cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BEA 2180 BR in Healthy Male Subjects

Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium bromide is able to protect of methacholine-induced bronchoconstriction compared to baseline (methacholine challenge at screening).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory test
* No finding deviating from normal and of clinical relevance
* No evidence of a clinically relevant concomitant disease
* Age ≥ 30 and Age ≤ 55 years
* Body Mass Index (BMI) ≥ 18.5 and BMI \< 30 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator (or his deputy)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance

Exclusion criteria specific for this study:

* Bronchial hyperreactivity as demonstrated by a 45% change of SGaw at or below a cumulative methacholine concentration of 10 mg/mL = 1%
* Asthma or bronchial hyperreactivity
* Allergic rhinitis (hay fever)
* Glaucoma
* Urinary tract obstruction
* Epilepsy
* History of cardiovascular disease
* History of peptic ulcer disease
* History of thyroid disease
Safety and Efficacy of Overnight Closed Loop in Children With Type 1Diabetes Mellitus in Luxembourg

The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .


Eligibility Criteria:
Inclusion Criteria:

* Between 6 - ≤12 years
* With type 1 diabetes for 6 months or more and
* Pump user for at least 6 months.
* HbAc1 should be \<11 %.
* No medication or physical or psychological disease should be present, which could interfere with the study.

Exclusion Criteria:

-None
Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients

Elevated blood pressure (BP) consists of a major public health concern especially in low and middle income countries. Besides being a highly prevalent condition, it is also a risk factor for several major cardiovascular events including stroke (which consists of the second leading cause of death in developing countries) and coronary artery disease, and is also related to cognitive decline. The OPTIMAL Stroke trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower target systolic blood pressure (SBP) as compared to the currently recommended target for stroke patients will reduce the occurrence of major cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

* History of ischemic stroke or transient ischemic attack (TIA), considered clinically stable in the 48 hours prior to inclusion in the study. (they will be classified into a recent stroke \<120 days or chronic when\> 120 days), AND
* Systolic Blood Pressure (SBP) between 130 and 180 mmHg:

  * 130 -180 and use of up to one antihypertensive drug;
  * 130-170 and use of up to two drugs;
  * 130-160 and use of up to three drugs;
  * 130-150 and use of up to four drugs. AND

Exclusion Criteria:

* Severe disability after the event that qualified the patient for the study, defined as a modified Rankin (mRankin) scale equal to or greater than 4.
* Being part of another clinical trial involving interventions for cardiovascular prevention.
* Body mass index \> 45 kg/m2.
* Pregnancy or Breastfeeding.
* Secondary hypertension.
* Class IV Canadian Cardiovascular Society (CCS) Resting Angina.
* Acute coronary syndrome in the last six months
* Severe renal dysfunction with GFR \< 20 mL/min/1.73m2 calculated by the CKD-EPI equation
* Refusal to consent.
* Symptomatic heart failure - Class IV New York Heart Association (NYHA) or ejection fraction \<35% on Doppler echocardiography.
* Conditions that, at the investigators' discretion, limit the patient's participation in the study, including but not limited to the following:

  * Recent history of alcohol and illicit drug abuse.
  * Psychiatric comorbidities (severe depression, schizophrenia, psychosis, etc.).
  * History of poor drug adherence and no attendance at consultations.
  * Planning to change of address in the next four years.
  * Planning to be absent from home city for more than three months in the next year.
  * Residing in the same residence of another patient previously included in this study.
The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology

The proposed research is an intervention and feasibility pilot trial designed to determine if short-term consumption of healthy cookies made with an oil rich in linoleic acid can influence mitochondria biology in white blood cells and muscle. The hypothesis of the study is that consuming 1 healthy cookie rich in linoleic acid each day for two weeks will improve mitochondrial biology in white blood cells and muscle.

Linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin and mitochondria.

The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following four specific aims

Aim 1) To assess muscle biopsy yield with a micro biopsy needle

Aim 2) To determine the amount of peripheral blood mononuclear cells (PBMC) and muscle needed to measure mitochondria function

Aim 3) To assess the feasibility of measuring mitochondria function on fresh PBMC and muscle samples

Aim 4) To determine the effect of short-term healthy cookies made with linoleic acid rich oil on measures of mitochondrial function in white blood cells and muscle as well as their relationship to lipid composition of the blood, markers of metabolic health and markers of mitochondria biogenesis

Eligibility Criteria:
Inclusion Criteria:

* Nonsmoker

Exclusion Criteria:

* Allergy/intolerance to lidocaine
* Gastrointestinal diseases or disorders (including pancreatic) or gastric bypass surgery
* Food Allergy or Intolerance
* Any dietary restriction where consumption of these healthy cookies or any ingredient would be contraindicated
* Use of medications where consuming the healthy cookies would be contraindicated
* Pregnancy
* Use of anticoagulant, antiplatelet, or other blood thinner medications
* Diabetes
"Assessing Barriers to ADA Guideline Adherence"

This project involves a comprehensive assessment of barriers to diabetes guidelines adherence across 25 practices in the Crozer-Keystone primary care PBRN. A Barrier Assessment Tool (BAT) will be validated to correlate with provider and practice adherence to diabetes care guidelines. The network is part of the Crozer-Keystone Health System located in Delaware County, Pennsylvania, in the southeast quadrant of the Philadelphia metropolitan region.

Study hypothesis: Questionnaire responses about perceived barriers to implementation of diabetes care recommendations, administered to primary care providers and staff, will be shown to correlate with that provider's and practice's success at implementing care guidelines.

Diabetes care in the U.S. consistently fails to meet recommended quality standards. Barriers impede the translation of evidence-based guidelines into sustainable practice. Few studies have considered multiple barriers, and there is a lack of evidence-based strategy in choosing interventions to overcome barriers. This study involves a comprehensive assessment of practice barriers to diabetes guidelines adherence across a primary care network. The BAT based upon a framework proposed by Cabana, et al (1999) will be validated to correlate with provider and practice adherence to diabetes care guidelines. A Diabetes Flow Sheet implemented in our Network to track adherence to guidelines will be assessed and correlated with measured barriers. This organizational strategy will support an evidence-based approach to quality initiative interventions. The BAT will be administered to practice team members: providers, support staff, and practice managers in our Network of 25 primary care practices. Five hypotheses are tested:

A: The BAT measures perceived barriers to adherence to diabetes guidelines, while showing adequate internal consistency and an identifiable subscale structure.

B: The BAT results inversely correlate with practice and provider adherence to ADA guidelines.

C: BAT scores will inversely correlate with use of the Diabetes Flow Sheet.

D: The BAT scores inversely correlate with clinical outcomes (glycemic and lipid control.)

E: Use of the Diabetes Flow Sheet correlates with higher provider and practice adherence to ADA guidelines.

The BAT would then provide the structure for comprehensive assessment of barriers. Study of the Crozer-Keystone PBRN is a real-world laboratory for research in the translation of evidence into diverse practices. The Network is optimally positioned to implement and study this organizational strategy.

Eligibility Criteria:
Inclusion Criteria:

* Crozer-Keystone Health Network primary care (Internal Medicine and Family Medicine) providers and support staff in the 25 primary care practices.
The Impact of Continuous Renal Replacement Therapy on the Outcomes of Burn Patients With Early Phase of Sepsis

The purpose of this study is to determine if early application of CRRT will result in an improvement of clinical outcomes of burn patients during the early phase of sepsis

The impact of Continuous Renal Replacement Therapy (CRRT) on the outcomes of patients with sepsis is controversial, and there is no consensus for the timing and dose of CRRT may improve the outcomes. The purpose of this prospective randomized study is to assess the effect of different CRRT intensity (25ml/kg/h or 50ml/kg/h) on the outcomes of burn patients with early phase of sepsis

Eligibility Criteria:
Inclusion Criteria:

* patients with documented sepsis
* clinically identified focus of infection associated with at least 2 SIRS -criteria and one or more sepsis-induced organ failures within the 24 hours -prior to inclusion
* age 18 to 70 years
* severe burned patients with 50% \< TBSA \< 85%

Exclusion Criteria:

* cirrhosis child class C
* too high APACHE II \& SOFA score at admission
* age over 70 years
* were presence of a malignant tumor, chronic renal insufficiency (serum creatinine \> 133 µmol/L), moribund state, receiving immunosuppressive therapy or receiving any kind of renal replacement therapy before randomization
Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis

The objective of this project is to determine the effect of aquatic exercise and aquatic exercise combined with an education program on decreasing fall risk in older adults with hip osteoarthritis. The hypothesis is that aquatic exercise will improve function, strength and balance and the addition of the education session will enhance confidence in movement.

Older adults with hip osteoarthritis (OA) often experience pain and loss of mobility that significantly impairs their ability to walk, climb stairs, shop or participate in exercise programs. This can result in social isolation, depression and loss of confidence in their ability to manage independently in the community. A decline in physical and psycho-social function leads to increased risk of falling. It is crucial to identify high-risk fallers as well as the best interventions to decrease that risk; hip fractures from falls are devastating, resulting in death or admission to long-term care for the majority who sustain them.

Exercise programs designed to improve balance, strength and mobility can help to improve function and decrease risk of falling. However, individuals with hip OA may have difficulty participating in these programs due to pain. Aquatic exercise offers an activity alternative to improve mobility, strength and decrease fall risk. As well, the addition of a group program designed to enhance confidence in movement may further reduce the risk of falls by improving independence to be more active at home and in the community.

This project will evaluate the effect of aquatic exercise and aquatic exercise combined with a group educational program on decreasing fall risk in older adults with hip OA. Determining optimal fall prevention programs may avert death and loss of quality of life for older adults, clearly an important contribution to preventative health care.

Eligibility Criteria:
Inclusion Criteria:

* over age 65
* clinical diagnosis of hip osteoarthritis

Exclusion Criteria:

* medical condition tha significantly decreases functional ability such that not safe to exercise in a community program
* already exercising in a moderate exercise program 2/week or more
Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury

This is a randomized controlled trial to study a nutrition education intervention in individuals with spinal cord injuries both in the acute rehabilitation setting (n = 100) and the community setting (n = 100). Participants in the treatment group will receive six interactive nutrition lectures based upon a successful program that has been used in older adults titled "Eat Smart, Stay Well". The goals of intervention are to improve whole-grain, fruit and vegetable, and low-fat dairy intake and reduce fat and saturated fat intake. Secondary outcomes will include improvements in waist circumference of body mass index and some biomarkers such as cholesterol and blood sugar.

The prevalence of SCI is significant. Obesity, diabetes, and CVD are more prevalent in the SCI population. Many individuals with SCI are unable or have a limited capacity to exercise. This reality makes good nutrition even more urgent. This study will be the first to test whether additional nutrition education can improve nutrition behavior and knowledge, diet quality, adiposity, and metabolic CVD risk factors in individuals with SCI and to determine the best setting to deliver nutrition education to individuals with SCI.

Eligibility Criteria:
Inclusion Criteria:

* American Spinal Injury Association classification A, B, C as long as they are not functional ambulators

Exclusion Criteria:

* Stage III or IV pressure ulcers, pregnancy, end-stage renal disease, treatment for cancer except for nonmelanoma skin cancer within the past five years, and chronic, nontobacco substance-abuse, cognitive impairment with inability to learn
Primary Osteoarthritis Lumbar Spine: Establishing Its Cause, Pathogenesis and Treatment.

The study was about a root cause of Primary Osteoarthritis Lumbar Spine producing disabilities in sitting, climbing and walking etc. In advance stage the person is bereft of his/her personal physical activities. The prevalent treatment is temporary and dis-satisfactory. A new treatment was designed and a trial was conducted on 154 patients (100 in the trial group, 50 in the control group) for a duration of six months.

The study was focused on establishing the cause, pathogenesis and treatment of painful Lumbar Spine disease (Primary Osteoarthritis Lumbar Spine = OA Lumbar Spine) at present the exact cause and treatment are not known. It was aimed to find out to latter through a hypothesis by designing a treatment and testing it with a clinical trial.

This established that the deficient full extension of the spinal joints (intervertebral joints between the adjacent vertebrae from T12 to S1) producing contracture in their capsules in front, was the cause and the correction (Contracture Correction Therapy = CCT) was the cure of the disease. The correction was carried out by intermittent and sustained extension of the lumbar spin through three designed body postures.

Eligibility Criteria:
Inclusion Criteria:

* Age =\>30 and \<=90 years
* Back/leg pain or both combined, which appears without any apparent cause, exacerbated by exertion and subsides by rest.
* Presence of limited morning stiffness
* No history of infection, inflammation or trauma to rule out secondary OA
* Disability in sitting, climbing stairs or walking

Exclusion Criteria:

* Neckache
* Frozen shoulder
* Central obesity
* Acute Lumbago
* X-ray spine with no OA signs
A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection

This study evaluates patients infected with both HIV and Hepatitis C virus (HCV) who are receiving anti-HIV drugs. The purpose of this study is to learn more about HCV infection in patients whose HIV blood level decreases to less than 500 copies/ml.

Sixty naive patients with HIV and confirmed hepatitis C who are co-enrolled in another AACTG antiretroviral study that involves the testing of HAART (Highly Active Antiretroviral Therapy) are entered on this prospective study. Patients who are defined as naive have never received specific, active antiretroviral agents that sustain viral suppression below the limit of detection (500 copies/ml) or have received those agents for only a very limited time. HAART is defined as therapy which is likely to result in HIV-1 RNA plasma levels less than 500 copies/ml for at least 16 weeks. Plasma is collected and evaluated during the study for additional quantitative measurements: Hepatitis C virus (HCV) by HCV RNA PCR and HIV-1 RNA levels. All evaluations for HIV-1 RNA are obtained from the co-enrolled study at the following time points: Pre-entry, entry, at least 2 measurements before Week 16, Week 16, and at least 1 measurement after Week 16.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive and have Hepatitis C.
* Have an HIV blood level of at least 2,500 copies/ml 30 days before study entry.
* Are co-enrolled in an active adult AIDS clinical trial using anti-HIV treatment.
* Are at least 13 years of age (parent or guardian consent required if under 18).

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have liver disease.
* Have cancer requiring chemotherapy.
* Have Hepatitis B.
* Abuse alcohol and/or drugs.
* Have received certain antiretroviral (anti-HIV) drugs in the past.
Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders

In neuromyelitis optica spectrum disorder (NMOSD),interleukin-6 (IL-6) may play an important role in facilitating plasma cells to produce pathological aquaporin 4 (AQP4) autoantibody. Inhibition of IL-6 signaling pathway by Tocilizumab (ACTEMRA®), a humanized monoclonal antibody may have shown beneficial clinical effects in a few patients with NMOSD.

Larger scale clincial trials may be needed to observe its efficacy and safety. Here, by choosing azathioprine, one of the most frequently used medication in case of relapses, the investigators compare the safety and efficacy of tocilizumab in preventing NMOSD attacks.

The investigators primarily aim to observe the time to first relapse from initiation of tocilizumab or azathioprine treatment. The proportion of participants who experience relapse-free in one year follow-up will be compared.

The secondary outcomes are to determine: The safety profile of tocilizumab and azathioprine in participants with NMO and whether tocilizumab improves visual function, Expanded Disability Status Scale (EDSS), et al.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 18 years old
2. Diagnosis of NMO or NMO spectrum disorder
3. Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months
4. Able and willing to give written informed consent and comply with the requirements of the study protocol.
5. EDSS \<= 7.5 (8 in special circumstances)
6. Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.

Exclusion Criteria:

1. Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus,human immunodeficiency virus, Hepatitis viruses, Syphilis, etc)
2. Pregnant, breastfeeding, or child-bearing potential during the course of the study
3. Patients will not participate in any other clinical therapeutic study or will not have participated in any other experimental treatment study within 30 days of screening
4. Participation in another interventional trial within the last 3 months
5. Heart or kidney insufficiency
6. Tumor disease currently or within last 5 years
7. Clinically relevant liver, kidney or bone marrow function disorder
8. Intolerance of azathioprine or previous relapses on azathioprine treatment
9. Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
TDM Guided Early Optimization of ADAL in Crohn's Disease

To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.

This is an investigator initiated randomized open label study. This study is designed to compare whether increasing the dose of adalimumab based on the level the drug in the blood to a target level early in the treatment course would lead to better outcomes for patients as compared to the standard doses.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation).
* Active disease based on Harvey Bradshaw Index (HBI \>5) and elevated C-reactive protein (CRP) (\>normal reference range for local laboratory) OR fecal calprotectin (FCP) (\>250 µg/g)
* Due to commence treatment with ADAL.

Exclusion Criteria:

* Severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease.
* History of active HIV, hepatitis B or C infection,
* Patients with ileostomy/colostomy, ileal-pouch anal anastomosis or severe perianal fistulising disease.
* Pregnancy
* Prior exposure to ADAL