cyrilzakka/clinical-trials huggingface dataset:
Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients

Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with breast cancer. These medications can cause side effects in some women, and occasionally they can be quite bothersome. We are doing a study to better understand the side effects of aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In particular, we are interested in pain and difficulty sleeping. This study is designed to assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the interplay of these side effects and their subsequent impact on daily activity. Each participant will fill out a series of questionnaires about pain, sleep quality, and fatigue and will also complete a sleep diary and wear an actigraphy watch for 10 days before starting an aromatase inhibitor and after taking it for 3 months. We hope to learn more about these symptoms so we can better manage medication toxicity in the future.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged 50 years or older, postmenopausal.
* Patients with histologically proven stage 0-III invasive carcinoma of the breast that is estrogen receptor and/or progesterone receptor positive by immunohistochemical staining, who are planning to start treatment with a standard dose of aromatase inhibitor (AI) therapy.
* Subjects must have undergone surgical resection of their primary tumor, as indicated. The most recent surgery must have been performed at least 4 weeks before the baseline evaluation and no additional surgeries (including reconstructive procedures) should be planned during study participation.
* Cytoxic chemotherapy, if applicable, must have been completed at least 4 weeks before the baseline evaluation.
* Radiation therapy, if applicable, must have been completed at least 2 weeks before baseline evaluation.
* Eastern Cooperative Oncology Group performance status 0-2.
* Ability to operate the accelerometer

Exclusion Criteria:

* Diagnosis of sleep apnea or restless leg syndrome.
* Use of a wheelchair for ambulation most of the time.
* Second or third shift workers or other non-traditional sleep schedules.
* History of medical arthritic disease that could confound or interfere with evaluation of pain or activity level, including but not limited to inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), Parkinson's disease, and cancer involving the bone.
* Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
Study to Evaluate the Impact of the "PROactive Telecoaching Program" on Physical Activity in Patients With COPD.

This study will test two instruments to measure physical activity in COPD patients: A questionnaire and two small physical activity monitors .Patients will be randomized to either receive the telecoaching program in addition to usual care or only the usual care. Study will include around 510 patients in 5 countries in Europe.

Chronic Obstructive Pulmonary Disease (COPD) has a negative influence on physical activity hence it may be beneficial for patients to increase physical activity levels. This study will test two instruments to measure physical activity: A questionnaire (completed on a personal digital assistant) and a physical activity monitor which patient wear during the day. Patients will be randomized to either receive the Telecoaching program in addition to usual care or only the usual care. The study will involve 4 clinic visits as well as some phone calls over duration of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male and female patients ≥ 40 years of age
* Diagnosis of COPD (GOLD criterion: post bronchodilator FEV1/FVC\< 70%)
* Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
* Patients should have at least 4 days of physical activity data recorded via activity monitor during 7 days prior to visit 101.

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study.

* Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients' condition/ co-morbidities are such that physical activity cannot be increased.
* Respiratory diseases other than COPD (e.g. asthma)
* Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the health base and PDA, as judged by the investigator
* Participating in or scheduled to start a rehabilitation program during the study. If the patient wishes to participate in pulmonary rehabilitation for any reason the patient can be enrolled in the study only at the end of rehabilitation.
* Women of child-bearing potential who have the intention to become pregnant during the course of the study and pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive β-hCG laboratory test.
Donor Simvastatin Treatment in Organ Transplantation

The aim of the study is to investigate the effects of donor simvastatin treatment on ischemia-reperfusion injury after heart transplantation.

The study hypothesis of the single center randomized double-blinded clinical trial is that donor simvastatin treatment reduces ischemia-reperfusion injury after heart transplantation. Also, it potentially decreases natural immune activity, rejection activation and thus improves long-term prognosis.

Simvastatin is administered to heart and/or lung donors through the nasogastric tube 4-6 hours prior to organ harvesting. Control organ donors do not receive simvastatin. The randomization and donor hospital instruction of the donor simvastatin treatment is performed by the transplant coordinator. All other caregivers and the transplant recipient are blinded to the treatment group allocation.

The impact of donor simvastatin treatment is investigated and analyzed by several specific blood samples and biopsies that are taken from the recipient at the various time-points during the perioperative and postoperative phase.

In heart transplant recipients (n=42 in the donor simvastatin treatment group and n=42 in the control group), the primary end-point is postoperative cardiac enzyme serum levels (TnT, TnI, and CK-MB 1 hour, 6 hours, 12 hours and 24 hours after transplantation) and primary graft failure. Secondary end-points include peri- and postoperative parameters hemodynamics, short- and long term survival, biopsy-proven rejections, rejection treatments, and chronic rejection at 1, 5, 10, and 20 years after transplantation.

Lung, kidney and liver transplant recipients that have received organs from donors randomized to the control group or donor simvastatin group will also be followed for ischemia-reperfusion injury, perioperative organ function, innate and adaptive immunity and patient survival.

Eligibility Criteria:
Inclusion criteria for a donor:

* Heart transplant donor
* Age 18-60 years
* Previously healthy
* No cholesterol medication
* Normal ECHO with LVEF \>45%, normal right ventricle and normal coronary angiography
* PiO2/FiO2 \> 40kPA, normal chest radiograph and normal bronchoscopy in lung donors

Exclusion Criteria for the heart/lung donor:

* Severe left ventricular hypertrophy \> 14 mm
* High dose of inotropes (dopamine or dobutamine \> 20ug/kg/min or norepinephrine \>0.2 ug/kg/min) at the time of procurement
* Donor outside of the study country Finland

Inclusion criteria for a transplant recipient:

* Age between 18-70 for heart transplant recipients
* Male or female
* Listed for heart, lung, kidney, or liver transplantation

Exclusive Criteria for the recipient

* systemic sepsis
* a positive cross match
CART-19 Cells For MRD Positive CD19+ ALL

CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of relapse as defined by MRD+ status.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Aged between 1-60 years
* Patients with MRD positive CD19+ ALL
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of CART-19 cells.
Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage

The goal of this observational study is to learn about the role of biomarkers in spontaneous subarachnoid hemorrhage (sSAH) as predictors of severity of clinical outcome. The test of biomarkers is based on regular blood and urinary samples. Blood levels of highly specific cardiac troponin (cTNI), natriuretic peptides (NT-ProBNP), S100 beta protein, neuron-specific enolase (NSE), glial fibrillary acidic protein (GFAP), ubiquitin carboxy-terminal hydrolase (UCH-L1), soluble Tumor Necrosis Factor Receptor-2 (sST2), and soluble urokinase plasminogen activator receptor (suPAR), as well as urinary levels of epinephrine and norepinephrine are the biomarkers explored. All adult participants with spontaneous subarachnoid hemorrhage are involved in the study.

The main questions aim to answer are:

* which of these molecules can be prognostic for patients' outcome
* which are the prognostic levels of these biomarkers to predict patients' outcome.

Participants will undergo blood and urinary samples during hospitalization at 24 hours, 72 hours and after 7 days.

Spontaneous subarachnoid hemorrhage (sSAH) is one of the most severe neurological conditions. The hemodynamic instability due to endogenous catecholamine response and inflammatory patterns influences the risk of an unfavorable outcome and the development of clinical implications such as neurological and non-neurological issues. Serum levels of highly specific cardiac troponin (cTNI), natriuretic peptides (NT-ProBNP), S100 beta protein, neuron-specific enolase (NSE), glial fibrillary acidic protein (GFAP), ubiquitin carboxy-terminal hydrolase (UCH-L1), soluble Tumor Necrosis Factor Receptor-2 (sST2), and soluble urokinase plasminogen activator receptor (suPAR), as well as urinary levels of epinephrine and norepinephrine, can be measured as biomarkers in sSAH to explore the systemic response to the stress of bleeding. However, not all sSAH cases equally develop this endogenous cascade responsible for neurological and systemic events. There is no clear validation of threshold levels of endogenous factors applicable in clinical practice to define hemodynamic instability that has only a neurological or multi-organ impact post-SAH.

Eligibility Criteria:
Inclusion Criteria:

* Patients with spontaneous subarachnoid hemorrhage, including those with perimesencephalic subarachnoid hemorrhage and aneurysmal subarachnoid hemorrhage.
* Adult patients.
* Confirmed presence of spontaneous subarachnoid hemorrhage through neuroimaging.
* Obtained informed consent for specific study biomarkers

Exclusion Criteria:

* Age \<18 years.
* Post-traumatic subarachnoid hemorrhage.
Improving Cardiac Rehabilitation Participation in Women and Men

The purpose of this study is to determine the effect of a pre-discharge written personal endorsement to the patient by the patient's attending cardiologist or cardiac surgeon (MD endorsement) to take part in the Cardiac Rehabilitation and Secondary Prevention (CR) program, in addition to the standard CR referral, compared to the standard CR referral alone, on CR program enrollment within 2 months of index hospital discharge following admission for myocardial infarction, unstable angina, coronary angioplasty, or coronary artery bypass.

There is compelling evidence that a comprehensive CR program comprising the delivery of lifestyle modifying education will reduce mortality, morbidity and improve quality of life in patients following myocardial infarction, angioplasty or, coronary artery bypass. However, less than 20% of eligible patients participate in CR programs. This study will look at a method of potentially improving enrollment and adherence to a CR program. It is expected that patients who receive the MD-endorsed referral will be more likely to attend the initial Orientation appointment and more closely adhere to the 6-month comprehensive CR program, as compared to the patients who receive a standard CR referral alone.

Eligibility Criteria:
Inclusion Criteria:

* Patient is admitted to hospital for myocardial infarction (MI), unstable angina (UA), percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass surgery (CABS)
* Patient resides within 1 hour driving time from London

Exclusion Criteria:

* Inability to provide written informed consent or complete survey due to language or cognitive difficulties
* Previous cardiac rehabilitation participation
* Patient scheduled to undergo PTCA or CABS within two months following the index hospital discharge
* Inability to exercise due to musculoskeletal problems or previous or current stroke
Alveolar Cleft Repair Using Osteoinductive Ceramics

In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty.

Rationale: Patients who undergo alveolar cleft grafting have to deal with postoperative pain and comorbidity due to harvesting of autologous bone.

Objective: To evaluate if using calcium phosphate based scaffolds for alveolar cleft grafting is as effective as the use of an autologous bone graft.

Study design: A 'stepped wedge' randomized controlled trial will be conducted by four centres.

Study population: Children between the ages of 8 to 12 years with a unilateral alveolar cleft.

Intervention: Study group undergoes alveolar cleft grafting with the use of a calcium phosphate based scaffold, the control group undergoes the same procedure, but with the use of an autologous chin bone graft.

Main study parameters/endpoints: Main study outcome is one year postoperative residual bone volume in the reconstructed alveolar cleft. Secondary objectives of importance are postoperative pain and eruption of the tooth adjacent to the cleft through the reconstructed area.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the control group will undergo a procedure that is currently seen as the gold standard. Patients in the study group will undergo the exact same risks as the control group, except there is no risk for donor site morbidity and postoperative pain is significantly less. Postoperative clinical and radiological evaluation of both groups is according to current treatment standards.

Eligibility Criteria:
Inclusion Criteria:

* unilateral alveolar cleft, early secondary alveolar cleft closure

Exclusion Criteria:

* cleft lip and palate in a syndromic context
Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes

The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent
* Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
* HbA1c ≥7.0% and ≤10.0%

Exclusion Criteria:

* Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
* Renal impairment as defined by a creatinine clearance \<60 mL/min/1.73 m2
* Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study
Manual Therapy Treatment for Myofascial Pain

This study is a pain intensity evaluation in patients with myofascial pain submitted kinesitherapy after trigger point injection.

Randomized prospective study conducted on 30 patients of both genders ranging in age from 18 to 60 years, with neck and shoulder girdle Myofascial Pain Syndrome (MFS), with a duration of ≥ 4 months and pain intensity ≥ 4.

Trigger point injection of 1 mL 0.25% bupivacaine at each point, once a week for 8 weeks (T1 to T8).

Group 1: kinesiotherapy once a week for 8 weeks Group 2: not submitted to kinesiotherapy Evaluation of pain intensity on the first assessment (T0) and after 1, 2, 3, 4, 5, 6, 7, 8, and 9 weeks

Eligibility Criteria:
Inclusion Criteria:

* myofascial pain of neck and shoulder girdle, lasting ≥ 4 months, pain intensity ≥ 4.

Exclusion Criteria:

* arrhythmia
* heart block
* coagulopathy
* cognitive alterations and infection at the site
* patients using anticoagulants, and pregnant women
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction

An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected to participate for up to 30 weeks. Eligible patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

* Male heterosexual patients aged 22-70 years.
* Confirmed clinical diagnosis of mild, moderate or severe ED for more than 3 months.
* Involved in a continuous heterosexual relationship with their partner for at least 6 months.

Exclusion Criteria:

* Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease.
* History of unstable medical or psychiatric condition or using any medication that, in the opinion of the Principal Investigator, is likely to affect the patient's ability to complete the investigation or precludes the patient's participation in the investigation.
AZD8330 First Time in Man in Patients With Advanced Malignancies

The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330 (ARRY-424704) in patients with Advanced Malignancies


Eligibility Criteria:
Inclusion Criteria:

* Cancer which is refractory to standard therapies, or no therapies exist;

Exclusion Criteria:

* Participated in radiotherapy, biological or chemotherapy within 21 days prior to study start;
* Hasn't participated in investigation drug study within 30 days;
* Brain metastases/spinal cord compression unless treated and stable,
* Off steroids/anticonvulsants.
Deep Brain Stimulation in Children With Autism

The purpose of this study is to evaluate the safety and possible effectiveness of deep brain stimulation (DBS) of the nucleus accumbens in children with autism spectrum disorder and treatment-refractory, repetitive self-injurious behavior. Six (6) patients will be recruited and enrolled in this pilot study and study duration for each patient will be one (1) year. All will undergo surgical implantation of the Medtronic DBS system and will receive stimulation of the nucleus accumbens (2 electrodes per patient).This will be an open, non-blinded, non-randomized, pilot, phase I trial.Expected study duration is 36 months.

This is a phase I, non-blinded, non-randomized, pilot trial for safety and efficacy of deep brain stimulation for medically-refractory, repetitive self-injurious behaviours in children with ASD (i.e. secondary stereotypies). The trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).

Patients who meet inclusion and exclusion criteria will be identified and recruited the Neurosurgical Clinic at The Hospital for Sick Children. The study will proceed according to the schedule laid out below, and both patients and treating team will be aware of all treatment parameters at all times. Six (6) subjects will be enrolled in this study and study duration for each patient will be one (1) year. Previous phase I trials of DBS in psychiatric and Alzheimer's Disease populations have utilized 6 subjects per surgical target. Such a number is sufficient to demonstrate initial safety, as well as feasibility and clinical effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Female or Male patients between age 7-18
* Diagnosis of Autism Spectrum Disorder (as defined by the DSM-5).
* Failure or non eligibility of medical therapy with ongoing repetitive self-injurious behaviours, at 6 months or more after instigation of therapy. Failure is defined as a lack of improvement in self-injurious behaviours, as documented by objective evidence, including caregiver logs or clinician assessment, if the clinician has documented a baseline status prior to instigation of the medical therapy.
* Diagnosis of secondary stereotypies, based on clinical assessment of the treating physicians with evidence of self-injury, documented in the patient records.
* Parents or legal guardians, including caregivers, informed and able to give written consent.
* Able to comply with all testing, follow-ups and study appointments and protocols for 12 months following the end of the duration of the study.

Exclusion Criteria:

* Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
* Any contraindication to MRI or PET scanning
* Likely to relocate away from the study site or move during the study's one year duration
* Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
* Pregnancy
* Unable to communicate adequately in English in order to complete the baseline and follow-up questionnaires.
Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: the Mind the Child Study

Background and study aims:

Mindfulness is a mental state that can be achieved through meditation. So far, studies have shown that practicing mindfulness on a consistent and regular basis can improve attentional functions and emotional well-being. Mindfulness has recently begun to be used in the field of child development. The aim of this study is to assess if a mindfulness program may help primary school students in reducing anxiety and depression while also improving their temperament.

Who can participate? Students attending the fourth or fifth year of primary school

What does the study involve? Participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions, while the control group will follow routine daily school activities.

Questionnaires will be used to assess temperament, anxiety and depression before and after the intervention.

What are the possible benefits and risks of participating? Benefits of participating in the study may include a lowering of anxiety and depression levels, as well as an improvement of temperament.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 9 to 11 years
2. Children have reasonable comprehension of spoken language and can follow simple instructions
3. Children and their parents are willing to attend all intervention sessions
4. Children and parents have an adequate understanding of English

Exclusion Criteria:

1. Concurrent enrollment in other intervention trials
2. Child or parent regularly practice complementary health interventions such as meditation