cyrilzakka/clinical-trials huggingface dataset:
BLI-800-301: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:

  * Evaluation of BE results
  * GI bleeding
  * Anemia of unknown etiology
  * Neoplastic disease surveillance
  * Endosonography
  * Inflammatory bowel disease
  * Unknown diarrhea or constipation etiology
  * Polypectomy
  * Laser therapy
  * Routine Screening
* At least 18 years of age
* Otherwise in good health, as determined by physical exam and medical history
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse)
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

* Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects who are undergoing colonoscopy for foreign body removal and decompression.
* Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
* Subjects with a history of renal or hepatic insufficiency or congestive heart failure.
* Subjects who had previous gastrointestinal surgeries
* Subjects who are pregnant or lactating, or intending to become pregnant during the study.
* Subjects of childbearing potential who refuse a pregnancy test.
* Subjects who are allergic to any preparation components
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days.
PMCF of Rotarex®S & Aspirex®S Catheters in Treating Thrombotic Occlusion of Arteriovenous Graft

Retrospective Post-Market Clinical Follow Up of Rotarex®S \& Aspirex®S Catheters in treating thrombotic occlusion of Arteriovenous Graft for dialysis access (Artificial Bypass)

To evaluate the safety, technical performance, and clinical efficacy of the Rotarex®S \& Aspirex®S Catheters as a stand-alone and adjunctive therapy for the treatment of acute thrombotic occlusion of arteriovenous graft for dialysis access (Artificial Bypass) in accordance with Rotarex®S \& Aspirex®S Catheters intended use.

Eligibility Criteria:
Inclusion Criteria:

1. Female or male subject with a minimum age of 18 years
2. Treatment performed between 2013 and 2020
3. Occlusion in arteriovenous graft
4. For the Rotarex®S group: use of Rotarex®S Catheter
5. For the Aspirex®S group: use of Aspirex®S Catheter

Exclusion Criteria:

1. Subjects not appropriate for this study according to the opinion of the principal investigator
TR1801-ADC in Patients With Tumors That Express c-Met

First-in-human, Phase 1 study to assess safety, tolerability, and pharmacokinetics of TR1801-ADC in patients with select solid tumors that express c-Met.

First-in-human, Phase 1, multiple dose-dose escalation study designed to determine safety, tolerability, maximum tolerated dose, and recommended phase 2 dose of TR1801-ADC in patients with select solid tumors that express c-Met. This study will also assess pharmacokinetics (PK), anti-tumor activity, and correlation between clinical outcomes (safety, anti-tumor activity, and PK) and c-Met expression.

Eligibility Criteria:
Inclusion Criteria:

* Compliance with all study procedures and visits to the clinical research site
* Locally advanced or metastatic disease that is not amenable to definitive therapy
* Histologically confirmed diagnosis of a solid tumor which expresses c-Met
* Must have progressed or have been intolerant to all available therapies known to confer clinical benefit appropriate for the patient's tumor type
* Measurable baseline disease as defined by RECIST Version 1.1
* ECOG Performance Status 0-1
* Body weight within 40 and 150 kg
* Clinical laboratory values with the limits as defined by the protocol
* Not pregnant or breast feeding
* Males and women of child-bearing potential must agree to use an effective method of contraception

Exclusion Criteria:

* Any disease or condition that may be considered to pose an increased risk from study treatment or the ability of the patient to participate and comply with study procedures
* Treatment with anti-cancer therapy (including cytotoxic chemotherapy, major surgery, radiation, biologic and investigational agents) within 21 days before first dose of study treatment
* Brain metastases that has not stabilized for at least 28 days after therapy and who have discontinued steroids for \<2 weeks
* Unresolved adverse events \>= Grade 2 from prior anticancer therapies
* Acute myocardial infarction, cerebral ischemic infarct, or other arterial thrombosis within 6 months of screening for this study.
* Uncontrolled hypertension, unstable angina, or NYHA Class III/IV heart failure
* History of capillary leak syndrome
* Corticosteroid intolerance
* History of anasarca
* Untreated or uncontrolled bacterial, viral or fungal infection
* HIV infection or active infection with hepatitis B or C
* Significant liver disease
* History of alcoholism or current alcoholism
* Signs of significant portal hypertension
* Significant kidney disease within 2 years
* Active or unstable gallstone disease
* Prior treatment with a c-Met targeted agent
* Prior hypersensitivity reaction to treatment with another monoclonal antibody
* QTcF \>=470 ms
* Patients may not start any new herbal or dietary supplement within 4 weeks before initiation of study treatment nor while receiving study treatment
* Administration of a live, attenuated vaccine within 28 days before the first dose of study treatment
Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered \[1\]. Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents \[2-5\].

The aim of this prospective randomized, multicenter study is to investigate the role of EST before fully covered SEMS placement in patients with neoplastic biliary obstruction.


Eligibility Criteria:
* Inclusion criteria

  * Patients referred for endoscopic retrograde cholangiopancreatography
  * Malignant bile duct obstruction
  * Signed written informed consent
  * Age \> 18
* Exclusion criteria

  * Inability to provide inform consent
  * Pregnancy or lactation
  * Suspected perforation of the GI tract
  * Anatomical alterations due to previous surgery (Billroth surgery)
  * Coagulation alterations
Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder

The investigators will enroll 100 participants using a randomized control trial design to implement and evaluate an individualized opioid taper program supporting rural Primary Care Physicians (PCPs) caring for patients with moderate to severe trauma discharged on opioids. This study will link a trauma center Physician Assistant (PA) with rural PCPs to facilitate pain care and the individualized opioid taper. The investigators seek to improve patient's pain and opioid outcomes and support the PCPs who assume care for these complex patients after hospital discharge.

Our long term goal is to provide a service that will help trauma patients as they go back into primary care and into pain- and opioid-free living.

This study explores the feasibility, efficacy, and potential sustainability of a collaborative pain care/opioid taper strategy for patients discharged to a rural PCP practice on opioids after hospitalization for moderate to severe traumatic injury.

The randomized control study design will provide important pilot data on the efficacy of opioid taper in the context of engaged pain management care at the PCP level when the PCP is supported by expert consultation and has broad implications for patient and clinician education.

Eligibility Criteria:
Inclusion Criteria:

1. Must be at least 18 years old
2. Injury Severity Score of 9 or greater
3. Resident of Washington state
4. Will be discharged to a rural zip code outside of king county.
5. Glasgow Coma Score of 15
6. Able to read, speak, and write English or Spanish.
7. Has an identifiable PCP or willing to accept referral to a local Federally Qualified Health Center (FQHC)
8. Has an insurer included in the All Payer Claims Database
9. Planned to be discharged on opioid medication
10. Planned to be discharged back to the community

Exclusion Criteria:

1. Less than 18 years old
2. Injury Severity Score less than 9
3. Patient is in judicial custody
4. Resident of a state other than Washington
5. Will not be discharged to a rural zip code outside of king county.
6. Evidence of OUD diagnosis (including using heroin or other illicit opioids in the past month, a DSM-5 OUD diagnosis, or evidence of taking methadone, buprenorphine, or naltrexone).
7. Currently in cancer treatment or enrolled in palliative or hospice care
8. Residing in a nursing home or assisted living facility
9. Using any implanted device for pain control
10. Self-report of heroin or other illicit opioid use in the past month
11. Psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year (including current admission).
School Located Adolescent Vaccination Study

The provision of adolescent vaccination in a school setting will be feasible and acceptable to parents as evidenced by the number and percentage of students immunized within each school compared to those in schools without a program. The likelihood of vaccination for diphtheria, tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal conjugate vaccine (MCV4) and all three combined) among eligible students enrolled in schools with a comprehensive school-based immunization program will be significantly higher than that of students enrolled in schools without a school-based immunization program.


Eligibility Criteria:
Inclusion Criteria:

* 2000 (1000 at intervention schools and 1000 in control schools) randomly selected students enrolled in 6th - 8th grade at randomly selected schools
* students who appear to be in need of one or more immunizations of interest at the beginning of the school year
* students enrolled in school by October 1st registration deadline will be included in the analysis

Exclusion Criteria:

* students who appear to have had all immunizations of interest at the beginning of the school year
* students enrolled after the October 1 school registration deadline will be excluded from the analysis
* students enrolled in grades other than 6th, 7th, or 8th grade will not be eligible to participate
Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases

Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of \<7.0% as the treatment goal.

Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain, and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance.

The abovementioned problems associated with insulin treatment in T1D can also be seen in insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in reducing the weight gain and insulin dose in insulin-treated patients with T2D without exacerbating the risk of hypoglycaemia.

Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin therapy for patients with T1D.

The investigators hypothesise that the add-on of exenatide to insulin therapy in patients with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve glycaemic control without increasing the risk of hypoglycaemia.


Eligibility Criteria:
Inclusion Criteria:

* T1D according to WHO criteria with duration of ≥1 year
* Age ≥18 years
* BMI \>22.0 kg/m2
* HbA1c \>7.5% and \<10.0% at visit 0 (screening)
* Able to count carbohydrates

Exclusion Criteria:

* Insulin pump treatment
* Hypoglycaemia unawareness (inability to register low blood glucose)
* Diabetic gastroparesis
* Compromised kidney function (eGFR \<60 ml/min/1.73m2, dialysis or kidney transplantation)
* Liver disease with elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
* History of acute and/or chronic pancreatitis
* Subjects with personal or family history of medullary carcinoma or MEN syndrome
* Inflammatory bowel disease
* Cancer unless in complete remission for \>5 years
* Proliferative retinopathy
* Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
* Alcohol/drug abuse
* Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
* Pregnant or nursing women
* Known or suspected hypersensitivity to trial product or related products
* Receipt of an investigational drug within 30 days prior to visit 0
* Simultaneous participation in any other clinical intervention trial
The Effect of Implementing a Limb Loss Prevention Program on Amputation Rates

The investigators plan to do a retrospective chart review on patients admitted to Parkland Hospital with diabetic foot infections, ulcers, and bone injuries from 2005 (5 years prior to the start of the diabetic limb preservation team) to present day. The investigators will collect information on demographics, medical/surgical history, social history, medications, laboratory results, peripheral arterial disease, wound severity, and treatment factors such as type of antibiotics, off-loading, debridement, wound healing, surgery interventions, complications, recurrence, and history and physical characteristics and exam from inpatient and outpatient encounters. This will be identified by current procedural terminology (CPT) codes for foot and leg amputations, and lower extremity revascularization procedures. Clinic visits will be identified to podiatry/foot wound, vascular surgery, invasive cardiology, general surgery, and physical therapy wound care in addition to inpatient encounters of these patients to determine the full scope of care received and to compare resources utilization before and after implementation of the diabetic limb preservation team.

This will be a retrospective chart review on patients admitted to Parkland Hospital with diabetic foot infections, ulcers, and bone injuries from 2005 (5 years prior to the start of the diabetic limb preservation team) to present day. The investigators will collect information from medical records on demographics, medical/surgical history, social history, medications, laboratory results, peripheral arterial disease, wound severity, and treatment factors such as type of antibiotics, off-loading, debridement, wound healing, surgery interventions, complications, recurrence, and history and physical characteristics and exam from inpatient and outpatient encounters. This will be identified by current procedural terminology (CPT) codes for foot and leg amputations, and lower extremity revascularization procedures. Clinic visits will be identified to podiatry/foot wound, vascular surgery, invasive cardiology, general surgery, and physical therapy wound care in addition to inpatient encounters of these patients to determine the full scope of care received and to compare resources utilization before and after implementation of the diabetic limb preservation team. Study records will by a study identification number that will be assigned to the subject as soon as data collection is completed on each individual chart.

Non-parametric statistical analyses comparing individuals within each group and also differences between the groups will be performed using IBM SPSS Statistics version 25 (IBM Corporation, Armonk, New York).

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to Parkland Hospital with diabetic foot infections, ulcers, and bone injuries from 2005 (5 years prior to the start of the diabetic limb preservation team) to present day.

Exclusion Criteria:

* not fitting inclusion criteria.
Web Based Investigation of Natural History of Keloid Disorder, an Online Survey

This trial intends to gather very basic clinical information about keloid, its patterns of presentation, family history, ethnic background and correlation with the type of keloid, as well as prior treatment results that patients have had received.

This will be a web based study, whereby patients will have to read and acknowledge the consent form online. Once patients agree and acknowledge the terms of the consent form, they will gain access to the questionnaire pages.

For those who are under age of 18, a parent or a legal guardian must sign the consent form and answer the online questions on behalf of the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have clinically confirmed diagnosis of keloid
2. Adults, age over 18
3. Parent or legal guardian may participate if patient is under the age of 18
4. Able and willing to complete a web based survey

Exclusion Criteria:

* No one will be excluded from this study as long as the inclusion criteria are met.
Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure

The purpose of this study is to determine acute effect the transctutaneous electrical nerve stimulation in sympathetic and parassympathetic system in individuals with heart failure.

Heart failure (HF) is the inability of the heart to maintain adequate levels of blood supply to tissues. In recent years there has been an increased prevalence of heart failure (HF), in Brazil there are about two million people diagnosed with HF and 240,000 new cases per year. Thus, the IC constitutes the most serious problem now and in the fields of cardiology and public health. Sympathetic activity is increased and correlates with a worse prognosis and survival in these patients. Currently, the pharmacological blockade of the sympathetic system by chronic use of beta-blockers are commonly used to treat hyperactivity, but these interventions have side effects. The transcutaneous electrical nerve stimulation (TENS) has been used successfully to control pain in different clinical conditions and may be a noninvasive strategy to reduce drug and not the severity of increased sympathetic.

Eligibility Criteria:
Inclusion Criteria:

* Possess stable heart failure grade II or III according to NYHA;
* Ejection fraction \<40% determined by echocardiography;
* Having no change in drug therapy one month before being included in the study;
* There have been Myocardial Infarction (AMI) three months before study entry;

Exclusion Criteria:

* Patients with grade IV heart failure according to NYHA;
* Acute respiratory;
* Unstable angina;
* Ventricular arrhythmia, unstable until three months before the start of the study;
* Pacemaker;
* Active smoking;
* Diabetes mellitus;
* And fever or infectious disease.
Equine Facilitated CBT Group Therapy for Youth Anxiety

The purpose of this study is to evaluate a 10-week equine facilitated cognitive behavioral therapy (CBT) group program for youth between ages of 6 to 17 with symptoms of anxiety. The program will be delivered at GallopNYC, a stable that provides equine-facilitated group therapy to youth with a range of mental health problems.

The equine-facilitated group therapy normally provided at GallopNYC (Treatment as Usual, TAU) will be compared to an augmented group program that will include CBT strategies, including psychoeducation to the child and caregiver about anxiety, coping strategies to use when anxious, and identifying and addressing dysfunctional thoughts that maintain anxiety. Seventy-five children between 6 to 17 years of age will be randomized to TAU (equine-facilitated group therapy), the augmented group therapy that contains CBT strategies, or wait list control. Outcomes include anxiety symptoms, self-efficacy,receipt of services, functioning and the child's relationship with the horse.

Eligibility Criteria:
Inclusion Criteria:

* A child aged 6-17 seeking services for anxiety at Gallop NYC, who (based on the screener administered by GallopNYC) evidence symptoms of anxiety (as measured by a score of 2 or more on the GAD 2 item questionnaire) and a minimum functioning score of 51 (as measured by the child global assessment scale)
* Caregivers will also serve as study respondents. To do so, they must meet the following criteria:
* Primary caregiver/ legal guardian of a child who meets eligibility criteria
* Aged 18 years or older
* English speaking

Providers will serve as study therapists. To do so, they must meet the following criteria:

* PATH-certified provider employed at Gallop NYC

Exclusion Criteria:

* Inability to provide informed consent
* Child does not meet criteria for anxiety symptoms (as measured by a score of 2 or more on the GAD 2 item questionnaire) and/or does not meet minimum level of functioning (does not meet a minimum functioning score of 51 as measured by the child global assessment scale)
Evaluation of the Evolution of Pregnancies in the First Trimester Following MAR Management During a COVD-19 Pandemic Period

Because of the physiological changes inherent in pregnancy, pregnant women with lower respiratory tract infections often have more worrisome outcomes compared to non-pregnant individuals, including a higher rate of hospital and intensive care unit admissions.


Eligibility Criteria:
Inclusion Criteria:

* Patient included in a Medically Assisted Procreation (MAR) protocol aged between 18 and 43 years of age
* Patient who has already signed a consent to management

Exclusion Criteria:

* Patient who expressed opposition to participating in the study