cyrilzakka/clinical-trials huggingface dataset:
Reamer Irrigator Aspirator (RIA) vs Autogenous Iliac Crest Bone Graft (AICBG) for the Treatment of Non-unions

The specific question the investigators will seek to answer is: can the Reamer Irrigator Aspirator (RIA) provide a bone graft source for the treatment of nonunions that is equally effective to Autogenous Iliac Crest Bone Graft (AICBG) while resulting in a decreased amount of post-operative pain and a lower rate of complications?

All subjects will be pre-screened by the treating physician. Subjects who present with a nonunion of a long bone will be invited to speak to the research coordinator regarding the study. An internet based randomization system will be used to allocate subjects to treatment groups. Participating sites will be given a unique ID and password to log into the secure website and register their subject.

Treating physicians will use 1 of 2 bone graft harvesting methods in patients with a nonunion of a long bone requiring grafting. The first method involves harvesting bone graft from the iliac crest area. The second method involves using the RIA to harvest bone graft from the femoral canal. Clinical assessments will occur at the time of hospital admission (baseline), at post-op day 1, and then at 2 weeks, 6 weeks, 3 months, 6 month, 12 months and 24 months post-surgery.

Surgical procedure at the nonunion site will not be standardized as this will vary greatly. Surgeons may use bone graft substitutes at the recipient site at their discretion. We will however, standardize surgical techniques for harvesting of the graft from the donor site.

Eligibility Criteria:
Inclusion Criteria:

* Subjects male or female, aged 18-65
* Subjects with a nonunion of a long bone requiring bone grafting in the -opinion of their orthopaedic surgeon (nonunion will be defined as "9 months duration of the nonunited fracture with no evidence of progressive healing over the previous 3 months")
* Subjects must have an uninjured, healthy iliac crest and a femur that has not previously been operated on
* Subjects must provide informed consent

Exclusion Criteria:

* Subjects requiring a structural bone graft
* Subjects presenting with an active systemic or local infection
* Subjects with a nonunion due to pathologic fracture
* Patients with severely compromised soft-tissue coverage at the nonunion site, sufficient to impair bone healing
* Patients receiving radiation, chemotherapy, immunosuppression, or chronic steroids
* Subjects with whom there are likely to be problems, in the judgment of the Investigator or Research Coordinator, with maintaining follow-up (such as no fixed address, plans to move out of town in the next year, etc.).
Study to Gather Information on the Safety and Use of Aflibercept Injections Into the Eye for the Treatment of Eye Disorders in Mexican Routine Clinical Practice

The study aims to collect data on the safety and use of intravitreal aflibercept injections into the eye for the treatment of eye disorders that cause blurred vision or a blind spot due to abnormal or blocked blood vessels. Data will be collected from patients who are being treated for such eye disorders in Mexican routine clinical practice.

The primary objective is to assess the safety of intravitreal aflibercept injections in patients with wet age-related macular degeneration (wAMD), myopic choroidal neovascularization (mCNV), diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO) or macular edema secondary to branch retinal vein occlusion (BRVO).

Secondary objectives comprise the comparison of the aflibercept safety profile between defined subgroups and the assessment of the real-world application of intravitreal aflibercept injections with special focus on CRVO, BRVO and mCNV indications.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a diagnosis of a wet age-related macular degeneration (wAMD), diffuse diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO), macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV);
* Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice and independently of study inclusion;
* Treatment naïve or pre-treated for macular diseases (to anti-VEGF and steroid intravitreal treatments); patients who underwent laser photocoagulation and/or are being treated with panretinal photocoagulation therapies are eligible for study participation;
* If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept

Exclusion Criteria:

* Patient diagnosed with two or more of the studied indications in the same eye (wAMD, DME, CRVO, BRVO and mCNV);
* Patients that were already treated with anti-VEGF or steroids are allowed to be enrolled only if they received the last dose of anti-VEGF 3 or more months ago and in the case of a steroid implant 6 months after the last dose;
* Current treatment with other intravitreal therapies
* Contra-indications according to Eylea's / Wetlia's local marketing authorization:

  * Ocular or periocular infection
  * Active intraocular Inflammation
  * Known hypersensitivity to aflibercept or to any of its excipients
  * Pregnant or lactating women.
* Participation in an interventional study
A Multi-center Cardiac PYP Scan Registry in Taiwan

Amyloid deposition in the heart is called cardiac amyloidosis (CA); 95% is immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). Hereditary (ATTRm) or wild-type (ATTRwt) depends on whether the ATTRm gene is mutated or not. The most common mutation in Taiwan is A97S, 80% have left ventricular hypertrophy. The good prognosis depends on early diagnosis and correct treatment strategy.

Bone-avid tracers such as 99mTc-PYP/DPD/HMDP could detect CA. The mechanism is not clear yet, which may be related to the microcalcification. AL amyloidosis is mostly between visual score grade 0-2, and ATTR-CM is usually grade≥2 on PYP scan, or heart to contralateral (H/CL) ratio, and it might replace invasive myocardial biopsy. However, there are no large-scale clinical studies, lack of standardization data, and limited information in comparison between clinical and imaging parameters.

The project will enroll patients with suspected or diagnosed with CA according to CA diagnostic algorithm. Clinical data and image parameters are collected and compared. The project aims to set up prediction models based on the multi-parameters of PYP scan using artificial intelligence technology, including imaging registration and alignment technology, and standardization. The investigators further use the key cardiovascular data elements and imaging-derived database using model training network to extract image features to develop the diagnostic and prognostic prediction models, which are expected to validate the clinical significance and improve patient-centric performance and efficient clinical decision making.

The investigators will retrospectively and prospectively collect total PYP scans that had been performed on suspected or diagnosed ATTR-CM patients in medical centers in Taiwan and follow-up at least 1 year. You are enrolled based on clinical suspicions such as "red-flag" signs using ultrasound, NT-pro BNP and clinical data according to the diagnostic algorithms. If you are with Grade 2 and 3 PYP myocardial uptake, genetic testing is arranged, serum and urine AL tests results will be confirmed. Before reading, the imaging quality will be evaluated (good quality, fair but interpretable, poor but interpretable, poor and insufficient for interpretation). All the images will be visually graded by experienced nuclear medicine physicians with consensus. It helps understand the real-world data.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 20 years of age
2. Documented diagnosis or r/o of ATTR amyloidosis

Exclusion Criteria:

1. Pregnant or nursing (lactating) women.
2. Important systemic diseases (except heart disease or neurological diseases) such as liver cirrhosis, active malignant tumors, etc., with a life expectancy of less than 6 months.
3. Patient who refused clinical follow up.
The Effects of Exercise on Appetite Regulation in Overweight/Obese Individuals

In this study the Investigators are examining the effects of a 12-week exercise program (intervention) on measures of appetite and food intake regulation in overweight to mildly obese healthy adults. The Investigators hypothesize that individuals who lose a significant amount of weight in response to the intervention will show a reduction in the brain response to food cues as measured by functional magnetic resonance imaging (fMRI) when compared to those who do not lose weight. These changes in neuronal activity will be associated to physiologic and behavioral measures.


Eligibility Criteria:
Inclusion Criteria:

* all ethnic groups and both genders;
* age: 21-45 yrs;
* BMI: 27-35;
* weight stable within +/- 5 percent in the last 6 months;
* sedentary (less than 1 hour of planned physical activity by self-report).

Exclusion Criteria:

* history of cardiovascular disease (CVD), diabetes mellitus, uncontrolled hypertension, untreated thyroid disease, renal disease, hepatic disease, or any other medical condition affecting weight or energy metabolism;
* unable to effectively exercise due to cardiac, pulmonary, neurologic or orthopedic reasons;
* unable to pass screening graded exercise treadmill test;
* currently smoking;
* medications affecting weight, Energy Intake (EI) or Energy Expenditure (EE) in the last 6 months;
* weight loss or weight gain of \>5 percent in past 6 months;
* currently pregnant, lactating or less than 6 months post-partum;
* bariatric surgery;
* major psychiatric disorder, presence of alcohol or substance abuse, current depression by history and/or a score \>21 on the he Center for Epidemiologic Studies Depression Scale (CES-D), history of eating disorders and/or a score of \>20 on the EATS-26;
* contraindication to MRI
The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

The study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been treated for C. difficile infection to determine if there are features associated with recurrent disease.

Patients who have recently been diagnosed with C. difficile infection and completed treatment will be enrolled to undergo evaluation of the colonic mucosa via sigmoid biopsies. Participants will also complete surveys, blood draw and stool collection. Overall goals are to identify whether C. difficile is persisting in the colon mucosa after treated infection, and whether this, and other clinical and microbiome factors may be playing a role in disease recurrence.

Eligibility Criteria:
Inclusion criteria:

* Adults aged 18 and over
* Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea

Exclusion criteria:

* Known pregnancy
* Prior diagnosis of C. difficile infection within 2 months of this diagnosis
* Other known active gastrointestinal infectious process
* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions
* Vulnerable adults
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly

The aim of this study is to generate epidemiological data to further explore determinants of Chronic Obstructive Pulmonary Disease (COPD) and the contribution of bacterial and viral pathogens to Acute Exacerbation of COPD (AECOPD) episodes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* Male or female subjects between, and including, 40 and 85 years of age, at the time of consent.
* Subjects with confirmed diagnosis of COPD with Forced Expiratory Volume of air expired in 1 second (FEV1) of \</=80% of predicted normal and FEV1/Forced expiratory Vital Capacity (FVC)\<0.7
* Subjects have moderate, severe, or very severe COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging.
* Subjects have a current or prior history of \>/=10 pack-years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked.
* Subjects present a documented history of \>/=1 exacerbation requiring antibiotics and/or oral corticosteroids or hospitalization in the previous 12 months.

Exclusion Criteria:

* Subject also has a confirmed diagnosis of asthma, cystic fibrosis, pneumonia risk factors or other respiratory disorders.
* Subjects having undergone lung surgery.
* Subject has a α-1 antitrypsin deficiency as underlying cause of COPD.
* Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids.
* Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit.
* Subject has other conditions that the principal investigator judges may interfere with the study findings. Women who are pregnant or lactating or are planning on becoming pregnant during the study.
Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with pressure and flow readings, are being investigated.

Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with pressure and flow readings, are being investigated. The diagnostic parameters will be correlated with Coronary Flow Reserve (CFR)values obtained using Positron Emission Tomography (PET) imaging. They will also be correlated with Fractional Flow Reserve (FFR).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or above
* Patients referred to a stress test by a Cardiologist
* Acute Chest pain, as per patient input.
* Risk Assessment with prior test results and/or previous history of known chronic stable CAD.
* Borderline or discordant stress testing where obstructive CAD remains a concern.
* New or worsening symptoms- Abnormal coronary angiography or abnormal prior stress imaging study.
* Coronary stenosis or anatomic abnormality of uncertain significance.
* In absence of reliable diagnostic information from another imaging modality.

Exclusion Criteria:

* Left ventricular ejection fraction less the 25% determined by gated SPECT imaging
* Non-dialysis dependent chronic kidney disease with baseline serum creatinine greater than 2.5 gm/dL.
* History of type II heparin-induced thrombocytopenia.
* Significant co-morbid condition that is medically unstable and would make coronary angiography prohibitive or contraindicated.
* Pregnant women.
* Incapacitated for Consent
Efficacy of Early Administration of Tocilizumab in COVID-19 Patients

The clinical study aims at assessing whether early administration of Tocilizumab compared to late administration of Tocilizumab can reduce the number of patients with COVID-19 pneumonia who require mechanical ventilation. The clinical study includes patients with recent-onset COVID-19 pneumonia who require hospital care, but not invasive or semi-invasive mechanical ventilation procedures.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* Informed consent for participation in the study
* Real time polymerase chain reaction (PCR) diagnosis of Sars-CoV2 infection
* Hospitalization due to clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or pulmonary ultrasound)
* Presence of acute respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2 / FiO2) between 200 and 300 mm/Hg
* Presence of exaggerated inflammatory response defined by the presence of at least 1 of the following criteria:
* At least one body temperature measurement \>38° C in the past two days;
* Serum CRP greater than or equal to 10 mg/dl;
* CRP increase of at least twice the basal value

Exclusion Criteria:

* Patients with respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2 / FiO2) \<200 mm/Hg or
* Patients in non-invasive ventilation or
* Patients in invasive ventilation or presence of shock or presence of concomitant organ failure that requires admission to the Intensive Care Unit
* Severe heart and kidney failure
* Pregnant or breastfeeding patient
* Patient who, in the opinion of the clinician or by the patient's express will, will not go to intensive care regardless of the evolution of the lung picture.
* Known hypersensitivity to TCZ or its excipients
* Patient being treated with immuno-depressors or anti-rejection drugs
* Known active infections or other clinical conditions that contraindicate TCZ and cannot be treated or resolved according to the physician's judgment
* glutamate-pyruvate transaminase (GPT) or glutamine oxaloacetic transaminase (GOT) \> 5 times the upper limit of the norm
* Neutrophils \<500 /mmc
* Platelets \<50.000 /mmc
* Diverticulitis or intestinal perforation
* Suspicion of latent tuberculosis
Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment

The study is designed to answer the following questions:

1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio in hypogonadism?
2. What is the effect of testosterone replacement on the visceral adiposity index and Triglycerides/HDL cholesterol ratio?

This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2007-2010.

Eligibility Criteria:
Inclusion Criteria:

* Men
* Congenital hypogonadism
* Treatment Naive

Exclusion Criteria:

* Previous history of androgen replacement
* Hypertension
* Diabetes mellitus
Observational Study of the Evaluation of Post Traumatic Stress Post Stroke

This prospective, observational, multicentre study evaluates the existence of Post-traumatic stress disorder following a stroke at 3 and 6 months after the management of the patient.

Questionnaires will be used to assess the presence of stroke post traumatic disorder.

The evaluation of stroke post traumatic disorder would allow to underline the importance of the awareness of the care teams in the the screening of these disorders and to evaluate if the Post-traumatic Stress Disorder Checklist Scale (PCL5) is an effective screening tool.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18years old
* Patient registered with a social security scheme
* Patient who was given a written information and who gave his/her non-opposition
* Patient who was hospitalized with a diagnosis of stroke in the neurology department and oriented to the post-stroke consultation (3 months after the hospital discharge) or un the follow-up care and readaptation department of hospital center of Dax or Mont de Marsan

Exclusion Criteria:

* Patient with a serious disability sequelae (mRS\>3),
* Patient without enough level of proficiency in the French language,
* Patient with neurocognitive and neurocognitive disorder diagnosed,
* Patient with history of significant psychiatric disorders diagnosed,
* Patient with seve aphasia
Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy

RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have relapsed prostate cancer following radiation therapy or radical prostatectomy.

OBJECTIVES:

* Determine the effect of celecoxib on prostate-specific antigen (PSA) levels in patients with prostate cancer in biochemical relapse after prior definitive radiotherapy or radical prostatectomy.
* Compare the PSA doubling times in patients treated with this drug vs historical controls.
* Compare the PSA doubling times in patients treated with this drug vs pretreatment PSA values.
* Determine the time to clinical recurrence in patients treated with this drug.

OUTLINE: Patients receive oral celecoxib twice daily. Treatment continues for 5 years in the absence of disease progression. Patients may continue treatment beyond 5 years at the discretion of the treating physician.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of clinically localized adenocarcinoma of the prostate

  * T1 or T2 disease
* Received prior primary treatment with definitive radiotherapy (at least 5,500 cGy) OR radical prostatectomy
* Biochemical relapse within 5 years after prior primary therapy, defined as 1 of the following:

  * Detectable and rising prostate-specific antigen (PSA) after surgery (at least 2 values above the residual cancer detection limit of the assay)
  * PSA at least 2 values above 1 ng/mL OR at least 3 rising values at any level after radiotherapy
* PSA no greater than 10 ng/mL

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* ALT no greater than 2.5 times upper limit of normal

Renal

* Creatinine normal

Other

* No allergy to cyclooxygenase-2 inhibitors, aspirin, nonsteroidal anti-inflammatory drugs, or sulfa drugs
* No untreated peptic ulcer disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* More than 6 months since prior adjuvant or neoadjuvant hormonal therapy

  * Duration of prior adjuvant or neoadjuvant hormonal therapy must have been no more than 6 months

Radiotherapy

* See Disease Characteristics
* Prior salvage radiotherapy after prostatectomy allowed

Surgery

* See Disease Characteristics
The Impact of Suction- Assisted Laryngoscopy and Airway Decontamination on Intubation Times

A study was formulated to test the hypothesis that comprehensive training in Suction- Assisted Laryngoscopy and Airway Decontamination techniques reduces mannequin intubation times for Anaesthesia trainees.

To assess the clinical impact of in Suction- Assisted Laryngoscopy and Airway Decontamination (SALAD) training among 37 anaesthesia trainees. Intubation mannequin will be used to assess intubation times for contaminated airways pre and post SALAD training.

Eligibility Criteria:
Inclusion Criteria:

All Anaesthesia trainees employment in Mater Misericordiae University hospital during the month of August 2019 - October 2019 were invited to partake in the study.

Exclusion Criteria:

All intensive care trainees with no training in intubation were excluded from the study.
Comparative Study of Postieror Ankle Fracture

To compare the clinical efficacy of open reduction and internal fixation (ORIF) with plate and screw for postieror malleolar fractures.


Eligibility Criteria:
Inclusion Criteria:

supination-external rotation Ⅳ type injury

Exclusion Criteria:

Pion fracture; Isolated posterior ankle fracture.