cyrilzakka/clinical-trials huggingface dataset:
Pilot Study Using a Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Hemodialysis Ultrafiltration

The purpose of this study is to use the photo-plethysmographic \[PPG\] waveform signal to guide the dialysis and ultrafiltration \[UF\] of chronic maintenance hemodialysis patients, and to further the investigators understanding of homeostasis in hemodialysis.

The investigators hypothesize that the signals generated from the PPG device along with traditional monitoring and nursing judgment, will allow experienced, oriented staff to anticipate hemodynamic instability, intervene to prevent or mitigate the intradialytic hypotention \[IDH\], forestalling the onset of non-facilitating compensatory reflexes that preclude the patient from achieving an appropriate post-dialysis weight consistent with euvolemia. Furthermore, it is hypothesized that the nephrologist and staff will be able to wean patients from anti-hypertensive medications and craft patient specific dialysis orders and UF profiles that achieve consistent, comfortable treatment to appropriate end points.

The study aims include:

Aim 1: To confirm the temporal sequence of PPG signals and changes in BP in routine hemodialysis.

Aim 2: To refine further the predictive algorithms of PPG, augmented with continuous cardiac event monitoring (pre-intra-post hemodialysis) Aim 3: To develop targeted interventions to reverse the cardiovascular stress indicated by the PPG and to maintain perfusion.

Aim 4: To develop care paths approved by the medical staff and primary care nephrologist allowing RNs to respond to signals from the PPG.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. On dialysis \> 6 months with a stable dialysis program
3. Consistent achievement of a spKt/V ≥ 1.2
4. HGB ≥ 10 gm% ± ESA support
5. Consistent failure to achieve a post weight ≤ dry weight + 0.5Kg
6. Able to give informed consent directly
7. Frequent hypotensive reactions (≥ 1 / treatment in 4 of last 8 treatments)

   * Symptoms of hypotension
   * Intervention administered because of IDH (saline, "turn downs, early termination, trendelenberg position)
   * Drop in BP irrespective of symptoms. SBP \< 90 mmHG intra or post HD if pre SBP was \> 110 mmHG; SBP \< 85 mmHG or 15 mmHG drop from start if starting BP ≤ 110 mmHG.
   * Or judged by the nursing staff to be difficult to achieve dry weight.

Exclusion Criteria:

1. Dialysis Catheter Access that may interfere with continuous data collection, per PI determination. (Catheter access is a relative exclusion based on the history of catheter performance.)
2. Cognitive Impairment precluding cooperation, and consent
3. Restless or unlikely to wear the monitor head-band
4. Too unstable in the judgment of their nephrologist to be included in a study of this nature.
On Dose Efficiency of Modern CT-scanners in Chest Scans

CT scans of the chest / thorax are of great importance both in the initial diagnosis and in the follow-up of pulmonary or thoracic diseases. As an example, CT angiography of the pulmonary arteries (CTPA) is worldwide considered to be gold standard test in patients with a suspicion for pulmonary embolism.

The aim of this study is to measure and compare dose efficiency of modern CT scanners for unenhanced and contrast-enhanced scan protocols of the chest/thorax. Patients who are referred for a CT of the chest/thorax will be randomly assigned to one of the three CT scanners currently in use at our institution.


Eligibility Criteria:
Inclusion Criteria:

* patient is referred for an unenhanced CT OR contrast-enhanced CT of the chest/thorax confirmed by a board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND
* patient is at least 18 years of age AND
* patient (is able to give informed consent and) has given informed consent.

Exclusion Criteria:

* high degree of medical urgency (i.e. patient cannot be consented for iv contrast according to routine procedures)
* known or suspected pregnancy, or lactating . contraindications for contrast agent (renal failure, allergy, hyperthyroidism)
Electroacupuncture Treatment of Behavioral and Psycological Symptoms in Patients With Alzheimer's Disease

This study aims to establish a prospective case registration research platform for electroacupuncture in treating behavioral and psychological symptoms in patients with mild to moderate Alzheimer's disease, and to investigate the dose-effect relationship and cost-effectiveness of electroacupuncture for these symptoms.

To establish a prospective case registration research platform aimed at treating mild to moderate Alzheimer's disease patients presenting with behavioral and psychological symptoms. This platform will document the electroacupuncture treatment process, conduct regular assessments using neuropsychiatric questionnaires (NPI) and the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Scale (ADAS-CGIC), and compare the effects of different parameters, treatment frequency, and duration of electroacupuncture on therapeutic outcomes for various behavioral and psychological symptoms in Alzheimer's disease patients. Furthermore, it aims to investigate the influencing factors of electroacupuncture treatment for behavioral and psychological symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for AD in the NIA-AA standard;
2. Clinical dementia rating scale ≤2 points;
3. Accompanied by at least one psychobehavioral symptom, NPI：frequency × degree ≥1 point;
4. Sign informed consent.

Exclusion Criteria:

1.There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal
Changes in Perioperative Blood Volume and Fluid Distribution in Patients Undergoing Primary Total Hip Replacement.

Clinical assessment of bleeding and calculation of perioperative blood loss do not provide an accurate estimate of blood volume. This makes rational fluid management difficult, which is of high importance for patient-related outcomes. The availability of carbon monoxide(CO)-rebreathing allows for simple, non-invasive and precise measurement of changes in blood volume.

The purpose of the study is to investigate and describe changes in blood volume and fluid distribution perioperative in patients undergoing total hip arthroplasty. Furthermore, to investigate the association between changes in blood volume and incidence of orthostatic insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for an elective total hip arthoplasty (THA) in a standardized fast track setting.
* Capable of participating in CO-rebreathing measurement
* Age ≥ 18 years
* Able to speak and understand Danish
* Has provided written informed consent.

Exclusion Criteria:

* Intraoperative blood loss exceeding 750 mL.
* Perioperative need for a blood transfusion.
* Confirmed or suspected coagulopathies.
* Factors that make CO-rebreathing measurement impossible.
* Known orthostatic intolerance.
* American Society of Anesthesiologists physical status (ASA) classification ≥ 4.
Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.

The primary objectives of this study were to assess the immunogenicity and the tolerance of the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age) with sickle cell disease when administred at 2,3, and 4 months of age.


Eligibility Criteria:
Inclusion Criteria

Infants with neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin electrophoresis.

Exclusion Criteria

Previous immunization with pneumococcal-containing vaccines.

History of pneumococcal invasive disease (meningitis, bacteremia, pneumonia).

Known or suspected impairments of the immune system (including HIV infection) or recipients of immuno-suppressant agents.

Other Exclusions apply.
Burden, Mortality and Supply Costs in Intensive Care Unit Patients

This study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs).

This study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs).

The 3 endpoints and 3 respective risk groups (high, intermediate, low) are

1. Endpoint burden of care due to Clinical Frailty Scale (Frailty) high 7 - 9 intermediate 5 - 6 low 1 - 4
2. Endpoint mortality due to severity of disease regarding Simplified Acute Physiology Score (SAPS) II score values high SAPS II \> 70, suspected mortality \> 40% intermediate SAPS II \> 40 - 70, suspected mortality 10 - 40% low SAPS II ≤ 40, suspected mortality \< 10%
3. Endpoint supply costs due to number of organ systems to be supported or replaced high ≥ 3 organ systems replaced intermediate 1 - 2 organ systems replaced low 0 - 2 organ systems replaced

Eligibility Criteria:
Inclusion Criteria:

* All patients dying on the ICU and all patients staying for at least 72 hours on the ICU

Exclusion Criteria:

* No
Media and Social Networks Consultation and Associated Factors Among Orthodontic Patients

"Context : An increasing number of patients are using the internet and social media to obtain information about oral health, including the field of orthodontics.

Aim : This study aimed to analyze the behavior and habits of patients regarding the use of social media to obtain information about orthodontics, as well as the factors associated with this usage.

Materials and methods : The study was designed as a single-center, cross-sectional, descriptive study. Orthodontic patients filled out a 28-question questionnaire that gathered demographic data, information-seeking behavior, platform use and online consultation habits, trust and impact, and interest in additional resources. A univariate and multivariate logistic regression models/analysis were conducted using Excel and IBM SPSS Statistics Version 29.0.1.0, (employing Chi2, Fisher's exact tests, univariate and multivariate models)."


Eligibility Criteria:
Inclusion Criteria:

- All patients, whether adults or minors accompanied by their legal representative, who consulted in the orthodontics unit, and had access to the internet.

Exclusion Criteria:

- All patients who declined to participate.
Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C

This study evaluates the incidence of monoclonal B-cell lymphocytosis MBL) in patients with chronic hepatitis C and to determine if monoclonal b-cell lymphocytosis is affected by treatment for hepatitis C.

PRIMARY OBJECTIVES:

I. To determine the prevalence of MBL in patients with chronic hepatitis C who are to begin therapy with directly acting antiviral (DAA), and compare with clinic controls who are seen in the general medicine clinic at Mayo Clinic.

II. To determine the correlation between the specific subtype of MBL (CD5- MBL, atypical CLL-phenotype MBL and CLL-phenotype MBL) relative to the hepatitis C virus (HCV) genotype.

III. To assess the proportion of individuals with MBL who have an improvement in the circulating monoclonal B-cell population following therapy with DAA.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and have medical records reviewed throughout study.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with chronic hepatitis C who are to begin therapy with DAA

  * Willing to submit a peripheral blood sample at baseline, end of therapy, 12 weeks after the end of therapy, and 52 weeks from baseline

Exclusion Criteria:

* Individuals with chronic hepatitis C who have cirrhosis

  * Individuals with chronic hepatitis C who have a past history of a lymphoproliferative disorder AND for which they received chemotherapy
Extracorporeal Elimination of Cytokines Following Abdominal-thoracic Esophagectomy

This study evaluates the effect of extracorporeal removal of inflammatory mediators on the systemic inflammation reaction of patients admitted to the intensive care unit following elective esophagectomy. Half of the participants will be treated with an adsorption device (CytoSorbents Adsorber), while the other half will be treated according to standard care. Significant reductions of interleukin-6 plasma concentration, SOFA score and catecholamine dosage in the intervention group are expected.

Radical esophagectomy combined with extensive lymphadenectomy for esophageal cancer is one of the most invasive surgical procedures. Even with progress made in surgical technique and postoperative management the rate of short- and long term complications remains high. The surgical trauma invariably causes liberation and activation of inflammatory mediators and danger associated molecular patterns, which in turn result in a pronounced systemic inflammatory reaction, leading to multiorgan dysfunction including adult respiratory distress syndrome (ARDS) in many patients. The subsequent counter regulation of the immune system induces immune paralysis, which is followed by infectious complications and increases the probability of severe sepsis. Moreover, severe systemic inflammation causes capillary leakage, resulting in impaired wound healing and endangered anastomoses.

Therefore, it seems that early and effective measures against the excessive production of mediators and cytokines are indicated without impairment of the innate and adaptive immune response as it would be expected with the administration of e.g. steroids. Instead, the removal of an excessive amount of circulating cytokines might be a desirable method having shown its effectivity in the therapy of septic shock in the past.

The aim of this study is to demonstrate the effectiveness of extracorporeal cytokine removal to dampen the systemic inflammatory response following abdominal-thoracic esophagectomy.

Eligibility Criteria:
Inclusion Criteria:

* abdominal-thoracic esophagectomy with radical lymphadenectomy
* post operative admission to ICU
* age \>= 18 yrs
* written informed consent

Exclusion Criteria:

* Participation in another interventional trial
* pregnancy or lactation
* systemic medication with high dose steroids and/or immunosuppressants and/or radiotherapy during the last 3 months
* known diseases of the immune system (benign and malign)
* contraindications for extracorporeal therapy
* Thrombocytopenia \< 50\*10\^9/l
* therapy limitations (DNR), moribund status
* missing informed consent
Reduction of Prehospital Delays in Stroke and Transient Ischaemic Attack (TIA)

In patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. The aim of the present study was to reduce prehospital delays in a population-based intervention.The intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS). The investigators additionally included a bookmark and sticker with the EMS telephone number. A total of 75,720 inhabitants received the intervention. Between 2004 and 2005, 741 patients with cerebrovascular events were admitted from the control areas (n=24) and 647 from the intervention areas (n=24).

Background and Purpose:

In patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. The aim of the present study was to reduce prehospital delays in a population-based intervention.

Methods:

We performed a cluster-randomized trial with 48 zip code areas as cluster units in the catchment area of three inner-city hospitals in Berlin. The primary endpoint was time between symptom onset and hospital admission. The intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS). We additionally included a bookmark and sticker with the EMS telephone number. We fitted a lognormal survival regression model (time-to-admission) with frailty terms shared by inhabitants of the same zip code area.

Eligibility Criteria:
Inclusion Criteria:

* All patients with stroke or transient ischaemic attacks from the postal code areas of the study being admitted to one of the participating hospitals

Exclusion Criteria:

* Patients with stroke or transient ischaemic attacks from outside the postal code areas of the study
Simultaneous Care: Linking Palliation to Clinical Trials

This is a multi-site randomized control trial taking place at six cancer centers. UC Davis is the lead site. Additional performance sites include the City of Hope Medical Center, Fred Hutchinson Cancer Center at the Univ. of Washington, USC Norris Cancer Center, UCSD Cancer Center, and Johns Hopkins Cancer Center. Clinical trial patients and their caregivers who are randomized to the intervention arm of the study are scheduled for three educational sessions. The sessions focus on teaching problem solving skills based on the COPE problem solving model.

The project introduces and evaluates the effects of a Simultaneous Care Education Intervention, using the COPE model (Creativity, Optimism, Planning and Expert Information) developed by D'Zurilla and Nezu, as one of its key components for cancer patients in Phase I, II and III clinical trials. The SCEI team will use the COPE problem solving educational model to instruct patients on how to problem solve and manage challenges associated not only with the investigational therapy, but also the psychosocial issues that arise from cancer diagnosis, disease progression, treatment, and disease or treatment related symptoms. The educational intervention also sets up a system for regularly contacting the patient and caregiver in order to reinforce what is taught. Patients and caregivers randomized to the intervention arm will receive three education sessions. Patients and designated caregiver will be asked to complete the set of measurement tools approximately every 30 days while enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* English speaking, must have caregiver who is willing to participate, must be entering a phase 1-3 oncology clinical trial. Must be able to complete first educational session on or before treatment start date. Solid tumor or lymphoma only.

Exclusion Criteria:

* Non-English speaking, no caregiver available, unable to complete first educational session on or before treatment start date.
HFNC Versus Conventional Nasal Cannula in Oxygen Performance in Patients Receiving Colonoscopy Under IV Sedation

The purpose of this study is to investigate if high flow nasal cannula (HFNC), as compared to conventional nasal cannula, improves oxygenation and prevents desaturation events in obese patients undergoing colonoscopy.

Intravenous sedation during colonoscopy has become the standard practice in United States given its higher patient satisfaction and procedural quality. The most common used short acting sedative agent is propofol. Although possessing safe and rapidly reversed pharmacokinetic properties, propofol intravenous infusion can lead to respiratory depression and hypoxemia. In one prospective study, hypoxemia events, defined by oxygen saturation less than 90 percent was found in 20 percent of patients receiving colonoscopy using propofol sedation. The mechanism of hypoxemia is mainly hypoventilation, airway collapse, and carbon dioxide (CO2) retention. When it comes to gastrointestinal procedures, using oxygen devices for augmenting ventilation is usually avoided, ex: positive pressure ventilation, since it can lead to bowel distention and affect quality of procedures. Therefore most hospitals in United States still use nasal cannula of oxygen therapy during gastrointestinal procedures, and there is lack of available options of oxygen therapy which can improve hypoventilation and prevent hypoxemia.

High flow nasal cannula (HFNC) is a new generation of oxygen therapy. It provides constant high flow oxygen delivery with heated and humidified air. Moreover, it has been studied that high velocity of airflow can create the effect of "positive end expiratory pressure" thus assist ventilation and work of breathing. Compared to conventional nasal cannula and face mask, HFNC has demonstrated superior performance in oxygenation, work of breathing and patient comfort in many studies. Since its invention, HFNC has been studied in post-cardiac surgery, post-extubation, bronchoscopy and dental procedures and all of them show equal to better oxygen performance in comparison of nasal cannula.

While capnographic monitoring has been studied to prevent hypoxemia during sedation, no studies have been done to evaluate the clinical utility of new generation oxygen therapy. Obesity is associated with increased frequency of sedation related complications especially hypoxemia during propofol mediated sedation for advanced endoscopic procedures. The Investigators hypothesized that HFNC may improve oxygen performance compared to conventional nasal cannula for obese patients receiving colonoscopy under intravenous sedation.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30.
* Age ≥ 18 years.
* ASA classification II and III.
* Scheduled for colonoscopy.
* Able to provide written informed consent.

Exclusion Criteria:

* Allergic to propofol and any of its contents.
* Baseline SpO2 less than 93%.
* Patients who require intubation for airway protection based on anesthesiologist discretion.
Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.

Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \[1\] and aflibercept \[2\] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound \[3\] is that it extends the injection interval in the Treat and Extend (T\&E) protocol, which is more extensive than with previous anti-VEGF agents.

The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.

As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient of legal age (≥18 years) with exudative AMD treated with IVT ranibizumab or aflibercept \> 1 year.
* Patient whose IVT injection interval is strictly less than 12 weeks.

Exclusion Criteria:

* Severe myopia (axial length \> 26 mm or sphere \< - 6 dioptres).

  * Presence of angioid striae.
  * Presence of moderate or more severe diabetic retinopathy.
  * History of diabetic macular edema.
  * History of uveitis.
  * Previous retinal vein occlusion (branch or central vein).
  * History of pseudovitelliform macular dystrophy.
  * Patient under guardianship or trusteeship
  * Pregnant or breast-feeding woman