cyrilzakka/clinical-trials huggingface dataset:
The Effects of SGC on Glucose Control in Critically Ill Patients With Sepsis

Poorly glycemic control in critically ill patients can increase their mortality, while safe and efficient glucose control is laborious and time-consuming. The Space Glucose Control which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose target range safely and effectively through regulating insulin dose rate, and decrease the glucose variability. This study is a random controlled trial involving the patients with sepsis in intensive care unit in order to evaluate the difference of safety and efficacy of blood glucose control between SGC directed and conventional treatment. At last, the trial results can determine whether the Space Glucose Control can control blood glucose safely and effectively in the patients with sepsis in intensive care units.

Design: The study was conducted as a single-centre, open randomized controlled, parallel trial.

Study population: Adult general ICU patients with sepsis and assumed to require at least 3 days of intensive care were recruited. Patients fulfilling the inclusion criterion of glucose≥9.0 mmol/L were randomly assigned using serially numbered to either the intervention group (BG control by SGC) or the control group (conventional empiric BG management). The both group aim to establish the BG levels 5.8-8.9mmol/L.

Study protocol: BG measurements were performed using glucometer to test the fingertip capillary blood sample for the BG levels. As for patients with shock or required vasopressor, arterial BG was sampled to measure through the glucometer. Insulin was infused intravenously applying the standard perfusor of the ICU. Average glucose, glucose variability, SOFA score, APACHE II score, and HLA-DR were recorded. All trial-related activities were carried out until the end of the patient's ICU stay, or for a period of 72 hours. Meanwhile, enteral and parenteral nutrition was administrated to patients according to their condition.

Statistical analysis was performed on an intention-to-treat basis. The percentage of values in the target range (5.8-8.9mmol/L) was defined as primary end point for the assessment of glucose control. Data are reported as mean±SD values if not otherwise indicated. Data analysis was performed using SPSS19.0.

Eligibility Criteria:
Inclusion Criteria:

1. Admitted to the ICU
2. At least one BG measurement 9.0mmol/L or higher
3. Expected to stay in ICU ≥3 days;
4. critically ill patients with sepsis
5. SOFA score≤2

Exclusion Criteria:

1. Aged \< 18 years;
2. Admitted because of diabetic ketoacidosis or nonketotic hyperosmolar state
3. Pregnant
4. In a state in which death was perceived as imminent
5. Without written informed consent
Reusable Face Masks to Reduce Risk of Viral Respiratory Infections and Asthma Exacerbations

REMASK trial is a Trial within Cohort study (TwiCs), nested within the COVIDENCE UK longitudinal study. It has been designed to determine whether the offer of a free reusable, elastomeric face mask to adults with asthma and other members of their household reduces risk of RT-PCR confirmed viral respiratory infections and asthma exacerbations.


Eligibility Criteria:
Eligibility criteria, participants with asthma ('index participants'):

Inclusion Criteria:

* Aged 16 or more years
* Doctor diagnosis of asthma
* Current prescription for treatment of asthma
* Participant in COVIDENCE UK nasal swab study

Exclusion Criteria:

* Regularly using any FFP-rated face mask when in an indoor public place
* Currently sharing household with one or more children
* Currently sharing household with one or more other COVIDENCE UK participants who have asthma
* Unable to tolerate wearing face mask

Eligibility criteria, household members of index participants:

Inclusion criteria

* Age 16 or more
* Living in same household as index participant who has consented to take part in trial

Exclusion criteria

- Unable to tolerate wearing face mask
Early Intervention for Suicide Risk Among Immigrant Youth

The purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. The intervention will focus on reducing suicide risk by reducing family conflict and intergenerational cultural conflict and improving parent-child communication. The investigators will first develop the 8-session preventive intervention with quantitative data from analysis of existing longitudinal studies and qualitative feedback from Latino youth and their caregivers, clinicians, administrators, and research consultants, as well as results from initial pilot testing of the intervention. The investigators will then conduct a pilot randomized trial with 40 adolescents and their families to test feasibility, acceptability, and impact on intervention targets. Successful development of the intervention would improve mental health outcomes for a growing and underserved portion of the U.S. population.

Suicide is the second-leading cause of death among adolescents, with rates increasing between 1999 and 2014. Family-based preventive interventions demonstrate promise for reducing suicide risk among adolescents, and are particularly relevant for addressing suicide risk factors specific to immigrant youth, who comprise one-fourth of the U.S. population under 18. The purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. In the first phase of intervention development, quantitative and qualitative data will be used to develop and if necessary refine a new family based preventive intervention (Early Intervention for Suicide Risk among Immigrant Youth, EISR-I). The investigators will then test the intervention in a pilot case series in order to finalize assessment and intervention protocols. In the second phase, the investigators will pilot test the preventive intervention, delivered by mental health clinicians to 1st and 2nd generation Latino/a early adolescents and their families, in order to assess feasibility, acceptability, and impact on the intervention targets (i.e. a positive signal of the intervention) on the study population. Twenty families will be randomized to receive the 8-session intervention and twenty will receive enhanced usual care including a safety planning and feedback session.

Eligibility Criteria:
Inclusion Criteria:

* Latino
* First generation (foreign-born) or second-generation (at least one parent foreign-born) immigrant
* 12 to 15 years old
* Speaks English or Spanish
* Reports current suicidal ideation with no plan, past-year suicidal ideation, or a suicide plan more than three months prior OR has a CAT-SS score\>34

Exclusion Criteria:

* Suicide attempt in the past three months
* Endorses psychotic symptoms on a pre-study screener
* Has severe major depressive disorder
* Has a prior diagnosis of severe intellectual disability
* Receiving individual or family therapy
Effects of Functional Exercise Program With Strength Load and Resistance in Children and Adolescents With Cerebral Palsy

This research project aims to evaluate the benefits of a functional exercise program with strength and resistance load in adolescents with cerebral palsy (CP), specifically classifiedat levels III and IV of the Gross Motor Function Classification System (GMFCS) scale. Participants will be included into control or intervention group in this randomized controlled trial. Changes in functional percentile, quality of life, and participation in daily environments will be analyzed based on scores obtained with validated assesment scales.

The study will be conducted at the Children's Neurorehabilitation Unit of Hospitalarias Foundation in Valencia, with an 18-week intervention plus a 6-month follow-up. This project seeks to provide evidence on rehabilitation strategies that promote autonomy and social inclusion for this population.

This research project is a randomized controlled trial designed to analyze the effects of a functional exercise program with strength and resistance load in adolescents with CP specifically classified at levels III and IV of the GMFCS scale. The study will include around 40 participants aged 10 to 18 years, randomly assigned to either an intervention group or a control group. The intervention group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate. The control group will perform the same functional exercises but without any load.

The protocol includes 36 sessions over 18 weeks, with evaluations at three key time points: before the intervention, at the end of the protocol, and six months post-intervention. The primary outcomes include functional percentile within the GMFCS, quality of life asperceived by patients and caregivers, and participation in daily environments.

The study will adhere to CONSORT guidelines and the Declaration of Helsinki and has been reviewed by an ethics committee.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 10 to 18 years.
* Diagnosis of spastic cerebral palsy (CP).
* Classification at levels III or IV of the GMFCS scale.

Exclusion Criteria:

* Multilevel surgery with osteotomy within the last 12 months.
* Microtenotomies or percutaneous needle lengthening (APAI) within the last 9months.
* Botulinum toxin injections within the last 3 months.
* Participation in specific strength training protocols.
* Lack of cognitive ability to perform the intervention protocol activities.
The Prevalence of White Spot Lesions During Orthodontic Treatment With Fixed Appliances

This study investigates how often cavities develop on the permanent teeth of patients with braces (orthodontic treatment). The hypothesis is that there is no difference in the number of cavities on the permanent teeth of patients with braces compared to similar patients without braces.

The purpose of this cross-sectional study is to determine the prevalence of early carious lesions (white spot lesions, or WSLs) for patients who are receiving orthodontic treatment compared to patients who are not receiving orthodontic treatment.

Subjects will be recruited from the University of Kentucky Orthodontic Clinic patient pool. Orthodontic care at the University of Kentucky College of Dentistry (UKCOD) is provided by orthodontic faculty, as well as students enrolled in the graduate orthodontic program at the UKCOD. Subjects will be invited to participate in this study after receiving an initial treatment plan with fixed appliances for at least one arch.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agreed to participate in this study
* Patients who receive orthodontic treatment with fixed appliances at University of Kentucky College of Dentistry
* Patients who have either metal or ceramic brackets for the treatment

Exclusion Criteria:

* Patients on a daily supplemental fluoride regimen
* Patients who has difficulty in their daily toothbrushing due to their physical disability
* Patients with lingual fixed appliances
* Patients who are pregnant
* Patients with restorations placed on the facial/buccal surface of the tooth from premolar to premolar for both arches.
Taiwanese People's Willingness to Participate in Cancer Screening: Colon, Oral Cavity, Breast, and Cervical Cancer Screening

Cancer Screening is necessary for promoting cancer prevention in the area of public health. The Department of Health, Executive Yuan of the Republic of China has expanded and included colon cancer screening, oral cavity cancer screening, breast cancer screening, and cervical cancer screening in national-wide preventive healthcare services. However, most of the Taiwanese do not have the concepts of what cancer screening is and regular participation of cancer screening. This will easily cause their neglect of quality of personal healthcare and habits of cancer screening. Recently, in order to reach the national goal of cancer prevention, the parallel methods, multi-promotion for reinforcing concepts and free cancer screening, have been utilized to cultivate Taiwanese people's active participation of cancer screening. Therefore, this study will use health service utilization model to investigate Taiwanese people's concepts of cancer-related knowledge and the major causes of low participation of cancer screening.

In order to investigate Taiwanese people's health service utilization model and quality of health life, this study first review the related regulations and screening rates of cancer prevention, including cancers of colon, oral cavity, breast, and cervical, in Taiwan. In addition, the structured questionnaire will be conducted to collect, investigate, and analyze the relationship between the willingness of participating the aforementioned cancer screening and personal characteristics, quality of health life, medical history, and concepts of cancer, etc. It is expected that the results of this study will provide accurate and effective promotions of cancer screening to medical institutions and medical affairs to reinforce the concepts of participation for raising the rates of cancer screening; furthermore, to awaken Taiwanese people's crucial awareness of early treatment improves the chances of recovery on cancer.


Eligibility Criteria:
Inclusion Criteria:

Cases who are willing to answer the questionnaire

Exclusion Criteria:

Cases who are not willing to answer the questionnaire
Trigger Finger Treatment

Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness and/or snapping during movement. This observational study compared all of the possible treatments and combinations of treatments for trigger finger at the A1 pulley, including surgery, cortisone injections and hand therapy.

Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness or snapping during movement. This can be very debilitating. Current treatment includes local steroid injection, oral NSAIDS, resting orthoses, physical or occupational therapy and surgical intervention. The aim of this prospective study with an observational design was to determine the outcome between surgical, hand therapy rehabilitation, and corticosteroid injection interventions for trigger finger. There were 6 treatment groups: surgery, corticosteroid injection, 1 visit of hand therapy for orthosis fabrication and therapeutic exercise, hand therapy in combination with cortisone injection, Modality hand therapy alone (ongoing visits) or with corticosteroid injections.

Eligibility Criteria:
Inclusion Criteria:

* trigger finger in digit 2-5

Exclusion Criteria:

* if prior treatment for trigger finger, or Trigger thumb
Absorption, Metabolism and Excretion of 14C-olorofim in Man

Single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy subjects. It is planned to enrol 6 healthy male subjects in Cohort A (standard mass balance and metabolite profiling cohort) and up to 6 subjects in Cohort B (biliary evaluation cohort); each subject will receive a single oral administration of 120 mg \[14C\]-olorofim oral solution containing approximately 3.7 MBq (100 µCi).

Subjects will be screened up to 28 days prior to dosing and eligible subjects will be admitted to the Clinical Research Unit (CRU) on the day prior to dosing (Day-1). Each subject will be dosed on the morning of Day 1 after an overnight fast.

Cohort A:

Subjects will remain resident in the CRU up to 336 h post-dose (Day 15), with whole blood, plasma, urine and faeces collected throughout this period. There may be up to two further 24 h residency periods (Days 21 to 22 and Days 28 to 29) for collection of plasma, urine and faeces if discharge criteria are not met.

Cohorts B1 and B2:

Subjects will remain resident in the CRU up to 96 h post-dose (Day 5) for collection of plasma, urine, faeces and bile. Subjects will return for a short follow-up visit on Day 10. Cohort B1 subjects will have bile sampling up to 6 h postdose and Cohort B2 subjects will have bile sampling up to 12 h postdose. Cohort B divided into 2 sub-cohorts for logistical reasons only.

Eligibility Criteria:
Inclusion Criteria:

* healthy males age 18 to 55 years of age with body mass index of 18 to 30 kg/m2 (inclusive), and a body weight of 50 to 100 kg (inclusive).
* Subjects must be in good health as determined by a medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is NOT acceptable).
* Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day).

Exclusion Criteria:

* Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator
* Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration
* Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration
* Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration
* Current smokers and those who have smoked or used nicotine containing products (eg electronic cigarettes) within the 3 months prior to check-in.
* Radiation exposure, including that from the present study exceeding 1 mSv in the last 12 months or 5 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
Food Matrix and Genetic Variability as Determinants of Bioavailability and Biological Effects of Beta-cryptoxanthin and Phytosterols

Regular consumption of a beverage containing β-cryptoxanthin (b-Cx) and plant sterols (Ps) has been shown to exert a synergic effect in reducing cardiovascular risk and bone remodeling markers (formation and resorption). The present project aims to assess the influence of technological treatment and genetic variability on the bioavailability and the health effects of the added components (Ps, b-Cx), in particular to their potential role in prevalent disorders.In vitro and in vivo studies will be carried out to this effect. In vitro and in vivo studies (human intervention study) will be performed and cardiovascular, bone turnover and inflammation markers will be evaluated. Additionally, an in vitro colonic fermentation model and cell cultures will be used to explore anticarcinogenic effects and potential cytotoxicity.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women; mild hypercholesterolemia

Exclusion Criteria:

* Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use
Effect of Exercise and Surgical Weight Loss on Polyneuropathy

The purpose of this research study is to evaluate how exercise and surgical weight loss affect how likely an individual is to develop peripheral neuropathy and other neurologic complications.

The length of this study, including screening is approximately 24 months. Patients at Bariatric Surgery Clinics will be recruited for this study. Both patients that decide to undergo bariatric surgery, and those that do not undergo surgery will be enrolled. Patients will be randomized to either a high intensity interval training (HIIT) or standard exercise regimen after eligibility is confirmed and the baseline visit is complete. All patients will complete follow-up appointments at 3 month, 12 months and 24 months. Patients that are randomized to the HIIT program will compete 2 supervised and 1 unsupervised training sessions a week for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Attending a bariatric surgery clinic
* BMI \> 35 with one comorbid condition present or BMI \> 40 without comorbid conditions present
* Willing and capable to sign the Institutional Review Board (IRB) approved consent form and cooperate with the medical procedures for the study duration
* Willing to accept random treatment assignment to HIIT or routine exercise counseling

Exclusion Criteria:

* History of distal symmetric polyneuropathy (DSP) from causes other than diabetes and/or the metabolic syndrome as determined through medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations;
* Use of warfarin, heparin, or other anticoagulants, which would increase the risk of complications from skin biopsy
* Contraindication to HIIT participation including a failed exercise stress test
* Participation in an experimental medication trial within 3 months of starting the study
* Undergoing therapy for malignant disease other than basal-cell or squamous-cell skin cancer
* Medical or psychiatric reason for not being a surgical candidate
* Requiring a walking assist device;
* Currently smoking
Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Ethiopia

The ENAT study will test the impact of packages of antenatal interventions to enhance maternal nutrition and manage pregnancy infections on the outcomes of infant birth size, gestational length, and infant growth in the first 6 months of life. Approximately 5,280 pregnant women will be enrolled into the study from 12 health centers in the Amhara region of Ethiopia. Routine antenatal care will be strengthened in all health centers, and six health centers will be randomized to additionally provide a nutritional intervention including daily multiple-micronutrient or a fortified balanced-energy protein supplement for malnourished women. Women across all 12 health centers will be individually randomized to receive one of three infection management interventions in pregnancy: 1) enhanced infection management package (screening-treatment for urinary tract infections and sexually transmitted infections, presumptive deworming); 2) presumptive azithromycin (2g at \<24 wks and a second dose at least 4 weeks later); or 3) placebo. The women and their infants will be followed until 6 months postpartum. Outcomes of interest include birth size (weight, length), gestational age, maternal weight gain in pregnancy, maternal anemia, antimicrobial resistance, and infant size at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women \<=24 weeks gestation with a viable pregnancy based on a best clinical algorithm (LMP and/or symphysis fundal height)

Exclusion Criteria:

* Pregnant women presenting at enrollment \>24 weeks
* Pregnant women presenting with non-viable fetus
* Women who do not intend to deliver in the study catchment area
* Known allergy to Azithromycin or macrolide antibiotic
* Women who refuse to provide consent