cyrilzakka/clinical-trials huggingface dataset:
Differences in Access to Emergency Paediatric Intensive Care and Care During Transport

There are fewer than 30 paediatric intensive care units (PICUs) in the United Kingdom (UK). This means that a critically ill child taken to their nearest hospital will need to be transferred to a PICU. Such transports are usually done by PICU retrieval teams (PICRTs), mobile teams who take specialist expertise to the child and safely transport them to a PICU.

There are national variations in how PICRTs are organised and deliver clinical care. There has been little research into these differences and how they might influence outcomes and experiences for sick children and families. The investigators do not know if national variation in how PICRT services are organised and delivered matters, or whether current standards help achieve the best outcomes for patients. This clinical study aims to understand how existing differences in access to paediatric intensive care and care provided by PICRTs affect clinical outcomes and experiences for transported critically ill children and families. The investigators will analyse routine national audit data to examine various aspects such as how long it takes a PICRT to reach the patient, how long it takes the child to reach the PICU, the seniority of clinicians performing the transport, medical procedures performed by the PICRT and any critical incidents during transport, and investigate whether any of these factors influence how likely a child is to survive. The investigators will also collect and analyse information about the experiences of sick children by interviewing the families involved, and staff experiences of PICU retrieval by interviewing clinicians. Alongside this work, the investigators will look at the costs of different ways of delivering PICRT services for sick children, and use mathematical techniques to study if and how alternate models of service delivery can improve clinical outcomes in a cost effective manner. The research team in this trial includes PICU and transport clinicians, parents, academic experts and an National Health Service (NHS) commissioner.

Independent committees consisting of clinicians and parents will be formed to oversee the study. The work from this study will directly inform the development of evidence-based national standards for PICU transport and help improve the patient experience for critically ill children and their families.


Eligibility Criteria:
Inclusion Criteria:

* Children and young people (age \<16 years) transported by a PIC retrieval team for emergency admission to a paediatric intensive care unit in England and Wales.

Exclusion Criteria:

* None
Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies

Pneumoperitoneum created during laparoscopic surgeries has some effects on human physiology. Increased intraabdominal pressure results in increased intrathoracic pressure, and eventually may result in increased intracranial and intraocular pressures. In this study we aimed to identify intraocular and intracranial pressure changes during the perioperative period due to the pneumoperitoneum created for laparoscopic cholecystectomy surgeries. Intraocular pressure will be measured directly from the eye. Intracranial pressure will be estimated by measuring optic nerve sheath diameter changes ultrasonographically.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) 1 or 2 physical status patients
* Elective surgeries

Exclusion Criteria:

* Patients with glaucoma
* ASA 3 or above patients
* Emergency surgeries
Nutritional Improvement in Chronic Heart Failure Patients

To assess the effect over the nutritional status in patients who are malnourished with chronic heart failure, of an educational intervention and the provision of nutritional supplements. Randomized clinical trial with blind assessors. Unicentric. Follow up: 12 months

Randomized clinical trial with blinded evaluators. (The evaluators will not know the group the patients are assigned. Blinded evaluators are no responsible for randomization and intervention once the patients have been randomized). Patients will be recruited from the cardiology inpatient unit of tertiary hospital, before discharge. Patients will be divided in two groups randomly:

In one arm will be held a double intervention:

* A structured educational intervention oriented to the patient and primary caregiver, with respect to dietary habits, highly energetic and healthy food, the frequency and manner of eating, exercise and programming breaks.
* supplementation with dietary supplements, distinguishing one type of product or another, depending on whether the subject to study: diabetes and or kidney failure.

In the other arm of the study was carried out regular interventions

Eligibility Criteria:
Inclusion Criteria:

* adult patients with the diagnosis of heart failure: who inadvertently lost at least 5% of their "dry weight" in the last six months and / or moderately or severely malnourished according to the GSA and / or at risk or malnourished according to Mini Nutritional Assessment.
* Willing to participate by accepting and signing an informed consent.
* On treatment with inhibitors of angiotensin converting enzyme (ACE) inhibitors and / or antagonists of angiotensin II receptors (ARBs) and / or beta blockers.

Exclusion Criteria:

* Concurrent active cancer diagnosed.
* Previous history Dementia or severe cognitive impairment.
* Participation in another clinical trial simultaneously.
* Social or health condition that makes the patient impossible to follow the treatment.
Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg

To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese males
* BMI ［body weight in kg /(height in m)2］ of at least 18.5 kg/m2 and less than 25.0 kg/m2 (as a result of at the screening examination)
* Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial

Exclusion Criteria:

* Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator, subinvestigator, or sponsor may place the subject at risk or interfere with outcome variables such as drug absorption, distribution, metabolism, and excretion
* History of serious mental disorder
* History of drug or alcohol abuse within 2 years prior to screening
* History of any significant drug allergy
* Use of another investigational drug within 120 days prior to the first administration of IMP
* Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, Star fruit, or Star fruit products within 72 hours prior to the first administration of IMP or consumption of alcohol within 72 hours prior to administration of IMP
* Use of prescription, over-the-counter (OTC), or herbal medication, or vitamin supplements, or consumption of food or beverages containing St. John's Wort within 14 days prior to the first administration of IMP, or use of antibiotics within 30 days prior to the first administration of IMP
* History of major surgery of the digestive tract (excluding appendectomy)
* Any subject who, in the judgement of the investigator or subinvestigator, should not participate in the trial
Acute Exposure of High Altitude on Cognitive Function

Randomized crossover Trial in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to High Altitude (2500m above sea level) on cognitive functions

Low altitude baseline measurements will be performed in Zurich (460m) including Echocardiography, Right heart catheterization, 6 Minute walk test, pulmonary function test, clinical assessment and blood gas analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

During the exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hour, the participants will perform cognitive function test .

The results will be compared to low altitude in Zurich (470m).

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding
Daily Monitoring of Exhaled Nitric Oxide in Asthmatic Patients

Previous studies have demonstrated that exhaled nitric oxide can be useful to monitor the efficacy of anti-inflammatory treatment as well as to predict a risk of asthma relapse in asthmatic patients.

The aim of the present study is to evaluate the time course of exhaled nitric oxide in mild asthmatic patients, stopping regular treatment with inhaled corticosteroids, if it is possible, in relationship with symptoms and lung function.

All patients were evaluated with pulmonary lung function, exhaled nitric oxide and peak expiratory flow (PEF) and fill in a personal diary for the first two weeks when patients are in treatment; the same evaluation will be made for other four weeks without treatment.

Eligibility Criteria:
Inclusion Criteria:

* mild asthmatic treated with low dose inhaled steroids for whom it has to be considered stop of steroid treatment according to GINA guidelines

Exclusion Criteria:

* age \< 5 years
* chronic respiratory diseases
Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes

The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.

The overall goal of this project is to further understand the impact of hormonal status on glycemic metrics and to test personalized changes to insulin dosing, through implementing the following specific aims:

Specific Aim 1: Using CGM, examine glucose levels among women with T1D by menstrual cycle phase over a three month period to establish baseline glycemic variability, to identify personalized patterns of glycemic control across the menstrual cycle phase, and to test glycemic responses to acute bouts of aerobic, interval and resistance training.

Specific Aim 2: Using the data from the observational period, examine patterns of glycemic variability by menstrual cycle phase in order to determine the appropriate alteration to insulin delivery needed to improve glycemic control across the menstrual cycle among women with T1D

Specific Aim 3: Test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase in a randomized intervention and control group. We will also examine responses to daily activity, planned exercise activities, and acute bouts of aerobic, interval and resistance exercise.

Eligibility Criteria:
Inclusion Criteria:

* Women 18-45 who have had type 1 diabetes for at least 12 months
* Premenopausal with either menstrual cycles or currently using oral contraceptives

Exclusion Criteria:

* Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy
Effect of Oxidized Plant Sterols on Serum Concentrations of Plant Sterol Oxidation Products (POP)

The study is a randomised, double-blind, placebocontrolled, parallel dose-response study with four study arms. Sixty subjects will be randomly allocated to consume study products containing varying amounts of plant sterol (PS) oxidation products (POP) or placebo for 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and women as judged by study physician.
* BMI \> 18 and \< 35 kg/m2.
* Total cholesterol levels at screening ≥5.0 and ≤8.0 mmol/L
* Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the study physician.

Exclusion Criteria:

* Recently (\<6 months) diagnosed with cardiovascular event(s) (stroke, TIA (Transient ischemic attack), angina, myocardial infarction, heart failure), revascularization or systemic inflammatory conditions.
* Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study.
* Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, angiotensin receptor blockers (ARB) and ACE (Angiotensin-converting enzyme) inhibitors)), to be judged by the principal investigator.
* Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to Day -2.
* Pregnant or lactating women.
* Reported alcohol consumption \> 14 units/week (female) or \> 21 units/week (male).
* Reported intense sporting activities \> 10 hours/week.
* Reported weight loss or gain of 3 kg or more during a period of 6 months prior to screening.
* Currently on a medically- or self-prescribed diet, or slimming diet, or the intention to use any kind of diet during the study.
* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.
Applicability of Cellular Application in Diabetes Type 2 Patients.

It was found that an important part of the factors impeding adherence to medication and a healthy lifestyle among the chronically ill diabetic patients lies in proper management of the disease. Since it is a chronic progressive disease the caregiver is the patient himself.Studies have shown that software system, sending text messages / messages / reminders daily and answering questionnaires can improve adherence to a change in lifestyle.

This study is an initial pilot study , which examines Feasibility ( Applicability ) of using a smart application that promotes a healthy lifestyle perseverance parallel use relaxation techniques .


Eligibility Criteria:
Inclusion Criteria:

* HbA1c above 7.5.
* Smartphone users.
* English and Hebrew literate.

Exclusion Criteria:

\*Pregnancy
Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: a Pilot Study Protocol

Endocrine therapy represents a foundational approach for managing hormone receptor-positive breast cancer, with treatment typically spanning 5 to 10 years. Although its clinical efficacy is well-established, medications like aromatase inhibitors frequently result in musculoskeletal (MS) complications, such as joint discomfort, stiffness (especially in the morning), carpal tunnel syndrome, tenosynovitis, myalgia, and reduced muscle strength. These issues, which can manifest intermittently or persistently, impact both central joints (spine, hips, shoulders) and peripheral ones (elbows, wrists, knees, feet), thereby substantially diminishing patients' quality of life (QoL). Evidence suggests that physical activity can mitigate these symptoms; however, adherence to exercise routines remains insufficient. Moreover, there is no agreement regarding the most effective type, intensity, or duration of exercise, and standardized guidelines are absent. Acknowledging the need for exercise as a sustainable habit, this research aims to design a home-based rehabilitation program customized for individuals undergoing endocrine therapy.


Eligibility Criteria:
Inclusion Criteria:1. Pathologically confirmed hormone receptor-positive breast cancer (stage I, II, III).

2. Initiation of treatment with aromatase inhibitors (e.g., anastrozole, letrozole, exemestane).

3. Postmenopausal women, including those with surgically induced menopause. 4. Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.

5. Informed consent obtained, with voluntary participation in the study. 6. Bone and joint symptoms with a Brief Pain Inventory (BPI) score of ≥3, or presence of at least one of the following risk factors: elevated bone turnover markers, reduced vitamin D levels, increased inflammatory cytokines, elevated C-reactive protein, or elevated rheumatoid factor.

7. Not participating in any physical therapy or exercise-based interventions that may interfere with this study.

-

Exclusion Criteria:

- 1. Recurrence of breast cancer or distant metastasis. 2. Presence of other malignancies. 3. Diagnosed rheumatoid arthritis, bone and joint trauma, or other severe bone and joint diseases.

4. Bone mineral density T-score \<-2.5. 5. Presence of absolute contraindications to exercise.
A Study to Assess the Persistence of Two GBS Antibodies in Women Previously Immunized With a GBS Vaccine

This study looks at the body's immune response to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody levels.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have given written consent.
* Individuals who participated in V98P2 and received the complete schedule of vaccinations.

Exclusion Criteria:

* Individuals who have not given written consent.
* Subjects who did not receive the complete schedule of vaccination in V98P2.
Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)

The purpose of this study is to see if Lung LLC's new experimental formulation of the medicine Beraprost Sodium, called Beraprost Sodium 314d Modified Release (BPS-314d-MR), can improve the symptoms of pulmonary arterial hypertension (PAH) in patients. An experimental drug is one that has not been approved by the U.S. Food and Drug Administration for use in the general public. This research study is for patients who have pulmonary arterial hypertension (PAH) and have just completed taking part in an earlier research study and received an older experimental formulation of Beraprost Sodium, called Beraprost Sodium Modified Release (BPS-MR). That earlier study was being done to see if BPS-MR could improve their PAH.

Patients may also be taking Tyvaso (treprostinil), Tracleer (bosentan), Letairis (ambrisentan), Adcirca (tadalafil) and/or Viagra or Revatio (sildenafil) to treat their PAH. The diagnosis of PAH means that the blood pressure in their lungs is higher than normal. The increased blood pressure in the lungs places a strain on the heart. The strain causes the heart to pump less blood into the lungs, causing shortness of breath and tiredness. The strain on the heart weakens the heart muscle making it less able to pump blood, a condition called heart failure. As heart failure develops, swelling in the feet and abdomen may occur.

According to Lung LLC, and from my review of summary results contained within the most recent version of the BPS-314d-MR Investigators' Brochure I concur, BPS-314d- MR has been shown to have a similar safety and pharmacokinetic profile in healthy volunteers to BPS-MR. It is also my understanding that at an End of Phase II meeting in April of this year, FDA acknowledged Lung LLC's intention to continue the development of BPS-314d-MR by conducting a Phase III pivotal study in PAH patients. This study, BPS-314d-MR-PAH-302 was subsequently initiated this past June.

In my opinion, and based upon the similarities of the two formulations, it is in the best interest of our patients to transition their treatment to BPS-314d-MR.

Lung LLC has agreed to supply BPS-314d-MR for the patients.

Eligibility Criteria:
Inclusion Criteria:

* Prior participation in Beraprost-MR study at Harbor-UCLA

Exclusion Criteria:

* No prior participation in Beraprost study at Harbor-UCLA
Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy

This clinical trial is undertaking by Qilu Hospital of Shandong University, aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.

The investigators are undertaking a single-center, non-randomized, non-controlled trial of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given rhTPO intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10\^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 18-50 years old.
2. After 12 weeks gestation.
3. Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
4. Patients who have no response or relapsed after Corticosteroid or IVIG.
5. Patients developed refractoriness to platelet transfusion.
6. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
7. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
4. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
5. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
6. Patients who are deemed unsuitable for the study by the investigator.