cyrilzakka/clinical-trials huggingface dataset:
Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles

This study evaluates the effect of a rotation based exercise program on core muscle thickness. Additionally, a second aim is to demonstrate the ability of a clinical assessment tool to identify muscle thickness changes. Half of participants receive the rotation based exercises, while the other half perform a traditional core exercise program. It was hypothesized that the rotation based exercises would result in greater changes in muscle thickness.

A number of exercise programs and assessment tools have been evaluated for their ability to influence and measure the core muscles. Inefficient stability and asymmetrical muscle activity of the core have been linked to a wide range of lower extremity injuries. Training of the abdominal muscles to obtain symmetrical recruitment for optimal trunk stabilization is a widespread clinical practice, however valid and reliable assessment tools and effective intervention protocols are lacking. This study uniquely uses both a clinical assessment tool and musculoskeletal ultrasound to measure changes in the core muscles following an exercise intervention. The overall purpose of this study was to design a valid and reliable assessment tool and an effective training protocol to activate the core muscles.

Eligibility Criteria:
Inclusion Criteria:

° Undergraduate and graduate subjects from the University of the Delaware student community.

Exclusion Criteria:

* You could be excluded if you have recently undergone surgery in the last 6 months.
* Currently suffering from low back pain.
* Or have a history of a neurological condition.
Does Bariatric Surgery Changes Eating Habits and Addiction in Morbid Obesity?

1. Obesity is a big health problem worldwide.
2. Mostly obese people have food addiction and bad eating habits.
3. Bariatric surgery is a good alternative for patients who failed to loose weight with other measures like behavioral changes, activities and sports, diet, etc..
4. The investigators know the changes occurred after surgery in eating habits due to restrictive and malabsorptive feature of the surgery performed.
5. There is no study in the literature to measure these changes.
6. The investigators will try to detect these kind of behavioral changes by a survey before and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with BMI \> 40 kg/m2
* Patients with BMI \> 35 kg7m2 \< 40 kg/m2 but with comorbidity
* Patients \> 18 years old
* Patients who sign the inform consent
* Patients who have no psychiatric disease
* Patients who have no endocrine disorders

Exclusion Criteria:

* All obese patients who do not fulfill the criteria above mentioned
Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

The investigators propose a randomized non-inferiority trial that compares preoperative Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential with regard to toxicity and cost. The metabolic response of the tumor, as assessed by 18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be used as a surrogate marker of cause specific outcome


Eligibility Criteria:
Inclusion Criteria:

* histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
* the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound

Exclusion Criteria:

* unresectable metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status \> 3
* patients not deemed fit for radiotherapy, capecitabine or surgery
* pregnant or lactating patients
* women with child bearing potential who lack effective contraception
* patients below 18 years old
3D OLV Training Intervention for Pediatric Anesthesia Trainees

One lung ventilation (OLV) in neonates and children is an advanced skill that is necessary for delivery of safe and quality anesthetic care. The current model of training for OLV in the paediatric patient is composed of the apprenticeship model. Trainees learn the techniques of doing the procedure when they encounter a case that allows for it. The model of training is often inadequate for mastery of skills such as OLV as children in this population often have severe debilitating disease often requiring the most experienced anesthesiologist to perform OLV. This limits the training exposure of anesthesia trainees.

Each participant will be subjected to three learning sessions on a 6 year old tracheo-bronchial model. Learning will either be spaced (1 week between learning/testing sessions) or non-spaced (30 minutes between learning/testing sessions). They will have 20 minutes to practice on this model before they are asked to perform the OLV on a younger tracheo-bronchial model (2 yrs, 3 months, 6 weeks). After each testing session, the participants will be provided with feedback. After all learning/testing sessions take place, the participants will be asked to complete a retention test on the 6 week old model six weeks after their last session.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric residents and fellows from the Hospital for Sick Children, Toronto

Exclusion Criteria:

* Refusal to participate in study
* Previous experience with at most two OLV in children
* Previous experience with at most two OLV in manikins
Post-incision Antimicrobial Wash Vs C. Acnes in Shoulder Arthroplasty

The purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will receive one of the following treatments:

* Post-incision application of Xperience Antimicrobial wash (NextScience, Jacksonville, FL)
* Post-incision application of 3% hydrogen peroxide
* Post-incision application of 10% povidone-iodine (betadine)
* No post-incision treatment (control)

The investigators hypothesize that the subjects treated with the antimicrobial solutions after initial incision will have lower rates of positive C. Acnes cultures. The investigators also hypothesize that post-incision application of Xperience Antimicrobial wash and Betadine will have an equal reduction in the incidence of C. acnes as Hydrogen Peroxide.

Cultures will be collected from the following sites:

* The surgical site prior to the initial incision
* The incision site after the initial incision
* The shoulder joint
* The room air

Cultures will be monitored daily for the presence of C. Acnes up to 18 days post-surgery. At postoperative clinic visits, patients in all groups will undergo a clinical evaluation by their surgeon, which includes assessment of wound healing and any complications at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery. A password-secured database and data points will be pulled from electronic medical records. Data will be analyzed and will be utilized to come to the conclusion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Indicated and scheduled for primary shoulder arthroplasty.
* Chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, rotator cuff arthropathy,
* Ability to read and understand English
* Age ≥18 years
* Patient failed ≥6 weeks of conservative treatment, which included non-steroidal anti-inflammatory drugs (NSAIDS)

Exclusion Criteria:

* Patient with history of prior native shoulder septic arthritis or infection
* Prior surgery of affected shoulder
* Proximal Humerus Fracture
* Active infection
* Cancer
* Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
* History of allergic reaction to citric acid-derived products
Cornell Translational Behavioral Science Research Consortium: Angioplasty Qualitative Study

To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.

1. To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.
2. To use the responses obtained in the qualitative interviews to inform how we should operationalize and tailor the positive affect induction and self-affirmation intervention methods in each of the populations under study. Specifically, this involves assessing what small gifts participants prefer to receive and what would be most effective in inducing positive affect.

Eligibility Criteria:
Inclusion Criteria:

* Post-angioplasty patients who had previously participated in an RCT designed to motivate multi-behavior change.

Exclusion Criteria:

* Patients who refuse to be interviewed, Patients who were not enrolled in the parent trial
Examining the Link Between Heart Disease and HIV Infection in Women

Recent studies have shown that HIV infected individuals have an increased risk of developing heart disease, but the reason for this is not fully understood. This study will examine ultrasound test results of blood vessels and laboratory data of HIV infected and HIV uninfected women to examine the link between heart disease and HIV infection.

HIV infected individuals are at increased risk for developing atherosclerosis, which is a build-up of plaque within the arteries and which may lead to various forms of heart disease. It is unknown, however, why individuals with HIV are more susceptible to heart disease compared to others. Atherosclerosis may develop more rapidly due to HIV infection, the use of antiretroviral medications, or a combination of the two. HIV lipodystrophy syndrome, in which body fat distribution is altered, may also be a risk factor. If heart disease is not properly treated, individuals place themselves at risk for heart attacks, strokes, or organ failure. In previous studies involving HIV and heart disease, women have been under-represented. This study will examine a group of women participating in the Women's Interagency HIV Study (WIHS), which is examining the impact of HIV infection and its clinical, laboratory, and psychosocial effects in women. By using ultrasound imaging, the progression of subclinical atherosclerosis will be assessed. WIHS study data will then be used to examine possible relationships between atherosclerosis and factors associated with HIV infection in women. The results of this study will have major implications for the development of strategies to predict, prevent, or reverse atherosclerosis and heart disease in HIV infected individuals.

This 4-year study will enroll 750 HIV infected women and 250 HIV uninfected women who are participating in the WIHS study. Participants will undergo an initial ultrasound imaging of the neck to measure the size and thickness of the arteries. They will return for a repeat ultrasound at Years 2, 3, and 4 to assess any progression of atherosclerosis. Data from the participants' biannual WIHS study visits, including HIV medication usage, viral load and CD4 test results, and occurrence of AIDS and other illnesses, will be reviewed. Results of participant's inflammation marker tests, which may indicate the presence of atherosclerosis, including white blood cell count, C-reactive protein, E-selectin, and intercellular adhesion molecule 1, will also be reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Women enrolled in the WIHS HIV cohort study
Evaluation of AKI by Measuring the NephroCheck Test After Pediatric Cardiac Surgery

Blood and urine samples of over 200 pediatric subjects (over 28 days to 3 years) undergoing complex cardiac surgery with cardiopulmonary bypass (CPB) will be collected at several time points to measure corresponding biomarkers such as serum creatinine, serum urea concentration, or NephroCheck test (\[TIMP-2\]\*\[IGFBP7) to evaluate the diagnostic performance of AKI by NephroCheck test .

At least 200 subjects having undergone pediatric cardiac surgery with cardiopulmonary bypass (CPB). Enrollment will continue with a maximum of 350 subjects until 30 cases of AKI (stage 2 and 3) are reached.

Blood and urines samples will be collected at several time points to measure biomarkers and set up a biobank.

The samples used within the scope of this protocol will be fresh urine samples (1 to 2 ml) and blood samples.

Urine samples for \[TIMP-2\]\*\[IGFBP7\] measurements will be taken from each subject included in the study during the first 48 hours following cardiopulmonary bypass initiation according to the following schedule:

* baseline before initiation of cardiopulmonary bypass (CPB, 0h).
* - 2h, 4h, 6h, 8h, 12h, 24h, 48h after initiation of CPB

Blood samples for serum creatinine and urea concentration measurement will be taken from each subject included in the study during the first 48 hours following cardiopulmonary bypass initiation according to the following schedule:

* baseline before initiation of cardiopulmonary bypass (CPB, 0h).
* 12h, 24h, 48h, 60h after initiation of CPB

Primary objective:

To evaluate the proportion of subjects predicted to be at risk of AKI (stage 2 and 3) using at least one measurement of NephroCheck in subjects having undergone pediatric cardiac surgery.

Secondary objectives:

* To evaluate the incidence of AKI (stage 2 and 3) according to the KDIGO guideline
* To study the kinetic profile of cell cycle arrest biomarkers (TIMP-2\*IGFBP-7) during the first 48 hours in subjects having undergone pediatric cardiac surgery
* To determine the baseline values of \[TIMP-2\]\*\[IGFBP7\] in the targeted population before surgery
* To determine profile differences of \[TIMP-2\]\*\[IGFBP7\] between AKI (stage 2 and 3) and non-AKI groups
* To evaluate the diagnostic performances of \[TIMP-2\]\*\[IGFBP7\] to predict AKI after pediatric cardiac surgery using a cut-off value of 0.3

Eligibility Criteria:
Inclusion Criteria:

* Must sign the consent form
* Clinical diagnosis of complex congenital heart surgery (Risk Adjusted classification for Congenital Heart Surgery \[RACHS\] score \>=2)
* Must undergo elective cardiac surgery with CPB

Exclusion Criteria:

* Clinical diagnosis of severe pre-existing renal insufficiency (SCr \>2 times age-adjusted normal range)
* Significant abnormalities of the kidneys or genitourinary tract
Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

The purpose of this study is to investigate if it is possible to lower the nighttime blood pressure in patients with type 2 diabetes mellitus by shifting the administration of antihypertensive drugs from morning to nighttime.

In recent years several studies have shown that high nighttime blood pressure is associated with increased cardiovascular risk independently of the average 24 hour blood pressure. As a consequence there has been increasing focus on nighttime blood pressure and how to lower it. One way of addressing the problem is to shift the administration of antihypertensive drugs from morning to nighttime. Studies on non-diabetic patients show that by doing this the nighttime blood pressure can be lowered with 3-5 mm Hg without negative effect on the 24 hour blood pressure.

Only recently a study was made on diabetic patients. This showed similar results as for non-diabetic patients.However this study was based on diabetic patients who did not receive any antihypertensive drugs before.

This study will investigate the effects on nighttime blood pressure when shifting administration of antihypertensive drugs from morning to nighttime. The population is diabetic patients who are already in antihypertensive treatment.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Systolic nighttime blood pressure above 120 mm Hg
* Systolic daytime blood pressure not exceeding 150 mm Hg
* Antihypertensive treatment which must include
* once-daily drugs
* at least one drug must be a Angiotensin-Converting Enzyme Inhibitor, Angiotensin II Receptor Blocker or Renin Inhibitor.

Exclusion Criteria:

* MI or stroke within 6 months
* heart failure (EF \< 45 %)
* atrial fibrillation
* eGFR \< 30 ml/min
A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers

This study is an open-label Phase 1 trial of MM-111.

Phase 1: Patients with any solid tumor type may be enrolled to evaluate the safety and tolerability of MM-111.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed advanced cancer that is:

  * HER2 amplified (IHC 2+ or greater) based on archived tumor evaluation
  * Heregulin positive based on a study required fresh biopsy sample performed at screening and confirmed by central laboratory
* Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue available for sectioning and immunohistochemical staining
* Patient's cancer must have recurred or progressed following standard therapy, have not responded to standard therapy, or for which no standard therapy exists.
* Patients must be \>= 18 years of age
* Patients or their legal representatives must be able to understand and sign an informed consent
* Patients may have measurable or non-measurable tumor(s)
* Patients should have ECOG Performance Score (PS) 0 or 1
* Patients must have adequate bone marrow reserves as evidenced by:

  * Absolute neutrophil count (ANC) \>= 1,500/uL and
  * Platelet count \>= 100,000/uL
  * Hemoglobin \>= 9 g/dL
* Patients must have tumor tissue amenable to biopsy
* Patients must be willing to undergo biopsy prior to treatment to MM-111

Exclusion Criteria:

* Patients for whom potentially curative antineoplastic therapy is available
* Patients who are pregnant or lactating
* Patients with an active infection or with an unexplained fever greater than 38.5 C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled)
* Patients with untreated and/or symptomatic primary or metastatic CNS malignancies (patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
* Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies (patients with a history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded)
* Patients with known HIV, hepatitis B or C (if patients have previously been treated for C and have undetectable viral loads, they can be considered eligible for the trial)
Interleukin-2 in Treating Patients With Myelodysplastic Syndrome

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 in treating patients with myelodysplastic syndrome.

OBJECTIVES:

* Determine the safety, tolerance, and maximum tolerated dose of subcutaneous interleukin-2 (aldesleukin; IL-2) in patients with myelodysplastic syndrome (MDS).
* Evaluate the hematologic effects of subcutaneous IL-2 in MDS.

OUTLINE: IL-2 will be administered in cycles of twice daily subcutaneous injections 7 days a week for 4 consecutive weeks. After each cycle the patient will be evaluated for response. The patient could continue IL-2 therapy for up to 12 cycles. There are 4 dose levels of IL-2. At each dose level 3 patients will be accrued sequentially.

Treatment with IL-2 should be continued until grade III toxicity or any side effects requiring hospitalization occurs. After the patient returns to baseline pretherapy values or grade I toxicity, the subject will resume IL-2 at 50% of the initial dose. If the patient again goes into grade III toxicity or is in need of hospitalization, IL-2 will be discontinued.

PROJECTED ACCRUAL: Between 12-24 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed myelodysplastic syndrome: Refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML)
* No patients with refractory anemia with excess blasts in transformation (RAEB-t)

PATIENT CHARACTERISTICS:

Age:

* 15 and over

Performance status:

* Karnofsky 70-100

Hematopoietic:

* Platelet count greater than 20,000

Hepatic:

* Bilirubin less than 1.6 mg/dL
* SGOT less than 150 U/L

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No symptoms of coronary artery disease, congestive heart failure, edema, clinically manifest hypotension, presence of cardiac arrhythmias on EKG, or severe hypertension

Pulmonary:

* No significant pleural effusion, dyspnea at rest or severe exertional dyspnea

Other:

* No patients with nephrotic syndrome
* No uncontrolled infections or active peptic ulcer disease
* No serious intercurrent medical illness
* Not pregnant or nursing
* Adequate contraception required of all patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunosuppressive therapy

Chemotherapy:

* At least 4 weeks since prior chemotherapy

Endocrine therapy:

* At least 2 weeks since corticosteroid therapy
* At least 4 weeks since other endocrine therapy

Radiotherapy:

* At least 4 weeks since prior radiotherapy

Surgery:

* Not specified
A Short SPIRIT Checklist for Peer Reviewers to Improve the Reporting Quality in Published Articles (SPIRIT-PR)

Transparent and accurate reporting is key, so that readers can adequately interpreting the results of a study. The aim of this project is to evaluate whether reminding peer reviewers of the most important SPIRIT reporting items (including a short explanation of those items) will result in higher adherence to SPIRIT guidelines in published protocols for RCTS. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the SPIRIT checklist including the ten most important and poorly reported SPIRIT items ; or (ii) no checklist. The aim is to find an intervention which improves the reporting, making it easier for readers to adequately interpret the presented articles.

The full protocol is available on Open Science Framework where the study was prospectively registered: https://osf.io/z2hm9

Eligibility Criteria:
Inclusion criteria for journals:

It was planned from the beginning that this study will only be conducted at the BMJ Open as it publishes numerous protocols. Hence, no inclusion criteria for the journal were specified.

Inclusion criteria for manuscripts:

All submitted manuscripts sent out for external review that described protocols for RCTs.

Exclusion criterial for manuscripts:

We excluded (i) Manuscripts which were clearly labelled as a pilot or feasibility study (ii) Studies randomizing animals or cells (iii) Separate publications of data analysis plans

Included peer-reviewers:

-Peer reviewers that were invited following usual journal practice