cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma

The purpose of this study is to determine whether a single IV dose of N6022 will have a significant bronchoprotective effect, compared with placebo, during methacholine challenge.

The number of patients with adverse events measured in both the treated and placebo groups from start of dosing until Day 28 post dose.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 35 kg/m2, inclusive, at screening.
* Patient has a ≤ 5 pack years smoking history and nonsmoking for ≥ one year.
* Documented history of mild bronchial asthma, first diagnosed at least 6 months and currently being treated only with intermittent short-acting beta-agonist therapy by inhalation.
* Pre-bronchodilator FEV1 ≥ 75% of predicted at screening.
* Sensitivity to methacholine with a provocation concentration of methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of ≤ 8 mg/ml at screening.
* Demonstrated stable lung function during screening with ≤10% variability between two assessments of FEV1 taken at least 7 days apart at approximately the same time of day.

Exclusion Criteria:

* Hypertension at screening is defined as systolic blood pressure (BP) \>150 mmHg or diastolic BP \> 90mmHg.
* Respiratory tract infection and/or exacerbation of asthma within prior 4 weeks
* History of life-threatening asthma
* Administration of steroids within 4 weeks of the screening visit.
* History of being unable to tolerate or complete MCh testing.
* Blood donation (500 mL) within 3 months of starting the clinical study.
* Tested positive for hepatitis C antibody or hepatitis B surface antigen.
* Tested positive for human immunodeficiency virus (HIV) antibodies.
Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers

This Study evaluates the possible drug interaction between FosD and verapamil when taken together.

An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers when Fostamatinib Disodium 150 mg is Administered Alone and in Combination with Verapamil.

Eligibility Criteria:
Inclusion Criteria:

* Weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 35 kg/m2, inclusive.
* Females must be of non-childbearing potential

Exclusion Criteria:

* History of clinically significant disease or disorder or presence of GI, hepatic or renal disease
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the drug
* Any clinically significant abnormalities in lab safety tests or vital signs as results as judged by the Investigator
* Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
* Current smokers or use of nicotine products within 1 month prior to enrollment
Weight Regain Study After Bariatric Surgery-A Pilot Project

There are three different phases to this study:

1. Screening phase to determine if you are eligible to participate in the study.
2. Study phase, which will entail diet and activity, exercise and then finally self monitoring goals.
3. End of treatment phase where you will be asked to complete questionnaires.

The purpose of this study is to determine the feasibility of a group treatment program for individuals experiencing weight regain after bariatric surgery and to evaluate the effectiveness of the group treatment program. There is little information on programs to assist patients who experience weight regain after bariatric surgery. This treatment program will focus on behavioral changes and activity.

Eligibility Criteria:
Inclusion Criteria:

* Weight regain post-RYGB of at least 5 kg since reaching their weight nadir.
* Male or Female age 18 - 65.
* Undergone RYGB 12 - 36 month prior.
* Ability to read, write and understand English.
* Experienced at least a 25% total weight loss since surgery.
* BMI at least 27 kg/m.
* Weight regain of no more than half of excess body weight. These cases will be referred back to the surgeon.

Exclusion Criteria:

* Taking Weight-suppressing medication (e.g. phentermine, bupropion)
* On medications known to cause weight gain
* Change in smoking status with past three months
* Change in antidepressant or other psychotropic medication or dosage in past six weeks
* Change in psychotherapy status in past six weeks
* Current purging behaviors occurring more than once per week over the past six weeks (vomiting or laxative/diuretic use for the purpose of weight loss
* Current alcohol abuse or dependence or illicit drug use in past three months
* Active bipolar or psychotic spectrum disorder
* Current suicidality or homicidality
* Severe neuropsychological disease (history of seizure, uncontrolled hypertension
* Condition associated with cognitive dysfunction (e.g. Alzheimer's dementia, other neurological conditions)
* Medically unstable condition or one which the investigators feel put the participant at risk in the study
* Functional limitations-not able to walk 2 block without assistance
* Exercise is contra-indicated (e.g., severe cardiovascular disease, uncontrolled hypertension, hematocrit.\<30%, chronic kidney disease, severe pulmonary disease
A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma

This is a multicenter, open-label, dose-escalation study designed to determine the maximum tolerated dose (MTD) by evaluating dose-limiting toxicities (DLTs) and to evaluate the safety, tolerability, pharmacokinetics, anti-tumor effect, and biomarkers of ERY974 in combination with atezolizumab and bevacizumab following premedication with tocilizumab in patients with locally advanced or metastatic HCC.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years at time of informed consent
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
* HCC that has been histologically confirmed

Exclusion Criteria:

* Previous or concomitant autoimmune disease
* Uncontrolled diabetes mellitus and hypertension
* Concurrent New York Heart Association (NYHA) Class ≥II congestive heart failure, myocardial infarction, arrhythmia, or unstable angina, or a history thereof within 6 months before enrollment.
* Concurrent symptomatic cerebrovascular disorder (e.g., subarachnoid hemorrhage, cerebral infarction, or transient ischemic attack), or a history thereof within 6 months before enrollment.
* Symptomatic, untreated, or actively progressing CNS metastases
Sentence Shaping - DHH

The proposed research addresses a long-standing and important challenge of improving literacy skills of children who are deaf and hard of hearing, a historically under researched group. The investigators aim to leverage shape coding - an empirically validated intervention approach for constructing sentences in spoken English - for improving how efficiently children who are deaf and hard of hearing learn to correctly construct sentences in written English. To advance the promising yet underutilized research on shape coding, the investigators complete the next logical step of applying the visual supports provided with shape coding to written language for deaf and hard of hearing children. Shape coding has been effective for teaching sentence structure in spoken English to children with language disabilities and has recently been applied to sentence structure in American Sign Language with deaf and hard of hearing children. Intervention involving shape coding is predicted to result in increased accuracy of word order in sentences in written English because deaf and hard of hearing children often benefit from visual information. The investigators will accomplish this aim using single case multiple probe across participants design studies with 30 fifth through eighth grade children who are deaf and hard of hearing. The knowledge gained will guide language and literacy intervention for children who are deaf and hard of hearing.


Eligibility Criteria:
Inclusion Criteria:

* Children in grades five through eight
* deaf or hard of hearing
* use spoken English and American Sign Language (ASL)
* bilateral hearing loss
* the ability to read and understand the grammatical structures of interest
* already be writing sentences, but demonstrate errors in word order and/or grammar.

Exclusion Criteria:

* diagnosis of dyslexia
* uncorrected vision impairment (i.e., identified vision loss without use of corrective lenses that interferes with eligibility evaluation tasks)
* evidence of severe motor impairment (i.e., insufficient motor skills to complete eligibility evaluation tasks independently).
Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study

Pulmonary aspiration of gastric contents is a serious patient safety problem accounting for 50% of anesthesia-related mortality. The risk is higher in patients undergoing emergency surgery as the gastric content is uncertain which poses a challenge to anesthetic decision-making. Standard clinical assessment to identify at-risk patients primarily relies on preoperative fasting guidelines and is not adequate for patients undergoing emergency surgeries. Point-of-care gastric ultrasound (GUS) has emerged as an accurate bedside tool providing information regarding the type and volume of gastric contents. When GUS was added to standard clinical assessment, anesthetic management plan changed in 71% of adult elective and 37% of pediatric emergency surgical procedures. Such data is lacking in adult patients undergoing emergency surgeries. The investigators propose a multicentre mixed-method study to evaluate the impact of GUS on aspiration risk assessment and subsequent Anesthetic Plan before emergency surgeries. The evidence from this study will improve patient safety by accurately identifying patients at risk of aspiration and tailoring anesthetic techniques and airway management to prevent pulmonary aspiration in patients undergoing emergency surgeries.

The proposed trial design is a mixed-method, multicenter study that includes a randomized controlled trial (RCT) and a qualitative assessment component. The RCT will evaluate the impact of adding GUS to the standard clinical assessment on the incidence of changes in the anesthetic plan for adult patients undergoing emergency surgery. The qualitative assessment will gather attending anesthesiologists' opinions on the addition of GUS in an emergency surgical setting.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* American Society of Anesthesiologists' (ASA) physical status I-III
* Patients scheduled for non-elective non-cardiac surgery.

Exclusion Criteria:

* Abnormal anatomy of the upper gastro-intestinal tract (including hiatus hernia, gastric tumors, and previous surgeries of the upper gastrointestinal tract).
* Extrinsic gastric compression obtained from the medical history or during the actual ultrasound examination.
* Pregnancy.
* Attending anesthesiologist refusal to include the patient for participation in the study
Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 or A*02-positive Advanced Solid Tumors

In this study, the investigators examine using a combination of two types of HLA-A\*2402 (or HLA-A\*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*2402 or HLA-A\*0201 restricted epitope peptides (VEGF-R1 and VEGF-R2) emulsified with Montanide ISA 51 for advanced solid tumors.

In this phase I/II trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402 or HLA-A\*0201-positive advanced solid tumor patients who are refractory to standard therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced solid tumors that are refractory to standard therapies or that cannot be treated with those due to medical reason.
2. ECOG performance status 0-1
3. Age between 20 to 85
4. Clinical efficacy can be evaluated by some methods
5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks
6. Life expectancy \> 3 months
7. Laboratory values as follows 1500/mm3 \< WBC \< 10000/mm3 Platelet count \> 75000/mm3 15% \< Lymphcyte fraction Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value
8. HLA-A\*2402 or HLA-A\*0201
9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
2. Myocardial infarction within six months before entry
3. Breastfeeding and Pregnancy (woman of child bearing potential)
4. Active and uncontrolled infectious disease
5. Concurrent treatment with steroids or immunosuppressing agent
6. Other malignancy requiring treatment
7. Non-cured traumatic wound
8. Decision of unsuitableness by principal investigator or physician-in-charge
A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke

The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).

This a prospective, randomized study in primary care practices.

Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 70 years of age who are new or established participants in the primary care practice
* Willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the Center for Medicare \& Medicaid Services (CMS) Medicare Claims Database and to access data from health records
* Health insurance by Medicare Parts A \& B (Medicare Fee-for-service)

Exclusion Criteria:

* Oral anticoagulation (OAC) for any indication at the time of enrollment
* History of Atrial Fibrillation (AF) or Atrial Flutter (AFL) as documented in the participant's current medical problem list
* Any condition the investigator considers a contraindication to OAC, e.g., bleeding that required medical attention or severe renal impairment
* Any condition the investigator considers will prevent compliance with study instructions
* Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders)
* History of allergy to adhesive
* Not able to wear the Zio®XT monitor or not able to apply the monitor by herself/himself or with the help of a caregiver

Other protocol-defined inclusion/exclusion criteria could apply
Alzheimer's Disease Multiple Intervention Trial

The purpose of this study is to conduct a two-year randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention.

The proposed study builds on our findings from a previous clinical trial that demonstrated the effectiveness of collaborative care for older adults with Alzheimer's disease cared for in primary care practices. In the prior trial, we demonstrated that guideline-level medical care resulted in improved quality of care and improved behavioral and psychological symptoms over one year among patients and their caregivers. However, despite finding significant differences among study groups on Neuropsychiatric Inventory scores, we did not find a significant difference between groups in functional decline. Both study groups experienced a significant decline in function over 18 months. The current study proposes to test a home-based intervention specifically designed to slow the rate of functional decline among older adults with Alzheimer's disease.

In addition to building on our past research, the study also builds from recently reported research which demonstrated the short-term efficacy of home-based occupational therapy interventions among older adults with dementia. These trials show that older adults with dementia, including Alzheimer's disease, can both participate in and benefit from occupational therapy-based interventions delivered in the home.

The specific aim of this study is to conduct a two-year, randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention. We will test the primary hypothesis that subjects with Alzheimer's disease in the intervention group will have improved function at two years compared with the best practice primary care control group.

Eligibility Criteria:
Patient Inclusion Criteria:

* Currently a patient within Wishard Health Services in Central Indiana
* Diagnosed with possible or probable Alzheimer's Disease
* Age 45 or older
* English speaking
* Hear well enough to answer questions in person or by telephone
* Community-dwelling (includes senior communities, but not skilled nursing facilities)
* Caregiver willing to participate in the study
* Willing to receive home visits
* Lives in Indianapolis metro area and planning to continue care at primary care clinic

Caregiver Inclusion Criteria

* Age 18 or older
* English speaking
* Hear well enough to answer questions in person or by telephone
* Community-dwelling
* Willing to receive home visits

Exclusion Criteria:

* Not a current patient within Wishard Health Services
* Does not speak English
* Currently enrolled in another study
* Non-community dwelling, or residing in a skilled nursing facility
Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia

Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and consolidation. Standard chemotherapy combination for induction treatment associates cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About 60-70% of patients achieved complete remission after this standard chemotherapy. As cytarabine competes with endogenous nucleotides to exert its activity, the aim of this protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of the induction treatment. Thus, intracellular nucleotides levels will be determined in peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment, and results will be compared with the efficacy of the treatment. This parameter will be assessed by the achievement of complete remission.


Eligibility Criteria:
Patients Inclusion Criteria:

* age over 18 years
* acute myeloid leukemia
* standard induction chemotherapy with cytarabine and daunorubicin
* patients who received the information and did not object to participate to the study

Patients Exclusion Criteria:

- patients with acute myeloid leukemia 3

healthy volunteers Inclusion Criteria :

* adults without known hematological disease,
* adults who received the information and did not object to participate in the study

healthy volunteers Exclusion Criteria :

- Volunteers with known hematological disease.
Red Cell Distribution Width and Mortality in Adult Pneumonia Patients

Abstract Pneumonia is a leading cause of severe morbidity and mortality among adults. During the last two decades, several scores were developed to evaluate the probability of morbidity and mortality among patients with community acquired pneumonia (CAP), such as the PORT score and the CURB65. Recently, several studies showed that elevated Red Cell Distribution Width (RDW) could be used as a prognostic tool for predicting severe morbidity and mortality among patients with cardiac diseases.

RDW is a quantitative measure for red blood cell (RBC) size variability. Recent studies have suggested that high levels of RDW are in association with higher mortality among cardiovascular patients.

RDW has not yet been studied as a prognostic sign in CAP. The goal of this study is to examine the role of RDW as a prognostic factor for severe morbidity and mortality among patients who were hospitalized with CAP , independently to Hemoglobin levels, renal function and inflammatory markers.


Eligibility Criteria:
Inclusion Criteria:

patients 18 years and older, hospitalized due to pneumonia between 2005-2010. All patients must have RDW values.

-

Exclusion Criteria:

* under 18 no RDW value The primary cause of hospitalization was not pneumonia
Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)

A post-marketing study using Optilume Catheter System for benign prostatic hyperplasia.

This is a post-marketing study for using Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter, to treat benign prostatic hyperplasia. Participants will go through screening process which include uroflow test (measure the strength of urine flow), post-void residual volume by bladder scan, questionnaires and transrectal ultrasound (TRUS) to determine the eligibility to the study. Participants will be followed up for 1 year after Optilume treatment procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Male subject with symptomatic BPH NOTE: Symptomatic BPH is defined as an International Prostate Symptom Score (IPSS) ≥ 13 and peak urinary flow rate (Qmax) of ≤15 mL/sec
2. Prostate dimensions suitable for treatment with the Optilume BPH Catheter System in accordance with the approved Instructions for Use NOTE: Prostate volume between 20 to 80 gm and prostatic urethral length between 32 mm and 55 mm as determined by TRUS
3. Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria:

1. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
2. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and a highly effective contraceptive for at least 6 months post-procedure
3. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
5. Confirmed or suspected malignancy of prostate or bladder
6. Active urinary tract infection (UTI) confirmed by culture
7. History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
8. Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g. urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.)
9. History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage)
10. Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
11. Significant obstruction from median lobe in the opinion of the investigator
12. Disease or other health condition that is not suitable for this study