cyrilzakka/clinical-trials huggingface dataset:
Substantial Equivalence Study for Kai Sensors RSpot Non-Contact Respiratory Rate Spot Check

The purpose of this study is to determine whether the respiratory rate provided by the Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is as accurate as that provided by the Welch Allyn Propaq Encore model 242 and the Embla Embletta system with Universal XactTrace respiratory effort sensor and Somnologica for Embletta software.

Currently, medical professionals obtain respiratory rate for vital signs assessments either by counting the number of breaths during a 15, 30, or 60 second interval and multiplying to obtain breaths per minute, or by reading the respiratory rate off of a multiparameter vital signs monitor (such as a Welch Allyn Propaq Monitor), that provides respiratory effort information based on the change of AC impedance through ECG leads. The Respiration channel (RESP) of the Welch Allyn Propaq is intended to detect the rate or absence of respiratory effort, deriving the signal by measuring the AC impedance between the selected terminals of the ECG electrodes. The RSpot 100 Non-Contact Respiratory Rate Spot Check provides an alternative to the medical professional counting respiratory rate or reading the rate from a vital signs monitor designed for continuous respiratory rate monitoring. The Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is used for a one-time measurement of respiratory rate as part of a vital signs assessment in the hospital or other clinical settings.

In this study, the RSpot is operated simultaneously with two other systems that provide a respiratory rate: Welch Allyn Propaq Encore model 242 and Embletta system with Universal XactTrace and Somnologica software. A respiratory rate is also obtained by counting respiratory excursions for the same duration as the RSpot measurement interval, 15, 30, or 60 seconds. The rates obtained from each of the four measurement methods are then compared.

Eligibility Criteria:
Inclusion Criteria:

* Adult \>18 years old
* Hospitalized on Tower 6 or Pauahi 6 or Pauahi 4
* Clinically stable
* Able to provide informed consent

Exclusion Criteria:

* Clinically unstable

  1. Hypotensive requiring pressors or intra-aortic balloon pump
  2. Intubated
  3. Dyspnea or chest pain at rest
  4. Resting tachycardia (heart rate \>100 bpm)
  5. Requires supplemental (e.g., nasal canula or face mask) oxygen
* Scheduled or planned (e.g., CT scan, central line placement) procedure during the 30 minute study period
Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery

The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥12 years (only 18 and above in Russia)
* Documented diagnosis of congenital fibrinogen deficiency, expected to require on-demand treatment for bleeding or surgical prophylaxis:
* Fibrinogen deficiency manifested as afibrinogenaemia or severe hypofibrinogenaemia.
* Historical plasma fibrinogen activity of \<50 mg/dL or levels below the limit of detection of the local assay method.
* Expected to have an acute bleeding episode (spontaneous or after trauma) or planning to undergo elective surgery.
* Informed consent signed by the subject or legal guardian.

Exclusion Criteria:

* Life expectancy \<6 months.
* Bleeding disorder other than congenital fibrinogen deficiency, including dysfibrinogenaemia.
* Prophylactic treatment with a fibrinogen concentrate.

Treatment with:

* Any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks prior to start of treatment for the bleeding episode or surgery.
* Any coagulation-active drug (i.e., non-steroidal anti-inflammatory drugs, warfarin, coumarin derivatives, platelet aggregation inhibitors) within 1 week prior to start of treatment for the bleeding episode or surgery, or as a planned or expected medication during the time period from Day 1 until 24 hours (i.e., 1 day) after the last Octafibrin infusion.

Presence or history of:

* Hypersensitivity to study medication.
* Deep vein thrombosis or pulmonary embolism within 1 year prior to start of treatment for the bleeding episode or surgery.
* Arterial thrombosis within 1 year prior to start of treatment for the bleeding episode or surgery
* Hypersensitivity to human plasma proteins.
* Oesophageal varicose bleeding.
* End-stage liver disease (i.e., Child-Pugh score B or C).

Pregnant women within the first 20 weeks of gestation.

Currently breast-feeding.

Known positive HIV infection with a viral load \>200 particles/μL or \>400,000 copies/mL.

Polytrauma 1 year prior to start of treatment for the bleeding episode or surgery.

Diagnosis or suspicion of a neutralizing anti-fibrinogen inhibitor currently or any time in the past.

Acute or chronic medical condition which may, in the opinion of investigator, affect the conduct of the study, including

* Subjects receiving immune-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to \>10 mg/day), or similar drugs at study start.
* Subjects having evidence or a history (within the previous 12 months) of abuse of any licit or illicit drug substance.

Participation in another interventional clinical study currently or during the past 4 weeks.
Pilot Trial of the First Conversational Agent for Smoking Cessation (QuitBot)

Conversational agents (CAs) are computer-powered digital coaches designed to form long-term social-emotional connections with users through conversations. We have developed a CA for cigarette smoking cessation. In a pilot randomized trial (N = 415), we will compare the experimental messaging program (n = 155) with the standard of care national government smoking cessation messaging program (n = 157), and then we will compare immediate (n=51) versus delayed (n=51) access to the the experimental messaging program, to assess 12-week usability, receptivity, and preliminary cessation results in adults in western Washington State and nationally across the US who want to quit smoking.

Cigarette smoking is the most preventable cause of cancer in the US, accounting for one-third of all cancer deaths. Within the Fred Hutchinson Center's western Washington State 13-county catchment area, there are enormous disparities in adult cigarette smoking rates. Our recently completed WebQuit website RCT for smoking cessation had low engagement and no personalization to users' needs. Fortunately, a potentially game-changing solution to the problems of engagement and lack of personalization provide a new direction for my research. Advances in machine learning, natural language processing, and cloud computing are making it possible to create and widely disseminate conversational agents (CAs), which are computer-powered digital coaches designed to form long-term social-emotional connections with users through conversations. We have developed a CA for cigarette smoking cessation. In a pilot randomized trial (N = 415), we will compare the experimental messaging program with the standard of care national government smoking cessation messaging program, and then we will compare immediate versus delayed access to the the experimental messaging program. Twelve-week usability, receptivity, and preliminary cessation results will provide critical and timely pilot data.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* smokes at least five cigarettes daily for at least past 12 months
* wants to quit cigarette smoking in the next 14 days
* if concurrently using any other nicotine or tobacco products, wants to quit using them within the next 14days
* resides in western Washington State (in the following counties: Clallam, Grays Harbor, Island, Jefferson, King, Kitsap, Mason, Pierce, San Juan, Skagit, Snohomish, Thurston, and Whatcom)
* interested in learning skills to quit smoking
* willing to be randomly assigned to either condition
* has at least daily access to their own personal smartphone
* has and uses both text messaging and Facebook Messenger on their smartphone
* willing and able to read in English
* not using other smoking cessation interventions (including apps or our other intervention studies).
* willing to complete one 3-month follow-up survey
* willing to provide email, phone, and mailing address.

Exclusion Criteria:

* The exclusion criteria are opposite of the inclusion criteria listed above.
Etomidate Versus Propofol in CABG Surgery

The objective of this single-blinded randomized controlled interventional clinical trial is to learn about the efficacy and long-term safety of etomidate compared to propofol as an anesthesia induction agent in patients undergoing coronary artery bypass graft (CABG) surgery. The primary aim of this study is to determine whether patients receiving etomidate or propofol exhibit similar requirements for vasopressor or ionotropic agents during both the intraoperative and postoperative periods.

To achieve this goal, participants who are scheduled for CABG surgery will be randomly assigned to receive either etomidate or propofol as the principal hypnotic agent. The researchers will then compare the effects of these two anesthesia induction agents on various factors, including the need for hemodynamic support, hemodynamic stability, duration of mechanical ventilation, length of stay in the intensive care unit (ICU), and overall hospital length of stay. Additionally, they will assess whether there are disparities in mortality rates and readmission rates within a 6-month timeframe after the surgery.

By comparing the outcomes between the two groups, the study aims to provide valuable insights into the potential differences in vasopressor or ionotropic agent requirements between etomidate and propofol. This information can help inform clinical decision-making and potentially optimize anesthesia management strategies for patients undergoing CABG surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for elective open coronary arteries bypass graft CABG surgery
2. Patients with American Society of Anesthesiology (ASA) physical status score I- IV
3. Patients with the ability to speak and read both English and Spanish

Exclusion Criteria:

1. Emergency CABG surgery, STAT cases, and add-on cases.
2. Refusal or lack of providing the study consent
3. Patients with a known current adrenocortical insufficiency
4. A patient who is presenting with any kind of shock, (e.g. septic, hypovolemic, cardiogenic, etc.)
5. Patients with chronic steroid use (defined as the use of glucocorticoids within 6 months preoperatively)
6. Patients with a known allergy to etomidate or propofol.
7. Patients with a known seizure disorder.
8. Patients who are enrolled in other clinical research studies that can compete with this study.
CO2-Patterns During Hyperoxia and Physical Exercise in COPD

The aim of the study is to investigate a possible correlation between the change in PCO2 during a hyperoxia-test and the change in PCO2 during walking in people with COPD

Rationale:

Carbon dioxide partial pressure (PCO2) varies significantly in patients with advanced chronic obstructive pulmonary disease (COPD). Data from the Swedish LTOT Registry showed that PCO2 is an independent predictor for mortality and that there is a U-shaped relationship. Patients with advanced COPD who are still normocapnic at rest may still develop a clinically relevant, exercise-induced carbon dioxide (CO2) retention during exercise/ activity. It is also known that altered breathing patterns at night in COPD patients can lead to nocturnal hypercapnia, especially during REM sleep. The course of PCO2 cannot be reliably predicted by lung function parameters or resting blood gas analysis. Since exercise tests with blood gas control or nightly PCO2 monitoring are rarely performed in clinical routine, exercise induced CO2 retention often remains undetected. In the literature, there is little information on PCO2 behaviour under everyday conditions (with or without LTOT) such as rest, physical exertion and nightly sleep. Therefore, predictors that could describe the PCO2 patterns are missing. However, one former study by O'Donnel from 2002 showed that the change in CO2 under hyperoxia conditions could provide predictive information for the change in CO2 with exercise.

Objective:

Primary aim of this study is to investigate whether the change of PCO2 during a hyperoxia-test (10l/min O2 at rest) correlates with the change of PCO2 during walking exercise with either a: l/min O2 as prescribed; b: medical air; c: 10l/min O2.

Design:

This study is a randomized, controlled cross-over trial. Following an initial maximal incremental shuttle walk test (ISWT), the participant will perform 3 endurance shuttle walk tests (ESWT) at 85% of the maximum ISWT pace on three consecutive days (24h break between ESWTs). In a randomized order, participants will perform one ESWTs with O2-flow as prescribed (e.g. study day 1), one with medical air (same flow rate as prescribed oxygen) (e.g. study day 2) and one with 10l/min O2 (e.g. study day 3). An additional hyperoxia test (10l/min O2 for ten minutes; at resting condition) will be perfomed on each day prior to performing an ESWT.

Eligibility Criteria:
Inclusion Criteria:

* COPD III/ IV
* 35mmHg \< PCO2 \<= 55mmHg (under resting conditions, breathing room air)
* Hypoxemia (PaO2\<60mmHg) under room air conditions (rest or during exercise) or SpO2 \<88% during exercise
* established oxygen therapy or given indication for oxygen therapy
* written informed consent

Exclusion Criteria:

* acute exacerbation of COPD
* exercise limiting cardiac or orthopedic comorbidites
* PaO2 \<50mmHg at rest, breathing room air
Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases

This clinical trial evaluated the safety and tolerability of CRS-100, an investigational agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is attenuated by genetic modification to limit cell to cell spread and invasion of liver cells. These attenuations result in decreased virulence of CRS-100 in mice but retain the ability of the investigational agent to stimulate immunity in test animals and generate anti-tumor activity in mice. The primary objective of this study was to determine the maximum tolerated dose (MTD) and to explore the safety profile of a single intravenous dose of CRS-100 in consenting volunteers. Immunological response to CRS-100 and tumor status of study participants were also measured. Participation in this first clinical trial with CRS-100 was restricted to adults with carcinoma refractory to standard treatment (or for whom no standard treatment is available) and who additionally had liver metastases.

Patients who consented to participate in the study were evaluated for eligibility according to their medical history, physical examination, blood testing, and computed tomography (CT) scan of thorax, abdomen, and pelvis. Those patients who qualified for the study received a single intravenous dose of CRS-100 on study day 1, after which they remained in the hospital for five days for safety monitoring of health status, including serial blood collections. Study participants returned for out-patient follow-up for further blood tests and additional monitoring of safety and immune response to CRS-100. At day 56, after administration of CRS-100, participants had a repeat CT scan to measure tumor size, and they were then discharged from the study.

Eligibility Criteria:
Inclusion Criteria (abbreviated):

1. Documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). Hepatocellular carcinoma (HCC) is not allowed.
2. Hepatic metastases
3. ECOG Performance Status of 0 or 1, or Karnofsky Performance Status (KPS) of 80% to 100%.
4. Adequate organ function as defined by clinical hematology and chemistry assays.

Exclusion Criteria (abbreviated):

1. Known central nervous system metastases.
2. History of allergic reactions attributed to sulfa or beta-lactam antibiotics.
3. Cardiac conditions associated with high- or moderate-risk of endocarditis.
4. Intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.
5. Artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed.
6. Known coagulation disorder or recent thromboembolic event.
7. Use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days prior to CRS-100; bone marrow or stem cell transplant or a major organ allograft; autoimmune disease.
8. Current history of gallstones or kidney stones.
9. Infection with HIV, human t-lymphotropic virus type 1 (HTLV-1), hepatitis c virus (HCV), or hepatitis b virus (HBV).
10. Pregnant or lactating
A Comparison of Two Contact Lenses

This study seeks to evaluate the clinical and subjective performance of two established soft contact lenses.


Eligibility Criteria:
Inclusion Criteria:

1. They are of legal age (18 years) and capacity to volunteer.
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
7. They are pregnant or lactating.
8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
10. They have diabetes.
11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Opportunistic Pneumococcal Immunisation Trial in MALnutrition

The goal of the OPTIMAL clinical trial is to learn if a dose of a pneumococcal conjugate vaccine (PCV) generates a good immune response in young children who are in hospital with severe acute malnutrition.

Researchers will compare an intervention group who get a dose of a PCV (Pneumosil) to a control group who get a dose of a Typhoid conjugate vaccine (Typbar TCV).

Participants will be visited monthly at their homes for six months after vaccination, and then once more at 12 months after vaccination. At the end of their involvement in the study participants will be offered a dose of the vaccine they did not get while in hospital.

This is a prospective, single-centre, double-blind, randomised controlled trial in 264 children aged 6-59 months hospitalised with severe acute malnutrition.

Participants will be randomised (1:1) to receive either a dose of a pneumococcal conjugate vaccine (Pneumosil, the intervention group) or a dose of a Typhoid conjugate vaccine (Typbar TCV, the control group). Stratification for randomisation will be done on (a) prior immunisation with a PCV (confirmed or unknown/unvaccinated); and (b) severity of malnurition (weight-for-height/length z-score \<-4 or \>=-4). Participants will be enrolled as soon as practical after admission to hospital, while randomisation and vaccine administration will occur once the participant is medically stable in the 'transition phase' of SAM care.

The primary objective is to demonstrate that immune responses to the 10 pneumococcal serotypes in Pneumosil are better in participants whoh receive Pneumosil, compared to those who receive Typbar TCV, when measured 6 months after vaccination.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 6-59 months at the time of hospitalisation
2. Hospitalised with severe acute malnutrition:

   1. weight-for-length/height z-score \<-3; or
   2. middle upper arm circumference \<11.5cm; or
   3. bilateral pitting pedal oedema unexplained by other causes
3. Parent/carer is willing for their child to participate in the study and has provided informed consent
4. Parent/carer is willing to comply with all study procedures outlined in the protocol, including specimen collection, for the duration of the study

Exclusion Criteria:

1. Known history of allergy or hypersensitivity to any component of either study vaccine, including diphtheria toxoid, or a history of anaphylactic shock.
2. Treatment with another investigational drug or other intervention in the 30 days prior to randomisation, or ongoing participation in another clinical trial.
3. Suspected primary or secondary immunodeficiency or prolonged administration (\>14 days) of an immune modifying drug (including oral glucocorticoids) in the past 3 months.
4. Known terminal illness expected to result in death within 6 months.
5. Participants who, in the opinion of the site Principal Investigator, are unable to comply with the study protocol, including scheduled visits, assessments, and any other protocol-required procedures.
6. Previously enrolled in this trial.
Efficacy and Safety of Transarterial Therapies+Donafenib + Anti-PD-1 Antibody for uHCC: A Retrospective Real-world Study

This Retrospective Real-world study was designed to evaluate the clinical efficacy and safety of the Combination of transarterial therapies with donafenib plus Anti-PD-1 Antibody for Unresectable Hepatocellular Carcinoma.

Data of Patients who have received Triplet therapy ( transarterial therapies+donafenib+Anti-PD-1 Antibody）will be collected，excluding incomplete data.

The primary endpoint was the objective response rate (ORR)，Secondary endpoints included disease control rate (DCR), progression-free survival rate (PFSR) \[ Time Frame: 6- and 12-month\], overall survival rate (OSR) \[ Time Frame: 6- and 12-month\], the median progression-free survival time (mPFS) and median overall survival time (mOS)， as well as adverse event.

Eligibility Criteria:
Inclusion Criteria:

1. clinically or histopathologically diagnosed HCC;
2. not suitable for curative surgery, or local ablation;
3. age 18\~75 years；
4. Barcelona Clinic Liver Cancer (BCLC) Stage-B or C HCC; 5) Child-Pugh score A or B7; 6) Eastern Cooperative Group (ECOG) performance status ≤1.;

7）no serious heart, lung, or renal dysfunction； 8）at least 1 measurable lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)

Exclusion Criteria:

1）comorbidity with other severe systemic diseases; 2）life expectancy is less than 3 months; 3) discontinuation of treatment for personal reasons or inability to tolerate; 4）incomplete data.

-