cyrilzakka/clinical-trials huggingface dataset:
Integration of a Trained Language Model to Improve Glycemic Control Through Increased Physical Activity: a Fully Digital My Heart Counts Smartphone App Randomized Trial

Type 2 diabetes (T2D) is one of the most common and fastest growing diseases, affecting 1 in 8 adults (nearly 800 million) worldwide by 2045. Sedentary behavior and increased adiposity are major risk factors for T2D. Cardiovascular disease is the leading cause of death in those with T2D, while diabetic microvascular disease, causing kidney disease, neuropathy, and retinopathy, contributes to T2D morbidity.

Physical activity is one of the most potent therapies in preventing/treating T2D and its complications. Mean daily steps is a proxy for physical activity, with even modest improvements in step count (i.e., +500 steps) associated with decreased T2D and mortality. However, adherence to regular physical activity remains low in T2D patients, with short-term decreases in daily step count associated with impaired glycemic control and T2D recurrence.

The investigators have developed an artificial intelligence (AI) language model (similar to ChatGPT), which can automatically generate coaching prompts to encourage physical activity by incorporating an individual's stage of change. The investigators will extend our research using the My Heart Counts (MHC) smartphone app to 1) validate the efficacy of the AI-generated prompts in patients with T2D and 2) perform a longer-term randomized crossover trial using the language model as a social accountability chatbot - encouraging participants to maintain their physical activity changes over months. The investigators hypothesize that my AI-assisted coaching prompts will significantly increase 1) mean daily step count by 500 steps in 1,000 adults recruited nationwide over a 7-day period, and 2) improve HbA1c and weight via long-term behavior change over a 24-week intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged ≥18 years old, with a clinical diagnosis of T2D, able to read and understand English, and who are physically able to walk, will be included in our study

Exclusion Criteria:

* Criteria that fall outside of the inclusion criteria.
Test of Excessive Anesthetic Fresh Gas Flow Alerting in the Electronic Medical Record to Reduce Excessive Fresh Gas Flow

The primary objective of this quality improvement intervention is to test the efficacy of excessive fresh gas flow alerting in the electronic medical record for anesthesia providers.


Eligibility Criteria:
Inclusion Criteria:

* Anesthesia provider using electronic medical record at study site

Exclusion Criteria:

* None
Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure

This is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure

LBBAP-AFHF is a prospective, multicenter, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may show superiority of improved LV function as compared with traditional biventricular pacing (BiVP) in patients with permanent atrial fibrillation and heart failure (LVEF\<50%) who receive atrioventricular nodal ablation due to fast ventricular rate or require high percentage of ventricular pacing due to slow ventricular rate. The primary endpoint of this trial is the change in the LVEF at 6 months after device implantation from baseline. A CRT-P/D device would be implanted and LBBAP lead would be connected to the RA port and LV lead to the LV port. Patients who receive successful LBBAP and BiVP simultaneously during the procedure would be 1:1 randomized to LBBAP or BiVP group after the procedure by device programming. Patients will be followed at 3 and 6 months post-discharge for LVEF and other echographic parameters (including LVESV, response rate), and rehospitalization for heart failure or all-cause death.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged more than 18 years old
* Patients diagnosed with heart failure (LVEF\<50%) and have received optimal medical therapy for at least 3 months
* Patients with permanent atrial fibrillation (QRS duration \<130ms) which need ventricular pacing, including:

  1. LVEF\<50%, NYHA II-IV, drug-refractory atrial fibrillation with the fast ventricular rate, planned atrioventricular nodal ablation due to 1). anticipated low success rate of atrial fibrillation catheter ablation or 2). patients refused to receive catheter ablation or 3). refused to receive another catheter ablation after a previous history of failed procedures
  2. LVEF\<50%, NYHA II-IV, atrial fibrillation with slow ventricular rate, anticipated ventricular pacing burden ≥ 40%
* Written informed consent was provided

Exclusion Criteria:

* expected survival time is less than 12 months
* Prior history of mechanical tricuspid valve replacement and/or congenital heart disease (including dextrocardia, transposition of the great arteries, single left persistent left superior vena cava, etc.)
* Plan for PCI or CABG due to unstable angina or myocardial infarction in 3 months
* Surgery is required within 1 year due to severe structural heart disease
* Pregnancy, planned pregnancy or heart transplant
* Prior history of HCM and/or ventricular septal defect repair, who are unlikely to achieve successful LBBAP procedure.
* Failure of lead placement due to abnormal anatomy of the coronary sinus or enlarged right atrium, which makes it unable to switch from one pacing modality to another
A Bioequivalence Study Comparing Two Different Tafamidis Formulations

Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis blood concentrations will be measured periodically for one week. After about 20 days, subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis concentrations from the two different formulations will be compared to determine if they are approximately the same.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 Kg and total body weight more than 50 Kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.
Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients

To evaluate if adjuvant concurrent chemoradiotherapy is associated with a recurrence-free survival benefit in comparison with radiotherapy alone in selected intermediate risk cervical cancer after radical surgery.

Adjuvant therapy for patients with cervical cancer (CC) with intermediate-risk factors remains controversial. According to result of GOG 92 trail, adjuvant radiotherapy significantly improved recurrence-free survival in early stage cervical cancer with intermediate risks (Sedlis criteria). However, significant heterogeneity exists in Sedlis criteria, high risk of relapse and death occurred in patients with (1) lympho-vascular space invasion(LVSI+) and deep 1/3 stromal invasion;(2) LVSI(+) and middle 1/3 stromal invasion, and tumor size≥4cm when compared with other factors. In addition, multiple studies have confirmed that (3)non-squamous histology is an independent prognostic factor in early stage cervical cancer, who might be benefited from adjuvant concurrent chemoradiotherapy. As a result, The objective of the trial is to evaluate if adjuvant concurrent chemoradiotherapy is associated with a recurrence-free survival benefit in comparison with radiotherapy alone in selected intermediate risk cervical cancer after radical surgery. The primary endpoint of the study is the recurrence-free survival from the day of randomization.

Eligibility Criteria:
Inclusion Criteria:

* • 18 Years to 80 Years

  * Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy
  * Accepted radical hysterectomy 3-4 weeks before
  * Karnofsky score \>70
  * Postoperative pathology with one of the three risk factors criterials: (1) lympho-vascular space invasion(LVSI+) and deep 1/3 stromal invasion; (2 ) LVSI(+) and middle 1/3 stromal invasion, and tumor size≥4cm (3)Non-squamous cell carcinoma;
  * Examination results showed no radiation or chemotherapy contraindication
  * Willing to accept treatment
  * Ability to comply with trial requirements

Exclusion Criteria:

* • Postoperative residual

  * Postoperative recurrence or metastasis
  * Pelvic lymph node metastasis
  * parametrial invasion
  * positive surgical margin
  * Without lymph node dissection
  * Postoperative pathology showed aortic lymph node metastasis
  * Examination results showed radiotherapy contraindications
  * No indications for radiotherapy
The China M-protein Screening Project in First-degree Relatives of Myeloma Patient - The CHAPERONE Study

The goal of the China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) study is to assess the clinical significance of screening for monoclonal gammopathy (M-protein) in first-degree relatives of patients with multiple myeloma in China population, and establish a prospective cohort of individuals with monoclonal gammopathy of undetermined significance (MGUS), a precursor conditions to multiple myeloma. We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.

The CHAPERONE study aims to assess the clinical significance of screening for monoclonal gammopathy in first-degree relatives of patients with multiple myeloma in China.

The main objectives it aims to answer are:

* Main research objectives: To study the prevalence of MGUS, the time of disease progression, and its influencing factors in first-degree relatives of multiple myeloma patients in China.
* Secondary study objective: To explore the clinical/genomic/epigenetic features, survival, and quality of life of MGUS patients in first-degree relatives of multiple myeloma patients in China.

All participants will receive M-protein screening by serum electrophoresis. Individuals with detected M-protein will undergo further diagnostic tests, and patients with MGUS will be carefully assessed and followed up.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female over the age of 18;
2. First-degree relatives (including parents, children, and biological siblings) have multiple myeloma diagnosed by the International Myeloma Working Group (IMWG) Myeloma Diagnostic Criteria;
3. Understand the purpose and procedure of this trial and voluntarily participate in this screening study;
4. Participants should be willing and able to follow the study follow-up plan and other protocol requirements.

Exclusion Criteria:

Patients with a known diagnosis of plasma cell diseases, such as MGUS, smoldering myeloma (SMM), or multiple myeloma
Characterization of the Gastrointestinal Microbiota in Newborn Infants

The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain.

The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria for the pregnant person:

  1. Healthy pregnant person in gestational week 36+0-38+0
  2. Age ≥ 18 years
  3. Normal singleton pregnancy
  4. Ability to read and speak Danish
  5. Normal ultrasound scan of the fetus at gestational age 19-20 weeks
  6. Plan to exclusively breastfeed
  7. Provided voluntary written informed consent.
* Inclusions Criteria for the newborn:

  1. Born at full-term ≥37+0
  2. Birth weight above 2500 g
  3. APGAR score of at least 7 within the first 5 min of life.

     Exclusion Criteria:
* Exclusion Criteria for the pregnant person:

  1. Pregnancy at over 38+0 weeks' gestation at recruitment
  2. Multiple pregnancy
  3. Pregnancy with any fetal abnormality
  4. Alcohol or drug abuse
  5. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
  6. Any contraindications for breastfeeding.

Exclusion Criteria for the newborn :

1. Congenital disorders that could affect their safety or the study outcome
2. Admission to Neonatal Intensive Care Unit for more than 24 hours
3. Participation in another clinical intervention study which can interfere with this probiotic intervention
4. No other probiotics than the study product.
Comparison Trial for Chloraprep Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia

A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.

A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.

The patients will assigned to the treatment group depending on where and when they are treated (site A or site B) and will continue the treatment until the end (continuous design): the patients of Site A will receive the first treatment option and those of Site B will receive the second treatment option during the first 6 months. After this, a rest period of 1 month will be established, during which patients will not be recruited and any of the two cutaneous aseptic methods will be used indiscriminately, in the opinion of the responsible nursing staff. After the resting period, the treatments will be reversed during the following 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU.
* Patients with age greater than or equal to 18 years.
* Patients who require at least one central venous catheters during 48h or more.
* Obtaining informed consent.

Exclusion Criteria:

* Intolerance or known allergy to chlorhexidine, isopropyl alcohol or orange yellow S (E110).
* High probability of death within 48 hours after admission.
* Use of coated catheter.
* Previously included in the study.
Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals

This study will determine the effectiveness of total sleep deprivation (TSD) for one night plus paroxetine versus either TSD plus placebo or paroxetine alone in inducing rapid symptom resolution of major depression in the elderly.

The clinical response to antidepressant treatment in the elderly is variable and often slow, and difficult to predict reliably before 4-5 weeks of treatment. The delayed onset of antidepressant activity is particularly problematic in the elderly, prolonging the duration of suffering and disability, reducing compliance, and increasing the risk for attempted and completed suicide.

This study seeks to develop a method for effective rapid treatment of major depressive episodes in the elderly and to improve early identification of treatment non-responders, by combining sleep deprivation (for one night) and paroxetine as probes of treatment response and treatment resistance.

This is an experimental study that is randomized, double-blind, and placebo-controlled. We will recruit 158 elderly depressed patients with current major depressive episodes and randomly assign 36 patients to each of three interventions: 1)TSD + paroxetine; 2)TSD + placebo; and 3)paroxetine alone without TSD). The duration of the experimental phase of the study is 17 days: 3 days for pre-treatment sleep studies and 14 days for initial paroxetine or placebo treatment under double-blind conditions.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00177294

http://clinicaltrials.gov/show/NCT00178074

Eligibility Criteria:
Inclusion Criteria:

* Age 60 and older
* Current episode of unipolar, major depression
* HRSD (17 item)score of 15 or higher
* Folstein Mini-Mental Status exam score of 17 or higher

Exclusion Criteria:

* Lifetime diagnosis of any psychotic disorder
* Lifetime diagnosis of bipolar disorder

  _Alcohol or drug abuse within the past 6 months
* Contraindication to treatment with SSRI therapy
* History of seizure disorder
* Baseline apnea/hypopnea index of 20 or higher
* Hyponatremia
A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020)

This study will evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of ertugliflozin following oral administration of unlabeled ertugliflozin (MK-8835) and intravenous (IV) and oral administration of 14\^C-labeled ertugliflozin in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 65 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs.)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies).
* Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
* A positive urine drug screen for drugs of abuse or recreational drugs.
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
* History of abuse of alcohol or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
* Current smokers and those who have smoked any substance within the last 12 months.
* Treatment with an investigational drug within 1 month preceding the first dose of study medication.
* Have participated in any clinical study with exposure to 14\^C in the last 12 months.
* Any radiation exposure, including that which is projected to result from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures. No occupationally exposed worker, as defined in the Ionising Radiation Regulation 1999, shall participate in the study.
* Use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days prior to the first dose of study medication.
* Use of herbal supplements within 28 days prior to the first dose of study medication.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
* Participants who have previously participated in a clinical trial for ertugliflozin.
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
The Study of Microglia/Macrophages Involved Dynamic Evolution of Glioma Microenvironment and the Function and Visualization of Targeted Molecules of Glioma

establishment of glioma microenvironment cell dynamic evolution database reveal the mechanism of GIM promoting malignant transformation of glioma cells reveal the dynamic regulation process of immune cells in the process of glioma evolution

To collect tissue samples from different stages of glioma evolution and establish a high-quality high-throughput sequencing database of immune microenvironment cells, so as to lay a data foundation for later mining the dialogue mechanism and key targets between immune cells and tumor cells in glioma microenvironment.

Based on the analysis results of the above database, the key role of key target molecules in the dialogue between GIM and glioma cells and the regulation ability of immune cells in the immune microenvironment were confirmed through cell and mouse animal experiments, which laid the foundation for later targeted drug research and development.

Combined with fluorescence imaging technology, through in vivo imaging of mice, it can provide more intuitive and effective visual verification for the dynamic infiltration process of GIM and other immune microenvironment cells in the process of glioma evolution, and provide a new theoretical basis for the visualization research of dynamic regulation of glioma immune microenvironment cells.

Eligibility Criteria:
Inclusion Criteria:

* The patients with glioma in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled

  1. They were 18-80 years old, male and female;
  2. The pathological results of frozen section during operation were gliomas (20 cases of who grade II, II and IV, respectively);
  3. Tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
  4. Sign informed consent.

Exclusion Criteria:

* Patients who meet any of the following criteria will not be included in this study:

  1. Participants in other clinical trials;
  2. Pregnant women.
Treating Post-Operative Thirst With Flavoured Ice Lollies or Water - a Comparative Study to Improve Post-operative Discomfort

Patients are asked not to eat and drink before their operation, and we know that this can make people feel thirstier when they wake up from their anaesthetic. We want to know if giving patients ice lollies improves their thirst more than if they were given water. Gloucestershire Royal Hospital is funding and running a research study to find ways to try and improve this.

The 2019 peri-operative quality improvement project (PQIP) run by the Royal College of Anaesthetists showed 79% of patients experience moderate to severe thirst post-operatively. As a significant source of post-operative discomfort, resolving patient thirst may significantly improve their experience.

Whilst provision of oral fluids may be able to alleviate some thirst, many patients are unable to drink sufficient quantities to quench their thirst following an anaesthetic. Furthermore, studies have shown that frozen water is able to quench thirst to a greater degree than liquids.

The purpose of this study is to determine whether ice lollies quench post-operative thirst to a greater degree than water. Patients are already routinely offered water post-operatively, the offering of flavoured ice lollies is a novel intervention for our hospital. We intend to investigate two primary outcomes. First, can ice lollies quench post-operative thirst to a greater degree than water and therefore improve patient discomfort. Second, if ice lollies are found to be superior to water in quenching thirst and improving post-operative discomfort, do these patients take less time to recover from their operation?

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age
2. Patients attending for elective surgery

Exclusion Criteria:

1. Allergy to products within the ice lolly
2. Designated nil-by-mouth by anaesthetic or surgical teams
3. Patient less than 18 years old
4. Patient unable to give consent
5. Refusal of patient to be involved with study