cyrilzakka/clinical-trials huggingface dataset:
Individualized Pharmaceutical-care for Inpatients With Cancer Pain

The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients

This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older;
* Histologically confirmed solid tumor;
* Diagnosed chronic cancer pain;
* Opioid-tolerant patients;
* Overall survival is expected to be over 3 months;
* Karnofsky performance score≥50;
* Willing and able to comply with the protocol

Exclusion Criteria:

* Current pregnancy or breastfeeding;
* Patients diagnosed with non-cancer pain;
* Patients treated with patient-controlled analgesia;
* Patients with pathological fracture, gastrointestinal obstruction, severe infection, non-opioid related intractable constipation;
* Patients with mental disorder;
* Creatinine clearance rate \<15mL/min;
* ALT or AST ≥ 10 fold of upper limit of normal value
Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs

The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a newly discovered SPL scheduled for EUS-guided tissue acquisition who can understand and provide a written consent.

Exclusion Criteria:

* Patients with uncorrected coagulopathies (INR \>1.5 or platelet count \<50,000) or patients treated with anticoagulants that cannot be discontinued.
* Pregnant or lactating females.
* Interposed, large vessels between the transducer and the target lesion.
Photo-therapy With a Topical Retinoid Versus Photo-therapy Alone for Actinic Keratoses

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy vs photodynamic therapy alone for the treatment of actinic keratoses.

Eligibility Criteria:
Inclusion Criteria

* Adults aged 18-80 years old
* Subjects with AK lesions who will receive PDT
* Subjects with AK lesions in two areas other than face and scalp each with a surface area of 10cm2 or greater and at least 3 clinically diagnosed non-hypertrophic AK lesions in each
* Subjects in good health
* Subjects with willingness and the ability to understand and provide informed consent

Exclusion Criteria

* Subjects who are pregnant or lactating
* Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
* Subjects with use of photosensitizing drugs within 1 week of study start
* Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
* Subjects who received previous treatment of target AKs within 4 weeks
* Subjects who are unable to understand the protocol or give informed consent
A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation

This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* in receipt of an initial cadaveric kidney transplant;
* in receipt of graft with biopsy;
* in receipt of a 'marginal' kidney transplant.

Exclusion Criteria:

* in receipt of a second kidney transplant;
* in receipt of a multi-organ transplant or a double kidney transplant;
* malignant tumor, or a history of cancer in past 5 years, other than successfully treated basal cell or spinocellular cancer or cancer in situ of cervix;
* replicating hepatitis B and/or C, or HIV positive serology.
Allergy to Almond in Children

Allergy to tree nuts are frequent in children but allergy to almond is one of the less described tree nuts allergy. The main objective of our study is to determine diagnostic values of skin prick-tests and specific IgE to almond in a population of children sensitized to almond and challenged in our unit from november 2013 to march 2020.

Secondary objectives are

* description of allergic reactions to almond (symptoms, severity)
* modelisation of eliciting dose to almond in our population
* evaluation of the association between atopic comorbidities and allergy to almond in children sensitized to almond
* evaluation of the association between allergy to almond and the importance of skin and sIgE sensitization

Eligibility Criteria:
Inclusion Criteria:

* oral food challenge to almond performed in the pediatric allergy department of the University Hospital of Nancy from november 2013 and march 2020

Exclusion Criteria:

* doubtful or incomplete oral food challenge to almond
Chest Physiotherapy in Infants Between 0 and 12 Months Old With Acute Bronchiolitis SRV(+)

The purpose of this research is to determine the effect of prolonged slow expiration techniques, provoked coughing and standard therapy compared to chest wall manual vibration and standard therapy in infants between 0 and 12 months old with confirmed diagnosis of acute bronchiolitis SRV (+). The effect will be measured on respiratory insufficiency and use of supplementary oxygen.

Bronchiolitis is the main cause of hospital admission for infants under 1 year old in Chile. Currently, approximately 4800 children are admitted to the hospital during the cold season, affecting the health services' effectiveness. The most frequent causal agent is the Respiratory Syncytial Virus (RSV). To date, there is no specific treatment for this disease and only support measures are recommended.

Chest physiotherapy is a support measure that improves the mucociliary clearance and reduces obstruction of the airways.

A clinical trial on the effect of prolonged slow expiration (PSE), chest wall vibrations, and provoked coughing as treatment for bronchiolitis in infants admitted to the hospital found that the subgroup with RSV required oxygen for 10 hours less than the control group. Gomes and Postiaux (2012) reported a 50% decrease on respiratory distress measured by the Wang score when PSE and suction were compared to traditional chest physiotherapy techniques in patients with bronchiolitis RSV(+).

Currently recommendations in Chile suggest chest physiotherapy for outpatients with bronchiolitis, but the guideline does not refer to the case of inpatients. It is proposed to carry out a randomized controlled trial in infants under one year old. The active group will receive standard therapy, PSE, and provoked coughing, while the control group will receive standard therapy and manual chest wall vibrations. The effectiveness of chest physiotherapy will be measured though a clinical score of respiratory distress, hours using supplementary oxygen, vital signs before and after the intervention in both groups during hospital stay. The main outcome is clinical severity score 48 hours after admission.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of bronchiolitis.
* RSV positive in direct immunofluorescence assay.
* Wang clinical severity score ≥ 4 points.

Exclusion Criteria:

* Patients with heart or neurological diseases.
* Previous episodes of wheezing.
* Chronic conditions such as bronchopulmonary dysplasia, immunodeficiency, or congenital diseases.
* Need of mechanical ventilation in Intensive Care Unit
* Contraindication criteria for chest physiotherapy (i.e. Pneumothorax, ribs fractures, hemodynamic instability).
* Patients not receiving supplementary oxygen.
Understanding Sports Nutrition Knowledge of High School Athletes and Influencers

The objective of this testing is to gain a better understanding of sports nutrition knowledge in high school athletes and their influencers (coaches, strength and conditioning coaches, athletic therapists, dieticians). Since the sports nutrition knowledge of the high school athletes will be limited, nutrition behaviors will be assessed to infer knowledge of sports nutrition.

The secondary objective is to determine the primary sources of nutrition knowledge in these populations.


Eligibility Criteria:
Inclusion Criteria for Athletes

1. Participants are male or female between 14-19 years of age, inclusive.
2. Participants must be participating on a high school varsity team, or Amateur Athletic Union, National, or State travel team.
3. Participants must be attending high school in the United States.
4. Participant understands what is required to complete the study and signs forms providing informed consent to complete the questionnaire
5. Participant or legal guardian is able and willing to sign the Informed Consent Form.

Inclusion Criteria for Influencers

1. Participants must be currently coaching, or a practitioner for a high school varsity team, or an Amateur Athletic Union, National, or State, travel team of high school students aged (14-19 years).
2. Participants must work with/at a high school in the United States.
3. Participant understands what is required to complete the study and signs forms providing informed consent to complete the questionnaire

Exclusion Criteria for Athletes

1. Participant has a condition the Investigator believes would interfere with his or her ability to provide informed consent, which might put the individual at undue risk.
2. Participant is pregnant.

Exclusion Criteria for Influencers

1. Participant has a condition the Investigator believes would interfere with his or her ability to provide informed consent, which might put the individual at undue risk.
AZISAST Study: AZIthromycin in Severe ASThma Study

The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.


Eligibility Criteria:
Inclusion Criteria:

1. patients who have given written informed consent
2. males or females of any race
3. 18-75 years of age
4. with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features
5. receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening
6. patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations within the previous 12 months
7. patients must be never-smokers or ex-smokers with a smoking history of ≤ 10 pack-years.

Exclusion Criteria:

1. females who are pregnant or who are breastfeeding
2. patients with severe bronchiectasis
3. patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)
4. patients with significant underlying medical conditions (e.g. infection, hematological disease, malignancy, neurologic, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
5. who are unable to perform spirometry or complete a patient diary or complete questionnaires
6. patients with known hypersensitivity to azithromycin or other macrolide antibiotics
7. patients who's heart rate corrected QT interval is prolonged
8. patients who have - in the judgement of the investigator - a clinically relevant laboratory abnormality
9. patients currently treated with macrolide antibiotics or recent macrolide treatment (in the past twelve weeks)
10. anti-IgE treatment
Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF)

The proposed study will determine the willingness of patients for participation. Furthermore, the assessment of tests to identify eligible patients and the type of exercise intervention that goes along with a high patient compliance is crucial. Also, more information about possible factors preventing patients from participating is required. Therefore, if the patient is willing to participate, the investigators will assess patients' medical history, medication and QoL as well as parameters of routine diagnostics (i.e. echocardiography, laboratory testing, MRI). Following, while the in-patient stay due to cardiac decompensation, the investigators will conduct several assessment-tests to determine the physical status, the exercise capacity and the cognitive function. Moreover, physiotherapists will instruct the patients in the exercise program. After discharge from the hospital, physiotherapist will visit the patient at home to instruct them again in the exercises. Then, the patients will conduct the program on their own for a period of 12 weeks. During the exercise period, a doctoral student will visit the patients at home every 3 weeks to check whether they are doing the exercises correctly and to determine whether there are any problems with the program. After the exercise period of 12 weeks, the baseline characteristics will be assessed again at the University Hospital Leipzig.

See above

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure irrespective of the ejection fraction
* Recent history of acute cardiac decompensation leading to hospitalization

Exclusion Criteria:

* Patients not willing to participate
* Patients with orthopedic diseases limiting their mobility
* Cognitive diseases that hinder adequate participation in the opinion of the investigator
* Inpatient rehabilitation.
Safety Study of ABT-263 in Combination With Paclitaxel in Subjects With Solid Tumors

Safety study of ABT-263 in Combination with Paclitaxel in Subjects with Solid Tumors.

A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination with Paclitaxel in the Treatment of Subjects with Solid Tumors.

Eligibility Criteria:
Inclusion Criteria

1. Subject must be greater than or equal to 18 years of age.
2. Subject must have a histologically and/or cytologically documented cancer for which paclitaxel has been determined an appropriate therapy, per the Investigator.
3. Subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 28 days prior to the first dose of study drug.
4. Subject has an Eastern Cooperative Oncology Group (ECOG) score of less than or equal to 1.
5. Subject must have adequate bone marrow, renal and hepatic function per protocol defined local laboratory testing parameters.

Exclusion Criteria

1. The subject has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding. The subject has a recent history of thrombocytopenia associated with bleeding within 1 year prior to first dose of study drug.
2. Subject is currently receiving or requires anticoagulation therapy (e.g., warfarin at any dose) or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications such as heparin that are used to maintain the patency of a central intravenous catheter.
3. The subject has active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
4. The subject has active immune thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
5. The subject has a significant history of cardiovascular (e.g., MI, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
Periperal Blood Lymphocytes During Prostate RT

Right now it is not possible to predict which patients are going to react more to RT. Many things could affect patient's response to radiation. One of the factors is whether the person can repair damage to the genetic material (DNA/RNA) caused by the RT. There is some evidence that a certain protein called Gamma H2AX is involved in DNA damage and repair and this can be used to predict the sensitivity of individual patients. The investigators will be studying this protein: Gamma H2AX) in the blood samples of prostate cancer patients exposed to both computed tomography (CT) scan and RT treatment. This will help us to understand why different individuals show differences in side effects following RT.


Eligibility Criteria:
Inclusion Criteria:

* Intermediate-risk prostate cancer patients (T1/T2N0M0 with either GS \< 7 and PSA between 10-20 ng/ml or GS 7 and PSA less than 20 ng/ml).
* Planned for radical RT to the prostate with IMRT planning (79Gy/39fractions or 60 Gy/20 fractions).
* No contraindications to diagnostic CT scanning.
* Prostate volumes will be less than 80 cc to control the planning dose volume histogram (DVH) as much as possible in terms of rectal and bladder volumes.
* No known DNA repair disorders (e.g. family history of AT, BRCA1/2 or Li Fraumeni syndrome) or contraindications to radical pelvic RT.

Exclusion Criteria:

* Inability to provide informed consent.
* Patient having contraindications to diagnostic CT scan.
* Patients who have unobtainable data regarding previous therapy and their clinical outcome.
* Patients should not have any diagnostic X-rays or CAT scans 2 weeks prior to their enrollment into the study.
Alzheimer's Disease Treatment With Combination of 40Hz Light and Cognitive Therapy

Electrical activity in the brain known as "gamma" brainwaves help connect and process information throughout the brain. These gamma waves are diminished in Alzheimer's disease. New research in Alzheimer's disease mouse models shows that exposure to light flickering at the rate of 40 flashes per second or 40Hz increased gamma brainwaves and led to clearing of beta amyloid plaques in the brain, a key abnormality in Alzheimer's disease. This project will test the ability of a novel iPad App (AlzLife https://www.alz.life/) that delivers light therapy at 40 Hz combined with cognitive therapy to improve cognition, function, and quality of life in Alzheimer's disease.

New research suggests that exposure to a light flickering at 40Hz may promote gamma brain wave activity through the photic entrainment phenomenon. These waves have the potential to activate critical cleaning cells in the brain that could eliminate beta amyloid plaques. The most recent research on light therapy for Alzheimer's disease appeared in the journal Nature in 2017, entitled "How flashing lights and pink noise might banish Alzheimer's, improve memory and more" (the full article can be freely accessed at: https://www.nature.com/articles/d41586-018-02391-6) and in 2016, entitled "Gamma frequency entrainment attenuates amyloid load and modifies microglia" (the article abstract can be accessed at: https://www.nature.com/articles/nature20587). Researchers from MIT found that shining a strobe light into the eyes of mice with a rodent version of Alzheimer's disease encouraged protective cells to phagocytize the harmful proteins that accumulate in the brain. The perfect rate of flashes was determined to be 40 per second. Exposure to the flashing light for an hour (light therapy) led to a noticeable reduction in beta amyloid levels the next day in regions of the neocortex and hippocampus. When done every day for a week, beta amyloid levels were greatly reduced.

In addition, there is a significant body of evidence that computerized brain training (cognitive therapy) improves the memory of patients with Alzheimer's and dementia, which could help avert some symptoms of cognitive decline.

The synergistic combination of light and cognitive therapy utilized in AlzLife has the potential to improve the brain's function better than either of these therapies alone. This project will test the ability of a novel iPad App ("ALZLIFE") that delivers light therapy at 40 Hz combined with cognitive therapy to improve cognition, function, and quality of life in Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease
* Cognitive Impairment

Exclusion Criteria:

* any previously noted epileptic seizures, including febrile seizures.
* any significant disease of the eye, such as macular degeneration. Since the 40Hz light therapy is delivered via eye stimulation, healthy eyes are required.
Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients

The third generation oral aromatase inhibitors (AIs) are increasingly being used in the management of estrogen receptor positive breast cancer. One of the issues related with administration of oral AIs is their side effects, particularly on the musculoskeletal system. Although the prevalence and importance of arthralgia and myalgia occurring in BC patients receiving adjuvant AIs are evident, the mechanisms clearly explaining these invalidating symptoms are unknown.

In this project, we aim to unravel the interaction between vitamin D and musculoskeletal adverse events experienced by AI users. We will also evaluate how vitamin D supplementation affects AI-induced musculoskeletal symptoms in breast cancer patients, by means of a randomized placebo-controlled double blind clinical trial. We will assess changes in the musculoskeletal system by using magnetic resonance imaging of joints, hand grip strength and also monitor serum IGF-I and estrogen levels together with bone resorption and formation markers.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal status
* Currently being treated with an AI in the adjuvant setting (minimum for 8 weeks)
* AIMSS as determined by new or worsened musculoskeletal complaints following AI therapy
* Vitamin D deficiency (\<30ng/ml)
* Caucasian

Exclusion Criteria:

* Hormone replacement therapy last 6 months
* Current use or in the last 12 months of bisphosphonates
* Tamoxifen use in last 6 months
* History of kidney stones
* History of hypercalcemia/hypercalciuria or hyperthyroidism
* Paget's disease of the bone
* Current use of Digitalis/digoxin or thiazide diuretics
* Current use of vitamin D (or multivitamin) supplementation should be stopped