Kornimate/medical-research-clean huggingface dataset:
healthy volunteer study comparing tablet and capsule formulations

Conditions: Fibrosis

Summary: single center, randomized, open label, two-part crossover study designed to evaluate the pk, food effect, dose proportionality, safety, and tolerability of bld-2660 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * able to provide written informed consent * agree to no smoking or alcohol or illegal substance 48 hours prior to dosing * normal bmi (18 to ≤ 35 kg/m2) * have a negative urine drug screen/alcohol breath test on admission to clinic * agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 90 days following completion of dosing * females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test on day -1 * be in general good health * clinical laboratory values within normal range exclusion criteria: * recent wound, or presence of an ongoing non-healing skin wound * presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the subject will complete the study per protocol * history or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period * blood donation or significant blood loss within 30 days prior to the first study drug administration * plasma donation within 7 days prior to the first study drug administration * administration of investigational product (ip) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer * females who are pregnant or lactating * surgery within the past 3 months prior to the first study drug administration determined by the pi to be clinically relevant * failure to satisfy the pi of fitness to participate for any other reason * active infection or history of recurrent infections * active malignancy and history of malignancy in the past 2 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia * antibiotic treatment within 3 months * chronic medical condition * any acute illness within 30 days prior other protocol defined inclusion/exclusion criteria could apply.
programmed death-1 (pd-1) antibody combined with chemoradiotherapy in high-risk recurrent nasopharyngeal carcinoma

Conditions: Recurrent Nasopharyngeal Carcinoma

Summary: this is a a prospective, single-arm phase ii clinical trial. the purpose of this study is to evaluate the efficacy and adverse effect of pd-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment; * not suitable for surgery; * newly histologic diagnosis of npc (who ii/iii); * clinical stage rii-iva (ajcc/uicc 8th); * ecog 0-1 point; * prancis score \> 252 points; * no treatment to rnpc, such as radiotherapy, chemotherapy, immunotherapy or biotherapy; * no contraindications to immunotherapy or chemoradiotherapy; * adequate marrow function: wbc count ≥ 3×10e9/l, ne count ≥ 1.5×10e9/l, hgb ≥ 90g/l, plt count ≥ 100×10e9/l; * adequate liver function: alt/ast ≤ 2.5×uln, tbil ≤ 2.0×uln; * adequate renal function: bun/cre ≤ 1.5×uln or endogenous creatinine clearance ≥ 60ml/min (cockcroft-gault formula); * take effective contraceptions during and two months after treatment; * patients must be informed of the investigational nature of this study and give written informed consent. exclusion criteria: * have recurrence with local necrosis; * have ≥g3 late toxicities, except for skin, subcutaneous tissue or mucosa; * unexplained fever \> 38.5 ℃, except for tumor fever; * treated with ≥ 5 days antibiotics one month before enrollment; * have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); * have a known history of human immunodeficiency virus (hiv), active hepatitis b (hbv-dna ≥10e3copiers/ml) or hepatitis c virus (hcv) antibody positive; * have previously treated with pd-1 antibody or other immunotherapy for pd-1/pd-l1 pathway; * have new york heart association (nyha) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; * have known allergy to large molecule protein products or any compound of study therapy; * pregnant or breastfeeding; * prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma; * have received a live vaccine within 30 days of planned start of study therapy has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial; * any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

Keywords: pd-1 antibody intensity-modulated radiation therapy chemotherapy efficacy adverse effects
a study of an investigational mrna-1273.815 covid-19 vaccine in previously vaccinated adults

Conditions: SARS-CoV-2

Summary: to evaluate immune responses of an investigational mrna-1273.815 vaccine against the omicron subvariant strain (xbb.1.5) of severe acute respiratory syndrome coronavirus 2 (sars-cov-2).


Eligibility criteria:
inclusion criteria: * participants of childbearing potential may be enrolled in the study if the participant fulfills all of the following criteria: 1. has a negative pregnancy test on the day of injection prior to vaccine dose being administered (day 1). 2. has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to day 1. 3. has agreed to continue using an effective contraception through 2 weeks following injection. 4. is not currently breastfeeding. exclusion criteria: * has known history of sars-cov-2 infection within 3 months prior to enrollment. * currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization for worsening disease, at the discretion of the investigator. * has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. * reported history of congenital or acquired immunodeficiency (for example, human immunodeficiency virus), immunosuppressive condition, asplenia, or recurrent severe infections disease. * has known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. * receipt of the following: 1. covid-19 vaccine within 3 months prior to enrollment 2. any other licensed vaccine within 28 days before or 2 weeks after the study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. 3. systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. note: inhaled, nasal, and topical steroids are allowed. 4. systemic immunoglobulins or blood products within 3 months prior to screening or plans for receipt during the study. * has donated ≥450 milliliters of blood products within 28 days prior to screening or plans to donate blood products during the study. * has participated in an interventional clinical study within 28 days prior to screening or plans to participate in an interventional clinical trial of an investigational vaccine or drug while participating in this study. note: other inclusion and exclusion criteria may apply.

Keywords: mrna-1273.815 mrna-1273.815 vaccine sars-cov-2 sars-cov-2 vaccine coronavirus messenger rna covid-19 covid-19 vaccine moderna
to evaluate add-on effect of nisha-amalaki tablets along with insulin on glycemic control in type 1 diabetes patients (rctna)

Conditions: Type 1 Diabetes

Summary: type-i diabetes mellitus (t1dm) is an autoimmune condition, in which the pancreas reduces/stops insulin production. patients with t dm have to take insulin injections with every meal and also usually a long-acting preparation. in india, approximately 8.6 lakh people suffer from t1dm, and one in six young patients dies without a diagnosis. significant advancements are being made in the field of t1dm research, including stem cell therapy, islet cell transplantation, and immunotherapies, which hold promise for the future. however, so far, there is no known permanent cure for t1dm. thus, treatment of t1dm aims at maintaining normal blood sugar levels through regular monitoring, insulin therapy, diet, and exercise. dietary constituents play an important role in the management of t1dm. studies have shown that the fruits of phyllanthus emblica linn, colloquially known as indian gooseberry (amla), and/or some of its important constituents (including gallic acid, gallotanin, ellagic acid, and corilagin) possess anti-diabetic actions through their antioxidant and free-radical-scavenging properties. amla has also been reported to prevent or reduce hyperglycemia, cardiac complications, diabetic nephropathy, neuropathy, cataract genesis, and protein wasting. however, clinical trial data with human subjects are limited and preliminary. numerous studies also report that turmeric (curcuma longa) has antioxidant, anti-inflammatory, and anti-diabetic activities and can lower lipid levels. the hypoglycaemic effect of turmeric may be due to increased peripheral glucose utilization, decreased hepatic glucose synthesis, and/or increased insulin secretion. in ayurveda, the combination of turmeric (haridra) and amla (amalaki) is strongly recommended for prameha (diabetes mellitus).


Eligibility criteria:
inclusion criteria: 1. k/c/o type-i dm for more than 1 year 2. age above 10 years, (10-18 years) irrespective of sex, religion, and economic status 3. parents provide consent and children providing assent for the study exclusion criteria: 1. k/c/o type-i dm for more than 1 year 2. age above 10 years, (10-18 years) irrespective of sex, religion, and economic status 3. parents provide consent and children providing assent for the study

Keywords: type-i diabetes mellitus haridra amalaki prameh
study to evaluate biib059 (litifilimab) in cutaneous lupus erythematosus (cle) with or without systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus; Active Cutaneous Lupus Erythematosus

Summary: the primary purpose of the study is to evaluate the efficacy of biib059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (sle) with active cutaneous manifestations and joint involvement (part a), and in participants with active cutaneous lupus erythematosus (cle) (subacute cutaneous lupus erythematosus (scle) or chronic cle, including discoid lupus erythematosus (dle)) with or without systemic manifestations (part b). the secondary objective is to evaluate additional efficacy parameters of biib059 in reducing sle/cle disease activity, pharmacokinetic parameters, safety and tolerability of biib059 (parts a and b).


Eligibility criteria:
key inclusion criteria: part a: 1. diagnosis of systemic lupus erythematosus (sle) fulfilling at least 4 out of 11 of the 1997 revised american college of rheumatology (acr) classification criteria for sle along with active skin manifestations and joint involvement. 2. at least 4 tender joints and at least 4 swollen joints with at least 4 of the swollen joints in the proximal interphalangeal (pip) joints, metacarpophalangeal (mcp) joints and/or wrist. 3. demonstrate at least one sign of active lupus skin disease, including acute cutaneous lupus erythematosus (acle), subacute cutaneous lupus erythematosus (scle), and/or chronic cutaneous lupus erythematosus (ccle) (e.g., discoid lupus erythematosus (dle)), with skin activity defined by sle disease activity index 2000 (sledai-2k) at the time of screening and randomization. part b: 1. active skin manifestations cutaneous lupus erythematosus disease area and severity index activity (clasi-a) ≥8)) and a diagnosis of cutaneous lupus erythematosus (cle) that has been histologically confirmed (in the past or at screening), with or without sle manifestations. key exclusion criteria: 1. active lupus nephritis or moderate-to-severe or chronic kidney disease. 2. any active skin conditions other than cle that may interfere with the study (e.g., psoriasis, non-le skin lupus, drug-induced lupus). 3. history of chronic, recurrent (3 or more of the same type of infection in a 12-month period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as determined by the investigator and requiring anti-infective treatment within 12 weeks prior to screening. 4. use of immunosuppressive or disease-modifying treatments for sle or cle that were initiated less than 12 weeks prior to randomization. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: cle, sle, cutaneous lupus erythematosus, systemic lupus erythematosus
effect of goal-directed fluid therapy on postoperative complications

Conditions: Liver Diseases; Pancreas Disease

Summary: * it has been known that the recent application of a goal-directed fluid therapy (gdft) to the intraoperative fluid infusion in patients contributes to decreasing the prevalence of postoperative complications and shortening the length of study in the intensive care unit as well as hospital stay compared with conventional methods. * laparoscopic surgery is in a trend that its application is being expanded recently, but there has been no report on the application of gdft to laparoscopic surgery so far. * to this end, this study aims to apply the intraoperative gdft protocol in patients undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether there is any difference in postoperative recovery and incidences of postoperative complications, by comparing with patients applied with the fluid therapy using existing conventional methods


Eligibility criteria:
inclusion criteria: * laparoscopic hepatobiliary or pancreatic surgery exclusion criteria: * patients who do not consent to participation in the study * pregnant women, breastfeeding women
trilogy comparison study - adults

Conditions: Respiratory Insufficiency; Respiratory Failure

Summary: the objective of this study (part ii) will be to compare the performance of the trilogy device and a conventional ventilator (participant's current device). both devices will be set to the participants' current mode and prescription settings.

a. primary hypothesis and end-point in patients with respiratory insufficiency, when compared to conventional ventilators, the trilogy device achieves comparable level of gas exchange (measured as partial pressure of co2 in arterial or venous blood)and spo2 levels during various modes of ventilation. b. secondary hypothesis and end-points in patients with respiratory insufficiency, when compared to conventional ventilators, the trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified borg dyspnea scale).

Eligibility criteria:
inclusion criteria: 1. age \> 21 years of age; \< 85 years of age 2. able to follow instructions 3. able to provide informed consent 4. considered clinically stable, with low flow oxygen requirements less than 15 lpm (or fio2 less than 60 %) and peep no greater than 10 cm h2o. 5. requiring mechanical ventilation through nasal/facial mask,tracheostomy or endotracheal tube (et tube) exclusion criteria: 1. clinically unstable, i.e., 1. acute respiratory failure 2. participants with refractory hypotension defined as systolic blood pressure less than 90 mm hg despite inotropic agents), 3. uncontrolled cardiac ischemia or arrhythmias, 4. or as otherwise determined inappropriate for the study as determined by the investigator. 2. patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders 3. pregnancy
olanzapine versus placebo in the treatment of adolescents with schizophrenia

Conditions: Schizophrenia

Summary: this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of schizophrenia in adolescents. both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.


Eligibility criteria:
inclusion criteria: * are male or female patients, 13 to 17 years of age * patients must have a diagnosis of schizophrenia per dsm-iv-tr. * female patients of child-bearing potential must test negative for pregnancy at the time of enrollment. * both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent. * patients must be capable of swallowing study medication whole (without crushing, dissolving, etc.) exclusion criteria: * female patients who are either pregnant or nursing. * patients with acute or unstable medical conditions. * patients who have been judged clinically to be at serious suicidal risks. * patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment. * patients who currently have delusional disorder, psychotic disorder nos, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder or major depressive disorder.
identification and treatment of hypoxemic respiratory failure and ards with protection, paralysis, and proning pathway

Conditions: Acute Respiratory Distress Syndrome; Hypoxemic Respiratory Failure; ARDS, Human

Summary: treatment of patients with hypoxemic respiratory failure (hrf) and acute respiratory distress syndrome (ards) is complex. therapies that have been shown to save the lives of patients with hrf and ards are available but they are not always provided. to reduce practice variation and improve adherence to evidence-informed therapies, the investigators developed the treatment of hypoxemic respiratory failure and ards with protection, paralysis, and proning (therappp) pathway. the overall objective of therappp pathway is to improve the quality of care for patients with hrf. implementation of the pathway across alberta will test the effectiveness and implementation of the therappp pathway.

hypoxemic respiratory failure (hrf) and ards are common conditions among patients admitted to the intensive care unit (icu). treatment of these patients is complex. evidence based therapies that can improve survival exist; however, implementation is extremely inconsistent. as a potential solution to this problem, the investigators developed the treatment of hypoxemic respiratory failure (hrf) and ards with protection, paralysis, and proning (therappp) pathway to reduce practice variation and improve adherence to evidence-informed therapy. the therappp pathway is a comprehensive evidence-based, stakeholder-informed pathway for the diagnosis and management of hrf. the overall objective of the pathway is to improve the quality of care for patients with hrf. the specific objectives are to evaluate: 1. effectiveness of the pathway. a cost-effectiveness analysis is a secondary objective. 2. implementation of the pathway by conducting a process evaluation which will assess fidelity of the delivered interventions and clinician perceptions about the acceptability of the pathway. mechanically ventilated patients admitted to any one of 17 adult icus in alberta will receive the intervention. one icu (calgary) is the setting for a pilot study (nct04070053). for data analysis, the investigators will use chart abstraction to quantitatively assess the fidelity of the delivered intervention, and surveys and focus groups to qualitatively assess clinician perceptions about the acceptability of the pathway. fidelity of the intervention will be tracked using process of care indicators that reflect the five key steps of the pathway.

Eligibility criteria:
inclusion criteria: * admitted to the one of the 17 adult intensive care units in alberta * invasively mechanically ventilated exclusion criteria: * none
thermal analgesia in newborns

Conditions: Pain

Summary: newborns routinely experience pain associated with invasive procedures such as blood sampling, immunization, vitamin k injection, or circumcision. prevention of pain is both an ethical expectation and a professional imperative, as untreated pain has deleterious consequences including altered pain sensitivity in later childhood and may be related to the permanent neuroanatomical and behavioral abnormalities as found in animal models. moreover, pain is a source of concern and distress for new parents. yet, pain reducing therapies are often underused for the numerous minor procedures that are a part of routine medical and nursing care for neonates. growing scientific and clinical literature provides evidence for the effectiveness of natural, non-pharmacological techniques in both animal and human newborns. this study compares the pain reliving effects of sweet taste to the combination of sweet taste and warmth.


Eligibility criteria:
inclusion criteria: * healthy infants exclusion criteria: * unhealthy infants

Keywords: infants undergoing vaccinations