cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study for Pharmacokinetic/Pharmacodynamic (PK/PD) Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient

To know the blood level of allopurinol in chronic kidney disease (CKD) patient.

After the result of this pilot study, we can prescribe the optimal dose of allopurinol in CKD patient.

Eligibility Criteria:
Inclusion Criteria:

* from 18yrs to 80yrs , man and women
* the patient who are taking allopurinol
* On screening, the patient shows that the level of protein/creatinine ratio is over 3.0
* On screening, the patient shows that MDRD GFR \>= 30 ml/min and \<= 60 ml/min
* the patient sign on the concent form

Exclusion Criteria:

* the patient have experience to take medication that have an effect on renal function
* the patient have experience to take cyclosporin within 3month
* At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP \<= 100 mmHg or \>=160 mmHg and DBP \<=60 mmHg \>=100 mmHg, or Heart rate \< 40 beats/min or \> 90 beats/min
* uncontrolled hypertension
* pregnancy or anticipate pregnancy with 6 month
* hypersensitivity to allopurinol
* acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
* serum albumin \< 3.5 mg/dL or \> 5mg/dL
* urinary retension, prostatic hyperplasia
* the patient show gout attack on taking allopurinol
* the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
* the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid
* the patient who had taken part in the other study within 3months
* the patient who had gotten blood transfusion
* pregnant, breast feeding
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.

This is a long-term continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States. This study is to evaluate the long-term safety and efficacy of belimumab (LymphoStat-B™) in subjects with SLE disease.

Eligibility Criteria:
Inclusion Criteria:

* Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.
* Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.

Exclusion Criteria:

* Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.
Mindfulness-Based Relapse Prevention for Methadone Maintenance

The current study was designed to inform protocol adaptation, and to evaluate the feasibility, acceptability, and preliminary efficacy of a mindfulness-based intervention for methadone maintenance clients. Adults (N=15) were recruited from a methadone clinic to participate in a 6-week mindfulness course. Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention. Outcome measures were self-report, and included depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up. Data were analyzed using qualitative and quantitative approaches. Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance. Results support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within this client population.

As rates of opiate misuse rise in the United States, there areso do significant associated health, and financial consequences to afflicted individuals, their families, and society at large. Methadone Maintenance Therapy (MMT) is one evidence-based approach to treating individuals with opiate addiction, yet supplemental psychosocial treatment to support this approach is lacking. Mindfulness-Based Relapse Prevention (MBRP) has shown to be efficacious in various substance use populations, but has yet to be assessed with MMT clients. The current study was designed to inform protocol adaptation for to MMT clients, and to evaluate the feasibility, acceptability, and preliminary efficacy of a MBRP for this population. The sample consisted of adults (N=15) recruited from a methadone clinic to participate in a 6-week MBRP course. Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention. Outcome measures were self-report, and included self-compassion, depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up. Data were analyzed using qualitative and quantitative approaches. Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance. Results from this initial pilot support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within the MMT community.

Eligibility Criteria:
Inclusion Criteria:

* Clearance from clinic staff
* Currently enrolled in a methadone maintenance program
* Agree to complete assessment questionnaires and attend treatment sessions
* Fluent in English

Exclusion Criteria:

* Indication of active psychosis
* Participation in past mindfulness-based relapse prevention group
Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

The study is performed to consider the effect of thiamine supplementation on symptoms and signs of patients with heart failure and systolic and diastolic function of left ventricle.

The study is performed to consider the effect of thiamine supplementation versus placebo on symptoms and signs of patients with heart failure systolic and diastolic function of left ventricle.

Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%) are randomized to receive tablets of 300mg or placebo for 1 months in a double-blind fashion. All subjects will be on stable optimal medical therapy according to the present guidelines for at least 3 months before enrolment. At randomization and at study end, echocardiography by a single observer will be performed and assessment of symptoms and signs and quality of life based on self scoring system (from 1 to 7) and objective physical examinations will be done.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%)
* Optimal medical therapy according to the present guidelines for at least 3 months before enrollment.

Exclusion Criteria:

* Decompensated heart failure
* Renal failure
* COPD
* Asthma
* Uncontrolled hypertension
* Bradycardia or tachycardia which needs increase or decrease in medications
Evidence Based QUality Improvement for Prescribing Stewardship in ICU (EQUIPS-ICU)

The goal of this observational study is to learn about the implementation of a process to review antimicrobial prescriptions for adult patients in Intensive Care Unit (ICU).

The main question it aims to answer is: can a structured antimicrobial review can be implemented in ICUs?

Implementation will be supported by the use of local protocols, audit and feedback, and education. It will be evaluated by daily data collection of clinical processes and interviews with local champions.

Resources to conduct the study are provided by the Wellcome Flagship Innovations award. ("Collaboration for Research, Implementation and Training in Critical Care in Asia and Africa", reference 224048/Z/21/Z).


Eligibility Criteria:
Inclusion Criteria:

* All adult ICUs within CCAA-affiliated Care Quality Registries
* ICUs must appoint a named Champion to facilitate implementation
* All antimicrobial prescriptions for adult patients within the ICUs described above

Exclusion Criteria:

• ICU's which demonstrate adoption and reach of 80% or greater (median over 2 months) of a pre-existing structured antimicrobial review
The Therapy of Large Endometrioma

Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve.

Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve.

In Lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy.

This protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above.

The aim of this study is to assess if cyst drainage associated with GnRH agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone


Eligibility Criteria:
Inclusion Criteria:

* Endometrioma size ≥ 6cm determined by MRI or ultrasonography
* Women with isolated endometrioma or other extraovarian endometriosis: peritoneal, infiltrating endometriotic lesions and adenomyosis.
* Cyst single or bilateral

Exclusion Criteria:

* Cyst with radiographic or macroscopic in laparoscopy atypia
* Pregnancy
* Patient with contraindication to GnRH agonist (Enantone® 3,75 mg et Decapeptyl® 3 mg)
* Patient with contraindication to laparoscopy
* Patient with contraindication to general anesthesia
* Subject refusing to participate in the study
PillCam Colon Capsule 2® (PCC2) in the Setting of Colorectal Cancer Screening Program

In this study the investigators evaluate the sensitivity of PCC2 (PillCam Colon Capsule 2 (R)) in identifying significant polyps in a CRC (Colo Recatal Cancer) screening program (primary outcome measure).

Each enrolled patient underwent three procedures: colon capsule endoscopy, CT-colonography and optical colonoscopy. In this study the reference standard is represented by the segmental unblinded colonoscopy (the unblinding is based on results of both capsule endoscopy and Ct colonography) The investigators also evaluated the tolerability of PCC2 as compared to optical colonoscopy (OC) and CT-colonography (CTC).

Asymptomatic average risk subjects with positive iFOBT (immunochemical Fecal Occult Blood Test), participating the regional screening program, were offered to undergo PCC2 (PillCam Colon Capsule 2 (R)) followed, 21 days later, by CTC and OC performed on the same day. The number, size and location of significant polyps (\>6mm) identified by each procedure were compared with the reference standard (RS), which was represented by the segmental unblinded colonoscopy. The unblinding was based on the integration of CTC and PCC2 results. For the PPC2 the quality of the bowel preparation (adequate/inadequate) and the completeness of the examination (capsule excreted still working or visualization of the anal verge) were also reported. In order to evaluate the tolerability, each subject was asked to identify, among the 3 procedures performed, which was the less tolerated one and which one he would be willing to repeat.

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic average risk subjects, participating the regional colon cancer screening program, with positive iFOBT referred for colonoscopy

Exclusion Criteria:

* presence of obstructive symptoms
* swallowing disorders
* presence of cardiac pacemaker
The Effect of Deep Brain Stimulation on Facial Expressions.

Whether Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS), a treatment commonly used to ameliorate the motor symptoms of Parkinson's disease (PD), affects on facial expressions is unclear. The purpose of this study was to investigate the potential effects of DBS and different frequencies on facial expressions of PD patients by volunteers via a web site: http://www.supporttoscience.com

Parkinson's disease (PD) is the second most frequent progressive neuro-degenerative disease with a worldwide prevalence of 4-6 million and the mask face is an important and also troublesome sign of PD. Deep Brain Stimulation (DBS) surgery can be a viable option which has recently emerged and been accepted as a useful surgical method for PD. Standard DBS targets include Subthalamic Nucleus (STN) and Globus Pallidus Internus (GPi). Although the STN-DBS application is known to have favorable effects on motor and non-motor symptoms of PD, there is a lack information about the effect on facial expressions of PD patients. Our aim is to analyze the effect of the STN-DBS stimulation and different frequencies on the facial expressions of PD patients.

The study initially recruited 18 patients with idiopathic PD who underwent DBS surgery for movement disorders caused by PD at Mustafa Kemal University Medical Faculty Neurosurgery Department.

Inclusion criteria:

* Idiopathic PD responsive to L-Dopa treatment,
* Between 40-75 years of age,
* Having received bilateral STN DBS surgery at least six months prior to the investigation to ensure stable stimulation parameters,
* Mentally normal patients that could understand and respond to a directives. The evaluation will be made by the face photos of the patients. The face photos for the expressions including \[normal\], \[sad\], \[happy\], and \[angry\] were obtained at frequencies including 130 Hz, 60 Hz, 99 Hz, 230 Hz and off-stimulation. The face photos will evaluate by the software and by the volunteers with the aim of a website: http://www.supporttoscience.com

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD responsive to L-Dopa treatment,
* Between 40-75 years of age,
* Having received bilateral STN DBS surgery at least one month prior to the investigation to ensure stable stimulation parameters,
* Mentally normal patients that could understand and respond to a questionnaire.

Exclusion Criteria:

* Above 75 years of age,
* Severe dementia,
* History of an additional neurologic disease,
* The presence of a disease, such as the facial paralysis, that could affect facial expressions,
* Having a wound on the face.
Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks

The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery

The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery (Phase I study). Air leaks from unhealed lung tissue are one of the most common complications after lung surgery including wedge resection, segmentectomy and lobectomy. Air leaks can lead to a delay in chest tube removal, prolonged pain, increased infections, prolonged hospital stay, and increased costs to the health care system. Different agents have been used to heal air leaks by creating a pleurodesis (adhesions to obliterate the pleural space between the visceral and parietal pleura). The success with these agents has been variable and come with the cost of complications that have restricted their use the post-operative period. There has been recent interest in the use of 50% hypertonic glucose (D50) to create pleurodesis with encouraging reports coming mostly from Asia. The investigators have performed a pilot study using 180 mL of D50 instilled through the chest tube for the management of post lobectomy air leak with very encouraging results. This preliminary study used strict inclusion criteria of only lobectomy patients and excluded all patients with known diabetes or any postoperative hyperglycemia. It is unknown if these patients would have benefitted from D50. Also, the optimal dose of D50 was chosen empirically and never clearly defined by previous work. It has been reported that high doses of D50 have been associated with acute lung injury. It is therefore critical that the optimal safe dose is clarified.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older
2. Lung resection is a wedge, segmentectomy, lobectomy or bilobectomy
3. Procedure performed by video-assisted thoracic surgery (VATS) or by Thoracotomy
4. Presence of an air leak on the digital draining system on postoperative day 2

Exclusion Criteria:

1. Large air leak arbitrarily defined as more than 1000 mL/min
2. Allergy to local anesthetics
3. Hemodynamic instability
4. Untreated coronary artery disease
5. Need for respiratory support
6. Any other early post-operative complication
7. Immunity disorder
8. Large pleural fluid output empirically defined as more than 500 mL in the last 12 hours
9. Inability to give consent
10. Fasting glucose ≥ 14 mmol/L the morning of the intervention (arbitrarily chosen cut-off in which patients' diabetes is considered very poorly controlled)
11. Endocrinology service not available to co-manage patients with either diabetes, or a fasting blood glucose ≥ 7 mmol/L, or HbA1c \> 6.5%
12. Postoperative evidence of an active thoracic (lung or pleura) infection with systemic inflammatory response syndrome (2 or more of temperature \> 38, heart rate \> 90, respiratory rate \> 20, white blood cell count \> 12)
Complete Infarct Related Artery Revascularization

CORAMI trial is a prospective, international, multicenter randomized study which will be performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary intervention) duty and patient enrollment will continue for 18 months (October 2010 - March 2012).The aim of the study is to compare strategy of complete vs target lesion-only primary PCI in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of STEMI (according to ESC 2007 definition)
* Chest pain onset \<12 hours
* signed informed consent
* Presence of two critical lesions requiring PCI in IRA (LAD - left anterior descending, Cx - circumflex, RCA - right coronary artery)
* Target/culprit lesion which requires immediate stenting (\>50 - 100%) and second critical lesion (70-90%) with TIMI 3 flow after PCI of the 1st target/culprit lesion
* Over 18 years of age
* IRA diameter ≥ 2.5 mm

Exclusion Criteria:

* Terminal illness with life expectancy less \<1 year or active cancer disease - Pregnancy or possibility of pregnancy
* Second critical lesion in IRA \>90% or occlusion
* Contraindications to PCI or/and stent implantation
* Contraindications to DES stent implantation
* Lesion diameters unsuitable for intended stent platform
* Active bleeding or coagulopathy
* Patient in cardiogenic shock (\<90mmHg SBP and/or requiring IABP - intraaortic balloon pump - or vasopressors) - Killip 4 class
* Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
* No future patient cooperation expected
* Patient is participating in another clinical study
Ventilatory Response After Non Invasive Ventilation in Type 1 Myotonic Dystrophy

It has been suggested that patients with Myotonic Dystrophy type 1 have primary altered ventilatory response to chemical stimuli and chronic hypoventilation is related not always to muscle weakness. Also, it is known that Non Invasive Mechanical Ventilation can improve ventilatory response to chemical stimuli, especially to hypercapnia.

This study evaluates the effect of Non Invasive Mechanical Ventilation on ventilatory response in patients with Type 1 Myotonic Dystrophy, the ventilatory response to chemical stimuli will be measured before and after mechanical ventilation in patients with myotonic dystrophy type 1.

Type 1 Myotonic Dystrophy is a hereditary neuromuscular disease with an autosomal dominant pattern whose prevalence is 1/8000 inhabitants and is the most common muscular dystrophy in adults. It is multisystem disease and is characterized by myotonia, progressive muscle loss and a wide spectrum of manifestations.

Myotonic dystrophy type 1 causes a high impact on health and quality of life of patients as functional impairment can reach the incapacity and total dependence in basic activities of daily living. As in most neuromuscular diseases, progressive muscle weakness at some point in the evolution affects the respiratory muscles. However, in some patients with myotonic dystrophy type 1 it has been observed that muscle weakness does not explain ventilatory failure, and is believed to be due to a primary reduction in the central ventilatory response to hypercapnia present in this disease.

Non Invasive Mechanical Ventilation (NIV) is a long-term treatment that provides ventilatory assistance through an interface that does not invade the airway and currently can be provided to patients in the home environment; It is a resource that has shown to improve the quality of life, daytime gas exchange and survival in patients with neuromuscular diseases, even when used only during sleep. It is not clear the mechanism by which NIV during daytime sleep improves gas exchange in patients with neuromuscular diseases, even in advanced stages where breathing muscles effectors are severely affected.

It has been proposed that NIV used during sleep can improve the sensitivity of the respiratory center to carbon dioxide but this has not been demonstrated in patients with Type 1 Myotonic Dystrophy, to answer this question, it is proposed to compare the central ventilatory response to chemical stimuli after a period of NIV in patients with Type 1 Myotonic Dystrophy.

Eligibility Criteria:
Inclusion Criteria:

* Classic variety of Myotonic Dystrophy Type 1
* Molecular confirmation through the standard method

Exclusion Criteria:

* Using currently invasive mechanical ventilation.
* Acute decompensation of respiratory or cardiac origin in the last 6 months, which required hospital care.
* Drugs that may alter the ventilatory response: benzodiazepines, neuroleptics, corticosteroids, theophylline, acetazolamide
The Effects of Ginger Supplementation on Inflammation in Exercising Individuals

The purpose of our graduate student research study is to observe the effects of ginger on hsCRP, IL-6, and TNF-α levels in exercising individuals based on their level of activity.

Participants will fill out a demographic questionnaire and a quality of life survey, (SF-36). Take a 3g supplement of ginger in powder form with meals once/day (preferably in the morning) for 8 weeks. By end of week 4 (halfway through the study), subjects will do another blood test for mid-intervention CRP, IL-6, and TNF-α values. By end of week 8, participants will do a final blood test for CRP values and fill out the SF-36 survey for post-intervention levels.

Eligibility Criteria:
Inclusion Criteria:

* 30 - 70 years of age
* Various levels of activity outlined by the General Physical Activities Defined by Level of Intensity by the American College of Sports Medicine (ACSM) and the Centers for Disease Control and Prevention (CDC).

  * Regular Exercisers- at least 30 minutes of moderate to vigorous activity at least 3 times per week.
  * Non-regular Exercisers- at least 30 minutes of moderate to vigorous activity 1-2 times per week.

Exclusion Criteria:

* Individuals currently taking...

  * Vit D
  * Aspirin
  * Coumadin
  * Ginger supplements more than 1x/week within the last month
  * Heparin
  * NSAIDs
  * Pain meds
* Individuals with chronic inflammatory conditions such as Cancer, CVD, Diabetes, Gastroesophageal reflux disease (GERD), Ginger allergies, Metabolic Syndrome, and/or autoimmune diseases such as Rheumatoid Arthritis