cyrilzakka/clinical-trials huggingface dataset:
Application of Elbow Manipulation in Archers

The aim of this study was to: (i) assess the impact of maximal muscle strength and stiffness on EMG and Myoton parameters for selected upper limb muscles; and (ii) assess how manipulation of the initial 2-s tension phase, in particular involving muscle stretching, affects these EMG and Myoton parameters during karting training.

EMG and Myoton measurements will be performed on selected muscles of the shoulder joint and forearm during karting drivers' training, initially at the beginning, after the athletes perform their first 8-minute run, after manipulation and after another 8-minute run.

Eligibility Criteria:
Inclusion Criteria:

* Healthy persons aged 18,
* A license to drive a kart,
* A competitor who regularly competes in the league,
* Expressing informed consent to participate in the study and undertakes to comply with the regulations on the track and wear a helmet.

Exclusion Criteria:

* Lack of volunteer consent,
* Previous upper, lower limb and spine surgeries,
* Other upper limb injuries in the last 6 months,
* Pain limiting participation in the study,
* Neurological diseases,
* Connective tissue diseases.
Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection

No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.

Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pancreatic cancer
* Preoperative chemotherapy
* Pancreatic resection

Exclusion Criteria:

* Metastatic disease
* ASA score 4
Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes

This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case management, with home telemonitoring of blood sugars and home HbA1c measurement will result in additional improvements in glycemic control compared to isolated nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower compared to usual nurse case management. Secondary aims include an additional 5 mmHg improvement in systolic blood pressure (among patients with hypertension at the time of enrollment), improved patient satisfaction with treatment, improved medication adherence, reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for telephone communication. Patients will be enrolled and actively case managed for 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled at Minneapolis VAMC,
* Type 1 or 2 Diabetes,
* HbA1c \>8.5%,
* active land-line telephone connection

Exclusion Criteria:

* Age \>75 years,
* primary care provider unwilling to have patient enrolled,
* active dialysis,
* resident of assisted living facility,
* research participant in previous diabetes case management study,
* life expectancy \<1 year,
* severe mental health condition,
* active substance abuse,
* pregnant or planning on becoming pregnant
A Study to Evaluate Vaccines Against COVID-19 in the Real World

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have afflicted tens of millions of people in a worldwide pandemic. Considering its high mortality and rapid spread, an effective vaccine is urgently needed to control this pandemic. Recently, mass vaccination campaigns using newly approved vaccines, ranging from conventional viral and protein-based vaccines to those that are more cutting edge, including DNA- and mRNA-based vaccines are beginning in many parts of the world. Randomized clinical trials of different vaccines reported efficacies for preventing COVID-19 in the range of 50% to 95%.

Although these randomized clinical trials are considered the "gold standard" for evaluating intervention effects, they have notable limitations of sample size and subgroup analysis, restrictive inclusion criteria, and a highly controlled setting that may not be replicated in a mass vaccine rollout.

The aim of this study is to evaluate the safety, tolerability, immunogenicity, and efficacy of different vaccines against COVID-19 under real-world practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects received COVID-19 vaccines;
* Able to comprehend and provide written informed consent in accordance with institutional guidelines.

Exclusion Criteria:

* Not received any COVID-19 vaccines;
* Not willing to participate and/or give their written informed consent.
Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.

The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil

Eligibility Criteria:
Inclusion Criteria:

* Health adults of both genders
* Age ≥ 18 ≤ 50 years
* Able to understand every required study procedure
* Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
* Normal values for pre-stablished laboratory assays
* Accpetance to participate and sign the consent form

Exclusion Criteria:

* Any chronic condition
* Be on immunossupressive or stimulant therapy
* Have egg alergy
* Have past history of alergy to sazonal influenza vaccine
* Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
* Acute infectious disease during seven days prior vaccination
* Female on breasthfeeding
* Confirmed prior infection by pandemic influenza A
* Participation in another clinical trial in the last 6 months
* Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer
Polymyalgia Rheumatica and Giant Cell Arteritis

The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica (PMR)/Giant Cell Arteritis (GCA) .

Introduction:

Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA) are common inflammatory conditions. The diagnosis of PMR/GCA poses many challenges since there are no specific diagnostic tests. Recent literature emphasizes the ability of 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) to assess global disease activity and/or inflammation burden. 18F-FDG PET/CT may lead to make diagnosis at an earlier stage than conventional imaging and assess response to therapy. With respect to the management of PMR/GCA, there are three significant areas of concern as follows: Vasculitis process/vascular stiffness, malignancy and osteoporosis.

Methods and Analysis:

Patients: All patients with the suspicion of PMR/GCR will be offered to participate in the study. The current protocol consists of 4 separate studies including: I) The association of clinical picture of PMR/GCA with PET detected vasculitis II) Evaluating validity of 18F-FDG PET/CT scan for diagnosis of PMR/GCA compared to temporal artery biopsy III) Incidence of new diagnosed malignancies in patients with PMR/GCA, or PMR like syndrome with the aim of PET/CT scan and Chest X ray/Abdominal ultrasound IV) Impact of disease process as well as steroid treatment on bone mineral density, body composition and vasculitis/vascular stiffness in PMR/GCA patients.

Eligibility Criteria:
Inclusion Criteria:

* At least five (A-E) components of the PMR diagnostic criteria, including:

  * A. Age ≥50 years,
  * B. Bilateral shoulder or hip pain,
  * C. Morning stiffness lasting \>45 min,
  * D. Elevated erythrocyte sedimentation rate (ESR),
  * E. Elevated C-reactive protein (CRP),
  * F. Disease duration \>2weeks, should be met to suspect PMR.
* For GCA following criteria's must be seen: Age \> 50 years, ESR/CRP \> 50, as well as at least two symptoms related to vasculitis (scalp tenderness, vision disturbances, headache (new or changed), jaw claudication, tenderness of the temporal arteria) if patients do not simultaneously have PMR. If the patient is suspected for PMR, one cranial symptom is enough to suspect GCA.

Exclusion Criteria:

* Dementia
* Inability to communicate in Danish
* Infections or malignancy when prednisolone is permanently unsuitable
* Contraindication to imaging studies (allergy to contrast materials, reduced kidney function, pregnancy and Blood Sugar (BS) \>8 mmol/l after 6 hours fasting)
* Initiation of steroid treatment before the PET scan
* Inability to provide informed consent
Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

The purpose of the study is to explore options for preventing and reducing symptoms of radiation esophagitis (RE). The researchers will also look what symptoms participants experience, and whether there are differences in weight loss in participants.

Embedded Randomized Study to Assess Two-Stage Consent Design:

There will be two separate randomizations in this study, one vs. two-stage consent and sucralfate vs. control. The will first approach patients and explain that we are comparing different methods of informing patients about trials. If the patients do not wish to participate in the consent trial, participants will be approached for consent onto the therapeutic trial using the traditional onestage research consent.

Patients who decline or who are not approached to take part in the randomized compression of consent methods based on physician discretion, may still take part in the randomized comparison of sucralfate vs. control (therapeutic trial).

Eligibility Criteria:
Inclusion Criteria:

* Patients being treated with thoracic irradiation with high-risk esophageal dose as determined below:

Esophageal dose:

* V50 ≥ 15% (25-35 once daily fractions) or 40 twice-daily \[BID\] fractions)
* V40 ≥ 15% (15-24 once daily fractions or 30 twice-daily \[BID\] fractions)
* V30 ≥ 15% (10-14 once daily fractions)

  * Age 18 years of age or older.

Exclusion Criteria:

* Known inability to take Sucralfate (tablet and/or suspension form), per physician discretion
* PEG tube
* Actively taking any opioid pain medications prior to radiation therapy
* History of an opioid use disorder
Characterizing Knee Pain and Response to Surgery Using Local Biomarkers

The diagnosis and monitoring of clinically-significant pathologies of the knee remains challenging, and it is unknown why only some injuries become painful or respond to surgical intervention. The limitations of diagnostic magnetic resonance imaging result in arthroscopy that is not always beneficial. Elucidation of biochemical pathways underlying pain in this condition may aid patient selection for surgery and provide pharmacotherapeutic targets. Cytokines or a novel yet uncharacterized protein may be involved in pain following meniscus injury and diagnostic cytokine assay may help physicians differentiate patients that may benefit from arthroscopy from those that may not. Additionally, evaluating post-operative biochemical profiles may provide a method of monitoring surgical outcome and understanding post-operative continuation or remission of pain.

Lavage of the operative and contralateral knee for comparison are performed under anesthesia prior to arthroscopy by the infusion of 10cc sterile saline into the knee joint followed by the immediate withdrawal into the syringe, and storage at -80°C in a tube containing a protease inhibitor. At 12wk post-operative a 10cc lavage is performed on the knee that underwent surgery. Clinical findings for each sample are quantified using gold-standard symptom severity questionnaires.

The specimens will be analyzed for 31 potential biomarkers using a multiplexed immunoassay panel, the results of which will be compared with pre- and post-operative clinical findings and radiographic imaging. Plans do not currently include microarray analysis, but this may be later included.

Eligibility Criteria:
Inclusion Criteria:

•Adult patients with knee pain (acute or chronic) who had failed conservative treatment and elected for arthroscopic management. Indications for surgery included the presence of mechanical symptoms on history, a physical examination positive for McMurray's maneuver or joint line tenderness or both, absence of severe joint space narrowing on plain radiography, and the presence of grade III signal changes on MRI in an anatomic location consistent with the history and physical examination.

Exclusion Criteria:

* Less than 18 years old.
* Recent (within three months) intra-articular corticosteroid injection and past or current medical history of autoimmune disease (i.e. rheumatoid arthritis).
* In addition, no patients involved in a worker's compensation claim or personal injury litigation were enrolled in the study.
The Canada Lymph Node Score Project: A Crossover Trial

Before deciding on treatment for patients with lung cancer, a critical step in the investigation is finding out whether the lymph nodes in the chest contain cancer cells. This is accomplished with a biopsy of the lymph nodes through the airway wall, known as Endobronchial Ultrasound-guided Transbronchial Needle Aspiration. Guidelines require that every single lymph node in the chest be biopsied through a process called Systematic Sampling. However, emerging data suggests that the lymph nodes that appear benign on imaging and ultrasound do not need a biopsy. A proposed alternative to the inefficient Systematic Sampling is the simplified Selective Targeted Sampling of the lymph nodes, whereby only lymph nodes that look malignant are biopsied. This trial will evaluate the simplified Selective Targeted Sampling of lymph nodes and compare it to Systematic Sampling to see whether it is equally as effective in staging lung cancer.

Treatment decisions in Non-Small Lung Cancer (NSCLC) are reliant on a thorough staging process that includes imaging with Computed Tomography (CT), Positron Emission Tomography (PET) and Systematic Sampling (SS) of mediastinal lymph nodes (LNs) by Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA). Collectively, the results of these staging procedures dictate whether patients will be treated with surgery, radiation and/or chemotherapy. Current guidelines for SS through EBUS-TBNA mandate the biopsy of at least 3 mediastinal LN stations (4R, 4L and 7) in the chest, even if they appear normal on CT and PET scan. Despite improvements in diagnostic techniques and safety, LN biopsies remain onerous for the patient and costly to our healthcare system. SS is also unreliable, yielding inconclusive pathology results in 42.14% of cases, especially for Triple Normal LNs, which are LNs that appear normal on PET, and CT, and EBUS. In fact, SS results in mostly negative or inconclusive biopsies for Triple Normal LNs, which may be due in part to their very low probability (\< 6%) of malignancy. As such, the researchers have proposed to replace the onerous and unreliable process of SS by a simpler Selective Targeted Sampling (STS) staging process. In STS, Triple Normal LNs will not be biopsied, due to the very high negative predictive value (NPV) of malignancy. STS follows the simple notion that only LNs that have the potential to be malignant should be biopsied, whereas LNs which are very likely benign (i.e. Triple Normal LNs) should not be biopsied.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Both CT and PET scans completed prior to EBUS
* Suspected or confirmed NSCLC requiring mediastinal staging
* cN0-cN1 as indicated by CT and PET scans

Exclusion Criteria:

* Patients with cN0 disease AND peripheral tumors AND tumor \< 2 cm in diameter, as they do not require mediastinal staging
* Evidence of cN2 disease or higher on CT and PET scans
Intraperitoneal Ropivacaine Irrigation in Bariatric Surgery

A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation (Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline (Control Group - CG).

A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation 300mg in 200 ml(Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline 200ml (Control Group - CG).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity.

Exclusion Criteria:

* patients undergoing other bariatric techniques or revisional surgery
* allergy to local anesthetics
* severe underlying cardiovascular diseases
* chronic renal failure
* hepatic dysfunction
* previous foregut surgery
* patients with any contraindication for bariatric surgery.
Amphotericin Versus Posaconazole for Pulmonary Mucormycosis

Pulmonary mucormycosis is a serious illness with high morbidity and mortality (approximately 57%). Surgery and antifungal therapy are central in the management of mucormycosis. Unlike rhino-orbital mucormycosis, surgery is not feasible in several patients with pulmonary mucormycosis. Hence, treatment is primarily with antifungal therapy. Amphotericin B is the standard of care in the medical management of mucormycosis. However, amphotericin B is expensive, has significant adverse events, and is available only in parenteral formulation. Posaconazole is effective against Mucorales, and is currently approved for salvage therapy of mucormycosis. Recent evidence suggest that in several patients, posaconazole may be effective as a monotherapy upfront. In the current study posaconazole versus amphotericin B will be evaluated for the management of pulmonary mucormycosis in a randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

Subjects with proven or probable pulmonary mucormycosis. Participants with a suspicion of pulmonary mucormycosis (as defined previously) based on compatible clinical presentation and compatible imaging will be screened for inclusion in the study.

Exclusion Criteria:

* Failure to provide informed consent
* Contraindications or hypersensitivity to amphotericin B, posaconazole or their components
* Already received \>4 days of antifungals prior to randomization into the study
* Pregnant women
* High chances of mortality within 48 hours of enrolment into the study

Subjects with possible pulmonary mucormycosis will also be excluded, if their diagnosis is not confirmed within four working days of enrollment
Distal Thigh Compression Garment Improves Knee Control and Safety Perceptions During Single Leg Triple Hop for Distance

This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)). The hypothesis was that the DTCG group would display superior dynamic knee valgus FPPA compared to the standard knee sleeve and no device groups.

Eighteen healthy college athletes participated in this prospective cohort study with a randomized device order. FPPA was measured during single leg triple hop for distance using two-dimensional biomechanical techniques to estimate dynamic knee valgus loading. A 10-cm visual analog scale survey collected data regarding subject perceived knee control, sports movement capability and overall satisfaction for each condition. Pearson correlations delineated knee valgus, safety and performance relationship perceptions (p \< 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* College athletes
* ≥ 18 years

Exclusion Criteria:

* Knee injury history
* Any current lower extremity injury
Acute Preoperative Pain and Chronic Post-surgical Pain in Emergency Surgery

Studies evaluating postoperative pain as a risk factor for CPSP are almost exclusively carried out in the context of scheduled surgery. As a result, the preoperative pain studied as a risk factor for chronicity is essentially a state of pain that has persisted for several weeks or even several months.

In emergency surgeries, patients are subject to acute preoperative pain of varying intensity and the duration of which may vary by a few days. A few studies have highlighted the intensity of acute preoperative pain as a factor favouring moderate to severe postoperative pain. At this point, no study has addressed the long-term consequences of this intense preoperative pain the emergency context.

An evaluation in the field of emergency surgery, where the preoperative pain is often intense and limited in time, would enable us to identify more precisely the impact of acute pain on the incidence of CPSP.

The investigators are hypothesising that the occurrence of CPSP at 3 months in patients undergoing emergency orthopaedic or abdominal surgery is associated with acute preoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old.
* Emergency orthopaedic and/or abdominal surgery.
* Informed consent.
* Affiliation to a social security scheme

Exclusion Criteria:

* Intraoperative complications that are life-threatening or require the surgical procedure to be discontinued.
* Post-operative intensive care unit admission.
* Ambulatory surgery.
* Endoscopic surgery.
* Repeat surgery at the same site in less that 3months.
* Pregnant or breast-feeding patients.
* Patients under guardianship or deprived of liberty.
* Patients suffering from psychiatric pathologies.
* Patients suffering from neurodegenerative pathologies.
* Patients for whom self-assessment of pain using a numerical scale (0-10) cannot be carried out (non-communicative patients, non-French-speaking patients, and so on).