cyrilzakka/clinical-trials huggingface dataset:
FGL2/Fibroleukin and Hepatitis C Virus Recurrence Post Liver Transplantation

The main objective of this study is to assess whether a recently-developed bioassay for the molecule "secreted fibrinogen-like protein 2" (sFGL2) can be used to predict the recurrence and/or progression of Hepatitis C Virus disease in post liver transplant patients. The hypothesis is that patients with chronic HCV have higher than normal levels of sFGL2 in their blood both pre- and post-transplantation and that this will inhibit their ability to clear HCV, and influence the progression of HCV disease when it recurs.

Hepatitis C Virus infection (HCV) is a serious health problem worldwide, accounting for significant morbidity and mortality. The current treatment, combination therapy with pegylated IFNa/ribavirin results in only a 50% sustained viral response such that HCV is now the leading indication for liver transplantation. Unfortunately, HCV recurrence post-transplantation is universal and it is often difficult to distinguish recurrent HCV from other processes such as rejection, leading to inappropriate or delayed treatment(s) and compounding graft damage. It would be beneficial to have access to a circulating biomarker to distinguish HCV disease recurrence from other processes and to predict the severity of HCV disease progression post-transplantation.

The molecule FGL2 is secreted by cells of the immune system and may be a key immunomodulator affecting graft survival and HCV recurrence. The aim of this study is to assess whether a bioassay for FGL2 can predict HCV disease recurrence and progression after liver transplantation and/or differentiate HCV disease recurrence from acute cellular rejection.

This study will also examine the form of Fc Receptor expressed in these patients. The Fc receptor is hypothesized to be the binding partner of FGL2.

Eligibility Criteria:
For HCV positive subjects:

Inclusion Criteria:

1. Able and willing to give written informed consent
2. Willing to follow the study protocol
3. Diagnosis of chronic HCV infection based on two positive serology tests
4. No history of active alcohol or drug abuse
5. All six viral genotypes are considered
6. Pre- and post transplant viral load data must be available

Exclusion Criteria:

1. Pregnancy
2. HBV, HDV or HIV co-infection

For Non-HCV subjects:

Inclusion Criteria:

1. Able and willing to give written informed consent
2. Willing to follow the study protocol

Exclusion Criteria:

1. Free from infection by any of the following: HCV, HBV, HDV or HIV.
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants

The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and \< 3 years)

The study is an Randomized, Double-blind, Active controlled Phase III study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women aged from 6 months to \< 3 years
* Subjects were born after full term pregnancy (37 weeks)
* Voluntary written informed consent was obtained from the subject and the subject's legally acceptable representative (consent of legally acceptable representative was required for subjects younger than 10 years of age (and for subjects younger than 7 years of age for the some institutions)).

Exclusion Criteria:

* Subject with a known allergy to eggs, chicken, neomycin, gentamicin or any components of the study vaccine
* Subject who had received an influenza vaccine within the last 6 months
* Subject who has, or has a family history of, an immune system disorder including immune deficiency disease
* Subject with a history of Guillain-Barre syndrome
* Subject with Down's syndrome or cytogenetic disorders.
* Subject with severe chronic disease which in the investigator's opinion would not make the subject a good candidate for the clinical trial
* Subject with hemophilia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
* Subject who had an acute fever with body temperature \> 38.0 Cº within 72 hours prior to administration of the study vaccine
* Subject who had previously received another vaccine within 28 days before administration of the study drug, or is scheduled to receive another vaccine during the study period.
* Subject who had received immunosuppressant or immune modifying drug within the last 3 months prior to administration of the study vaccine
* Subject who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study.
* Subject who had participated in another experimental study within 30 days prior to administration of the study vaccine
* Subject with other clinically significant medical or psychological condition who in the investigator's opinion would not be suitable for the study.
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent prior to performing study procedures (participants ≥ 18 years of age) or assent (participants ≥ 12 and \< 18 years of age) prior to performing study procedures. For participants ≥ 12 and \< 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures
* Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
* Currently hospitalized and requiring medical care for COVID-19
* Peripheral capillary oxygen saturation (SpO2) \> 94% on room air at screening
* Radiographic evidence of pulmonary infiltrates

Key Exclusion Criteria:

* Participation in any other clinical trial of an experimental treatment for COVID-19
* Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
* Requiring mechanical ventilation at screening
* Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN)
* Creatinine clearance \< 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants \< 18 years of age

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients

Mother spend a large amount of time with their children. It is assumed that mother contributes to their neurological development not only with visual stimuli, but also with auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response to the self-name being spoken by the mother than by a stranger. Therefore, investigators suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten the emergence from general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 2 and 8 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive ophthalmology or otorhinolaryngology surgery under general anesthesia

Exclusion Criteria:

* ASA PS III or IV
* with developmental delay or neurological diseases associated with symptoms of agitation
* refusal of consent
* maternal mutism
* absence of mother
* with allergy or contraindication to use of ketamine (increased intracranial pressure, open-globe injury, and a psychiatric or seizure disorder)
Use of Tilapia Skin for Palate Repair and Protection After Graft Removal

Randomised Clinical Study to evaluate the efficacy of tilapia skin as an occlusive biological dressing on palatal wound healing after free gingival graft harvesting.

Autogenous grafts are currently considered the gold standard in regenerative and reconstructive procedures. However, these procedures require a second surgical site to provide the tissue graft. In autogenous gingival grafts, the area commonly selected for graft harvesting is the palate, which is linked to great discomfort and morbidity for the patient. In order to overcome these limitations, xenogeneic and alloplastic materials have been tested as tissue substitutes, but their results are still considerably inferior when compared to autogenous grafts. Faced with this superiority, another approach to favor the use of autogenous grafting is to develop materials that provide greater postoperative comfort and patient safety. Since the main complaint arising from the technique is related to pain resulting from the remaining surgical wound on the palate, it is interesting to look for mechanisms to reduce this sensitivity and accelerate the healing process. For this, the use of tilapia skin as a postoperative dressing seems to be a good alternative. Thus, the purpose of this study is to evaluate the use of tilapia skin, with the intention of accelerating the palate healing process, and to serve as a protector barrier during the healing process. Patients treated according to two techniques for palate protection after autogenous gingival graft harvesting will be evaluated: C- use of surgical cement and T- use of tilapia skin. Will be selected 60 patients of both sexes,\> 18 years old, requiring the removal of the palate graft for periodontal surgery. At the time of graft removal, palate thickness and graft dimensions will be measured. After 7, 14 and 30 days, the patient's discomfort and the difficulty in chewing and speaking will be recorded through a visual analog scale, the consumption of analgesic, and the dimensions of the surgical wound on the palate. For statistical analysis, two-way ANOVA will be performed and t-test paired on the obtained results.

Eligibility Criteria:
Inclusion Criteria:

* Patients need periodontal or peri-implant surgical procedures requiring palate gingival graft

Exclusion Criteria:

* Patients with an infectious condition that compromises the procedures
* Users of drugs that can act on periodontal tissues or the healing process
* Pregnant
* Smokers
* Diabetes
* Irradiated
The Effects of mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy

evaluate the health empowerment program with mHealth to promote physical activity for overweight and obese pregnant women.

This two-phase study develops an mhealth application (app) based on social-cognitive theory (SCT) and evaluates its effectiveness for overweight and obese women, which can help to prevent excessive GWG by enhancing optimal weight and healthy behavior during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

1. pregnant women--who have had, 8-12 weeks
2. pre-pregnancy body mass index \> 25 kg/m2

Exclusion Criteria:

-
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease

The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderate to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.


Eligibility Criteria:
Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderate to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during this study. Patient enrollment requires previous participation in study AN100226-CD301 (please refer to the clinical trial listing for CD301).
Turkish Adaptation, Validity and Reliability of Community Integration Questionnaire-Revised (CIQ-R)

The aim of this study is to adapt the Community Integration Questionnaire-Revised (CIQ-R) scale to Turkish society and to make its validity and reliability in Turkish. The CIQ-R scale developed by Callaway et al assesses home integration, social integration, productivity, and electronic social networking in neurological diseases. It has 18 questions. This study will be conducted with stroke patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 130 participants will be included in the study. In order to evaluate the validity of the CIQ-R, the Mini Mental State Examination (MMSE), which can evaluates general cognitive functioning and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.

The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale, Callaway and Willer approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of CIQ-R will be able to be modified. The data of CIQ-R are collecting through face-to-face when the patients came to the rehabilitation center. 145 participants will be included in the study.

In order to evaluate the validity of the CIQ-R, the Mini Mental State Examination (MMSE), which can evaluates general cognitive functioning and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

Patients with

* duration of hemiplegia ≤ 3 year
* able to speak and read Turkish
* those with a Mini Mental State Examination score of 24 and above

Exclusion Criteria: Patients with

* communication or cognitive problems,
* aphasia and speech disorders
* unstable medical conditions
Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma

The purpose of this study is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma and pseudophakia (currently present or to be performed during the concomitant implantation surgery in subjects with age-related cataract eligible to intra-capsular IOL placement). The main questions it aims to answer are how safe the investigational drug is and how the body tolerates it.

The study will also check:

* how safely the implant is placed in and removed from the eye and how the body responds to the procedure,
* how safe different doses of timolol are and how the body handles taking it,
* the amount of Timolol released in the bloodstream,
* if there is any positive effect on the pressure inside the eye.

Timolol will be delivered through an investigational drug called 'TimoD implant'. This implant is placed inside one eye, the study eye, with the help of an instrument (investigational device) called an injector system.

Three dose ranges of TimoD implant will be tested (low, intermediate, and high) in 3 groups of 6 participants.

The Timolol will be released slowly through the implant for up to 1 year (main phase).

Approximately 1 year after the TimoD implant is placed into the eye and in absence of contraindications, the participants will be invited to continue the study in an extension phase. If the participants agree to enter the extension phase and the study investigator confirms it is safe for them, the TimoD implant will remain in the study eye for one additional year.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving signed informed consent.
* In good general and mental health without ongoing clinically significant abnormalities in medical history.
* Clinically proven diagnosis of primary open-angle glaucoma (POAG) in the previous 12 months.
* Subjects with IOP not adequately controlled with the standard medication.
* Pseudophakia.

Exclusion Criteria:

* Concomitant treatment with timolol (systemic), corticosteroids, cytochrome P450 2D6 inhibitors, or α2-agonists.
* Subjects with a history of hypersensitivity or contraindications to β-blockers.
* Significant risks caused by washout of ocular hypotensive medications.
* History of any glaucoma not specified as POAG.
* History of elevated IOP due to corticosteroid use.
* History of ocular trauma.
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

Disturbances of acquired immunity are considered to be responsible, at least partly, for the high infection rate and inadequate response to vaccinations observed in hemodialysis (HD) patients and renal transplant recipient (RTR). The present prospective trial aims at (a) evaluating the immunogenicity of a standard influenza vaccine in HD and RTR patients and (b) at identifying determinants of the immune response.


Eligibility Criteria:
Inclusion Criteria:

* maintenance hemodialysis patients or
* renal transplant recipients (beyond month 3 after transplantation)

Exclusion Criteria:

* patients with known allergy to chicken proteins
Chewing Side Preference and Hemispheric Laterality in Healthy Adults

The study is aimed to investigate if chewing side preference (CSP) can be used as another indicator of hemispheric laterality in healthy adults. Healthy volunteers with no oral/dental problems with Angle I occlusion relationship and without any missing teeth will be included in the study. The CSP will be determined with the visual analog scale (VAS), which is the highly reliable method. Laterality test will be used to determine the preferred side for hands, feet, ears and eyes.

Lateral preference is important to determine hemispheric laterality, which is usually diagnosed by hand and other sidedness, including footedness, eyedness and earedness. study is aimed to investigate if chewing side preference (CSP) can be used as another indicator of hemispheric laterality in healthy adults. Healthy volunteers with no oral/dental problems with Angle I occlusion relationship and without any missing teeth will be included in the study. The CSP will be determined with the visual analog scale (VAS), which is the highly reliable method. Laterality test will be used to determine the preferred side for hands, feet, ears and eyes.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers;

* Between the ages of 18-50 years
* Have no oral/dental problems with Angle I occlusion relationship and without any missing teeth
* Have no orofacial pain and/or no oral appliances will be included in the study.

Exclusion Criteria:

Participants;

* Under the age of 18 years and above the age of 50 years
* Have oral/dental problems with missing teeth
* Have orofacial pain
* Have oral appliances will be excluded from the study.
The Use of VSL#3 in Irritable Bowel Syndrome in Children

The goal of this study is to determine whether the oral administration of the probiotic VSL#3 under randomized, placebo-controlled conditions will improve symptoms of irritable bowel syndrome in children, safely.

Determine the safety and efficacy of different doses of VSL#3 in the treatment of children with irritable bowel syndrome: Children will be recruited from the pediatric gastroenterology clinic at The Children's Medical Center in Dayton, Ohio. Eighty four children will be enrolled in this controlled, double-blinded, randomized study. All children will have had a prior evaluation by a pediatric gastroenterologist who has diagnosed these patients with irritable bowel syndrome and excluded organic disease as a cause of the child's abdominal pain.

Eligibility Criteria:
Inclusion Criteria:

* All children should fulfill Rome ll criteria for IBS.
* Organic disease has been excluded.
* Age 13-18 years.
* Have active symptoms for at least 2 weeks prior to randomization. A minimum of 4.0 on the 7-point Likert scale for the two weeks prior to randomization on the GSRS-IBS composite pain score will be required.
* Diarrhea predominant IBS: Diarrhea is defined as increased stool frequency more than 3 times daily or change in form to loose or watery stools.

Exclusion Criteria:

* Children not fulfilling the inclusion criteria.
* Children receiving medication for the treatment of irritable bowel syndrome within 2 weeks of randomization.
* Children receiving antibiotic therapy or other probiotic agents within 4 weeks of randomization.
* Children receiving other medication known to cause abdominal pain.
* Children diagnosed with any of the following GI disorders: IBD (Crohn's disease or UC), Celiac disease, Gastroparesis, abdominal adhesions, Gastrointestinal perforation, Gastrointestinal obstruction and/or stricture, chronic or recurrent pancreatitis.
* Children who had undergone previous abdominal surgery (with the exception of uncomplicated appendectomy or cholecystectomy greater than or equal to 6 months prior to enrollment).
* Children with a history of any disease that may affect bowel motility such as diabetes mellitus, or poorly controlled hypo/hyperthyroidism.
* Children with immune deficiency, on immune-suppressants, or have active psychiatric, neurological, metabolic, renal, hepatic, infectious, hematological, cardiovascular or pulmonary disease.
* Children with a history of malignancy.
* Pregnancy.
* Children with history of allergy to maize or probiotics.