cyrilzakka/clinical-trials huggingface dataset:
Value of Cardiac Output Monitoring by Supra-sternal Doppler/Echocardiography in Intensive Care Unit

The aim of this study is to evaluate the concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring in intensive care patients already equipped with an invasive monitoring. This invasive monitoring consists of catheters used to measure the cardiac output allowing the supply of organs and is installed when there is need to monitor the blood flow in different hemodynamic reasons. The patient's care will not be modified, the study just requires a supplementary measure in an exam already perform in the standard care. The principal hypothesis is that we can show a concordance between this non-invasive measure and the standard invasive monitoring.

The aim of this study is to evaluate the concordance between the measurement of cardiac output by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring (trans pulmonary thermodilution or right heart catheterization) in intensive care patients already equipped with an invasive monitoring. Cross sectional study was performed in Reims university hospital. Patients who will be included in this study are patients who already have an invasive cardiac output monitoring such as trans pulmonary thermodilution or right heart catheterization for many reason as septic shock, cardiogenic shock or any shock state. Cardiac output will be measured by supra-sternal and transthoracic echography and by invasive monitoring (trans pulmonary thermodilution or right heart catheterization). Intra-class correlation coefficient will be calculated to assess the concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring.

Eligibility Criteria:
Inclusion Criteria :

- patient admitted in intensive care unit at the Reims University Hospital and in whom invasive monitoring of cardiac output is already placed.

Exclusion Criteria:

- Age under 18 yo
Non-interventional Long Term Follow-up Study of Participants Previously Enrolled in the STARLIGHT Study

The current study is a non-interventional long-term safety follow-up of the subjects who completed STARLIGHT, in accordance with FDA guidance on recipients of human gene therapy products.

This study is designed to follow subjects with Stargardt Disease (SD) previously enrolled in study NTXMCO-004 (STARLIGHT, NCT05417126). In that study, all 6 enrolled subjects received MCO-010, an ambient light-activated, Multi-Characteristic Opsin (MCO) transgene in an adeno-associated virus serotype 2 (AAV2) vector via intravitreal injection (IVT). MCO-010 has the potential to restore vision irrespective of the underlying gene mutation, and because it is directed at bipolar retinal cells, intact photoreceptors are not required. Further details on MCO-010 and the underlying disease under investigation are included in the protocol for STARLIGHT and are not repeated herein

Eligibility Criteria:
Inclusion Criteria:

* Subjects are eligible to be included in the study only if all of the following criteria apply:

  1. Previously enrolled in study NTXMCO-004 study
  2. Able to comprehend and give informed consent.
  3. Able to comply with testing and all protocol tests.
  4. Agree to participate for the full 4-year study duration to the best of their ability and barring any unforeseen circumstances.

Exclusion Criteria:

* Not applicable. Subjects will be included in this study and will be consented after completion of all assessments at the Week 48 visit for the STARLIGHT study
Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study

To determine whether acute ionized hypomagnesemia and hypocalcemia immediately following foscarnet infusions can be lessened or eliminated by prior infusion of magnesium sulfate. To determine whether reductions in ionized magnesium, ionized calcium, and parathyroid hormone levels following foscarnet infusions are lessened by preinfusion of magnesium sulfate. To evaluate the safety of intravenous magnesium sulfate prior to foscarnet infusion by monitoring blood pressure, heart rate, and heart rhythm. To characterize the effect of magnesium sulfate on foscarnet blood levels and urinary excretion of calcium, magnesium, phosphate, and foscarnet.

Patients are randomized to one of four treatment groups. Intravenous foscarnet is administered for 4 days. Patients receive one of three doses of magnesium sulfate or placebo in normal saline according to one of four schedules. Sequence of doses will differ for each group.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* AIDS by CDC criteria.
* Documented CMV disease.
* Tolerance of foscarnet dose of 90 mg/kg bid.
* Normal serum calcium, serum creatinine, and serum phosphate.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known allergy to Foscarnet.
* In extremis or incapacitated because of underlying illness (e.g., comatose or tracheally intubated).
* Volume depletion.

Concurrent Medication:

Excluded:

* Nephrotoxic drugs such as IV pentamidine, amphotericin B, aminoglycosides, and cisplatin.
* Other investigational drugs that affect metabolic balance, such as human growth hormone.
* Oral or parenteral magnesium and calcium supplementation.

Patients with the following prior condition are excluded:

History of heart block.
Use of Temperature Controlling Mattress Pad for Sleep Improvement

A dual arm interventional study in which chliipad and ooler sleep system users voluntarily opt out of using their device for 2 out of 4 weeks. Assessments of sleep via self report and Oura Ring sleep quality and duration.


Eligibility Criteria:
Inclusion Criteria:

* has a chili sleep system
* has an Oura Ring

Exclusion Criteria:

* medically treatable issue
* recent injury
* expected significant travel over study period
Chinese CKD-MBD Prevalence Survey (CRISS-MBD)

This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population.

The prevalence of Chronic Kidney Disease (CKD) in Chinese population is over 10% and increasing rapidly. Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) is a constellation of conditions secondary to CKD, including 1) metabolic disorders of calcium, phosphorus and Parathyroid Hormone (PTH), 2) bone diseases and 3) calcifications in blood vessels and soft tissues. CKD-MBD could increase the risks of cardiovascular diseases and bone fracture and overall mortality. However, the data of prevalence of CKD-MBD in Chinese population with different CKD stages is lacking. This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population.This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population. A questionnaire was designed to collect the information of demographic data, medical history, laboratory test results and medications from the patients. Multistage stratified cluster sampling method will be used. Based on the sample size estimation, a total of 14-28 tertiary hospitals and 42-56 level II hospitals distributed in seven different geographic regions across China will be included. At least 9863 subjects will be enrolled. The primary outcome is the prevalence of CKD-MBD, including the prevalence of hypocalcemia, hyperphosphatemia and secondary hyperparathyroidism.

Eligibility Criteria:
Inclusion Criteria:

* Kidney damage for ≥ 3 months, and one of the following criteria:

  1. Glomerular filtration rate (GFR) \<60 mL/min/1.73m2 for 3 months or more, irrespective of cause.
  2. proteinuria (\>30 mg of urinary albumin excretion per gram of urinary creatinine, \> 50 mg of urinary protein excretion per gram of urinary creatinine, \>1+ for proteinuria in dipstick, \> 0.3g of 24 hour urine protein)
  3. structural renal abnormalities
* hospitalized patients not on dialysis or dialysis patients followed regularly in Hemodialysis centers or Peritoneal Dialysis centers

Exclusion Criteria:

* no available test results within 3 months prior to this study
* no available information of medication or past medical history
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients

As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following approval (until 19 September 2022). Out of all the enrolled patients, at least 18 cases (20%) will be followed up until the 52nd week to see the long term safety of Xeljanz.

This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (ie, investigators). The study population will be adult patients with moderately to severely active UC who have had an inadequate response or intolerance to the basic treatments or biological agents. Clinical Severity of Ulcerative Colitis is classified as mild, moderate, or severe based on the Mayo score or partial Mayo score. Xeljanz will be administered according to the "Dosage and Administration" of the approved labeling. There is no visit or activity mandated by this study. The investigator will collect patient data and record the information on each patient's case report form (CRF).

Eligibility Criteria:
Inclusion Criteria:

* Adult ulcerative colitis patients with moderately to severely active disease who has received at least 1 dose of Xeljanz according to the local labeling

Exclusion Criteria:

* Patients meeting any of the following criteria as per local labeling will not be included in the study.

  1. Patients with a history of hypersensitivity to any ingredients of this product.
  2. Patients with serious infection (sepsis, etc.) or active infection including localized infection.
  3. Patients with active tuberculosis.
  4. Patients with severe hepatic function disorder.
  5. Patients with an absolute neutrophil count (ANC) \<1,000 cells/mm3.
  6. Patients with a lymphocyte count \<500 cells/mm3.
  7. Patients with a hemoglobin level \<9 g/dL.
  8. Pregnant or possibly pregnant women.
  9. Because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy

Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma patients. The Danish nation-wide training and rehabilitation offer 'Body \& Cancer' offers intensive resistance and endurance training to all Danish cancer patients receiving chemotherapy with the aim of reducing treatment-related fatigue and physical impairments, but the potential of the training to preserve or improve muscle mass is uninvestigated.

Furthermore, the underlying biological mechanisms of treatment and/or exercise induced changes in muscle mass in cancer patients remains uninvestigated.

Thus, the primary purpose of the present study is to investigate changes in body composition during chemotherapy and after resistance and aerobic training combined with protein supplementation during ongoing chemotherapy in cancer patients. Secondly, we aim to investigate the underlying biological mechanisms of muscle mass regulation in biopsies obtained before and after a control period as well as after 10 weeks of exercise, both during chemotherapy.

We hypothesize that 10 weeks exercise will improve muscle mass and body composition in cancer patients during chemotherapy as compared to a control period during chemotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Currently receiving curative, adjuvant, neo-adjuvant or palliative chemotherapy
* No documented bone metastases or myelomatosis
* No documented CNS affection
* WHO performance status 0-1
* No chronical thrombocytopenia or leukopenia
* No physical conditions preventing exercise participation
* No serious symptoms of heart disease
* No dementia or mental illness preventing participation
* Signed written concent
* Age above 18 years

Exclusion Criteria:

* Participation in systematic resistance training three months prior to inclusion
E-Manage: A Brief mHelath Intervention for University Students

This study is a two-part transdiagnostic psychological intervention aimed to help people respond to negative emotion and emotional distress in more adaptive ways using a technology called "ecological momentary intervention" (or EMI) that delivers intervention content using a smartphone app. Participants in this study will be Rutgers students recruited through-or currently affiliated with - Counseling, Alcohol and Other Drug Assistance Program \& Psychiatric Services (CAPS) at Rutgers. Participants will first attend either one-on-one or group telehealth therapy sessions/workshops, where they will learn the therapeutic skills that are part of the study. Then, they will complete up to 8 weeks of smartphone monitoring that involves assessments and opportunities to practice the skills learned in therapy.


Eligibility Criteria:
Inclusion Criteria

* Age 18 years or older
* Matriculated at Rutgers during Fall of 2020 (on campus and/or remote)
* Currently residing in US
* Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures
* iOS and Android smartphone compatible with MetricWire. Nearly all phones since 2014 are compatible

Exclusion Criteria

* Non-English speaking
* Unable to understand or provide informed consent
Non-invasive Imaging of Cetuximab-Zr. 89 Uptake Wit PET: a Phase I Trial in Stage IV Cancer Patients

Non invasive imaging of cetuximab uptake with PET could help to select the patients who could be treated by cetuximab, a registered but expensive monoclonal antibody against EGFR. Other monoclonal antibodies labelled with Zirconium-89 have already been used with success in patients. The combination of cetuximab labelled with Zirconium-89 is a promising new probe to determine cetuximab uptake, which has been tested in various pre-clinical animal models in Maastricht with excellent results.

We propose a two step study design (see figure 1). As our ultimate goal for the future is to determine the uptake of 89Zr-cetuximab in the tumour before and during therapy, we need to investigate the toxicity of two consecutive low doses of 89Zr-cetuximab in the first place. However, as in future studies and in some patients, it is also possible that a single, larger dose of 89Zr-cetuximab is needed to obtain the best image quality, we will also investigate the toxicity of a single larger dose.

Step 1: Determination of the toxicity of two low doses of 89Zr-cetuximab In three patients a standard loading dose of 400 mg/m2 of cetuximab will be administered, partly labelled with 89Zr (60 MBq, 2.5mg) on day 0.

On day 14, a second injection with dose of 250 mg/m2 of cetuximab, partly labelled with 89Zr (60 MBq, 2.5mg), will be given.

Step 2: Determination of the toxicity of one larger dose of 89Zr-cetuximab A standard loading dose of 400 mg/m2 of cetuximab will be administered in 3 patients, a part labelled with 89Zr (120MBq, 5mg).

Toxicity will be scored twice a week from the day of first injection (day 0) up to day 14, according to the CTCAE3.0 scoring system. As after 14 days, the activity of Zr89 is low (four half-lives of Zr89 is 4 x 3.2 days = 12.8 days), no additional toxic effect is expected. Blood sampling will be done weekly (haematology, liver and kidney function).

When in 0/3 patients a toxicity of grade 3 or more has occurred step 2 is considered safe. If in 1/3 patients a grade 3 has occurred, 3 more patients will be included in this step. If another grade 3 toxicity occurs in 1/3 patients, the study will be stopped. When at maximum 1/6 patients experience a grade 3 toxicity, this step will be considered safe. When step 2 is considered safe, the study is ended.

After the injection, visualization of all tumour sites will be analyzed by performing a PET-CT scan on day 4, 5 and 6 post injection. An additional scan on day 3 or 7 is optional.\* At day 5 post injection a perfusion PET-CT will be performed.

Eligibility Criteria:
Inclusion criteria:

* Stage IV cancer (primary or recurrent)
* Normal white blood cell count and formula
* Normal platelet count
* No anemia requiring blood transfusion or erythropoietin
* Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution).
* Calculated Creatinin clearance at least 60 ml/min
* No previous administration of cetuximab
Discovering Patterns in Experiences of Patients in Esophageal Cancer Clinical Research

Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups.

This study will investigate the safety and efficacy of esophageal cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future esophageal cancer research.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Diagnosis of esophageal cancer
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Inability to perform regular electronic reporting
Adherence in Global Airways - Steroid Intake and Effects on Chronic Rhinosinosinutis

The purpose of this study is to investigate the relationship between long-term use of systemic steroids in patients with upper and lower respiratory tract diseases and their own production of cortisol (cross-sectional), as well as whether those with low cortisol levels have an impact on bone density. As patients with CRSwNP have a high use of steroids, they routinely undergo a DEXA scan at the Respiratory Clinic, Department of Ear-Nose-Throat Surgery and Audiology (ENT) - Rigshospitalet (RH) to examine whether their bone density and structure are affected. The scan will be included as a clinical secondary outcome to assess whether systemic steroid use has an impact on this.

The purpose of the study is therefore to compare steroid intake, baseline P-cortisol, the body's response to ACTH (measured by cortisol levels after the test), and bone density in patients with chronic sinusitis (CRS) with and without asthma in an unselected population at the Respiratory Clinic (cross-sectional). In addition, at the 4-month follow-up (exploratory follow-up, pilot project), it will be investigated whether good adherence (\>80%) to inhalation therapy (nasal steroid and lung steroid) and additional treatment with biologicals has a negative effect on the body's own production of P-cortisol.


Eligibility Criteria:
Inclusion Criteria: cross sectional study

* Diagnosed with chronic rhinosinusitis (CRS)
* possibly asthma
* Aged over 18 years

Exclusion Criteria - cross sectional study

* Unable to read or speak Danish
* Presence of severe psychiatric comorbidities
* Patients who have never taken systemic steroids
* Inability to participate or comply with local treatment according to the investigators' assessment
* Does not provide consent for lookup in FMK-online

In/exclusion criteria for exploratory study - 4-month follow-up (pilot project)

Inclusion criteria:

* Diagnosed with CRS and possibly asthma
* Age over 18 years
* Low adherence: Foster score, i.e. the number of treatments taken compared to prescribed \< 80% (4 weeks out of 16 weeks) and/or measured on MARS-5 L/N ≤35 at the first visit (corresponding to less than 80%). If the patient does not have asthma, it is MARS-5N ≤ 19
* If asthma: ACQ ≥1.2 or ACT ≤ 17 (partly uncontrolled asthma)
* SNOT-22 score ≥35 (partly uncontrolled CRS)
* Participation in the cross-sectional study at the initial visit to the Respiratory Clinic

Exclusion criteria:

Adherence:

* Foster score \>80% and/or on MARS-5-L/N \>35 points at the first visit
* Cannot read or speak Danish
* Severe psychiatric comorbidities
* Patients who have never taken systemic steroids
* After investigators' experience, will not be able to participate or comply with local treatment
* Does not give permission to look up data in FMK-online.
Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis

The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation


Eligibility Criteria:
Inclusion Criteria:

* Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event
* On stable statin dose
* Clinically stable at time of screening and randomization

Exclusion Criteria:

* Women of child bearing potential
* Medical conditions that would impact the absorption of the study drug
Mini-implant-supported Twin-Block in Treating Patients With Class II Division 1 Malocclusion

Correcting the skeletal class II using functional appliances, whether removable or fixed, always leads to skeletal and alveolar effects. However, some of these effects are unfavorable, the most significant being the loss of support in the lower dental arch. This loss of support leads to an uncontrolled labial inclination of the lower incisors and mesial movement of the lower; these dentoalveolar effects impact the degree of skeletal correction that can be achieved. Therefore, this study aimed to evaluate the skeletal and dentoalveolar effects following the use of a mini-implant-supported Twin-Block appliance compared to the conventional Twin-Block.

Many attempts have been made to modify the Twin-Block appliance to decrease the dentoalveolar effects, such as omitting the upper labial bow, including torquing spurs on the upper incisors, and adding acrylic capping on the lower incisors. However, these modifications have not been successful in eliminating the dentoalveolar effects. This is because the Twin-Block and other functional appliances are supported by teeth rather than bone. As a result, the components of the appliance exert force on the teeth while the mandible attempts to return to its natural resting position. No previous clinical trial described the use of the Twin-Block appliance supported by orthodontic mini-implants and the potential benefits of using mini-implants with Twin-Block in functional treatment.

Eligibility Criteria:
Inclusion Criteria:

1. The wrist radiograph (stage 4 S and stage 5 MP3 cap)
2. Skeletal Class II division 1 malocclusion caused by mandibular retrusion
3. ANB (5°- 9°)
4. SNB (72°- 77°)
5. overjet (5 - 8 mm),
6. Minimal crowding in dental arches (≤ 3 mm),
7. MM≤30°
8. lower second molars erupting.

Exclusion Criteria:

1. Previous orthodontic procedures.
2. Systemic diseases.
3. Temporal Mandibular Joint disorders.
4. Poor oral hygiene