cyrilzakka/clinical-trials huggingface dataset:
Smart Linkage-to-HIV Care Via a Smartphone App

This randomized controlled trial evaluates the provision of individual patient laboratory results to newly diagnosed HIV positive smartphone users through a secure application (app) as a method to get them linked to and retained in care, and engage with educational materials purposefully developed to explain their results. Message prompts will also be used to alert patients that their results are ready and provide information on how to link to care, and assistance to re-link to care if they fall out of the health system for any reason. Prompts will be sent to patients to remind health care workers if they are due for repeat laboratory monitoring. The primary endpoint is linkage to care (a HIV-related laboratory test) at 6 months. The control group received standard of care.

This evaluation of a newly designed smartphone application (app) for linkage to care, HIV treatment adherence and retention in care, is taking place at five Johannesburg health facilities. Intervention allocation is random with individuals either receiving the smartphone app or standard of care. The trial is motivated by evidence from elsewhere that sending lab results via app acceptable, and loss of patients in need of HIV care can be reduced with mobile Health interventions. There is a growing number of smartphones in South Africa (at the time of baseline assessment, about 40% of the surveyed population had an Android smartphone with data, and the majority of new phones are smartphones). The trial's objectives are: a) Test whether routine linkage to HIV care at public sector services is improved by providing HIV positive clients with a smartphone-enabled app when compared to standard of care; b) Determine HIV treatment initiation rates between intervention and control arm; c) Test the feasibility and acceptability of receiving lab results via app; d) Assess secondary effects from improved participant information, including return rates after falling out of care, participant satisfaction, and rates of repeat blood tests; e) Determine knowledge levels on HIV care; and f) Assess the effect in priority groups for better linkage to care (male HIV cases and HIV positive youth). If data allow, a cost-benefit analysis will also be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed HIV positive clients presenting at selected public health facilities, irrespective of CD4 count
* Access to an Android smartphone with data
* Willing to pay the (very small) cost to access their laboratory result
* Age - 18 years and older
* Proof of ID/passport/refugee number (for identification/security, and to confirm the single patient identifier)
* Can read English or Zulu
* Ability and willingness to sign informed consent

Exclusion Criteria:

* Clients presenting for antenatal care services, as these women will be enrolled in the national MomConnect program
* Refusal to participate
Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812

The purposes of this study are to determine if there is a difference in how SB-773812 is distributed through the bloodstream before and after multiple doses of ketoconazole have been given and to determine if there is a difference in how safe and well tolerated SB-773812 is when given on its own and given with ketoconazole.


Eligibility Criteria:
Inclusion criteria:

* Healthy
* Body Weight \>/=50kg and BMI 18.5-29.9 kg/m2 inclusive
* Normal 12-lead ECG, physical examination and lab screen

Exclusion criteria:

* A history of psychiatric illness,
* A history or presence gastro-intestinal,
* A hepatic or renal disease or orthostatic hypotension.
FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

The goal of this clinical trial is to learn about treatment with fresh frozen plasma (FFP) in individuals with moderate to severe traumatic brain injury. The two main question\[s\]it aims to answer are:

* Is the FFP treatment safe?
* Does the FFP treatment impact the 24-hour, 3-month and 6-month outcomes, intensive-care free days, mortality, and hospital brain and physical function at discharge. Patients with moderate to severe TBI will randomly receive either:

  * Standard of care treatment
  * Standard of care treatment + 2 units of FFP. Researchers will compare participants receiving standard of care treatment to those receiving experimental fresh frozen plasma (FFP) treatment to see if the FFP is safe and beneficial to participant outcomes.

The two units of fresh frozen plasma will consist of 400-500 ml. The 24-hour, 3-month and 6-month outcome measures include hemorrhagic progression of contusion (HPC) measured on 24-hour follow-up CT scan, the Disability Rating Score (DRS), 24-hour Glasgow Coma Scale (GCS) and the 3-month and 6-month Extended Glasgow Outcome Score (GOS-E).

A third sub aim of the trial is to establish peripheral blood biomarkers, and radiographic features on the initial cross- sectional imaging, that could identify the optimal target population and predict the response to treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between the ages of 18 and 65 years
2. Moderate to severe TBI: GCS 3-12
3. Cerebral contusion confirmed on the initial CT scan with Brain Injury Guidelines (BIG) = 3 (corresponding to lesion ≥ 8 mm )

Exclusion Criteria:

1. Persons with a known history of adverse reaction to plasma products.
2. Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen.
3. Persons who are currently incarcerated.
4. Persons with inadequate venous access.
5. Treatment cannot start within 1 hour of arrival at the hospital.
6. The time of injury is unknown.
7. Non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon.
8. Interfacility transfers
9. Class 3 hemorrhagic shock
10. Persons with known "do not resuscitate" orders prior to randomization
11. Persons who refuse the administration of blood products
12. Persons with a research "opt out" bracelet
13. Persons who require FFP for any other indication (e.g., reversal of coagulopathy)
Effect of Galactose Ingestion on Postprandial Lipemia

This study aims to assess the postprandial triglyceride response to the ingestion of a high-fat meal with co-ingestion of either galactose, or glucose.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 18 to 35 years old
* Body mass index \<30 kg/m2

Exclusion Criteria:

* Female
* Body mass index \>29.9 kg/m2
* Any history of metabolic disease
* Allergies or intolerances to milk and/or cream
WSO BEAT STROKE Initiative

The WSO Brain and hEart globAl iniTiative - STROKE (BEAT-STROKE) is a cluster randomized controlled trial, testing whether an educational and implementation Neurocardiology tool can improve adherence to best practice recommendations for secondary stroke prevention of cardioembolic strokes, as defined by the WSO Systematic Review and Synthesis of Global Stroke Guidelines or more recent high-quality evidence published after the last stroke guidelines1

The World Stroke Organization (WSO) Brain and Heart Task Force developed The Brain \&amp;amp; hEart globAl iniTiative (BEAT), a pilot feasibility program aimed at establishing clinical collaborations between cardiologists and stroke physicians.1 The WSO BEAT pilot project focused on atrial fibrillation (AF) and patent foramen ovale (PFO) detection and management, highly prevalent cardioembolic causes of ischemic stroke and transient ischemic attack (TIA).

The pilot feasibility WSO BEAT program comprised 10 sites from 8 countries, including Brazil, China, Egypt, Germany, Japan, Mexico, Romania, and the USA. Of the 10 sites, two belonged exclusively to the public sector and one was public and private. The primary objective of the pilot WSO BEAT program was to assess its feasibility by achieving a composite feasibility outcome including: (1) developing site-specific clinical pathways for the diagnosis and management of AF, PFO, and the stroke heart syndrome; (2) establishing regular Neurocardiology rounds (e.g., monthly, bimonthly, etc.); and (3) incorporating a cardiologist to the stroke team.

Overall, the WSO BEAT program successfully achieved the pre-specified goals at most sites. Regarding the three primary program objectives, 9/10 (90%) of the sites were able to design or update the proposed clinical care pathways, establish Neurocardiology rounds, and designate a dedicated cardiologist for the stroke team, respectively.

To date it is unknown whether the implementation of Neurocardiology educational tools and collaborations between cardiologists and neurologists can improve adherence to best practice recommendations focused on the management of cardioembolic strokes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic stroke or TIA of any etiology.

Exclusion Criteria:

* N/A
Suture Versus Glue (Dermabond) Closure During Cesarean Delivery

To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome.

Women undergoing planned CS were randomized to either intracutaneous suture closure or glue closure using a 1:1 allocation algorithm. Participants and outcome assessors were blinded to group allocation. Scar evaluation was performed after two months.

Primary outcome measures were Patient and Observer Scar Assessment Scale (POSAS) summary scores 2 months after surgery. Secondary outcome measures were, duration of surgery, and development of hematoma, seroma, surgical site infection (SSI) or wound disruption.

Data were analyzed according to the intention to treat principle.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 18 and 45 years
* Elective cesarian section

Exclusion Criteria:

* Clinical signs of infection at the time of CS
* History of keloids and a medical disorder that could affect wound healing
* Hypersensitivity to any of the suture materials used in the protocol
* Diabetes mellitus
* Disorders requiring chronic corticosteroid use or immunosuppression
Major Depression and Inflammatory Risk Markers for Coronary Heart Disease

The overall purpose of this research is to examine whether depression influences immune system function. Studies indicate that individuals who are depressed experience coronary heart disease at a higher rate than expected. This study's goal is to begin identifying mechanisms that might be responsible for this process. This research also examines whether behavioral processes (e.g. smoking) or hormonal processes (e.g. adrenaline release) are responsible for immune system differences between depressed and nondepressed people

To qualify for participation, subjects are to be between the ages of 18-55, medically healthy and free of all medication three months prior to enrollment. Half of them will be clinically depressed; the remaining one half will be healthy controls without a history of psychiatric illness. All subjects who qualify for the study will attend two laboratory sessions. During the first visit, participants will undergo a structured psychological interview, complete questionnaires about their mood, personality, and behavior, and have blood drawn to assess their immune system function. During the second visit, participants will complete additional questionnaires about their mood, personality, and behavior. The subjects will also participate in a mock job interview to look at their body's response to stress. Before and after the interview, the subjects will have blood drawn and be asked to collect saliva samples to assess their immune system function. In addition to the two laboratory visits, participants will be asked to collect additional information while going about their normal activities. In order to accomplish this, they will be given a small hand held portable computer. Four times each day for four days, the computer will signal them to collect a saliva sample. This will be used later to measure hormone levels. This study will explore changes in the immune system and metabolic system that might predispose depressed individuals to develop heart disease

Eligibility Criteria:
For eligibility, potential subjects will be 18-55 years of age, free of all medication during the past three months, and have no history of chronic illness involving the cardiovascular, endocrine, immune systems
Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension

Current recommendations today suggest that use of therapeutic lifestyle changes, such as supplementation with specific dietary components and moderate exercise, are appropriate interventions for individuals with borderline high blood pressure. Dietary intervention with natural products, such as flaxseed, is associated with decreased prevalence of cardiovascular disease (Adolphe 2010). Lignans are the active compounds in flaxseed believed to mediate the cardiovascular health benefits following flaxseed consumption (Peterson 2010). Clinical trials indicate benefit of Flax Lignan Enriched Complex (FLC) (BeneFlax® from Archer Daniels Midland, a natural product derived from flaxseed composed of 34-38% lignan) for reducing blood cholesterol and glucose (Pan 2007; Zhang 2008) and blood pressure (Cornish 2009). Furthermore, a recent study in atherosclerosis patients showed significant clinical benefit of flaxseed meal for reducing blood pressure (Rodriguez-Leyva 2013). As a therapeutic lifestyle change that could prevent a need to introduce drug therapy in elderly patients, the effectiveness of FLC supplementation alone or in combination with moderate exercise merits investigation.


Eligibility Criteria:
Inclusion Criteria:

* High normal blood pressure (130/85 - 139/89) or stage I hypertension (140/90 - 150/90)
* Ability to follow simple instructions

Exclusion Criteria:

* Age below 60 years.
* Individuals living in long term care homes.
* Individuals unable to walk for 30 minutes.
* Unstable diabetes, or diabetics taking insulin (note: eligible diabetic participants will undergo additional testing during the study ).
* Current cancer or diagnosed with cancer in the past 2 years.
* Significant liver or other gastrointestinal disorder including inflammatory bowel disease. (While constipation is the most common gastrointestinal problem in the elderly, it would not be a contraindication)
* Significant kidney disorder.
* Have taken oral antibiotics in the past three months
* Unstable or severe cardiac disease, recent myocardial infarction, or stroke (either in past 6 months or significantly affecting physical mobility).
* Unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder.
* Migraine with aura within the last year (as this is a risk factor for stroke).
* Current diagnosis of a bleeding condition, or at risk of bleeding.
* Significant immune-compromise.
* Current use of hormone replacement therapy (except thyroid).
* Current use of blood pressure medications and/or diuretics
* Current use of flax seed supplement
* Participation in any other clinical trial with an investigational agent within one month prior to randomization.
Effectiveness of Video Monitoring and Care Transition for Heart Failure Patients (EVIT-HF): Randomized Clinical Trial

The goal of this clinical trial is to measure the effectiveness of video monitoring associated with the transition of care for patients with heart failure.

The main questions it aims to answer is: Is video monitoring superior to monitoring via audio calls in patients with heart failure?

Researchers will compare monitoring by video to a monitoring by audio to see if drug videomonitoring works to improve selfcare in heart failure and other outocomes.

Participants will:

intervention group receive video calls guided by cardiologist nurses at 7, 30, 60, 180 and 365 days after hospital discharge.

the control group will receive audio calls for data collection, at the same time mentioned.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older;
* Admitted for decompensated HFrEF
* Ejection fraction less than 40% confirmed by echocardiogram performed in the last 3 months
* Who access to a mobile device with internet access

Exclusion Criteria:

* heart transplant waiting list;
* who had undergone coronary artery bypass in the last 3 months ;
* who were in palliative care;
* who had a life expectancy of less than 1 year
NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment

NeuroN-QI aims to evaluate the effects of an intervention consisting of periods of: 1) parents/preterm infants skin-to-skin contact and auditory stimulation by the parents's voice and 2) calm without manipulation with olfactory stimulation with breast milk in the incubator/bed both combined with appropriate light and noise levels to promote neurodevelopment preterm infants.


Eligibility Criteria:
Inclusion Criteria for preterm infants:

* born between 24 and 33 6/7 weeks GA;
* ready for SSC

Inclusion criteria for mothers and fathers:

* agree to do at least one SSC session/week combined with 10 min of auditory stimulation until 36 weeks of GA of their preterm infant;
* mothers express breast milk for their preterm infants

For twin births (twin pregnancies), fathers will also be invited to participate in the study, so that both infants can participate in the study.

Exclusion criteria for preterm infants:

* congenital anomalies or genetic disorders
* intraventricular hemorrhage \> grade II
* are small for GA defined as birth weight \<10th percentile
* on postnatal day 19 (maximum days targeted for study start)
* are still receiving analgesics, sedatives, paralyzing agents
* are under mechanical ventilation

Exclusion criteria mothers and fathers:

* are aged \<18 years;
* have a physical condition that does not allow the SSC
* abuse illicit substances or alcohol that could influence stress, anxiety and parent- child interactions
* feed their preterm infant exclusively with commercial infant formula
* mothers had a breast surgery that could influence their breast milk production
* do not speak, read or write in French or in English
Detecting Circulating Emboli in Patients with Acute Venous Thromboembolism

The purpose of this study is to further evaluate and adjust the photoacoustic flow cytometry device and its use in detecting circulating emboli.

Study Design: Cohort 1: Normal healthy volunteers will be enrolled to further adjust the device settings. Cohort 2: Use the Phatoacoustic flow cytometry (PAFC) to detect circulating emboli in vivo in patients with venous thromboembolism at diagnosis, during and after anticoagulation therapy.

Laser beam from the investigational device Phatoacoustic flow cytometry PAFC will be applied to skin and underlying blood vessels. The optical and ultrasound signal will be collected for analysis. On each tested vessel, we will estimate the vessels diameter (using optical or/and ultrasound imaging). The subject's skin pigmentation will be classified as light, medium, or dark. A photoacoustic (PA) contrast will be considered usable for detection of circulating emboli if the photoacoustic signal from the vessels is more than 1.3-fold higher than the photoacoustic signal from surrounding tissue. The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. D-dimer test will be performed on each time point as part of their normal standard of care however if the D-dimer test is not ordered as part of the standard of care it will be required for the study.. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.

Eligibility Criteria:
Inclusion Criteria Cohort 1:

* Age 18 years and older
* Willing to adhere to protocol.
* Signed informed consent

Exclusion Criteria Cohort 1:

* Unable to provide informed consent.
* History of venous thromboembolism.
* Currently receiving anticoagulant therapy.

Inclusion Criteria Cohort 2:

* Ages 18 years and older
* Confirmed new diagnosis of acute venous thromboembolism.
* performance status of equal to or less than 2.
* Able to receive anticoagulation therapy.
* Willing to adhere to specific protocol requirements.
* Signed informed consent.

Exclusion Criteria Cohort 2:

* Life threatening venous thromboembolism.
Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of Apatinib for patients with Relapsed Refractory Diffuse Large B Cell Lymphoma.

Patients with relapsed /refractory diffuse large B cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. Apatinib is a new type of oral tyrosine kinase inhibitor targeting VEGFR-2.The investigators have been proceeding this trial to evaluate the efficacy and safety of Apatinib in the patients with relapsed refractory diffuse large B cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Age range 14-70 years old; ECOG performance status 0-2.
* Estimated survival time \> 6 months.
* Histological confirmed diffuse large B cell lymphoma.
* Have taken first-line chemotherapy regimen and failed.
* None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal.
* At least one measurable lesion.
* None of other serious diseases, cardiopulmonary function is normal.
* Pregnancy test of women at reproductive age must be negative.
* Patients could be followed up.
* None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
* Volunteers who signed informed consent.

Exclusion Criteria:

* Disagreement on blood sample collection.
* Patients allergic of any of drug in this regimen or with metabolic disorder.
* Pregnant or lactating women.
* Serious medical illness likely to interfere with participation.
* Serious infection.
* Primitive or secondary tumors of central nervous system.
* Chemotherapy or radiotherapy contraindication.
* The evidence of CNS metastasis.
* History of peripheral nervous disorder or dysphrenia.
* Patients participating in other clinical trials.
* Patients taking other antitumor drugs.
* Patients estimated to be unsuitable by investigator.
Behavioral Intervention in Reducing Indoor Tanning

This randomized clinical trial tests the efficacy of a behavioral intervention works in reducing indoor tanning. Artificial ultraviolet indoor tanning increases the chance of developing skin cancers. Behavioral interventions use techniques to help participants change the way they react to environmental triggers that may cause a negative reaction.

PRIMARY OBJECTIVE:

To develop and evaluate an online tailored indoor tanning (IT) intervention based on findings from phase 1.

OUTLINE:

INTERVENTION: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks.

GROUP II: Participants are placed on wait-list and may receive full intervention after follow-up.

After completion of study, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Use of IT at least 25 times in the past year
* Women