cyrilzakka/clinical-trials huggingface dataset:
Effect of Ephedrine vs. Norepinephrine on Prevention of Fetal Acidosis During Cesarean Section Under Spinal Anesthesia

This study compares the effects of two medications, ephedrine and norepinephrine, on the baby (fetus) when used to treat low blood pressure (hypotension) during cesarean section under spinal anesthesia. Hypotension is a common side effect during spinal anesthesia, and it can affect the blood flow to the baby. Both medications are commonly used to manage this condition. The goal of the study is to determine which medication is more effective and safer for the baby, by measuring the pH level in the umbilical artery after birth. The study will also examine maternal blood pressure, heart rate, and the baby's Apgar scores.

This is a prospective, randomized, double-blind, controlled clinical trial designed to compare the effects of ephedrine and norepinephrine on fetal acidosis during cesarean section performed under spinal anesthesia. Maternal hypotension is a frequent complication associated with spinal anesthesia, and the management of this condition is critical for maintaining adequate uteroplacental perfusion. While both ephedrine and norepinephrine are commonly used vasopressors, there is ongoing debate regarding their relative safety and efficacy, particularly in terms of fetal outcomes.

The primary aim of this study is to evaluate the incidence of fetal acidosis, defined as an umbilical artery pH \< 7.20, in patients receiving either ephedrine or norepinephrine. Secondary outcomes include maternal blood pressure control, heart rate, incidence of maternal and fetal tachycardia, Apgar scores at 1 and 5 minutes, and the need for additional vasopressor support. A total of 100 pregnant women undergoing elective cesarean section will be enrolled, with 50 participants in each treatment group. All participants will receive standardized spinal anesthesia, and vasopressors will be titrated according to protocol.

The study is designed to inform clinical decision-making regarding optimal vasopressor selection in obstetric anesthesia, with a focus on balancing maternal hemodynamic stability and fetal well-being.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged between 18 and 45 years
* Singleton pregnancy at ≥ 37 weeks of gestation
* Scheduled for elective cesarean section under spinal anesthesia
* ASA (American Society of Anesthesiologists) physical status classification I or II
* Ability to understand and sign the informed consent form

Exclusion Criteria:

* History of allergy or hypersensitivity to ephedrine or norepinephrine
* Multiple gestation pregnancies
* Diagnosis of pre-eclampsia, eclampsia, or other hypertensive disorders of pregnancy
* Known cardiovascular disease or arrhythmia
* Placental abnormalities (e.g., placenta previa, placental abruption)
* Fetal structural or chromosomal anomalies
* Morbid obesity (BMI \> 40 kg/m²)
* Refusal to participate or inability to provide informed consent
A Comparison of 12 Month Daily Wear of Two Novel O2 Permeable Silicone Hydrogel CLs (HOP/SiH) and A Control, Standard O2 Lens

The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses by studying its effects on human eyes. Usual and customary care will be given in the form of eyeglasses and/or contact lenses.

The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses on bacterial binding to corneal cells and central epithelial thickness. Usual and customary care will be given in the form of eyeglasses and contact lenses. To compare long-term Daily wear vs. immediate Overnight wear (Extended wear) of a new hyper-oxygen permeable silicone hydrogel contact lens on binding of Pseudomonas Aeruginosa to exfoliated human surface corneal cells collected from the eyes of human patients and on central corneal thickness, as follows: 1) a hyper Dk/t lens for 12 months of daily wear, 2) a hyper Dk/t lens for 12 months of de novo 6 night extended wear, and 3) a hyper Dk/t lens for 12 months of de novo 30 night extended wear.

Eligibility Criteria:
Inclusion Criteria: The age requirement for this study is between 18-38 years old. The subject has to have nearsightedness in between -1.00D and -6.00D with regular astigmatism of an amount in both eyes that will not necessitate the need for toric lenses. No prior history of any lens wear within one month of entry into the contact lens phase of the study. Visual acuity of 20/30 or better during test lens wear. Normal anatomy and physiology of the eye. No eye cosmetic use on the day of study visits. Normal appearance of the cornea with slit lamp examination, stable tear film and sufficient tear production. Intraocular pressure less than or equal to 21 mmHg by Goldmann applanation. Absence of any intraocular inflammation. Normal appearance of optic nerve, macula and peripheral retina by direct fundus examination.

Exclusion Criteria: Patients with chronic ocular conditions are excluded from the study (i.e. dry eye, recurrent corneal epithelial erosion). History of allergic eye disease either seasonal or associated with previous contact lens wear. Use of any topically applied ocular medication or systemic medication specifically including but not limited to, antihistamines, aspirin-related drugs, or psychoactive or anti-depressant medication. Oral contraceptives are allowed. Currently suspected or actual pregnancy. Study terminates if pregnancy occurs. Patients will not be enrolled if they are currently in another ophthalmic research project.
Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome

This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.


Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age.
* Diagnosis of Zollinger-Ellison Syndrome or idiopathic hypersecretion

Exclusion Criteria:

* Pregnant or lactating females
* History of drug addiction or alcohol abuse within 12 months prior to Screening.
* History of intolerance to any proton pump inhibitors or any ingredient in their formulation.
Effect of Using Virtual Reality Goggles on Fear and Pain Level During Vaccination in Children

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using Virtual Reality Glasses reducing fear and pain during routine vaccination in children.

In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to examine the effect of distraction by using Virtual Reality Glasses in reducing fear and pain during routine vaccination in children.

This study is a prospective, randomized and controlled trial. Children aged 48 months who required routine vaccination were divided into two groups; Virtual Reality Glasses and Control. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's anxiety levels were also assessed using the Children's Fear Scale. The children's pain levels were assessed and reported by the parents and observers and the children themselves who selfreported using Wong-Baker FACES.

The study population consisted of the children's during routine vaccination in children aged 48 months. Sample of the study consisted of a total of 64 children who met the sample selection criteria and were selected via randomization method.

Children were randomized into two groups: Virtual Reality Glasses group (n= 32) and Control group (n= 32). Data were collected using the Interview and Observation Form, Children's Fear Scale, and Wong-Baker FACES Pain Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* Children the ages of 48 months,
* Volunteering of the child and parent to participate in the study,
* Healthy children,
* Vaccination should be done by the same nurse,

Exclusion Criteria:

* The child has any acute or chronic disease,
* The child has a mental disability, vision, speech or communication problems,
* The parent has hearing, vision or verbal communication difficulties,
* The child used analgesics in the last 6 hours,
* Infection, disruption of skin integrity and rash in the area where the application will be made,
* Exclusion criteria were that the parent or child wanted to leave the study at any point.
PROSTACOX : Metastatic Prostate Chemotherapy

Clinical response to chemotherapy. Biological parameter (PSA) and RECIST evaluation. Association of Docetaxel (J 15) and Celecoxib.

Association Docetaxel (J 15) and celecoxib Patient survival Biological parameter : PSA Clinical status RECIST evaluation

Eligibility Criteria:
Inclusion Criteria:

* metastatic prostate cancer
* ASCO progression criteria

Exclusion Criteria:

* other prostate chemotherapy
Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines

This study is designed to evaluate the safety, efficacy, and subject and investigator satisfaction of 2 different injection volumes of Dysport in the glabellar lines.

1. To determine the proportion of composite responders (based on blinded evaluator and subject assessments) who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) at maximum frown line on Day 30.
2. To assess the GLSS, at maximum frown and at rest, by live assessment at all visits.
3. To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2 visit (subject and blinded evaluator).
4. To assess the subject's satisfaction with the treatment.
5. To evaluate investigator satisfaction of treatment outcome.
6. To evaluate subject psychological well-being.
7. To evaluate subject age appraisal.
8. To evaluate all adverse events during the course of the study.

Five month, randomized, subject- and evaluator-blinded, multi-center, mult-visit study. Subjects treated with Dysport following the US on-label guidelines.

Eligibility Criteria:
Key Inclusion Criteria:

1. Botulinum toxin naïve subject (facial area)
2. Moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown and mild to severe (GLSS = 1, 2, or 3) glabellar lines at rest using the validated 4-point Photographic Scale, as assessed by the treating investigator and the blinded evaluator.

Key Exclusion Criteria:

1. Have known allergies or sensitivities to Dysport®, any of its excipients, or cow's milk protein
2. Have rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
3. Have a history or have signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator
4. Have clinical or subclinical neuromuscular junctional disorders (eg, myasthenia gravis, Lambert Eaton syndrome, or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration
5. Are women who are pregnant or breast-feeding or who intend to get pregnant within the duration of the study
6. Have an active inflammation or infection in the areas to be treated or had any prior surgery, tattoos, piercings, or scarring in the facial area that, in the opinion of the investigator, may interfere with the results
7. Have had any previous insertion of any permanent or semi-permanent material, hyaluronic acid, or collagen fillers in the glabellar region
8. Have any chronic or acute medical condition that, may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this study
The Effectiveness of Dual Task Training in Elderly With Cognitive Decline

Cognitive decline is the impairment of memory, execution, or language. Early detection of the individuals who manifest cognitive decline and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Many studies have found that dual-task training combining cognitive training and exercise can improve cognitive function in older adults. However, it is yet not clear the appropriate frequency of the effective dual-task training for elderly with cognitive decline. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency dual-task training for elderly with cognitive decline.

Cognitive decline is the impairment of memory, execution, or language. Early detection of the individuals who manifest cognitive decline and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Many studies have found that dual-task training combining cognitive training and exercise can improve cognitive function in older adults. However, it is yet not clear the appropriate frequency of the effective dual-task training for elderly with cognitive decline. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency dual-task training for elderly with cognitive decline.

We anticipate recruiting a total of 80 participants with cognitive decline. The participants will be assigned into 2 groups: high frequency dual-task training (HF) and low frequency dual-task training (LF) groups. The participants of HF will receive a total of 36 training sessions, and each session will contain 90-120 minutes of training. The participants of LF will receive a total of 12 training sessions, and each session will contain 90-120 minutes of training. The programs are based on dual-task trainings which contain cognitive training and exercise simultaneously. For physical exercise, we will design the programs that involve balance or strength training components in the aerobic exercises. In terms of cognitive training, we will design self-made teaching aids and board games to train different domains of cognitive functions. We plan to assess the participants before and after the intervention programs. We expect that elders receiving dual-task training will improve on outcome measures, and the group with more frequency will have better performance. The results of the study will provide evidence of interventions for elderly with cognitive decline, thereby reducing the burden on their caregivers and the cost of medical resource.

Eligibility Criteria:
Inclusion Criteria:

* able to follow instruction (MMSE\>= 20)
* self- or informant-reported memory or cognitive complaint.

Exclusion Criteria:

* recent myocardial infarction,heart failure,recent heart surgery,
* severe asthma, concomitant with other neurological disorders, or joint deformity that might prevents them performing exercise or cognitive training.
Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: \> 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

* Understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age);
* Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age);
* Are aged \>= 16 years (from the 16th birthday) at screening;
* Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial);
* Have a negative pregnancy test result at the first medical examination (if female and capable of bearing children);
* Agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children);
* Agree to keep a Subject Diary.

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

* Have a history of any previous tick-borne encephalitis (TBE) vaccination;
* Have a history of TBE infection;
* Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis);
* Have a history of allergic reactions, in particular to one of the components of the vaccine;
* Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
* Have a known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent level of other alcoholic beverages);
* Have donated blood or plasma within 30 days of study entry;
* Have received a blood transfusion or immunoglobulins within 30 days of study entry;
* Are known to be HIV positive (an HIV test is not required specifically for the purpose of this study);
* Are simultaneously participating in another clinical trial including administration of an investigational product;
* Have participated in any other clinical study within six weeks prior to study entry;
* Are pregnant or breastfeeding (if female);
* Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
* Have received any other vaccination within two weeks prior to study entry.
Ocular Manifestation and Related Risk Factors of Covid-19 Associated Mucormycosis: a Multicenter Study in Iran

Coronavirus disease 2019 (COVID-19) infection caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may manifest as a variety of disease patterns, ranging from mild to life-threatening pneumonia.

Mucormycosis has been suspected to cause significant morbidity in infected people since the outbreak of the COVID-19 pandemic. Individuals who require hospitalization and intensive care are more vulnerable, as they have reached an advanced stage of their disease. Investigators will discuss the major risk factors, ocular presentation, and outcome of mucormycosis in individuals infected with SARS-CoV-2 in this study. From August 2021 to January 2022, a cross-sectional descriptive multicenter investigation would be conducted on patients with biopsy-confirmed mucormycosis and RTPCR confirmed COVID19. Demographic data, the time interval between COVID19 and mucormycosis, underlying systemic disorders, clinical characteristics, disease course, and outcomes would be analyzed.

Investigators will achieved the following data from the participants:

1. Demographic
2. Past medical/habitual history
3. COVID-19 status and related risk factors
4. Mucormycosis status and related risk factors
5. Ocular examination and imaging
6. Follow-up

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed case of Mucormycosis in COVID-19 pandemic

Exclusion Criteria:

* People with acute or severely ill conditions that prevent them from ophthalmic examination.
* Patient, or legal representative opposing the pursuit of the research
Genetic Markers of Patients With History of Pulmonary Embolism Post Total Joint Arthroplasty

This study seeks to uncover potential genetic determinants of pulmonary embolism (PE). Our translational goal is to ultimately identify certain genetic markers that will allow us to stratify patients in terms of their PE risk post total knee or total hip arthroplasty. The clinical implications for this study would allow for better patient care by lowering the risk of post-operative bleeding while still preventing symptomatic PEs and deep vein thromboses (DVTs). We look to sample patients who have a history of PE after undergoing total knee or total hip arthroplasty. We will sample these patients' blood DNA for a set of DNA genetic markers. To do so, we will utilize the Taqman assay, which is a PCR-based 5'-nuclease allelic discrimination assay to determine single nucleotide polymorphism (SNP) genotypes at specified loci. The region flanking the SNP is amplified using two allele-specific fluorescent probes, allowing for the detection of each allele in a single tube. Using this assay, there is no post-PCR processing because the probes are included in the PCR reaction (Hui). Using this approach, we will measure the frequency of genetic mutations in patients who have developed a PE after a total joint arthroplasty. This data would then be used to perform a prospective study to determine a subset of genetic markers that can definitively be used to risk stratify patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with a history of Pulmonary Embolism and Total Hip Arthroplasty or Total Knee Arthroplasty, between the ages of 18 and 70 years

Exclusion Criteria:
Anger and Psychotrauma: Data From Military and Civilians

Post-Traumatic Stress Disorder (PTSD) is mainly associated with several emotions such as anger, guilt or shame. By interfering with psychotherapeutic work these emotions can be problematic. When suffering from PTSD, pervasive anger can also have relational consequences. Anger and PTSD are mutually reinforcing: anger can aggravate PTSD symptoms and aggressive behaviours, and conversely, PTSD promotes high levels of anger and aggression. A few explanatory hypotheses have been proposed. In terms of personality factors, anger-treatment may promote the severity of PTSD symptoms and the development of aggressive behaviours. In terms of stressors, exposure to combat and combat-related moral harms could play a role in the relationship between PTSD, anger and traumatic experiences over the course of life. Finally, in clinical terms, in the presence of PTSD, anger and aggressive behaviours may be triggered by substance abuse and depression.

Within the Anglo-Saxon literature, it is recognized that both civilians and military personnel with PTSD exhibit high levels of anger, with a possible predominance among military personnel. While we know that anger management mechanisms can be strongly influenced by cultural aspects and the type of event, there is no data in the French population.

This study proposes to fill in our knowledge of anger-PSTD relationships in the French population and by comparing civilian and military population.


Eligibility Criteria:
Inclusion Criteria:

* To have a PTSD diagnosis
* To be at least 18 years of age

Exclusion Criteria:

* To suffer from trauma-related physical condition (including Traumatic Brain Injury)