cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients

When narcotic pain medicine, like fentanyl or morphine, is given to adults and children for several days, they often develop a tolerance to the medicine. This means they may need higher doses over time to get the same amount of pain control. When it is time to stop the medicine, the dose has to be decreased slowly so that the patient does not have withdrawal symptoms.

Naloxone is a medicine that at high doses can reverse the effects of narcotics. At very small doses it may help prevent tolerance and lessen the severity of withdrawal symptoms. This could mean less narcotic pain medicine is needed over fewer days.

The purpose of this research study is to see if giving naloxone to neonates who require narcotic infusions is safe and effective. Safety will be measured by the incidence of side effects. Efficacy will be measured by monitoring for changes in pain and sedation scores and need for more pain medicine.

This is a prospective, non-randomized, single center, open label dose escalation study. We hypothesize that critically ill patients in the NICU may benefit from a low dose naloxone infusion resulting in decreased tolerance, less severe withdrawal symptoms, lower cumulative doses of opiates, and fewer total days of opiates, all while maintaining adequate or enhanced pain control and sedation. Establishing safety and efficacy data for this potentially beneficial therapy is an important first step towards using this therapy to decrease the risk of opioid tolerance and withdrawal in this population of infants.

Eligibility Criteria:
Inclusion Criteria:

* Neonates \> 36 0/7 weeks estimated gestational age
* Less than 30 days of life
* Requiring admission to to the Neonatal Intensive Care Unit
* Requiring continuous infusions of fentanyl or morphine analgesia
* Anticipated to require opioid infusions for at least four days
* Patients must be enrolled within 120 hours of initiating opioid infusions
* All patients will also require mechanical ventilation prior to study entry.

Exclusion Criteria:

* Preterm infants \< 36 weeks gestation
* Neonates with major neurologic anomalies, seizures
* Opioid infusion administration for \> 120 hours prior to study entry
* Patients requiring ECMO support prior to study entry
* Neonates born to mothers who are known to be opioid dependent
Enzastaurin Versus Lomustine in Glioblastoma

This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).


Eligibility Criteria:
Inclusion Criteria:

1. Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme).
2. Your cancer has returned following therapy.
3. Patient may have undergone prior surgery to remove cancer.
4. Patient must be able to care for self.

Exclusion Criteria:

1. Have a second type of cancer (except adequately treated basal cell carcinoma of the skin). Patient who has had another cancer in the past, must be free of cancer for more than 2 years.
2. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of entry.
3. Patients receiving medication for seizures must discontinue 14 days prior to enrolling.
4. Cannot be on blood thinning medication at study enrollment.
5. Cannot be on other medicines to prevent cancer at study enrollment.
6. Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.
Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects

To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of adenocarcinoma of the colon or rectum
* Tumor tissue sample available for KRAS and BRAF assessment
* Measurable metastatic Stage IV disease including at least one measurable lesion that has not previously been radiated
* No prior chemotherapy for metastatic CRC
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver, and renal function; adequate clotting parameters

Exclusion Criteria:

* Prior treatment with sorafenib
* Clinical or radiographic evidence of brain metastasis
* Major surgery, surgical biopsy, or significant traumatic injury within 28 days of randomization; evidence or history of bleeding diathesis or coagulopathy
* Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growth factor use within 28 days before randomization
* Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months before randomization
* Serious, non-healing wound, ulcer, or bone fracture; Grade 3 or 4 hemorrhage within 28 days before randomization
* Use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk of thrombosis due to placement of a semi-permanent central venous port for administration of chemotherapy is allowed. The use of coumadin and related compounds is excluded.)
* Uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic pressure \> 100 mmHg on repeated measurement) despite optimal medical management
* Thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident, including transient ischemic attacks) within 6 months before randomization
* Active cardiac disease including:

  * Congestive heart failure
  * Unstable angina or myocardial infarction within the 6 months before randomization
  * Cardiac ventricular arrhythmias requiring antiarrhythmic treatment
* Peripheral neuropathy \> Grade 1 (CTCAE)
* Known HIV infection or chronic hepatitis B or C infection
* Any active infection \>/= Grade 2 (CTCAE)
* Any medical, psychological, or social condition that may interfere with the subject's participation in the study or evaluation of the study results
* Use of any investigational drug within 28 days or 5 half-lives of that drug, whichever is longer, before randomization
* Subjects with metastatic CRC who are currently candidates for surgery with curative intent
PROOF OF CONCEPT STUDY ON THE EFFICACY OF INHALATORY TARGETED IMATINIB NANOFORMULATIONS IN PULMONARY HYPERTENSION AND POST-INFLAMMATORY FIBROSIS.

The PROMPTLY study is a proof-of-concept research project evaluating the efficacy of XHALIP, an innovative inhalable formulation of Imatinib, in treating pulmonary arterial hypertension (PAH) and post-inflammatory fibrosing lung diseases (LFD).

Main Objective To demonstrate the ability of XHALIP to improve the prognosis of PAH and LFD by reducing pulmonary fibrosis and vascular remodeling.

Key Research Questions Is XHALIP effectively absorbed by pathological lung cells? Does it have a beneficial biological effect on cell proliferation and extracellular matrix deposition? Study Plan Preclinical phase: In vitro tests on cells obtained from patients with PAH and LFD.

Absorption and distribution analysis: In vitro lung tissue models to assess drug penetration and effectiveness.

Biological activity assessment: Evaluating XHALIP's ability to inhibit epithelial-mesenchymal transition and cell proliferation.

Participants Patients aged ≥ 18 years diagnosed with PAH or LFD, either candidates for or recipients of lung transplantation.

Biological samples (bronchoalveolar lavage and explanted lung tissues). Methodology Confocal microscopy and flow cytometry to analyze absorption. RT-PCR and Western Blot to assess biological efficacy. Alveolo-capillary models to test drug release and distribution. The study aims to translate preclinical findings into a potential future clinical trial for the development of XHALIP as a novel inhalation-based therapeutic strategy for rare lung diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years diagnosed with fibrosing lung disease, obliterative bronchiolitis, or PAH, who are candidates for or have undergone lung transplantation.
* Obtaining informed consent for all patients enrolled prospectively and all those enrolled retrospectively at their first clinical occurrence at our center.

Exclusion Criteria:

* Suspected or confirmed diagnosis of pulmonary neoplastic disease.
Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases

Fatigue is common and debilitating in rheumatic inflammatory diseases as for other chronical medical conditions. The purpose of this study is to develope and evaluate a cognitive behavioural intervention targeting fatigue. The aim of the intervention is to improve fatigue self-management by changing behavioral and cognitive factors contributing to perceived fatigue. Levels of fatigue, depressive symptoms and self esteem will be measured before, after and three months after the intervention.


Eligibility Criteria:
Inclusion Criteria:

• Men and women over 18 years with inflammatory rheumatic diseases and fatigue at Department of Rheumatology, Diakonhjemmet Hospital

Exclusion Criteria:

* Unable to provide informed consent
* Unable to read and understand Norwegian
* Unable to complete a survey
The Effect of Different Images Watched With Virtual Reality During Phlebotomy

Aim: The purpose of this study was to investigate the effect of watching a cold environment image via virtual reality on pain and anxiety related to phlebotomy procedure in volunteer blood donors.

Methods: The study was conducted between June 2019 and December 2019 with 120 healthy individuals who applied for blood donation for the first time in Northern Turkey. Individuals included in the study were assigned to intervention, placebo and control groups with 40 people in each group by block randomization method. During the phlebotomy procedure, the intervention group watched a cold environment image via virtual reality, the placebo group watched a hot environment image, and the control group received standard application. "Descriptive Characteristics Form", "Visual Comparison Scale", "State and Trait Anxiety Inventory" and The CONSORT checklist were used to collect data.


Eligibility Criteria:
Inclusion Criteria:

* Being in accordance with time and place
* Being aged between 18 and 35 years
* Being able to evaluate the visual analog scale correctly
* Participating voluntarily in the research.
* Being willing to donate blood
* Donating blood for the first time
* Have a body mass index within normal limits (18.5-24.9 kg/m2)
* Have no vision or hearing problems
* Have no disease that may affect pain perception
* Have no vertigo, heart or lung disease
* Have no signs of infection, dermatitis, phlebitis, scar tissue or incision in the area where invasive intervention will be performed
* Have no psychiatric disease
* Being able to accurately assess the state and trait anxiety inventory with the VAS
* Have an average pressure pain threshold value of 8-16 Lb obtained from three measurements taken at 5-second intervals from the elbow region of the left upper extremity where no intervention was performed
* Have no vertigo, heart or lung disease
* Have no signs of infection, dermatitis, phlebitis, scar tissue or incision in the area where invasive intervention will be performed
* Have no psychiatric disease
* Being able to accurately assess the state and trait anxiety inventory with the VAS
* Have an average pressure pain threshold value of 8-16 pounds (Lb) obtained from three measurements taken at 5-second intervals from the elbow region of the left upper extremity where no intervention was performed

Exclusion Criteria:

* Not participating voluntarily in the research
* Not fitting the inclusion criteria of the research
* Having a vision or hearing problem
* Failure of phlebotomy at the first attempt
* Development of syncope after phlebotomy
The 001-DIOR Multicenter Registry

The 001 DIOR study is a prospective, multicenter registry of percutaneous coronary intervention (PCI) to assess the clinical success, efficacy and safety of the Paclitaxel-eluting balloon DIOR (Eurocor GmbH, Germany) for the treatment of de novo ostial bifurcated lesions (001 of Medina classification). The DIOR balloon will be used to treat the stenotic site branch.


Eligibility Criteria:
Inclusion Criteria:

* De novo bifurcated lesions 001 of Medina classification, with significant stenosis only in the ostium of the side branch and a reference vessel diameter is bigger or equal 2.0mm; the DIOR balloon will be used to the treat the side branch.
* The patient has clinical evidence of myocardial ischemia (stable or unstable angina, acute and non acute myocardial infarction, silent ischemia: ECG, exercise test, etz...)
* As the maximal length of the DIORTM balloon is 30 mm, all eligible lesions should be no longer than 25 mm to ensure an adequate drug elution in the treated segment, avoiding the phenomenon of "geographical miss" .
* Target lesion(s) stenosis is more or equal 50% by visual estimation.

Exclusion Criteria:

* Cardiogenic shock
* Any serious disease that might limit patient survival to less than one year
* Inability to perform clinical follow-up for a period of 1 year
* Left main bifurcation lesions: ostial left circumflex or ostial left anterior descending artery stenosis.
* Lesion length \> 25 mm
* Target vessel reference diameter \< 2mm
* Stenosis \< 50% of the reference luminal diameter
* Severe angiographic calcification at the level of the target lesion
Clinical Effects of Hard and Soft Tissue Grafting With Dental Implants

The study will be done to see if Implant placement and simultaneous grafting using alloderm alone will result in the same facial ridge contour and soft tissue thickness as alloderm plus bovine derived xenograft. Is the facial soft tissue contour and thickness for alloderm plus bovine derived xenograft is significantly increased compared to alloderm alone.

Thirty sequentially entered patients will have a dental implant placed in maxillary sites from 4 to 13. Any implant system is acceptable since the objective of the study is to evaluate soft tissue contour due to graft placement, not to evaluate the implant. Once selected for participation immediately prior to treatment, they are randomized for a treatment group by a coin toss. Fifteen patients will receive Alloderm alone (Positive Control Group) while another fifteen will receive Alloderm plus Bovine derived Xenograft (Test Group). The graft will be placed simultaneously with the dental implant. A blinded examiner Dr.Jodie Lusby will be used. Should the examiner become unblinded the subject will be excluded from the study. Means and standard deviations will be calculated for all parameters. A paired test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups. A sample size of 12 will afford ≥ 80% statistical power to detect a difference of 0.4 mm soft tissue thickness between groups. P value will be set at p≤0.05.

Eligibility Criteria:
Inclusion Criteria:

1. Have one edentulous site bordered by 2 teeth in maxillary sites from second premolar to second premolar (maxillary 4 to 13) to receive an implant with simultaneous grafting with an ADMG with or without BDX.
2. Healthy persons at least 18 years old.
3. Understands and has signed the informed consent.

Exclusion Criteria:

1. Patients with uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium.
2. Previous head and neck radiation.
3. Patients who have taken oral bisphosphonates for \> 3 years or any IV bisphosphonates.
4. Smokers (or other tobacco habits that might interfere with soft tissue healing).
5. Patients who need prophylactic antibiotics prior to dental procedures.
6. Patients with allergies to any medication or material used in the study, or that would adversely affect study procedures.
7. Chemotherapy in the previous 12 months.
8. Psychological problems that would interfere with treatment.
9. Pregnant subjects will be excluded due to risk of miscarriage
10. Patients unable or unwilling to sign the informed consent.

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Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes

The management goals of diabetic ketoacidosis (DKA) in the pediatric type 1 diabetes (T1DM) population are fluid and electrolyte repletion, insulin administration, and correction of acidosis in order to stabilize the patient. Traditionally, a rapid-acting insulin IV infusion is begun immediately and continued until the acidosis is corrected and hyperglycemia normalized. Once the acidosis is corrected, patients are able to be transitioned to a subcutaneous insulin regimen.

The role that a subcutaneous long-acting insulin such as glargine has in the acute treatment of DKA has not been extensively studied. While giving glargine during the treatment of DKA is becoming more common place, few studies have examined the potential risks and benefits of its use. This study will investigate the effects of early administration of glargine during DKA in patients with newly diagnosed TIDM.

The design of this study is a prospective, double-blind study of children ages 2-21 who are admitted to the hospital in DKA with a diagnosis of T1DM. The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.


Eligibility Criteria:
Inclusion Criteria:

* T1DM
* Hyperglycemia \>200 mg/dl
* Bicarbonate ≤ 15 mmol/L
* pH \< 7.3
* Ketonemia
* Ketonuria
* Glucosuria
* Admission to PICU (Pediatric Intensive Care Unit)
* Ages 1-21 years

Exclusion Criteria:

* Patients who received glargine within the last 24 hours
* Patients with sepsis
Psycho-Educational Cognition Intervention in Patients With Blood and Lymph Cancer

This pilot trial studies how well a psycho-educational program called Emerging from the Haze works in helping patients with blood and lymph cancer. Sometimes, patients who have undergone treatment for cancer experience thinking or memory problems that make work, school, or everyday life activities, such as grocery shopping, difficult. The Emerging from the Haze program may provide resources to help deal with these types of challenges in patients with blood and lymph cancer.

PRIMARY OBJECTIVES:

I. Demonstrate feasibility and acceptability for young adult survivors of various cancers utilizing Emerging from the Haze program.

SECONDARY OBJECTIVES:

I. Describe, summarize study population. II. Characterize, compare the measure scores at pre-intervention assessment to the measure scores at post-intervention assessment.

OUTLINE:

Patients participate in the Emerging from the Haze psycho-educational program weekly over 2 hours for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of a hematological malignancy.
* Having received chemotherapy with or without radiation therapy.
* Physician approval.
* Functional Assessment of Cancer Therapy-Cognition (FACT-COG) score \< 59 on the perceived cognitive impairments (PCI) subscale.
* Eligible after 2 months (60 +/- 5 days) of completing all their active cancer treatment with the exception of patients that are post-transplant.
* Subjective complaint of cognitive concerns at time of enrollment.
* Must be able to understand and communicate proficiently in English.
* Ability to understand and the willingness to sign a written informed consent.
* Agree to complete study surveys.

Exclusion Criteria:

* Patients who have significant personality disorders or unstable psychiatric disorders as assessed by the interviewing clinician.
* Patients with known brain metastases, history of brain metastases or radiation to the brain.
* Patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction.
* Non-English speaking patients.
Behavioral Medicine Intervention With Depressed Patients in a Community Health Center Setting

The linkage between the Massachusetts General Hospital (MGH)-Community Health Associates and the MGH-Benson Henry Institute for Mind-Body Medicine began in order to address the concern of providing affordable, easily accessible, culturally appropriate behavioral medicine interventions for low income patients served by MGH Community Health Centers, as well as the desire to demonstrate the efficacy and economics of these interventions. Since depression was such a prevalent issue among health center patients, with a significant impact on health care service utilization, it was decided to focus on offering Mind/Body services to this population first.

The application of behavioral medicine programs in community health settings is important to explore, as that application empowers the patient to apply self-care modalities that can be utilized in the long-term, for depression as well as for many other stress-related illnesses.

Behavioral and Mind/Body techniques, such as the Relaxation Response, have been reported to be useful therapeutically (often as an adjunct to medical treatment) in numerous conditions that are caused or exacerbated by stress including: mild to moderate depression/anxiety; anxiety; headache; back/neck pain; myocardial ischemia; premature ventricular contractions in stable ischemic heart disease or hypertension; osteoarthritis; stress symptoms; improved outcomes after cardiac and other surgery; pain relief and anxiety reduction in femoral arteriography and other invasive medical procedures; premenstrual syndrome; infertility; psychosomatic complaints; chronic pain; insomnia; musculoskeletal disorders; wound healing; rheumatoid arthritis; fibromyalgia and disease and treatment related symptoms of cancer. In our recent review of the literature, we suggest that the Relaxation Response may be an appropriate and relevant therapeutic state to counteract several stress-related disease processes.

Eligibility Criteria:
Inclusion Criteria:

* Patients 21 years of age or older
* Diagnosis of depression
* Currently being treated for depression with medications and/or psychological counseling through one of the MGH-HealthCare Centers.
* Planning to continue using the health center as their main source of general medical services for the coming year.

Exclusion Criteria:

* History of bipolar disorder
* Active substance abuse
* History of psychosis
* Severe cognitive dysfunction (MMSE ≤ 24)
* Inability to speak English
* We will not exclude patients on the basis of their religious preferences or practices.