cyrilzakka/clinical-trials huggingface dataset:
Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging

Subjects were recruited if their healthcare provider decided that they needed treatment with a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators did this study to see if part of the nerve organ, called the sympathetic nervous system, may be responsible for the improvement seen in patients that receive biventricular pacing. The investigators had three ways to measure sympathetic nervous activity: 1) by using a special blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan.

The Specific Aim #1 of this study is to assess, with 123iodine metaiodobenzylguanidine (123I-MIBG imaging), whether cardiac resynchronization therapy (CRT) rebalances and improves the integrity and function of sympathetic nerve terminals in the failing myocardium. The study will test the hypothesis that resynchronization of biventricular contractility attenuates excessive sympathetic drive, and improves autonomic function and cardiac performance.

The Specific Aim #2 of this study is to determine the relationship between 123I-MIBG labeling of sympathetic activity and physiological measures of cardiopulmonary and autonomic function. This aim is to test the hypothesis that impaired cardiac sympathetic activity, determined by 123I-MIBG imaging will be associated with poorer submaximal exercise gas exchange (higher ventilation - carbon dioxide (CO2) slopes, low end tidal CO2, reduced oxygen pulse and a more rapid frequency response) as well as reduced heart rate power spectral frequencies, a blunted response to positional changes and a delayed heart rate recovery.

Eligibility Criteria:
Inclusion criteria: Indications for Biv-ICD implantation

1. Chronic moderate to severe congestive heart failure (CHF) (NYHA class II or IV)
2. Left ventricular ejection fraction (LVEF) of 35% or less
3. Q wave, R wave and S wave (QRS complex) QRS duration of 120 ms or more
4. On optimized anti-heart failure medical regimen
5. Meet one of the following indications for ICD

   * Survivors of cardiac arrest due to ventricular fibrillation (VF) or ventricular tachycardia (VT) or spontaneous sustained VT
   * Nonsustained VT with coronary disease, prior myocardial infarction, LVEF 35% or less, and inducible VF or sustained VT at electrophysiologic study
   * LVEF of 30% or less with severe coronary artery disease

Exclusion criteria:

1. Patient condition is unstable
2. Patient is unable to give informed consent
3. Not feasible for patient to be followed at Mayo Clinic
4. Female in pregnancy and breast feeding
Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C

Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Magnetic resonance imaging represents the most available noninvasive technique to assess the level of iron in the liver.there is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.


Eligibility Criteria:
Inclusion Criteria:

* multitransfused beta thalassemic children with super added hepatitis C virus (HCV) infection diagnosed by serological detection of HCV antibodies and HCV RNA by polymerase chain reaction.

Exclusion Criteria:

* liver decompensation child younger than 3 years patients with hepatitis B infection contraindications to perform MRI (intraocular metallic foreign body, cardiac pacemaker, intracranial clips of arterial brain aneurysms) refusal to participate in the study
Detection and Characterization of Sessile Serrated Lesions (SSL) of the Right Colon

There are a few studies regarding Sessile Serrated Lesions (SSL). They are recently identified as precancerous lesions. Yet, digestive tract serrated lesions would be part of a new colic carcinogenesis way : the serrated tumor way. Evolution from polyp to cancer would be faster than through the usual adenoma to cancer way. It would be then responsible of a lot of "missed" lesions or interval cancer. The missed SSL rate is estimated at between 27% and 59%.

Current diagnosis methods show weakness to identify those SSL. In order to improve their detection, the investigators dispose of several coloration techniques. Indigo carmine chromoendoscopy enhance neoplastic lesion detection as part of the hereditary rectal carcinoma screening. NBI electronic coloration, which is faster and easier has not shown any efficacy on the adenoma detection rate, except for patients with Lynch syndrome.

The objective is to better describe the SSL endoscopic semiology (detection and characterization) and to establish standards for the endoscopic techniques in order to improve the colonoscopy diagnosis quality. The investigators propose to evaluate 2 fundamental endoscopic techniques (Narrow Band Imaging (NBI) and indigo carmine), widely used for other indications, in comparison with the White Light technique (WLI).

Therefore, the investigators propose a prospective, observational, multicentric cohort study in order to 1) define SSL endoscopic various aspects 2) establish which technique (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) is the best to diagnose SSL, namely detection and characterization 3) evaluate the multifocal dimension rate for those lesions at ascending colon level.

The diagnosis impact is immediate, and could allow to consider an update for boh endoscopic NICE and Kudo Pit Pattern classification, and good practice guidances for colonoscopic diagnosis. Better SSL detectability thus their systematic resection could have a long term effect in reducing both colon cancer rate and interval cancer


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years of age or older
* Patient having an indication for colonoscopy to detect colorectal neoplastic lesions, which meet at least one of the following conditions :
* Positive fecal occult blood test
* 1st degree family history of colorectal cancer or adenoma before 60 years of age
* Personal history of colorectal adenoma or colorectal cancer
* Unexplained digestive symptoms after 50 years of age or those not responding to symptomatic treatment : modification of bowel movements, abdominal pains
* Isolated or repeated rectal bleeding after 50 years of age or occult bleeding
* Acromegaly
* Infectious endocarditis with digestive bacteria
* Suspicion of sessile serrated lesion in the right colon
* None opposite of patient for participating

Exclusion Criteria:

* History of digestive resection as resection of the right colon (right ileocolectomy, right hemicolectomy) or large colic resection.
CGF Influence on Post-operative Complications.

The aim of the study is to evaluate the influence of CGF application into post-operative soft tissue and bone defects on post-operative complications and wound healing.

The research was conducted in twenty patients with symmetric single tooth qualified to extraction. On one side of dental arch, post-operative region was field with CGF material, while on the other side it was left to normal healing. In both cases pain, swelling, alveolar osteitis, antibiotics and analgesics intake in post-operative period were evaluated in the first, fourth and seventh day after surgery. Wound healing was assessed seven and thirty days after extraction.

Eligibility Criteria:
Inclusion Criteria:

* no known medical history of abnormal platelet counts,
* patients with symmetric teeth qualified for extraction,

Exclusion Criteria:

* systemic diseases,
* pregnancy,
* lactation,
* drugs known to affect the number or function of platelets,
* abnormal platelet counts
Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population

The primary aim of this study is to evaluate the pharmacokinetics of serum ropivacaine concentrations following erector spinae plane peripheral nerve blocks in the pediatric population.

Secondary outcomes will assess the efficacy of the block with perioperative morphine equivalent consumption and pain scores.

This pilot study will enroll patients at Texas Children's Hospital, aged 6 months to \<18 years scheduled to undergo a clinically indicated thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. A single shot erector spinae plane block is commonly offered for unilateral video-assisted thoracoscopic surgery (VATS) and unilateral chest tube insertions. Following parental consent and child assent to the block, participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg. This pilot study poses no additional risk to the patient and the thoracic surgical procedures outlined are those for which an erector spinae plane block would be offered. Furthermore, the block dosing of 0.3ml/kg volumes with ropivacaine 0.2% or 0.5% are not outside of the standard of care or accepted dosages for peripheral nerve blocks.

Venous sample serum ropivacaine levels will be collected prior to ESP block and at 30, 60, 90-minutes and 2, 4, 6 -hours from intravenous access in situ. A baseline alpha-1 acid glycoprotein (AGP) test will be collected and processed by TCH Pathology. Amide local anesthetics are predominantly protein bound to AGP. It is the unbound form that is active. While this study seeks to understand the pharmacokinetics of ropivacaine following a single shot erector spinae plane block, correlate of the AGP will simultaneously ascertain the free vs bound portion.

Samples will be analyzed for the total and free serum ropivacaine concentrations. Pain scores will be collected from nursing records starting from arrival in the Post-Anesthesia Care Unit every 4 hours (up to 12 hours after arrival in PACU). Pain will be measured using The Face, Legs, Activity, Cry, Consolability scale (FLACC), the Wong-Baker FACES Pain Rating Scale (FACES), and the Visual Analogue Scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Age: 6 months - \< 18 years old;
* Chest tubes or minimally invasive video assisted thoracic surgery;
* Surgery scheduled between 7AM and 5PM
* Weight greater than 4kg

Exclusion Criteria:

* Renal dysfunction;
* Liver dysfunction;
* Hypoalbuminemia;
* Allergy to local anesthetic;
* Spinal hardware or instrumentation;
* Scoliosis;
* Obesity defined as a BMI \>95% percentile
Lupus Interval Monitoring to Manage Disease Flare and Enable Treatment Optimization

To develop a test to characterize and monitor SLE disease activity status from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.

Systemic lupus erythematosus (SLE or lupus) is a chronic inflammatory autoimmune disorder of poorly understood etiology associated with a wide range of symptoms and physical findings.

Many patients have incompletely controlled disease progressing to end-stage organ involvement. Recognizing and predicting flares and under associated organ damage would facilitate better treatment timing and selection. Recent improvements in care have dramatically enhanced the survival of lupus patients but increased mortality remains a major concern and current treatments for lupus remain inadequate. Development of novel therapies to manage lupus has been hampered by several challenges, including poorly understood pathogenesis, the heterogeneity of disease activity across and within patient populations, and difficulties conducting interventional studies. There remains a need for reliable and timely monitoring of disease activity and degree of organ damage to adequately evaluate response to treatments and long-term outcome. It is also important to differentiate genuine lupus activity and flares from another intercurrent disease such as infection.

To fill this gap, panels of reliable biomarkers that can classify patients with lupus into more homogenous subsets that are linked to disease activity are needed. Such a panel can be developed from signatures found in lupus patients' transcriptome sequencing data. DxTerity's proprietary DxCollect® Microcollector Device (MCD) is intended to facilitate the collection, stabilization, and shipping of a microsample (about 150μL) of blood. This microsample provides sufficient amounts of quality RNA to perform transcriptome sequencing, allowing identification and validation of candidate biomarker signatures. A rapid blood test to monitor and predict disease activity and treatment response would be an innovative diagnostic product. It could bring significant clinical benefits by enabling the individualized lupus monitoring and treatment to better control the disease and slow organ damage. This may assist with unburdening healthcare costs, help identify flares before they happen, and dramatically improve the management of lupus.

The study will collect participant self-collected blood samples from a fingerstick collection kit that can be done from home and self-reported information from up to 2500 participants for analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients age 18 or older
2. Have a permanent address in the United States for the duration of the study
3. Have an email address and access to the internet for the duration of the study
4. Able to provide informed consent
5. Self-reported diagnosis of lupus

Exclusion Criteria:

1. None
Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy

Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles during RT(66 Gy/6.5 w).

Vinorelbine (NVB) + CDDP is considered a standard trt in induction or concomitantly with RT (Vokes, Fournel, Krzakowski). NVBo simplifies the administration of trt and provides the same efficacy as intravenous NVB (NVBiv). In order to assess this and to improve the tolerance, a trial was started with NVBiv and NVBo + CDDP as induction followed by a fractionated administration of NVBo + CDDP during RT.

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed stage IIIA (only N2),
* dry IIIB previously untreated inoperable NSCLC,
* 18 to 75 years old,
* Karnofsky Performance Status (KPS) ≥ 80%,
* weight loss ≤ 10% within the previous 3 months,
* normal organ functions were eligible.
* at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) \[10\].

Exclusion Criteria:

* stages I, II, IIIA (excepted N2), IIIB with pleural effucion and stage IV,
* pregnant or breastfeeding women. Women of Childbearing Age: Women of childbearing potential should take reliable contraceptive measures
* Symptomatic Neuropathy \> grade 1,
* associated Pathology and/or not controled diseases(cardiac insuficiency, myocardial infarction within 3 months before the inclusion ; hypertension, arythmia or uncontroled hypercalcémia; infection requiering iv antibiotic administration within 2 weeks before inculion),
* other associated cancer with the exception of cervical carcinoma in situ or skin cancer baso-cellular correctely treated,
* Previous treatment with an other antineoplasic,
* Known hypersensibility to drugs with a similar chemical structure ti this studied.
* important malabsorbtion syndrom or disease of gastro-intestinal track,
* Participation to another clinical trial within 30 days before inclusion
Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia

Four methods are routinely used to monitor CO2 in patients. End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. CO2 is also monitored in other healthcare settings transcutaneously (TCO2), via finger stick capillary CO2 (CapCO2), and arterial blood gas (ABG). The purpose of this study is to perform all four measurements simultaneously during general anesthesia to identify which measure provides the most accurate data with the least amount of patient risk.


Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype)
* Hemodynamically stable undergoing general anesthesia for a scheduled procedure

Exclusion Criteria:

* Patients not diagnosed with CF
* CF patients undergoing anesthesia for emergency procedures
Double Blind Crossover Comparison of Diuretics in the Young

The principle objective of the study is to determine whether low-renin (i.e. salt sensitive) hypertension at a young age is caused by the kidneys hanging onto too much salt as a result of an over active salt pump in the kidney.

The kidneys have four different salt pumps, and each is blocked by a different type of diuretic (salt losing tablet)If one out of the four is overactive, we would expect patients to respond much better to one diuretic than to the alternatives - rather than responding equally well to all available types of diuretic.

Studies suggest that patients with low renin hypertension respond better to diuretics than other hypertensive drug groups. The aim of the study is to rotate patients through the four main diuretic groups and see if it is possible to identify the most effective diuretic for this group, as measured by a \>=10mgHg decrease in Systolic blood pressure in one specific group a compared to the others.

As most caucasians with Low renin hypertension are older (\>55), presentation with this type of hypertension at a younger age suggests the presence of substantial genetic variation in order to cause the atypical presentation. It is hoped that by identifying the best diuretic for these patients we will also be able to identify:

1. Whether the young low-renin hypertensives can be sub-classified according to their most effective diuretic;
2. Whether this sub-classification helps us to identify the genes and mutations responsible, since these are to expected to be in the so-called sodium channels (i.e. salt pumps)which the kidneys use to prevent salt being excreted in the urine.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-45
* male or female
* Hypertensive - 3 clinic SBP \>=140mmHg; or 3 clinic DBP \>=90mmHg; or ABPM or home BP \>=130(SBP) or 85(DBP)
* 24hr Na+\<160mmol/l
* EITHER {Plasma renin\<=10mU/L (measured untreated, or whilst receiving only CCB+/-diuretic} + {Plasma renin \<=40mU/L (measured on an ACEi or ARB, which approximately double s the plasma renin)} OR Plasma renin \<5mU/L (measured untreated, or receiving any antihypertensive drug other than a beta-blocker

Exclusion Criteria:

* Documented history of gout
* Abnormal renal function (both elevated serum creatinine and reduced creatinine clearance
* SBP \> 170mmHg or Diastolic \>110mmHg despite treatment with permitted background treatment
Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer

RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve physical function and quality of life in patients who have early-stage breast cancer or prostate cancer.

PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and exercise-based counseling program with that of a standard home-based counseling program in promoting health in patients who have early-stage breast cancer or prostate cancer.

OBJECTIVES:

* Compare the efficacy of a diet and exercise-based home-based counseling program versus a standard home-based counseling program for improving physical function at 6 and 12 months for patients with early-stage breast or prostate cancer.
* Compare the effects of these home-based programs on diet quality, physical activity, weight status, depression, and quality of life of these patients.
* Compare the factors, such as gender, race, and social support, that interact with these home-based programs to predict program efficacy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive home-based telephone counseling by a personal nutritionist and a personal trainer.
* Arm II: Patients receive home-based standard health telephone counseling in unrelated areas of cancer care (e.g., sun exposure, screening, and falls prevention).

In both arms, counseling continues every 2 weeks for 6 months.

Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 420 patients (210 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of early-stage breast or prostate cancer within the past 18 months
* Dietary and physical activity habits and baseline functional status that places patient at risk
* Potentially able to increase physical activity and to follow a low-fat, plant-based diet
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 65 and over

Sex:

* Male or female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Able to speak and write English
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No other illness or condition that would preclude adherence to a plant-based diet or exercise

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Bortezomib as First Salvage Therapy for Myeloma Patients Previously Exposed to Bortezomib as Initial Treatment.

This observational, non-interventional, retrospective, multicenter, national study focuses on collecting information about the effectiveness and safety of bortezomib re-use at first relapse in MM patients already treated in their first line with a bortezomib-based regimen, re-challenged with the same drug according to current clinical practice and/or Italian SIE/SIES/GITMO, IMWG and/or NCCN Guidelines/Treatment Recommendations.

Data will be collected retrospectively from approximately 25 haematologic/oncologic sites in Italy. Approximately, data of up to 100 patients will be collected.


Eligibility Criteria:
Inclusion Criteria:

Patients satisfying all of the following criteria will be enclosed in the study:

* Age ≥ 18 years old
* Patients with documented multiple myeloma that received bortezomib-based regimens as first line treatment (both in clinical practice or clinical trials) even if followed by ASCT (Autologous stem cell transplantation) and that after their first line treatment's clinical or biochemical relapse received again a bortezomib-based treatment according to current clinical practice and/or Italian Societies of Hematology (SIE), Experimental Hematology (SIES) and Transplantation (GITMO), International Myeloma Working group (IMWG) and/or National Cancer Comprehensive Cancer Network (NCCN) guidelines/treatment recommendations.
* Signed Informed Consent form if feasible

Exclusion Criteria:

* Patients not treated with bortezomib as first line therapy and/or second line therapy
* Patients with more than one relapse before bortezomib re-use
* Patients unable to understand and sign Informed Consent form (see exceptions listed in section 8 "Informed consent")
* Patients who received bortezomib at relapse in combination with any investigational drug not-approved.