cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms

The purpose of this study is to evaluate the safety of a single dose baloxavir marboxil compared with 5 days of oseltamivir administered twice a day (BID) in Chinese pediatric participants aged 1 to \< 12 years with influenza symptoms.


Eligibility Criteria:
Inclusion Criteria:

* A participant who has a diagnosis of influenza virus infection and meets all the following conditions:

  * Fever ≥ 38°C (tympanic temperature) at screening
  * At least one of the respiratory symptoms of influenza virus infection
* A rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) shows positive for influenza A/B, e.g., point-of-care/local laboratory results with use of nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample)
* The time interval between the onset of symptoms and screening is ≤ 48 hours
* PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care/local laboratory test with nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample)

Exclusion Criteria:

* A participant having severe influenza virus infection symptoms requiring inpatient treatment
* Received systemic corticosteroid or immunosuppressive therapy
* Primary immunodeficiency syndrome
* History of organ transplantation
* Human immunodeficiency virus (HIV) infection
* Immunization with a live/attenuated influenza vaccine in 2 weeks prior to randomization
* Previous malignancy within the last 5 years or has an active cancer at any site
* A participant who received any medications with anti-flu effect such as baloxavir, peramivir, oseltamivir, zanamivir, favipiravir, arbidol, amantadine or traditional Chinese anti-influenza medicines within 30 days before screening
* Diagnosed with or suspected SARS-CoV-2 infection, or close contacts of diagnosed or suspected SARS-CoV-2 infected patients
* Severe underlying disease or condition potentially affecting study evaluation in the opinion of the investigator/sub-investigator
* A participant who received an investigational or unapproved drug product within 30 days or 5 x the half-life before screening, whichever is longer
BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study

This is a prospective, randomized, double-blind, parallel group, multicentre global phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of BOW015 (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male and female, aged 18 to 80
2. Diagnosis of Rheumatoid Arthritis (RA) according to the revised ACR/ EULAR 2010 classification criteria for RA
3. Patients must have ACR/EULAR 2010 classification criteria score ≥ 6
4. Patients must have active disease
5. Patients must have been on treatment with methotrexate

Key Exclusion Criteria:

1. Prior use of infliximab, adalimumab, certolizumab, golimumab, tocilizumab, rituximab, or etanercept or any other biological treatment
2. Patients with any prior or current use of anakinra and abatacept
3. Patients with suspected or confirmed current active tuberculosis (TB)
4. Patients with latent tuberculosis must start treatment for latent tuberculosis
5. Patients who have a current or past history of chronic infection with Hepatitis B, Hepatitis C, or infection with Human Immunodeficiency Virus-1 or-2
6. History of completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma
7. History of lymphoproliferative disease
8. History or presence of any other form of malignancy
9. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease
10. History of congestive heart failure or unstable angina
11. History of any autoimmune disease other than RA
12. Major surgery within 12 weeks and planned major surgery
13. History of serious infection
14. Pre-existing central nervous system demyelinating disorders
15. Administration of live or live-attenuated vaccine within 4 weeks of screening
16. Clinically significant adverse reaction to murine or chimeric proteins
17. History or presence of any medical or psychiatric condition or disease, or clinically significant laboratory abnormality
18. Participation in any clinical study of an investigational product within the previous 3 months prior to screening
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction

The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 21-60 years
* Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer
* Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage
* Planning to undergo nipple-sparing or skin-sparing mastectomy
* Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion
* Intraoperative confirmation of prepectoral plane viability by operating physician

Exclusion Criteria:

* History of radiotherapy to the operative breast
* Current smoker
* Non-English speaking patients
* Planning to undergo direct-to-implant reconstruction
* Prior sternotomy
Taste Perception, Salivary Proteins & the Oral Microbiome

Genetic differences in taste are believed to play an important role in food selection, especially for strong-tasting foods and beverages. The overall goal of this project is to better understand how genes that control food preferences differ among people and whether saliva composition and oral health are related to these differences.

This study examines the effects of a daily cranberry extract oral rinse on salivary protein responses and the oral microbiome (as a proxy measure of oral health). The study will be conducted in healthy adults who are presumably at high-risk (non-tasters of PROP; homozygous recessive for tas2R38 gene) or low-risk (super-taster of PROP; homozygous dominant for tas2R38 gene) of oral disease.

The specific aims are to determine if the use of cranberry polyphenol extract rinse will:

1. alter the oral microbial profile
2. induce changes in the salivary protein response
3. be associated with changes in taste and flavor perception

Participants will be screened for good overall and oral health (see inclusion/exclusion criteria below). Each subject's period of participation will be 2 weeks. Days 1-3 of the study is a run-in period. Subjects rinse with spring water 2-times/day (after brushing their teeth in the morning and evening). During days 4-14, subjects will rinse in a similar manner with a solution of cranberry-derived polyphenol extract (CPE) in spring water. Saliva will be collected from subjects in a brief session (10 min) on Days 3 and Day 14. Saliva samples will be analyzed for salivary proteins and microbial profile analysis. The purpose of this analysis is to measure the relative ratios of beneficial vs. disease-causing microbes in the mouth using 16S RNA sequencing. On each of the testing days, subjects will also evaluate food samples for standard taste and flavor attributes.


Eligibility Criteria:
Inclusion Criteria:

* PROP insensitive individuals (PROP non-tasters; homozygous recessive for tas2R38 gene)
* PROP high-sensitive individuals (PROP super-tasters; homozygous dominant for tas2R38 gene)
* Overall healthy; good oral health and hygiene routine
* Current on a routine checkup by a oral/dental health professional
* Recently underwent dental/cleaning by a oral/dental health professional
* No ongoing oral health problems
* Agree to use intervention material as prescribed
* Agree to refrain from using any other oral rinse material during the term of the study

Exclusion Criteria:

* PROP medium-taster individuals (heterozygous for tas2R38 gene)
* Taste or smell dysfunction
* Pregnant or nursing
* Oral piercings
* Smoking
* Use of medications other than birth control
Dexmedetomidine Premedication in Children

The aim of this retrospective study was to detect the effectiveness of 1µg/kg oral dexmedetomidine premedication on preoperative cooperation and emergence delirium of the the young children underwent complete dental treatment.

One Hundred children between the ages 2-6 years of ASA I status underwent full mouth dental rehabilitation were enrolled in the study. Group Dex (n=50) received 1µg/kg dexmedetomidine in apple juice and Group control (n=50) received apple juice only. Patients' Ramsey Sedation Scale (RSS), The Parental Seperation Anxiety Scale (PSAS), Mask Acceptance Scale (MAS) and Post anesthesia emergence delirium scale (PAEDS) and hemodynamic parameters were noted from their patient file. Premedication period was 45 minutes and measurements of RSS and hemodynamic parameters were recorded in baseline and every 15 minutes until the patients were transferred to the operating room. The data were analysed using the Kruskal-Wallis test, two sample t- tests, chi-square tests and ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria is age between 2 to 6 years and American Society og Anesthesiology (ASA) grade 1.

Exclusion Criteria:

* The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.
Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study

ZygoFix has developed a system consisting of zLOCK Facet Fusion System. The zLOCK Facet Fusion System is intended for single level stabilization of a spinal motion segment to promote bonny fusion of the joint. The system is designed for percutaneous deployment. The zLOCK implant is designed to be deployed in the facet joint thereby utilizing the body's natural mechanical structure without adding an external scaffold (see figure below).

The zLOCK implant is inserted into the facet joint space while it adapts to the joint's changing geometry. Stabilization is achieved by firm grip of each joint bone and resisting to any relative motion. The zLOCK implant is placed percutaneously and requires only one incision per side, thereby reducing the invasiveness, procedure duration and shorten the recovery period.

This pilot study was designed in order to assess the safety and effectiveness of the zLOCK system.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is scheduled for spine surgery with at least one of the following:

   When used in adjunct to an intervertebral front cage:
   * Degenerative Spondylolisthesis up to grade 2
   * Mild to Moderate Degenerative disc disease (DDD)
   * Degeneration of the facets - following validating the pain source by facet injection.

   When used stand-alone:
   * Degenerative Spondylolisthesis grade 1-2
   * Moderate to severe Stenosis with listhesis
   * Moderate to severe stenosis without listhesis (in cases that the investigator determines stabilization is required).
   * Degeneration of the facets- following validating the pain source by facet injection.
2. Claudication due to moderate to severe stenosis (central/ foraminal) as verified by imaging.
3. 18\< Age \< 75
4. Weight \< 100Kg
5. Signed informed consent form
6. At least 3 months of unsuccessful conventional treatments

Exclusion Criteria:

1. Fusion procedure performed or required in more than one inter-vertebrae space.
2. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.
3. Osteoporosis
4. Absence of posterior spinal elements including the pedicle, pars interarticularis, facet joints, spinous process and the majority of the lamina which make it unstable or not possible to place.
5. Any entity or conditions that totally preclude the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia, are relative contraindications.
6. Obesity (BMI ≥30)
7. Foreign body sensitivity
8. Alcoholism, or drug abuse
9. Subject with a cardiac pacemaker or other implanted electro medical device
10. Subject with known condition of drug abuse and/or alcoholism
11. Women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception)
12. Concurrent participation in another clinical trial using any investigational drug or device.
13. Mental disorders.
Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance

Depending on recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.

Recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.

Eligibility Criteria:
Inclusion Criteria:

The data of the patients who fulfilled the following criteria are evaluated.

1. Term infants between 38 and 40 weeks of gestational age and/or with a birth weight of \> 2500grams who are either breastfed or formula fed.

   Selection of the subgroup using oral nutrition
2. Feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life
3. Feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life Selection of the subgroup not using oral nutritional supplement (control group)
4. Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)

Exclusion Criteria:

* Infants with major congenital abnormalities will be excluded.
* Infants with lack of data will also be excluded.
* Infants, whose parents don't agree with informed consent, will be excluded.
Evaluation of DIDGET TM World Reports

The purpose of this study is to evaluate a Diabetes data management program in the hands of potential users, both lay persons and healthcare professionals. With this data management system glucose results from the DIDGET TM meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels.

Diabetes data management programs upload glucose meter results to computers to provide information to lay persons and their health care professionals. With this data management system glucose results from the DIDGET TM meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels. During the study subjects performed specific tasks, such as uploading meter results and displaying reports. The study evaluates the subjects' success in using the software program, the program's ease of use, clarity and usefulness of user instructions, and user satisfaction with the diabetes data management program.

Eligibility Criteria:
Inclusion Criteria:

* Lay users must be:

  1. Be at least 18 years of age
  2. Have diabetes or be the parent or legal guardian of a child with diabetes
  3. Be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month
  4. Be able to speak, read, and understand English
  5. Have experience using a PC, navigating software programs, or browsing the internet
* Healthcare professionals must:

  1. Have experience using the internet
  2. Have experience using diabetes data management software in the medical office

Exclusion Criteria:

1. Person working for a competitive medical device company
2. Person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study.
A Clinical Trial to Verify the Efficacy and Safety of Electric Phlegm Suction System

Manual airway aspiration is a task performed by a nurse or caregiver and if the nursing/care work is overloaded, it has the disadvantage that airway aspiration cannot be performed an appropriate number of times according to the needs of the patient. Therefore, an electric phlegm suction system that can compensate for the shortcomings has been developed. The purpose of this clinical trial is to compare and evaluate the efficacy and safety of the test device by applying the unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000) and the conventional manual airway aspiration procedure to the patients who received mechanical ventilation through the artificial airway in this clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Those aged ≥19 among the in-patients in the intensive care unit of the study site.
* Patients who have been applied with mechanical ventilation through the artificial airway such as tracheal intubation or tracheotomy and have maintained PaO2/FiO2 values above 100mmHg.
* Patients whose application time of mechanical ventilation does not exceed 36 hours
* Those who are expected to see continued application of mechanical ventilation for at least 72 hours after participating in this study

Exclusion Criteria:

* The subject or a legally acceptable representative refuses to participate in the study
* Those who have become pregnant or are planning to become pregnant during the study period
* Patients who need to maintain their plateau pressure with the mechanical ventilation setting of FiO2 exceeding 80% or exceeding Pplat of 30cmH2O.
* Patients with severely lowered immune function such as advanced hematologic malignancy, bone marrow transplantation failure, agranulocytosis, and absolute neutrophil count (ANC) of \<500/mm3
* Those with unstable cardiovascular conditions such as arrhythmia accompanied by hemodynamic instability and severe hypoxemia
* Those who continue to bleed due to hemorrhagic causes, including multiple traumas or thrombocytopenia
* If the patient is scheduled for or had performed a solid organ transportation on the day of study participation, or self-recovered through cardiopulmonary resuscitation (CPR)
* Patients with pulmonary disease accompanied by hemoptysis
* In addition, if the medical staff decides that it is not appropriate to apply the investigational device to the subject or perform bronchoscopy
Health Experiences & Early Life Disadvantages

Growing up in a low-income household has been shown to increase risk for, and susceptibility to many illnesses.The purpose of the study is to test an affective intervention for reversing biological risk factors, as related to childhood adversity, in midlife.

Participants will be asked to make two lab visits; attend six weekly, 1-hour meditation classes; as well as complete brief online daily surveys for 11 weeks, five biweekly surveys, and two 30-minute surveys prior to each lab visit. During the lab visits, participants will have their psychophysiology monitored for heart rate, blood pressure, respiration, and pulse. Participants will also have their blood drawn.

All surveys and questionnaires inquire about participants' current demographics, family history, perceptions about life and well-being, physical health, and monetary choices.


Eligibility Criteria:
Inclusion Criteria:

* fluent in written and spoken English
* have daily access to internet and a computer

Exclusion Criteria:

* engaged in regular meditation practice, either recently or in the past
* previously participated in a meditation study
* have allergies to adhesive materials (includes latex)
The Effects of Pilates on Functional Capacity and Blood Glucose Levels in Adults With Diabetes Type 2

The aim of this study is to investigate the effects of the Pilates training on Functional Capacity among adults with type 2 diabetes The aim of this study is to investigate the effects of the Pilates training on blood glucose response among adults with type 2 diabetes

A Randomized Control Trial study of 3 month period will be arranged, at Riphah International University Faisalabad after the approval of synopsis. The convenience sampling technique will be selected for registration of patients. According to specified inclusion, exclusion criteria, patients will be chosen. Calculation of Sample size for the study tells need of both males and females (45 yrs-65 yrs) that will fulfill the certain criteria. The participants of group A will receive Pilates exercise and standard care and participants of group B will receive a brisk walk on treadmill and standard care. The evaluation of patients will be done at baseline, at 6th week, 12th week and at follow up after one month of discontinuation of treatment. The patient's outcome will be measured by 6-Minute Walk Test (distance), hemoglobin A1c level and Blood Glucose level and the recording of the patient's data will be at pre-treatment and post-treatment. The data of before treatment and after treatment will be compared at follow up after one month of discontinuation of treatment. For each patient informed consent will be taken. Through Statistical Package of Social Sciences 20 software, data entry and analysis will be done

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patient both male and female with diagnosed with type ii diabetes
* 45-65 years old
* Lack of psychic disease, dementia and mental retardation

Exclusion Criteria:

* ulcers in extremities
* Peripheral neuropathy
* Severe or decompensated heart disease
* Limited coronary heart disease
* Insulin therapy