cyrilzakka/clinical-trials huggingface dataset:
Immune Tolerance Study With Aldurazyme® (Laronidase)

The purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme replacement therapy with laronidase in severe Mucopolysaccharidosis I (MPS I) participants.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is required from the parent(s) or legal guardian(s) prior to any protocol-related procedures being performed. (A separate informed consent will be requested from the parent(s) for their genotyping, which is independent of the inclusion)
* Participant's parent(s) or legal guardian(s) allow their child's participation and are willing and able to comply with trial procedures
* The participant must be up to and including 5 years of age at the time of enrollment
* Clinical diagnosis of the severe (Hurler) phenotype of MPS I
* Confirmed presence of 2 nonsense mutations in the alfa-L-iduronidase (IDUA) gene (that is, compound heterozygosity or homozygosity). For the purpose of enrollment, genotyping may be performed by a local laboratory. If no genotyping is performed by a local laboratory, a sample is collected for analysis by a central laboratory before enrollment
* Documented IDUA deficiency with fibroblast, plasma, serum, leukocyte or dried blood spot IDUA enzyme activity assay

Exclusion Criteria:

* The participant has a clinically significant organ disease including: cardiovascular, hepatic, pulmonary, neurologic, or renal disease, other serious intercurrent illness or extenuating circumstances that, in the opinion of the investigator, precludes participation in the trial or potentially decrease survival
* The participant has previously received treatment with laronidase
* The participant has known severe hypersensitivity to any excipients of the delivery solution for laronidase or to any of the other investigational drugs used in the study
* The participant has undergone a haematopoietic stem cell transplant (HSCT), regardless of outcome, or is currently under consideration for such a transplant. If a family later decides to obtain HSCT, the participant will be discontinued from the trial
* The participant has received an investigational product within the 30 days prior to enrollment
* The participant has prior treatment in any experimental protocol (for example, fibroblast injections) that might potentially induce antibodies to laronidase or might affect the interpretation of the participant's antibody response to laronidase
* The participant has received vaccination(s) within 1 month prior to enrollment, or is unwilling to postpone vaccinations during the Tolerance Induction Period in the trial
* The participant is homozygous for thiopurine methyltransferase (TPMT) deficiency, as determined by the genotype (the presence of 2 known null alleles for TPMT) or phenotype (near to complete absence of TPMT enzyme activity)
* The participant has a prior history of tuberculosis or a positive test for latent tuberculosis infection
The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury

Test the hypothesis that a certain set of osteopathic manipulation procedures preformed on patients with mild to moderate traumatic brain injury will result in accelerated rates of recovery assessed using vestibular function tests, quality of life questionnaires and measurements of the levels of anti-inflammatory metabolite and protein biomarkers in the blood and urine.

This project proposes to test the hypothesis that a certain set of osteopathic manipulative treatment (OMT) procedures performed on patients with mild to moderate traumatic brain injury (TBI) will result in accelerated rates of recovery as assessed using vestibular function tests, patient response on quality of life questionnaires, and measurements of the levels of anti-inflammatory metabolite and protein biomarkers in urine and blood. The OMT techniques, performed ensemble (as a set) and in sequence, will encompass: (a) soft tissue to the upper-mid thoracic spine; (b) soft tissue to the cervical spine; (c) suboccipital release; (d) condylar decompression; and (e) cranial venous sinus release. The key clinical outcome measures will include Neurocom Balance Manager assessments (Modified Clinical Test of Sensory Interaction and Balance; Stability Evaluation Test; Rhythmic Weight Shift; Limits of Stability), Vestibular Oculomotor Screen, Motion Sensitivity Test, as well as questionnaires such as Headache Impact Test (HIT-6), Dizziness Handicap Inventory, and the more general quality of life measures (dressing, bathing, medication management, etc. as assessed by the SF 36 QOL questionnaire).

A unique and trail blazing aspect of our proposed work is to screen for biochemical alterations in the plasma and urine of these patients following administration of OMT and to correlate these changes with vestibular function tests and other clinical parameters that may shed light on the biological mechanism(s) underlying the OMT. The impact of our proposed research lies in our attempt to establish a foundation for the basis of using OMT procedures to accelerate recovery of patients following mild to moderate brain injury and to find correlations between cognitive functions, biochemical markers, and self-reported assessments of quality of life.

The successful achievement of positive outcomes in this project will serve as the basis for our future efforts to seek funding from the National Institutes of Health for recruitment of larger numbers of subjects in a multi-center research effort.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate traumatic brain injury
* Chief complaint of headache and/or dizziness
* 18 years or older
* Medically stable/free from acute infection or fever
* Not a danger to self or others
* Not actively engaged in substance abuse
* Minimum Ranchos Los Amigos Level of 4 (http://www.traumaticbraininjury.com/symptoms-of-tbi/).

Exclusion Criteria:

* Minors below age of 18
* Any acute fracture or bleeding
* Head, neck or back wounds that would prevent OMT treatment
Study of LY2140023 in Schizophrenia Comparing LY2140023, Olanzapine, and Placebo

Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic activity) in the treatment of schizophrenia.

The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score.

The primary objective of this study was to determine if LY2140023 dosed at 40 mg twice daily (BID) for 28 days was superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) total score. The secondary objectives of the study were to assess the safety and tolerability of LY2140023 compared with placebo and olanzapine; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS positive symptom subset score; efficacy of LY2140023 compared with placebo in the responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS total score; efficacy of LY2140023 compared with placebo in responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS positive symptom subset score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS negative symptom subset score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in mood and anxiety as measured by the Hamilton Anxiety Scale (HAMA) total score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the Clinical Global Impression-Severity (CGI-S); effect of LY2140023 on prolactin levels of the patients after 4 weeks of treatment; efficacy of olanzapine compared with placebo on the PANSS total score; pharmacokinetics of LY2140023 and LY404039 in patients, and to explore the relationship between exposure and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* meet the DSM-IV criteria for schizophrenia as confirmed by modified SCID

Exclusion Criteria:

* meet the full syndromal criteria for other Axis I disorder
* have taken any depot antipsychotic within 4 weeks before screening
* are taking mood-stabilizing agents
Development of a Methodology to Design a High Order Sliding Mode Controller for Drug Dosage

The aim of this observational study is to create a data base to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.

The aim of this observational study is to create a database to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.

The observed drugs in this study are fast acting insulin, propofol and sodium nitroprusside.

The effect of insulin will be measured by a continuous glucose monitor, the effect of propofol by a bispectral index monitor and the the effect of sodium nitroprusside by a invasive blood pressure monitor.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I, II, II

Exclusion Criteria:

* Impossibility to measure depth of anesthesia or invasive blood pressure. Impossibility of using glucose monitor.
A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam

The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female of non-childbearing potential subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
* Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply
Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With B-cell Non-Hodgkin's Lymphoma That Has Relapsed Following Peripheral Stem Cell Transplantation

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab plus chemotherapy with vinorelbine in treating patients with B-cell non-Hodgkin's lymphoma that has relapsed following autologous peripheral stem cell transplantation.

OBJECTIVES:

* Determine the tolerability and toxicity of rituximab combined with vinorelbine in patients with relapsed non-Hodgkin's lymphoma following autologous peripheral blood stem cell transplantation.
* Assess the response rate and duration of response to this regimen in these patients.

OUTLINE: Patients receive rituximab IV weekly on weeks 1-4, 6, 8, 10, and 12 and vinorelbine IV on weeks 2-4, 6-8, and 10-12. Patients who achieve partial response may continue on vinorelbine from week 14 until disease progression.

Patients are followed until disease progression.

PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with B-cell Lymphoma, relapsing after high dose chemotherapy and autologous stem cell transplantation or allogeneneic stem cell or bone marrow transplant
* Age \> 18 years old
* Adequate hematologic function, as manifested by ANC \> 1000/mm3 and platelet count \> 40,000/mm3
* PS WHO: \< 3

Exclusion Criteria:

* Patients with serum creatinine \> 2 mg%, transaminases (ALT, AST) \> 3 times upper normal value, direct bilirubin \> 2 mg%, unless they result from tumor involvement
* Pregnant or lactating females
* History of myelodysplastic syndrome
* Uncontrolled CNS disease
* Active serious infection
* History of refractoriness to vinorelbine. However, prior treatment with rituxan is not an exclusion (synergy may still occur)
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy

Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* cirrhosis diagnosed by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis
* at least 1 hospitalization for documented HE within the last 12 months.
* abdominal CT scan anytime in the past

Exclusion Criteria:

* Patients with MELD score \> 35
* end stage organ failure (major dysfunction requiring organ support)
* kidney injury defined by a creatinine \> 2 mg/dl or rise in creatinine by 0.5 gm/dl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm/kg up to 100 gm/day)
* active malignancy
* uncontrolled diabetes mellitus with A1c\>9.5 (to avoid altered muscle protein metabolism
* medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass
* recent gastrointestinal surgery within past 12 months
* ongoing infection (positive blood or other body fluid cultures)
* active gastrointestinal bleeding.
Evaluating the Use of Thromboelastography (TEG) in Patient's Requiring Extracorporeal Membrane Oxygenation (ECMO)

This is a pilot study that seeks to evaluate the feasibility and safety of using a TEG algorithm in addition to traditional laboratory tests to guide transfusion and coagulation management of ECMO patients.

All adult patients requiring ECMO will be considered for the trial, with a target enrollment of 50 participants over a two-year period. For each enrolled participant, a TEG transfusion algorithm will be followed for patients exhibiting inadequate hemostasis in the operating room (Flowchart 1). Once patient has a normal TEG result with adequate hemostasis, either heparin or bivalirudin will be used as the anticoagulant. If patients are receiving no anticoagulation or heparin anticoagulation then a second TEG algorithm will be followed in the ICU when hemostasis is normal and heparin is introduced (Flowchart 2). If patients are receiving bivalirudin as their anticoagulation strategy, the transfusion parameters with TEG application will not apply. In addition to determining the compliance and feasibility of following these TEG algorithms, clinical outcome data including transfusion rates, types of blood products transfused, estimated blood loss and thrombotic events will be collected for every enrolled patient until they are discontinued from ECMO. Statistical analysis of the primary, secondary and tertiary endpoints of this study will determine the likelihood of exploring future clinical trials involving TEG-driven coagulation and transfusion management of the ECMO population.

Eligibility Criteria:
Inclusion Criteria:

* Patient's requiring ECMO placement

Exclusion Criteria:

* Other than children less than 18 years of age, no one will be excluded.
A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors

The purpose of this study is to assess the safety, drug levels, immunogenicity and preliminary efficacy of BMS-986213 (nivolumab-relatlimab fixed-dose combination) in Chinese participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
* Participants must have received, and then progressed, or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
* ECOG status of 0 or 1
* Life expectancy of ≥ 12 weeks at the time of informed consent per Investigator assessment

Exclusion Criteria:

* Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
* Participants with an active, known or suspected autoimmune disease
* Participants with primary CNS tumors

Other protocol-defined inclusion/exclusion criteria apply
Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)

To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.

All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects diagnosed with skin and soft tissue infection, sexually-transmitted infection, and infection of the oral.
* Subjects must have no prior experience with Azithromycin SR.

Exclusion Criteria:

* Patients not administered Azithromycin SR.
Morpho-functional Changes After Oral Supplementation of Antioxidants and Anti-inflammatory Treatment in Age-Related Macular Degeneration.

In patients with AMD a deterioration of the antioxidant mechanisms of the retina is observed and therefore an increase in the production of free radicals responsible for tissue damage.

The Age-Related Eye Disease Study (AREDS) found that the intake of antioxidants reduces the risk of progression of the disease to an advanced stage (choroidal neovascularization or geographic atrophy ) and reduces the loss of visual acuity.

In this study the investigators want to analyze the functional retinal changes (mfERG) of the macular region, in patients with dry age-related macular degeneration, after the use for 6 months of an oral supplementation based on Ganoderma lucidum (Reishi), Calendula Officinalis, Lutepure-Marigold ( 5% Lutein and 1% Zeaxanthin) Blueberry, Rutin, Alpha-lipoic acid, Bromelain, NAC, Vtiamine C, B9, B12, D3, Selenium, Zinc and Copper.


Eligibility Criteria:
Inclusion Criteria:

* age\> 50;
* dry AMD not in therapy with oral supplements or antioxidants
* visual acuity ≥ 20/40
* ability to provide written informed consent and to follow the procedures of the study;

Exclusion Criteria:

* spherical refractive error greater than ±6 diopters
* cylindrical refractive error greater than ±3 dioptres
* opacity of diopter means
* any active or past retinal pathology other than AMD
* history of ocular surgery (\<6 months)
* Pregnancy
Safety and Efficacy Study of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.

The purpose of this study is to determine any significant differences in the efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of gastrointestinal subjects undergoing a colon examination.

The composite principal objective of the current study will therefore be, to determine any significant differences in the joint variable of efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of subjects undergoing a colon examination.

The evaluation will be carried out by two blinded assessors, independent of the investigator who performed the procedure (endoscopist investigator). It will be assessed from images of different sections of the colon: cecum, ascending, transverse, descending and rectum and subsequent confirmation by Principal Investigator if an agreement has been reached between the two blinded assessors or whether it is necessary to reach consensus.

The evaluation of the subject's acceptability will be assessed using a 5 point scale which assesses the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug.

The secondary objective is to evaluate the safety of CitraFleet.

In addition a second exploratory arm of CitraFleet was included in this study (CitraFleet Exploratory arm). The study is not powered to make formal statistical comparisons for this arm. Exploratory assessment of this arm against the main CitraFleet regimen and Klean-Prep will be made in order to run future trials design with this schedule.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are between 18 and 80 years of age.
* Subjects undergoing complete colonoscopy and therefore require prior preparation with either Klean Prep® or CitraFleet.
* Subjects capable of maintaining appropriate oral hydration during the intestinal preparation process.
* Subjects that have provided written informed consent.
* Subjects in whom the use of any of the study drugs (KleanPrep®,CitraFleet) is not contraindicated.
* Subjects who can communicate with the study personnel and comply with study requirements.
* Subjects undergoing a complete exploratory diagnostic colonoscopy for the first time.

Exclusion Criteria:

* Severe renal insufficiency.
* Ascites.
* Congestive heart failure.
* Gastrointestinal obstruction, gastric retention, intestinal perforation and/or ileus.
* Megacolon and/or toxic colitis.
* Nausea and/or vomiting and/or abdominal pain.
* Severe dehydration.
* Hypermagnesemia.
* Rhabdomyolysis.
* Pregnant women.
* Subjects who have participated in a clinical trial in the previous 30 days.
* Abdominal surgery for any acute process (for example acute appendicitis).
* Active inflammatory intestinal disease.
* Known allergy to any of the active ingredients or excipients of the study drugs.
* Subjects not providing written informed consent.
* Subjects not complying with all of the inclusion criteria.