cyrilzakka/clinical-trials huggingface dataset:
An Observational Post Authorisation Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands

The study design is a prospective, non-interventional, observational single arm study.

A minimum of 150 patients will be recruited from approximately 30 haematology/oncology sites in the Netherlands. In all cases, the decision to treat the patient with azacitidine was already made prior to the decision to enter the subject into the study.

Recruitment will continue until end of June 2015, provided a minimum of 150 patients have been included in the study. When this date is reached, all patients on azacitidine will continue to be followed until the last patient enrolled has been followed for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age who understand and voluntarily sign an informed consent form.
* Patients who are treated with azacitidine in accordance with registered indication and clinical practice.

Exclusion Criteria:

* Refusal to participate in the study.
* Participation in an interventional clinical study.
* Patients previously treated with azacitidine except when given as induction therapy for a maximum of three courses.
* Women who are pregnant or breast-feeding.
* Hypersensitivity to the active substance or to any of the excipients.
* Advanced malignant hepatic tumors.
The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen

The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age
* Pre-bronchodilatory FEV1 ≥70% of predicted normal allergic asthmatic with a history of episodic wheeze
* Positive allergen induced early and late airway bronchoconstriction showing ≥ 20% fall in FEV1 for the early and ≥ 15% for the late response
* Positive skin prick test to common aeroallergens

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal finding at screening examinations
* Smoker or ex-smoker who has stopped smoking \< 12 months prior to study start
* Worsening of asthma or respiratory infection within 6 weeks from visit 1
* Allergen-specific immunotherapy within 6 months prior to visit 1
African American Resilient Caregivers

The purpose of this pilot study is to test the feasibility of a virtual intervention to prevent child obesity and cardiovascular disease in African American families.

African American children experience a high prevalence of child obesity, increasing their subsequent risk of cardiovascular disease and diabetes. There is a lack of effective obesity prevention interventions for this population. Investigators also know that African American parents and caregivers experience high levels of stress and the manifestations of stress for African American women in particular may be unique and specific. Parent stress can lead to unhealthy family behaviors including less physical activity and a less healthy diet for parents and children. Given this background the investigators are creating a new intervention that combines an adapted evidence-based obesity prevention program (Competency Based Approach to Community Health - COACH) with mindfulness-based stress reduction tailored to African American women. As an initial step the investigators will pilot the intervention in a small number of African American women to determine whether the program is feasible.

Eligibility Criteria:
Inclusion Criteria:

* Identify as African American and female
* Have a child between the ages of 2-5 who lives with them at least 4 days per week that they care for as a parent or guardian.
* Feel comfortable discussing personal experiences and goals related to diet, PA, stress, parenting, etc. in front of a group of peers
* Access to zoom, preferably with video

Exclusion Criteria:

• Non English Speaking
Determining Beta-hCG Levels in Patients Through Alternative Sample Types

This study is to determine if there is any quantifiable correlation between serum beta hCG and dried blood spot (DBS) beta hCG levels. This data will be used to develop a less invasive collection method to determine quantitative hCG levels.

A cohort of 40 individuals at various stages of pregnancy or medical abortion will be recruited for the study. Each participant will provide biospecimens that include the following: serum, saliva, urine, and dried blood spot (DBS). These samples will be collected and stored at the clinic under appropriate storage conditions until they can be shipped, under dry ice, to the testing lab. Once samples arrive at the lab, serum samples will be thawed and prepared to run on an ECL analyzer to determine reference beta hCG values in mIU/mL for each participant.

Samples will be run as they are received by the lab. The initial 10-12 samples will be used to evaluate study feasiblility and determine if there is one sample type that performs better than the others. The other matched sample types will be processed and run on the ECL analyzer. The values for beta hCG mIU/mL of the other sample types will then be compared to the matched serum to determine if there are any consistent correlations.

In the first 10-12 samples, if one sample type is shown to perform better than the others, the study will shift focus towards prioritizing the analysis of that particular sample type in regards to correlation with serum. If more than one sample type is shown to perform well, then those sample types will be equally prioritized. If no sample type shows any correlation, the study will end.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years old
* Have not taken antibiotics in the last 21 days
* Are here for services related to a current or recent pregnancy
* Agree to provide all required samples
* Have not previously participated in this study

Exclusion Criteria:

* Are under18 years old
* Have taken antibiotics in the last 21 days
* Are not here for services related to a current or recent pregnancy
* Disagree or unable to provide all required samples
* Have previously participated in this study
Bladder Irrigation 0.05% Lidocaine Decreases Postoperative CRBD

Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is very distressing, and it may get worse in patients undergoing transurethral surgery for damage urethra by a surgical instrument as well as a sizable and urinary catheter placement. Lidocaine, a local anesthetic, showed of analgesic, sedative, and anti-inflammatory effect. Therefore, the investigators prepared a 0.05% lidocaine in normal saline as a bladder irrigation solution after surgery to reduce Catheter-related bladder discomfort.

Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is very distressing. It is not unusual that patients who have been catheterized under anesthesia complain of an urge to void in the postoperative period because of catheter-related bladder irritation. Bladder catheterization induces bladder irritation whose symptoms (urge to void and discomfort in the suprapubic region) are similar to the symptoms of an overactive bladder (urinary frequency and urgency with or without urge incontinence), caused by involuntary contractions of the bladder mediated by muscarinic receptors. The discomforts are quickly getting worse in patients undergoing transurethral surgery by a surgical instrument as well as a sizable urinary catheter placement. Recently, antimuscarinic drugs for treat overactive bladder, such as tolterodine and oxybutynin, have been tried for prevention of CRBD with variable success. However, they may cause side effect including palpitation, dry mouth, drowsiness, dizziness or headache. Lidocaine, a local anesthetic, showed of analgesic, sedative and anti-inflammatory effect. Therefore, the investigators prepared a 0.05% lidocaine in normal saline as a bladder irrigation solution after surgery to reduce Catheter-related bladder discomfort.

Objectives:

The aim of this study were:

1. to evaluate the efficacy to prevent CRBD with Bladder irrigation with 0.05% Lidocaine normal saline solution
2. to observe the change of vital sign with Bladder irrigation with 0.05% Lidocaine normal saline solution
3. to see the side effect of with Bladder irrigation with 0.05% Lidocaine normal saline solution

Eligibility Criteria:
Inclusion Criteria:

* Patients who received regular transurethral surgery were inserted left foley catheter for urine drainage or bladder irrigation.
* American Society of Anesthesiologists(ASA)class:Ι-Ⅲ
* Age:20-70years
* Sex:Male

Exclusion Criteria:

* Lidocaine allergy
* cardiac conduction with partial or total block
* patient with progressive hepatic or renal impairment
* patient with class III anti-arrhythmia agent(ex:amiodarone)
* patient with acute porphyria
Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer

The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one or two contiguous levels.


Eligibility Criteria:
Inclusion Criteria:

* Lumbar spinal stenosis as defined by leg, buttock or groin pain, with or without back pain, that relieves during flexion, with radiographic confirmation of spinal stenosis by CT or MRI scans at one or two contiguous levels between L1 and S1. If back pain is also present, it must be partially relieved during flexion
* Narrowing of the spinal canal, nerve root canal or intervertebral foramen at one or two levels
* Able to sit for 50 minutes without pain
* Able to walk 50 feet or more
* Age 50 years or over
* Has completed at least 6 months of conservative treatment
* Has a Zurich Claudication Questionnaire (ZCQ) score of ≥ 1.5 for Physical Function (PF) and ≥ 1.5 for Symptom Severity (SS)
* Other as specified in the approved protocol

Exclusion Criteria:

* Cannot sit for 50 minutes without pain
* Cannot walk for more than 50 feet
* Unremitting pain in any spinal position
* Axial back pain only without leg, buttock, or groin pain
* Fixed motor deficit
* Cauda equine syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retension or incontinence) dysfunction
* Severe symptomatic lumbar spinal stenosis at more than two levels
* Significant instability of the lumbar spine
* Has had any surgery of the lumbar spine
* Morbid obesity defined as a body mass index \>40 or a weight more than 100 lbs over ideal body weight
* Active systemic disease such as AIDS, HIV, Hepatitis, etc.
* Active systemic or local infection
* Angina, active rheumatoid arthritis, advanced diabetes or any other systemic disease that would affect the subject's welfare or outcome of the study
* Osteoporosis, defined as DEXA bone density measured T-score \< -2.5
* Spinal metastasis to the vertebrae
* Known allergy to device materials titanium, tantalum, or polyetheretherketone (PEEK) polymer
* Other as specified in approved protocol
N-acetylcysteine (NAC) for Children With Tourette Syndrome

Tourette syndrome is a childhood-onset neuropsychiatric disorder characterized by multiple motor and vocal tics that last for at least a year in duration. Currently, there exist several effective pharmacological treatments for childhood tics including alpha-2 agonist medications (guanfacine and clonidine) and neuroleptics (antipsychotic) medications. These medications, however, have significant side-effects and are only partially efficacy in treating tics.

N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and glutamate modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with NAC is nausea and this side-effect is seldom seen in the doses used in this trial.

NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled trial in adults with trichotillomania (chronic hair pulling). Hairpulling is hypothesized to be closely related to tics because these conditions (1) have similar clinical characteristics -- both groups typically experience urges before engaging in pulling or tics, (2) neuroimaging studies suggest they involve similar brain circuits -- the basal ganglia, (3) the same pharmacological treatments (neuroleptics) may be effective for both conditions and (4) they tend to be inherited together in families. In other trials NAC has evidence of some efficacy in treating diverse psychiatric conditions such as bipolar depression, schizophrenia and cocaine dependence.

The investigators are conducting this trial to determine if NAC is an effective treatment for tics.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 8-17 years.
* Primary diagnosis of Tourette syndrome or chronic tic disorder.
* Duration of tics greater than 1 year.
* Significant Current tic symptoms: Current YGTSS score greater than or equal to 22 with a TS diagnosis or greater than or equal to 14 with a chronic tic disorder.

Exclusion Criteria:

* Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (IQ\<70).
* Recent change (less than 4 weeks) in medications that have potential effects on tic severity (such as neuroleptic medications, dopamine agonists, alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, psychostimulants, or anxiolytics). Medication change is defined to include dose changes or medication discontinuation.
* Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
* Asthma requiring medication use within the last 3 months
* Known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation
* Positive pregnancy test or drug screening test.
* Previous use of N-acetylcysteine (dose greater than 600mg for more than 2 weeks)
Characterization of the Charcot Foot

The project concerns a type of very debilitating diabetic foot complications called Charcots osteoarthropathy (COA). This disease is characterized by a rapidly progressing destruction of the load bearing joints, primarily in the feet, resulting in loss of structure and remodeling. Untreated this cascade leads to the collapse of the bones, meaning severe pain and walking disability for the patient. Reconstruction is often very difficult or impossible, and furthermore the collapse can lead to chronic foot ulcers and infections, which in the worst case can be fatal.

Treatment options are currently limited to early diagnosis and physical offloading (immobilisation), assisted wound healing and surgical intervention.

The purpose of this project is to investigate and describe the bone-related factors, which separate COA from other, less acute, diabetic foot changes. The investigators wish to describe the long term consequences of COA - both anatomically, physiologically and biochemically.

The investigators will be doing this in a follow-up investigations on a group of COA patients tested 8 years ago. Little is known of the long term changes to the bone structure after acute COA, and the investigators want to visualize to what extend the bone damage is permanent.

To do this the investigators will be using DXA-scans, x-ray, blood tests including bone markers, neurophysiological tests and occlusion plethysmography.

please see above

Eligibility Criteria:
Inclusion Criteria:

* Followed in the previous study

Exclusion Criteria:

* Unable to attend follow-up
Botswana Vitamin D Supplementation Study in HIV/AIDS

The goal is to determine the vit D supplementation dose that safely results in optimal serum vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).

Many people living with HIV/AIDS in African countries are vit D deficient or insufficient. Vit D deficiency in HIV/AIDS may be due to low dietary vit D intake, increased requirements, malabsorption, specific drug therapies (antiretrovirals, in particular), reduced outdoor physical activity, reduced vit D synthesis from UV light exposure in dark skin pigmented individuals, or unknown HIV-associated factors. Vit D deficiency likely contributes to abnormal immune status and increased inflammatory state, and to poor growth, bone, and muscle function, and may contribute to risk for tuberculosis (TB) infection. The goal is to determine the vit D supplementation dose that safely results in optimal serum 25D concentrations in HIV-infected children and adults living in Botswana.

To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Ages 5.0 to 50.9 y
* In usual state of good health
* Subject and/or family commitment to the 12-week study

Exclusion Criteria:

* Other chronic health conditions unrelated to HIV/AIDS that may affect nutritional status
* Use of vit D supplementation above 400 IU/d
NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball Players

To determine the validity of the Gx Sweat Patch in measuring sweating rate and sweat chloride concentration during moderate-high intensity practice against well-established reference methods in field conditions with basketball athletes


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years of age
* Subject is participating in training/competition with the NBA G-league
* Subject is participating in a coach led practice

Exclusion Criteria:

* Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages)
* Subject has participated in a clinical trial within past 30 days
* Subject has participated in any PepsiCo trial within past 6 months
* Subject has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal

Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. We are interested in knowing if a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved drug, palonosetron) can more effectively treat withdrawal symptoms with or without combination with an antihistamine called hydroxyzine (vistaril).

We hope to learn if Palonosetron and/or combination with hydroxyzine can be used to prevent or attenuate the signs and symptoms of opioid withdrawal. If we find that it can help prevent these symptoms, it may become a new treatment that can aid patients suffering from these symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Ages 18-35
* No allergies to morphine or palonosetron
* No history of addiction or substance abuse

Exclusion Criteria:

* Female
* Younger than 18 or older than 35
* History of substance abuse
* Raynaud's disease or coronary artery disease
* Allergies to morphine or palonosetron
To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves

This proposal will test if, in patients with type 1 diabetes, wide blood glucose fluctuations lead to the injury to heart nerves , called cardiac autonomic neuropathy (CAN), and to impaired heart contractile (pumping) function and heart failure. It will also evaluate the natural history of heart failure and enhanced cardiac risk in patients with type 1 diabetes in the current standard of diabetes care.


Eligibility Criteria:
Inclusion/Exclusion Criteria:

* Male or female between the ages 18-65, with type 1 diabetes of 5-10 years duration who are free of complications and age-and-sex-matched healthy control volunteers.
* Hemoglobin A1c greater than 7 %. (For Type 1 diabetics)
* If you are a woman of childbearing potential you must agree to use an acceptable birth control method throughout the duration of the study. The methods of birth control that you can use are: Oral contraceptives (birth control pill), IUD or a barrier method (e.g. diaphragm or condom with spermicide).
* You should have no history of any cardiovascular disease including any form of coronary artery disease, congestive heart failure, known arrhythmias (irregular heart beats), valvular disease or high blood pressure.
* If you have any pacemaker or ICD, if you have any metallic foreign body such as surgical implants or clips or foreign bodies in the eye or orbits, wearing medication patches containing foil, or any other metal in the body or if you are claustrophobic you cannot participate in this study.
* You should be free of any diabetic complications (e.g. nephropathy or kidney damage, retinopathy or eye damage), have no history of previous kidney, pancreas or cardiac transplantation, any other severe chronic illness that has neuropathy (numbness, burning or tingling) and/or neurologic disease as a recognized complication (e.g. Parkinson's disease, epilepsy), or any other serious medical conditions that may shorten life span (e.g. disabling stroke, Chronic Obstructive Pulmonary Disease).
* You should be free of any malignancy other than basal cell skin cancer.
* No history of alcohol abuse.
* You should not use any agents or drugs that interfere with the imaging techniques described below.
* You must be able to cooperate with the test protocols that are described below and be willing to sign this consent form.

Inclusion for Control group:

* BMI \<30
* If female, must not be pregnant or nursing
* Normal blood pressure
* Normal labs-(glucose and lipids)