cyrilzakka/clinical-trials huggingface dataset:
Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula

The goal of this interventional clinical trial is to test the effectiveness of enhancing immunity in newly born infants fed with Feihe investigational formula product containing Lactoferrin fortified with HMO. The main question it aims to answer is:

- whether the immunity functions of participants in terms of frequency of catching flu and cold in the study product arm is significantly better than participants assigned in the other two arms.

240 qualified participants will be randomized to 3 arms (investigational formula, control formula, and breast-feeding) to consume assigned formula or breast-feeding for 12 months according to protocol. There will be up to 6 site visits arranged for each participant during the study, and all relevant clinical and questionnaire data, including the most important primary outcome - frequency of catching flu and cold for each visit interval, will be captured, recorded and entered to CMTS (Clinical Management Trial System) for statistical analysis and reporting.

Researchers will compare the three arms to validate the assumption that the consumption of Feihe investigational formula product containing Lactoferrin fortified with HMO will improve immunity in newly born infants, along with physical development.


Eligibility Criteria:
Inclusion Criteria:

* Newborn baby, study entry before weaning (within 28 days of birth)
* Exclusively formula for at least 3 days fed prior to onset of study period.
* Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).
* Birth weight of 2500g (5 lbs. 8 oz.) or more.
* Signed informed consent obtained for infant's participation in the study.
* Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study.

Exclusion Criteria:

* History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.
* Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).
* Evidence of growth problems or concern for growth.
* Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.
* Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury.
* Use of probiotics/prebiotics before and during the study.
Expanded Access for CC-4047

This is an expanded access program (EAP) for eligible participants designed to provide access to CC-4047.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam

This study is part of International Vaccine Institutes (IVI)'s typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The primary objectives of the study are to evaluate the logistic feasibility of a mass typhoid fever immunization campaign program targeting school age children in Hue City, Vietnam and to assess the knowledge, attitudes, beliefs, and practices of parents and healthcare providers in Hue City regarding typhoid fever prevention and treatment.

Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs due to the following reasons: it has been shown to have consistent efficacy results even in areas of high typhoid incidence, is given as a single dose, lacks patent protection and requires less strict cold chain requirements. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (Hepatitis A) was designed to determine the logistic feasibility of providing Vi vaccine under actual programmatic conditions among school students in Hue City. The vaccines used in this study are internationally produced and locally licensed.

Secondary objectives of this trial are:

* To estimate the cost-effectiveness (cost of illness, willingness to pay, vaccine delivery costs, private vaccine costs, etc) of Vi vaccination
* To determine the effectiveness of the Vi polysaccharide vaccine following routine administration of a 1-dose schedule to school students (aged \>=6 years)
* To determine the safety and immunogenicity of the Vi vaccine
* To study typhoid risk factors among students

A nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Hue City.

Eligibility Criteria:
Inclusion Criteria:

* Local students whose parents/guardians provide written consent to receive Vi vaccine
* Attending any of the 66 registered schools in Hue
* Registered in the project census
* Lives in Hue City

Exclusion Criteria:

* Fever (\>37.5 degrees Celsius, axillary)
* Pregnancy
* Lactating
Tele-rehabilitation Intervention for People Post Hip Fracture - Pilot Study

Most surviving hip-fracture patients experience reduced mobility and lose their functional ability, which increases the risk of complications and rehospitalization. Post-discharge transitional programs to reduce readmissions have shown some success. Telerehabilitation refers to the use of technologies to provide rehabilitation services to people in their homes. Considering the need for long-term follow-up care for people with hip fracture, in-home telerehabilitation could increase independence, decrease hospital stays and reduce the burden for caregivers.

The purpose of the pilot study is to examine the feasibility and acceptability of the research methods evaluating telerehabilitation with adults who have experienced hip fracture, in preparation for a larger randomized controlled study. A one-group (N=6) pre-test/post-test design is currently being constructed. Results of the pilot study will be used to determine what adaptations to the design may be required to ensure successful implementation. Recruitment, retention and attendance rates, as well as percentages completing the outcome measures, will be examined to plan the time frame of the main trial.

The intervention will include 10 videoconferencing sessions from an occupational therapist in the presence of the primary caregiver. Each session will be utilized to guide the participants to achieve their self-identified goals, focusing on problem-solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities.


Eligibility Criteria:
Inclusion Criteria:

* Older adults (age ≥60 years)
* post hip fracture - discharged from the inpatient rehabilitation unit of Herzog Hospital, Jerusalem, between January 2017 and December 2017.
* Discharge from rehabilitation to a non-institutionalized setting.
* broadband or Wi-Fi in their home and must be able to operate an iPad independently.
* FIM\>90 at discharge.
* Has a designated caregiver (a close friend, family member, or support worker) aged over 18, and a Hebrew, English or Arabic speaker, who will agree to cooperate in the research.

Exclusion Criteria:

* Aphasia.
* cognitive impairment (Montreal Cognitive Assessment scores : MOCA\<19 or MMSE\<21).
* degenerative neurological diagnoses.
* current major depressive or psychotic disorder.
* other acute or chronic health condition that will influence their ability to participate in the study.
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass

The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.

The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.

1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.
2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.
3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.

The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.

The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.

1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.
2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.
3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* healthy control without diabetes or active organ disease
* Individuals with bariatric surgery
* recurrent hypoglycemia post gastric bypass

Exclusion Criteria:

* pregnancy
* significant anemia
* diabetes currently unless pre-op for bariatric surgery procedure
* GI obstruction
Methods Study to Evaluate Use of Cardiac Ultrasound to Assess Heart Valve Abnormality in People.

Methods study to evaluate use of cardiac ultrasound to assess heart valve abnormality in people.


Eligibility Criteria:
Inclusion Criteria:

* \>=18 years of age subjects with stable concomitant diseases with BMI \>=30 kg/m2

Exclusion Criteria:

* Pregnant females
* Those with unstable/new onset diseases
* Those who are on agents known to be associated with cardiac valvular heart disease
Comparison of the Efficiency of Game-Based Exercise Program and Trunk Stabilization Exercise Training in Adolescent Playing Archery

The aim of our study is to investigate the effects of a game-based exercise (Exergame) program and trunk stabilization exercise training on shooting performance, reaction time, trunk muscle endurance and balance in adolescents playing archery. While the importance of the effect of trunk stabilization on shooting performance is mentioned in individuals practicing archery, it is emphasized that trunk stabilization training increases sportive performance and protects against injuries in individuals interested in sports for the upper extremity. However, no study is found that directly compared game-based exercise programs and trunk stabilization exercise training in adolescents who play archery. Therefore, two different training programs will be given to the adolescents playing archery at the Archers Foundation Sports Club in Istanbul, and Shooting performance, reaction time, trunk muscle endurance, and balance levels will be evaluated before and after the training.


Eligibility Criteria:
Inclusion Criteria:

* Archers who have been practicing archery for at least 1 year
* Roller or Olympic archers

Exclusion Criteria:

* Archers with a history of musculoskeletal injuries causing physical limitation in the last 6 months.
* Archers who did not volunteer to participate in the study.
* Archers with any visual and hearing disabilities.
Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

This is a proof-of-principle, placebo-controlled, open label study to assess the improvement in the Treg counts and PASI Scores with PEVCO given at 1000 mg four times daily in patients with PsO (subjects may or may not have PsA) , who have active disease and are not currently receiving other therapy (as defined by the inclusion/exclusion criteria) compared to healthy subjects.

The patients and healthy controls will receive placebo or PEVCO for a total of 9 weeks (3 weeks for placebo, followed by 6 weeks for PEVCO). No topical or systemic medications will be used during this period.


Eligibility Criteria:
Inclusion Criteria:

* Have an active \[psoriatric plaque \>2cm

Exclusion Criteria:

* History of sensitivity to study compound or any of their excipients
* Previous intolerance to PEVCO or related compounds
* Current (within 3 months of screening) treatment with DMARDs
* Current (within 3 months of screening) treatment with biologic therapies (including but limited to anti-TNF,anti-IL-17, anti-IL-12/23)
* Current antibiotic treatment (within 3 months of screening)
* current consumption of probiotics (within 3 months of screening)
* Severe hepatic impairment (eg, ac-sites and/or clinical signs of coagulopathy)
* Renal failure (eGFR ,30 or require dialysis) by history
* History of other autoimmune or inflammatory skin disease
* Current immunodeficiency state (cancer, HIV, others)
* Current immunodeficiency state (cancer, HIV, Other)
* Concern for inability of the patient to comply with study procedure, and or follow up (alcohol or drug abuse)
Comparing Approaches to Increasing Fruit and Vegetable Intake and Their Influence on Metabolic Health

This experimental study aims to evaluate the effects of different strategies for increasing fruit and vegetable intake and to see how these interventions influence markers of health in people aged 18-65 who currently consume fewer than 2 portions of fruit and vegetables a day.

The main questions it aims to answer are:

1. How does 5-a-day advice, with and without the inclusion of fruit juice, impact fruit and vegetable intake over a four-week period?
2. What are the acceptability and perceived ease of increasing fruit and vegetable intake with and without the inclusion of fruit juice in 5-a-day recommendations?
3. What are the effects of increasing fruit and vegetable intake with and without fruit juice on markers of metabolic health?

Researchers will answer these questions by comparing results from three groups of participants. All participants will provide a pre- and post-intervention blood sample, complete various questionnaires, and follow a four-week intervention that comprises educational material and a weekly £10 voucher. Over the course of the four weeks, they will report what they ate in a day on four different days.

The groups differ in the educational materials provided and where they can spend their voucher:

* Group 1 (Control) - information on the importance of including an experimental control in research and a weekly voucher to spend at a retailer of their choice,
* Group 2 (F\&V) - information on 5-a-day advice (excluding fruit juice) and a weekly voucher to spend in a supermarket on F\&V, and
* Group 3 (F\&V + Juice) - information on 5-a-day advice (including fruit juice) and a weekly voucher to spend in a supermarket on F\&V.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 65 years
* Currently consuming ≤2 portions of fruit and vegetables per day

Exclusion Criteria:

* Using high-dose vitamins, minerals or dietary supplements that could interfere with biomarker assessment of fruit and vegetable consumption
* Have a food sensitivity, allergy or other dietary restriction (e.g., following a weight loss diet) that would limit the ability to take part in the study
* Have a medical condition (e.g., diabetes or gastrointestinal disorders) that would limit the ability to take part in the study
* Currently pregnant or lactating
FNS (FEMORAL NECK SYSTEM) Study

A post-market, prospective study to evaluate the reoperation rate of displaced and nondisplaced femoral neck fractures treated with the Femoral Neck System (FNS)™

To evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the Femoral Neck System (FNS)™ at one year post-operation. The Femoral Neck System (FNS)™ represents a new generation of implants designed to improve outcomes in the treatment of femoral neck fractures. These implants offer a fixed angle construct and all of its mechanical advantages with regards to neutralizing shear and providing stability while not exerting a rotational malreduction force on the fracture. The FNS system has been shown to compare favorably to traditional fixed angle constructs in a cadaveric model

Eligibility Criteria:
Inclusion Criteria:

* The subject must provide written informed consent
* The subject must be eighteen (18) years of age or older.
* The subject must be willing and able to make all required study visits including one (1) year post-operative follow-up.
* The subject must be able to follow instructions.
* Subject has experienced displaced or non-displaced intracapsular femoral neck fracture

Exclusion Criteria:

* Subject with fracture occurring more than 7 days prior to the date of surgery
* Subject has more than one fracture on target extremity.
* Subject is obese as defined by a Body Mass Index (BMI) \> 45 at the time of surgery.
* Subject, in the opinion of the Investigator, has an emotional or neurological condition that preludes cooperation and compliance with the rehabilitation regimen.
* Therapy with another investigational agent within thirty (30) days of Screening or planned therapy with another investigational agent during the course of the study.
* Subject has a physical condition that, in the opinion of the Investigator, would preclude adequate implant support or impede healing (e.g. blood supply impairment insufficient bone quality or quantity, or an active, local or systemic infection). If this is identified at the time of surgery, the subject will be screen failed.
* Subject has undergone previous surgery on the target hip.
* Current systemic therapy with cytotoxic drugs.
* Subjects with a history of poor compliance with medical treatment.
* Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects

A clinical study to assess next-day driving performance following evening administrations of ACT-541468 in middle-aged and elderly subjects


Eligibility Criteria:
Inclusion Criteria

General criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male and female subjects aged between 50 and 80 years (inclusive) at Screening.
* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.
* Women of non-childbearing potential (i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis).

Study-specific criteria

* Subject has a valid driving license for more than 5 years, has driven at least 3000 km/year on average in the past 2 years.
* Normal visual acuity (corrected or uncorrected).

Exclusion Criteria:

General criteria:

* Pregnant or lactating women.
* Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results.
* History or presence of rhythm disorders
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Study-specific criteria:

* Current or previous diagnosis of insomnia-related disorder according to the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria.
* History of alcoholism, drug abuse, or regular use of sedative drugs or hypnotics within 3 years prior to Screening.
* History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females). One unit is equivalent to a half-pint (approx. 250 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.
* Modified Swiss Narcolepsy Scale total score \< 0 at Screening or history of narcolepsy or cataplexy.
* Activities that disturb the circadian rhythm (e.g., working night shift, travelling across 3 time zones) within 2 weeks before (each) study treatment.
Low-grade Infections of the Intervertebral Discs

The purpose of this prospective, observational study was to evaluate frequency and characteristics of low-grade infections of the intervertebral discs in an unselected real-life patient population undergoing surgery for degenerative pathologies of the spine.

Low-grade infection of the intervertebral discs, causing disc degeneration and consecutive pain and disability is reported in literature. Microorganisms are also held responsible for Modic Changes of the vertebral bodies.

Patients underwent surgery for degenerative pathology of the spine independent of this study. After being informed about this study, all patients giving written informed consent who met eligibility requirements were included. Treatment of the patients was independent of this study. Intraoperative removed disc tissue was examined using microbiological culture, viral polymerase chain reaction (PCR), and histopathological analysis.

Other used data were demographic data (Gender, age), Modic Changes on MRI, preoperative Oswestry Disability Index (ODI), preoperative Neck Disability Index (NDI), and preoperative C-reactive protein (CRP).

Frequency of positive microbiological culture findings, viral PCR, and inflammation signs in histopathological analysis was described, and statistical analysis was performed to identify if any of the above mentioned parameters influences the frequency of positive microbiological culture and Modic Changes significant.

Eligibility Criteria:
Inclusion Criteria:

* Spine surgery including discectomy due to degenerative diseases
* Availability of removed disc tissue for further analysis

Exclusion Criteria:

* Signs of spondylodiscitis (clinical signs, inflammation parameters, radiological)
* Suspected or known tumor disease
* Traumatic fractures