cyrilzakka/clinical-trials huggingface dataset:
Linkage and Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa

The purpose of this study is to test the effects of a health system navigator intervention on rates of linkage to human immunodeficiency virus (HIV) and tuberculosis (TB) care among newly diagnosed HIV-infected outpatients in Durban, South Africa. Subjects will be approached in the outpatient department and enrolled prior to an HIV test. Subjects will then be randomized to the navigator arm or the standard of care arm. Subjects in the navigator arm will receive scheduled phone and short message service (SMS) contacts throughout the follow-up period to help guide them through the HIV and TB care pathways. The navigator will provide personalized support to help subjects overcome barriers they may face along the way.

This project is a randomized controlled trial of an intervention to improve linkage to HIV and TB care for South Africans undergoing HIV testing. Subjects undergoing HIV testing will be enrolled at three sites in the greater Durban area. These sites comprise two hospital-affiliated outpatient departments and primary health clinics served by a mobile health van. Routine TB screening, regardless of signs or symptoms, will be offered to all HIV-infected participants. HIV-infected participants will be randomized to determine whether they will be assigned to a health system navigator or will receive the current standard of care in Durban. Block randomization will be stratified by site and gender, with blocks of varying length.

The health system navigator will help patients identify barriers to entering care and devise solutions, optimize use of available resources, and serve as a trusted social supporter who is knowledgeable about the health care system but remains outside of it. The health system navigator will help subjects engage the HIV and TB care system through face-to-face contact, telephone conversations, and short messaging service SMS text reminders which are free for patients to receive. These phone contacts and SMS will follow a standardized protocol. We will evaluate the efficacy of the intervention, as measured by increased rates of antiretroviral therapy (ART) initiation and, for those with TB co-infection, TB treatment completion. We will also evaluate the cost and cost-effectiveness of this intervention.

Eligibility Criteria:
Inclusion Criteria:

* English or Zulu speaking
* Presenting for outpatient care
* Voluntarily undergoing an HIV test
* Able to give informed consent
* Report no prior HIV test
* Willing to share HIV and TB test results with research staff

Exclusion Criteria:

* Pregnant
* Lying in a stretcher
* Not oriented to person, place and time
Study to Measure the Effect of Part Time Versus Full Time Orthodontic Appliance Wear

The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring following wear of a twin block functional appliance (removable brace which postures the lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing time periods.

Functional appliances are ordinarily worn full time in adolescence between 11 and 14 years with a discrepancy between their upper and lower jaws. The reason it is worn between these ages is to avail of the pre pubertal growth spurt, evidence for full time wear is merely empirical.If this appliance only had to be worn part time it would have a significant change in orthodontics in terms of patient acceptance and compliance.The investigators plan on recruiting 84 patients to the study and these subjects will be referred from hospital colleagues. The investigators will randomly allocate the subjects into 2 groups, Group 1 will wear the appliance Full Time(24hours), group 2 will wear the appliance part time(12hours).

The study will be conducted in the Dental Institute at the Royal London Hospital, this hospital setting will be the sole site.

The study will last for 15 months from the time the last patient is recruited. Participants will undergo an initial records appointment where a radiograph and clinical measurements will be taken followed by 12 months of functional appliance treatment where the patient will be reviewed at 6-8weekly intervals and clinical measurements taken.A final radiograph will be taken at 15months.

Eligibility Criteria:
Inclusion Criteria:

* Class II div 1 malocclusion(upper front teeth lying more forward than lower front teeth with upper front teeth proclined),
* Overjet(horizontal difference between upper and lower front teeth) measuring minimum of 7mm,
* Male subjects 12--14 years at the start of treatment,
* Female subjects 11--13 years at start of treatment,
* Willingness of the patient and parent to participate in the study.

Exclusion Criteria:

* No previous orthodontic treatment
* No relevant medical history or craniofacial syndrome
Insulin Glargine Versus Twice-Daily NPH

To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly NPH insulin alone.

Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when compared to twice-daily NPH insulin is not known when used in low-income ethnic minority patients. This study investigates whether insulin glargine may be more or less effective and safe than twice-daily NPH insulin in this population.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-75
* Type 2 diabetes diagnosed for at least 1 year
* Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on stable and maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime injection of NPH insulin
* Except for the subject's current bedtime NPH insulin, no other past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
* Average fasting plasma glucose level \<130 mg/dL without fasting hypoglycemia
* Hemoglobin A1c between 7.5% and 12%
* Body mass index (BMI) between 20 and 40 kg/m2

Exclusion Criteria:

* History of confirmed (or clinical suspicion of ) type 1 diabetes
* Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception.
* Current pregnancy or lactation.
* Subjects for whom intensive insulin therapy is contraindicated
* Subjects with advanced proliferative diabetic retinopathy
* Subjects who are unable to stay on a consistent daily meal schedule
* History of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult.
* Subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study
* Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
* Subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.
Sensorimotor Training Versus Resistance Training in Patients With Knee Osteoarthritis

People with knee osteoarthritis (OA) have functional instability and defective neuromuscular function, it was recently suggested that sensorimotor exercises may be important and needed to improve the effectiveness of training programs for these patients. This study objective was to compare the effectiveness of a supervised resistance muscular training (RT) versus sensorimotor training (SMT) for patients with Knee OA, on decrease of pain and functional improvement.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with tibiofemoral osteoarthritis;
* Both genders;
* Age\> 50 years \<75 years;
* Completion of clinical and radiological criteria of the American College of Rheumatology (ACR) criteria for knee OA;
* No physical activity in the previous 3 months;
* Education level from the 4th grade of primary school.

Exclusion Criteria:

* uncontrolled hypertension;
* decompensated diabetes mellitus;
* uncontrolled thyroid diseases;
* cardiorespiratory disease (ischemia, arrhythmia, chest pain, or exercise-induced bronchospasm), liver abnormalities;
* Patients with grade IV functional limitation that needed devices to walk(Kellgren-Lawrence radiographic classification);
* Patients in a period of sick leave by the INSS or any other related factor;
* Other rheumatic diseases.
Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection

This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on enhancing host resilience to the effects of viral influenza infection in humans.

This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on increasing host resilience against the pathogenic effects of influenza virus infection in normal and immune compromised individuals by measuring a biomarker profile designed to reflect immune components associated with antiviral natural killer cell numbers and activity, cytotoxic T cell numbers, vaccine-related flu-specific antibody responses and cytokine profiles associated with host antiviral innate and adaptive immune responses.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-59 (study group 1) or ages 65 and above (study group 2)
* Any chronic illness must be determined (by PI team) to be stable as evidenced by no changes in medical regimens within 30 days of enrollment.
* Ability to comprehend the specific activities required to participate in the trial for which the participant is to be enrolled.

Exclusion Criteria:

* Any acute illness or significant injury within 30 days of enrollment.
* Specific disease entities, which, in the opinion of the PI, could reasonably be assumed to have dysfunctional immune function as a component of their illness. These include HIV, AIDS, uncontrolled asthma, uncontrolled eczema, uncontrolled allergic rhinitis, uncontrolled urticaria, Rheumatoid arthritis, lupus, inflammatory bowel disease, multiple sclerosis, Type-1 diabetes mellitus, Guillain-Barr syndrome, Grave's disease, Hashimoto's thyroiditis, myasthenia gravis or vasculitis.
* Active autoimmune diseases regardless of clinical stability. A history of autoimmune disease that is not considered active (i.e. no medical therapy for at least 1 year prior to enrollment) will not be excluded.
* History of unstable chronic illness within 30 days of enrollment.
* Unable/unwilling to commit to multiple research clinic visits which will be described in detail.
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria

* Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis) as judged by the Investigator.
* Male and women of non-childbearing potential (WONCBP)

Exclusion Criteria

* History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or central nervous system (CNS) infections (e.g., meningitis)
* History of clinically significant hypersensitivity or allergic reactions
* Abnormal blood pressure
* Abnormal pulse rate
* History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities
* Positive test for drugs of abuse or alcohol
* Evidence of human immunodeficiency virus (HIV) infection
* Presence of hepatitis B surface antigen (HBsAg) or positive HCV antibody test result at screening or within 3 months prior to starting study treatment
* Participants who regularly smoke more than 5 cigarettes daily or the equivalent and are unable or unwilling not to smoke during the in-house period
A Trial of Prednisolone in Combination with SPI-62 or Placebo in Subjects with Polymyalgia Rheumatica (PMR)

This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR.

This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR. Up to 6 cohorts of 12 participants could be recruited (12 to 72 participants). Each participant who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a screening period up to 28 days (Day -28 to Day-1), a 4-week treatment period (Day 1 to Day 28) and a follow up Period (Day 29 to Day 56). During the 4-week treatment period for the first cohort, all participants will receive prednisolone 10mg per day for 4-weeks plus SPI-62 for 2-weeks and matching placebo for 2-weeks. For cohorts 2 through 6, the dose of prednisolone co-administered with SPI-62 could be adjusted. For cohorts 5 and 6, the dose of SPI-62 could be adjusted.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Diagnosis of PMR according to EULAR/ACR classification criteria
* Absence of PMR relapse based on symptoms and acute phase markers
* Daily oral prednisolone 10mg dose that will have been stable for at least 1-week at the Baseline visit and is expected to remain stable during the treatment period

Exclusion Criteria:

* Any contraindication for prednisolone administration.
* A diagnosis or any clinical features of giant cell arteritis.
* Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR.
* Use of medications for treatment of PMR within specified intervals prior to the Baseline Visit other than oral prednisolone.
* Use of other medications likely to interfere with trial assessments.
* History or diagnosis of endogenous hypercortisolism.
* Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results.
African American Depression Intervention Trial (AADI)

Primary Aim 1: Examine effectiveness of the Oh Happy Day Class (OHDC) compared to the Coping With Depression (CWD)in increasing retention, adherence, engagement, satisfaction, and treatment-seeking. The investigators hypothesize the OHDC compared to the CWD will result in greater increases in: 1a. retention, 1b. adherence, 1c. engagement, and 1d. satisfaction at the middle and end of the intervention, and 2.e. greater increase in treatment-seeking 3-, 6-, 9-, and 12- months post-intervention. Outcome measures: logs: attendance, homework completion, class-participation level; Client Satisfaction Inventory; and Cornell Service Index. Primary Aim 2: Examine effectiveness of the OHDC in reducing symptoms of depression at the middle and immediate end of the intervention, and 3-, 6-, 9-, and 12- months post-intervention. The investigators hypothesize the OHDC will result in greater reduction in depressive symptoms compared to the CWD at 3-months post-intervention. Outcome measures: Center for Epidemiologic Studies Depression Scale and Quick Inventory of Depression Symptoms. Secondary Aim 3: Examine the effectiveness of the OHDC in improving self-reports of mental and physical health status and reducing self-reports of perceived disability. The investigators hypothesize the OHDC compared to the CWD will result in greater self-report of: 3a. improved mental and physical health status, and 3b. reduced self-report of disability at the immediate end of the intervention and 3-,6-, 9-, 12- months post-intervention. Outcome measures: SF-12 Health Survey, and World Health Organization Disability Assessment Schedule.

Public Health Impact: Based on CAI research, the OHDC has the potential to be four times more effective than the CWD. If our hypotheses are proven, the OHDC will be the first evidence-based culturally adapted depression intervention designed specifically for African American men and women between the ages of 30-60.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria. Self-identified African-American men and women, between the ages of 30 to 60, with symptoms of depression as evidenced by data from the Composite International Diagnostic Interview 2.1 (CIDI). Although age of inclusion is broad, our pilot studies have shown positive outcomes with mixed aged groups

Exclusion Criteria:

* Exclusion criteria. Individuals will be excluded from the study if they have: (1) self-reported alcohol or other drug abuse/dependence, (2) major psychotic illnesses, such as schizophrenia as evidenced by results of the CIDI, (3) self-reported changes in antidepressants (dosage or type) less than 6 weeks prior to participating in the study, (4) self-report of current psychotherapy treatment, or (5) self-report of current suicidal ideations (our psychiatrist will conduct additional suicide risk assessment and facilitate referral for appropriate care.
Alterations of Gut Microbiota and Serum Biochemical Markers in DILI Patients

Drug-induced liver injury is a leading cause of acute liver failure worldwide and one of the least understood areas in hepatology research. Increasing evidence has shown that drug-induced liver injury is associated with gut microbiota.

Background:

Drug-induced liver injury(DILI) refers to the liver injury induced by all kinds of drugs and is the leading cause of acute liver failure worldwide. China has a large population base and a wide variety of clinical drugs, and it is common for the population to use drugs irregularly. Therefore, the incidence of DILI is increasing year by year. The pathogenesis of DILI is complicated, and there are often multiple mechanisms successively or altogether. As a result of the same effect, it is particularly important to study the pathogenesis of DILI and find its therapeutic target. Increasing evidence shows that DILI is related to the gut microbiota, which provides broader insights and opportunities for understanding and treating this disease.

Aims:

We aim to map the alterations of gut microbiota and serum biochemical markers in patients with DILI, and to investigate the effects and mechanisms of key strains on the development of DILI, providing a theoretical basis and potential targets for its treatment.

Methods:

Patients who meet the inclusion criteria will sign informed consent, their demographic data, clinical labs, serum, and feces will be collected at baseline. Fecal samples will be subject to 16S rRNA amplicon sequencing. Serum samples were taken for metabolomics detection.

Anticipated Results:

Compared to the healthy control group, patients with DILI will suffer from gut microbiota dysbiosis and have more microbes and microbial genes associated with inflammation and injury. The levels of serum biochemical markers are associated with the severity of DILI.

Implications and Future Studies:

Results of altered gut microbiome and serum biochemical markers could provide potential targets for manipulating intestinal microbiota to prevent or treat DILI.

Eligibility Criteria:
Inclusion Criteria:

1. The group of DILI:

1. aged \>18 years;
2. patients who meet the diagnostic criteria of DILI in Guidelines for Diagnosis and Treatment of Drug-induced Liver Injury;
3. history of taking hepatotoxic drugs;
4. with relatively complete clinical data and good compliance.

2. The group of healthy control:

1. aged \>18 years;
2. no history of liver disease and other diseases.

Exclusion Criteria:

1. with hepatocellular carcinoma (HCC) or hepatic metastases;
2. combined with infectious liver diseases, such as hepatitis A virus, hepatitis B virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, and human immunodeficiency virus (HIV);
3. combined with non-infectious liver diseases, such as non-alcoholic fatty liver disease, alcoholic liver disease, autoimmune liver disease, immunoglobulin G4-related liver disease, Wilson's disease, alpha 1-antitrypsin deficiency, Budd-Chiari syndrome, and other congenital liver diseases;
4. combined with severe organic lesions of other organs;
5. pregnant and lactating women.
Comparison Between Two Methods of Oral Care on the Incidence of VAP

Patients on ventilator are in high risk to develop ventilator associated pneumonia (VAP). This acquired infection significantly increases morbidity and mortality of these patients.

Studies that investigated the factors influencing the incidence of VAP proved that infectious agents located in the throat and oral cavity are important factors.

The assimilation of oral cavity treatment, including teeth brushing, cleaning and removal of secretions may significantly decrease the incidence of VAP. Choosing the method of oral cavity cleaning is based on few studies that demonstrated the optimal influence of combining mechanical cleansing, the use of a non alcoholic antiseptic material and lubrication of the lips and the oral cavity. Most of these studies are retrospective. The study will compare the traditional method of oral cavity treatment with the use of protocol that use special suction connected toothbrush to clean the teeth and the oral cavity, use of non alcoholic antiseptic solution and lubrication of the lips and the oral cavity.

The current study is a prospective, open label, statistically balanced study that will investigate the connection between the method of oral cavity treatment and the incidence of VAP. 100 patients will be included.

All ventilated patients in the ICU will be eligible and will be included after an informed consent will be signed by the patient, or by his legal guardian. Exclusion criteria include age less than 18 y/o, pregnancy, expected survival of less than 48 hours, immunosupression (excluding patients on steroids), severe burns, existing pneumonia and patient already included in another study.

The main outcome will be 30 days all cause mortality. Secondary outcomes include the development of VAP, days on ventilator, LOS in the ICU and LOS in the hospital.


Eligibility Criteria:
Inclusion Criteria:

* All ventilated patients in the ICU
* Older than 18 y/o

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Immunosuperessed patients
* Expected survival of less than 48 hours
* Burns
* Existing pneumonia