cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study in Subjects With Asthma

The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.

The study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. The study will enroll asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment with an FEV1 of between 40-85% of predicted normal and with airway reversibility as demonstrated by an increase in FEV1 of ≥12% and ≥200ml .

Efficacy assessments include 24-hour serial lung function testing. Safety assessments include incidence of adverse events and measurement of vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient
* ≥18 years of age at Visit 1
* Male or Eligible Female
* Diagnosis of asthma at least 12 weeks prior to Visit 1
* Disease reversibility
* Current anti-asthma therapy
* Appropriately signed and dated informed consent has been obtained
* Able to comply with all the study requirements

Exclusion Criteria:

* History of Life-Threatening Asthma
* No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
* No concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation
* Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate
* History of severe milk protein allergy
* Non-compliance with study medication and other study-related requirements
* No use of inhaled tobacco products within the past three months or historical use of 10 pack years or more
* Administration of prohibited medications and non-drug therapies and corresponding timeframes as outlined in the protocol
Atomoxetine for Freezing of Gait in Parkinson's Disease

Subjects are being asked to participate in this study to determine the safety and effectiveness of a drug called atomoxetine in the treatment of freezing of gait for Parkinson's Disease patients. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD, but has been found to be well tolerated in this patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn and Yahr stage 2-4
2. A positive response to item 14 of the UPDRS, part 2.
3. Age range 18-80
4. Ability to walk a minimum of 20 feet without assistive device and with one observed freezing episode which may be triggered by visual cue
5. Letter of medical clearance by primary care physician dated within preceding 2 months of subject's initial active study visit.
6. Stable on PD medications for ≥ 3 months

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Exclusion Criteria:

1. Intolerance to drug class
2. Mini-Mental Status Examination \<26/30
3. No observable episodes of freezing of gait despite common visual cues
4. Not on stable PD medications for 3 months
5. Subjects who whose gait disturbance is due to other conditions not related to PD or FOG.
6. Current use of monoamine oxidase inhibitor (MAO-I)
7. Hypersensitivity to drug class
8. Narrow angle glaucoma
9. Pheochromocytoma
10. Severe cardiovascular disorders, i.e. patients with pre-existing conditions that would be expected to deteriorate if their heart rate or blood pressure were to increase in a clinically significant manner (e.g. 15-20 mmHg increase in blood pressure or 20 beats per minute in heart rate).
11. Patients with uncontrolled hypertension.
12. Patients with a history of symptomatic tachyarrhythmias.
13. Presence of uncontrolled depression and suicidal ideation.

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The 2-minute Walk Test in Hemodialysis Patients

Walking tests are widely used to assess functional capacity in different populations because of their ease of administration, interpretability and representativeness of activities of daily living.The aim of our study was to investigate the validity and reliability of the 2-minute walk test in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with end stage renal disease receiving hemodialysis
* Being clinically stable
* Being Aged between 18-80
* Volunteering to participate in this study

Exclusion Criteria:

* Having a musculoskeletal problem that may affect functional capacity measurement
* Having had a cardiac event in the past 3 months
The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures

The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with distal radius fractures treated with open reduction and Locking Compression Plates(LCP).

Despite fractures of the wrist being widely regarded as "fragility fractures", there is good evidence that they are caused by diminished Bone Mineral Density (BMD) and that a low BMD value predicts a higher fracture risk at the distal radius. Both measurements of areal BMD with DXA and volumetric BMD with peripheral Quantitative Computer Tomography (pQCT)showed a lower BMD in women with Colles' fractures. Thus, Colles' fractures can be recognized as a good indication of underlying osteoporosis. High resolution peripheral Quantitative Computer Tomography at the distal radius will be evaluated in a subset of patients.

Clinical experts are concerned that osteoporosis increases the risk for poor outcomes and complication rates in surgical patients with osteoporosis. However, this has not yet been confirmed in clinical studies. It is important to investigate this question in order to correctly advise clinicians and patients and possibly develop tailored approaches for treatment of osteoporotic patients with distal radius fractures.

Eligibility Criteria:
Inclusion Criteria:

* Radiologically confirmed closed fracture (within 7 days) of the distal radius
* Primary fracture treatment with a volar LCP 2.4 mm
* Age equal greater 50 and equal younger 90 years
* Willing and able to give written informed consent to participate in the study
* Willing and able to participate in the study follow-ups according to the CIP
* Willing and able to comply with the post-operative management program
* Able to understand and read country national language at an elementary level

Exclusion Criteria:

* Fracture of ulna (except an associated fracture of the ulnar styloid process)
* Open distal radius fracture
* Concomitant contralateral radius fracture
* Previous distal radius fracture on either side after the age of 25 years
* Time to operation \> 7 days
* Polytrauma
* Regular systemic therapy with corticosteroids due to chronic disease
* Legal incompetence
* Patient received radio- or chemotherapy prior to, during, or within the last year
* Currently active cancer
* Recent history of substance abuse (i.e recreational drugs, alcohol)
* Prisoner
* Currently involved in a pharmaceutical study
* Has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metabolic disorders)
Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation

Children, ages 8 - 17, will be enrolled in a research study about the impact of aromatherapy on nausea in the pediatric rehabilitation unit.

Children will participate in the study for two weeks. One week the child will receive a aromatherapy product for nausea and the other week the child will not receive the product.

If this aromatherapy is effective at decreasing nausea, the child may be more likely to participate in their rehabilitation therapy sessions. Information gathered during the study may potentially benefit other patients by helping to develop hospital practices of using aromatherapy in the pediatric rehabilitation unit.

Children participating in the study may or may not help the child but may help children in the future:

1. Children may have less nausea, which could help them feel better, more likely to participate in their rehabilitation activities, and may be able to take better care of themselves.
2. Children may have a reduction in the need for taking medications that help nausea.
3. The research may benefit children in the future by helping to develop hospital practices about using aromatherapy in pediatric rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 8 to 17 years of age on the rehabilitation unit and service at Arkansas Children's Hospital
* Patients with a Glascow Coma Scale (GCS) of 13-15
* Patients with a Rancho Los Amigos Revised Scale score of 5 or higher
* Ability to read and write in English
* Patient to have an expected length of stay of at least 2 weeks

Exclusion Criteria:

* Patients with any mechanical or obstructive pathophysiology (appendicitis, bowel obstruction, or intussusception, etc.)
* Known allergy or sensitivity to lavender, peppermint, spearmint, or ginger
* Patients with known asthma and/or pulmonary conditions
* Wards of the State or any other agency or institution
Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation

Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic stem cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplants from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed.

The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.

Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects.

As such, it may be effective for both prevention and treatment of acute GVHD after allogeneic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years
2. Acute GVHD grade I/II
3. No history of psychosis
4. Signed informed concent

Exclusion Criteria:

1. Acute GVHD grade \> II
2. History of psychosis
3. History of asthma
Influence of Monopoly Game on Subtle Behaviors

The purpose of this research study is to investigate how social standing in a game of Monopoly may influence behavior.

Participants will be asked to fill out questionnaires/surveys and health measures will be collected throughout the study visit. These health measures will include: blood pressure, heart rate, height/weight, waist circumference, percent body fat, resting metabolic rate, and salivary cortisol. Breakfast will be provided and then a 40-minute game of Monopoly™ will be played, and lunch will be provided after the game. Participants will be given an accelerometer to measure movements, and a food diary to be used for a 24-hour period. Once the 24-hour monitoring period has been completed, the participants will be finished with the study activities. The accelerometer and food diary will be returned by either bringing them to the investigators or mailing the items back to the investigators.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic American adolescents born in the United States
* Have played Monopoly before

Exclusion Criteria:

* Clinical depression
* A diagnosis of cardiovascular disease (active or within the past 6 months), cancer (active or within the past 2 years, except non-melanoma skin cancer), diabetes (type 1 or 2), active or chronic infections, gastrointestinal disease, active kidney disease, lung disease, uncontrolled psychiatric disease
* An eating disorder or severely restricted diet
* Use of tobacco products
* Substance abuse disorder
* Take any medications known to affect appetite or body composition
* Participation in any weight-reduction programs, weight-loss diets, or other special diets within the previous 3 months
* Experience of weight loss or gain of 10 pounds or more of body weight in the past 6 months for any reason except post-partum weight loss
* Current/Anticipation of pregnancy during study
* Currently nursing or within 6 weeks of having completed nursing
Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation

This study on patient's compliance in clinical workaday life aims to assess and to improve CML treatment in Germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 years) CML patients in the chronic phase
* Medical history of cytogenetically confirmed CML-CP by the presence of the Philadelphia chromosome on bone marrow aspirates (a minimum of 20metaphases is required; FISH cannot be used); Philadelphia chromosome negative but BCR- ABL-positive CML patients can be included
* ECOG performance status of \< 2
* Imatinib treatment for at least 1 year and showing CCyR or MMR
* Prior treatment with chemotherapeutics such as hydroxyurea or interferon- alpha is allowed
* Prior periods of accelerated phases are allowed
* Negative pregnancy test for female patients of childbearing potential within 7 days before initiation of study drug
* Ability to understand and willingness to sign a written informed consent document prior to any study related screening procedures
* Written informed consent, including the consent to be called for interviews by the external, neutral institution.

Exclusion Criteria:

* Patients with prior blast crisis or stem cell transplantation
* Patients with severe medical condition(s) that in the discretion of the investigator prohibits participation in the study (e.g., clinically significant heart diseases, uncontrolled diabetes, active or uncontrolled infection, impaired gastrointestinal function/diseases)
* Treatment with drugs or substances, especially those known to modify the cytochrome P450 activity, should be either discontinued or exchanged by different medication (see link for complete list of these medications: http://medicine.iupui.edu/flockhart/table.htm.)
* Pregnant or breastfeeding women
* Male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib

The purpose of this study is to evaluate the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib.

200 subjects who meet the inclusion/exclusion criteria treated by capecitabine +/- lapatinib, will be enrolled into the study. Adherence to treatment of all subjects will be assessed during a first adherence evaluation period of 3 cycles in order to identify patients who need educational intervention(non adherent patients). Only nonadherent patients (adherence rate \< 80%) will receive an education intervention. During the educational program, the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib will be evaluated for the 6 subsequent cycles.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* histologically confirmed breast cancer or colorectal cancer
* Patient starting oral treatment : capecitabine alone or in combination with lapatinib (can be included before the first cycle or during the first 2 cycles).
* Volunteer to participate in the study.
* ambulatory treated patient
* Able to read, write and understand French.
* Subject who accept to use MEMS monitors to automatically compile their drug dosing histories
* Written informed consent

Exclusion Criteria:

* more than 3 metastatic chemotherapies
* any severe concomitant condition which makes it undesirable for the patient to participate in the study or which would jeopardize adherence with trial protocol
Effect of EGb761® on Brain Glucose Metabolism in Three Groups of Elderly Defined by Cognitive Functions

The aim of the study is to evaluate the effect of EGb761®, in comparison to placebo, on cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild Alzheimer's disease (AD), memory complaint patients with cognitive impairment (MC) and memory complaint patients cognitively normal (CNE). The first phase includes four weeks treatment with EGb761® for all groups, with change in brain glucose metabolism at month 1 using 18 FDG-PET, as primary endpoint which will be followed by an open 17 months follow-up (FU) period with EGb761® treatment in MC and CNE patients.


Eligibility Criteria:
Inclusion Criteria:

* Group Specific Inclusion Criteria:

Cognitively normal elderly (CNE)

* Spontaneous memory complaint by patient,
* Mini-Mental State Exam score ≥ 28.
* Clinical Dementia Rating = 0.
* No Diagnostic And Statistical Manual Of Mental Disorders, Fourth Edition (DSMIV) criteria for Dementia.

Memory complaints (MC) :

* Spontaneous memory complaint by patient
* Mini-Mental State Exam score ≥ 25
* Clinical Dementia Rating 0.5.
* No DSMIV criteria for Dementia.

Mild Alzheimer's Disease (AD):

* Mini Mental Status Examination (MMSE) between 20 and 28 (inclusive).
* Clinical Dementia Rating ≥ 1.0
* DSMIV criteria for Dementia.
* National Institute of Neurological and Communicative Diseases and Stroke / Alzheimer's Disease and Related Disorders Association(NINCDS/ADRDA) criteria for probable AD.
* Newly diagnosed patients without treatment by Cholinesterase Inhibitors or Memantine.
* ≥ 65 years of age, both sex
* Geriatric Depression Scale (GDS) \< 15
* Informed consent signed by the patient or, if necessary by legal representative

Exclusion Criteria:

* Contraindication to Magnetic Resonance Imaging (MRI) and/or Positron-Emission Tomography (PET) scan
* Forbidden Concomitant medications (Cholinesterase inhibitors and memantine, Specific psychoactive medications,e.g., neuroleptics, chronic anxiolytics including meprobamate, or sedative hypnotics other than benzodiazepines, Monoamine oxidase inhibitors (MAOIs) including selective MAOIs. Drugs acting on cerebral nervous system, Antidiabetes medications , Antioxidants medications, Medications known to interfere with cognitive evaluations
* Significant neurological disease and psychiatric disorders/psychotic feature
* Significant medical illness
Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

This pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. Diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise require biopsy for confirmation.

PRIMARY OBJECTIVES:

I. To obtain preliminary data to support the hypothesis that contrast enhanced mammography (CEM) can reduce benign tissue diagnosis (FP3) and therefore improve positive predictive value 3 (PPV3).

SECONDARY OBJECTIVES:

I. Identify specific CEM characteristics that accurately classify a finding as benign, high-risk or malignant.

II. Assess the positive and negative predictive values for each digital breast tomosynthesis (DBT), breast ultrasound and CEM.

EXPLORATORY OBJECTIVES:

I. To compare the outcomes/endpoints stratified by age to determine if age affects the ability of CEM to accurately define a lesion as benign, probably benign or suspicious.

OUTLINE:

Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day or up to 3 days later.

Eligibility Criteria:
Inclusion Criteria:

* Women with digital breast tomosynthesis and/or ultrasound assessments of Breast Imaging Reporting and Data System (BI-RADS) 4 and 5 lesions with recommendation of needle biopsy for tissue diagnosis.
* Abnormal findings include masses, focal, global or developing asymmetries, architecture distortions, or \> 1 cm of suspicious calcifications with or without associated ultrasound abnormal findings.
* Scheduled for imaging guided percutaneous needle biopsy.
* Provide signed and dated informed consent form.
* If patient is of childbearing potential, a negative pregnancy test, urine or blood, within 14 days prior to the scan.

Exclusion Criteria:

* \< 1 cm span of calcifications without an ultrasound correlate.
* Pregnant patients.
* Patients with known allergy to iodinated contrast material.
* If patient answers YES to any of the below questions they need glomerular filtration rate (gFR) prior to contrast administration regardless of their age:

  * Have you ever been told you have renal problems?
  * Have you ever been told you have protein in your urine?
  * Do you have high blood pressure?
  * Do you have diabetes?
  * Do you have gout?
  * Have you ever had kidney surgery?
Chair Rise and Step Ups on Cardiopulmonary Parameters Among Preserved Ejection Heart Failure Patients

To determine the effects of Chair Rise and Step ups on cardiopulmonary parameters among Preserved ejection Heart Failure Patients


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Preserved ejection Heart Failure Patients
* Both male and female
* Age \> 60 years
* Preserved ejection fraction ≥ 45 %
* HF Duration ≥4 years

Exclusion Criteria:

* End stage heart failure
* Acute coronary syndrome
* Functional status limited due to condition other than heart failure
* Inability to adhere to study protocols.
[68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients

Stimulator of interferon gene (STING) protein plays a vital role in the immune surveillance of tumor microenvironment. Monitoring STING expression in tumors benefits the relevant STING therapy. This study will investigate the safety, biodistribution and potential usefulness of a novel 68Ga-labeled agonist (\[68Ga\]Ga-Sa-DABI-4) for noninvasive positron emission tomography (PET) imaging of STING expression in the tumor microenvironment.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Patients with suspected or newly diagnosed or previously malignant disease.

Exclusion Criteria:

1. Patients with non-malignant disease.
2. Patients with pregnancy.
3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
4. Known or expected hypersensitivity to \[68Ga\]Ga-Sa-DABI-4 or any of its components.
5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.