cyrilzakka/clinical-trials huggingface dataset:
BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved control as bowel preparations prior to colonoscopy in adult patients.


Eligibility Criteria:
Inclusion Criteria:

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.

At least 18 years of age

If female, and of child-bearing potential, is using an acceptable form of birth control

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 who had previous significant gastrointestinal surgeries

Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on screening 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 prior history of renal, liver or cardiac insufficiency

Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

Subjects undergoing colonoscopy for foreign body removal and/or decompression.

Subjects who are pregnant or lactating, or intending to become pregnant during the study.

Subjects of childbearing potential who refuse a pregnancy test.

Subjects 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 surgical, drug, or device study within the past 30 days.

Subjects who withdraw consent before completion of Visit 1 procedures.
Comparative Effectiveness of Three Lucid Dreaming and Sleep Hygiene Techniques

In this study, the investigators will compare traditional lucid dream induction techniques, stress reduction strategies, and sleep hygiene across three study groups: (1) lucid dream and stress reduction techniques, and sleep hygiene; (2) lucid dream reduction and sleep hygiene; and (3) sleep hygiene. Participants will be first-year occupational therapy students embarking upon their first full-time 3-month clinical internship. Enrolled participants will be randomized to one of the three groups. The intervention will span 12 weeks and allow for participants to learn about and practice lucid dream induction, stress management, and sleep hygiene in bi-monthly online group sessions and through daily home exercises.

A significant impediment to completing academic health care programs is student stress level, which have been reported to be increasing in the last decade. Many students are not prepared for the rigor and intensity of their first clinical internship and experience exacerbations of stress and anxiety at this time. There is evidence that lucid dream induction methods have effectively alleviated stress and anxiety in veterans with post-traumatic stress disorder, and depression in community dwelling adults. Although lucid dream techniques have been used to manage anxiety in some populations, it has never been used to help health care students on clinical internship experiencing heightened stress levels. In this study, the investigators aim to determine whether lucid dream induction techniques combined with stress management and sleep hygiene could effectively help students on their first clinical internship to better manage stress and anxiety. The investigators hope to gain a greater understanding of which of three study conditions can best alleviate stress and anxiety in participants.

Eligibility Criteria:
Inclusion Criteria:

* Current occupational therapy student attending Columbia University and participating in clinical internship

Exclusion Criteria:

* none
Characterization and Verification of the Intensive Care Standard Operating Procedure (SOP) Adherence of the Treated COVID-19 Patients

As part of the internal quality management (QM project), this retrospective cohort study examines the adherence to Standard Operating Procedures (SOP) of the COVID-19 patients treated since January 1st, 2020 to February 28th, 2021 in intensive care units of the Clinic for Anesthesiology m.S. operative intensive care medicine CCM / CVK.


Eligibility Criteria:
Inclusion Criteria:

* During the intensive care stay with SARS-CoV-2 infected intensive care patients of the Charité - Universitätsmedizin Berlin, admitted to the intensive care units of the Department of Anesthesiology and operative intensive care medicine (CCM / CVK)
* Treatment period: 01/01/2020 to 02/28/2021
* At least 18 years old

Exclusion Criteria:

• Incomplete electronic documentation
The Role of Regulatory T Cell in Patients With Type 1 Diabetes Mellitus

Evaluate the regulatory T cell function in patients with type 1 diabetes mellitus, and find the pathogenesis of this autoimmune disease.

Type 1 diabetes mellitus (T1D) is an autoimmune disease characterized with T cell mediated destruction of pancreatic βcell. Dysregulated B and T cells were reported in the animal model. The loss of maintenance of immune homeostasis is thought to be major mechanism and result in persistence of autoreactive T cell in the periphery. Therapies which modulate the immune dysfunction may be helpful for the patients of T1D.

Immune homeostasis means a balance between the responses that control infection and tumor growth and reciprocal responses that prevent inflammation and autoimmune disease. CD4+ CD25+ regulatory T cells (Tregs) are critical to maintain such functions. Their actions can be through cell-to-cell contact or bystander effect. The specific markers of Tregs include CD25 molecule (IL-2 receptorαchain), Foxp3 (forkhead-winged helix transcription factor). The Foxp3 is a transcription factor that controls some genes encoding Tregs associated molecules, such as CD25, CTLA-4 and GITR.

The previous studies of modulation of Tregs in T1D show positive results in animal model. But the relative sizes of CD4+CD25+ population in human are still controversial. Our hypothesis is that the imbalance of Tregs and autoreactive T cells is the pathogenesis of T1D. Therefore, we used flow cytometry to determine the number of CD4+CD25+ Tregs population and quantitative real-time PCR to assay the expression of Foxp3, CLTA-4, GITR in patients with different stages and normal control. Besides, autoantibodies to GAD65 is associated with T1D in 60-80% patients. It is a marker of autoimmune diabetes. We anticipated that the realization of Tregs functions in patients of T1D will help our further guide of immunotherapy of patients with T1D and other autoimmune disease.

Eligibility Criteria:
Inclusion Criteria:

* pediatric type 1 DM

Exclusion Criteria:

-
Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices

The purpose of this study is to gather data on patients diagnosed with and treated for classical Hodgkin Lymphoma (cHL). It aims to closely observe how treatment for cHL is rendered, as well as assess the outcome of those treatment options and their impact on quality of life. Additional analyses will also attempt to identify prognostic or predictive biomarkers


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
* Patients who are treatment-naïve, or are within ± 2 weeks beginning any line of therapy at time of enrollment
* Patients must be within ± 2 weeks of Day 1 of the first cycle of any line of therapy to enroll; a cycle is practice-defined for chemotherapy, targeted therapy, or immunotherapy-based regimens.
* Any Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (PS)
* Patients must have available medical records for the date of diagnosis of cHL and available medical records documenting any prior treatment and treatment dates for the Hodgkin lymphoma, including chemotherapy, radiation, surgery and other anti-cancer therapy received.
* Patients must consent for use of their FFPE tissue blocks for exploratory analyses

Exclusion Criteria:

* Patients on supportive care only and not receiving anti-cancer therapy are not eligible to enroll
* Patients with unknown date of diagnosis of cHL
* Patients whose prior cHL therapy, and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
* Any other non-HL (non-Hodgkin Lymphoma) active malignancy for which the patient is receiving treatment
* Patients participating in a clinical study that does not allow enrollment into a non-interventional study
* Patients enrolled who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up.

Other protocol defined inclusion/exclusion criteria could apply
Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
* Post-operative Computed Tomography (CT) scan of the CI electrode available
* Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
* Subject implanted with MED-EL cochlear implant(s)
* Subjects received a Flex28, FlexSoft or Standard electrode
* Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side
* Audio processor not yet activated on the newly implanted side
* The most apical active electrode contact has to be inserted at least 450°
* Minimum of 10 active channels can be activated
* Fluent in the language of the test centre
* Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure

Exclusion Criteria:

* Lack of compliance with any inclusion criteria
* Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)
* Implanted with C40+, C40X and C40C
* Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study
Respiratory Knowledge Portal Computer and Phone Application to Improve Quality of Mechanical Ventilation by Reducing the Number of Ventilator Associated Events, Injury Created by the Ventilator and Unsafe Setting of Alarms.

Ventilator associated events (VAE) is a quality metric defined by 48 hours of stability followed by 48 hours of escalation of ventilator settings within the ICU. VAE have been associated with poor outcomes and increases the cost of care, yet is not easy to avoid. Operationalizing all the standards of care known to improve outcomes of those requiring mechanical ventilation in the critical care environment requires a comprehensive approach. ICU teams are encouraged to follow best practice protocols to help liberate and prevent VAEs. Yet, compliance with protocols in most ICUs is suboptimal for multiple reasons. With the advent of computerized mechanical ventilators capable of streaming data from breath to breath and biomedical integration systems (BMDI) such as Capsule (UTMB's BMDI system), software systems have been developed to help identify variances in the standard of care. Automation in near real-time ventilator data feedback has been shown to reduce the incidences of VAEs.

This quality improvement project will leverage Vyaire's Respiratory Knowledge Portal (RKP) to collect and store meaningful data regarding ventilator-associated events (VAE), alarm policy compliance, ventilator weaning, and lung protective analytics.

Goals:

1. To collect quality metrics utilizing RKP from patients requiring mechanical ventilation over a 3-4-month period for a retrospective baseline analysis.
2. Provide the RKP tool to the ICU team to determine if the use of RKP's webportal and Messenger Zebra phone app improves quality of mechanical ventilation and outcomes.
3. To determine a return on investment (ROI) for a software system like RKP.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects requiring invasive mechanical ventilation.
2. Subjects is in one of the monitored Galveston campus ICUs.
3. Ages 0-100

Exclusion Criteria:

1. Is in an ICU not monitored by RKP.
2. Adults on high frequency ventilation (pediatric patients are NOT excluded).
3. Any patient requiring ECMO.
Deep vs Moderate Block: Impact on Operating Conditions & Patient Satisfaction

This study compares surgeon's satisfaction of operating conditions and patient's satisfaction following laparoscopic gynecological surgeries in two groups of patients, half of whom will receive deep neuromuscular blockade and the other half, moderate neuromuscular blockade.

Deep neuromuscular blockade in anesthesia has been shown to improve operating conditions in retroperitoneal surgeries, while there is minimal evidence regarding this method in laparoscopic gynecological procedures.The advantage of improving surgical conditions with a deep neuromuscular blockade in laparoscopic surgery may however lead to a delayed neuromuscular recovery and hence a delay in turnover of patients.

Rocuronium will be used for muscle relaxation in order to achieve the necessary depth of neuromuscular blockade. Sugammadex is a modified cyclodextrin that forms complexes with rocuronium, reducing free plasma concentrations of rocuronium and reversing its neuromuscular blocking action from any depth.

The use of rocuronium will therefore aid in achieving a deep neuromuscular blockade which the investigators postulate will improve surgical conditions and the reversal with sugammadex will ensure a rapid recovery thereafter.

Eligibility Criteria:
Inclusion Criteria:

1. Patients identified from the anaesthetic clinic scheduled to undergo a laparoscopic gynaecological procedure under general anaesthesia

   * requiring tracheal intubation
   * elective surgeries (eg. laparoscopy \& dye insufflation, bilateral tubal ligation, cystectomy, myomectomy, hysterectomy, salpingo-oophorectomy)
2. American Society of Anaesthesiology (ASA) I-II

Exclusion Criteria:

1. Anticipated difficult airway
2. Patients requiring rapid sequence induction
3. Patient anticipated to require admission to the intensive care unit (ICU) or not planned for extubation
4. Patient with liver or renal failure (creatinine clearance \<50mls/min)
5. Patients with a baseline heart rate \<50/min
6. Patients with documented or suspected neuromuscular disorder

   * Guillain - Barre syndrome
   * Cerebrovascular accidents with residual neurology
   * Parkinson's Disease
   * Myasthenia Gravis
7. Any condition making the administration of patient satisfaction questionnaire difficult/impossible

   • speech or hearing impairment and language barriers
8. Patients on fusidic acid or toremifene 24 hours before surgery
9. Patients on hormonal contraceptives; oral or otherwise
10. Patients on drugs, medical problems that may prolong or shorten the duration of rocuronium- (eg.. aminoglycosides, magnesium)
11. Patients with a history of allergy to rocuronium or sugammadex
Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography

The objective of this study is to evaluate the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (cCTA) by current version of HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical coherence tomography (OCT) as reference standard.

Analysis of cCTA and OCT was conducted under blind in independent organizations.

After unblinding the cCTA and OCT case identification number, the OCT image was co-registered to cCTA data.

After co-registration of cCTA and OCT lesion locations, the minimal lumen area (MLA) was detected with both modalities. FFROCT was calculated using OCT-updated models in which cCTA-based lumen geometry was replaced by OCT-based lumen geometry.

Lesions were grouped according to their severity of calcification (using Agatston score) and minimum lumen diameter.

Eligibility Criteria:
Inclusion Criteria:

- Patients who underwent cCTA prior to coronary angiography and OCT within 6 months.

Exclusion Criteria:

1. Prior coronary artery bypass graft (CABG) surgery
2. Contraindication to beta blocker agents or nitrates
3. Tachycardia or significant arrhythmia
4. Impaired chronic renal function (eGFR \<30)
5. Subjects with known anaphylactic allergy to iodinated contrast material
6. Pregnancy or unknown pregnancy status in subject of childbearing potential
7. Cases with poor OCT or CCTA image for analyzing
Impact of the Organization of the First Responders in the Remote Areas on Cardiac Arrest Victim Survival

Emergency medical services (EMS) provide emergency care not only in the urban but also in the remote areas which could be up to 40 minutes from the EMS station. Thus, a cardiac arrest victim in those remote areas has a low likelihood to survive the cardiopulmonary resuscitation. Therefore, we have organized first responders (who are mostly volunteer fire-fighters) in the remote areas and taught them how to perform basic life support (BLS) with use of an automated external defibrillator (AED). In the case of a cardiac arrest the medical dispatcher activates simultaneously the EMS and the first responders, who perform the BLS with the use of an AED before the arrival of EMS.

The aim of the study is to analyze and compare the survival of the cardiac arrest victims in remote areas in the time period when the first responders were not organized yet compared to the time period when the first responders were activated to perform BLS.


Eligibility Criteria:
Inclusion Criteria:

* cardiac arrest in adult victims

Exclusion Criteria:

* cardiac arrest in pediatric population
Peginterferon and TIL Therapy for Metastatic Melanoma

Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from the patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 are administered to support T cell activation and proliferation in vivo.

In this trial the therapy is combined with peginterferon (the pegylated form of interferon alpha 2b). Interferon alpha has immunomodulatory effects and is known to upregulate HLA expression on melanoma cells and are hypothesized to synergize with TIL therapy.


Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed unresectable stage III or stage IV metastatic melanoma Metastasis available for surgical resection (about 2 cm3) and residual measurable disease after resection

ECOG performance status 0-1

Life expectancy ≥ 3 months

No significant toxicity from prior treatments

Adequate renal, hepatic and hematologic function

Women of childbearing potential (WOCBP) and men in a sexual relationship with a WOCBP must be using an effective method of contraception during treatment and for at least 6 months after completion af treatment.

Able to comprehend the information given and willing to sign informed consent

-

Exclusion Criteria:

Other Malignancies, unless followed for ≥ 5 years with no sign of disease, except squamous cell carcinoma or adequately treated carcinoma in situ colli uteri.

Cerebral metastasis. Patients with previously treated CNS metastases can participate if CNS metastases are surgically removed or treated with stereotactic radiosurgery and stable ≥ 28 days after treatment measured by MRI. Patients with asymptomatic, stable and untreated CNS metastasis can in be included according to investigators and sponsors decision.

Patients with ocular melanoma

Severe allergies, history of anaphylaxis or known allergies to the administered drugs.

Serious medical or psychiatric comorbidity

Creatinine clearance \< 70 ml/min

Acute or chronic infection with e.g. HIV, hepatitis, tuberculosis

Severe and active autoimmune disease

Pregnant and nursing women

Need for immunosuppressive treatment, e.g. corticosteroids or methotrexate

Concomitant treatment with other experimental drugs

Patients with uncontrolled hypercalcemia

Less than four weeks since prior systemic antineoplastic treatment at the time of treatment.

-
Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients

The objective of this exploratory study is to evaluate, for the first time, the sensitivity of 18F-Fludarabine to the initial diagnosis of MM compared to FDG-PET and MRI. The interest of this molecule will also be investigated as part of the end-of-treatment therapeutic evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic MM in the first line in patients who are not candidates for autologous bone marrow transplantation.
* Patients eligible for one of the treatments considered as standard in a patient who is not eligible for autograft, according to ESMO's European recommendations
* MM with measurable disease either by the serum evaluation of the monoclonal component or by the determination of free light chains (serum or urinary).
* Patient affiliated with a social insurance scheme
* The patient must understand and voluntarily sign the informed consent form
* Women of childbearing potential must have a serum pregnancy test (performed within 2 days before each PET scan.)
* Women of childbearing potential must use an effective contraceptive method throughout the course of the study and for 30 days after the last PET.
* Male patients (vasectomised or not) with a pregnant partner or a partner of childbearing potential must use a condom and a spermicide until 90 days after the last PET.
* HIV serology known to be negative
* Karnofsky ≥ 70 or ECOG 0-1

Exclusion Criteria:

* Age under 18 years
* Pregnancy or breastfeeding
* Male or female refusing birth control conditions
* Primary AL amyloidosis and myeloma complicated by amyloidosis
* Neutropenia \<1000 PN / mm3
* Thrombocytopenia \<70,000 / mm3
* Hepatic impairment: bilirubin\> 35μmol / L and SGOT, SGPT, alkaline phosphatase greater than 3 N
* Renal impairment defined by creatinine clearance \<50 ml / min
* History of other malignancies with the exception of basal cell carcinoma and stage I cervical cancer
* Severe active infection
* Active infection with known hepatitis B or C virus.
* Patient with insulin-dependent or non-insulin-dependent diabetes mellitus.
* Intolerance or known allergy to any of the study drugs or any of its analogues
* Psychiatric illness that may interfere with participation in the study
* Patient under safeguard of justice
* Intellectual inability to sign informed consent
* Persons protected by law