cyrilzakka/clinical-trials huggingface dataset:
Placebo- Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Elderly Adults

The purpose of this study is to evaluate the safety and immunogenicity of the RSV- F Vaccine in elderly subjects, as well as rate the incidence of medically- attended RSV disease in vaccine and placebo recipients.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥60 years of age who are ambulatory and live in the community or in residential facilities which provide minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:

   * Absence of changes in medical therapy within one month due to treatment failure or toxicity,
   * Absence of medical events qualifying as serious adverse events (SAEs) within two months, and
   * Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.
2. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
3. Able to comply with study requirements; including access to transportation for study visits.
4. Access to inbound and outbound telephone communication with caregivers and study staff.

Exclusion Criteria:

1. Participation in research involving investigational product (drug / biologic / device) within 45 days before the planned date of the Day 0 vaccination.
2. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
3. Received any vaccine other than an inactivated influenza vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time.
4. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
5. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
6. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
7. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥38.0°C on the planned day of vaccine administration).
8. Known disturbance of coagulation.
9. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
10. Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).
The Purpose of This Registry Study is to Learn More About Metabolic Health: Approximately 15,000 Participants Who Are Overweight or Have Obesity With or Without Metabolic Diseases Are Expected to Participate in This Registry Study.

The purpose of this registry study is to learn more about metabolic health. The information gathered will be used to support research on the natural history of obesity and weight related diseases, their treatments, and how it affects overall health. Approximately 15,000 participants who are overweight or have obesity with or without metabolic diseases are expected to participate in this registry study.

The VITALITY Registry is a research study to collect healthcare information on people with conditions related to their weight which is stored in a database. Participants, along with their doctor, provide the health information that makes up this database. Participants will not be asked to take any special treatments or tests as part of the study.

Participants will be asked to complete questionnaires 2 times a year for up to 10 years, and the doctor will be asked to enter certain available information from office visits 1 time per year for up to 10 years regarding health, treatments, and symptoms related to the participants metabolic health.

The information that will be collected for this study will include demographics (for example, age, gender, race, employment, etc.), medical history (including all prior and current treatments), social history, details about your metabolic health, how metabolic health impacts daily life, mental health, and satisfaction with treatment.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age (or age of majority)
* Willing to provide consent to participate

Exclusion Criteria:

-
The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)

The purpose of this study is to investigate the differences of gut Microbiome/Metabolite between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.


Eligibility Criteria:
For Healthy Subjects

Inclusion Criteria:

* Age over 18 years old
* Liver and kidney function is normal
* 18.5≤BMI≤29.9
* Agree to sign the informed consent form

Exclusion Criteria:

* Diagnosed as Metabolic syndrome
* Diagnosed as Cirrhosis
* Diagnosed as kidney disease
* Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
* Taking antibiotics or antifungal drugs within 30 days before the study

For ESRD patients

Inclusion criteria:

* Age over 18 years old
* Patients who diagnosed as ESRD with hemodialysis
* Fixed hemodialysis cycle (average 3 times a week)
* Agree to sign the informed consent form

Exclusion criteria:

* Taking antibiotics or antifungal drugs within 30 days before the study
* Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
* Reasercher are not sure whether the subjects are willing or able to complete the study
* Subject participated in other research projects within two months before the study
TENS and Taping for Older People

Aim: To examine the acute effects of transcutaneous electrical nerve stimulation (TENS) and Kinesio Taping (KT) on lower limb joint proprioception, static standing balance, limits of stability and functional balance performance in community-dwelling older adults.

Design: A one-group experimental study with a repeated-measures design. Sample: 24+ community-dwelling older adults Interventions: TENS and KT, TENS and sham taping, KT and sham TENS, and sham TENS and sham taping (30 minutes each) Major outcomes: Outcomes will be evaluated during each of the intervention conditions. Lower limb joint active repositioning error will be evaluated using a joint position sense test; a force platform will be used to assess the single-leg standing body sway path length and velocity; a functional reach test will give a score that reflects the limits of stability of the participants; and the timed up-and-go test will be used to quantify functional balance performance of the participants.

Anticipated results and significance: It is predicted that both TENS and KT, when applied together, may best improve lower limb joint proprioception and facilitate all balance performances among the community-dwelling older adults. These interventions could be applied in clinical settings to improve joint proprioception and postural control of the elderly people.


Eligibility Criteria:
Inclusion criteria:

* Between 60 and 75 years old
* Able to ambulate independently and safely without using any walking aid
* Able to follow instructions

Exclusion criteria:

* Known unstable medical condition (e.g., uncontrolled hypertension)
* Known sensorimotor or neurological disorders (e.g., stroke and epilepsy)
* Significant musculoskeletal disorder of the lower limbs (e.g., osteoarthritis of the knee)
* Cognitive disorder
* Presence of an implanted electrical device (e.g., cardiac pacemaker)
* Cancer
* A change in skin sensation
* Wound around the lower limb joints
* A recent injury that may affect test performance
* Allergy to adhesive tapes
Effect of a Specific Blend of Fibers and Probiotics on the Microbiome

The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent signed
2. Adult men and women aged 18 to 45 years
3. Healthy based on the medical screening visit and medical questionnaire
4. BMI in the range of 18.5 to 29.9 kg/m2.

Exclusion Criteria:

1. Known food allergy and intolerance
2. Currently participating in another clinical trial or research project
3. Fewer than 5 spontaneous bowel movements per week on average
4. Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
5. Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment
6. Medications or supplements that are known to alter gut function or microflora during the 4 weeks prior to study enrolment
7. Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or anticoagulant agents
8. Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy)
9. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
10. Artificially sweetened beverage intake higher than 1000 ml/ per day
11. Female subjects will be excluded if they are pregnant, gave birth in the last 6 months, or are lactating.
12. Subject having a hierarchical or family link with the research team members.
Auditory Profile and Language Development in Children Operated for Cleft Palate

Observational study about children with cleft palate from surgery to pre-adolescence :Description of language development and hearing profile.

"Children with cleft palates are prone to complications that can impact on their overall development. Several factors such as serous otitis media or abnormal musculature of the velum can have consequences on hearing and language. In this context, it seems important to describe the evolution of this disease after surgery to better anticipate complications and improve their subsequent management. The aim of this study is to describe the hearing profile and language development of children with cleft palate from surgery to pre-adolescence. The hearing profile is assessed though an audiogram once or twice a year during the annual follow-up with the referring surgeon. Language development is assessed by the intelligibility scale, a validated questionnaire. This study will allow identification of : - predictive criteria for poor hearing and poor language development; - risk groups: type of cleft, medical history, genetic background, etc; - Level of speech disorder other than intelligibility: rhinolalia, eagerness for communication; - Other factors in the history of the disease: âge at surgery ; - history of chronic otitis media, ventilation tube placements; - nasalization and language disorder; - speech-language pathology; - History of hearing impairment; - age of first words; - Other ENT clinical history; - History of malformations; - Socio-economic level of the household; - Mother's language / number of languages spoken at home. This is a retrospective and prospective cohort study. Children aged 5 to 11 with a cleft palate operated on for a veloplasty at Robert Debré Hospital between 2008 and 2014 were included in the study between 2008 and 2014.

"

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5 to 11 years old operated on for a veloplasty at the Robert Debré Hospital
* operated between 2008 and 2014
* having a cleft veil with or without a cleft lip and palate

Exclusion Criteria:

* Children operated on for primary veloplasty outside the Robert Debré Hospital, and coming for secondary veloplasty.

Child operated on for a veloplasty for a cause other than the velar cleft.
Cervix Hypoxia FAZA

The purpose of this study is to look for low levels of oxygen (hypoxia) in your cervix cancer using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have an effect on how cervix cancer grows and responds to treatments like radiotherapy and chemotherapy. Doctors at Princess Margaret Hospital have measured hypoxia in over 300 patients. The use of PET scans to measure hypoxia may be better and simpler than the methods used previously.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
* TNM (7th edition) cT1-4, N0-1, M0-1
* Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group
* No cytotoxic anti-cancer therapy for cervix cancer prior to study entry
* A negative urine or serum pregnancy test within the two week interval immediately prior to PET-CT imaging, in women of child-bearing age
* Ability to provide written informed consent to participate in the study

Exclusion Criteria:

* Prior complete or partial hysterectomy
* Carcinoma of the cervical stump
* Inability to lie supine for more than 30 minutes
* Patients taking the drug disulfuram (Antabuse)
Efficacy of Kinesiotaping During Rehabilitation Following Total Knee Replacement Surgery

The aim of this study was to examine the efficacy of Kinesiotaping (KT) within postoperative rehabilitation after Total Knee Replacement (TKR) surgery by determining whether KT enhances early postoperative outcomes, in terms of reduction of swelling, pain relief and improvement in the function of the knee joint, compared to conventional rehabilitation without the use of KT.

Kinesiotaping and Rehabilitation after Total Knee Replacement The effectiveness of Kinesiotaping (KT) in postoperative rehabilitation remains scientifically unproven, despite its widespread use. KT is believed to reduce pain and swelling, improve muscle function, and enhance joint mobility by promoting blood flow and lymphatic drainage. However, high-quality studies assessing its efficacy, particularly following Total Knee Replacement (TKR), are lacking.

Aim of the Study The aim of this study is to demonstrate that KT, when applied during inpatient rehabilitation after TKR, improves clinical outcomes compared to standard rehabilitation without KT.

Specifically, the investigators aim to show that:

KT reduces postoperative swelling and pain, thereby enhancing knee function. KT promotes faster recovery of muscle strength and range of motion. KT shortens the time needed to achieve key postoperative milestones, allowing for a more effective rehabilitation process.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥18 years.
* Patients who have undergone primary Total Knee Replacement (TKR) with uncomplicated wound conditions.
* No signs of infection post-surgery.
* Ability to understand study procedures and complete required questionnaires.

Exclusion Criteria:

* Revision TKR surgeries.
* Early postoperative complications (e.g., wound healing disorders, deep infections, thrombosis).
* Severe comorbidities (e.g., heart failure NYHA class 3-4, renal insufficiency grade 3-4, chronic lymphedema, dermatological conditions).
* Known allergies to Kinesiotaping (KT) or adhesive materials.
* Neurological or neuromuscular disorders.
* Cognitive impairments (e.g., dementia) affecting compliance.
Performance of Novel Bed Side Scores as Predictors of Hospital Outcome in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Among Women; Cohort Study

* Assess predictors of mortality in COPD exacerbation between men and women.
* Evaluate the clinical outcomes in acute exacerbation of COPD in women.
* Evaluate the validity of new scoring systems ( NIVO, DECAF, HACOR ) as a predictor for hospital outcome in acute exacerbation of COPD.
* Compare these new scoring system with the most widely used APACHE IV.
* Assessment of serum level of granulocyte colony stimulating factor ( GM-CSF) in detecting the severity of COPD exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AECOPD leading to hypoxemia, hypercapnia and respiratory acidosis with pH \< 7.35 and PaCO2 \> 45 mm of Hg will be admitted to the respiratory intensive care unit (ICU) for NIV or the ward will be eligible for inclusion and not in need for mechanical ventilation

Exclusion Criteria:

* Requirement for emergency intubation.
* Other contraindications to NIPPV including cardiac or respiratory arrest; nonrespiratory organ failure (eg, severe encephalopathy, severe gastrointestinal bleeding, hemodynamic instability with or without unstable cardiac angina); facial surgery or trauma; upper-airway obstruction; inability to protect the airway and/or high risk of aspiration; and inability to clear secretions.(6)
* Age \< 35 years.
Stroke Card Long-term Follow-Up

We undertook the STROKE-CARD trial (NCT02156778) between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease-management program STROKE-CARD care. To further investigate the long-term efficacy of STROKE-CARD care all participants of the original trial will be invited for a Long-term in Person follow-up (3 - 6 years).


Eligibility Criteria:
Inclusion Criteria:

* Inclusion in the previous STROKE-CARD trial (NCT02156778)
* Written informed consent

Exclusion Criteria:

* none
Three-Year Clinical Performance of Fiber-reinforced Versus Indirect Resin Composite Posterior Restorations

This study aimed to perform a comparison between the clinical performance of short fiber-reinforced composite and indirect lab composite restorations in posterior dentition.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 20-35 year from both genders.
2. Good oral hygiene: patients with low and moderate caries risk (according to Caries management by caries risk assessment CAMBRA sheets) were enrolled in this study.
3. The visual examination should reveal the presence of a minimum of three primary occlusal or proximal caries (Black Class I and II) with a severity score of 4 or 5 according to the International Caries Detection and Assessment System (ICDAS).
4. The carious teeth must exhibit vitality and do not display periapical radiolucency as evaluated by periapical radiography.
5. The selected teeth must be under stable occlusion.

Exclusion Criteria:

1. Uncontrolled systemic disease
2. Extremely poor oral hygiene
3. Chronic periodontitis
4. Heavy bruxism
5. Cavities with a buccolingual width exceeding two-thirds of the intercuspal distance or requiring cusp covering.
6. Patients undergoing orthodontic procedures.
7. Patients unable to attend the scheduled recall appointments.
Early Diagnosis Of Childhood Cerebral ALD

The goal of this single institution study is to evaluate boys with adrenoleukodystrophy (ALD) diagnosed early in life, and to prospectively monitor them to determine parameters that will facilitate earlier detection of the childhood cerebral form of the disease. These at-risk subjects will be assessed yearly through travel to the University of Minnesota, where plasma and cerebral spinal fluid (CSF) biomarker studies, MRI based imaging and neuropsychological assessments will be performed at the University of Minnesota Masonic Children's Hospital and Clinics. The MRI and lumbar puncture to obtain CSF will be obtained under sedation. In addition, at intervening 6 months intervals information will be obtained remotely, including surveys and MRI's in their home location. Also at that time blood samples will be obtained locally and shipped to the University of Minnesota for study. There is no therapeutic intent in this study.


Eligibility Criteria:
Inclusion Criteria:

* Boys with confirmed adrenoleukodystrophy, as determined by very long chain fatty acid (VLCFA) analysis and/or genotyping. Genotyping is not necessary for diagnosis.
* Between 1 and 5 years of age, inclusive at the time of consent.
* Able to undergo a sedation
* English as primary language of the household, to maximize consistency of the neuropsychological/developmental testing.
* Voluntary written parental/guardian consent

Exclusion Criteria:

* Evidence of cerebral disease at time of enrollment - patients over 3 years of age must have an MRI within 4 months of signing consent to confirm that there is no evidence of cerebral disease
* Inability or unwillingness to travel to the University of Minnesota once a year for the duration of the study
* Evidence of cerebral disease by standard T2/FLAIR MRI. If a subject develops cerebral ALD during the study, they will come off study, as it is anticipated that they would be considered for transplantation.
Community Health Worker And MHealth to ImProve Viral Suppression

The overall goal of this study is to evaluate the effects of the CHAMPS intervention for people living with HIV (PLWH) in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a combined community health worker (CHW) and smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a rigorous theoretical model of supportive accountability and building on preliminary work, this intervention has the potential to enable PLWH to self-manage their ART regimens while CHW monitor their ART adherence in real-time ultimately leading to viral suppression and ART adherence.

Persons living with HIV (PLWH) now achieve a near-normal life expectancy due to antiretroviral therapy (ART) which has transformed HIV from a terminal diagnosis to a manageable chronic condition. Despite widespread availability of ART in the United States (US), many of the country's approximate 1.1 million PLWH are not fully benefitting from ART due to poor adherence. These suboptimal HIV health outcomes occur at a time when clinicians have limited time and the US healthcare system remains fragmented, further exacerbating the challenges inherent in the lives of underserved, marginalized groups, such as PLWH. Therefore, the development and evaluation of interventions using a cadre of community health workers (CHW) holds promise for addressing these challenges in the US. This study addresses limitations in current research on CHW interventions to improve viral suppression and ART adherence. The investigators propose to build on strong preliminary data to strengthen a community health worker (CHW) intervention using an existing mHealth approach, and provide further information regarding the successful wide-scale implementation of this combination intervention.

Eligibility Criteria:
Inclusion Criteria:

* Be able to communicate and read in English or Spanish
* Willing to participate in any assigned arm of the intervention
* Diagnosed with HIV ≥6 months ago
* Have an HIV-1 RNA level \>200 copies/mL, or have at least one "no-show" visit in the past 12 months, or report being virally unsuppressed in the past 12 months
* Have ART adherence \<80%, as measured through Single-Item Self-Rating Adherence Scale (SRSI)
* Own a smartphone

Exclusion Criteria:

* Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment
* Terminal illness with life expectancy \<6 months
* Planning to move out of the area in the next 12 months