cyrilzakka/clinical-trials huggingface dataset:
Assessment of a Femtosecond Laser to Perform Capsulorhexis During Cataract Surgery

This study is a Pre-market first-in-man clinical investigation to validate performance of a hand-held femtosecond laser named CATSYS.

Interventional, prospective, longitudinal (follow-up: 30 ± 10 days), single-arm, single center, open trial. The "first-in-man" character of this investigation relies on the ergonomics of CATSYS (handpiece), and not on the laser technique, which is similar to other FLACS.

The purpose of the clinical investigation is to document the compliance of the investigational medical device with the general requirements of performance, safety and clinical benefit, in order to complete existing data and obtaining CE-mark for CATSYS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cataract requiring surgery according to current guidelines;
* Eligible to lens removal by phacoemulsification and replacement by a prosthetic lens under local anesthesia;
* Who have been informed and gave informed consent to participate in the study.

Exclusion Criteria:

* Eye with an anterior chamber depth \< 2.5 mm or \> 3.8 mm;
* Corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light;
* Eye with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally;
* Patient with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye;
* History of steroid-responsive rise in IOP, glaucoma, or preoperative IOP\>21 mm Hg in either eye;
* Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, pseudoexfoliation syndrome, etc;
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye;
* Any recent penetrating incision of the eyeball;
* Tilt of lens \> 7;
* Presence of any obstacle that may interfere with the stabilization of the device on the limbus: pterygium, limbic tumor, etc;
* Pregnant or lactating woman;
* Patient with any contra-indication to neosynephrine, tropicamide and oxybuprocaïne;
* Patient presenting any contraindications to cataract surgery under local anesthesia (ex: allergy to anesthetic drops; neurodegenerative disease; schizophrenia; severe anxiety; etc.);
* Patient who participates to another clinical trial (except observational studies), or in the exclusion period of another clinical trial;
* Patient under guardianship, trusteeship or deprived of liberty;
* Patient not affiliated to the French social security system;
* Patient unable to participate in the study for psychiatric, cognitive or linguistic reasons.
Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation

Primary graft dysfunction (PGD) is a severe lung injury that can occur in the days following lung transplant surgery. The purpose of this study is to identify genetic factors that may put someone at risk for developing PGD.

PGD is a severe complication that affects up to 25% of lung transplant patients following surgery. Pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with PGD experience. Treatment for this condition is often expensive, and it is the leading cause of death following lung transplant. Many potential donors and recipients are considered unsuitable for lung transplant because of concern for the development of PGD. Therefore, the ability to accurately predict which individuals are at risk for developing PGD may allow more lung transplants to be performed. Specific characteristics in both lung donors and recipients may play an important role in determining the risk of PGD. For example, genetic variations in how the body deals with harmful chemicals called oxidants may be associated with the development of PGD. The purpose of this study is to identify the specific genetic biomarkers in donors and recipients that put individuals at risk for developing PGD following a lung transplant.

This study will enroll individuals who are undergoing lung transplantation. Blood samples will be collected from lung donors and from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will monitor participants for 72 hours following surgery for symptoms of PGD. There will be no additional study visits.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing lung transplant surgery

Exclusion Criteria:

- Individuals undergoing multi-organ transplantation except heart/lung transplants
Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome

This phase 2B is designed to test the effectiveness of intranasal Oxytocin on Prader Willi Syndrome (PWS).

This is a prospective, multicentre, randomised, double-blind, Phase 2B clinical study planned to include around 24 PWS patients aged 2-17 years and 5 months.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between 2 years and 17 years and 5 months at inclusion.
2. Genetically confirmed diagnosis of PWS.
3. Parents (or legal representative) have signed the informed consent form and are willing to comply with all study procedures.

Exclusion Criteria:

1. A history of hypersensitivity to the study drug or drugs with similar chemical structures, to excipients of the product, or to latex;
2. Intolerance of intranasal administrations (including when due to a major behavioural problem);
3. Hyponatremia (clinically relevant at the discretion of the investigator);
4. Hypokalaemia (clinically relevant at the discretion of the investigator);
5. Prolongation of the QT interval and/or family history of prolongation of the QT interval;
6. Concomitant treatment prolonging the QT interval;
7. Start of growth hormone (GH) treatment within the last 4 weeks before inclusion;
8. History of abnormal electrocardiogram (ECG) (validated by a cardiologist);
9. Pregnant girls; (for girls with childbearing potential who do not have contraception and are sexually active, a negative pregnancy test will be required)
10. Patient with clinical signs in the context of contact with COVID-19 infected person.
11. Patient included in another study protocol on a medicinal product within the last 6 months;
12. Administrative problems:

    1. Inability to give parents (or legal representatives) expert medical information;
    2. No coverage by a social security regime.
The Effect of Using Preendoscopic Proton Pump Inhibitors in Upper Gastrointestinal System Bleeding on Patient Prognosis

In this study, we aimed to investigate the effectiveness of ppi use in upper gastrointestinal bleeding in patients over the age of 18 who underwent endoscopy on mortality, length of hospital stay, rebleeding, and cost. The European Society of Gastrointestinal Endoscopy 2021 recommends the use of preendoscopic ppi in patients with nonvariceal upper gastrointestinal bleeding as it reduces the need for endoscopic treatment. This recommendation is recommended by the British Institute for Health and Care Excellence not to use proton pump inhibitors. Likewise, the 2021 American Gastroenterology Association did not make a recommendation for its use because the benefit of using preendoscopic ppi is uncertain. This has led to confusion about the efficacy of ppi and has questioned the necessity of routinely given high-dose ppi therapy. In this study, we aim to reveal the effectiveness of the treatment by comparing the patients who were given and not given ppi. Our research is a retrospective cohort study. Patients over the age of 18 who applied to the emergency department and had a preliminary diagnosis of upper gastrointestinal bleeding and underwent endoscopy will be included in the study. Patients who underwent endoscopy and were given ppi and those who were not will be compared. In upper gastrointestinal bleeding, patients with a Glasgow Blatchford score of 2 and above are taken to endoscopy. Therefore, patients over the age of 18 who underwent endoscopy will be included in the study.

Due to the problems experienced in the supply of ppi, ppi was not available in our hospital for a while. Therefore, ppi could not be given to the patients. It was started to be given after the drug was re-supplied. In our study, we retrospectively analyzed patients who could and could not receive ppi. The data of the patients were as follows: age, gender, complaints on admission, known diseases, vital signs, medications used, rectal examination, whole blood parameters, biochemistry parameters, Glasgow Blatchford scores, endoscopy results, whether they received blood products, how much of each product they received, emergency We recorded service outcomes and emergency room costs.

Eligibility Criteria:
Inclusion Criteria:

* having an endoscopy at the time of admission to the emergency room
* Glasgow Blatchford score of 2 or higher
* be over 18 years old

Exclusion Criteria:

* patients who do not meet the inclusion criteria will be excluded
Motivating Structured Walking Activity in Intermittent Claudication

Peripheral arterial disease can cause leg pain or discomfort (called intermittent claudication (IC)), which limits the ability to walk and carry out everyday activities. Lifestyle changes, like increasing walking, can lead to improvements, but can be a challenge to begin and then continue. The aim of this study is to investigate if a physiotherapist-led, behaviour change treatment effects walking in people with IC. The treatment is designed to build an understanding of IC and walking exercise and help individuals develop strategies to increase regular walking. The trial will recruit 192 adults (aged 50 years and over) with IC. All participants will visit King's College London or their local hospital to complete two short walking tests and answer questionnaires about their daily activities, beliefs about their symptoms and treatment, quality of life and the costs of having IC.

Participants will then be randomly assigned to receive either the new treatment or continue with their usual NHS care. The new treatment involves two 60-minute face-to-face sessions (at the participant's home or local hospital) and two 20-minute telephone calls with a physiotherapist who will discuss participants' understanding and beliefs about IC, walking and help participants to set goals and plans to increase walking over 12 weeks. Participants will be provided with a step counter (pedometer) and walking record.

After 12 weeks, all participants will attend a second appointment where they will repeat the walking tests and fill out another set of questionnaires. A final set of questionnaires will be completed by all participants after 6 months (by post or electronically). Some participants will be invited to provide feedback on their experience of the treatment and trial by telephone or a face-to-face interview with a researcher.


Eligibility Criteria:
Inclusion Criteria:

* ≥50 years of age;
* established PAD (Ankle Brachial Pressure Index ≤0.90 and/or radiographic evidence or clinician reported diagnosis) and IC (presence of symptoms reported on the San Diego Claudication Questionnaire)
* able to participate in MOSAIC
* able and willing to provide informed consent

Exclusion Criteria:

* Unstable IC (self-reported change in symptoms during previous 3 months)
* walking \>90 minutes/week (reported on Brief International Physical Activity Questionnaire
* contraindications to walking exercise (e.g., unstable angina) confirmed by their vascular specialist
* have completed any prescribed supervised exercise sessions in the previous 6 months or been offered prescribed exercise sessions in the next 6 months.
Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease

There is some evidence that dietary supplementation with fish oil has health benefits, especially in respect of some of the known risk factors for cardiovascular (heart) disease such as cardiac arrhythmia. However, supplies of fish oil are limited, and it is desirable to validate alternative sustainable sources of the important omega-3 fatty acid components. It has been suggested that oil from krill, which are small marine crustaceans, may be as effective or possibly more beneficial than fish oil, and may provide a more effective and beneficial supplement. Dietary management of cardiovascular health parameters (such as blood lipids)is becoming more and more important as the rising trends in obesity nationally and worldwide are leading to escalating incidence of diabetes and heart disease. The investigators propose to use some specific novel lipid measurements of cardiovascular risk to test this possibility in a group of men who, although generally healthy, show some risk factors in terms of their weight and metabolic profile.This pilot study will provide preliminary data to show whether krill oil has similar or different effects from fish oil on the cardiovascular health of overweight but otherwise healthy men, and in particular will provide detailed information on alterations in novel lipid markers of cardiovascular disease, which may be a better diagnostic tool than classical lipid measurements (e.g. serum cholesterol). The investigators have been developing and validating new techniques to measure emerging lipid markers of cardiovascular risk accurately and will continue to develop and investigate these techniques during the course of this project. The investigators hypothesise that krill oil will be more efficacious in reducing markers of risk relating to cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* waist circumference ≥ 94cm

Plus any two of the below:

* Raised triglycerides : ≥ 150 mg/dL (1.7 mmol/L)
* Reduced HDL cholesterol: \< 40 mg/dL (1.03 mmol/L)
* Raised blood pressure: ≥ 130/85 mm Hg
* Raised fasting plasma glucose: ≥ 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

* Drug treatment for cardiovascular disease or diabetes,
* currently taking fish oil supplements
* Individuals who would require carers or guardians to make decisions
* Known history of liver disease
Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy

This is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.

The purpose of this study is to assess the ability of Herombopag to elevate platelet counts thereby reducing the need for platelet transfusions in patients with thrombocytopenia before hepatectomy. The clinical benefit of Herombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an hepatectomy. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events will be monitored during this time and for up to 3 months after undergoing a hepatectomy to help further evaluate clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* 1. Male and female subjects ≥18 years of age；
* 2.Patients prepared to receive hepatectomy；
* 3.50×10\^9/L≤platelet count≤80×10\^9/L；
* 4.Child-PUgh score A or grade B (≤7 )；
* 5.Life expectancy ≥3 months；
* 6.Normal Bone marrow hematopoiesis and renal function;
* 7.Voluntary participation and written informed consent;

Exclusion Criteria:

* 1.Central nervous system diseases caused by liver disease;
* 2.Platelet transfusion within 7 days prior to the first dose of study drug;
* 3.History of any primary hematologic disorder;
* 4.History of arterial or venous thrombosis, including thrombosis of any part of the splenic-mesenteric system;
* 5.Pre-diagnosed Immune Thrombocytopenic Purpura (ITP);
* 6.History of Myelodysplastic Syndrome (MDS);
* 7.Those with bleeding tendency，have evidence of hereditary bleeding or blood coagulation disorder;
* 8.Females who are pregnant (positive β-hCG test ) or breastfeeding;
* 9.Subjects who have participated in another investigational trial within 30 days prior to Visit 1;
* 10.Those with uncontrollable neurological and psychiatric diseases or mental disorders, poor compliance, unable to cooperate and describe treatment response;
* 11.Subjects with known intolerance or allergy to any of the ingredients in eltrombopag tablets;
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a GLP-1 Agonist

Adult participants with BMI between 22 - 35 kg/m2 will be enrolled and randomized to receive either NG101 (20 mg BID) or placebo for 5 days beginning on Day 1. On Day 2, all participants will receive a single subcutaneous injection of a GLP-1 agonist (semaglutide). Participants will remain at the clinical research unit for the duration of the treatment period.

The goal of this clinical trial is to evaluate the safety and efficacy of NG101 compared to placebo, when also administered along with a GLP-1 agonist, in the management of gastrointestinal side effects commonly associated with GLP-1 agonists for overweight or obesity. Adverse event information will be collected. GI-specific questionnaires will be used to capture additional details if GI-related adverse events are reported.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* Male or female
* BMI between 22 - 35 kg/m2 at screening

Exclusion Criteria:

* Presence or history of illness that might confound the results of the study or pose an -
* History of presence of gastroparesis, gallbladder disease, acute or chronic pancreatitis, or surgery of the abdomen
* History or presence of Type 1 or Type 2 diabetes
An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours

The primary purpose of this study is to examine the safety and potential effectiveness of a drug molecule called 64Cu-SARTATE as a potential new way to detect neuroendocrine cancers.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Age greater than or equal to 18 years
3. Life expectancy greater than or equal to 8 weeks
4. Low and Intermediate Grade (Ki-67 index \<20%) neuroendocrine tumors (NET)
5. At least one site of active somatostatin receptor positive malignancy, as demonstrated on the pre-study 68Ga-DOTATATE PET/CT scan performed as part of routine clinical care
6. Subjects with an estimated glomerular filtration rate (eGFR) greater than 60ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease).
7. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2

Exclusion Criteria:

1. Pregnant or breastfeeding females
2. Known sensitivity or allergy to somatostatin analogues
3. Subjects who have received interventional treatment for their NET in the interval between 68Ga-DOTATATE PET/CT \& 64Cu-SARTATE PET/CT scan
4. Treatment with long acting somatostatin analogues within 28 days prior to the administration of Investigational Product
5. Treatment with short acting somatostatin analogues within 24hrs prior to the administration of Investigational Product
6. QTc interval greater than 0.44seconds as measured by screening ECG
7. Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
8. Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared

To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Participation in primary study
* Written informed consent obtained before each long term follow up visit.
HEALTH AND EXERCISE IN THE DEFENSE FORCES

The most important goal is to create a cost-effective, stimulating model for improving the employee's quality of life, work ability, and job satisfaction in the military operating environment. This is achieved by finding out how to activate an individual with the phone-based gaming and web-based feedback system to improve his physical condition. This study also tries to find out the adequate amount of physical activity to maintain the physical health of workers.

Personnel work ability, to work safe in service and effective operation capability of emergency forces require a worker's state of total well-being, in which the health and the physical condition are important parts. The changes in these affects the individual's fitness to military. This study develops a model to encourage an individual to carry out physical activity by himself. This will lead to reduce the sick leaves and improve the health and fitness.

Physical activity reduces morbidity. Professional soldiers must maintain their physical condition and skills. The study explores the optimum amount of working-age physical activity. It helps to maintain the working ability and one's fitness to field operations. With the help of the developed model it is possible cost-effectively activate a large number of employees to move more and to live more healthily.

In this study it will be used motion sensors which are sending feedback to individuals mobile phone. Feedback is also given by email and in an interview after analyzing data from cloud service.

In the beginning of the study it will analyzed blood test, salivary test, body composition, height weight and basic motion. All volunteers are also answering a questionnaire.

There will be an intervention group and a control group. The intervention group will receive feedback during the all six months they are carrying the motion sensor.

After 6 and 12 months the basic analyzes will be repeated. Sick leaves and the changes in the muscular fitness test and changes in the 12-minutes running test will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Voluntaries armed forces workers.

Exclusion Criteria:

* Health enough to participate the military fitness test.