cyrilzakka/clinical-trials huggingface dataset:
Clinical MR Spectroscopy of Brain Metastases at 1,5T and 3T.

Increasing magnetic field is known to give improvements in signal-to-noise-ratio (SNR) and spectral resolution. To investigate this, spectra from different subjects were examined using two clinical MR instruments operating at 1.5T and 3T respectively.


Eligibility Criteria:
Inclusion Criteria:

* brain metastases

Exclusion Criteria:

* children
* pregnancy
A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.

The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve Stimulation (VNS) Therapy as adjunctive therapy.

The population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management.

The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview (MINI).

A minimum of five hundred (500) patients will be implanted with a VNS Therapy System and up to eighty (80) sites may participate in this study.

Enrollment will take 8 years, based on competitive enrollment. For each subject a baseline visit will occur between 1 and 6 weeks before implant.

Once implanted with the device, subjects will be followed-up for a minimum of 36 months and a maximum of 60 months. The study may stop when the last subject has reached the 36 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age.
* Have a documented primary diagnosis of chronic (\>2 years) or recurrent (2 or more prior episodes) major depressive episode that has not adequately responded to an adequate number of antidepressant treatments, as per local medical standards. This diagnosis must be confirmed using the MINI.
* Provide written Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent and Health Insurance Portability and Accountability Act (HIPAA, US only) authorization (as applicable according to local requirements).
* Currently is receiving at least one antidepressant treatment (i.e., antidepressant drug, maintenance electroconvulsive therapy, or formal psychotherapy including supportive psychotherapy) or mood stabilizing treatment for bipolar patients (such as lithium, anticonvulsants, or atypical antipsychotics).
* Able and willing to comply with the frequency of (outpatient) clinic visits and to reliably complete all the evaluations as specified in the study protocol.Hence based on the nature of their disease, the following patients should not be included: patients with mental retardation, current severe or significant substance/alcohol abuse, diagnosis of one or more schizophrenia-spectrum or other psychotic disorders, diagnosis of borderline or severe personality disorder as determined by clinical judgment which, in the investigator's opinion, would significantly interfere with subject's participation in the study)

Exclusion Criteria:

There are no exclusion criteria; the investigator should refer to the (local applicable) VNS Therapy Physician's Manual.
Natural History of Liver Cirrhosis Diagnosed by Transient Elastography in HIV/HCV-coinfected Patients

Prospective multicenter cohort recruiting consecutive patients from 7 hospitals in Andalusia, southern Spain, according to following criteria: 1) HIV infection, 2) Chronic active HCV infection, 3) Older than 18 years, 4) New diagnosis of liver cirrhosis on the basis of a liver stiffness above 14 kiloPascals, 5) No previous or concomitant decompensation of liver disease. Patients are prospectively followed-up according to a uniform protocol of care. Epidemiological, clinical and laboratory variables are periodically recorded. The primary outcomes are the emergence of a liver decompensation (including hepatocellular carcinoma), liver transplant or death. The predictors of these outcomes are analyzed.


Eligibility Criteria:
Inclusion Criteria:

* HIV Infection
* HCV chronic active infection (positive serum RNA HCV at inclusion)
* New diagnosis of cirrhosis on the basis of a liver stiffness equal or greater than 14 kiloPascals.
* No previous or concomitant decompensation of liver disease

Exclusion Criteria:

-
Intratympanic Steroids for Sudden Hearing Loss

For patients with sudden hearing loss, the initial treatment is not usually effective. We use Dexamethasone or Methylprednisolone to be an Intratympanic steroid administration as a salvage treatment. An randomized, double-blind, multi-center study is designed to find the difference between Dexamethasone or Methylprednisolone.


Eligibility Criteria:
Inclusion Criteria:

sudden hearing loss and initial treatment is not effective

Exclusion Criteria:

the patients refused intratympanic steroids treatment.
Cast Immobilization for Non-Displaced Scaphoid Fractures

This trial is trying to understand if immobilization of the thumb after a non-displaced scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for free movement of the thumb, and in the United States it is a cast that immobilizes the thumb. This study is attempting to understand if there is a difference.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Isolated fracture of the scaphoid
3. No displacement of the scaphoid fracture on CT scan

Exclusion Criteria:

1. Associated ipsilateral ligament injury or fracture
2. Pregnant Patient
Study of Changes in Estrogen Levels and Grip Strength in Postmenopausal Women Who Have Received 4 to 6 Years of Hormone Therapy for Breast Cancer and Are Currently Receiving Letrozole on Clinical Trial IBCSG-35-07

RATIONALE: Studying samples of blood in the laboratory from patients receiving treatment for cancer may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying changes in estrogen levels and grip strength in postmenopausal women who have received 4 to 6 years of hormone therapy for breast cancer and are currently receiving letrozole on clinical trial IBCSG-35-07.

OBJECTIVES:

Primary

* To determine the serum level of estrogens (Estradiol \[E2\], Estrone \[E1\], and Estrone Sulphate \[E1S\] and sex hormone binding globulin \[SHBG\]) in postmenopausal women with prior endocrine-responsive, node-positive, resectable breast cancer completing 4 to 6 years of adjuvant endocrine therapy and enrolled on clinical trial IBCSG-35-07 receiving letrozole.
* To determine the degree of recovery of E2, E1, and E1S during the 3-month letrozole-off gap.

Secondary

* To determine the association between estrogen level changes and the clinical outcomes of toxicity and quality of life.
* To determine the effect of prior adjuvant endocrine therapy, age, body mass index, and type of menopause on estrogen levels.
* To determine the variability of estrogen level changes and its association with germline single nucleotide polymorphisms.
* To examine changes in grip-strength score.

OUTLINE: This is a multicenter study.

All patients undergo blood sample collection at baseline for the analysis of single nucleotide polymorphisms, after randomization on clinical trial IBCSG-35-07 and prior to the beginning treatment on IBCSG-35-07. Patients also undergo serum collection at baseline and at 9, 10.5, and 12 months for the analysis of estrogen levels and sex hormone binding globulins. Patients undergo measurement of grip strength at baseline and at 9 and 12 months. Samples may be banked for future research studies.

Patients complete quality-of-life questionnaires (Breast Cancer Prevention Trial \[BCPT\] Symptom Scales on Form 35-PRS and IBCSG Trial 35-07 QL Form) periodically.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Previously diagnosed with breast cancer

  * Endocrine-responsive, node-positive, resectable disease
* Disease-free following 4-6 years of prior adjuvant endocrine therapy with selective estrogen-receptor modulators and/or aromatase inhibitors
* Patient must be currently enrolled on clinical trial IBCSG-35-07 as well as the Quality-of-Life substudy
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Postmenopausal

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Tolerability of Iron Therapy in Women With AUB

Telephone surveys of female patients using liposomally-bound iron and traditional iron sulphate preparations for the management of iron deficiency anemia to determine gastrointestinal tolerability.

1. Rationale and Background:

   Abnormal uterine bleeding (AUB) affects women worldwide. In high income countries, heavy menstrual bleeding (a subset of AUB) is the most common cause of iron deficiency (ID) and iron deficiency anemia (IDA). Although estimates vary, it appears that 20-30% of IDA is a result of heavy menstrual bleeding. Oral iron replacement is a common treatment modality among patients diagnosed with IDA. However, traditional oral iron preparations commonly result in significant gastrointestinal side effects due to the metabolism of the complex that the iron is bound to. Gastrointestinal side effects related to iron therapy, including: metallic taste, nausea, flatulence, constipation, diarrhea, epigastric distress, vomiting, and melena. Therefore, liposomally bound iron is thought to provide a better side effect profile due to avoiding these traditional complexes. In theory, this will lead to higher rates of compliance and treatment efficacy if patients are not experiencing these side effects. Although we have limited data on the efficacy of this iron preparation, the literature suggests that other types of liposomally bound medications have similar efficacy as traditional preparations. Therefore, we believe that liposomally bound iron will provide an effective and well tolerated option for women suffering from IDA secondary to AUB.
2. Research Question and Objectives:

   How does a novel liposomally-bound iron therapy compare to ferrous sulphate in women with anemia secondary to abnormal uterine bleeding? 2a. Determine if it has less gastrointestinal side effects than ferrous sulphate 2b. Determine if it has similar efficacy to ferrous sulphate in correcting anemia secondary to abnormal uterine bleeding
3. Methods:

Pre-menopausal women, diagnosed with anemia secondary to abnormal uterine bleeding Recruitment via physician offices of gynecologists in Calgary, AB Two treatment arms, n=10 per arm Ferrous sulphate compared to treatment arm (liposomally bound iron) Baseline hemoglobin prior to iron therapy initiation Pre-op hemoglobin to compare efficacy of iron therapy Phone interview with patients using standardized, validated questionnaire to collect information regarding gastrointestinal side effects

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with iron deficiency secondary to abnormal uterine bleeding

Exclusion Criteria:

* Postmenopausal, premenarchal and pregnant women are excluded, as they do not have regular uterine bleeding associated with menses.
Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches

The present study will be divided into 5 phases:

1. Collection of bone marrow and peripheral blood (PB) samples from AML patients at diagnosis;
2. Measurement of Midregional Proadrenomedullin (MR-proADM) plasma concentrations with an Immunoluminometric Assay of newly diagnosed AML patients not affected by concomitant cardiovascular disease or sepsis.
3. Analysis of exosomes and microvesicles derived from PB and bone marrow samples of AML patients and culture media collected from AML samples stimulated with ADM and/or ADM (22-52)
4. Study of adrenomedullin system in leukemic stem cells (CD44+/CD38-/CD31+/Lin-) in order to define a correlated expression of ADM and ADM receptors (RAMPs, PAM) with adhesion molecules (CD31, CD38, CD44s, CD44v6), cell cycle regulatory proteins (p21, p27) and genes or molecules involved in the hematopoietic differentiation process (Cul5, CD11b, CD11c, CD66, CD14, CD15, PML-RARα)
5. In vitro evaluation of ADM activity in the growth, maturation and trans-endothelial migration of blasts and/or fusion of leukemic cells with endothelial cells. To do this, leukemic cells will be alternatively cultured by using in vitro models of endosteal and vascular niches.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with new diagnosis of primary or secondary AML.
2. Participant is willing and able to give signed written informed consent according to ICH/EU/GCP and national local laws.
3. Male or Female, aged \>18 years.

Exclusion Criteria:

1. Patients affected by concomitant cardiovascular disease , such as essential hypertension (any grade), chronic renal failure (creatinine\>1.5 mg/dL), heart failure (any NYHA class), and peripheral arterial occlusive diseases, or sepsis.
2. Patients affected by HIV, B or C hepatitis.
Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.005% Latanoprost that is applied to the outside of one eyelid.

Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects.

Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
* Male or Female patients aged at least 18 years of age.
* Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
* A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential.
* Best-Corrected Visual Acuity of 20/800 or better in both eyes
* Written informed consent.
* Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.

Exclusion Criteria:

* Uncontrolled glaucoma
* Glaucoma requiring more than a single agent for IOP control
* Patients with a corneal thickness greater then 620 micrometers
* Female patients who are pregnant, nursing, or planning a pregnancy during the study
* Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study
* Active intraocular inflammation
* Cystoid Macular Edema
Cimetidine Biowaivers

The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.

The investigators anticipate that common excipients do not cause bioINequivalence. 1) The hypothesize is that commonly used excipients in oral medications change the rate or extent of Class 3 drug absorption and result in bioINequivalence. 2) Alternative hypothesis is that commonly used excipients in oral medications do not change the rate or extent of Class 3 drug absorption and do not result in bioINequivalence.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age 18-55
* Healthy volunteers: Subjects in good health, as determined by screening evaluation that is not greater than 30 days before the first drug study visit
* Willing to avoid caffeine containing products 24 hours prior to and day of study visits
* Willing to stop all over the counter medications for 24 hours prior to and during study visits
* Able to provide informed consent

Exclusion Criteria:

* Presence of significant medical disease (including cardiovascular, pulmonary, hematologic, endocrine, immunologic, neurologic, gastrointestinal or psychiatric)
* Presence of hepatic, renal disease
* Pregnant women, breast feeding or trying to become pregnant
* Excessive alcohol use (i.e. current physical, behavioral, or personal manifestations related to the abuse or dependency on alcohol)
* Routine use (i.e. daily or weekly) prescription medication except birth control pills
* Routine use (i.e. daily or weekly) use of acid blockers, antacids, anti-diarrhea, stimulants, appetite suppressants, or anti nausea medication or other drugs that modulate gastrointestinal function
* Currently taking cimetidine or medication known to interact with cimetidine
* Allergic to cimetidine
* Undergoing therapy for solid tumor or blood malignancy
* Any condition in which in the opinion of the PI or medical physician would increase risk to the subject or interfere with the integrity of the study.
Osteogenic Cell Viability in Bone Graft

The purpose of this study is to find out if the cells in bone graft samples collected using a reamer are similar to the cells in bone graft samples collected using the iliac crest bone graft method.

Although iliac crest bone grafting is the gold standard for autogenous bone grafting procedures, limited quantity in some individuals and donor site morbidity have lead surgeons to look for alternative harvest sites or sources such as allograft or osteobiologics. Of these alternative harvest sites is the femoral shaft. Intramedullary contents from reaming are composed of bone marrow, and blood and bone spicules. In this respect, the reamed contents are similar to the bone routinely harvested from the iliac crest. Studies have shown that despite the reaming process using standard reamers, cells maintain their viability and are able to produce new bone. However, the addition of aspiration and irrigation used in the RIA system could potentially compromise the harvested cell viability and limit their osteogenic potential. In addition, Wenisch et al. have concluded that the harvested cells using standard intramedullary reamers not only proceed toward osteogenic differentiation, but also can be directed toward neurogenic differentiation. This suggests that reaming debris is a viable source of stem cells as well. RIA allows for these cells to be harvested. It is our hypothesis that the intramedullary contents harvested using the RIA system is similar to ICBG in cell viability and osteogenic potential.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 years or older
* Subjects undergoing a bone grafting procedure, either using an iliac crest or RIA system harvesting technique, or
* Subjects undergoing reamed femoral intramedullary nailing using the RIA reaming technique

Exclusion Criteria:

* Subjects under age 18
* Subjects with a history of: leukemia; cancer with bone metastases; renal failure, receiving dialysis; or on immunosuppressive medications
Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30) treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be randomized in a 1:1:1 fashion to one of the following three arms:

1. no bone anti-resorptive therapy (standard of care)
2. concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D;
3. a 24 week delay in initiation of a 24 week course of alendronate/vitamin D

Assessments (including clinical evaluation, questionnaires, adherence, basic laboratory evaluation, and BMD measurement) will be performed at baseline, 24 and 48 weeks. The primary objective will involve calculation of σ and ρ using all data; δ will be estimated by comparing the two alendronate arms pooled to the no-treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection
* Adult (aged \>18 years or as per local guidelines)
* Premenopausal, if female
* Antiretroviral-naïve
* Starting first-line ART including tenofovir/emtricitabine with either efavirenz (co-formulated as Atripla®) or elvitegravir, cobicistat (co-formulated as Stribild®)
* Low (\<10%) ten-year fracture risk as assessed by the FRAX score validated for Canadian populations

Exclusion Criteria:

* Presence of established osteoporosis at baseline as determined by BMD measurement
* Prior or current use of any bone anti-resorptive therapy (eg. bisphosphonate, estrogens with the exception of oral contraceptive pills, etc.)
* Inability to communicate in English
* Creatinine clearance \<35 mL/min (using Cockcroft-Gault formula)
* Hypersensitivity to alendronate, other bisphosphonates, or any component of the formulation
* Hypocalcemia
* Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
* Inability to stand or sit upright for at least 30 minutes
* Pregnancy, active plans to become pregnant, or lactation
Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation

This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Non-invasive alteration in locus coeruleus output is of interest in regard to basic science and has potential clinical implications in a number of conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, 18 years of age or older.

Exclusion Criteria:

* self-report of mood disorders, prescription and non-prescription drug use which includes stimulants including caffeine and nicotine