cyrilzakka/clinical-trials huggingface dataset:
Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants

It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Novel oral anticoagulants-NOACs (include rivaroxaban, apixaban, dabigatran and so on) have advantages of convenient use and no need of monitoring, compared with the traditional vitamin K antagonist. With lack of predicted biomarkers, especially the research data of Chinese, it has the important significance in studying individual differences of NOACs in the anticoagulant efficacy and safety, through the pharmacogenomics research.

The aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug transporters and drug target genes in Chinese population. By detecting the gene polymorphism, we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG) correlation of NOACs and provide scientific basis for accurate medication guide for people to use NOACs.


Eligibility Criteria:
Inclusion Criteria:

(I)Chinese Healthy Volunteers

* In accordance with the inclusion criteria for each bioequivalence trial of NOACs;
* Sign informed consent of the research;
* Complete to collect indexes of pharmacodynamics and pharmacogenomics in the cycle with control drug.

(II)Chinese Patients

* In accordance with anticoagulation indications of NOACs, include prevention of thrombosis in non valvular atrial fibrillation, prevention and treatment of deep vein thrombosis / pulmonary embolism and prevention of thrombosis after knee / hip replacement;
* More than 18 years of age, male or female;
* Never received NOACs in a month and intend to take NOACs or have received NOACs for more than one week continuously;
* sign informed consent.

Exclusion Criteria:

(I)Chinese Healthy Volunteers

* In accordance with the exclusion criteria for each bioequivalence trial of NOACs;

(II)Chinese Patients

* With history of immunodeficiency disease, including positive HIV index;
* Positive Hepatitis B surface antigen (HBsAg) and HCV index;
* Combined therapy of CYP3A4 strong inhibitors and P-gp inhibitors (e.g., systemic pyrrole antifungal agents such as ketoconazole, itraconazole, voriconazole and posaconazole; human immunodeficiency virus (HIV) - protease inhibitors such as ritonavir), CYP3A4 strong inducers and P-gp inducers (e.g., rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort, etc.) in 14 days before treatment with NOACs;
* Severe liver dysfunction and abnormal renal function;
* Include contraindications of NOACs, such as hypersensitivity, active bleeding, moderate or severe liver disease, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days.
A Trial of Topical Aloe Vera Gel in Emergency Department Patients Presenting With Simple Traumatic Wounds

This is a double blind placebo-controlled RCT comparing the speed of healing of simple traumatic wounds with Aloe Vera gel compared to both control (Ultrasound gel) and standard care.

Simple traumatic wounds are a common presenting symptom to the ED affecting thousands of patients worldwide every day. Aloe Vera is a natural product that has been linked to better healing both anecdotally and in animal studies. A recent Cochrane review failed to find any human studies on acute wounds such as those seen in the ED. The aim of this study is to see whether Aloe Vera gel improves the wound healing time in these patients. We plan to enrol 270 participants presenting to the Royal Infirmary of Edinburgh ED with simple traumatic wounds into a randomised controlled trial. Participants will be assessed at baseline using the Bates-Jensen wound assessment tool. They will be then be randomized to one of three groups, and allocated to receive either Aloe Vera gel, control (Ultrasound gel) or standard care. The participants in the two gel groups will have identical packaging and the treating clinician will be unaware as to which group they are allocated. They will be asked to place the allocated substance onto the wound twice daily and cover with a supplied dressing on each occasion for 1 week. All groups will be asked to return to the ED for a repeat Bates-Jensen wound assessment, and will also be asked to record the number of days that their wound took to heal. The gel groups will have assessment of product usage. Participants will also be telephoned at 3 weeks. Primary outcome will be number of days for wound to heal. Secondary outcome will be change in Bates-Jensen wound assessment score between baseline and day 10, change in wound size between baseline and day 10 and baseline and day 21, changes in wound characteristics at day 21 as reported by participants, wound infection rate, participant satisfaction and participant compliance with treatment.

Eligibility Criteria:
Inclusion Criteria: Patients deemed by their treating clinician to have a simple traumatic wound will be considered for enrolment.

Exclusion Criteria:

1. Known allergy to either Aloe Vera or ultrasound gel
2. Patients under 16 year of age
3. No telephone number for follow-up
4. Patient lacking capacity
5. Patient currently using antibiotics
6. Patient having a puncture or bite wound
7. Patient having underlying tendon or bone involvement or wound overlying a joint
8. Patients with burn wounds
9. Wounds more than 24 hours old
10. Patient unable/unwilling to attend follow-up
11. Patients unable to self administer treatment.
12. Wound that treating clinician would not routinely dress e.g. facial wounds (face, ear, eyebrow, nose, lip, eyelid, scalp), mucosa and hair covered areas, or wounds that require specialist dressing
13. Self reported pregnancy
14. Patients with a known allergy to the study dressing
15. Patients currently recruited in another clinical trial
16. Patients already recruited in the ALOE Study
Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

This study will determine if modified adaptive servoventilation (ASV) is as effective as the conventional ASV in treating periodic breathing. The study will determine if the modified ASV reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive airway pressure compared to conventional ASV.

Adaptive servoventilation (ASV) is a type of non-invasive ventilation which ameliorates central sleep and/or mixed apnea and periodic breathing. Previous studies in the field have shown that treatment of periodic breathing with ASV improves sleep quality and quality of life. In reducing central apneas, ASV reduces overall arousal index, and increases overall slow wave sleep and rapid eye movement (REM) sleep more than oxygen, continuous positive airway pressure or bi-level treatments. ASV can also more effectively reduce central apnea and overall apnea/hypopnea index (AHI) in patients on long-term opiates, and appears to effectively treat Complex Sleep Apnea Syndrome. It is more effective than other forms of non-invasive ventilation for patients with central and/or mixed apnea or periodic breathing, and is better tolerated.

This is a prospective, randomised, crossover, observational study. Subjects will spend one night on conventional ASV and one night on modified ASV with full in-lab polysomnography (PSG) during therapy on both nights.

Objective and subjective parameters will be recorded and analysed.

Eligibility Criteria:
Inclusion Criteria:

* 21+ years old
* Chronic ResMed ASV therapy patient
* Current ASV therapy for at least 4 weeks
* Able to understand fully the study information and participation requirements
* Provide signed informed consent

Exclusion Criteria:

* Acute cardiac decompensation
* Acute myocardial infarction within last 3 months
* Resuscitation within last 3 months
* Stroke with swallowing disorders or persistent hemiparesis
* Blood pressure test at end expiratory pressure (EEP) 10cmH2O not passed
* Untreated restless legs syndrome
* Alcohol or drug abuse
* Known cancer
* Pregnancy
* Conditions that could interfere with patients participating in and completing the protocol and/or the investigator deems their enrolment unsuitable
A Medication Adherence Intervention for HIV Infected Veterans

It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently.

Background:

It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently.

Objectives:

Optimizing health for HIV patients requires excellent adherence to antiretroviral medication regimens. However, its unclear how best to incorporate adherence education and support programs into VA HIV outpatient care. We implemented and evaluated a pharmacist program (ACE) and a Pager reminder program to support adherence in veterans with HIV.

Methods:

We used a quasi-experimental design with pre-post evaluation at four VA Centers. Three treatment conditions (ACE, Pager, Usual Care) were rolled-in sequentially over two study phases, allowing for group comparisons between conditions. ACE is a multi-component manualized 4-session, individual patient education and support program by trained pharmacists. The Pager intervention used alphanumeric pagers to remind patients of dosing times. Electronically-monitored medication adherence (MEMS), self-report questionnaires, and pharmacy refill records were collected. Qualitative site interviews were collected before and after interventions to assist with program evaluation. Multilevel mixed models were used to analyze main study outcomes over time. Secondary analyses compared subgroup who actually received all ACE sessions (�as treated�) to controls.

Status:

Project has been completed and Final Report submitted to HSR\&D CO.

Eligibility Criteria:
Inclusion Criteria:

Patients must be greater than or equal to 18 years old, must be enrolled in HIV Primary care at one of 4 VA study sites and be taking antiretroviral therapy.

Exclusion Criteria:
Almond Supplementation on Mild to Moderate Acne

This study will assess the effect of almond supplementation on acne and on gut health.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 15 years of age until 45 years of age.
* The presence of mild to moderate acne based on investigator global assessment.
* Individuals who have remained stable on their topical or oral acne regimen for at least 4 weeks, except if the medication is a noted exclusion.

Exclusion Criteria:

* The presence of severe acne as noted by the investigator global assessment.
* Those with a nut allergy.
* Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling.
* Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling.
* Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention.
* Individuals who have been on an oral antibiotic for acne within the previous 1 month.
* Individuals who are pregnant or breastfeeding.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
* Oral supplementation that has nuts in it.
* Use of isotretinoin within the three months prior to joining the study.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Ruxolitinib in Patients With Breast Cancer

Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is thought that this pathway might be important in certain types of breast cancer, and that blocking this pathway might lead to anti-cancer effects. This study is testing the effects of ruxolitinib in patients with breast cancer.

Objectives:

Primary

* The primary objective of this two-stage, phase II study is to estimate the objective response rate to ruxolitinib in patients with metastatic or unresectable locally advanced breast cancer which is pStat3+ and which has progressed on at least one line of chemotherapy for advanced disease, and/or has recurred within 12 months of completion of neoadjuvant/adjuvant chemotherapy.

Secondary

* To describe the toxicity profile
* To evaluate clinical benefit rate (CR + PR + SD \>/= 24 weeks)
* To estimate progression-free and overall survival

Exploratory

* To explore whether baseline hs-CRP level higher than the group median is associated with objective response
* To explore whether baseline IL-6 level higher than the group median is associated with objective response
* To describe hs-CRP level over time, and to describe the proportion of patients with a) hs-CRP \> 3mg/L at baseline, on treatment, and at time of progression, and b) hs-CRP \> 1mg/L at baseline, on treatment, and at time of progression
* To describe IL-6 level over time, and to describe the proportion of patients with IL-6 level above the upper limit of normal at baseline, on treatment, and at time of progression
* To describe pStat3 status by IHC in baseline metastatic biopsies
* To describe pStat3 status by IHC in on-study biopsies
* To describe pStat3 status by IHC in the time of progression biopsy samples
* To characterize archival and metastatic biopsy samples using triple immunofluorescence for CD44, CD24, and pStat3
* To characterize archival and metastatic biopsy samples using a previously characterized pStat3 gene signature
* To characterize circulating tumor cells (CTCs) for CD44, CD24, and pStat3 at baseline and time of progression

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed invasive breast cancer
* Must have known ER, PR and HER2 status
* Either, Triple Negative Metastatic Breast Cancer or
* Inflammatory Breast Cancer with any ER, PR HER2 status
* Availability of archival tissue specimen suitable for pStat3 testing
* Life expectancy of greater than 3 months
* Measurable disease by RECIST
* At least one prior chemotherapy regimen for treatment of metastatic breast cancer and/or recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy or
* For patients with inflammatory breast cancer but no distant metastases, progression through standard neoadjuvant chemotherapy is required

Exclusion Criteria:

* Pregnant or breastfeeding
* Active brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib
* Clinically significant malabsorption syndrome
* Concurrent use of medications/substances that are strong inhibitors of CY3A4
* No uncontrolled intercurrent illness
Preliminary Anti-tumour Activity of mTor Kinase Inhibitor in Advanced Tumours

To investigate the safety and tolerability of AZD8055 intermittent dosing schedules when given orally to patients with advanced solid malignancies and lymphomas. Two intermittent dosing schedules will be explored with increasing doses until a maximum tolerated dose is determined for each schedule.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of an advanced solid malignant tumour or lymphoma which is refactory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria)
* WHO performance status 0-2
* Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients

Exclusion Criteria:

* Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug.
* Any investigational agents or study drugs from a previous clinical study within 30 days, any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
* Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions
Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma

This clinical trial studies how well an interactive tailored website works in promoting sun protection and skin self-check behaviors in patients with stage 0-III melanoma. An internet-based program may help individuals to perform skin self-checks and engage in sun protection behaviors.

PRIMARY OBJECTIVES:

I. To evaluate the impact of the interactive tailored website (ITW) versus usual care on skin self-examination (SSE) and sun protection behaviors among individuals diagnosed with melanoma.

SECONDARY OBJECTIVES:

I. To examine mediators of the impact of the intervention. The effects of the intervention on SSE and sun protection behaviors will be mediated by melanoma knowledge, self-efficacy for SSE and sun protection behaviors, perceived benefits of SSE and sun protection behaviors, perceived barriers to SSE and sun protection behaviors, and perceived controllability of melanoma.

TERTIARY OBJECTIVES:

I. To examine moderators of the impact of the intervention. To evaluate whether ITW effects are moderated by the following factors: time since diagnosis, disease stage, age, sex, income, education, Internet experience, distress about melanoma, worry about recurrence, and evaluation and usage of the ITW.

OUTLINE:

Phase I: Patients review draft website content materials in a semi-structured format and provide feedback via open- and closed-ended questions for the development, testing, and finalization of ITW.

Phase II: Patients are randomized into 1 of 2 arms.

ARM I: Patients access ITW and complete each module over 30-40 minutes.

ARM II: Patients receive usual care and are then offered ITW.

All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Phase I: Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
* Phase I: From 3-36 months post-surgical treatment
* Phase I: Access to the internet
* Phase I: Able to speak and read English
* Phase I: Able to provide informed consent
* Phase II: Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
* Phase II: From 3-24 months post-surgical treatment
* Phase II: Not adherent to thorough SSE (i.e., did not check every area of the body at least once during the past 2 months)
* Phase II: Not adherent to sun protection recommendations (i.e., mean score \< 4 \[which corresponds to "often"\] on a 5-point scale \[from 1 = "never" to 5 = "always"\] that assesses the frequency of engaging in four sun protection behaviors)
* Phase II: Access to a computer connected to the internet
* Phase II: Able to speak and read English
* Phase II: Able to provide informed consent
Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

The role of laparoscopic surgery in pediatric inguinal hernia repair is clear. Laparoscopic hernia repair is especially advantageous for bilateral diseases and minimally invasive technique in children because it avoids vas injury. However, the problem of recurrent rate has not been resolved. The aim of this study was to refine the current criteria used the lateral umbilicus ligament covering the internal hernia opening region, and eliminated recurrence in laparoscopic inguinal hernia (LIH) repair in children. The investigators hypothesized that the lateral umbilicus ligament covering the internal hernia opening region after the laparoscopic purse-string knot would result in lower recurrence and the same operation relative complication

The primary outcome measure was the recurrence rate after surgery, and the secondary outcome measures included degree of postoperative pain, the amount of postoperative analgesia, procedural duration, number of days to recovery normal activity, surgical complications, cosmetic results, and patient satisfaction. The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery. The cosmetic result was scored (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3) by the patients or parents, the attending nurse, and the surgeon (maximum points = 9). The patient satisfaction was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3). The long axis of the testes was measured.

Eligibility Criteria:
Inclusion Criteria:

* unilateral inguinal hernia
* age between 2 years and 17 years
* no history of abdominal or inguinal operations
* the age range was based on the day surgery criteria of our hospital
* of male patients, only those with completely descended testes were included

Exclusion Criteria:

* the bilateral hernia
* the recurrence hernia
Effects of Carnitine on Oxidative Stress to IVIR Administration to CKD Patients:Impact of Haptoglobin Genotype

Anemia is a common disorder in CKD patients. It is largely attributed to decreased erythropoietin (EPO) production and iron deficiency. Therefore, besides EPO, therapy includes iron replenishment. However, the latter induces oxidative stress. Haptoglobin (Hp) protein is the main line of defense against the oxidative effects of Hemoglobin/Iron. There are 3 genotypes: 1-1, 2-1 and 2-2. Hp 2-2 protein is inferior to Hp 1-1 as antioxidant. So far, there is no evidence whether haptoglobin genotype affects iron-induced oxidative stress in CKD patients.

In this proposed study we wished to examine whether Hp genotype influences intravenous iron administration (IVIR)-induced oxidative stress in CKD patients, and its impact on the response of these patients to L-Carnitine therapy.

This study will include at least 25 anemic CKD patients (stages 3-4) that will be given a weekly IVIR (Sodium ferric gluconate, \[125 mg/100 ml\] for 8 weeks, and during weeks 5-8 also received Carnitine (20mg/kg, IV) prior to IVIR. Weekly blood samples will drawn before and after each IVIR for Hp genotype, C-reactive protein (CRP), advanced oxidative protein products (AOPP), neutrophil gelatinase-associated lipocalin (NGAL), besides complete blood count and biochemical analyses.

Eligibility Criteria:
Inclusion Criteria:

1. Patients that have been diagnosed as suffering from chronic kidney diseases at stages 3-4 and confirmed by MDRD.
2. CKD patients with Hb of less than 10 g%.
3. At age ≥18 y.

Exclusion Criteria:

1. Pregnant women.
2. Patient with CKD stage 5 on Dialysis.
3. Patients with severe liver diseases.
4. Patients with severe CHF.
5. Inter-current illness such as fever.
6. Allergic rhinitis.