cyrilzakka/clinical-trials huggingface dataset:
Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)

EZ Holdco Inc. has developed two devices for the measurement of gastric content pH. The devices, EZ-NG and EZ-pH, rapidly check gastric pH by aspirating gastric contents into the device through a nasogastric (NG) tube and causing a color change in the device. The color change is then compared to the reference indicator on the device to determine a pH value of the aspirate. Currently there is no bedside rapid way to check gastric pH that protects the clinician from being exposed to the aspirate.

1. Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved pH probe.
2. Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH indicator could have been used to determine proper placement of the NG tube when initially placed.


Eligibility Criteria:
Inclusion Criteria:

* Consented elective surgical patient

Exclusion Criteria:

-
A Food-Effect Study of SHC014748M in Healthy Subjects

The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of SHC014748M Capsules following single dose administration with and without a meal.

This study will be an open-label, randomized, two-period, crossover PK food effect study of SHC014748M Capsules administered orally at 200 mg.

For each of 2 study periods, subjects will be admitted to the clinical research unit on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 200 mg SHC014748M Capsules in either the fasted or fed state. Subjects will remain at the clinical research unit for at least 72 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring.

Eligibility Criteria:
Inclusion Criteria:

* 1. Healthy male subject,18-45 years of age.

  2. BMI between 19 and 26; Weight between 50 and 80 kg.

  3. Healthy medical examination ,various laboratory inspection indicators normal, or the abnormal signs have no clinical significance.

  4. Subjects (including their partners) who are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose.

  5. Sign the informed consent form before the study and fully understand the study content, process and possible adverse reactions.

Exclusion Criteria:

* 1. Nervous system, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, musculoskeletal system, etc. are abnormal and have clinical significance as determined by investigator.

  2. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity.

  3. Addicted to smoking and drinking in 3 months before the trial.

  4. Hemorrhage over 200mL , receive blood transfusions or use blood products in 3 months before the trial.

  5. Other conditions not suitable for trial, by judgement of investigator.
A Study of Patients With Relapsed/Refractory Mantle Cell Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting

The purpose of this study is to understand the long-term safety and effectiveness of lisocabtagene maraleucel (liso-cel) for the treatment of Mantle Cell Lymphoma (MCL).


Eligibility Criteria:
Inclusion Criteria:

• Participants must have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel (Liso-cel) used for the treatment of Mantle Cell Lymphoma (MCL) according to the FDA-approved indication and dose range (ie, per the US Prescribing Information) and with a product meeting the specifications for commercial release approved in the USA

Exclusion Criteria:

* Participants known to be participating in investigational studies at the time of liso-cel infusion.
* Participants treated with non-conforming CAR T-cell product.
A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus

The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.

Enrollment will occur in sequential, ascending, dose-sequence design, where a higher CC-930 dose level and longer duration of dosing (cohort) will not be initiated until supportive safety profile is demonstrated in the preceding cohort. There will be 4 cohorts as described here;

Cohort 1: 25 mg once daily for 4 weeks Cohort 2: 50 mg once daily for 4 weeks Cohort 3: 100 mg once daily for 6 weeks Cohort 4: 100 mg twice daily for 6 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years
2. Good health as assessed by Investigator
3. DLE for at least 16 weeks prior to screening and consistent histological findings.
4. Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy.
5. Cutaneous Lupus Area and Severity Index (CLASI) activity score of at least 10, as determined by investigator.
6. Subjects using hydroxychloroquine, chloroquine, or quinacrine must have documented ophthalmologic exam within 24 weeks of baseline visit.
7. Must meet laboratory criteria for white blood cells, absolute neutrophils, platelets, serum creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin and hemoglobin.
8. Subjects, male and female, must agree to strict pregnancy prevention and testing requirements.

Exclusion Criteria:

1. Significant illnesses as determined by physician.
2. History of significant cardiac conditions or interventions within prior 6 months including abnormal electrocardiogram (ECG) findings.
3. Systolic blood pressure \< 95 or \> 150 mm Hg
4. Diastolic blood pressure \> 90 mm Hg.
5. Pregnancy or breast feeding.
6. Other dermatological conditions that would interfere with CLASI Activity Score assessments.
7. History of or active; malignancy, human immunodeficiency virus (HIV), tuberculosis infection, other mycobacterial infection, congenital or acquired immunodeficiency, Hepatitis B and C.
8. Clinically significant abnormality on chest X-ray.
9. Participation in multiple CC-930 cohorts.
10. History of thrombolytic event.
11. Positive tests for lupus anticoagulant, anti-cardiolipin antibodies, antibodies to beta-2 glycoprotein 1 or phosphatidylserine at screening.
12. Positive antineutrophilic cytoplasmic antibody (ANCA) at screening.
13. Diagnosis of SLE.
14. Presence or history of medically significant Systemic Lupus Erythematosis (SLE) or Lupus Erythematosis (LE) comorbidities.
15. History of seizures, chorea or psychosis.
16. Presence or history of persistent proteinuria or urinary cellular casts.
17. Prohibited prior or concomitant medications.
Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia

The purpose of this study is to determine whether epratuzumab provides effective therapy in Waldenström's Macroglobulinemia (WM).

This multi-center, single-arm study of epratuzumab is in patients with Waldenström's Macroglobulinemia (WM) who failed chemotherapy. After baseline evaluations, patients receive epratuzumab infused over approximately 30-60 minutes at 360 mg/m2, administered once weekly for 4 consecutive weeks (days 1, 8, 15, 22). Post-treatment evaluations occur on the day of the last infusion, then at 6 and 12 weeks. Patients without progression of disease continue long-term follow up until disease progression or for at least 5 years, with evaluations every 3 months for 2 years, then semi-annually. Otherwise, follow-up is only required until resolution of any treatment related abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Waldenström's Macroglobulinemia using criteria proposed at 2nd International Workshop on WM, Athens, Greece, 2002.
* Measurable disease, defined as serum monoclonal IgM protein ≥1000 mg/dL by electrophoresis.
* Lymphoplasmacytic infiltration of the bone marrow \>10% involvement.
* Failed at least one, but no more than 3, regimen(s) of prior therapy.

(Please consult with study site for full eligibility criteria)
The R-CITY Project: A Collaborative Intervention With Teachers and Youth

"R-CITY" refers to the Collaborative Intervention with Teachers and Youth to practice and apply the 4 "Rs" of equity literacy skills in the classroom - Recognizing, Responding, Restoring Relationships, and Resilience. R-CITY is a collaborative teacher- and youth-focused prevention intervention that offers equity literacy lessons to accompany the Second Step social and emotional learning (SEL) curriculum. The lessons are designed to build teachers' and students' "equity stamina" and promote SEL skills to create safe and positive learning environments for all.

The R-CITY Project uses a school-level randomized controlled trial (RCT) design to test the integration of the Second Step universal classroom-based evidence-based SEL program that Anne Arundel County Public Schools (AACPS) had been scaling up district wide with the R-CITY equity lessons. The purpose of the RCT is to determine the "value-added" of the SEL + Equity Condition, compared to the SEL curriculum alone (SEL Only) in AACPS elementary and middle schools. Students in both conditions get access the Second Step SEL content, there is no true control condition, but rather an active comparison condition.

The study aims to test the R-CITY intervention in 30 elementary and middle schools in AACPS in Maryland. The investigator team plans to enroll the schools across 3 cohorts. The first cohort of schools included 8 elementary schools (2021-2022). Seven to 8 elementary and middle schools are in the process of being recruited for cohort 2 (2022-2023). The third and final cohort will be recruited in fall 2023.

Eligibility Criteria:
Inclusion Criteria:

- General education teachers of core subjects (Mathematics, Science, Social Studies, English/Language Arts).
Advancing Research and Clinical Practice Through Close Collaboration (ARCC): A Pilot Test of an Intervention to Improve Evidence-Based Care and Patient Outcomes

The primary aim of this pilot study is to evaluate the effects of two variations of the ARCC Intervention Program on nursing processes and outcomes (job satisfaction, group cohesion, EBP knowledge, EBP implementation, EBP beliefs), patient/family outcomes (e.g. pt/family satisfaction with care), and institutional processes and outcomes (e.g. nurse-physician collaboration, cost, RN turnover, incidence frequency relevant to the topic). Secondary aims are to test the feasibility of study methods and reliability and validity of questionnaires.

This study is designed as a three-group randomized clinical trial with repeated measures. Three inpatient units (medicine, surgery, surgical intensive care) will be randomly assigned to one of three interventions: ARCC enhanced (didactic content presentations, use of an EBP tool kit which will stay on the unit, environmental EBP prompts, availability of an EBP coach on the unit); ARCC standard (all of the above, but without the coach); non-EBP intervention (didactic content and environmental prompts, but not related to EBP; placebo). The interventions will be implemented over an estimated 14 weeks, including a 4-week training period, and an estimated 10 weeks to implement an EBP initiative that the nurses on the two ARCC intervention units will develop.

Baseline information and questionnaires will be collected from nurses at the start of the study, and again at completion of the intervention phase. Outcome data will be collected from nurses approximately 10 weeks after implementation of the ARCC interventions are completed (i.e., 22 weeks after the study is commenced). Nurse-physician collaboration data will be collected from physicians working with study unit nurses as well as from the nurses. Patient satisfaction data will not be separately collected in this study, but will include use of unit-level Press-Ganey scores immediately prior to and over the study time period. Unit level and institutional RN turnover will be tracked monthly during the entire study period and will be compared across units at the same time as well as compared within each study over time (i.e., unit retention during those same months in the previous year). Costs of each EBP intervention will be tracked during the study and compared descriptively. Survey data will be analyzed using analysis of variance statistics. Questionnaires will be tested for reliability and construct validity. Because this is a pilot study, statistically significant differences are not expected, however, effect sizes will be calculated


Eligibility Criteria:
Inclusion Criteria:

* employed by Upstate
* working full or part time on study unit
* able to attend all education sessions

Exclusion Criteria:

* employed by temporary agency
* not able to attend all education sessions
Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia?

Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be justified by the agreement between various clinical situations in which BIS monitoring appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death , and the diagnosis of amniotic fluid embolism. The current controversy concerning the "triple low" state reinforces the need for an accurate study in this field. Furthermore, the recent review by Bidd argues in this sense.


Eligibility Criteria:
Inclusion Criteria:

* Adult (over-18) patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth
* Good echogenicity
* Social security coverage

Exclusion Criteria:

* Pregnancy
* Subjects with black skin (a known technical limitation of plethysmography)
* Cardiac arrhythmia
* Sepsis
* Poor echogenicity
* Legal guardianship or incarceration
* Complications of anaesthesia during induction (anaphylactic shock, cardiac arrest, arrhythmia, or intubation not possible)
Follow-up for Locking Plate Fixaion of Distal Radius Fracture

The current status of the disease under study. Including natural history, disease prognosis.

Distal radial fractures (DRF, distal radius fractures) are the most common fractures, allowing the user to lock the steel plate to accelerate the recovery of the wrist, but related injuries such as the triangular fibrocartilage cartilage complex (TFCC) tear or distal radius ulna joint (DRUJ) ligament tear with DRUJ instability requires time fixed or further repair surgery. If these issues are ignored, there will be weakness in the future. The ulnar shortening commonly used by hand surgeons is to improve the damage of TFCC or DRUJ instability. In the case of distal radial fracture combined with DRUJ instability, it is not clear that the distal radial fracture combined with DRUJ instability patients has long-term prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient following for at least one year

Exclusion Criteria:

* (1) Injury or arthritis before; (2) Open fractures, or more wounds require surgery
Management of Patients With Diagnosis of Hypothyroidism, as Hospitalized and as Outpatients, in Internal Medicine Units: Observational Study Before & After Educational Programme

There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. The aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (CPRs) in evidence-based guidelines (EBGs); 2) the improvement of patient management by means of a standardized educational programme (EP).

Methods: A nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening EP (phase 2) in half of the centres and no EP in the other half, was conducted. The EP was based on outreach visits. Centres were assigned to the two arms of the study, labelled the training group (TG) and control group (CG) respectively, by cluster randomization.

Hypothyroidism (HT) is a common disorder that affects more than 4% of the general population. Since this percentage does increase with advancing age, it is reasonable to suppose that hypothyroidism is becoming a widespread disease condition. Furthermore hypothyroidism is correlated with significant cardiovascular morbidity and mortality.

Although the potential clinical impact of hypothyroidism, the clinical profile of patients affected by hypothyroidism and managed in the Internal Medicine setting it is not very well known so far. This study has the aim to take a real-life picture of Internal Medicine patients with diagnosis of hypothyroidism, in order to evaluate possible deviations between the current clinical practice and the evidence-based guidelines, and possibly improving the management by means of an educational program.

The FADOI-TIAMO study is designed as a replicate of two cross-sectional surveys (Phase 1 and 3) interspersed with an educational program (Phase 2) to be conducted in 11 out of the 22 participating Centres. The data collection in Phases 1 and 3 will be based on the review of medical records of the last 30 consecutive patients with known or de novo diagnosis of HT observed in each Centre (globally, 1200 patients).

Eligibility Criteria:
Inclusion Criteria:

* known diagnosis of hypothyroidism on the basis of medical history or laboratory results, as indicated in the clinical record of inpatients admitted to the IM department for any condition

Exclusion Criteria:

* none
Multi-Center Registry for ME/CFS

The ME/CFS study (MECFS-R) aims to create a large-scale registry that provides data on epidemiology, phenotypes, and disease trajectories of and health care for ME/CFS at any age in Germany, which can be used for future clinical trials.

ME/CFS (ICD-10 G93.3) is a multisystem chronic disease that can lead to severe disability. Pre-pandemic prevalence was estimated at approximately 0.3% worldwide, and increasing prevalence is observed due to ME/CFS in the context of long-term sequelae of coronavirus diseases 2019 (COVID-19). In Germany, the number of affected people in Germany was estimated as approximately 350.000-400.000 in 2018/2019 and almost 500.000 in 2021. ME/CFS can manifest at any age, with peak prevalence in adolescents and young adults. Common triggers include COVID, influenza, and Epstein-Barr virus-associated infectious mononucleosis (EBV-IM). Non-infectious triggers are known as well. Autoimmunity and dysfunction of the autonomic nervous system (ANS) were suggested as possible pathomechanisms. Core symptoms include fatigue, post-exertional malaise (PEM), and unrefreshing sleep. Additional symptoms comprise cognitive deficits ("brain fog"), orthostatic intolerance, neuroendocrine, and immunological symptoms. ME/CFS is diagnosed according to clinical criteria (mostly criteria by the Institute of Medicine (IOM) or Canadian Consensus Criteria) and by appropriate differential diagnostics to exclude other disorders with similar symptoms. So far, no biomarker or specific therapy is available. Therapeutic approaches are holistic and aim at the palliation of symptoms as well as psychosocial support. Self-management with pacing is recommended. Knowledge of ME/CFS among healthcare providers is still scarce, and many patients do not receive adequate care.

With this web-based, German-wide registry, the investigators aim at deep phenotyping of the disease, identification of subtypes and risk factors, describing trajectories of the disease and patient journeys, and providing clinical data for future clinical trials. Patients are also invited to contribute biosamples for future translational research.

Eligibility Criteria:
Inclusion Criteria:

* ME/CFS diagnosis (ICD-10 G93.3) based on internationally established criteria
* Informed consent by patients and/or guardian(s)

Exclusion Criteria:

* No ME/CFS (ICD-10 G93.3)
* No informed consent
Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)

Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.

Endovascular treatment with mechanical thrombectomy is the standard treatment for acute large vessel occlusion.

Dexmedetomidine is a commonly used sedative in endovascular thrombectomy of acute ischemic stroke.

Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury.

The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* 2≤NIHSS≤25
* mRS score before stroke was less than 3
* Acute ischemic stroke (including anterior circulation)
* mTICI rate 2b or 3
* According to the 2018 AHA/ASA guidelines for the management of acute ischemic stroke, patients who plan to receive mechanical thrombectomy under local anesthesia and sedation
* Informed consent was signed by patient or legal representative

Exclusion Criteria:

* Intracerebral hemorrhage occurred in the responsible vessel area in the past 6 weeks
* Patients who had received stent treatment at the responsible vessel in the past
* Neurological function was restored at or before angiography
* Patients who are allergic to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, poly (n-butyl methacrylate), stainless steel, anesthetics and contrast agents or have contraindications
* Hemoglobin was less than 70g/L, platelet count was less than 50×109/L, international normalized ratio (INR) greater than 1.5 (irreversible), there are uncorrectable bleeding factors
* Blood glucose \< 2.7 mmol/L or \> 22.2 mmol/L
* Severe liver or kidney disfunction, ALT\>3 times the upper limit of normal value or AST\>3 times the upper limit of normal value, creatinine\>1.5 times the upper limit of normal value
* Pregnant or lactating women
* Previous history of mental illness
* Stroke with other acute diseases or postoperative stroke of other operation
* Heart rate less than 50bpm, second or third degree of atrioventricular block (except for pacemaker implantation), systolic blood pressure less than 90mmHg (two vasoactive drugs were already infused continuously )