cyrilzakka/clinical-trials huggingface dataset:
Validation of Breath Tests in Diagnosing Small Bowel Bacterial Overgrowth

Normally the gastrointestinal tract is only sparsely colonized with bacteria. The normal flora of the duodenal or jejunal aspirate contains no more than 10\^5 bacteria per milliliter. Small bowel bacterial overgrowth (SBBO) is defined as a pathologically increased number of bacteria or the presence of colonic flora in the proximal intestine. The reasons for this condition are manifold, ranging from diabetic neuropathy to surgical bypass. SBBO is frequent in elderly people. Therapy is targeted at correcting the underlying small bowel abnormalities that predispose to the condition and at providing appropriate antibiotic therapy. The symptoms and signs of SBBO can be reversed with this approach. However, in many patients the conditions predisposing to SBBO persist life-long, once present. This suggests that noninvasive, sensitive diagnostic tools with high specificity are required. Bacterial culture of upper intestinal content is considered the diagnostic gold standard. However, since endoscopic harvesting of duodenal or jejunal fluid is difficult and invasive, indirect tests such as breath tests have been advocated as diagnostic tools. Hydrogen breath tests are commonly employed since the substrates can be easily obtained and the measurement is simple. Hydrogen is formed when carbohydrates are fermented in the intestine. Breath hydrogen analysis allows a separation of metabolic activity of the intestinal flora from that of the host, since no known hydrogen production occurs in mammalian tissue. The hydrogen breath test most often used in routine clinical practice uses glucose. However, the utility of this test is mostly limited by its low sensitivity, because there are "nonproducers" in up to 25% of the subjects tested. The investigators have developed a stable isotope breath test using 13C-labeled lactose-ureide. Glycosyl-ureides are condensation products of reducing sugars and urea in aqueous acid. Lactose-\[13C\]ureide has been used to investigate oro-caecal transit time because it resists digestion by small intestinal enzymes and is hydrolyzed by bacterial enzymes in the large intestine. A number of studies have described the use of this substrate in adults and children. The aim of the present study was to investigate the lactose-\[13C\]ureide breath test in subjects with suspected SBBO and to compare its results with the results of the glucose hydrogen breath test. Microbiological analyses of upper intestinal bacterial cultures were used as gold standard to identify SBBO.


Eligibility Criteria:
Inclusion Criteria:

* Suspected small bowel bacterial overgrowth

Exclusion Criteria:

* Age \< 18 years
* Antibiotic therapy
Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian Foods

The aim of the study is to determine the glycaemic and insulinaemic index of pasta products and local foods. It is hypothesized that different pasta cuts and wholegrain composition of pasta and local foods have different GI depending on the nature of the carbohydrate content and the food structure within each food.

There will be a total of 9 test sessions and each session will last up to 3.5 hours. The order of sessions will be determined with an online randomizer. At each test session, the following procedures will be performed: two finger-prick blood samples, five minutes apart to measure baseline blood glucose and insulin concentrations Subject will be served the test food and to consume within15 minutes Following the test meal, blood samples will be collected at the following time points: 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and insulin measurements will be collected at 30, 60, 90, 120, 150 and 180min.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Asian - Indian and Chinese ethnicity
* Age between 21-40 years
* Body mass index between 18.5 to 25 kg/m2
* Normal blood pressure (\<140/90 mmHg)
* Fasting blood glucose \< 6 mmol/L

Exclusion Criteria:

* Is a current smoker
* Is currently pregnant
* Have any metabolic diseases (such as diabetes, hypertension etc)
* Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* Have medical conditions and/or taking medications known to affect glycemia(glucocorticoids, thyroid hormones, thiazide diuretics)
* Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug
* Have any severe food allergy (e.g. anaphylaxis to peanuts)
* Have any known allergies to any food components of the study protocol
* Have active Tuberculosis (TB) or currently receiving treatment for TB
* Have any known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
* Is a study team member or an immediate family of any study team member. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study.
* Have partake in sports at the competitive and/or endurance levels
* Have intentionally restrict food intake
An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A

This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety, efficacy, and repeat PK period (Part 3) and also includes a surgical sub-study for subjects enrolled in Parts 2 and 3.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe hemophilia A defined as \<1% FVIII:C documented in medical records.
* Males between 18 and 65 years of age (Parts 1 and 2).
* Males between 12 and 65 years of age (Part 3).
* Subjects who have received or are currently receiving FVIII products (plasma-derived and/or recombinant FVIII) and have had \>150 exposure days (EDs) with a FVIII product
* Written informed consent for study participation obtained before undergoing any study specific procedures.

Exclusion Criteria:

* Any history of or current FVIII inhibitors
* Any first order family history of FVIII inhibitors
* Use of an Investigational Medicinal Product within 30 days prior to the first rVIII-SingleChain administration.
* Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to administration of rVIII-SingleChain or reference product.
* Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
* Any known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
* Platelet count \< 100,000/µL at screening.
* Human immunodeficiency virus (HIV) positive subjects with a CD4 count \< 200/mm3, in their medical history or at screening if available results are older than one year. (HIV positive subjects may participate in the study and antiviral therapy are permitted, at the discretion of the Investigator).
* Subject currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
* Subject with serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) values \> 5 times (x) the upper limit of normal (ULN) at Screening.
* Subjects with serum creatinine values \> 2 x ULN at Screening.
* Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to Day 1.
* Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to Day 1.
Development and Validation of the EFT for Adolescents With Cancer

There is increasing evidence of interventions shown to be effective to promote physical activity in adolescents with cancer. Nevertheless, adolescents with cancer become physically inactive after the end of the interventions. These interventions emphasized heavily on interventionists' role to assess adolescents' physical fitness and prescribe exercises. After the intervention, the adolescents were unable to follow the previous exercise prescriptions due to their changing medical conditions. To promote physical activity sustainably, it is vital to develop a patient-based assessment tool to allow adolescents with cancer to self-assess their own appropriate levels of physical activity that they could perform. However, a review of literature indicates a lack of such a tool.

A cross-sectional study design will be used. A convenience sample of 400 adolescents who (1) are aged 13-18; (2) are diagnosed with cancer; (3) can communicate in Cantonese and read Chinese will be recruited in Hong Kong Children's Hospital. The outcome measures will include demographic characteristics, pain scores, cardiopulmonary function measurements, EFT scores and ratings of the oncologist for the fitness of subjects for physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Aged 13-18
* are diagnosed with cancer
* are able to communicate in Cantonese and read Chinese

Exclusion Criteria:

* with physical or cognitive impairment and learning problems as identified from the medical records
CloudCare in the Treatment of Type 1 Diabetes in Pediatrics

This prospective cohort study aims to estimate the effect of the CloudCare application in daily practice on treatment satisfaction and emotional burden for pediatric patients and their parents/caregivers, patients' glycemic control (glucometrics), healthcare professional satisfaction, and the impact on costs.

A total of 600 pediatric patients (1-15 years) with type 1 diabetes will be enrolled into the study.

This is a multi center prospective cohort study in Europe with pre- and post-measurements in type 1 diabetes with 12 months follow-up. This study will only include pediatric patients for which CloudCare is part of their (new) standard care of type 1 diabetes. Participants will be enrolled in several hospitals/healthcare organisations in Europe. Participant's data will be retrieved from their medical records and from uploaded data of their medical devices used for their type 1 diabetes treatment.

The study will consist of two periods. A 3 months' retrospective period in which data will be retrieved from patients' dossier followed by a 12 months' prospective period after introduction of CloudCare as part of patients' standard care by the treating physician.

The 3 months' retrospective period is the control period for the prospective period.

Eligibility Criteria:
Inclusion Criteria:

* Parents/caregivers and, depending on local laws and regulations, also the patient are willing to sign the study informed consent form prior to any data collection for this study
* Clinical diagnosis, based on investigator assessment, of type 1 diabetes and using insulin with or without metformin for at least 6 months.
* Age between 1 and 15 years old.
* Use of multiple daily injections of insulin (MDI, with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion (CSII) with Flash or Continuous Glucose Monitoring (FGM/CGM), but without CloudCare for at least three months.
* Receiving CloudCare as part of their standard care for at least 6 months.

Exclusion Criteria:

* Patients with type 1 diabetes on glucose lowering treatments other than insulin with or without metformin.
* Any known factor, condition, or disease that might interfere with study conduct or interpretation of the results, as deemed by the investigator.
Behavioral and Physiological Effects of Visual Training

The primary objective of this study is to evaluate the learnability of a 3 week, 40 minutes per day, 5 day per week, computer-based visual training exercise by healthy mature individuals undergoing normal aging.

Virtually all adults will suffer a decline in their cognitive capacities to some degree. Typically, cognitive decline is characterized by a slow, progressive decline in abilities (frequently in memory, attention, inhibition and speed of processing) relative to younger adults, commonly called normal aging, age-associated memory impairment, age-consistent memory impairment, benign senescent forgetfulness, late-life forgetfulness, ageing-associated cognitive decline, and the preferred term, age-related cognitive decline (ARCD) As virtually all adults experience a reduction in their cognitive abilities with age, ARCD has generally been considered to be a normal, inevitable, and irreversible part of aging; and the extremely severe forms of pathological cognitive decline (e.g., Alzheimer's disease, AD) have dominated therapeutic research in this area. However, ARCD represents an important cause of quality of life decline in almost every older adult, as the impact of forgetfulness and mental slowing increasingly change the abilities of individuals to successfully manage their day-to-day activities. Therapeutic approaches targeting the specific problems of ARCD in normal aging (as opposed to the pathological problems of AD) would unto themselves represent important clinical advances.

This trial investigates the effects of a computer-based visual training exercise built on the principles of positive brain plasticity and designed for use by healthy mature individuals. The program is specifically designed to improve the fidelity of sensory representations in early visual cortex.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 or older at the time of consent.
* Mini-Mental Status Examination (MMSE) score of 26 or higher.
* Adequate visual capacity adequate to read.
* Adequate hearing capacity.
* Willing and able to commit to study time requirements.

Exclusion Criteria:

* Self-report of current diagnosis or history of major neurological illness.
* Self-report of current diagnosis or history of psychiatric illness. c. History of psychiatric hospitalization in the past twenty years.
* History of a stroke, transient ischemic attack (TIA) or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems. - Fibromyalgia or symptoms of severe tremor.
* Self-report of current substance abuse, including alcoholism.
* Current useof medications with substantial CNS effects. Inappropriate behaviors during screening or baseline visits.
* Inability to perform behavioral evaluations.
* Participant is not capable of giving informed consent or unable to comprehend and/or follow instructions.
* Participant is enrolled in a concurrent clinical study that could affect the outcome of this study.
Rate Adaptive Atrial Pacing in Heart Failure

The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting.

Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial stimulation to restore functional capacity and quality of life in heart failure patients with chronotropic incompetence.

Methods: heart failure patients (left ventricular ejection fraction ≤35% \& New York Heart Assessment II or III) who were implanted with a 2-chamber implantable cardioverter defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3 months the pacing mode will be switched to the opposite mode.


Eligibility Criteria:
Inclusion Criteria:

1. Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS)
2. Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor
3. Symptomatic congestive heart failure (NYHA class II-III)
4. Left ventricular systolic dysfunction (LVEF \<35%)
5. Optimal medical therapy
6. Sinus rhythm
7. Subjects should be able to perform normal daily activities

Exclusion Criteria:

1. Age \<18 or incapacitated adult
2. Documented atrial fibrillation in the last 3 months prior to inclusion
3. Indication for pacing (SSS, AV conduction abnormalities requiring pacing)
4. Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator
5. Patients who are unable to tolerate increased pacing rates
6. Indication for cardiac resynchronization therapy

Beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion
Efficacy and Safety of the ELIOS Laser in Combined Cataract and Glaucoma Surgery

Glaucoma is an irreversible optic neuropathy. It is the second most common cause of blindness worldwide. Glaucoma can be treated with topical medications (eye drops), laser or surgery. Traditional surgery is invasive and has a high complication rate (hypotonia, endophthalmitis, cataracts, etc.). As a result, several types of micro-invasive surgery (MIGS) have been developed to reduce the risks of surgery while maintaining their effectiveness in lowering intraocular pressure (IOP). The ELIOS laser system is the only ophthalmological excimer laser designed for the surgical treatment of glaucoma. The aim of the procedure is to ablate the trabecular meshwork and inner wall of Schlemm´s canal ab interno, with the creation of 10 microchannels of 210 um in the trabeculum using the ELIOS laser with a wavelength of 308 nm, in order to improve trabecular outflow to achieve a reduction in IOP. The ELIOS laser is an example of Microinvasive Glaucoma surgery (MIGS) with published results demonstrating efficacy and safety. The ELIOS laser is already in use in France (AMM / CE mark achieved). Its use as part of a prospective interventional study will enable us to collect data in order to treat patients more effectively and improve the quality of care provided to glaucoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age who agree to take part in the study and have signed an informed consent form
* Visually significant cataract with indication for surgery
* Primary open-angle glaucoma, or secondary open-angle glaucoma (pseudoexfoliative glaucoma or pigmentary glaucoma) with indication for cataract surgery.
* Open iridocorneal angle (Shaffer classification grade 2-4)
* Early to moderate glaucoma (advanced glaucoma, with MD from VFs worse than -12dB, will be excluded)

Exclusion Criteria:

* Presence of severe systemic pathologies 2024-A01891-46_Protocol_V6_21112024_Elios Page 20 / 58
* Pregnant or breastfeeding women
* \<18 years of age
* Presence of other ophthalmological pathologies (except cataracts), and exclusion of severe dry eye.
* History of intraocular surgery, trauma, or conjunctival scarring in the quadrant intended for surgery
* Visual acuity worse than "counting fingers".
* Closure of the iridocorneal angle (and angle-closure glaucoma), angle-closure glaucoma secondary to iridocorneal synechiae, neovascular glaucoma or neovascularization of the iris.
* Normal-pressure glaucoma
* Pachymetry \< 490 um or \> 620 μm
* Glaucomatous visual field with mean deviation worse than ≤-12 dB
* IOP \> 35 mmHg
* Autoimmune disorder, especially collagenosis
* Patient under protective supervision
* Patient not covered by a social security scheme
GENETIC VARIANTS of ANNEXIN A2 and CRYPTOGENIC STROKE

Stroke is the third most common cause of death in developed countries. Various mechanisms of ischemic stroke exist. However, in young population, in a third of cases, the cause of a stroke cannot be determined despite an extensive evaluation. Many studies have highlighted the link between stroke and fibrinolysis. Genetic variants of tPA and PAI-1 genes have been suggested to be the risk factors for stroke.

ANXA2 plays a pivotal role in plasmin generation and fibrinolysis. Several studies showed the role of ANXA2 and S100A10 subunits in regulation of fibrinolysis in vivo. Recently, the efficacy of recombinant ANXA2 for fibrinolytic therapy in a rat embolic stroke has been demonstrated. Some single nucleotide polymorphisms in ANXA2 gene could be associated with increased risk of stroke in sickle cell disease.

Therefore, these data invite us to test hypothesis that genetic variants of ANXA2 gene could be associated with ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Completed ischemic stroke defined as a rapidly developing focal neurologic deficit with no apparent cause other than a vascular origin that persisted beyond 24 hours in surviving patients
* Age from 18 years old

Exclusion Criteria:

* Transient ischemic attack
* Pregnancy
Evaluation of Group Culture in WOW Dishes of Human Embryos in Order to Optimize the Single Embryo Transfer (SET) Strategy.

In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are cultured individually, however when bovine embryos are cultured in groups a typical 25-35% of blastocysts can be observed. This tendency, i.e. improved embryo development in group culture, has also been demonstrated in other mammalian species, such as mouse, cat and human. The main reason for this beneficial outcome of group culture has been ascribed to the presence of autocrine factors, which are factors secreted by preimplantation embryos that act upon the embryo itself or the neighboring embryos .

Although group culture systems are common in in vitro production systems for animal embryos, it is rarely done in human settings, where individual follow-up of the embryo during the whole culture period is of utmost importance. Recently a CE-labelled culture device has been designed for human embryos, that allow to combine the benefits of both group culture approaches and individual culture. The WOW dish is commercially available by Primo Vision and consists of 9 small microwells on the bottom of the plate, so that the embryos can be cultivated individually in a microwell, but covered by the same drop of culture medium.

In this clinical randomized trial, 158 patients will be included of which half of the fertilized oocytes will be cultured individually (standard culture system) and half of the fertilized oocytes will be cultured in group in a WOW dish, both during five days of culture. The aim of this study is to increase the number of blastocysts suitable for transfer or cryopreservation by culturing the embryos in WOW dishes.


Eligibility Criteria:
Inclusion Criteria:

* Sperm obtained by ejaculation
* Conventional IVF/ICSI
* At least 10 fertilized oocytes (2 PN)

Exclusion Criteria:

-
Intra-operative Monitoring of Blood Loss

Certain types of surgery are associated with occult blood loss, which is hard to detect intraoperatively by intermittent conventional, invasive Hb concentration measurements using the clinical standard of Hb monitoring by satellite laboratory analysis (Hbsatlab). The investigators want to see whether continuous non-invasive transcutaneous Hb measurement using a finger sensor (SpHb), (a) reduces the total time (area under the curve, AUC) a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate (RBC), and (b) prevents a decrease in total oxygen delivery (DO2) possibly associated with transfusion below a critical haemoglobin concentration. Furthermore, the investigators want to study if SpHb monitoring changes the timing of RBC administration and reduces the need for intra- and post-operative RBC transfusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients at the age of 18 years or older, planned for elective surgery at-risk for undetected blood loss.
* American Society of Anesthesiologists (ASA) classification I, II, III, IV

Exclusion Criteria:

* Patient refusal
* Emergency surgery