cyrilzakka/clinical-trials huggingface dataset:
Genetic Susceptibility to Rheumatic Heart Disease in the Pacific Region

The purpose of this study is to investigate whether there are genetic differences between patients with rheumatic heart disease and members of the general population.

The investigators will micro-array genotype approximately 300,000 single nucleotide polymorphisms (SNP) using DNA samples from patients with rheumatic heart disease (cases) from New Caledonia and Fiji, and members of the general population (controls) from New Caledonia, Vanuatu and Fiji. The investigators will perform standard quality control checks on the SNP data using measures such as call rate, heterozygosity, duplication and relatedness, and exclude variants on the basis of deviation from Hardy-Weinberg equilibrium and minor allele frequency. We will also impute variants not present on the micro-array with reference to the latest release of 1000 Genomes data and whole-genome sequence data from sixty Melanesian individuals from New Caledonia from the phenotypic extremes in this study.

The investigators will conduct a discovery analysis in using a genome-wide association study approach focusing on Oceanic cases and controls from the Francophone nations of New Caledonia and Vanuatu. This analysis will be corrected for bias due to population stratification using the Linear Mixed Model (LMM) and consider additive, dominant and recessive genetic models. The investigators will then perform LMM association testing for variants with P-value in the discovery analysis less than 1x10\^-5 in Oceanic cases and controls from Fiji and combine the association statistics by fixed-effects meta-analysis. The investigators will consider variants with significant effects in the same direction in discovery and replication analyses with combined P-value less than 1x10\^-8 to have replicated. Unless there is clear evidence that associated variants are specific to Oceanic populations, further replication analyses for associated variants in cases and controls of Indian Descent from Fiji, as well as individuals of other and admixed ethnicities from both Fiji and New Caledonia.

Recruitment completed in December 2013. After receipt of funding from the British Heart Foundation, genotyping and analysis will begin in July 2014.

Eligibility Criteria:
1. Cases

   1. Inclusion Criteria:

      * Diagnosis of rheumatic heart disease based on one of:

        * World Heart Federation definite echocardiographic criteria
        * World Heart Federation borderline echocardiographic criteria and history of acute rheumatic fever
        * Mitral stenosis with valve area less than 2.0 cm2
        * Previous surgery for rheumatic heart disease
   2. Exclusion Criteria:

      * Age less than five years
      * Inability to give consent
2. New Controls

   1. Inclusion criteria:

      * Healthy individual living in a community where cases were identified
   2. Exclusion Criteria:

      * Past medical history or systems suggestive of rheumatic heart disease, acute rheumatic fever or other valvular heart disease
      * Age less than five years
      * Inability to give consent
Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in Vietnam

The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated antiretroviral therapy (ART) drugs.

This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in combination with different ART regimens in Vietnamese HIV infected patients with pulmonary tuberculosis, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.

Patients will be offered to participated in the study when they start TB treatment. All the enrolled patients will immediately be switched to rifabutin and randomized, to one of the RBT doses that will be then adapted to the allocated RBT regimen according to a cross over scheme. Three full pharmacokinetics profile will be performed at different time point : before initiation of ARV, after three weeks of the first RBT dosage and after three weeks of the secondRBT dosage. Patients will then be referred to the national program for further treatment. A follow-up visit will be planned at the end of the antiTB treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary tuberculosis defined as either

  * at least 2 sputum smears positive for AFB
  * 1 sputum smear positive for AFB and a chest radiograph compatible with active tuberculosis
  * 1 sputum culture positive and and a chest radiograph compatible with active tuberculosis
  * a clinical history and chest radiograph compatible with active tuberculosis and 2 sputum smear negative for AFB
* Positive HIV antibody and CD4 count \<=250 /mm3
* Weight \> 40 kg
* No history of ART
* No grade 3 or 4 clinical or laboratory findings
* Negative pregnancy test and appropriate contraceptive measures during the duration of the trial for female of childbearing age
* Having a firm home address that is readily accessible
* Karnofsky score\>=80%

Exclusion Criteria:

* History of TB or MDR TB treatment
* Concomitant OI requiring additional anti-infectious treatment
* Formal contraindication to any drug used in the trial
* Diabetes mellitus requiring drug treatment
* Recreational drug or alcohol abuse
* History of drug hypersensitivity to TB or related medications
* Interrupted TB therapy for more than 1 week
* Less than 90% adherent to first 6 weeks of intensive phase chemotherapy
* Mental illness that could impair ability to give informed consent or result in poor adherence to trial protocol and therapy
* Neutropenia \<1200 /L, anaemia \<6.8 g/dL, liver function test \> grade 2
* Requiring concomitant medications that may potentially interact with study drugs
* Pregnant or lactating women
* Karnofsky score \>80%
* Any condition rendering the patient unable to understand the nature, scope, and possible consequences of thes study and to provide consent
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of diabetes mellitus, type 2
* Patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 12 weeks prior to screening
* HbA1c \>/=7% and \</=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
* Fasting plasma glucose \</=240 mg/dL at pre-randomization visit
* Agreement to maintain diet and exercise habits during the study

Exclusion Criteria:

* Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
* Any previous treatment with thiazolidinedione or a dual PPAR agonist
* Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
* Any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening
* Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery

Ulinastatin reduce the amount of bleeding and fibrinolysis in high risk patients undergoing off-pump coronary bypass surgery (OPCAB).


Eligibility Criteria:
Inclusion Criteria:

* Eighty high risk patients undergoing OPCAB (High risk patients: Euro score ≥ 6 , acute coronary syndrome, preoperative CK-MB increased over 5 times than normal value and high sensitivity CRP ≥2.0)

Exclusion Criteria:

* The patients who receive additional operations, the patients who don't agree to participate in this trial, the patients who has a past hypersensitive experience on Ulinastatin
Effect of Telephone-supported Joint Protection Technique Training

There is limited evidence of the efficacy of joint protection principles in individuals diagnosed with lateral epicondylitis in the literature. The aim of this study was to investigate the effect of training of the telephone supported joint protection technique education on pain and upper extremity function in individuals with lateral epicondylitis. New information will be obtained according to the results.

There is limited evidence of the efficacy of joint protection principles in individuals diagnosed with lateral epicondylitis in the literature. The aim of this study was to investigate the effect of training of the telephone supported joint protection technique education on pain and upper extremity function in individuals with lateral epicondylitis. New information will be obtained according to the results.

Eligibility Criteria:
* unilateral lateral epicondylitis diagnosis
* Individuals between 18-40

Exclusion Criteria:

-individuals with a history of surgery
The Assessment of Airway Resistance and Airtrapping in Elderly COPD Patients by Forced Oscillation Technique (FOT)

The study hypothesize that parameters of new function machine---'forced oscillation technique' (FOT) can correlate well with the conventional lung function data for measurement of airway resistance and airtrapping in elderly COPD patients.

INTRODUCTION:

Forced oscillation technique (FOT) may be a good supplementary tool to assess lung function in elderly since it is a simple and fast tool requiring minimal patients' cooperation.

AIMS:

To investigate the accuracy of forced oscillation test FOT in assessment of airway resistance and airtrapping in elderly COPD patients by comparing FOT parameters to various conventional lung function parameters including FEV1, FEF 25-75, RV/TLC ratio, IC etc. The best FOT parameter for airway resistance and airtrapping is also determined.

STUDY DESIGN:

A cross-sectional study conducted in Kwong Wah Hospital, Hong Kong, SAR

METHODS:

COPD patients were recruited from 1st Jan, 2010 to 31st Dec 2011. Both of the lung function tests (forced oscillation technique (FOT) and conventional lung function test) were performed. Parameters of FOT (FRes FDep, RAvr, XAvr, were compared with conventional lung function test for assessment of both airway resistance and airtrapping in COPD subjects. Adjusted FOT parameters (FResRatio and FDep) were also compared with %FEV1 and different GOLD stages.

Statistics:

Comparison between FOT parameters and spirometric parameters was done by correlation test and expressed as Spearman coefficient. ANOVA test is used to compare FOT parameters among different groups of GOLD stages (stage 1 to 4) and groups with various degree of airtrapping (stage 1 to 3). Post hoc analysis was estimated by Bonferroni test.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients with previous lung function tests confirming irreversible obstructive pattern

Exclusion Criteria:

* Lung function test failed to show any obstructive pattern
* Paitents with co-existing pulmonary diseases including asthma, interstitial lung diseases, lung malignancy etc.
* Patients with active infectious diseases like tuberculosis
SMS Reminder to Assess Adherence

6 months open label non-interventional observational study acc to § 4, section 23 and § 67, section 6 German Medicines Act with two parallel groups

1. the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram
2. the control group not receiving a daily SMS reminder

Purpose:

Study Design:

observational

Eligibility Criteria:
Inclusion criteria:

* Chronic obstructive pulmonary disease (COPD) patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines
* User of mobile phone

Exclusion criteria:

- Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the SPC
Female Sexual Dysfunctions in Chronic Kidney Disease

A myriad of sexual problems affect men and women with chronic kidney disease (CKD), including decreased libido, erectile dysfunction, dysmenorrhea, and infertility. Menstrual abnormalities are common in CKD and many women are an-ovulatory.

Sexual dysfunction in CKD is multifactorial including hormonal alterations along with vascular, neurologic, psychogenic, and other factors, such as medications, contribute to the development of sexual dysfunction. Sexual dysfunction in females is mainly due to hormonal factors and manifests mainly as menstrual irregularities, amenorrhea, lack of vaginal lubrication, and failure to conceive.

The study will be conducted on 100 female patients divided in to two equal group:

1. Group A: The patient group include 50 female patients with chronic renal failure (eGFR \<15ml/min/1.7m2 )
2. Group B: The control group including 50 healthy females age matched with the patient group.

The Female Sexual Function Index (FSFI) will be used to assess sexual function. This index includes 19 questions related to 6 parameters: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction and dyspareunia. A face-to-face inter-view with each participant in which the FSFI questions will be verbally asked and answered and compare between both groups in sexual activity and effect of chronic kidney disease on sexuality.

Duration of chronic kidney disease, duration of dialysis ,number of sessions of dialysis per week, medical treatment, haemoglobin,creatinine level will be fulfilled.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with chronic kidney disease stage 5 with estimated glomerular filtration rate (eGFR) \<15 ml/min/1.7m2 using the equation of MDRD (modification of diet in renal disease) on dialysis or not.
* Age from 18 to 45 years old.
* Married.
* Sexually active during the last 6 months.

Exclusion Criteria:

* Pregnant women.
* Other medical diseases (diabetes mellitus, coronary artery disease, neurological disorders and other systematic diseases).
* Taking medications affect sexuality function e.g. antidepressant drugs.
Demographics and Clinical Characteristics of Paediatric Intraocular Inflammation in Singapore

Data on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017, will be retrieved and analyzed from the uveitis database retrospectively.

The results will be compared with other published studies on different study populations.

Data on demographics, etiology, clinical features, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017, will be retrieved from the uveitis database retrospectively.

Data on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes will be analyzed using statistical software.

The results will be compared with other published studies on different study populations.

The results of this study will lead to an improved clinical practice with better treatment selections and an optimised monitoring protocol for follow up care for our paediatric patients with intraocular inflammation. This will lead to better clinical outcomes and prevention of serious sight threatening complications.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 16 years and below
* Clinical diagnosis of intraocular inflammation

Exclusion Criteria:

•Children with ocular conditions other than intraocular inflammation.
Clinical Assessment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and/or Chronic Heart Failure (CHF)

Cigarette smoking, the major risk factor for COPD, causes not only airway and lung inflammation, but also systemic effects. These systemic effects of smoking could substantially contribute to the development of chronic diseases, other than COPD, particularly chronic heart failure (CHF). The aim of this project is to assess the frequency and severity of CHF and COPD in outpatients with history of smoking referred to Hospital because of dyspnea and/or chronic cough.

We will recruit 100 patients older than 50 years with diagnosis of COPD and/or CHF. COPD is defined by presence of fixed airflow obstruction (post-bronchodilator FEV1/FVC less than 70%) according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines. Each patient will be characterized by medical history and physical examination. Patients with a diagnosis of COPD must have: 1) had a history of chronic respiratory symptoms, i.e., cough and sputum and/or breathlessness and only occasional wheezing (SGRQ and MMRC Questionnaire); 2) they had to be smokers or ex-smokers with more than 10 pack-years, and 3) a documented absence of a history of variable airflow obstruction and/or diagnosis of asthma. Each patient will perform pulmonary function tests, including reversibility to inhaled bronchodilator (400 µg albuterol); arterial blood gases, and routine blood tests. In addition, each patient will undergo regular PA/LL chest x-ray. The diagnosis of CHF is established according to the criteria of European Society of Cardiology. At time of entry in the study, all patients will be in clinically stable condition (ie, no changes in medication dosage or frequency, and no exacerbations of disease or hospital admissions in the preceding 6 weeks). Clinical and biological follow-up of these patients will be prospectively followed for 2 years, from 2009 to 2011.

Eligibility Criteria:
Inclusion Criteria:

* Caucasians
* Males and females
* Age \> 50 years
* Smoking history \> 10 pack years
* Diagnosis of COPD according to GOLD 2008 and/or diagnosis of CHF according to ESC 2008

Exclusion Criteria:

* History of bronchial asthma
* Fixed airflow limitation due to other chronic diseases such as cystic fibrosis, bronchiolitis obliterans organizing pneumonia (BOOP), bronchiectasis, TBC etc.
* Combined restrictive-obstructive functional impairment
Effects of Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Periodontitis

This study aimed to compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis.

The additional use of agents with antibacterial and anti-inflammatory activities such as hyaluronic acid (HA) in treating periodontal disease has recently become popular. This study aimed to evaluate the effects of using an interdental brush dipped in 0.2% HA gel on clinical periodontal parameters.This randomized controlled trial was conducted among 33 female patients and 27 male patients with stage II/III grade A/B periodontitis. After the initial periodontal treatment, patients were randomly divided into two groups; those in the test group were asked to use an interdental brush dipped in 0.2% HA gel twice a day after brushing, while those in the control group were asked to use a regular interdental brush. Clinical periodontal parameters including the pocket depth, clinical attachment loss, gingival index, plaque index, and papillary bleeding index (PBI) were assessed at baseline and in the 1st and 3rd months after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18-55 years of age
2. Being systemically healthy
3. Having periodontitis (Stage 3)
4. Not to have used any medication in the last three months
5. Not smoking
6. Right-handed
7. At least 20 natural teeth

Exclusion Criteria:

1. Patients with interdental caries
2. Patients with orthodontic appliances
3. Patients with removable (partial) prostheses
4. Patients with oral and/or peri-oral pain
5. Patients with significant oral lesions
6. Patients with antibiotic use in the last 3 months, pregnancy and breastfeeding
7. Patients who have undergone periodontal treatment within the last 6 months
Validation of the English Version of the Drug Hypersensitivity Quality of Life Questionnaire

We aim to validate the English (UK) translation of the DrHy-Q, and test its reliability in the UK population. This will facilitate for the subsequent economical evaluation of penicillin allergy delabelling.

This research project is part of an MSc in Allergy undertaken by the principal applicant, Dr Patricia Romero, supervised through Imperial College London.

Target population are patients with a drug allergy diagnosed by an Allergist prospectively at the Drug Allergy Clinic.

Is the English version of the Drug Hypersensitivity Quality of Life Questionnaire suitable to be used in the UK population?


Eligibility Criteria:
Inclusion Criteria:

* • Age \>18 years

  * Ability to read English and consent.
  * Confirmed diagnosis of a drug hypersensitivity reaction.
  * Written informed consent

Exclusion Criteria:

* • \< 18y/o.

  * Not able to read English. No mental capacity to consent or unwilling to consent.
  * Unconfirmed diagnosis of a drug hypersensitivity reaction.
Sorafenib for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3-ITD Positive AML

The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD positive acute myeloid leukemia (AML).

Internal tandem duplication of FMS-like tyrosine kinase 3 (FLT3-ITD) mutations have been reported in 20%-30% of patients with acute myeloid leukemia (AML). FLT3-ITD-positive AML patients have an inferior survival, primarily due to lower complete remission (CR) rate and higher relapse rate. Although allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the outcomes of some FLT3-ITD-positive AML, a significant number will suffer disease recurrence after allo-HSCT. Sorafenib, an inhibitor of multiple kinases including FLT3, has shown promising activity in FLT3-ITD-positive AML. Recent studies have shown that sorafenib monotherapy or in combination with chemotherapy are effective in attaining CR, but they do not have significant improvement in relapse. Currently, prophylactic use of sorafenib after allo-HSCT has been rarely reported, and whether it can improve outcomes of FLT3-ITD-positive AML remains unclear.

Eligibility Criteria:
Inclusion Criteria:

* FLT3-ITD Positive AML
* Allo-HSCT Recipients

Exclusion Criteria:

* cardiac dysfunction (particularly congestive heart failure)
* hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
* renal dysfunction (creatinine clearance rate \< 30 mL/min)
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)