cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a demonstrated patent ductus arteriosus
2. Female or male
3. Belonging to any ethnic group
4. Age between \> 6 months and 70 years
5. Body weight \> 6 kg \< 120 kg

Exclusion Criteria:

1. Associated congenital cardiac anomalies,
2. Body weight \< 6 Kilograms

General exclusion criteria

* presence of a known coagulation disorder
* thrombus at the position allocated for the implantation
* a vein thrombosis in the blood vessels chosen for the introducing system
* an active infection
* Nitinol intolerance (nickel or titanium)
* contrast medium intolerance
* patients who have a vascular system which is too small to admit the required sheath
* patients with pulmonary hypertension and pulmonary-vascular resistance of \>8 Woods Units or a lung - / systemic resistance (PR/SR) of \>0.4.
Core Stabilization Training in Juvenile Spondyloarthropathy

Core stabilization exercises developed by McGill have been shown to be one of the physiotherapy techniques aimed at reducing pain, increasing aerobic capacity, enhancing muscle strength, and thereby improving bone health in children with JIA. However, there is no study that has investigated core stabilization training for different types of JIA. In our study, we aim to compare the effectiveness of core stabilization training and a daily physical activity program in children with spondyloarthropathy, to help identify the most effective strategy for clinical practice. Additionally, highlighting the specific effects of core stabilization training on the treatment of juvenile spondyloarthropathy (pain, functional status, fatigue, and quality of life) will make a significant contribution to the literature.

Taking into account the gaps in the literature, our study will investigate the effect of core stabilization training on pain, functional status, fatigue, and quality of life in patients with juvenile spondyloarthropathy.

Core stabilization exercises are one of the physiotherapy techniques aimed at reducing pain, increasing aerobic capacity, enhancing muscle strength, and thereby improving bone health in children with JIA (1). Spondyloarthropathy typically begins as asymmetric oligoarthritis in children, and enthesitis and axial skeleton involvement may develop over the course of the disease (4). Since juvenile spondyloarthropathies can lead to severe functional impairments and long-term sequelae, the primary goal in treatment should be to suppress inflammation as early as possible and to prevent sequelae (5). Physiotherapy is recommended for children and adolescents with enthesitis or sacroiliitis, or those with functional limitations (6). Yoga exercises focusing on the core region have shown significant effects on lower extremity functional status, pain levels, and quality of life in patients with enthesitis-related conditions (2). Studies have supported that core stabilization exercises, combined with traditional physical therapy aimed at improving bone health status and functional capacity, serve as an effective combination therapy for children with JIA involving multiple joint involvement (3).

Therefore, this study aims to fill the knowledge gap regarding core stabilization training in children with spondyloarthropathy.

Eligibility Criteria:
Inclusion Criteria:

* "According to the International League of Associations for Rheumatology criteria, individuals aged 10-18 diagnosed with spondyloarthritis within the JIA subgroup will be included.
* Only cases with stable disease activity and without additional neurological or orthopedic conditions will be considered.
* Participants must also possess the cognitive ability to engage in active rehabilitation.

Exclusion Criteria:

* Individuals with a cardiovascular disease that impedes exercise
* those who have participated in a rehabilitation program within the last 6 months
* cases with variable medical treatment will be excluded.
Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin

The aim of the study is to determine, in pregnant women who have undergone sleeve gastrectomy (SG), whether ghrelin changes could be involved in in utero growth restriction (IUGR) and whether therefore a correlation between maternal ghrelin levels and birth weight is observed.

Bariatric surgery (BS) has developed rapidly in recent years and the candidates are predominantly women of childbearing age. A negative impact on fetal growth (FG), has been described after BS whose mechanisms are not elucidated. The sleeve gastrectomy (SG), the most commonly practiced BS technique, is supposed to induce fewer nutritional deficiencies than gastric bypass. This is why it seems to be the technique of choice for young women, although the lack of hindsight does not allow recommendations to be made.

However, latest work showed that birth weight (BW) was affected as much after SG as after RYGB (Roux-en-Y Gastric Bypass), with 50% of BW Z-score \<0 and 19% of small newborns for gestational age. In addition, only weight gain during pregnancy and maternal protein status were related to BW, but these parameters explained only 16% and 8% of the variance of the BW Z-score, respectively, suggesting that other factors are therefore involved.

Sleeve gastrectomy induces the loss of the majority of gastric cells secreting ghrelin, an orexigenic hormone involved in the regulation of appetite but also in the pituitary secretion of growth hormone, which could influence fetal growth, as shown in a model of pregnant rats. However, no studies have evaluated the link between maternal ghrelin and pregnancy outcome in women undergoing bariatric surgery.

The study population will include pregnant women who have undergone bariatric surgery such as sleeve gastrectomy (which is currently the most frequently performed technique) before pregnancy, coming to consult between the 3rd and 6th month of pregnancy (2nd trimester) for a nutritional check-up in a day hospital.

Eligibility Criteria:
Inclusion Criteria:

* Woman previously operated of sleeve gastrectomy
* Pregnant from 3 to 6 months
* Having a mono-fetal pregnancy
* Coming to consult in day hospital for a nutritional assessment

Exclusion Criteria:

* Twin pregnancy
* Identified cause of IUGR apart from those related to sleeve gastrectomy
* Woman who has undergone another bariatric surgery technique
* Lack of individual information and collection of the consent form
* Problems of understanding
* Lack of affiliation to a social security scheme or state medical aid
* Patient benefiting from a legal protection measure (with guardians or curators)
LOL: It's All Improv After Cancer!™

This is a 2-arm randomized waitlist controlled trial. A total of 46 of subjects are planned. Subjects will be assigned to the intervention vs. waitlist control group in a randomized fashion. All subjects will complete baseline assessments prior to randomization. Baseline assessments will be completed within two weeks before the start of the improv series. Subjects in the intervention group will complete 6 consecutive improv classes. Patients in the control group will be permitted to complete the improv course (within 10-12 weeks) and follow-up after their 10 week control timeline is complete. Evaluations for the intervention group will be taken at baseline (T0), the last day of class (T1), one month after the last day of class (T2), and 6 months after the last day of class (T3). Evaluations for the waitlist control group will be taken at baseline #1 (T0), 6 weeks after T0 (T1), one month after T1 (T2), first day of class (Baseline 2, T0b), last day of class (T1b), one month after the last day of class (T2b), and 6 months after the last day of class (T3b). Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

Total duration of the study is expected to be 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast cancer stage 1-3 (no distant metastases)
* Completed cancer treatment (including chemotherapy, radiation therapy, biologic treatment, and/or any combination). At time of consent, patient must be at least 2 months (60 days) from their last treatment and no more than 18 months (547 days) post-treatment. Long term hormonal/biologic treatments are ok.
* Adult female age ≥18
* Scores ≤82 on the FACT-G (Patients do not need to maintain score ≤82 after initial screening FACT-G to remain on study)
* Agrees to complete study surveys
* Agrees to attend at least 4 of 6 Improv classes
* English speaking
* Reasonable medical stability (per physician clearance).
* Emotionally stable (per physician clearance) to participate in this series.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Patients who have significant personality disorders or unstable psychiatric disorders that are severe enough to detract from the group process, as determined by their treating physician.
* Patients with severe cognitive impairments, as determined by their treating physician.
* Non-English speakers.
* Patients who have previously participated in an improvisational comedy program in the past year.
Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU

The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
* Current or previous smoker with a smoking history of 10 or more pack years
* Lung function parameters: FEV1/FVC \< 70%, post-bronchodilator and post-bronchodilator FEV1 \< 80% of predicted normal value

Exclusion Criteria:

* History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
* Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
* Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.
High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth

Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.


Eligibility Criteria:
Inclusion Criteria:

* Non-breastfeeding women 3-36 months after childbirth
* Voluntarily signed informed consent form
* BMI ≤ 30 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Cardiac pacemakers
* Implanted defibrillators, implanted neurostimulators
* Electronic implants
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Application in the head area
* Application in the heart area
* Malignant tumor
* Fever
* Pregnancy
* Breastfeeding
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over areas of the skin which lack normal sensation
* Scars, open lesions and wounds at the treatment area
* Unrepaired abdominal hernia
* Patients after Cesarean section delivery
Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2)

Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

Cross-sectional analysis about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

All clinical variables are gathered from two EMR softwares (Mambrino XXI and Turriano).

Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant.

The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Age: 18 yrs. or older

Exclusion Criteria:

* Other diabetes types.
* Younger than 18 years.
To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets

To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to Merrell Dow's 100 mg Norpramin tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Written Self-disclosure for Youth Abdominal Pain

The aims are to evaluate: (1) the effectiveness of written self-disclosure (WSD) on health status of youth ages 12-18 with functional recurrent abdominal pain (RAP); (2) whether effectiveness of WSD is similar for younger (12-14) and older (15-18) youth with functional RAP; and (3) the feasibility and acceptability of WSD when extended to the pediatric health care setting.We will implement a randomized, controlled trial (RCT) designed to compare health status in 140 youths (ages 12-18) with functional RAP assigned either to standard medical care (SMC) or WSD provided in the health care setting in addition to SMC. Health status will be measured at Baseline and 3- and 6-months thereafter. Primary measures of health status are symptom severity and episode frequency, consistent with the definition of RAP. Secondary measures of health are functional health, psychological distress, health-related quality of life, and health care utilization. Total use and diagnostic tests will index health care utilization, collected for the 6-mos prior to and following Baseline. Mixed model ANOVA or MANOVA will be used to test directional hypotheses corresponding to the specific aims.


Eligibility Criteria:
* Ages 12-18.
* Diagnosis of RAP by the examining pediatric gastroenterologist using Apley's (1975) criteria: (a) 3 episodes of abdominal pain, (b) severe enough to interrupt activities and occurring, (c) over a period of at least 3 months, (d) without an identifiable organic cause (If an organic cause is identified during participation in protocol, then participant is withdrawn from database prior to analysis).
* Free of a known chronic health condition.
* Physical and mental ability to complete the procedures, as judged by Dr. Madan-Swain.
* Consents to complete the protocol over the next 6 months.
* Parent(s) consents to participate and agrees to support the youth in completing the protocol.
* Access to a phone on the days writing sessions are to be completed at home.
Constitution of a Biobank for Studies Related to Organ Transplantation (Lyon Centaure Biocollection)

This study aims to constitute a collection of biological materials from in transplant patients and to provide biological materials from transplanted patients in order :

i) validate new theory on the cause of allograft loss, ii) develop innovative biomarker for rejection and other transplantation-related conditions (such as BK virus nephropathy, Post-transplant lymphoproliferative disorder ( PTLD) ...)


Eligibility Criteria:
Inclusion Criteria:

* Male or Female patient ≥18 years old
* Recipient of an organ transplant
* Written informed consent

Exclusion Criteria:

* Non-affiliation to a social security system.
* Subjects deprived of liberties
* Pregnant or breastfeeding woman
Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients.

The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account.

The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer.

Secondary endpoints include:

1. bleeding
2. complications
3. conversions
4. number of pelvic lymph nodes


Eligibility Criteria:
Inclusion Criteria:

* Endometrial cancer operations, which means hysterectomy, bilateral salphingo-oophorectomy and pelvic lymphadenectomy
* Gr 1 and 2 differentiation type

Exclusion Criteria:

* The operation cannot be made with an laparoscopy operation
* Age more than 85 years or young under 30 years patient
CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)

This is an investigation of the efficacy and safety of CRD007 compared to placebo in the treatment of patients with abdominal aortic aneurysm.


Eligibility Criteria:
Inclusion Criteria:

* Infra-renal abdominal aortic aneurysm

Exclusion Criteria:

* Previous infra-renal aortic surgery
* Known diabetes
Cytomegalovirus (CMV) Infection in Pregnancy

The purpose of this study is to determine if (recurrent) cytomegalovirus (CMV) infection of the mother results in pregnancy complications such as preterm delivery, severe preeclampsia, poor fetal growth, or stillbirth.

CMV infection in adults with a normal immune system is rarely a serious event. Once a person has been infected with CMV, they may have recurrences (relapses) of the infection. If a mother is infected with the virus or relapses during pregnancy, her fetus may be at risk for infection. Unlike infection in adults, fetal infection may result in serious complications (congenital infection). The effects of fetal infection with CMV are well understood and many efforts have been made to potentially reduce the risk of congenital infection. However, the effect of CMV infection on the pregnancy itself (when the fetus is not affected by CMV) is less understood.

In this study, we plan to determine if CMV recurrence in the mother results in pregnancy complications. The pregnancy complications listed above have been associated with poor placental function. We also plan to determine if (recurrent) CMV infection in the mother is associated with CMV infection of the placenta.

Eligibility Criteria:
Inclusion Criteria:

* Women who deliver at term without pregnancy complications
* Women who deliver (preterm, less than 37 weeks gestation) as a result of spontaneous preterm labor
* Women whose pregnancies are complicated by severe preeclampsia
* Women whose pregnancies are complicated by unexplained poor fetal growth (less than the 10th percentile).
* Women whose pregnancies are complicated by unexplained stillbirth.

Exclusion Criteria:

* Women with multi-gestational pregnancies, or whose pregnancies are complicated by a congenital malformation or chromosomal abnormality.
* Women who have a medical history of hypertension (high blood pressure), diabetes, or severe renal (kidney) disease
Management of Index Episode in Patients With Bipolar Disorder Treated by Seroquel XR

The primary purpose of the study is to explore management of symptomatology in patients with bipolar disorder that experience a new manic,depressive or mixed episode and are treated with Seroquel XR monotherapy/adjuctive, in routine clinical practice in Romania


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for entry into the study, male and females, will have a diagnosis of bipolar disorder, as defined by DSM-IV-TR and the current episode, whether it is manic, depressed or mixed will be treated with Seroquel XR since 1 week before entering the programme.
* All eligible patients will be included in the programme provided they will receive information in advance and will sign consent to grant access to the data collected with regard to their condition during the observation interval proposed.

Exclusion Criteria:

* All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
* Concomitant medication, that could result in drug interactions and could jeopardize patient safety will be carefully considered before having the patient enrolled. Additionally, all precautions applicable for special category patients will be taken into account, as detailed in current valid Romanian SmPC.
The Comparison of Cataract Lasers Using the Optimedica Catalys Laser and the Alcon LenSx Laser.

This study compares two FDA approved Cataract Lasers.

The purpose of this study is to systematically evaluate the performance of two commercially available and FDA cleared femtosecond laser systems in patients undergoing femtosecond laser-assisted cataract surgery. Objective data on the repeatability and accuracy of the studied parameters will be gathered and reported as endpoints of the study.

The two systems studied are the Catalys™ Precision Laser System (OptiMedica, CA, USA) and the LenSx® Laser System (Alcon Laboratories, Inc., Fort Worth, TX).

Published data have suggested that the femtosecond laser is a useful tool for cataract surgery.

This study is to determine whether differences or similarities exist in specific treatment parameters achieved with two FDA cleared and commercially available femtosecond laser cataract surgery platforms

Eligibility Criteria:
Inclusion Criteria:

* Have grade 2 to 4 nuclear sclerotic and or cortical or posterior subcapsular cataracts with visual impairment.
* Pupillary dilation of at least 6.0 mm
* Axial length between 21 mm to 26 mm
* Age ≥ 22 years of either gender
* Require laser assisted corneal incisions, capsulotomy and nucleus segmentation
* Understand and sign a written Informed Consent form
* Be able to comply with the treatment and follow-up schedule

Exclusion Criteria:

* Enrolment in another drug or device study within the prior 3 months
* History of ocular trauma
* Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
* Uncontrolled systemic or ocular disease
* Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies, severe corneal opacities, significant corneal edema, etc)
* Diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule
* Corneal ring and/or inlay implant(s)
* Pseudoexfoliation
* Known steroid IOP responder or ocular hypertension IOP \>25 mmHg by tonometry
* Retinal detachment within the last 6 months
* Anterior chamber depth less than 2.5 mm