cyrilzakka/clinical-trials huggingface dataset:
Effect of the SCOT-HEART 2 Trial on Lifestyle.

This study will recruit 400 participants who are taking part in the Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (SCOT-HEART 2) trial. The investigator will assess diet, activity and habits at the start of the study and 6 months later. This will help us understand the effects taking part in the study may have on lifestyle. In addition, for participants who have CT scans, the investigator will present the results of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to patients.

This is a sub-study of the SCOT-HEART 2 trial (which aims to determine the best way to prevent heart attacks).

The purpose of this sub-study is to determine the effect of getting information on heart disease risk on lifestyle. At present doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the SCOT-HEART 2 study the investigator will compare this "risk score" to a specialised heart scan (a computed tomography coronary angiogram or CTCA scan). In this study the investigator would like to understand more about the effects of receiving this information about the heart on lifestyle, including effects on smoking, diet and activity.

This study will recruit 400 participants who are taking part in the SCOT-HEART 2 trial. The investigator will assess lifestyle by using a detailed questionnaire which will be done at the start of the study and 6 months later. The investigator will also perform some simple investigations including a carbon monoxide breath test, blood pressure tests and measurements of activity such as step counts. This will help us understand the effects on lifestyle of getting information about a "risk score" or having a CT scan. In addition, for people who have CT scans the investigator will either provide a verbal explanation of the results, as is usual, or show pictures of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to partipants.

Eligibility Criteria:
Inclusion Criteria:

* MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Exclusion Criteria:

* MUST BE ENROLLED IN SCOTHEART 2 TRIAL
Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head

The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting and surgical bypass are currently the two competing treatment options. There is currently no randomized trial comparing the recently developed metal stents to surgical bypass. Furthermore, there is very limited data on quality of life of these patients receiving either therapy. While endoscopic stenting represents the less invasive treatment, surgery may provide better long-term control requiring one-time treatment. Due to the incomplete evidence the present randomized controlled trial is designed to compare quality of life of patients undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused by cancer of the pancreatic head requiring with low bile duct obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Age equal or greater than 18 years
* Diagnosis of unresectable cancer of the pancreatic head (after clinical, laboratory, radiological assessment) requiring palliative treatment for biliary obstruction. In unclear cases an exploratory laparotomy will be performed and resectability will be evaluated intraoperatively
* Operability certified by anesthesiologist
* Written informed consent

Exclusion Criteria:

* Intervention technically/medically not feasible
* Expected lack of compliance
* One treatment option considered to be clearly in favor of the patient
Validation of a French-version of the Leeds Food Preference Questionnaire in Normal Weight and Patients With Obesity

While Food reward is an important component of the appetite control to consider, there is actually no tool that has been developed in French to perform its evaluation.

The Leeds Food Preference Questionnaire (LFPQ) is a validated and recognized tool to assess food reward, being however developed for British populations.

The aim of this work is to validate a French version of the LFPQ among lean and obese adults.

50 lean and 50 patients with obesity between 20 and 55 years old (50% women and 50% men), will be recruited. After an evaluation of their body composition by impedance meter, and of their dietary status by questionnaires (TFEQ/DEBQ), they will be asked to perform twice the same experimental sessions. They will be asked during this session to arrive at 08:00 am after a 12-hour fast and will receive a calibrated breakfast. Before and after a lunch calibrated meal, they will be asked to perform the French version of the computerized questionnaire LFPQ. Appetite feelings will be assessed at regular intervals.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 30 and 38 kg.m² for the obese patients and 20 and 25 for the lean ones.
* registered to the national social security system
* Signed consent

Exclusion Criteria:

* eating disorders
* metabolic disease such as hypertension and Type 2 diabetes
Reducing Delay in Vaccination of Children: Logistic Barriers

This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.

Parents of children less than 11 months of age will be identified as delayed or missing vaccinations due to logistic barriers in the Kaiser Permanente Colorado population. Parents identified will be randomized to the intervention arm or the usual care arm. Those in the intervention arm will receive automated reminders for the 6 month and 12 month vaccine visits. Reminders will include scheduling information as well as access to a website with vaccine and scheduling information. They will also have an opportunity to provide preferences in how they receive the automated reminders (text, phone or email). There will be 2 reminders before the 6 and 12 month visits and 2 after the 6 and 12 month visits. Parents will be excluded from receiving reminders if they have received vaccines within the time frame when they are eligible to receive another vaccine or have a well child visit scheduled.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children less than 11 months of age
* Currently enrolled at Kaiser Permanente Colorado at the time of identification
* The child is missing recommended vaccinations

Exclusion Criteria:

* Non-english speaking
* diagnosis code indicating parent vaccine refusal
Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures

The purpose of this study is to monitor the use in routine clinical practice of REKOVELLE®. This study will collect information from patients who never underwent previous in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatments for up to three consecutive treatment cycles.

The ovarian stimulation protocol with REKOVELLE®, a new recombinant human Follicle Stimulating Hormone (FSH) prescribed for ovarian stimulation, is individualised with a dosing regimen that is based on two parameters: the body weight and the level of a hormone, the Anti Müllerian Hormone, (AMH), a parameter used to predict how the ovaries will respond to the ovarian stimulation.


Eligibility Criteria:
Inclusion Criteria: Patients who meet all of the following criteria are eligible for participation:

* Females are prescribed REKOVELLE® for their first in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor
* Willing and able to provide written informed consent

Exclusion Criteria: Patients who meet any of the following criteria are not eligible for participation:

* Participating in an interventional clinical trial in which any treatment or follow-up is mandated
* Women with a contraindication for prescription of REKOVELLE® treatment
* Oocyte donors
* Women undergoing ovarian stimulation for fertility preservation
Mouse Allergen and Asthma Intervention Trial

The MAAIT is a randomized, controlled trial of a home intervention to reduce mouse allergen exposure in mouse allergic children with asthma and mouse allergen exposure. Participants will be randomized to either the Integrated Pest Management (IPM) Group or the Education Group. The IPM Group will receive professional mouse abatement, education, two HEPA filters, allergen-proof mattress and pillow encasements, and targeted cleaning. The Education Group will receive education about IPM at the beginning of the trial and then after completion of the trial, will receive the IPM intervention. Participants will be followed for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* persistent asthma
* exacerbation, previous 12 months
* evidence of mouse sensitization
* high levels of mouse allergen in home
* ages 5-17 years

Exclusion Criteria:

* intermittent asthma
* no exacerbation in previous 12 months
* not sensitized to mouse
* low or undetectable mouse allergen in home
* other lung disease aside from asthma
A Genetic Linkage Study of Schizophrenia

We propose to study 900 sib-pairs with the disorder. Our Specific Aims are: 1) To clinical assess a pedigree sample having adequate power to detect genes for schizophrenia. 2) To conduct a genome scan to find such loci. 3) To transmit all data to the NIMH designated cell repository and data management centers. We will attain these goals by achieving the following: 1) From Taiwan and China, we will collect 900 Han Chinese sib-pairs having DSM-IV schizophrenia. 2) We will examine all family members using the Diagnostic Interview for Genetic Study and the Family Interviews for Genetic Study. The PI participated in the development and field testing of these interviews and has an already established training program for their use. They have been translated into Mandarin by the Taiwanese investigators, who have used them in prior studies. 3) Blood samples will be sent to the NIMH designated cell repository for creation of lymphoblastoid cell lines. 4) Clinical Data will be entered using the database software created for the NIMH Human Genetics Initiative. Data will be vetted and sent to the NIMH designated data management center. 5) We will complete a genome scan using 450 markers spaced at an average of 10 cM intervals using markers that have been optimized for use in the Han Chinese population. The scan will be completed with no cost to the NIMH through an agreement with Millennim Pharmaceuticals, a biotechnogy company in the the Boston area that the PI has worked with on a prior genetic linkage study of schizophrenia. All genetic analyses will be approved by our consultant, Eric Lander, PhD. 6) All clinical data will be made available to the scientific community by the end of the funding period. All genotypes wil be available one year after they are created but no later than a year after the funding period. This project as feasible because 1) The PI has already coordinated one multi-site genetic linkage study of schizophrenia and has participated in a second. 2) We have a long-standing relationship with our Taiwanese collaborators and an effective, albeit, more recent working relationship with our Chinese collaborators. 3) We have conservatively estimated that each site has access to more than enough available families having two schizophrenic siblings. 4) The PI's Harvard team has had prior experience collaborating on genotyping and linkage analysis projects with Millennium Pharmaceuticals. This, and Millennium's prior genotyping experience shows that the genotyping phase of the work is feasible.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia
* Han Chinese population
* Two Schizophrenia siblings, one normal parent and one normal sibling
High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients

The incidence of pulmonary complications such as pulmonary atelectasis, pneumonia (including ventilator-associated pneumonia), and acute respiratory failure is high in critical care patients. The incidence of ventilator-associated pneumonia can be as high as 27% amongst mechanically ventilated patients. Studies have shown that 16% of critically ill patients have been reported to develop acute respiratory failure, which is associated with prolonged intensive care unit stay, resulting in significantly higher mortality than non-respiratory failure patients. Increased morbidity and mortality contribute to the burden on the health care system and lead to poor health-related outcomes. Multimodal physiotherapy plays a role in the management of these critically ill patients. High frequency percussive ventilation (HFPV) is used in patients with underlying pulmonary atelectasis, excessive airway secretions, and respiratory failure. HFPV is a non-continuous form of high-frequency ventilation delivered by a pneumatic device that provides small bursts of sub-physiological tidal breaths at a frequency of 60-600 cycles/minute superimposed on a patient's breathing cycle. The high-frequency breaths create shear forces causing dislodgement of the airway secretions. Furthermore, the HFPV breath cycle has an asymmetrical flow pattern characterized by larger expiratory flow rates, which may propel the airway secretions towards the central airway. In addition, the applied positive pressure recruits the lung units, resulting in a more homogeneous distribution of ventilation and improved gas exchange. In acute care and critical care settings, HFPV intervention is used in a range of patients, from spontaneously breathing patients to those receiving invasive mechanical ventilation where HFPV breaths can be superimposed on a patient's breathing cycle or superimposed on breaths delivered by a mechanical ventilator. The most common indications for HFPV use are reported as removal of excessive bronchial secretions, improving gas exchange, and recruitment of atelectatic lung segments. This study aims to assess the lung physiological response to HFPV in terms of aeration and ventilation distribution.


Eligibility Criteria:
Inclusion Criteria:

* more than 48 hours of invasive mechanical ventilation
* presence of tracheostomy
* need for two or more broncoaspirations per hour in the previous 8 hours

Exclusion Criteria:

* life threatening cardiac arrythmia
* pneumothorax
* acute spinal injury
* chest trauma
* brain injury in the previous 15 days
* hemodynamic instability
* chest or abdominal surgery in the previous 7 days
* pregnancy
* enrollment in other study protocols
Clinical Study for Combined Analysis of CTC and Exosomes on Predicting the Efficacy of Immunotherapy in Patients With Hepatocellular Carcinoma

This project intends to perform CTC PD-L1 imaging, exosomal PD-L1 protein detection, and exosomal LAG-3 protein detection, so as to resolve the functional marker profiles of immunotherapy in the peripheral blood of HCC patients and comprehensively present the responsiveness of patients to immunotherapy.

Liquid biopsy methods such as PD-L1 of CTC, number of peripheral immune cells and their subtypes, and exosomal PD-L1 provide a dynamic monitoring strategy for immunotherapy evaluation. Monitoring CTC and immune-related functional markers in peripheral blood can dynamically reflect the multi-dimensional characteristics of tumor microenvironment, comprehensively represent the response of patients to immunotherapy, and provide a new strategy of companion diagnostics for immunotherapy in HCC. This project intends to perform CTC PD-L1 imaging, exosomal PD-L1 protein detection, and exosomal LAG-3 protein detection, so as to resolve the functional marker profiles of immunotherapy in the peripheral blood of HCC patients and comprehensively present the responsiveness of patients to immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* having signed informed consent
* clinically or pathologically confirmed hepatocellular carcinoma;
* liver tumor load not exceeding 50% of liver volume;
* expected survival ≥ 12 weeks;
* vital organ function meeting enrollment criteria; and (6) no need for pregnancy.

Exclusion Criteria:

* Patients who have been diagnosed with malignant tumors of other systems or organs;
* Patients with hematologic disorders and extreme physical failure;
* Patients with immune deficiencies or organ transplants;
* Other conditions deemed by the investigator to be inappropriate for participation in this study.
The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer

The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer

The study is a multicenter, prospective clinical study, expected to include subjects who visited the selected research center from April 2024 to March 2026, underwent radical tumor resection surgery, and were pathologically diagnosed with pancreatic adenocarcinoma. The subjects are divided into two groups. One group is the standard chemotherapy group, with a planned inclusion of no less than 428 subjects. The chemotherapy will be treated using the Class 1A chemotherapy regimen recommended by the 2022 version of the CSCO guidelines; One group is the Huaier treatment group, with a planned inclusion of no less than 214 subjects. All subjects voluntarily give up the postoperative adjuvant treatment recommended by the guidelines and only choose Huaier granules for postoperative adjuvant treatment. A total of no less than 642 subjects are planned to be included.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 18 to 80 years old, regardless of gender;
* Pancreatic cancer was diagnosed by histopathology after radical surgery within 12 weeks before enrollment;
* Did not receive neoadjuvant therapy before surgery and did not receive any adjuvant therapy after surgery;
* ECOG score 0-3 points;
* Those who choose to use standard chemotherapy independently based on their own situation, or choose Huaier granules for subsequent treatment, voluntarily participate in and cooperate with various research work, including but not limited to cooperating with treatment and follow-up, cooperating with researchers for data collection, and not actively taking other treatments.
* The subjects voluntarily signed a written informed consent form before participating in this study.

Exclusion Criteria:

* Known to be allergic to the components of Huaier granules or to avoid or use Huai er granules with caution (Huaier group);
* Difficulties in taking oral medication due to active gastrointestinal bleeding, perforation, gastric paralysis, etc;
* Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study.
* History of merging with other malignant tumors;
* Patients with concomitant myocardial infarction, cerebral infarction, and other thromboembolic diseases requiring surgical treatment;
* Concomitant severe infection;
* Child Pugh C-grade liver function, renal function 2-5 grades (glomerular filtration rate\<90ml/min);
* Pregnant or lactating women or those planning to conceive;
* The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect, chemotherapy or physical therapy in the past 4 weeks(including but not limited to compound cantharidin capsules, cinobufotalin capsules, Kangai injection, please refer to the drug instructions for details).
Population Pharmacokinetics of Teicoplanin, Levofloxacin, Piperacillin/Tazobactam, Meropenem, Vancomycin, Remifentanil, Cefepime, Cefpirome, Sufentanil, Midazolam, Clopidogrel, Ticagrelor, Prasugrel During Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)

Extracorporeal membrane oxygenation (ECMO) is the device which increases the supply of oxygen to the body tissues in vitro and to assist in heart and lung function. Venoarterial (VA) ECMO is used in patients with cardiogenic shock, cardiac arrest, ventricular arrhythmia and is able to secure a time to self-recovery by reducing the excessive stimulation applied to the heart. However, in ECMO patients, pharmacokinetics of drugs are changing such as increased volume of distribution (Vd) or decreased clearance (CL). For this reason, it is hard to provide the best treatment in ECMO patients. The study is to evaluate whether the PK of drugs is influenced by VA ECMO and to recommend the optimal dosing strategies for proposed drugs in adult patients receiving VA ECMO.


Eligibility Criteria:
Inclusion Criteria:

* patient who are ≥ 19 years old and receiving VA ECMO in Severance Hospital, Yonsei University Health System.
* patient who are receiving one of these drugs: teicoplanin or levofloxacin or piperacillin/tazobactam or meropenem or vancomycin or remifentanil or cefepime or cefpirome or sufentanil or midazolam or clopidogrel or ticagrelor or prasugrel
* patients who are agreed to participate in this study

Exclusion Criteria:

* patients who are pregnant
* patients who are receiving drugs that could affect study drug's concentration due to drug-drug interaction.
Do Changes in Plasma Osmolality Influence Ventilation?

Primary hypothesis: osmolality changes influence the sensitivity of the respiratory center to carbon dioxide, hyponatraemia causing hyperventilation, and hypernatraemia depressing ventilation.

Secondary hypothesis: There are gender differences in the sensitivity to osmolality changes.

10 women and 10 men will on different occasions drink water or receive hypertonic saline intravenously, in order to lower or increase plasma osmolality. The women will participate during both faces of the menstruation cycle. On each occasion the subject´s sensitivity to carbon dioxide will be tested, and blood samples will be drawn for analysis of blood gases,electrolyte and osmolality.Subjects who interrupt participation before completion of all planned occasions, will be substituted, so that 10 subjects of either sex will have participated as planned. All results from all participants will be analyzed.

Healthy volunteers will on different occasions be subject to reduced plasma osmolality caused by drinking water, and increased osmolality caused by intravenous infusion of hypertonic saline.Before and after each osmolality change, sensitivity to carbon dioxide will be tested by partial rebreathing through a so called Bain-system. Throughout the whole experiment heart rate, blood pressure and oxygen saturation will be recorded.Blood samples will be collected before each rebreathing test and every 20 minutes during the two hours of water or salt load. Urine will be collected and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Females with regular menstruations, males

Exclusion Criteria:

* Consumption of nicotine, BMI \> 26,
* pregnancy,any hormone treatment,
* treatment with diuretics,
* diabetes or kidney disease,
* BMI \> 26,