cyrilzakka/clinical-trials huggingface dataset:
Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer

Our study aims to assess the relationship between the Seismofit® derived VO2 peak estimate and CPET-measured VO2 peak in patients who are having CPET as part of their preoperative workup. Our aim is to establish whether Seismofit® can be considered a cheaper, less resource intensive and better tolerated alternative to the CPET, or whether it might be useful as a screening tool to efficiently identify patients with exercise intolerance who may benefit from further characterisation by CPET.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18
2. Scheduled for elective surgery for resection of HPB, colorectal or gastro-oesophageal primary or secondary cancer
3. Undergoing CPET as part of routine pre-operative investigations

Exclusion Criteria:

1. Subjects unable to give voluntary written informed consent to participate in this study
2. Diagnosis of moderate or worse stenosis or regurgitation of any cardiac valve
3. Previous aortic or mitral valve surgery, valvuloplasty or transcatheter valve implantation
4. Permanent pacemaker or cardiac resynchronisation device in situ
5. Diagnosis of severe pulmonary hypertension
6. Permanent atrial fibrillation
Human Epidermal Growth Factor Receptor 2 (HER-2) Status in Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma

The primary objective is to evaluate the concordance between human epidermal growth factor receptor 2 (HER2) status determined by the participating laboratory and by the centralized laboratory. HER2 status of samples was tested by the participating laboratories (investigator's choice of immunohistochemistry \[IHC\] and in situ hybridization \[ISH\] methods) and by the centralized laboratories (IHC using the 4B5 anti-HER antibody and Silver ISH). Positive HER2 status was defined as a score of IHC3+ or IHC2+/ISH+.


Eligibility Criteria:
Inclusion Criteria:

* Tumor samples with histologically confirmed gastric or gastro-esophageal junction (GEJ) adenocarcinoma, any stage
* Samples with sufficient tumor material for centralized analysis
* Samples fixed and embedded in paraffin (formalin-fixed paraffin-embedded tissue \[FFPET\] samples).

Exclusion Criteria:

- Fixatives not allowed: Bouin's solution
Interleukin-2 Following Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-2 following bone marrow transplantation in treating patients who have hematologic cancer at risk of relapse.

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of interleukin-2 following allogeneic T-cell depleted bone marrow transplant in patients with hematologic malignancies at high risk of relapse. II. Determine the optimal dose of interleukin-2 in this regimen which will result in maximal natural killer cell and lymphokine activated killer cell activity in vitro.

OUTLINE: This is a dose escalation study. Patients receive CD34+ stem cell augmented donor bone marrow on day 0 on another protocol. Patients then receive interleukin-2 (IL-2) subcutaneously on day 30. Treatment continues for 12 weeks in the absence of dose limiting toxicity. Cohorts of 4 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose prior to that which causes at least grade 3 toxicity.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Any of the following diagnoses eligible: Acute myelogenous leukemia beyond first complete remission Acute lymphoblastic leukemia Chemotherapy resistant non-Hodgkin's lymphoma Chemotherapy resistant Hodgkin's disease Multiple myeloma Primary refractory acute leukemia Secondary leukemia Chronic myelomonocytic leukemia No chronic myelogenous leukemia, aplastic anemia, or myelofibrosis HLA identical related donor required

PATIENT CHARACTERISTICS: Age: 0.5 to 65 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characterisitics Hepatic: Bilirubin less than 2.5 mg/dL (unless Gilbert's syndrome present) Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within past 12 months Pulmonary: No requirement for oxygen Other: Afebrile for greater than 48 hours No active, serious infection (e.g., sepsis, mucormycosis, or uncontrolled aspergillosis) No debilitating medical or psychiatric illness that would preclude compliance Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplant Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified
Instrument-assisted Soft Tissue Mobilization in CrossFitters

Objective. To determine the effectiveness of instrument assisted soft tissue mobilization and horizontal adduction stretch in CrossFit practitioners' shoulders.

Setting: Acero CrossFit center, city of Toledo (Spain) Design: Randomized, single-blind pilot study, with follow-up period. Participants: Twenty-one subjects of both sexes, being regular CrossFitters and in the age range of 18 to 40 years.

Intervention: The experimental group (n = 11) received 30 seconds of stretching with isometric contraction of 5 seconds and instrument assisted soft tissue mobilization. The control group (n = 10) received only 40 seconds of instrument assisted soft tissue mobilization. Each session lasted 2 to 5 minutes, 2 days a week, over a period of 4 weeks, prior to each workout.

Main Outcome measures: Shoulder internal rotation and horizontal adduction (digital inclinometer), and posterior shoulder stretch perception (Park scale) were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes
* Being regular CrossFitters (workouts at least two days a week)
* In the age range of 18 to 40 years

Exclusion Criteria:

* Had suffered a shoulder injury in the 3 months prior to the study
* Had undergone shoulder surgery in the previous six months
* Had a non-attendance rate of over 15% of the intervention sessions (2 sessions)
* Had not signed the informed consent document
IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

The purpose of this research study is to show that non-steroidal treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (CLE) patients.

The ultimate goal of this pilot project is to generate proof-of-concept data showing that treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (CLE) patients. This project has relevant clinical implications due to the severe side effects of and lack of response to current therapies.

From the review of literature, it can be postulated that:

1. the beneficial effects of IVIg for patients with CLE should be prompt, with marked improvement within a few weeks;
2. clinical improvement should last several weeks after the last infusion; and
3. remission may be prolonged by maintenance IVIg therapy.

Although this is only a non-controlled study, the investigator expects that IVIg will improve CLE, including those resistant to standard treatments. It is anticipated that treatment with IVIg will facilitate healing of extensive cutaneous lesions and achieve rapid remission. Maintenance therapy with repeated monthly pulses of IVIg is expected to keep the disease in remission during the treatment-free follow up observational period. The results will provide the basis a multicenter randomized controlled study to identify which CLE subsets will benefit the most and which protocol will provide the optimal clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Be at least 18 years of age at time of informed consent.
* Have had a diagnosis of CLE
* Currently has active CLE (any subtype) established by standard clinical and histo- and immunopathologic criteria
* Falls into one of the two following cohorts:
* Cohort 1 - Has received a standard systemic therapy without a therapeutic response for a minimum of one month
* Cohort 2 - Has not received any systemic treatment

Exclusion Criteria:

* Subject is not over 18 years of age.
* Subject cannot understand or follow directions.
* Subject is a female of child-bearing potential and unwilling to use a form of highly effective birth control.
* Subject is pregnant, planning to get pregnant, or breast feeding.
* Subject has a known history of immunoglobulin A (IgA) deficiency.
Effectiveness of Early Detection of Atrial Fibrillation

To verify if the screening opportunistic of Atrial Fibrillation (AF) by means of the measurement of the arterial peripheral pulse is more effective than the habitual practice for the early detection of AF in 65-year-old who come to Primary care


Eligibility Criteria:
Inclusion Criteria:

* Patients that come to his center of health for any motive.

  * That give his assent informed to take part in the study.

Exclusion Criteria:

* FA previous Diagnosis
Cognitive Screening and Cognitive Training in Seniors

This study will provide cognitive screenings for seniors age 50 and older. It will also investigate the benefits of two different cognitive training programs for seniors who have lower baseline performance on memory and/or gist reasoning tests.

This study consists of two parts which includes cognitive screening and cognitive training. Participants will initially participate in the cognitive screening portion of the study. If qualified, participants will participate in the cognitive training portion of this study which includes additional cognitive communication, neuropsychological testing, and EEG.

Eligibility Criteria:
Inclusion Criteria:

* Cognitive complaints in the absence of dementia
* Participate in tasks involving motor abilities such as use of at least one arm and hand
* Read, speak, and comprehend English
* At least 50 years of age
* Comprehend simple instructions, perform tasks, and take part in intervention

Exclusion Criteria:

* Not proficient in reading,comprehending, and speaking English
* History of learning disability, stroke, cognitive impairment, major psychiatric illness, alcoholism, or substance abuse
Microecology and Immunity in Patients With Anti-MDA5 Antibody Positive Dermatomyositis and Interstitial Lung Disease

The purpose of this study was to analyze the relationship between the microbial community, host immunity and the presence or absence of concurrent rapidly progressive interstitial lung disease patients with anti-MDA5 antibody positive dermatomyositis.

Methods: Bronchoalveolar lavage specimens of patients with anti-MDA5 antibody positive dermatomyositis and interstitial lung disease were collected and studied to analyze the relationship between the composition of patients' microecology and the occurrence and development of disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the diagnostic criteria of dermatomyositis and anti-MDA 5 antibody positive.
* Anti-MDA5 antibody positive DM patients with RPILD meet the diagnostic criteria for RPILD.
* Must have undergone bronchoalveolar lavage.
* Age≥18 years old.
* Patients who signed informed consent forms

Exclusion Criteria:

* Patients who had other connective tissue diseases.
* Patients with ILD or RPILD caused by infection, tumors, drugs, biochemistry and other factors.
* Pregnant or lactating patients.
* The patient also participated in any other clinical trial.
* Disagreement for inclusion in this study
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.

To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.


Eligibility Criteria:
Inclusion criteria

* Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models)
* Moderate to severe mitral regurgitation
* Symptom status NYHA II-III
* Treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before inclusion
* Age ≥ 18 and \< 90 years
* Written informed consent

Exclusion criteria

* MR mechanism/anatomy precluding MitraClip therapy
* Groin blood vessels are not eligible for TAVI procedure
* Massive or torrential tricuspid regurgitation
* Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen.
* Life expectancy \< 1 year due to non-cardiac conditions
* LVEF ≤ 25%
* Hypotension (systolic pressure \< 90 mmHg) or requirement of inotropic support or mechanical hemodynamic support
* Cardiomyopathy other than dilated cardiomyopathy
* Fixed pulmonary artery systolic pressure \> 70 mm Hg
* Any prior mitral valve surgery or transcatheter mitral valve procedure
* Stroke or transient ischemic event within 6 months prior to randomization
* Severe symptomatic carotid stenosis
* Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 90 days prior to randomization
* Untreated clinically significant coronary artery disease requiring revascularization
* Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to randomization, or any cardiac surgery within six months prior to randomization.
* Need for any other cardiovascular surgery (other than MV or AV disease)
* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
* Active endocarditis or active infections requiring current antibiotic treatment
* Any condition making it unlikely that the patient will be able to complete all protocol procedures
* Patient unable to provide written informed consent prior to study enrolment
* Pregnant or nursing women
* Women of child bearing potential
* Current participation in any other interventional clinical trial
* Patients under legal supervision or guardianship Patients placed in an institution by official or court order
PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging

In this study, the investigators will prospectively assess fever rates and other adverse events in pregnant women after administration of inactivated influenza vaccine (IIV) using text messaging. The investigators hypothesize that women \<20 weeks gestational age who receive IIV will be willing to enroll in a text messaging-based vaccine adverse event monitoring program and will use it to report fever in the post-vaccination period as well as continue to text pregnancy-related outcomes through the end of their pregnancy.


Eligibility Criteria:
Inclusion Criteria:

1. Are pregnant with a gestational age of \<20 weeks either by last menstrual period (LMP) and/or ultrasound
2. Are at least 18 years of age
3. Have a visit at a study site during the enrollment period
4. Receive IIV at that visit
5. Have a cell phone with text messaging capabilities
6. Are English or Spanish-speaking
7. Are willing to report via text message through end of pregnancy

Exclusion Criteria:

1. Decision to not continue with pregnancy
2. Any contraindication to receipt of inactivated influenza vaccines
3. Receipt LAIV (live attenuated influenza vaccine) at that visit
4. Previous receipt of IIV in this pregnancy
5. Presence of fever \>=100.4F at time of vaccination;
6. Administration of any antipyretic in the 6-hour period prior to vaccination,
7. Stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever;
8. Patient only speaks a language other than English or Spanish
9. Patient does not have a cell phone with text messaging
10. Patient's inability to read text messages
A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine

The primary outcome of this study is to evaluate the effects of low frequency subthreshold repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of patients with refractory schizophrenia on the severity of auditory hallucinations.

The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of life, functionality and general psychopathology.

Seventeen patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. First group received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).

Second group received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and refering auditory hallucinations occuring at least 5 times a day.

Eligibility Criteria:
Inclusion Criteria:

* Patients with DSM IV TR diagnose of schizophrenia with treatment-resistant auditory hallucinations.
* Use of at least 400mg/day of clozapine
* Men and women from 18 to 65 years old
* Fertile women must be using adequate contraceptive method
* BPRS score of at least 27

Exclusion Criteria:

* Suicide risk
* Patients with epilepsy, brain surgery and/or head trauma in the past, use of cardiac pace maker or metalic clip in the head
* Diagnose of substance abuse/dependance
* Severe uncontrolled organic disease that may interfere in the patient´s participation in the study
* Any other reason that, in the investigator´s opinion, might interfere with the patient´s participation in the study, such as non compliance.
Dosimetric Planning Study Comparing Intensity Modulated Radiotherapy (IMRT) and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix

A theoretical planning study to compare the normal tissue irradiation when using intensity modulated radiotherapy (IMRT) as opposed to standard radiotherapy for the definitive treatment of cervical cancer.

Radiotherapy in combination with chemotherapy is the standard treatment of locally advanced cervix cancer, however with traditional techniques large volumes of bowel and bladder are irradiated causing short-term and long-term genito-urinary and gastro-intestinal side effects. IMRT has the potential to conform precisely to the target and spare normal tissues and reduce side effects. However because there are large dose gradients there is the potential to miss the target due to organ motion. Recent studies have documented organ motion and will be used to define the target. Approximately 60 planning scans, previously used to treat patients with cervix cancer, will be used to replan using an IMRT technique and differences in doses to tumour and normal tissues compared.

Eligibility Criteria:
Inclusion Criteria:

* last 60 patients treated definitively for cervical cancer at Sunnybrook Odette Cancer Centre

Exclusion Criteria:

* no imaging and no anatomical description of disease
Basics in Acute Shortness of Breath EvaLuation (BASEL V) Study

To improve the diagnostic and prognostic utility of various biomarkers, detailed patient's history, physical examinations and technical devices in patients presenting with acute dyspnea.

Background: Acute heart failure is a common disease associated with high morbidity and mortality. Unfortunately, pathophysiology and optimal initial treatment are both ill defined.

Working Hypothesis:

* Improved understanding of the pathophysiology underlying heart failure might allow more cause-specific treatment to this syndrome.
* More rapid diagnosis of acute heart failure may allow to more rapidly initiate the appropriate treatment.
* Cardiac dysfunction especially in comorbid dyspneic patients is not adequately characterized and the spectrum of acute heart failure is more diverse than originally thought.

Methods: This is a large multicenter center, observational study enrolling unselected, consecutive patients with acute dyspnea presenting to the Emergency Department. Patient history, physical examination and laboratory parameters will be systematically obtained. Echocardiographic examinations will be routinely performed. Follow-up will be done at specified intervals (3, 6 and 12 months) after the initial presentation and risk predictors will be analyzed in multivariable regression models.

Expected Value of the Proposed Project: The data obtained during this project will help to further improve diagnostics and prognostics in patients with acute dyspnea and to better understand underlying pathology of cardiac dysfunction in this cohort.

Significance: The study aims are up-to-date and deal with an important health care problem in society. Conclusions drawn will significantly change care of patients with acute heart failure probably leading to a significant reduction of rehospitalization, morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* chief complaint of dyspnea (not penetrating injury or trauma related)
* subjects must be at least 18 years of age

Exclusion Criteria:

* patient is unable or unwilling to give informed consent
* patient on hemodialysis
AbioKin - Antibiotic Kinetics

The purpose of this study is to investigate the pharmacokinetic properties in critically ill patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem, piperacillin/tazobactam, vancomycin). The primary objective is the identification of the clinical parameters affecting the kinetics of these drugs and the study of the contribution of extracorporeal depuration techniques to the elimination of these molecules. The secondary objective is to describe and compare the therapeutic therapies adopted in the Intensive Care Units participating in the project.

For each molecule, the study will involve 300 patients admitted to Intensive Care Units. For each patient five blood samples will be collected on average, in order to measure drug plasma concentrations. Patient clinical conditions will be collected through an electronic clinical record. Finally, on the basis of those data, pharmacokinetic models will be developed to describe the evolution in time of drug plasma concentrations.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing antibiotic therapy with amikacin, linezolid, meropenem, piperacillin/tazobactam, or vancomycin.
* patients whose antibiotic therapy started during the stay in ICU or less than 24h before admission to ICU.
* patients with anticipated length of stay in ICU of at least 24h.
* patients with already-placed catheter

Exclusion Criteria:

* patients undergoing antibiotic prophylaxis
* lack of informed consent