cyrilzakka/clinical-trials huggingface dataset:
Wearable Dark-adaptometer in Normal Adult Healthy Volunteers

Conventional dark-adaptometers are unsuitable as a mass screening tool due to their high cost, lack of easy portability, need of trained staff and a totally dark room to be operated, arbitrary testing procedures, associated time waste in clinic and patient burden to mention a few. Consequently, dark adaptometers are not routinely used as clinical tools for retinal diagnosis and monitoring despite the inherent benefits over other visual electrophysiology equipment such as the ERG system, whose cost and features may often be surplus to optometrists' requirements.

This trial will assess the dark-adaptometry testing performance of a novel light-emitting system by generating full dark-adaptation threshold functions in normal adult healthy volunteers.

The novel system has been proposed to overcome the issues associated with current instrumentation; it is semi-automatic and easy to use without the need of any skilled operator.

It is envisaged that this system could spread the practice of dark-adaptometry testing and its adoption by high-street optometrists. This will allow diagnosing a number of retinal pathologies more quickly and more reliably that, faced with an ageing population, represents a major asset to the Health Community and the NHS.

This trial will involve 20 healthy volunteers, distributed in equal number in 2 groups of 18-40 and 50-70 years old, respectively. Proven the good health and eye condition of the participants, one of their eyes will be randomly-allocated and undergo dark-adaptometry testing 3 times on separate days within 3 weeks.

Testing will clarify whether by using the novel system it is possible to reproduce state-of-the-art threshold measurements as good or better than those produced by commercially-available dark-adaptometers. Threshold measurements in the elderly will be compared with literature data adjusted to exclude aged crystalline lens and pupillary miosis contributions. Data variability and system usability will be also assessed.

All details elsewhere in the documentation

Eligibility Criteria:
Inclusion Criteria:

* Refractive error: ≤ ±5 dioptres spherical (myopia/hyperopia) equivalent; ≤ 3 dioptres cylinder (astigmatism) equivalent.

Exclusion Criteria:

* Subjects not in age range and/or unable to fully understand the informed consent and/or unable to comply with study procedures.
* Self-reported history of depression, lack of sleep, psychiatric disorders, or neurological diseases such as Alzheimer's and Parkinson's disease.
* Self-reported history of diabetes, stroke, or multiple sclerosis.
* Self-reported hypovitaminosis A, alcoholism, liver or intestinal disease, malabsorption, protein calorie malnutrition, or sickle cell anaemia.
* Use of psychoactive drugs (including lithium salts for mood stabilisation).
* Use of dietary intake of ascorbic acid, vitamin A, B, E or other antioxidant supplements in the last two weeks.
* Recurrent practice of activities that expose the retina to ultra-violet radiation such as sailing, fishing, sunbathing or tanning saloons.
Etiology of Uncomplicated Fever in Children <5 in Rural Zanzibar

The purpose of this study is to study the most common etiologies of uncomplicated fever diseases among children under five years of age in rural Zanzibar.

During the last 6 years Zanzibar has undergone a dramatic change in malaria epidemiology and burden of disease, with a marked decline of Plasmodium falciparum malaria among febrile children from approximately 30% to 1% or below and a reduction of crude child mortality of 50%. Millions of children in Africa die of neonatal disorders, acute respiratory tract infections (ARI), diarrhea, malaria, measles, HIV and malnutrition. A majority of these illnesses are also a common cause of febrile illness in out-patient departments. However, most of the few fever studies made in Africa are hospital based Very few studies on etiology of childhood febrile disease have been conducted on first level health facilities in the least developed countries in Africa. This study will therefore focus on children between 2 months to 5 years of age that have been diagnosed with a negative rapid diagnostic test (RDT) for malaria and their causes of fever at the first referral level in out-patient clinics in Zanzibar.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 2-59 months of age with confirmed fever, with a measured axillary temperature of ≥37.5˚C, or history of fever within the preceding 24 hours.
* Presenting at the health facility from 8.00 to 16.00 Monday to Friday.
* Informed consent.
* Able and willing to complete stipulated follow-up.

Exclusion Criteria:

* Decision by the clinician to refer the patient to another health facility than the PHCC where the study is conducted.
* Symptoms/ signs of severe disease that requires immediate referral from the PHCC as defined by the clinicians. These symptoms/signs of severe disease are according to the IMCI guidelines.
Tumor Immunotherapy and Microbiome Analysis

The composition of the gut microbiome has been associated with response and the development of toxicities on immune checkpoint inhibitors (ICIs) in multiple tumor types. The aim of this study is to examine the gut microbiome composition in patients undergoing standard of care treatment for advanced/unresectable and/or metastatic solid tumors with ICIs. Fecal samples and peripheral blood samples will be collected to further characterize the diversity of gut bacteria and to study potential mechanisms by which gut bacteria impact the immune response.

This is a prospective study of gut microbial markers. Patients with histologically confirmed advanced/unresectable or metastatic solid tumors who are planned to initiate standard of care ICIs or are undergoing standard of care treatment with ICIs will be approached for participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Sign written and voluntary informed consent
* Adult patients aged \>=18, male or female
* Eastern Cooperative Group (ECOG) performance status 0-2
* Histologic diagnosis of an advanced/unresectable or metastatic solid tumor
* Measurable disease as per RECIST 1.1 criteria
* Be suitable for or receiving ICI treatment
* Prior immunotherapy allowed
* Be willing and able to provide fecal and blood specimens for analysis as per protocol

Exclusion Criteria:

* Subjects with a history of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator
Eccentric Exercise and Oxidative Stress

The purpose of the present investigation is to compare the responses and adaptations of young and elderly individuals to repeated eccentric exercise in regards to muscle function and redox homeostasis in a side-by-side comparison.

Despite the progress of analytic techniques and the refinement of study designs, striking disagreement exists among studies regarding the influence of exercise on muscle function and redox homeostasis in the elderly. A specific exercise protocol will be applied (the repeated eccentric model) to produce long-lasting and extensive changes in redox biomarkers and to examine more easily the potential effects of aging. Ten young men and ten elderly men will underwent an isokinetic eccentric exercise session, which will be repeated after three weeks. Muscle function indices and redox biomarkers will be assessed in urine, plasma or erythrocytes pre exercise, immediately post exercise, 2 and 4 days post exercise.

Eligibility Criteria:
Inclusion Criteria:

* subject provides written informed consent
* physiological health profile
* stable at their anthropometric characteristics for at least the last year

Exclusion Criteria:

* muscle disease
* prior history of musculoskeletal injury to the lower limbs
* smokers
* consumed any nutritional supplement the last 3 months
* performed intense eccentric exercise the last 6 months
* non Caucasian
Lung and Diaphragm Ultrasound in the Early Postoperative Course Following Lung Transplantation

This feasibility study tries to define the value of daily Lung and Diaphragm Ultrasound in the early postoperative course following Lung transplantation by comparing its diagnostic accuracy with that of standard of care diagnostic procedures

Lung transplantation remains a high risk procedure. Common complications in the early postoperative course are, among others, primary graft dysfunction (PGD), hemorrhage, anastomosis insufficiency leading to pneumothorax, pneumonia, atelectasis and diaphragm dysfunction. Early diagnosis of complications is important to avoid further deterioration. Lung ultrasound (LUS) and diaphragm ultrasound (DUS) has a high diagnostic accuracy for identifying frequent conditions in the critically ill. Studies evaluating its value in patients following lung transplantation are missing. This study investigates the feasibility and clinical ability of LUS and DUS to identify common complications following lung transplantation and compares it to standard of care diagnostic procedures. The investigators start a prospective cohort study of lung transplant recipients who undergo lung transplantation at the university hospital Munich. Daily LUS and DUS in the early postoperative phase will be performed to detect and monitor complications. The US results will be compared to the results of diagnostic procedures of the clinical routine such as clinical examination, chest x ray, hemodynamic monitoring, expert opinion on PGD and laboratory parameters.

The hypothesis is that daily LUS and DUS following lung transplantation helps to diagnose complications early and with higher accuracy compared to the results of diagnostic procedures of the clinical routine.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* patient following lung transplantation

Exclusion Criteria:

* no informed consent
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies

The purpose of this study is to obtain long-term clinical data from patients approximately 15 years after their first clinical event, who participated in the former BENEFIT 304747 study and were treated at least once within that study.

This study will collect clinical information on the disease course, on disability, relapses, cognitive function over time, quality of life, depression, fatigue, resource use, and employment status. In addition, brain MRI is performed.


Eligibility Criteria:
Inclusion Criteria:

* All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study

Exclusion Criteria:

* Subjects who, according to the investigator's judgment, have medical, psychiatric, or other conditions that compromise the subject's ability to understand the purpose of the study
* Suspected clinical instability or unpredictability of the clinical course during the study(e.g., due to previous surgery or acute stroke)
Study of Gulf War Illness (GWI) by Comparing GWI and Healthy Veterans

Determine if:

* genetic differences of CNDP1 gene
* the previously defined GWI/Chronic Fatigue Syndrome (GWI/CFS) cerebrospinal fluid proteome contents
* psychometric
* other variables can differentiate between veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms and those without these complaints.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:

  * Persian Gulf waters and adjacent land areas
  * Other global locations
  * U.S. only
* Status prior to 1990 and 1991:

  * Active duty
  * National Guard
  * Reserves

Exclusion Criteria:

* Current active duty military personnel
* Any one who was not active duty military personnel between August 1, 1990 and July 31, 1991
* HIV/AIDS; pregnancy or lactation; potential hepatitis; drug addiction; chronic inflammatory, infectious, or autoimmune medical illnesses not associated with GWI; incarceration; dementia, other cognitive limitation; or reliance on a care-giver in order to respond to the questionnaires and other study tests.

Amputations of one or both hands and forearms will be permitted but hand grip tests will not be tested
Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants

The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth (for corticosteroids, this will mean prednisone, or equivalent, \>= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations.
* Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment..
* History of confirmed rotavirus gastroenteritis.
* Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
* Previous vaccination with rotavirus vaccine or planned to use during the study period.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
The Effects of Endurance and Strength Training in Subjects With Asthma

Emerging evidence suggests that regular exercise can complement medical treatment for asthma. Furthermore there are no specific recommendation on how plan exercise training. To the best of current knowledge, there isn't enough evidence of the effect of a strength training in subjects with asthma. Therefore the aim of this study is to evaluate the short and long term effects of a strength and endurance training compared with endurance training alone in subjects with asthma.

To the best of current knowledge, there isn't enough evidence of the effect of a strength training in subjects with asthma. Aim of the study is evaluate the short (after pulmonary rehabilitation) and long term (after 12 months) effects of a strength and endurance training compared with endurance training alone in improving quality of life and disease control in subjects with asthma of Global Initiative for Asthma (GINA) stage from 4 to 5.This is a prospective randomized control trial. Subjects with diagnosis of asthma according to the GINA guidelines admitted to a reference centre for inpatient pulmonary rehabilitation will be randomly assigned to study or control group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma step 4 to 5 under optimal medical treatment for at least 6 months according to GINA guideline
* Symptomatic despite being on treatment: Asthma Control Test (ACT) score ≥ 20 ≤24
* Able to perform and complete with studies procedures (FeNO, CPET, Six Minute Walking Test (6MWT), MVS.

Exclusion Criteria:

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the Global initiative for Obstructive Lung Disease (GOLD) guidelines criteria
* Smokers or ex-smokers with pack/years ≥10
* Body Mass Index (BMI) ≥30
* Change in asthma medications in the last 30 days
* Cognitive impairment (Mini-Mental State Examination score \<22)
* History of oncological, neurological, cardiovascular diseases, musculoskeletal impairment and/or medical diseases precluding exercise testing and pulmonary rehabilitation
Severe Acute Respiratory Syndrome Coronavirus 2 Re-Infection Risk and Vaccine Efficacy in Austria

The coronavirus disease 2019 (COVID-19) pandemic was caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. In this study, we aim to evaluate how strong and how long are individuals in Austria after vaccination and/or infection with SARS-CoV-2 protected against COVID-19 disease.

In this project, we will analyze national health data from all inhabitants of Austria (about 9 million persons) during the COVID-19 pandemic. The population of Austria will be stratified into different groups according to previous vaccinations against SARS-CoV-2 and previous SARS-CoV-2 infections.

We primarily evaluate how strong and how long after vaccination against SARS-CoV-2 and/or infection with SARS-CoV-2, the risk for COVID-19 deaths is reduced or altered as compared to less vaccinated and/or infected persons. As secondary study aims, we perform such analyses also for SARS-CoV-2 infections, hospitalizations and intensive care unit (ICU) stays, with or due to SARS-CoV-2. These analyses will be performed during different time periods of the COVID-19 pandemic, and we will also perform various subgroup analyses as for example according to age and gender. Given that antibodies against SARS-CoV-2 are usually detected after vaccination and/or infection, we will use such antibody data from blood donors in Tyrol, to elucidate how well the national health data on SARS-CoV-2 infections and vaccinations match with the respective antibody data, and how well these antibody data indicate risk of COVID-19 deaths and infections.

We will calculate the probability of dying due to a SARS-CoV-2 infection (case/infection fatality rate) for different times of the COVID-19 pandemic, in order to document the health threat due to SARS-CoV-2. Based on all these data, we will calculate how many persons have to be vaccinated against SARS-CoV-2 to prevent one COVID-19 death at different times during this COVID-19 pandemic. We will consider the respective COVID-19 policies such as mask mandates, lock-downs, SARS-CoV-2 test mandates in our analyses and will evaluate the impact of these policies on COVID-19 deaths and diseases. In addition, we will evaluate data on total mortality according to the number of SARS-CoV-2 vaccinations and/or infections, and we will aim to collaborate with other research groups in order to extend our analyses.

In conclusion, the results of this study should provide an overview on the COVID-19 pandemic with respect to protection conferred by vaccinations and previous SARS-CoV-2 infections, as well as the health threat of SARS-CoV-2, in order to provide knowledge for future COVID-19 policy and future pandemics.


Eligibility Criteria:
Inclusion Criteria:

- Residency in Austria.

Exclusion Criteria:

- None.
HBM for Empowering Parental Toothbrushing and Sugar Intake Control

It has been recognized that oral health education for parents is critical for the prevention of early childhood caries (ECC). Few parents practiced caries prevention procedures for their children in daily life, though. Inspired by Health Belief Model (HBM) and using text messaging as a vehicle, a novel intervention scheme will be developed in this study. The objective of the present randomized clinical trial (RCT) is to investigate the effectiveness of the HBM-based behavioral intervention using text message to reduce early childhood caries of children at age 4 through promoting the parental oral health care behaviors (toothbrushing and sugar intake control) for their young children compared to conventional oral health education. This RCT will recruit child-parent dyads in 26-36 child help centers or kindergartens with nursery classes located in Hong Kong. A total of 518-628 dyads will be recruited and randomly allocated into the test or control group with a 1:1 ratio. For parents in the test group, the intervention will consist of a set of HBM-based text messages sent regularly in the following 48 weeks. A standard text message will be sent to the parents in the control group. The primary outcome will be dental caries measured by dmft/dmfs of the children at 4 years old.

By HBM-based intervention via a low-cost text messaging vehicle, it should be able to help the parents establish proper oral health behaviors for their children and safeguard the oral health of children in Hong Kong.


Eligibility Criteria:
Inclusion Criteria:

* young child aged18-30 months
* young children not having any severe medical conditions complicating oral health and dental examination
* parents having a mobile phone with certain Apps to receive the text messages in time (e.g. WhatsApp or WeChat)
* parents who can read Chinese

Exclusion Criteria:

* families that have been participating in another oral health promotion program
Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis

Cross sectional observational ultrasound study of transplanted kidneys and the carotid artery in consecutive recruited outpatients.


Eligibility Criteria:
Inclusion criteria:

* Patients after renal transplantation with stable renal function

Exclusion criteria:

* Known impairment of renal function (e.g. acute rejection)
* Known renal artery or carotid artery stenosis
Management of Lower Limb Apophysitis: A Cross-sectional Study on Long-term Impact on Health Status

Lower limb apophysitis cause long-term pain, decrease in function, and can reduce or completely hinder participation in sports and physical activity, yet there is little knowledge on the long-term consequences for health. Our objective with this investigation is to capture self-reported health-status for all adults having been diagnosed with lower limb apophysitis in the period of 1977 to 2020 and compared these data with normative values for the background population. We are therefore conducting a national cross-sectional study based on data from the Danish National Patient Registry. In this protocol we describe, as detailed as possible, the planned methods.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18-55 having received diagnostics codes pertaining to lower limb apophysitis (Severs, Sinding-Larsen Johansson, Osgood Schlatter) in the years 1977-2020 in Denmark will be eligible to participate.

Exclusion Criteria:

* Diseased participants will be censored