cyrilzakka/clinical-trials huggingface dataset:
The Cost-effectiveness of Hysterosalpingography Versus Hysterosalpingo-foam Sonography During Fertility Work-up

Hysterosalpingography (HSG) and hysterosalpingo-foam sonography are two methods to assess tubal patency during fertility work-up. This study aims to investigate the effectiveness of tubal flushing with oil-based contrast during HSG compared to tubal flushing during HyFoSy in women undergoing fertility work-up. The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births than tubal flushing during HyFoSy.

Background: The diagnostic work-up for infertility generally includes estimating the risk for tubal pathology and if indicated assessing tubal patency. Traditionally, tubal patency testing during the fertility work-up is performed with hysterosalpingography (HSG). In previous studies it has been demonstrated that tubal flushing with oil-based contrast during HSG resulted in more ongoing pregnancies than when HSG is performed with water-based contrast. HyFoSy is a more patient friendly alternative for HSG. Up till now, the fertility enhancing effect of tubal flushing with ExEm Foam during HyFoSy has only been studied in relatively small and observational studies.

Objectives:The main objective of this study is to determine whether tubal flushing with oil-based contrast during HSG results into more pregnancies leading to live births when compared to tubal flushing with ExEm Foam during HyFoSy, and whether this approach is cost-effective. In this study the safety of both strategies will also be compared.

Rationale: The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births compared to tubal flushing with ExEm Foam during HyFoSy in women with an indication for tubal patency testing. If more live births are achieved, expensive fertility treatments will be less needed, which makes tubal flushing with oil-based contrast during HSG a cost-effective strategy.

Study design: This study is a multicenter randomized controlled trial with an economic analysis alongside it. Women with indication for tubal patency testing will be randomized to tubal flushing with oil-based contrast during HSG and tubal flushing with ExEm Foam during HyFoSy.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women or women with oligo-or anovulation
* Indication for tubal patency testing during the fertility work-up
* Sufficient understanding of the Dutch or English language
* Signed informed consent

Exclusion Criteria:

* Severe male factor with a total motile sperm count \<3x106ml (pre-washed)
* Known contrast (iodine) allergy
* Women who have had a gynecologic procedure within the last 30 days
* Women with known or suspected reproductive tract neoplasia
FILIP: Fat Intake, Inflammation and LIPids

Low-grade inflammation is involved in the pathogenesis of type 2 diabetes and cardiovascular disease. Increasing evidence suggests that dietary intake may be involved in the inflammatory process. How nutritional composition of the diet affects the inflammatory response is however not well understood.

The aim of this project is to study if intake of three different fat sources induce different effects on inflammation markers, blood lipids, blood glucose and the microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* Willing to eat the study diet

Exclusion Criteria:

* malabsorption-related condition
* contraindications to consume a high fat diet
* intolerance to any foods used in the study (e.g. cow's milk, egg, gluten)
* established cardiovascular disease, diabetes or cancer
* current use of medication known to affect lipid metabolism (e.g. statins) or inflammation (e.g. NSAID, glucocorticoids).
* hemoglobin \&lt;100 g/L
* ongoing pregnancy or lactation
Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants

This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Infants 3 months of age who had not received any epidemic encephalitis vaccine at the time of screening
* The legal guardian or delegate has given informed consent, has voluntarily signed an informed consent form, and is able to comply with the requirements of the clinical study protocol

Exclusion Criteria:

First dose exclusion criteria

* Fever before vaccination, axillary temperature \>37.0°C
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
* History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
* Acute infections or active chronic diseases, severe infectious or allergic skin diseases
* Known allergy to a component of the vaccine, especially to diphtheria toxoid, or to previous administration of the product
* Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate

Subsequent dose exclusion criteria

* Severe allergic reactions after a previous dose of vaccine
* Those with serious adverse reactions causally related to the previous dose of vaccination
* Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

The goal of this pilot clinical trial is to determine if conducting a larger study using venous excess ultrasound (VEXUS) to guide fluid management in patients with septic shock is feasible. Septic shock is a life-threatening condition where infection causes dangerously low blood pressure. While fluids are essential for treatment, too much fluid can harm the kidneys and result in the need for dialysis. The main questions it aims to answer are:

1. Is it feasible to recruit patients, obtain consent, and follow the VEXUS-guided management protocol?
2. Does VEXUS-guided management, compared with usual care, improve the health and well-being of patients with septic shock?

Researchers will compare two groups: one receiving VEXUS-guided fluid management versus another receiving standard care, to assess the feasibility of a larger trial and explore whether VEXUS prevents fluid overload and kidney problems.

Participants in the VEXUS group will:

1. Undergo VEXUS scans every 24 hours for 3 days
2. Receive fluid management guided by VEXUS findings (including fluid restriction or removal if we identify venous congestion) and undergo cardiac ultrasound if we identify moderate to severe congestion
3. Be monitored for 28 days to track kidney function, need for dialysis, and survival.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥18 years)
2. Within 12 hours of meeting septic shock diagnosis based on following Sepsis-3 criteria: requirement for vasopressors to maintain organ perfusion, lactate \> 2 mmol/L, and suspected or confirmed infection)
3. Within 48 hours of intensive care unit admission.

Exclusion Criteria:

1. Already receiving renal replacement therapy
2. Patients for whom a decision to initiate renal replacement therapy has been made prior to study enrolment
3. Patients who have limitations on medical therapy or restrictions on goals of care
4. Active bleeding causing hemodynamic instability
5. Veno-venous or veno-arterial extracorporeal membrane oxygenation
6. Previously enrolment in study
7. 10% or more of body surface area acute burn injury
8. Suspected or confirmed liver cirrhosis
9. Established allergy to sulfa drugs;
10. Patients receiving treatments that require continuous IV fluid infusions (e.g., diabetic ketoacidosis, diabetes insipidus)
11. Unable to measure fluid balance accurately
12. Contra-indication to study recommended interventions (e.g., diuretics, inotropes)
13. Unable to perform VEXUS due to anatomical barriers (e.g., surgical dressings);
14. Unable to complete VEXUS scan during the 6-hour resuscitation window
15. Moderate to Severe Tricuspid Regurgitation
16. Untreated Metabolic/biochemical findings (Hypokalemia \[K+\]\< 3.0 mmol/L; metabolic alkalosis \[Bicarbonate \> 40 mmol/L and/or pH \> 7.55\], Hypomagnesemia \[Mg2+\] \< 0.6, and Hypernatremia \[Na+\] \> 155 mmol/L)
WheelSeeU Feasibility Study

Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important psychological factor for wheelchair mobility. A feasibility study will evaluate a novel self-efficacy enhanced wheelchair training intervention for older adults (WheelSeeU) to determine if: 1.WheelSeeU is feasible to administer; 2. WheelSeeU improves wheelchair use, confidence for wheelchair use, wheelchair mobility, and satisfaction with participation in older adults compared to group-based information sessions; and 3. the study design is appropriate. This feasibility study will allow for study design and protocol refinement and will provide pilot data for an experimental trial.

This study will use a two-site (Vancouver and Quebec City), single blinded (Tester) RCT to compare differences in older adults' wheelchair skill with WheelSeeU versus group-based information sessions. Subjects will be randomly assigned to the experimental group (WheelSeeU) or a control group (information sessions) using a 1:1 allocation ratio between groups. To support balance between groups and blinding of assignment, a central computerized randomization process will be designed by our team statistician, with an undisclosed block size and stratified by site (Vancouver n = 20 \[+4 for 20% dropout\]; Quebec City n = 20 +4 ). Once subjects are enrolled, the Tester will collect baseline data and enter them into a secure database. The Site Coordinator will contact Dr. Goldsmith via telephone or email and obtain group assignment within 48 hours. Subject contact information will be forwarded to the appropriate group Trainer to arrange for an initial training session or peer support session. To address bias, subjects will be instructed not to discuss their program and the Testers (1 per site) will be blinded to group allocation. Follow-up testing will occur at immediately and 6 months post-intervention.

To mask the participants from the study objectives, participants in both the intervention and control groups will be told that the intervention is designed to improve wheelchair use. The findings from the study will be summarized and mailed to each participant upon study completion.

WheelSeeU and the control group will be held at Blusson Spinal Cord Centre, GF Strong or in the community depending on participant preference.

Eligibility Criteria:
Inclusion Criteria:

* 55 years of age or older
* live in the community
* self-propel a manual wheelchair at least 1 hour/day
* have wheelchair mobility goals
* are cognitively able to engage in the program (Modified Mini-mental Status Exam score of ≥ 24).

Exclusion Criteria:

* cannot communicate and complete study questionnaires in English
* anticipate a health condition or procedure that contraindicates training (e.g., surgery scheduled which would impair physical activity)
* have a degenerative condition that is expected to progress quickly (e.g., Amyotrophic lateral sclerosis (ALS))
* are concurrently or are planning to receive wheelchair mobility training during the period of the study.
Adolescent Idiopathic Scoliosis (AIS) Patient Positioning in EOS System®

The EOS® imaging system, a new imaging modality which offers low dose, weight bearing and full body X-ray imaging, requires a new standing position where patients put their hands and forearms on the wall vertically for stability. Although this method provides enough support for the patients during the extended X-ray acquisition time, its impact on the postural balance and sagittal profile of the spine and sacro-pelvic parameters has not been evaluated. The goal of this study is to identify the impact of patients' arm positioning on the sagittal profile and postural balance of the patient and subsequently propose a standardized method for full spine X-ray acquisition in the EOS® imaging system.

Spino-pelvic sagittal analysis and postural assessment are important parameters in adolescent idiopathic scoliosis (AIS) treatment and surgical planning.The three-dimensional (3D) shape of the spine is impacted by the patients' posture particularly in adolescents with flexible spinal curves. The latter highlights the importance of the patients' positioning during X-ray acquisition in order to avoid any misleading measurements that may adversely impact monitoring and surgical curve correction in AIS.

Participating subjects will undergo two bi-planar X-rays in different positions. The positions will be instructed by the means of graphical presentation and verbal explanation by the radiology technician. The first standing position in the EOS® imaging system for full spinal X-ray acquisition will consist of putting both hands and forearms in front of the subject on the wall vertically. In the second position, knuckles are loosely placed on ipsi-lateral clavicles. Bi-planar X-rays will be taken in the EOS® imaging system for both positions.

Moreover to compare the postural balance of the patient in the two described positions, a pressure mat will be placed in the EOS® system. The pressure mat will be calibrated with the EOS® system and permits to identify the position of the center of pressure (COP) with respect to the anatomical landmarks. The magnitude of pressure under the patients' feet will be measured during each X-ray and compared.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 10-18
* Diagnosis of adolescent idiopathic scoliosis
* Prescribed bi-planar full spine X-ray images
* Must be able to stand still for 10 seconds without any support
* Must be able to follow verbal and visual instruction

Exclusion Criteria:

* Previous surgical treatment
* Diagnosis of a neuro-muscular disorder
* Have supernumerary vertebrae, congenital deformities, spondylolisthesis, or spina bifida
* Have any other musculoskeletal disorder that impacts standing balance such as hip, knee, ankle pain and instability or lower back pain
* BMI higher than 30
* Pregnant or lactating females
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Internet Delivered Self-help for Insomnia

The current study aims to evaluate the effects of internet-delivered self-help CBT for insomnia through a randomised controlled trial. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be randomised into treatment groups or the waiting list. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia
* Access to the internet

Exclusion Criteria:

* Alcohol or substance abuse
* Severe depression
* Being suicidal
* Sleep apnea
* Schizophrenic or having a psychosis disorder
Excretion Balance and Metabolism After a Single Oral Dose of 14C-Labelled ORM-12741

The study is conducted to examine absorption of C14-ORM-12741 from intestine to bloodstream, distribution to bloodstream, metabolism in the liver and excretion of the parent drug and metabolites to faeces, urine and expired air

Six healthy males will receive 3 mg of ORM-12741 as a single oral solution(0.1mg/mL). The oral dose contains 0.73 mg of 14C-ORM-12741 (2.5 MBq), 1 mg of 13C-ORM-12741 and 1.27 mg of ORM-12741.

Subjects will be confined to the study site from Day -1 (the afternoon prior to the day of dosing) up to at least 168 hours following drug administration (Day 8). Subjects will be discharged on Day 8 if radioactivity in urine and faeces meet pre-defined criteria (urinary excretion \<0.5% and faecal excretion \<0.5% of the dose per 24 hours based on 14C radioactivity quick counts, which will be measured from Day 7 onwards). If on Day 8 these pre defined criteria are not met, subjects will remain hospitalised for a maximum of seven more days (Day 15) until the criteria are met (daily check on quick counts). If on Day 15 these pre defined criteria are not met, subjects will be discharged and requested to collect a 24-hour sample of urine and/or faeces at home once per week and to deliver this to the clinical research unit in Zuidlaren. These weekly collections will be continued until the criteria are met. The total duration of the study will be approximately 5 - 6 weeks for each subject.

Eligibility Criteria:
Inclusion Criteria:

* Gender male
* Age 18-60 years, inclusive
* Weight 55-100 kg, inclusive
* Body mass index (BMI) 18.0 - 30.0 kg/m2 (inclusive)
* Ability and willingness to abstain from alcohol, tobacco products, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks"), and grape fruit (juice) from 48 hours prior to entry in the clinical research centre until discharge
* Medical history without major pathology
* All values for haematology and for clinical chemistry tests of blood and urine within normal range or showing no clinically relevant deviations as judged by the Medical Investigator
* Willingness to use adequate contraception from the time of dosing until three months after the end-of-study visit
* Willingness to sign the written Informed Consent Form (ICF)

Exclusion Criteria:

* Evidence of clinically relevant pathology
* Mental handicap
* History of relevant drug and/or food allergies
* At screening visit, abnormal 12-lead ECG of clinical relevance
* Regular/routine treatment with non-topical medication within 30 days prior to drug administration
* Irregular defecation pattern (less than once per two days)
* Exposure to radiation for diagnostic reasons (except dental X-days and plain X-rays of thorax and body skeleton (excluding spinal column)) during work or during participation in a medical trial in the previous year
A Clinical Study of TRUVIEW ART™(Advanced Reconstruction Tech)to Improve Image Quality on Chest Radiograph

To validate the following theory: "With TRUVIEW ART™ applied a detector's quantitative performance index, MTF(Modulation Transfer Function), is increased 20% or more". This is to examine the effect of the increased MTF index, whether it influences or not the interpreter's preference

Background of Study :

DRTECH Corp. has developed and applied for patenting the unique technology of TRUVIEW ART™. TRUVIEW ART™ is advanced image reconstruction technology that restores image quality from the side effects of scattering signals in indirect type scintillator detectors. It is an advanced image pre-processing technology that constructs signal scattering models (PSF) of indirect type detector scintillators. Image sharpness (MTF) is improved by predicting scattering models and eliminating the scattering signal.

Purpose of Research and Assumption :

Indirect conversion type detectors using scintillators are universal in today's diagnostic imaging area. However, they have a disadvantage of signal scattering compared with direct conversion type detectors. TRUVIEW ART™(Advanced Reconstruction Technology) can restore images from the scattering problems. The purpose of this study is to verify how well it improves the usefulness in clinical diagnostic imaging. Evaluation will measure the improvements in MTF, which is the quantitative performance index of a detector.

Eligibility Criteria:
Inclusion Criteria:

* Adults of age 20 or higher
* Person who is able to fully understand the clinical research procedures
* Signed up agreement form
* Patient who visits for Chest computed tomography (CT)

Exclusion Criteria:

* Subject is pregnant or suspicious of being pregnant
* Not able or willing to provide Informed Consent, or consent is withdrawn
* Not able to collect all required case information
Evaluation of Respiratory Function and Functional Capacity in Pediatric Patients With Chronic Kidney Disease (CKD)

Chronic kidney disease (CKD) is defined as a permanent abnormality in kidney structure or function that persists for more than 3 months (for example, glomerular filtration rate \[GFR\] \<60 mL/min/1.73 m2 or albuminuria ≥30 mg/24 hours) and, it effects the 8% to 16% of the population worldwide.In pediatric patients with CKD, exercise capacity begins to decline in stage 3 of the disease and progressively decreases in stage 5, in dialysis and transplant patients (4, 5). Reduction in respiratory muscle strength and six minute walk test (6MWT) is observed in patients with CKD treated with hemodialysis (HD).The aim in present study is to evaluate the relationship between functional capacity and respiratory functions in stage 1-5 pediatric chronic kidney disease patients.

The aim of this study is to evaluate functional capacity with six minutes walk test (6MWT), respiratory functions with spirometer and the correlation between functional capacity and respiratory functions in pediatric CKD patients.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 5-18, having stage I-V chronic kidney disease,
* Having chronic kidney disease for at least 6 months,
* Not having visual and hearing impairment

Exclusion Criteria:

Presence of mental retardation,

* Insufficient Turkish communication, Inability to communicate,
* Having metabolic-neurological problems,
* Presence of cardiomyopathy, angina pectoris,
* Presence of orthopedic problem that will prevent standing and walking
* Cerebrovascular disease
* Patients will not be included in the study in the presence of metastatic carcinoma.
Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients

The goal of this interventional study is to learn about the efficacy of first-line chemotherapy with Gemcitabine in metastatic pancreatic adenocarcinoma patients expressing the GemCore signature in their tumor. The main question it aims to answer is to assess efficacy of Gemcitabine (tumor response, survival rate) in the population of patient bearing the GemCore signature.

Participants will start the chemotherapy with Gemcitabine as usually performed in standard care of their center. They will consent to a genomic analyze of their tumor to know if it bears the GemCore signature. The center will manage the participant's follow up as usually realized in standard care.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic pancreatic adenocarcinoma histological proved
* FOLFIRINOX chemotherapy-ineligible patient and going to receive first-line metastatic chemotherapy with gemcitabine monotherapy
* Tumor material allowing assessment of GEMCore status (i.e. FFPE block with tumor cellularity ≥ 10%);
* Life expectancy \> 2 months;
* Measurable target according to RECIST 1.1 criteria;
* No previous treatment in metastatic situation;
* Age ≥ 18 years;
* Patient not opposed to study participation;
* Affiliation to a social security system, or beneficiary of such a scheme.

Exclusion Criteria:

* Contraindication to Gemcitabine treatment;
* ECOG performance status ≥ 3;
* Person in emergency situation or unable to express non-opposition;
* Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice);
* Unable to undergo medical follow-up for geographical, social or psychological reasons.