cyrilzakka/clinical-trials huggingface dataset:
The Effect of Adenomoyosis on Pregnancy Outcomes

Adenomyosis can be defined as the settling of endometrial gland cells in the myometrium and deformity in the uterus and the prevalence of adenomyosis is according to the patient population and countries around 20%. There are recent publications reporting that this rate increases up to 50% in women dealing with infertility. In adenomyosis, where uterine morphology is affected, it is not thought that the uterus, which is expected to provide many morphological adaptations during pregnancy, will not be affected. Therefore, in this prospective study, it was planned to investigate the effects of adenomyosis during pregnancy.

For this study the presence of adenomyosis will be questioned by using ultrasonographic morphological uterine limitation (MUSA) in women who apply to the outpatient clinic with suspicion of pregnancy and undergo transvaginal ultrasonography for the diagnosis of pregnancy before sixth gestational week.

Patients will be divided into two groups according to the presence of adenomyosis and pregnancy complications such as preterm labor, premature rupture of membranes, cesarean section rates, preeclampsia, fetal malpresentation and preeclampsia will be compared between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-35 years
* Being diagnosed before the 6th gestational week
* Having all pregnancy follow-ups and deliveries in our hospital

Exclusion Criteria:

* Previous uterine surgery
* Multiple pregnancies
* Pregnant women with uterine malformations
* Pregnant women with fetal anomalies
* Those who got pregnant using assisted reproductive technique
Motor Imagery and Action Observation in Patients With Knee Osteoarthritis

The main objective of this study is to evaluate the effects of an exercise programme combined with motor imagery and action observation, both in the short and long term.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with severe knee OA (according to the clinical and radiographic criteria of the American College of Rheumatology Guidelines)

Exclusion Criteria:

* pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities),
* undergone another hip or knee joint replacement in the previous year
* any medical condition in which exercise was contraindicated or if they had participated in exercise programs or motor imagery/action observation intervention
Review of Trend in Incidence and Characteristics of Hospital-acquired Acute Kidney Injury in Hospital Selayang

This retrospective cohort study aims to investigate the incidence, risk factors and outcomes of Hospital-acquired Acute Kidney Injury in Hospital Selayang, a tertiary hospital at Malaysia, over 15 years.

This is a retrospective cohort study involving 5-yearly trend from 2002 to 2017 for analysis. Laboratory serum creatinine (SCr) results of all patients admitted during study period will be retrieved from the hospital Laboratory Information System. A preliminary screening list will be generated by using STATA program from the SCr results. The nephrologist will then determine HA-AKI and CA-AKI as per inclusion and exclusion criteria. Data collectors will collect all relevant data from these patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult admissions to Hospital Selayang from

  * 1st July 2001 to 30th June 2002
  * 1st July 2006 to 30th June 2007
  * 1st July 2011 to 30th June 2012
  * 1st July 2016 to 30th June 2017

Exclusion Criteria:

* End Stage Renal Failure and on Renal Replacement Therapy (Hemodialysis, peritoneal dialysis or Renal Transplant)
Application of Virtual Reality Technology to Treatment of Social Anxiety

The purpose of this study is to compare CBT VR exposure + VR social skills treatment to CBT Imaginal exposure + mindfulness, in reducing the severity of social anxiety in adults with autism and social anxiety (SA), to identify characteristics associated with benefitting from the CBT-VR treatment and to assess acceptability and feasibility of the VR intervention for patients receiving it and use findings to improve methods and to prepare for a community based pragmatic trial.


Eligibility Criteria:
Inclusion Criteria:

* Autism Spectrum Disorder (ASD) (diagnosed by a qualified professional)
* verbal and literate in English or Spanish
* average or greater intellectual ability, based on history and interview
* able to operate a computer (Windows or Mac).

Exclusion Criteria:

* current or historical severe mental illness such as schizophrenia, bipolar disorder, or severe depression
* intellectual disability or a learning disability that would interfere with participating (e.g., unable to read)
* unable use the technology or do not have access to the technology
* unable to read
Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops.

Introduction: Glaucoma is the second leading cause of blindness globally. Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. Autologous serum eye drops (ASED), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. This study investigates the efficacy of 20% ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops.

Methods: The present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment.

The primary outcome is the comparison of National Eye Institute (NEI) scores between autologous serum drops and placebo-treated eyes at two months. Secondary outcomes include Schirmer's test scores, visual acuity, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, intraocular pressure, and complication rates.

The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue.


Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma who developed corneal epitheliopathy secondary to antihypertensive drops;
* Epitheliopathy refractory to conventional therapies (Artificial Tears, ointment, topical cyclosporine or punctal plug, etc.);
* National Eye Institute score of 3 or more for both eyes;
* Adults aged 18 to 90 years inclusively.

Exclusion Criteria:

* Corneal epitheliopathy of other origin (ie. mechanical, neurotrophic, toxic, post-infectious, limbal stem cell deficiency);
* Glaucoma surgery within the last six (6) months;
* Previous corneal surgery;
* Active autoimmune disease;
* Frequent contact lense wear;
* Pregnant or actively breast-feeding;
* Known systemic infection with HIV, hepatitis B and C or syphilis;
* Known severe anemia (Hb \< 100 g/L);
* Inability to give informed consent
Inertial Sensors for Obstetrical Walking Epidural Tracking

Freedom of movement and the ability to walk are crucial during the first stage of labor, potentially reducing labor duration, cesarean section risk, epidural analgesia use, and bladder catheterization. While the clinical effects of ambulation during labor remain controversial, there is a consensus on its positive impact on the birthing experience and satisfaction.

Epidural analgesia remains the gold standard for pain control during labor, with a utilization rate of 82% in France. Recent advancements in obstetric analgesia have allowed for lower doses of analgesics, often administered via patient-controlled analgesia, which maintains the potential for ambulation during labor. However, only a small number of maternity units in France offer this technique. The main barriers include organizational issues such as unsuitable facilities, lack of wireless telemetry, and potential risks such as falls and hypotension.

Significant changes in gait characteristics are observed throughout pregnancy, particularly during the third trimester, and are studied in laboratory settings using video capture and analysis. Gait during labor is influenced by pain, fetal progression, and anatomical changes in the pelvis. The presence of epidural analgesia, where local anesthetics likely affect neural transmission, may impact motor commands and sensory feedback, further altering gait characteristics. These biomechanical aspects of labor remain understudied.

Wearable inertial sensors show promise in maternal health monitoring by providing real-time data for motion and gait studies. However, their application has not been described or validated during labor, particularly in walking conditions. Continuous dynamic study of gait in these conditions could enable non-invasive, non-intrusive monitoring of analgesia effectiveness, fall risk prediction, and labor progression analysis.

The aim of this feasibility study is to validate the use of wearable inertial sensors to quantify movements and characterize gait during the first stage of labor, both with and without low-dose epidural analgesia.


Eligibility Criteria:
Inclusion Criteria:

* pregnancy \>= 38 gestation weeks
* no significant medical history (American Society of Anesthesiologists class ASA 1)
* receiving low-dose epidural analgesia with ambulation (in accordance with current service protocol)
* not opposed to the study

Exclusion Criteria:

* Refusal to participate in this study
* Non-French-speaking patient
* History of osteoarticular pathology likely to change gate (severe scoliosis, spinal surgery, congenital hip deformity, pelvic fracture, ligament or knee joint pathology)
* adults under legal protection
* multiple pregnancy
* need for continuous intravenous infusion with infusion stand during ambulation
Effect of Whole-body Vibration on the Ankle Joint, Plantar Pressure, and Running Paramethers

The main purpose of this study was the assessment of whole-body vibration warm-up, modified drop jumps, and combination of both on the range of motion of dorsiflexion in the ankle joint and running time. 16 recreationally active runners performed 4 different warm-up variants one week apart: 5 sets of 30 s calf raises on the platform but without vibration (CTRL), the same as CTRL group but with vibration with 30 s rest intervals between sets (WBV), 6 drop jumps with a 30 s rest interval between sets (DJ); last group was combination of both WBV and DJ groups (WBV+DJ). The study included muscle flexibility tests for the soleus and gastrocnemius muscles performed before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run on a treadmill. The running time was measured and the run had to be completed in the shortest possible time.

Additionally, in the third week of the study there were performed static and dynamic foot measurements immediately before and after a 3000 m treadmill run. The main purpose of that gait analysis was to assess the impact of a 3km run on plantar pressure patterns and gait parameters in recreational runners.


Eligibility Criteria:
Inclusion Criteria:

* healthy and recreationally active males
* minimum two years of running training experience

Exclusion Criteria:

* rheumatological disease
* neurological disease
* orthopaedic disease
* genetic disease
* cardiovascular system disease
* pain in lower limbs in the last year
* pain in lumbar spine in the last year
* surgeries of lower limbs in the last year
* surgeries of spine in the last year
* musculoskeletal injuries in the lower limbs in the last year
* musculoskeletal injuries in the lumbar spine in the last year
* the absence during one or more training day
Inspiratory Muscle Training in COVID-19 Patients

This study aims to investigate whether adjunctive inspiratory muscle training (IMT) can enhance the benefits of pulmonary rehabilitation (PR) in patients with COVID-19. 120 patients will be randomized into an interventional group (PR plus IMT) and a control group (sham IMT plus PR). Improvement in quality of life, peak VO2 and VE/VCO2 slope will be defined as a primary outcome. Maximal inspiratory pressure, inspiratory muscle endurance, pulmonary function testing, severity of fatigue, cost-effectiveness and six minute walk test will be defined as the secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

To be eligible, participants must be:

* over 18 years of age
* confirmed COVID-19 diagnosis
* Individuals that required hospitalization and either i) non-invasive respiratory support (CPAP, high-flow oxygen catheter, non-breathing oxygen mask, or ii) invasive mechanical ventilation within three months of study recruitment.

Exclusion Criteria:

* Pregnancy
* Dependence on others to perform activities of daily living during the month prior to the current ICU admission (gait aids are acceptable)
* documented cognitive impairment
* Proven or suspected spinal cord injury, or other neuromuscular diseases that will result in a permanent or prolonged weakness (not including ICU acquired weakness)
* Severe neurological disease
* Death is deemed inevitable as a result of the current illness and either the patient or treating clinical or substitute decision-maker are not committed to full active treatment.
Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis

Primary Objective:

- To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg - pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg - pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60) in patients with seasonal allergic rhinitis (SAR).

Secondary Objectives:

* To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily activity impairment.
* To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.

The study duration for each patient is 3 weeks and 3 days:

1. Lead-in period: 1 week
2. Treatment period: 2 weeks
3. Follow-up period: 3 days

Eligibility Criteria:
Inclusion criteria:

- Patients with seasonal allergic rhinitis (SAR): Patients with a history of SAR symptoms during the season when cedar pollen levels are increased for at least 2-years

Exclusion criteria:

* At the start of the placebo lead-in period:

  * Patients who are negative for IgE Antibody test
  * Expected nasal congestion score is less than 2
* The last 3 days of the lead-in period:

  * Nasal congestion scores are 2 or more and not all 4
  * Patients with all nasal symptoms (sneezing, rhinorrhea, and nasal congestion). A total score for nasal symptoms (sneezing, rhinorrhea, and nasal congestion) and eye symptom is less than 6
  * Patients with 2 or more nasal symptoms (sneezing and rhinorrhea) and eye symptoms score is 4

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

The main purpose of this study is to investigate the effect of retatrutide on renal function in participants with overweight or obesity and chronic kidney disease (CKD), with or without Type 2 Diabetes (T2D). The study will last around 31 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) ≥27 kilogram/square meter (kg/m²)
* Have either

  * no T2D with an HbA1c \< 6.5% or
  * have T2D with an HbA1c ≤ 9.5% and treated with diet and exercise only or with stable doses of up to 3 oral antihyperglycemic medications, with or without basal insulin for at least 90 days before screening.
* Have been diagnosed with chronic kidney disease (CKD).

Exclusion Criteria:

* Have a self-reported change in body weight \>5 kilogram (kg) (11 pounds) within 90 days before screening.
* Have used in 90 days before the screening any of the following antihyperglycemic class: Dipeptidyl Peptidase IV (DPP4) inhibitors, amylin analogs, glucagon-like peptide-RA (GLP-RA), gastric inhibitory polypeptide (GIP)/GIP-1 RA, and short acting or rapid acting insulins or U500 Insulin
* Have a prior or planned surgical treatment for obesity
* Have Type 1 Diabetes (T1D)
* Have acute or chronic hepatitis
* Have a history of malignant disease within 5 years before screening.
Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation

The purpose of this study is to evaluate the the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Patients with mechanical ventilation.
* Patients with diffuse lung disease of unknown etiology.
* Need for confirming/excluding a diagnosis, with therapeutical and prognosis implications.
* Inform consent signed by family.

Exclusion Criteria:

* Use of anticoagulant therapy or presence of a coagulation disorder (abnormal platelets counts, international normalized ratio \> 1.5).
* Comorbidities that could increase the risk of the TBLB.
* Bullous emphysema.
* Hemoptysis, pneumothorax.
* Severe respiratory insufficiency requiring PEEP \>12 cm H2O
Nomograms for Optimization of Amikacin First Dose in Critically Ill Patients Using a Population Pharmacokinetics Model

The aim of this study is to elaborate nomograms to optimize amikacine first dosing in critically ill patients, using a population pharmacokinetics model elaborated with multicentric data.

French guidelines recommend for probabilistic therapy to reach an amikacin concentration 1 hour after beginning the infusion ≥ 60 mg/L. This target is rarely achieved in the ICU despite a 30 mg/kg recommended dosage. Using data collected prospectively in critically ill patients of Nîmes (France) (1) and Nantes (France), we will elaborate a population pharmacokinetic model on the non-parametric software Pmetrics and on the parametric software Monolix. We will calculate probability of target attainment of Monte-Carlo simulations, using the non-parametric model. Nomograms to determine optimal first dose of amikacin in critically ill patients, according to a few variables previously identified, will be produced.

Eligibility Criteria:
Inclusion Criteria:

* patients treated with amikacin for sepsis in one of the participating ICU will be included.

Exclusion Criteria:

* patients with aminoglycoside allergy, history of myasthenia, pregnancy, under guardianship.
Safety Study of Eteplirsen to Treat Advanced Stage Duchenne Muscular Dystrophy

The primary objective of this study is to explore safety and tolerability of eteplirsen in participants with advanced stage Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping.

This is an open-label, multi-center study to explore the safety and tolerability of eteplirsen injection in participants with advanced stage DMD with confirmed genetic mutations amenable to treatment by exon 51 skipping.

Participants will be evaluated for inclusion during a Screening/Baseline period of up to 4 weeks. Eligible participants will receive once weekly intravenous (IV) infusions of 30 mg/kg eteplirsen for 96 weeks, followed by a safety extension (not to exceed 48 weeks).

Safety will be regularly assessed throughout the study via the collection of adverse events (AEs), laboratory tests, electrocardiograms (ECGs), echocardiograms (ECHOs), vital signs, and physical examinations.

Eligibility Criteria:
Inclusion Criteria:

* Male 7 - 21 years of age
* Diagnosis of DMD with a mutation that is amenable to exon 51 skipping, confirmed by a genetic report
* Stable dose of oral corticosteroids for at least 24 weeks or has not received corticosteroids for at least 24 weeks
* Non-ambulatory, or incapable of walking ≥300 meters on the 6-Minute Walk Test (6MWT).
* Score of ≤4 on the Brooke Score for Arms and Shoulders.
* Stable cardiac and pulmonary function
* Use of contraceptives for sexually active males throughout the study
* Willing to provide consent and comply with the study

Exclusion Criteria:

* Use of any pharmacologic treatment (other than corticosteroids) within 12 weeks that may have an effect on muscle strength or function (e.g., growth hormone, anabolic steroids).
* Previous treatment with SMT C1100/BMN 195 at any time.
* Previous treatment with drisapersen (PRO051) within the last 6 months.
* Participation in any other DMD interventional clinical study within 12 weeks
* Major change in physiotherapy regimen within the past 3 months
* Major surgery within 3 months
* Presence of other clinically significant illness
* Use of an aminoglycoside antibiotic within 12 weeks or the need for this antibiotic or statin during study
* Forced vital capacity % predicted \[FVC % predicted\] \<40%, or requiring daytime ventilation.
* Require antiarrhythmic and/or antidiuretic therapy for heart failure.
* Have a left ventricular ejection fraction (LVEF) of \<40%.
* Prior or ongoing medical condition that could adversely affect the safety of the patient, make it unlikely that the course of treatment would be completed, or impair the assessment of study results.
COvid-19 National Survey for Assessing VIral Spread by Nonaffected CarriErs (CON-VINCE)

CON-VINCE (COvid-19 National survey for assessing VIral spread by Non-affected CarriErs) is a national, monocentric, and longitudinal study aiming to evaluate the spread dynamics of the COVID-19 disease within the Luxembourgish population. Participants who are clinically asymptomatic or present with only mild symptoms will be followed up longitudinally, regularly tested for SARS-CoV-2 by RT-PCR, antibody status, and subjected to an epidemiological, clinical and biological phenotyping to better understand the nature, dynamics of infectivity and spread of the virus in the population. CON-VINCE will also track the psychological and socio-economic impact of long-term containment measures on the general population.

To capture the dynamics and impact of the virus spread in the Luxembourgish population, data and sample collection is done every two weeks for two months (4 times in total) with a final follow-up one year after the participant's inclusion in the study. Participants complete questionnaires before each sample collection. The baseline questionnaire captures demographic data, medical history, behavioral and psychological data, and socio-economic status. Participants provided information on medical history, history of allergies, smoking, and chronic medication taken regularly. COVID-19-related data and environmental conditions of the household were obtained.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 and older of both genders, with a full capacity of consent.
* SARS-CoV-2-positive individuals with an asymptomatic or oligosymptomatic infection (mild or oligosymptomatic disease course is defined as absence of fever and respiratory distress or cough not attributable to other known chronic disease).
* OR SARS-CoV-2-negative individuals at the time of inclusion.
* OR post-infectious SARS-CoV-2-negative individuals with acquired immunity to SARS-CoV-2 and a mild disease course.

Exclusion Criteria:

* Evolution of the COVID-19 disease requiring a hospital admission before inclusion in the study
* Presence of fever and respiratory distress/cough at the time of inclusion not attributable to other known chronic disease