluated using the liver frailty index. frail and pre-frail patients will be randomized into two groups: one group that will receive a multifactorial intervention, consisting of exercise at home, branched-chain amino acids and multispecies probiotic for one year, and one control group. the evolution of the liver frailty index and other parameters (muscle and cognitive function, bioimpedance, risk of falls, quality of life) and biomarkers (miostatin, immune response, microbiota) of fs, and the incidence of hospitalizations, falls and mortality in both groups will be prospectively analyzed.

Eligibility criteria:
inclusion criteria: * male or female patients * aged \>18 years old, with cirrhosis diagnosed by clinical, analytical and ultrasound criteria or liver biopsy * conscious and oriented in time and space and able to understand and follow the indications of the study. exclusion criteria: * liver cirrhosis with poor prognosis (meld \[model for end stage liver disease\]\> 25) * hepatocellular carcinoma or other active neoplastic disease * expected survival \<6 months * acute and/or chronic hepatic encephalopathy * neurological disorder that hinders the performance of the tests * active alcoholism in the previous 3 months * severe comorbidities * hospitalization in the previous month * contraindications to exercise or probiotic treatment (immunosuppression) * refusal to sign informed consent.

Keywords: falls hospitalizations mortality phase angle body composition
the association between asparaginase enzyme activity levels and toxicities in childhood acute lymphoblastic leukaemia in nophoall 2008

Conditions: Acute Lymphoblastic Leukemia

Summary: evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with acute lymphoblastic leukemia treated in the nopho-all 2008 protocol.

asparaginase treatment in acute lymphoblastic leukemia in children is jeopardized by a huge toxicity burden and the toxicities are often preventing further treatment. the most common asparaginase associated toxicities are hypersensitivity, pancreatitis, thromboembolism and osteonecrosis. in the nopho all2008 protocol asparaginase associated toxicities have been registered since the protocol opened in july 2008. in addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively. this study evaluate the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with all treated in the nopho-all 2008 protocol.

Eligibility criteria:
inclusion criteria: * all, standard or intermediate risk * included in the nopho all2008 protocol (july 2016 - february 2016) * children (1-17,9 years at diagnosis) exclusion criteria: * all: high risk disease, ph-, genetic predisposition, bilinear all * \< 2 samples for asparaginase enzyme activity measurements
effect of toradol on post-operative foot and ankle healing

Conditions: Ankle Fractures; Trauma Injury

Summary: the use of toradol for pain control in surgical orthopedic cases is currently a topic of interest within the field. the proposed study is a prospective randomized study evaluating postoperative pain, opioid requirement, complication/reoperation rates and nonunion rates in patients undergoing surgical treatment for isolated lateral malleolar fibula fractures. patients will be randomized to either the treatment group (toradol) or the control group (non-toradol). both toradol and non-toradol drug regimens are currently prescribed by the foot and ankle team at the rothman institute and this study will serve as a valuable comparison.


Eligibility criteria:
inclusion criteria: * patients over age of 18 undergoing outpatient open reduction and internal fixation (orif) by a fellowship-trained foot and ankle orthopaedic surgeon for isolated lateral malleolar, bimalleolar, or trimalleolar ankle fractures. exclusion criteria: * open fracture * allergies to one or more of the study medications * existing use of narcotics * renal insufficiency as defined by history and preoperative creatinine level * pregnancy * hospital admittance
single patient study to treat relapsing polychondritis with tocilizumab

Conditions: Relapsing Polychondritis

Summary: relapsing polychondritis (rp) is a rare, immune-mediated disease associated with inflammation in cartilaginous structures and other tissues throughout the body. prognosis can be poor, especially in cases where there is acute involvement of the laryngotracheal cartilages leading to airway destruction, which are resistant to treatments such as corticosteroids, immunosuppressive or cytotoxic drugs. the pathogenesis remains unclear although it is thought that autoimmune reactions to antigens present in cartilages, such as type ii collagen and matrilin may evoke symptoms. there are no known clinical or laboratory measures that predict the expression of specific disease manifestations or the overall disease course. two recently published case reports have shown an association with elevated serum il-6 levels and relapsing polychondritis. in these case reports, both patients with refractory relapsing polychondritis were treated with tocilizumab, a humanized monoclonal antibody to the interleukin 6 receptor, and achieved sustained response to the drug. this single patient trial aims to evaluate the response to tocilizumab in an eight year old boy with relapsing polychondritis who has been shown to have elevated serum il-6 levels and who has responded poorly to conventional therapies. the study hypothesis is that tocilizumab will be able to control the disease in this patient.

in this n = 1 study a single known patient with relapsing polychondritis who has failed methotrexate, various anti tnf medications, anti il1 medication and prolongued glucocorticosteroids will be recruited to receive tocilizumab 8 mg /kg q 2 weeks iv. the objective is to assess efficacy of tociliuzmab in combination with stable ongoing therapy. our patient received tocilizumab 8 mg/kg over 1 hour by intravenous infusion every 2 weeks throughout the course of the study. to assess tocilizumab efficacy, the primary objective is the change in physician global assessment on a 100-mm horizontal visual analogue scale (vas) of disease activity. the secondary objectives were the change in parent global assessment of disease activity on a 100 mm vas and the glucocorticoid dose in mg per day. frequency of adverse events was also measured at baseline and after each biweekly tocilizumab infusion.

Eligibility criteria:
inclusion criteria: * refractory relapsing polychondritis * failed glucocorticoid and methotrexate therapy exclusion criteria: * this is an n=1 clinical trial with a known patient, therefore, exclusion criteria are non-applicable.

Keywords: relapsing polychondritis single patient study tocilizumab