cyrilzakka/clinical-trials huggingface dataset:
Bone Marrow Suppression and Recovery During Radionuclide Treatment

Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant prostate cancer and bone metastases. More than 20 % of patients treated at Rigshospitalet develop bone marrow suppression as a side effect to Radium therapy The aim of the study is to examine biomarkers of bone marrow suppression and recovery during Radium therapy as well as markers of bone remodeling.

Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant prostate cancer and bone metastases. Therapy is administered intravenously every 4 weeks for up to 6 cycles. More than 20 % of patients treated at Rigshospitalet develop bone marrow suppression as a side effect to Radium therapy, which delays or excludes the patient from further oncological therapy. Especially thrombocytopenia is a frequent side-effect and can be long lasting.

The aim of the study is to examine whether biomarkers of bone marrow recovery (immature platelets, platelet volume, reticulocytes, red cell distribution width) can predict development of hematological toxicity during Radium therapy. Furthermore, to investigate whether these biomarkers can predict recovery from toxicity in patients who develop bone marrow suppression during therapy.

A secondary aim of the study is to evaluate whether dynamics in biomarkers of bone remodeling during Radium therapy is correlated to overall survival and time to symptomatic skeletal event. Optimally these biomarkers can aid in monitoring therapy.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic castration resistant prostate cancer
* Planned to initiate Radium therapy
* Age \> 18 years
* Able to understand study protocol and give informed consent

Exclusion Criteria:

* None
Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia

Most chronic pain patients with insomnia are currently not well-managed using existing medications. If found to safely improve sleep with chronic pain patients, nabilone could be added to the treatment options available in the management of fibromyalgia and associated symptoms.

The principle hypothesis of this study is that nabilone at a dose of 0.5-1mg is as efficacious as amitriptyline at a dose of 10-20mg, in improving sleep quality in patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years;
* A diagnosis of fibromyalgia according to the American College of Rheumatology classification criteria (Wolfe F, Smythe HA, et al 1990);
* Suffering from self-reported disturbed sleep;
* Negative urine screen for cannabinoids;
* Women of childbearing potential must agree to use adequate contraception during study and for 3 months after study;
* Ability to attend research centre every second week for approximately seven to nine weeks and be able to be contacted by telephone during the study period;
* Stable drug regimen for 1 month prior to randomization;
* Normal liver (AST \<3x normal) and renal function (serum creatinine \<133µmol/L);
* Haematocrit \>38%;
* Negative serum bHCG;
* Proficient in English or French;
* Willing and able to give written informed consent;
* Ability to follow study protocol (cognitive and situational).

Exclusion Criteria:

* Patients currently using cannabis or cannabinoid or tricyclic antidepressants (TCA) and who are unable to undergo a 2 week washout period before entering the study;
* Pain due to cancer;
* Unstable cardiac disease such as cardiac arrhythmias, cardiac failure, ischaemic heart disease and/or hypertension on clinical history and examination;
* History of psychotic disorder or schizophrenia;
* Known hypersensitivity to cannabinoids, amitriptyline, or related tricyclic antidepressants;
* Currently taking or unable to stop taking monoamine oxidase inhibitors (a two-week washout period is necessary for subjects taking MAOIs);
* History of seizures/epilepsy;
* Diagnosis of glaucoma;
* Urinary retention;
* Pregnancy and/or breast-feeding;
* Participation in other clinical trial in the 30 days prior to randomization;
* A recent manic episode (within the past year);
* Current suicidal ideation or history of suicide attempts
Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia

The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10\^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10\^9/L for at least 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have previously been treated with a cytoreductive therapy and been intolerant or refractory to that therapy.

Exclusion Criteria:

* Subjects should not have any other underlying conditions or medications that would confound the study analysis or interact with the study medication.
Pain Response to Cannabidiol in Opioid-induced Hyperalgesia, Acute Nociceptive Pain and Allodynia By Using a Model Mimicking Acute Pain in Healthy Adults

Prospective, randomized, placebo-controlled, double-blinded, crossover study to investigate the effect of cannabidiol (CBD) on remifentanil-induced hyperalgesia in healthy volunteers in a well-established acute pain model. Participants are randomized according to the order of the two treatments (CBD + Remifentanil or Placebo + Remifentanil).

Opioid-induced hyperalgesia (OIH) is a clinically often neglected, but well described phenomenon. OIH could also be shown for Remifentanil in an acute pain model. As CBD showed antihyperalgesic potential in the animal model, this brings up the question if CBD might be used to prevent or diminish OIH. Until today there are no studies investigating CBD as an adjunct to remifentanil or other opioids regarding the OIH. This is however of great clinical value because CBD with its possible antihyperalgesic effect on the OIH might be a worthful adjunct for opioid based anaesthesia and analgesia.

Every participant will pass through two interventions with electrically induced pain (Koppert model). CBD will be applied orally at the beginning of the intervention. Pain, allodynia and hyperalgesia will be assessed and recorded every 10 min during the remifentanil infusion and afterwards.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 until 25 kg/m2
* Able to give informed consent

Exclusion Criteria:

* Regular consumption of cannabinoids or other drugs / substances
* Regular intake of medications potentially interfering with pain sensation (analgesics, antihistamines, calcium and potassium channel blockers, serotonin / noradrenaline reuptake inhibitors, corticosteroids)
* Neuropathy
* Chronic pain
* Neuromuscular disease
* Psychiatric disease
* Known or suspected kidney or liver disease
* Pregnancy (cf. 8.6 Trial specific preventive measures) / Lactation
* Allergy / hypersensitivity to cannabidiol
* Contraindications for Remifentanil (e.g. hypersensitivity)
A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization

Immunization injections are a significant source of pain for infants. Tactile stimulation (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it is cost neutral, and has been shown to be effective in children and adults undergoing injections. The aim of this study is to determine the added benefit of tactile stimulation when added to other proven analgesic interventions during routine infant immunization injections.

Immunization injections are a significant source of pain for infants. At present, effective and feasible pain-relieving interventions include sugar water, fast injection without aspiration, and holding infants during the procedure. These methods, however, do not eliminate pain in all infants. Additional interventions are therefore needed.

Tactile stimulation (rubbing/applying pressure) has been shown to reduce injection pain in children and adults, and may be a suitable intervention for infant injections. It is cost neutral, requires no preparation, and is easily incorporated into practice.

The aim of this study is to determine the effectiveness of tactile stimulation when added to other proven analgesic interventions on reducing pain during infant immunization injections.

Eligibility Criteria:
Inclusion Criteria:

* infants 1-12 months of age receiving routine immunization injections in an outpatient pediatric clinic in Toronto

Exclusion Criteria:

* impaired neurological development
* history of seizure
* use of topical anesthetics
* use of sedatives or narcotics within 24 hours
* fever or illness that would prevent administration of vaccine
* prior participation in the trial
Atrial Fibrillation and By-pass Surgery

The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone and statine is better than beta-blocker alone for the prevention of atrial fibrillation after coronary by-pass surgery.


Eligibility Criteria:
Inclusion Criteria:

* significant coronary disease, sinus rhythm

Exclusion Criteria:

* valvular disease, former by-pass surgery
Evaluation of Target Organs Damage in Hypertensive Patients

Evaluation of target organs damage in hypertensive patients with no known cardiovascular (CV) or renal disease, stratified according to level of blood pressure control


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of essential hypertension (treated or untreated); HT not discovered on the day of the consultation; no documented clinical cardiovascular or renal disease.

Exclusion Criteria:

-
Cell Therapy in Chagas Cardiomyopathy

The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.

The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dilated cardiomyopathy according to WHO criteria
* Syndromic heart failure in functional class III or IV of the NYHA
* Enrollment and continuous follow-up in cardiac out-patient clinic
* Adequate medical therapy after optimization therapy
* Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule

Exclusion Criteria:

* Valvular diseases, except functional mitral or tricuspid reflow
* Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
* Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
* Sustained ventricular tachycardia
* Abusive use of alcohol or illicit drugs
* Pregnancy
* Use of cardio toxic drugs
* Any co-morbidity with impact in life expectancy in 2 years
* Renal function compromised (creatinine above 2 mg/dl)
* Definitive implant of pace-makers, resynchronizers and CDIs
* Heart failure with symptoms initiating less than 1 year ago
* Active systemic arterial hypertension or history of hypertension
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.

The study is an open randomized multicentre study in which patients with multiple myeloma refractory to melphalan therapy are randomized between bortezomib and thalidomide therapy, in both arms with the addition of dexamethasone. In case of failure to the initially given treatment the patient will be crossed over to the alternative treatment.

The number of patients needed is calculated to 300, based upon the hypothesis of a 50% difference in progression free survival, a significance level of 95% and a power of 80%. With 12 patients being recruited each month during 25 months and a 4 months follow-up after the last included patient, the total study time will be 29 months.

The dose regimens for bortezomib and thalidomide follow general clinical praxis as regards recommendations for optimal dosing in the Nordic countries.

Evaluation of response and toxicity is performed every 3 weeks for at least 12 weeks, thereafter every 6 weeks. Evaluation of efficacy is done according to The International Myeloma Working Group Uniform Response Criteria. Evaluation of toxicity is done by CTCAE grading. Evaluation of quality of life is done by the EORTC QLQ30 questionnaires with the addition of the myeloma specific MY-24 module which are mailed to the patients at predetermined intervals during the study.

Eligibility Criteria:
Inclusion Criteria:

* Treatment demanding multiple myeloma
* Refractoriness to melphalan
* Acceptance of rules for prevention of pregnancy

Exclusion Criteria:

* Previous treatment with bortezomib, thalidomide, or lenalidomide
* Sensory neuropathy grade III or neuropathic pain grade II
* Severe concomitant disorder, e.g. other malignancy or severe heart disease
* Transformation to plasma cell leukemia or aggressive lymphoma
* Frequent visits for bortezomib injections not feasible
* Anticipated non-adherence to study protocol
* Pregnancy
* Anticipated non-adherence to rules for prevention of pregnancy
* Severe thrombocytopenia (Thrombocyte count less than 25000/microliter)
Plasma Ropivacaine Concentrations After Sciatic Nerve Block in Patients With Chronic Kidney Disease

This prospective observational study aimed to examine the pharmacokinetics of ropivacaine in patients with chronic kidney disease after sciatic nerve block.

Sciatic nerve block for foot and ankle surgery will be performed using ropivacaine under ultrasound-guidance, and arterial blood test will be taken for total plasma ropivacaine concentration at 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for foot and ankle surgery
* Patients with chronic kidney disease (glomerular filtration rate \< 60 ml/min/1.73m2) (changed from 30 ml/min/1.73m2 to facilitate patient recruitment)
* Patients who are thought to be clinically helpful to receive sciatic nerve block rather than general anesthesia because of comorbidities such as cardiopulmonary dysfunction and cerebral dysfunction

Exclusion Criteria:

* Patients who need to renal replacement therapy, such as hemodialysis
* Patients with liver disease (aspartate transaminase OR alanine transaminase \> 80 IU/L)
* Patients with allergic disease
* Patients with previous history of drug allery
* Patients with chronic pain persisting 3 months
Nutrition Status, BMD, and SSRIs

The association between selective serotonin reuptake inhibitor (SSRI) use and bone mass density (BMD) has been debated. Some have suggested features of depression, which SSRIs are prescribed to treat, may be a cause of decreased BMD, such as poor overall food intake at the time of SSRI use. Our study seeks to determine whether SSRI use in adults is associated with lower than average BMD, and if there is an association between low micronutrient intake, SSRI use, and a low BMD.


Eligibility Criteria:
Inclusion Criteria:

* Included adult NHANES participants are those who participated in the Dual-Energy X-ray Absorptiometry (DXA) femur-neck BMD test and responded in full to the demographic, pharmaceutical, and dietary surveys.

Exclusion Criteria:

* Pregnancy, incomplete survey responses, incomplete DXA results
UPLYFT For Lymphoma Survivors

The main purpose of this study is to field test and pilot an intervention called UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence Therapy) that includes information about lymphoma survivorship and tools to improve quality of life and reduce lymphoma-related worries among lymphoma survivors.

This is a two phase pilot study to develop and pilot the UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence Therapy) program intervention that includes lymphoma survivorship information and acceptance and commitment therapy strategies to alleviate fear of cancer recurrence, reduce distress, and improve quality of life among lymphoma survivors.

Phase 1 will be a two-part development process of the UPLYFT program based on interview feedback from lymphoma and mental health clinicians and then feedback from a six-person group of lymphoma survivors after participation in an UPLYFT program field test. Phase 2 is a randomized pilot study using the UPLFYT program finalized in Phase 1.

Research procedures include:

* In depth interview (lymphoma and mental health clinicians)
* Screening for eligibility
* 6 weekly intervention sessions (lymphoma survivors)
* Baseline Assessments and Questionnaires (lymphoma survivors)

  74 people are expected to participate in this study with 14 in Phase 1 and 60 in Phase 2.

The American Society of Hematology is providing funding for the trial.

Eligibility Criteria:
Inclusion Criteria:

Lymphoma Survivors Phase 1 and 2:

* Diagnosis of lymphoma (indolent non-Hodgkin lymphoma, aggressive non-Hodgkin lymphoma, or classic Hodgkin lymphoma)
* Age ≥ 18 years
* Interval of 3 months to 24 months from completion of first-line treatment
* In complete remission after first line of treatment
* Clinically significant FCR (score of ≥ 16 on the validated FCR Inventory-Severity Subscale \[FCRI-SS).
* Access to computer (for videoconferencing)

Lymphoma clinicians and mental health clinicians Phase 1:

* Lymphoma clinicians ≥ 1 year from oncology fellowship completion OR mental health clinicians (psychologists, social workers, psychiatrists) ≥ 1 year from completion of clinical training.
* Longitudinal clinical care for patients with lymphoma by oncologists OR provision of care for patients with cancer by mental health clinicians

Exclusion Criteria:

Lymphoma Survivors Phase 1:

* Age \< 18 years
* Concurrent other malignancy
* Patients with uncontrolled/untreated psychotic disorders or untreated bipolar and borderline personality disorder (as ascertained from medical record screen).

Lymphoma Survivors Phase 2:

* Age \< 18 years
* Concurrent other malignancy
* Patients with uncontrolled/untreated psychotic disorders or untreated bipolar and borderline personality disorders (as ascertained from medical record screen).

  * Our study will exclude members of the following special populations:

    * Adults unable to consent
    * Individuals who are not yet adults (infants, children, teenagers)
    * Pregnant women
    * Prisoners
Ocular Surface Immune Response in Dry Eye Disease

In vivo confocal microscopy (IVCM) is a sensitive imaging tool for detecting dry eye-associated subclinical inflammation. Studies have previously shown that IVCM provides an in vivo metric to measure inflammatory changes in the central cornea. The objective of the current study is to assess inflammatory response changes in the peripheral cornea and the conjunctiva by analyzing epithelial immune cell density and morphology in these areas and then correlating the IVCM findings to clinical signs and symptoms to establish novel objective imaging biomarkers.


Eligibility Criteria:
For Dry Eye Disease Participants

Inclusion Criteria:

* Age \>18
* Ability to consent to study
* Symptoms of dry eye disease for at least 6 months, such foreign body sensation, burning, stinging, light sensitivity
* Positive vital dye staining of the cornea
* At least one of the following objective signs: (Schirmer I \<10 mm at 5 minutes), decreased (\<0.2 mm) tear meniscus, decreased tear breakup time (TBUT) of \<10 seconds, positive vital dye staining of the conjunctiva

For Age-Match Controls

Inclusion Criteria:

* Between the ages of 18-89
* The ability to provide informed consent for study inclusion
* Clear, healthy cornea
* Normal tear meniscus (\> 0.3 mm)

For Dry Eye Disease Participants

Exclusion Criteria:

* History of contact lens wear in the past 3 months
* History of ocular surgery in the past 6 months
* Active ocular allergies
* History of ocular infection in the past 3 months
* History of diabetes
* History of topical or systemic anti-inflammatory therapy in the past 1 month

For Age-Match Controls

Exclusion Criteria:

* History of ocular or eyelid surgery within the past 12 months
* History of herpetic or other infectious keratitis or other inflammatory eye disease
* History of any other acute ocular disease
* Current use of topical medications (not including artificial tears)
* Current use of contact lenses
* History of ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy
* History of cancer elsewhere in the body which is currently under systemic chemotherapy
* Current glaucoma disease requiring use of glaucoma drops
* History of Diabetes mellitus
* Current diagnosis of dry eye disease
Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus

OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and complications of diazepam and lorazepam given intravenously as prehospital therapy to patients in status epilepticus.

II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the subsequent emergency department admission.

III. Establish whether prehospital therapy alters hospital management of these patients and ultimately affects patient outcome.

PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by center.

Patients en route to the hospital in a San Francisco Department of Health Paramedic Division ambulance are randomly assigned to 1 of 3 treatment groups. Informed consent is waived due to impaired consciousness.

Patients receive intravenous diazepam, lorazepam, or placebo during transport. The patient is re-treated if the seizure is sustained after the first dose or recurs after the first dose without the patient regaining consciousness.

Upon arrival at the hospital, all patients receive the standard status epilepticus treatment in use at that site.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Status epilepticus with at least 5 minutes of sustained seizure activity with a depressed level of consciousness, or 2 or more discrete seizures without recovery or consciousness between seizures Verified by bystander or observed by paramedic from San Francisco Department of Health --Prior/Concurrent Therapy-- No chronic benzodiazepines for seizure disorder --Patient Characteristics-- Cardiovascular: Systolic blood pressure at least 100 mm Hg No second- or third- degree atrioventricular block No sustained ectopic tachyrhythmia Pulse rate between 60 and 150 No severe myocardial insufficiency No hypovolemic, cardiogenic, or obstructive shock Pulmonary: No history of asthma No history of chronic obstructive airway disease No history of limited pulmonary reserve Other: No allergy or prior sensitivity to benzodiazepines No distributive shock (e.g., septic, neurogenic, or anaphylactic)