cyrilzakka/clinical-trials huggingface dataset:
Identification of Prognostic Parameters in Patients With " Senile " Amyloid Cardiomyopathy

The aging of the population is a reality in our society, with a strong increase in the number of elderly patients hospitalized for heart failure in our institutions. Heart failure in these patients is more present than to younger patients, with preserved ejection fraction form (HFpEF). Aging is responsible for the onset of senile amyloid cardiomyopathy. This pathology is still imperfectly understood and its link with the increase in the frequency of HFpEF is important. In addition, specific treatments have just shown their effectiveness. It is therefore urgent to better identify the prognostic predictive parameters of this cardiomyopathy.

The pathophysiological involvement of the coronary microcirculation responsible for a true microvascular coronary disease (CMVD) has been described as predictive factor in all cardiomyopathies. However the implementation of preventive strategies and / or therapeutic of the coronary microcirculation dysfunction are limited because we lack of diagnostic tests available and applicable to large cohorts of patients.

Our team INSERM U1039 Radiopharmaceutiques Biocliniques in collaboration with the laboratory GIPSA-lab (Grenoble Images Speech Signal Automatique), laboratory specialized in the signal analysis, has developed a new method of analysis allowing to measure the coronary microcirculation dysfunction usable in SPECT thanks to the measurement of a myocardial perfusion heterogeneity index (IHPM) (patented technique). The 3C registry (NCT03479580) is a registry studying the prevalence and cardiovascular prognosis of macro and microcirculatory coronary artery disease using the latest coronary evaluation techniques in patient with cardiomyopathy. This registry deployed on interventional cardiology centers on the Alpine Arc is therefore also addressed to patients with senile cardiomyopathy. The data collected will provide a better understanding of the factors influencing the prognosis of senile cardiomyopathy and the prognostic contribution of the measurement of the IHPM will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient, over 75 years old
* Social Security Affiliate
* Any patient with the diagnosis of cardiac amyloidosis after etiological evaluation in one of the 4 Alpin arc interventional cardiology centers (Grenoble University Hospital, GHM Grenoble, Annecy Hospital and Chambéry Hospital).
* Non opposition to participation

Exclusion Criteria:

* Concomitant ischemic cardiopathy with revascularization following cardiac scintigraphy exploration and subsequent coronary angiography.
* Concomitant non-amyloid non-ischemic cardiopathy (valvular cardiopathy)
* Major non-cardiac illness (eg, disseminated malignancy, severe neurological dysfunction at the time of diagnosis) or social condition that may preclude participation in a research study
* Major patient protected by law (article L1121-8)
* Person deprived of liberty (Article L1121-8)
Effects of Sugary Drink Warning Labels on Parent Choices

Sugar-sweetened beverages (SSBs) are a significant contributor to adult and childhood obesity. Policies to place health warning labels on sugar-sweetened beverages are being pursued, but there is little empirical data on how such labels influence people. The proposed research will evaluate the impact of different types of sugar-sweetened beverage warning labels relative to standard calorie labels on the purchasing and consumption behaviors of parents and children.

The primary objective of this proposal is to determine, before wide-scale implementation, to what degree SSB warning labels increase consumers' knowledge about the potential health harms of SSBs and reduce SSB intake. The study is designed to answer two additional questions: 1) Do some warning labels work better than others? 3) If warning labels influence behavior, is it because they increase knowledge or simply provide a salient reminder that some drinks are less healthy? This aim is designed to test the effect of warning labels on total kilocalories (kcals) purchased and consumed by parents and children. We will examine how SSB warning labels influence snack and beverage purchases and intake among 405 racially and ethnically diverse parent-child pairs.

Eligibility Criteria:
Inclusion Criteria:

* Participant pairs must be:
* Primary caregiver of a child 6-11 years old; 18 years or older; can read and speak English; did not participate in related studies from our group
* Child is between 6 and 11 years old; drinks SSBs at least 12 times per month (\~3 times per week)

Exclusion Criteria:

* Unable to participate in person in Philadelphia
* Parent did not purchase food and beverage for their child
* Parent or caregiver refused to give child permission to participate
The Analgesic Efficacy Supra-scapular Nerve RF After Breast Surgery

Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients received fluoroscopically guided supra-scapular nerve injection of of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.

Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups ; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection through the radiofrequency needle of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients received fluoroscopically guided supra-scapular nerve injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.

Eligibility Criteria:
Inclusion Criteria:

* patients with post-mastectomy pain

Exclusion Criteria:

* Exclusion criteria are patients with any medical contraindications to neurolysis, patients with other bone metastases.
Breath Analysis in Asthma

The purpose of this study is to answer the question whether a disease-specific profile of breath in patients with asthma can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed asthma. Diagnosis of asthma is made with episodic chest symptoms and a documented reversibility of at least 12% and/or 200 ml in FEV1 after 200 ug of inhaled salbutamol or airway hyperresponsiveness in the case of normal lung function testing (PC20 methacholine \< 4mg/ml) at the time of diagnosis.
2. Age between 18 and 80 years at study entry.
3. Healthy controls: never-smokers, normal spirometry (baseline FEV1 \> 85% predicted and FEV1/FVC greater than 0.7).

Exclusion Criteria:

1. Asthma exacerbation within the last 6 weeks, defined as worsening of asthma symptoms requiring a change in therapy by a physician or a change in regular asthma therapy (including short course of oral corticosteroids)
2. Any lung disease other than asthma.
3. Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
4. Regular intake of oral steroids.
5. Active smoking habits / positive history of smoking.
6. Acute or chronic hepatic disease.
7. Renal failure or renal replacement therapy.
8. Pregnancy.
Effect of Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer

The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol versus conventional treatment on patients who underwent liver resection for hepatocellular carcinoma(HCC).

212 patients are randomly recruited from inpatients of Shanghai Zhongshan Hospital, Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province and Affiliated Tumor Hospital of Nantong University from February 2016 to July 2016. Randomly assigned about half of the patients to receive Enhanced Recovery After Surgery(ERAS) protocol and the other half to receive conventional treatment. Evaluate the safety and efficacy of the ERAS protocol.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HCC with indications for surgery
* Without any surgical contraindications
* Under went open liver resection
* Operation ranges less than 4 hepatic segments
* Informed consent

Exclusion Criteria:

* Not suitable for surgery
* Benign lesions or other lesions proved by pathology
* Surgical procedure changed during operation or combined evisceration
* Refused to participate or drop out
Surgical Outcome of Type II Odontoid Fracture, Harms Technique

Cervical trauma is a common cause of disability following spinal cord injury, especially in athletic populations. The biomechanics in the atlantoaxial joint carry more than 50% of the rotational movement which can be affected in transverse ligament tear associated with odontoid fracture type II. Odontoid fracture type II considered an unstable fracture with a high rate of non-union in conservative treatment. Limitation of the odontoid screws in some cases gives the chance of posterior cervical fixation to have the superior role. Use of polyaxial screws in Harms technique gives the best results in maintaining the majority of the biomechanics.

Purpose: our aim in this study to evaluate Harms technique in those patients regarding pain improvement and restoration of the motor power and to report the complications.

Study design: A retrospective case series study. We Used the Frankel grading system to evaluate the postoperative neurological state.

After approval of Research Ethics Committee, twelve patients with post-traumatic odontoid fracture type II were scheduled in our Neurosurgery department at Sohag University Hospital for atlantoaxial fusion using polyaxial C1 lateral mass and C2 pedicle screws between January 2015 and January 2018.

Eligibility Criteria:
Inclusion Criteria:

1. C1-C2 displacement that needs intra-operative reduction
2. Short neck not suitable for anterior odontoid screw
3. Osteoporotic patients
4. Odontoid fracture associated with transverse ligament tear suspected.
5. Oblique line of fracture
6. Failure of union after conservative treatment.

Exclusion Criteria:

* Associated spinal fractures
* Other comorbidities
Perinatal Opioid Use

To compare maternal and newborn outcomes among pregnant women with OUD receiving care via telemedicine versus in-person.

Participants: Pregnant women with OUD.

Intervention: Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine.

Design: A cohort derived from a prospectively collected database including 98 women receiving perinatal OUD treatment in an obstetric practice by telemedicine or in-person and followed until 6-8 weeks postpartum from September, 2017 to December, 2018. Logistic regression with propensity score adjustment was applied to reduce group selection bias and control for potentially confounding variables.

Setting: Four outpatient obstetric practices in the southeast.

Eligibility Criteria:
Inclusion Criteria:

* Adult females, any race or ethnicity, age 18-45 years
* Currently pregnant
* Opioid Use Disorder (OUD)
* received in person or telemedicine treatment for OUD in their obstetrician's office

Exclusion Criteria:

* Not currently pregnant or receiving perinatal care
* Not in agreement with Patient-Physician Agreement
Cost-utility of VIRTUAL FIBROWALK

The main objective of this study is to assess the effectiveness and cost-utility of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as- usual (TAU) compared to TAU alone.

This is a two-arm RCT focused on the effectiveness and cost-utility of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as- usual (TAU) vs. TAU alone (in a 3-month follow-up RCT) VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 75 years-old.
* 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
* Able to understand Spanish and accept to participate in the study.

Exclusion Criteria:

* Participating in concurrent or past RCTs (previous year).
* Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.
Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer

The study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection.

Laparoscopic surgeons commonly make rectal transection intracorporeally by laparoscopic linear stapler during rectal anterior resection and perform an end-to-end anastomosis by circular stapler. But the so-called 'dog ears', two stapled corners of the rectal stump after laparoscopic linear transection of rectum, are very common. The lateral intersections of double-stapled anastomoses are structural weak spot area, and they are considered to be the potential ischemic areas leading to anastomosis leakage and the possible sites occurring local recurrence. Previous study reported a modified technique for rectal reconstruction during open surgery, and they could use circular stapler to eliminate the staple line on the rectal stump and cut off the 'dog ears'. But because of the narrow pelvic cavity, it is very difficult to perform this technique in laparoscopic rectal surgery and there is no related report on laparoscopic application. In this study, we evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique, to eliminate the "dog ears" in laparoscopic rectal anterior resection by laparoscopic suturing on the staple line.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility rule of enrollment
* Rectal adenocarcinoma above the peritoneal reflection
* at least 18 years old \& at most 80 years old
* Clinically diagnosed cT1-T4aN0-2 disease
* no contraindication to laparoscopic surgery
* without other malignancies in medical history

Exclusion Criteria:

* concurrent or previous diagnosis of invasive cancer within 5 years
* locally advanced cancers requiring en bloc multivisceral resection
* intestinal obstruction
* intestinal perforation
* American Society of Anesthesiologists(ASA) class 4 or 5
* pregnant or breast-feeding women
* history of mental disorder
* participation in another rectal cancer clinical trial relating to surgical technique
Wellness Engagement Project, Petersburg

This study tests the feasibility of a health and wellness trial designed with community input. This 12-week program will be tested over a 24-week period using a delayed treatment control group.

This 12-week program was designed based on input from Petersburg, VA community residents, collected through various methods over a two-year period. The 12 week program is designed to impact three levels: individual, family and community. At the individual level, participants receive print material lessons related to healthy eating and increasing physical activity, as well as videos that model these lessons; participants will also have access to a peer support coach who will contact them on a biweekly basis and are trained to help them identify and reach their own personal health goals. At the family level, participants are encouraged to share all of the information they receive as a part of this program with the rest of their family, and are asked to begin walking regularly and to attend fitness and nutrition classes held within their neighborhood (by the WE program) with family members. On a community level, local church groups and neighborhood organizations will receive assistance in launching walking clubs, and all community residents are invited to attend the physical activity and nutrition classes that the WE project hosts within the community.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years.
* Must have a school going child between 12-17 living in the home.
* BMI between 25 and 50 kg/m2.

Exclusion Criteria:

* report not being able to walk 2 blocks (1/4 mile) without stopping
* currently participating in another weight loss program
* taking a weight loss medication
* have a history of bariatric surgery
* pregnant or plan to become pregnant during the intervention timeframe
* report an unsupervised heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
* report a medical condition that would jeopardize their safety if involved in a weight management program with diet and exercise guidelines (e.g., uncontrolled heart problem)
* fail medical screening by study medical staff)
* report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., planned move from the area, dementia, substance abuse).
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

This is a multiregional open-label extension (OLE) to assess the safety, tolerability, and efficacy of long-term treatment with tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant intravenous (IV) enzyme replacement therapy (ERT) for Hunter syndrome (MPS II). Participants who complete at least through the Week 49 visit in Study DNLI-E-0002 and do not discontinue study intervention early and participants who complete Study DNLI-E-0007 will be enrolled in this OLE. All participants will receive DNL310 for up to 5 years from the time of entry in this OLE. Participants, site staff, and the Sponsor will remain blinded to the original treatment assignment for participants entering this OLE from Study DNLI-E-0007.


Eligibility Criteria:
Key Inclusion Criteria:

* For participants from Study DNLI-E-0002 only: Completed at least through the Week 49 visit in Study DNLI-E-0002 and did not discontinue study intervention early
* For participants from Study DNLI-E-0007 only: Completed the treatment period of 96 weeks in Cohort A for nMPS II participants and 48 weeks in Cohort B for nnMPS II participants

Key Exclusion Criteria:

* Unstable or poorly controlled medical condition(s) or significant medical or psychological comorbidity or comorbidities that, in the opinion of the investigator, would interfere with safe participation in the trial or interpretation of study assessments
Study Developed to Evaluate the Effect of ANG-3777 on QT/QTc Interval

The purpose of this study is to evaluate the effect of ANG-3777 on placebo-corrected change from baseline, QT/corrected QT (QTc) interval, following single intravenous (IV) doses in healthy volunteer adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or non-pregnant, non-lactating healthy females
2. Aged 18 to 55 years inclusive at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
4. Weight ≥50 kg and ≤100 kg at screening and admission
5. Must be willing and able to comply with all study requirements
6. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures
7. Must agree to use an adequate method of contraception

Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days.
2. Subjects who are study site or sponsor employees, or are immediate family members of a study site or sponsor employee
3. Evidence of current SARS-CoV-2 infection
4. History of any drug or alcohol abuse in the past 2 years
5. Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine)
6. A confirmed positive alcohol urine test at screening or admission
7. Current smokers and those who have smoked within the last 12 months or current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
8. A confirmed positive urine cotinine test at screening or admission.
9. Positive drugs of abuse test result
The Intraocular Pressure Measured by Different Tonometers in Corneal Edema

The investigators conduct this study to access the effect of corneal edema (the investigators are particularly interested in those who have the clinical central corneal edema) on the variation of intraocular pressure values measured by 3 commercial-available tonometers compare to the current gold standard tonometer; Goldmann applanation tonometer.

Previous published articles reported on the effect of corneal edema on the accuracy of tonometry were performed in enucleated cadaver eyes, or contact lens-induced corneal edema eyes. Thus, it remains unclear as to how the clinical corneal edema that is found in routine clinical practice will affect the variation of intraocular pressure measurement using the standard Goldmann applanation tonometer and other more modern tonometers such as the dynamic contour tonometer, the iCare, and the Tonopen.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 year-old
* Patients who have a clinical central corneal edema after clear cornea phacoemulsification and intraocular lens implantation
* Agree to participate in the study and willing to sign an informed consent

Exclusion Criteria:

* Combined phacoemulsification and trabeculectomy
* Clear cornea phacoemulsification that has suture on the cornea
* Previous history of intraocular surgery, ocular trauma prior to phacoemulsification
* Vitrectomized eye
* History of glaucoma or ocular hypertension or using IOP lowering medication
* History of diabetic retinopathy staged as severe non-proliferative or worse
* Pregnant or breast-feeding women
* History of refractive surgery or any keratoplastic procedure
* Corneal opacities or diseases making no suitable tonometry
* Severe dry eye syndrome
* Wears contact lenses
* Astigmatism higher than 2.5 diopters
* Microphthalmos or buphthalmos
* Subjects with having poor or eccentric fixation or nystagmus
* Excessive eye squeezing
* Known allergy to topical anesthesia
* Known allergy to fluorescein solution
a Randomized Clinical Trial Evaluating the Effectiveness of Carbon Dioxide Use in Cardiac Surgery

study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive

prospective randomized clinical single-center study of the efficacy and safety of using carbon dioxide in deaeration of cardiac cavities during cardiac surgery (repeated interventions and minimally invasive interventions)

Eligibility Criteria:
Inclusion Criteria:

* Planned cardiac surgery on the left heart with limited deaeration: Minimally invasive approach (mininotomy, minimally invasive lateral thoracotomy); Re-intervention
* Signed informed voluntary consent

Exclusion Criteria:

* Patient refusal to participate in any stage of the study
* History of stroke, transient ischemic attack
* Hemodynamically significant stenosis of the brachiocephalic arteries (more than 70%)
* Swelling or thrombosis of the heart
* LV dysfunction (EF less than 30%)
* Atherosclerosis of the aorta (atheromatosis)
* Surgical access conversion