cyrilzakka/clinical-trials huggingface dataset:
Antiretroviral Adherence and Drug-level Monitoring

This observational study aims to investigate medication adherence and drug-level monitoring of antiretroviral agents in a cohort of people living with HIV in Indonesia. The study is conducted in outpatients receiving tenofovir-based regimens in a university medical centre.

Optimal adherence is critical to achieve and sustain viral suppression. Currently, there is no gold standard measure of antiretroviral adherence and exposure in clinical practice. Recent studies have evaluated the use of emerging biological matrices such as dried blood spots, urine, and saliva as means of objective adherence measures. For drug-level monitoring, tenofovir is selected as a drug of interest and thus only people receiving tenofovir disoproxil fumarate-based regimens will be monitored. Some studies have reported that higher plasma trough concentrations of tenofovir were associated with renal toxicity. Therefore, this project aims to measure level of adherence and tenofovir concentrations in plasma and emerging matrices among people living with HIV in Indonesia. Primary outcome is adherence to ART that will be measured using multi methods, including self-report questionnaire, pill counting, electronic monitoring, and drug-level testing. Secondary outcomes include tenofovir concentrations in plasma, urine, saliva, and dried blood spots and clinical outcomes (viral load and CD4 count). Assays for measuring tenofovir concentrations will be developed using high-performance liquid chromatography-tandem mass spectrometry. Concentrations derived from dried blood spots, saliva, and urine will be compared to plasma concentrations. Pharmacokinetic models will be used to interpret drug-level monitoring. The association of adherence measures as well as drug concentrations and clinical outcomes will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Adults with HIV who have been receiving antiretroviral therapy containing tenofovir-based regimens for at least six months

Exclusion Criteria:

* Pregnant and breastfeeding women, people with kidney failure, undergoing hemodialysis or peritoneal dialysis, uncontrolled diabetes, uncontrolled hypertension, and hypersensitivity to tenofovir
Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage

To determine the effectiveness of using two medications simultaneously versus one medication, as is standard of care, in preventing early postpartum hemorrhage.

There have been studies that looked at giving two medications and that there were reduced odds of postpartum hemorrhage.

Specific Aim 1: Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in reducing postpartum hemorrhage.

Specific Aim 2: Determine any potential side effects of a double simultaneous uterotonic agentregimen (misoprostol and oxytocin) versus a single agent (oxytocin only).

Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality in the world, accounting for a quarter of all maternal deaths globally. Most cases of PPH can be attributed to uterine atony, failure of the uterus to contract in the immediate postpartum period. Efforts to prevent uterine atony and thereby PPH have focused on active clinical management of the third stage of labor (the period between delivery of the infant and placenta) and the administration of uterotonic agents (medication that induces uterine contraction). Universal standard of care to prevent postpartum hemorrhage, according to the American College of Obstetrics and Gynecologists and World Health Organization includes various dose infusions of oxytocin. Additional uterotonics are given if necessary, according to noted blood loss and uterine tone. The best uterotonic(s), combination, route, and dose, however, remain actively debated. Randomized controlled trials have not proven that misoprostol is superior to oxytocin or methergine to treat postpartum hemorrhage, but it is a medication that is often used conjunctively or after other agents fail. A Cochrane review of treatment of primary postpartum hemorrhage revealed that oxytocin, ergot alkaloids (i.e., methergine), and combined oxytocin-ergot alkaloid administration were equally effective in preventing PPH in the general obstetric population, whereas prostaglandins alone (i.e., misoprostol) were not. In an effort to determine the benefit of a simultaneous double uterotonic agent regimen in the prevention of PPH, the investigators propose to conduct a controlled trial in which women will be randomly assigned to an intervention group (buccal misoprostol and intravenous oxytocin administered simultaneously) versus a control group (standard of care, intravenous oxytocin alone).

Eligibility Criteria:
Inclusion Criteria:

- All women 18 years and older admitted to delivery at Stony Brook University hospital who agree to participate in the study

Exclusion Criteria:

* Women under 18 years old
* Women with known coagulation disorders
* Women with planned cesarean hysterectomy
* Women with known placental accreta spectrum disorders
* Women with known allergy to prostaglandins
Photobiomodulation Therapy on Inflammatory Mediators on Low Back Pain

Low back pain (LBP) is ranked as one of the most prevalent health conditions. It is likely that some inflammatory mediators could be associated with pain and disability in these patients. Photobiomodulation therapy (PBMT) is a non-pharmacological therapy often used in patients with LBP that decrease release of inflammatory mediators and accelerate muscle repair in different muscle skeletal conditions, as mechanisms of action. The present research project aims to evaluate the effects of PBMT on systemic levels of inflammatory markers and levels of pain intensity in patients with chronic non-specific low back pain.

This is a randomized, triple-blinded (therapist, assessor and patient), placebo-controlled trial, with voluntary patients with non-specific chronic low back pain.

Eighteen patients will be randomly allocated to two treatment groups: Placebo or PBMT and one single session of treatment will be provided.

The data will be collected by a blinded assessor and the outcomes of interest it will be levels of inflammatory markers and pain intensity and it will be collected at baseline and 15 minutes after the single session of treatment.

The statistical analysis will follow the intention-to-treat principles. The findings will be tested for their normality using the Shapiro-Wilk test. Parametric data will be expressed as mean and standard deviation and non-parametric data as median and respective upper and lower limits. Parametric data will be analyzed by two-way repeated measures analysis of variance (ANOVA; time versus experimental group) with post-hoc Bonferroni correction. Non-parametric data will be analyzed using the Friedman test and, secondarily, the Wilcoxon signed-rank test.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month);
* with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale;
* aged between 18 and 65 years;

Exclusion Criteria:

* evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit);
* serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases);
* serious cardiovascular and metabolic diseases;
* previous back surgery;
* pregnancy.
* severe skin diseases (eg. skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
Occupational Hazards and Associated Health Effects Among Workers in Main Assiut University Printing Press

Occupational Hazards and Associated Health Effects among Workers in Main Assiut University Printing Press

Printing in its simplest forms has existed for thousands of years, in the form of signet rings, royal seals and punches used by gold and silver-smiths.

Each printing process is divided into 3 major steps: prepress, press, and post-press. Prepress operations include the composition, typesetting, graphic arts photography, assembly of images and preparation of image carrier. Press includes the actual printing operation. Post-press involves the assembly of printed materials, binding and finishing operations.

Workers in printing press are exposed to, chemical, physical, ergonomic, and psychological hazards.

Chemical hazards are the most serious one. due to exposure to lot of chemical substances such as organic solvents, inks, adhesives, organic and inorganic pigments, The most important chemical substances used are Volatile Organic compounds, and inks.

Exposure to these chemicals occurs through both inhalation and dermal contact, The Acute symptoms include dizziness, drowsiness, eye irritation,.etc. Long-term health effects may include damage of internal organs as liver, kidneys and lungs, brain, reproductive system, bladder etc.

Dermatitis is a common health effect among printing workers due to exposure to chemicals.

One of the intended components of inks, solvents, and cleaning agents form is Benzene, long term exposure to benzene cause blood disorders. It specifically affects bone marrow, thus leading to decrease in the erythrocytes and leukocytes production resulting in anemia, myeloid leukemia, thrombocytopenia.

Noise is health hazard to which those workers are exposed, it occurs during printing, binding, folding.

Ergonomic hazards are hazards among those workers in the form of serious accidents and musculoskeletal disorders.

Eligibility Criteria:
Inclusion Criteria:

* 1. Workers with more than one year work duration.
* 2. both sexes, males and females.

Exclusion Criteria:

- 1. Workers who have any blood health problems as blood cells disorders and bleeding disorders before they started working.

2. Pre-employment liver diseases and kidney diseases among those workers. 3. Workers with less than one year work duration.
Can 3D Kinematic Parameters Assess the Symptomatic and Functional Severity of KOA?

There is little study focusing on kinematic parameters in the assessment of the symptomatic and functional severity of knee osteoarthritis (KOA). The purpose of this study is to evaluate the correlations between kinematic parameters and the severity of symptoms and functions in patients with KOA.


Eligibility Criteria:
Inclusion Criteria:

1. age\> 50 years
2. body mass index\<30;
3. confirmed radiographically and assessed according to KL score;
4. knee pain in their knees at least three months;
5. absolute medial compartment KOA according to atlas criteria13;
6. able to walk unaided

Exclusion Criteria:

1. history of knee surgery;
2. Corticosteroid or Sodium Hyaluronate injection within 6 months;
3. neuropathic arthropathy or rheumatoid arthritis;
4. any other muscular or neurological diseases that affected the condition of the lower limbs;
5. any treatments or training (e.g. kneepad) to improve the symptoms of KOA;
6. history of foot/ankle/hip injury or disease;
7. unable to walk independently;
8. history of heart disease;
9. lateral KOA according to atlas criteria13;
10. body mass index\> 30;
11. age\> 90 years;
12. unable to finish the procedure
A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.

This single arm study will assess the efficacy and safety of Xeloda + oxaliplatin when given as first line treatment for patients with metastatic nasopharyngeal cancer. Patients will receive Xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7 days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* history of nasopharyngeal cancer and distant metastases;
* no previous chemotherapy in past 6 months;
* recovery from previous radiotherapy;
* ability to swallow and retain oral medication.

Exclusion Criteria:

* previous cytotoxic chemotherapy;
* radiotherapy within 4 weeks of treatment start;
* history of another malignancy within the last 5 years;
* clinically significant cardiac disease.
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery

The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.

All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Colorectal surgery

Exclusion Criteria:

* Pregnant women
* Black skin
* Chronic renal insufficiency (MDRD \<30 ml/min)
Evaluation and Correlation of Serum Fetuin-A Levels in Periodontal Health and Disease: A Clinico-biochemical Study

The present clinico-biochemical study was carried out to estimate the levels of Fetuin A and MMP7 in serum of systemically healthy subjects in periodontal health and disease and to evaluate the impact of periodontal interventional therapy (scaling and root planing) on the same.

Sixty sex-matched subjects (30 males and 30 females) belonging to a common age group (30-39 yrs) were enrolled for the study to eliminate bias from confounding factors. They were divided into three groups consisting of 20 subjects in each group based on the clinical and radiological parameters; Periodontally healthy (Group I), Chronic gingivitis (Group II) and chronic periodontitis ( Group IIIa) from whom serum samples were collected. The Group IIIb further comprised of the subjects from Group IIIa, who had received non-surgical periodontal therapy (scaling and root planing). Serum samples were collected at baseline and at 12 weeks post therapy. Fetuin A and MMP-7 concentration was determined from serum samples of patients using ELISA. The results of our study depicted that Fetuin A concentration negatively correlates, whereas, MMP7 positively correlates with the extent of periodontal inflammation. Further, Periodontal therapy demonstrated a significant increase in serum Fetuin A and decrease in MMP 7 levels establishing the influence of periodontal therapy in stabilizing their levels.

Eligibility Criteria:
Inclusion Criteria:

1. Age group of 30-39 years.
2. Systemically healthy subjects.
3. Patient who are co-operative and able to attend follow up.
4. Patient who have not received any periodontal treatment within the past six months of baseline examination.
5. Dentition with at least 20 functional teeth.

Exclusion Criteria:

1. Medically compromised patients (history of diabetes mellitus, liver diseases, cardiovascular disease, kidney diseases, rheumatoid arthritis, bone diseases pulmonary disease, viral and fungal infections).
2. Patients with calcification disorders (chronic kidney disease with vascular calcification, hyperparathyroidism, excessive intake of vitamin D, valvular calcific aortic stenosis
3. Aggressive periodontitis.
4. Bleeding disorders
5. Gross oral pathology and suppuration
6. Patients who had received antibiotic therapy and anti inflammatory within the last six months.
7. Anomalies of the immune system.
8. Pregnancy and lactation.
VisONE Heart Failure Study: Pilot

The VisONE HF pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering Asymptomatic Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™ implantable system for 12 months.

This 12 month study is intended to validate the early benefits observed with Asymptomatic Diaphragmatic Stimulation (ADS) as a primary form of heart failure therapy with low rates and severity of adverse effects. Medical refractory symptomatic heart failure patients with reduced ejection fraction and no evidence of arrhythmias or ventricular dysynchrony will undergo laparoscopic implantation of the VisONE™ implantable system comprised of a pulse generator and two leads, programmed to deliver cardiac-gaited diaphragmatic stimulation pulses at asymptomatic outputs. Patients will be followed in pre-specified durations of 1,3,6 and 12-months using a series of evaluations of hemodynamic, echocardiographic, heart failure status, diaphragmatic function, implanted system data and standard safety measures including adverse events, for comparison with their baseline values. The results are intended to be used for designing a subsequent larger study for performing statistical power calculations.

Eligibility Criteria:
Inclusion Criteria

* NYHA class II/III medical refractory despite guideline indicated heart failure medications
* Sinus rhythm with \<10% ectopy
* EF ≤ 35%
* NT-proBNP \> 500 (250 if on loop diuretics)

Exclusion Criteria

* 6MHW \>500 m or \< 200 m
* Resting HR \> 140 bpm
* SBP \<80 mmHg or \> 170 mmHg
* Serum creatine \> 2.5 mg/dL
* Ventricular dyssynchrony by ECG with QRS ≥ 140ms
* Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT, sustained VT or VF, or DCCV within 3 months
* Intermittent inotropic drug treatment
* Existing pacemaker or indications for a pacemaker
* Severe primary pulmonary disease including pulmonary arterial hypertension or severe COPD, or other respiratory or lung diseases where FEV \< 50% or any condition with severe diaphragmatic dysfunction
* Previous open laparotomy within 1 year or contraindications to laparoscopy, as determined by implanting physician
* Known or active intra-abdominal infections, or known intra-abdominal pathology
* Previous thoracic or abdominal organ transplant, transplant waiting list
* Pregnancy
Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)

This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.


Eligibility Criteria:
Inclusion Criteria:

* obese (body mass index \[BMI\] ≥30 kg/m² and ≤40 kg/m²) male participants and female participants of non-childbearing potential
* has been diagnosed with T2D (Panel B)
* is not actively participating in a weight loss program

Exclusion Criteria:

* has a history of clinically-significant disease (other than T2D)
* has a history of cancer
* has estimated creatinine clearance ≤60 mL/min
* is unable to refrain from or anticipates the use of any prescription or non-prescription medication
* consumes excessive amounts of alcohol or caffeine
* has participated in a previous omarigliptin study
Evaluation of the Public Health Impact of Seasonal Intermittent Preventive Treatment (IPT) in Children in Senegal

In areas of seasonal malaria transmission the burden of severe disease and mortality due to malaria is mainly among children under 5 years of age. Intermittent preventive treatment (IPT) with antimalarial drugs given to all children once a month during the transmission season is a promising new strategy for malaria prevention. Studies in Senegal, Ghana, Mali and The Gambia have shown this approach can be highly effective. In Senegal, seasonal IPT with sulfadoxine-pyrimethamine (SP) and one dose of artesunate resulted in a 90% reduction in incidence of clinical malaria in a recent trial in Senegal (Cisse et al., Lancet 2006). The purpose of the present project is to determine the public health impact and cost effectiveness of this intervention when it is delivered through the routine health service to communities in rural areas in Senegal. Demographic surveillance will be set up in the rural population of three districts (Mbour, Bambey and Fatick) which comprises approximately 540,000 people, including 100,000 children under 5 yrs, and is served by 54 health posts, as an expansion of the area covered by the existing DSS of Niakhar. Information about births, deaths and migrations, household characteristics such as socioeconomic status, and vaccination status of children and their use of bednets, will be recorded in 6-monthly rounds of all households. In selected areas, deaths among children under 10 years will be investigated using verbal autopsies. Over four years from September 2008 - November 2011, seasonal IPT (three monthly administrations of SP (sulfalene-pyrimethamine) plus amodiaquine during the transmission season each year to children 3-59 months of age) will be introduced gradually, in a step-wedge design, by 9 health posts in 2008, by an additional 18 posts in 2009, and another 18 in 2010 and 9 in 2011. At the end of each transmission season, a cross-sectional survey of 2400 children under 5 yrs of age, in which finger prick blood samples will be taken, will be used to estimate the prevalence of molecular markers of drug resistance to Plasmodium falciparum, the prevalence of anaemia and the nutritional status of children. Malaria incidence will be monitored by passive surveillance through health posts, health centres, and hospitals. Cost effectiveness will be assessed. Due to changes in the epidemiology of malaria in the study area, the upper age limit for inclusion was increased from 5 to 10 years old from September 2009.


Eligibility Criteria:
Inclusion Criteria:

* Age 3-119 months at time of first administration of IPT in September
* Consent of mother or carer and the local community

Exclusion Criteria:

* History of allergy to SP or AQ
* Age \< 3 months or \>119 months at time of first administration of IPT in September

From 2009, the age for inclusion has been changed from 3-59 months to 3 months to 10 years of age.