cyrilzakka/clinical-trials huggingface dataset:
Effects of Synbiotic Supplementation in Metabolic Syndrome

To evaluate the effects of synbiotic supplementation on insulin resistance, and lipid profile in subjects with metabolic syndrome, in a randomized, double-blind, placebo-controlled pilot study, 38 subjects with metabolic syndrome will be supplemented with either synbiotic or placebo capsules twice/day for 28 weeks. Both the synbiotic (G1) and the placebo (G2) groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome and insulin resistance will be measured every 7 weeks during the study course.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report
* BMI : 25≥ BMI ≥ 40

Exclusion Criteria:

* Use antibiotic 2 weeks before recruitment to the study
* A history of alcohol consumption
* Pregnancy \& Breast feeding , Professional athelets
* A history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease
The Effect of Communication Training on the Communication Skills of the Students

Patient safety, which is an important concept in terms of providing effective and high-quality health care, is defined as "preventing health care errors and eliminating or reducing patient damage caused by health care errors". Worldwide, adverse events from unsafe care are estimated to be one of the 10 leading causes of death and disability. Ineffective communication between healthcare professionals, which is among the factors that cause errors related to patient safety, is reported as one of the factors that have the most impact on medical errors and unintentional patient harm. Studies show that ineffective communication between healthcare professionals may be responsible for up to 80% of all preventable adverse events rather than the patient's medical condition. Considering the number of lawsuits and cost increase due to errors that violate patient safety, it is stated that medical errors are higher especially in the field of perinatology. In studies conducted, errors in the communication process were identified as the main cause in 72% of all perinatal deaths. The perinatal period is a physiological process. However, undesirable events can develop suddenly and rapidly, and this situation threatens both pregnant/mother and fetus/newborn health. Therefore, it is necessary to maintain uninterrupted communication in this area. It is very important for students to acquire these communication skills effectively before they graduate. Therefore, this research; In order to determine the effect of professional communication training among health professionals to be given to nursing students on the professional communication skills of students, a parallel-group was planned as a randomized controlled trial. The study is planned to be conducted in Hacettepe University Nursing Faculty. Research data will be collected using the Student Introductory Information Form, Effective Communication Skills Among Healthcare Professionals Evaluation Form, Self-Assessment Form for Effective Communication among Healthcare Professionals, and Semi-Structured Focus Group Interview Form. Nursing students who meet the inclusion criteria will be included in the research. Students will be divided into 2 groups as the experimental and the control group. Students in the experimental group will be given training on effective communication among health professionals. No training will be given to the control group.


Eligibility Criteria:
Inclusion Criteria:

* To have taken the course of Obstetrics-Gynecology Nursing,
* To be able to understand, and speak Turkish at a good level,
* Being able to use a computer,
* Having personal internet access.
* To be a volunteer.

Exclusion Criteria:

* Not participating in any stage of the research,
* Having a disability (physical/visual/auditory) that may prevent computer and internet use,
* Wanting to leave the at any stage of the research.
Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients

The incidence of surgical-site infection (SSI) and complications related to wound healing reaches 10-20% of gynecological cancer patients. Each complication may dramatically prolong the hospitalization period and increase the economic burden of hospital care. Appropriate wound care and tissue oxygenation are of special importance for wound healing. Assuming adequate perfusion, the easiest, safest, and most effective way to improve tissue oxygenation is to increase the fraction of inspired oxygen. However, there is considerable controversy as to whether supplemental oxygen actually reduces SSI and healing-related complications as to date, there is absence of relevant data.

This study aims to investigate the prophylactic value of postoperative oxygen administration against the development of wound infections in obese gynecological oncology patients undergoing laparotomy for the treatment of endometrial or ovarian cancer. At the same time, the factors that lead to an increase in this risk will be outlined.

Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI\>30kg/m2) gynecological cancer patients
* Optimized preoperative CBC values (hemoglobin \>11g/dl, WBC 4.000-11.000 X 109/L, platelets 150,000 to 400,000 X 109/L)
* In the case of neoadjuvant therapy an interval longer than three weeks between the last cycle and the operation

Exclusion Criteria:

* Active immunosuppresion
* Preexisting infection of the abdominal wall
* Preexisting sepsis
Safety of Therapeutic Step-down in Neuromyelitis Optica

Neuromyelitis Optica (NMO) is a neuroinflammatory disease related to multiple sclerosis (MS). It affects young subjects and causes a lot of handicap without treatment. Thus, aggressive treatments are frequently introduced early in the life of patients and maintained over the long term. A long duration of treatment exposes to iatrogenism. Therapeutic de-escalation trials in MS or other autoimmune diseases show rebound phenomena. In the NMO, there are no published data on the tolerance of desescalations to guide such strategies.


Eligibility Criteria:
Inclusion criteria:

* Major patients who have received long-term treatment for NMO
* Patients with a prospectively diagnosed NMO using the 2015 NMO classification criteria (IPND)
* Patients who retrospectively meet the classification criteria of the 2015 NMO (IPND)
* Patients who have not expressed their opposition, after information, to the reuse of their data for research purposes.

Exclusion criteria:

* Patient who expressed his opposition to participating in the study
* Lack of data on the assay of anti-AQP4 and anti-MOG antibodies
* Less than a year of taking a second-line treatment before the relay
* End of follow-up \<1 year following the transfer, this therefore includes patients whose transfer took place less than one year before the date of data extraction
A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants

The main purpose of this study is to assess the effect of food on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it after a high-fat meal, and the effect of a change in gastric pH after multiple doses of omeprazole on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it when administered under fasted and fed conditions in healthy participants. The study will also evaluate the safety and tolerability of selpercatinib in healthy participants. The study will last up to 33 days excluding the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Non-vasectomized, male participants must have agreed to use a condom with spermicide or abstain from sexual intercourse during the study until 6 months after the last dosing. (No restrictions were required for a vasectomized male provided his vasectomy had been performed 4 months or more prior to the first dosing of study drug)
* If male, must have agreed not to donate sperm from the first dosing until 6 months after the last dosing
* Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

* Had a history of gastritis, gastrointestinal tract or hepatic disorder or other clinical condition that might have, in the opinion of the Principal Investigator or designee, and as confirmed by the Sponsor, affected the absorption, distribution, biotransformation, or excretion of LOXO 292 or omeprazole
Determining Elements of Anti-Fungal Immunity in BURN Patients

Scientific justification Invasive fungal diseases (IFDs) pose a substantial threat, especially in immunocompromised patients, necessitating urgent research focus and therapeutic advancements. The IFI-BURN study, involving a cohort of patients with severe burn injury (n=276), revealed a significant IFD incidence of 31.6% and underscored their critical impact on morbidity and mortality. While fungi are present everywhere, for moulds within the environment and for yeasts within our microbiota, why certain patients develop IFDs and others do not, remains poorly understood. The answer most likely resides in the impact of the burn injury on the immune response, loss of skin barrier and particular predisposing immune phenotype of patients. The immune system is composed of both cellular and humoral components, but the latter is far less studied in antifungal immunity although they exert multiple antimicrobial mechanisms.


Eligibility Criteria:
Inclusion Criteria:

Burn patients

* Adult patients ≥ 18 years old
* Admission \< 4 days following burn injury
* Total burn surface Area ≥ 15%
* Non opposition of the patient or his/her relatives to the research
* Affiliation to social security or any health insurance

Exclusion Criteria:

* Pregnancy
* Opposition of the patient or his/her relatives
* Decision not to resuscitate or to limit or stop active therapies
The Application of Probe-based Confocal Laser Endomicroscopy in the Diagnosis of Deep Endometriosis

Endometriosis is defined as the presence of endometrial glands and stroma outside of the uterus.Endometriosis affects 5%-15% of women in the reproductive age. Deep endometriosis is mostly defined as a single endometrial nodule, located in the vesico-uterine fold or close to the distal 20 cm of the large bowel. Current guidelines recommends that laparoscopy with histology should be done to diagnose endometriosis. Probe-based confocal laser endomicroscopy (pCLE) has been used as a GI tract endoscopy additive tool in recent years, providing in-vivo cellular-level imaging, a concept known as "optical biopsy". considering the rectal bleeding that occurs in patients suffering from bowel endometriosis, usually with a normal mucosa seen at standard endoscopy (personal data), we hypothesized that there might be histological architectural changes in the vessels or the mucosa/sub mucosa in bowel endometriosis.

Endometriosis is defined as the presence of endometrial glands and stroma outside of the uterus, most commonly over the ovaries, fallopian tubes, bladder, recto-sigmoid colon and the uterine myometrium.Endometriosis affects 5%-15% of women in the reproductive age causing pelvic or abdominal pain, infertility and occasionally rectal bleeding (if involving the bowel). Deep endometriosis is mostly defined as a single endometrial nodule, usually larger than 1 cm which is located in the vesico-uterine fold or close to the distal 20 cm of the large bowel. Those lesions usually infiltrate at least 5 mm into the tissue involved. The gold standard of diagnosis is histological proven endometriosis, usually obtained during explorative laparoscopy. Other imaging tests that aid in the diagnosis are trans-vaginal or trans-rectal sonography (TRUS), MRI \& CT. Current guidelines recommends that laparoscopy with histology should be done to diagnose endometriosis. Negative (normal) laparoscopy is highly accurate in excluding endometriosis, but a positive laparoscopy (i.e. with macroscopic findings) without biopsy has a limited value. In practice, many clinicians refrain from taking biopsies due-to the risk of bowel surgery, particularly on an un-prepared bowel. Probe-based confocal laser endomicroscopy (pCLE) has been used as a GI tract endoscopy additive tool in recent years, providing in-vivo cellular-level imaging, a concept known as "optical biopsy". considering the rectal bleeding that occurs in patients suffering from bowel endometriosis, usually with a normal mucosa seen at standard endoscopy (personal data), we hypothesized that there might be histological architectural changes in the vessels or the mucosa/sub mucosa in bowel endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Endometriosis

Exclusion Criteria:

* Unable or unwilling to give and sign an informed consent
* Allergy to fluorescein
* Colitis
* Critical illness
* Pregnancy
* Malignancy
The Effects of Safety Seeking Behaviors During Exposure Therapy for Adults With Spider Phobia

Exposure-based cognitive-behavioral therapy (i.e., "exposure therapy"), which entails repeated and prolonged confrontation with feared situations/stimuli, is the most effective treatment for anxiety disorders (e.g., arachnophobia). Safety behaviors are actions performed to prevent, minimize, or escape a feared catastrophe and/or associated distress (e.g., wearing thick shoes or gloves when around areas where there might be spiders). It is understood that safety behaviors contribute to the development and maintenance of anxiety disorders; accordingly, patients' safety behaviors are traditionally eliminated as soon as possible during exposure therapy (i.e., "response prevention"). Unfortunately, not everyone who receives exposure therapy benefits from this approach. To address the limitations of exposure's effectiveness, some experts have questioned the clinical convention of response prevention during exposure therapy. Specifically, they propose the "judicious use of safety behaviors": the careful and strategic incorporation of safety behaviors during exposure therapy. The controversial role of permitting safety behaviors during exposure has garnered substantial research attention, yet study findings are mixed. The current study, therefore, was designed to improve upon the methodological limitations of previous related research and examine the relative efficacy of traditional exposure with response prevention (E/RP) and the experimental exposure with the judicious use of safety behaviors (E/JU) in a sample of adults with arachnophobia. In light of previous related research, several hypotheses were made regarding the short- (posttreatment) and long-term (1-month follow-up) treatment effects:

1. Primary outcomes: E/RP participants will demonstrate greater improvement in spider phobia than the E/JU participants along behavioral and self-report symptom measures at follow-up.
2. Secondary outcomes: Treatment acceptability and tolerability will be higher for E/JU participants, relative to E/RP participants, before beginning exposures and at posttreatment, but not at follow-up. In addition, hypothesize that E/RP participants will report greater reductions in peak distress and greater improvements in distress tolerance relative to E/JU participants at follow-up.
3. Additional outcome: Exploratory analyses will be conducted to compare the relative rate of behavioral approach and exposure goal completion between treatment conditions.


Eligibility Criteria:
Inclusion Criteria:

* Being at least 18 years old
* Presence of clinically significant spider phobia
* English fluency
* Willingness to attend and audiotape all study sessions

Exclusion Criteria:

* Spider or bee allergies
* Previous trial of exposure-based cognitive-behavioral therapy for any anxiety problem
* Current alcohol or substance use disorder
* Lifetime symptoms of mania or psychosis
* Voluntarily report current suicidal ideation
* Complete 10 or more steps on the behavioral approach task administered at the pre-treatment assessment
Language Proficiency and Quality of Life After Receiving Cochlear Implantation as a Child

Treatment with cochlear implantation is now offered to proximately 95 % of children with deafness in Norway. More than 500 children have been operated at Oslo University Hospital. The study is a cross-sectional study aimed to investigate speech perception, language skills, quality of life in all childhood cochlear implant (CI) recipients in Norway from 1988-2012. Factors such as child characteristics, characteristics with the family, the cochlear implant, the rehabilitation situation, choice of communication mode, school and work situation are surveyed to see if these factors can be associated with variations in outcome. The study will include pre and post lingual deaf children and children with multiple disabilities. Participants are recruited and examined in conjunction with their annual CI control at the hospital. It will be conducted a series of tests determining listening, speech and language development, non-verbal intelligence. Questionnaires are used to collect background information and quality of life experience. The questionnaires include self-report forms for different age groups, and a parent report form. The patient will be tested for the most common genetic causes of deafness. Additional data will be collected from patient records and from local health register at Oslo University Hospital.

Test protocol includes:

Hearing and Language assessment:

Single syllable word perception, Hearing in noise test (HINT), Mullen Scale of Early Learning, British Picture Vocabulary Scale, Peabody Picture Vocabulary Test - Fourth Edition, Clinical Evaluation of Language Fundamentals (CELF) - Fourth Edition 4 , Raven progressive matrices, Motor Coordination + Visual Perception (VMI), Wechsler Preschool and Primary Scale of Intelligence (WPPSI), Wechsler Intelligence Scale for Children (WISC) and Wechsler Adult Intelligence Scale (WAIS).

Quality of Life assessment:

Satisfaction of Life Scale for Children Pediatric Quality of Life Inventory TM (PedsQL TM) Questionnaire for quality of life assessments (KINDL)

Eligibility Criteria:
Inclusion Criteria:

* All people in Norway that have received Cochlear implants as a child and that have one or more than one year with CI experience.

Exclusion Criteria:

* Cochlear implant users with less than one year with CI experience and people implanted after 18 years of age.
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males

This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.


Eligibility Criteria:
Inclusion Criteria:

* Males between 18-75 years of age
* Two fasting serum testosterone levels \<300 ng/dL

Exclusion Criteria:

* Previous use of the study drug
* History of prostate or breast cancer
* Prostate-Specific Antigen (PSA) ≥3 ng/mL
* Subject is sexually active and not willing to use adequate contraception
CrisisCope: ICBT for Psychological Symptoms Related to Life Crises.

The aim with this study is to investigate the effects of internet-based cognitive behavioral therapy (ICBT) on psychological symptoms related to one or more life crises. The target group is adults (18 years or older) who have symptoms of depression, anxiety, stress, or other psychological distress related to one or more life crises. The ICBT consists of eight modules during eight weeks with weekly support by a therapist and the treatment group will be compared to a wait-list control condition. Participants will be recruited in Sweden with nationwide recruitment.

The study is a randomized controlled trial about the effects of ICBT aiming to target psychological symptoms related to one or more life crises. Primary outcome measures are depressive symptoms (measured with Beck Depression inventory-II) and anxiety symptoms (measured with Generalized Anxiety Disorder-7). Other outcome measures used will for example be about adaptability, stress symptoms, sleep problems, post traumatic stress symptoms and quality of life.

Because the psychological impact of a life crisis can be diverse, between different people and between different kinds of crises, a transdiagnostic individually tailored treatment will be used that has been tested in several previous trials. This treatment has been adopted to target psychological symptoms related to life crises.

Eligibility Criteria:
Inclusion Criteria:

* Experience psychological symptoms related to one or more life crises.
* 18 years or older
* Adequate ability to speak, read and write Swedish
* Having access to the internet and a smartphone, computer or other device

Exclusion Criteria:

* Severe psychiatric or somatic issues that makes participation harder or impossible
* Ongoing addiction
* Acute suicidality
* Other ongoing psychological treatment
* Recent (within the past three months) changes in dose of psychotropic medication or planned change during the treatment weeks
Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient

The purpose of the study is to demonstrate the non-inferiority of CHF1535 pMDI versus Symbicort® Turbohaler® in terms of lung function parameters and patients reported outcomes and to assess its safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 40 years, Chinese ethnicity
* Patients with COPD diagnosed at least 12 months before the screening visit.
* A smoking history of at least 10 pack years
* Post-bronchodilator FEV1 \< 50% of the predicted normal value
* Post-bronchodilator FEV1/FVC ratio \< 0.7
* One exacerbation in the 12 months prior the screening visit

Exclusion Criteria:

* Patients requiring OCS/antibiotics/PDE inhibitors in the 4 weeks prior to screening
* COPD exacerbation requiring OCS/antibiotics or hospitalization during the run-in period
* Known respiratory disorders other than COPD
* Diagnosis of asthma