cyrilzakka/clinical-trials huggingface dataset:
L5-S1 Disc Fate in Thoracolumbar Arthrodesis Stopping at L5

Spinal deformity in adults is one of the most frequently treated pathologies in spinal surgery. Their surgical treatment remains a challenge. In particular, the choice of the borderline vertebrae for thoracolumbar fusion correction remains controversial, including the choice between an instrumented last vertebra at L5 and an arthrodesis extending to the pelvis. Studies and meta-analyses show that an ilio-sacral socket provides better correction of pelvic parameters and avoids the development of distal junctional syndrome. On the other hand, there is more proximal junctional syndrome in patients fixed to the sacrum, and the sacral socket exposes patients to the risk of pseudarthrosis of the L5-S1 level and failure of the fixation hardware. Moreover, although this factor is not described in the studies, it would seem that an ilio-sacral socket is more stiffening. Overall, no study has shown a statistically significant difference in clinical scores between patients whose last instrumented vertebra is L5 and those with pelvic fixation.

One of the theoretical risks of an extended fixation with a proximal thoracic grasp is to observe a premature disc degeneration of the L5-S1 disc since it would be subjected to more stress. This degeneration could be the cause of distal junctional syndrome and lumbo-radiculalgia due to inflammatory disc disease and disco-radicular impingement. However, to Investigator's knowledge, no clinical study has yet investigated the medium- and long-term fate of the L5-S1 disc in patients with extended fusion correction of a thoracic vertebra to L5.

Investigator's team has sometimes favored a final instrumented vertebra at L5 when possible, i.e., when the L5-S1 disc was considered to be minimally or not degenerative and when its horizontality could be obtained after correction of the underlying curvature. Investigators therefore have a cohort of patients who have undergone this technique. The usual follow-up of these patients includes a consultation appointment every 2 to 5 years and a control MRI at a distance of more than 5 years: investigators thus have a control MRI and the clinical score of the patients.

Investigator's objective is to determine whether there is degeneration of the L5-S1 disc, using MRI imaging data, which has never been published to investigator's knowledge.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Spinal fixation extended from the thorax to L5,
* Performed between 2007 (15 years of recoil and beginning of systematic preoperative MRI) and 2017 (5 years of recoil minimum)
* French speaking patient

Exclusion Criteria:

* Neuromuscular scoliosis
* Indication of fixation for fracture of ankylosed spine (impossibility of analyzing the L5-S1 disc)
* Contraindication to the realization of an MRI except if the patient has been operated on for a complementary fixation of L5-S1 in the aftermath
* Patient under guardianship or curatorship (unless consent is provided for this purpose)
* Patient deprived of liberty
* Patients who oppose participation in the study
Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

Most stroke patients are initially evaluated at the closest hospital but some need to be transferred to a hospital that can provide more advanced care. The "Door-In-Door-Out" (DIDO) process at the first hospital can take time making transferred patients no longer able to get the advanced treatments. This study will help hospitals across the US "stand up" new ways to evaluate stroke patients, decide who needs to be transferred, and transfer them quickly for advanced treatment.

Nearly 800,000 people in the United States (US) each year experience acute stroke, which remains the leading cause of adult disability and 5th leading cause of death. Despite the proliferation of stroke centers nationwide, almost half of the US population lives beyond a 60-minute drive of a comprehensive stroke center (CSC) and many patients require inter-hospital transfer (IHT) from a non-CSC to a CSC. Building upon prior work to reduce door-in-door-out (DIDO) time at referring hospitals, this proposal entitled "Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition (HI-SPEED)" study seeks to (1) implement a novel, evidence-based, multi-component DIDO intervention in eight diverse stroke systems of care across multiple regions of the US and (2) conduct a dual evaluation of its effectiveness in reducing median DIDO time (primary outcome) and disability (secondary outcome) and of the fidelity and quality of implementation. The HI-SPEED study will definitively establish the effectiveness and generalizability of a multi-component evidence-based DIDO intervention and provide information about contextual adaptations for high-quality implementation and widespread dissemination. This study benefits from our well-established interdisciplinary expertise in stroke, emergency and prehospital medicine, systems and quality engineering, health services research, and strong multicenter research collaborations. Findings from HI-SPEED will have substantial implications for a wide range of hospitals and stroke systems of care worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* Final diagnosis: AIS, ICH, or SAH

Exclusion Criteria:

* Final diagnosis: TIA or stroke NOS
* Age \<18 years
* Comfort care measures on day 0 or 1
* Left hospital against medical advice
* Enrolled in clinical trial related to stroke that is competing with this study
Chair-based and Standard Exercise Programs in People With COPD

Patients who are diagnosed with COPD by a pulmonology specialist and referred to pulmonary rehabilitation will be included in the study. Cases that meet the inclusion criteria will be randomized and divided into two groups, standard exercise program group (SGr) and chair-based exercise. program group will be called (ChGr). While standard exercises will be given to SGr, chair-based exercises will be applied to ChGr. All evaluation and initial training sessions of the cases will be held in the hospital. Apart from this, they will be asked to do their exercises at home with the exercise videos that will be sent to them. In order to ensure that home exercises are performed completely and correctly, 2 sessions of online simultaneous exercise training will be provided with a physiotherapist via videoconference on a smartphone, and exercise follow-ups will be carried out by calling once a week. The program duration is 8 weeks, 5 days a week.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-75 years
* Having a diagnosis of COPD diagnosed according to clinical diagnostic criteria according to the American Thoracic and European Respiratory Societies (ATS-ERS).
* Presence of dyspnea on exertion
* Stable clinical status at inclusion without infection or exacerbation in the previous 4 weeks \*Having smart phone usage skills

Exclusion Criteria:

* Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and requiring high-flow oxygen therapy (˃ 3-4 L\\min).
* A history of exertional syncope or the presence of any comorbidities (such as severe orthopedic or neurological deficits or unstable heart disease) that preclude exercise training.
* Having participated in a pulmonary rehabilitation program within the last 12 months.
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia

The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.


Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* critical limb ischemia (Rutherford class 4-6)
* angiographic stenosis\>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled

Exclusion Criteria:

* need for major amputation known before intervention
* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients with persistent or longstanding persistent AF. Results were assessed with the use of an implanted monitoring device (IMD).


Eligibility Criteria:
Inclusion Criteria:

* Persistent and longstanding persistent AF

Exclusion Criteria:

* congestive heart failure
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm
AI Health Assistant and Type 2 Diabetes

The developed health assistant has the functions of intelligent analysis of health data inside and outside the hospital, health reminder, etc. The advantages of AI health assistant management group compared with conventional management group in terms of comprehensive compliance rate, metabolic index level, hypoglycemia incidence rate was further studied.

1. The investigators have developed an AI health assistant suitable for diabetes patients, which has the functions of automatically uploading blood pressure, blood glucose data, intelligent reminder, automatic analysis of reports inside and outside the hospital, intelligent question and answer, etc. it is simple to operate, highly interactive, and maximizes the management level of diabetes patients outside the hospital.
2. Through AI personal health assistant, 196 diabetes patients were managed to further improving the comprehensive compliance rate of metabolic indicators such as blood glucose and blood pressure of diabetes patients, improving the patients' self-management ability.

Eligibility Criteria:
Inclusion Criteria:

The diagnostic criteria of T2DM patients are the diagnostic criteria of the 2017 China guidelines for the prevention and treatment of type 2 diabetes HbA1c 7.5-13% Age: 18-65y BMI 18.5-30kg/m2 The course of disease is less than 5 years Have good cognitive ability and can correctly use health assistants

Exclusion Criteria:

Acute complications of diabetes (diabetes ketosis, etc.) Diabetes complicating pregnancy or preparing for pregnancy HbA1c \< 7.5% or \> 13% Age \< 18y or age \> 65y Pre pregnancy BMI \< 18.5 or \> 30kg / m2 Severe liver and kidney dysfunction (ALT greater than 2.5 times the upper limit of normal, EGFR less than 45 ml / min / 1.73m2) Using drugs that may affect blood glucose are being used (including steroids, hydroxyprogesterone hexanoate, anti AIDS drugs, etc.)
Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.


Eligibility Criteria:
Inclusion criteria:

Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control \[glycosylated hemoglobin (HbA1c 7% to 10%)\] despite therapy with a sulfonylurea drug

Exclusion criteria:

Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance
Dose Escalation Study of NKP-1339 to Treat Advanced Solid Tumors

The purpose of this study is to determine the safety and maximal tolerated dose of NKP-1339, a ruthenium containing compound administered intravenously on a weekly schedule, in patients with advanced solid tumors. The responses to treatment in this population will be evaluated. In addition, the PD and PK properties of the compound will be explored.

NKP-1339 is a novel GRP78 targeted ruthenium based anti-cancer compound which is intravenously administered. GRP78 is a key regulator of misfolded protein processing, which is unregulated in cancer cells. In nonclinical anti-tumor studies, NKP-1339 showed activity against many tumor types, including those resistant to platinum and other standard anti-cancer agents. This Phase I trial evaluates the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of NKP-1339.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years with histologically or cytologically confirmed advanced solid tumors refractory to standard therapies who have signed an IRB approved Informed Consent Form (ICF).
* ECOG PS 0 or 1.
* Adequate hematologic, hepatic and renal function
* Minimum life expectancy ≥ 12 weeks

Exclusion Criteria:

* No supplemental Iron, i.e., therapeutic or as part of a multivitamin regimen.
* No chemotherapy, immunotherapy, or radiotherapy for \< 4 weeks, BMTs \< 9 months or major surgery \< 3 weeks.
* No symptomatic central nervous system metastases. No primary brain tumors or known brain metastasis unless clinically stable and on stable or reducing dose of steroids.
* No evidence of ischemia, MI within the past 6 months, or other significant abnormality on ECG.
* No clinically significant active infection including HIV, hepatitis B, or hepatitis C.
* No Peripheral neuropathy ≥ Grade 2
PRIMARY NEEDLE KNIFE FISTULOTOMY

Evaluate the outcomes of NKF as an initial method for biliary access.

Introduction

A previous feasibility study has suggested that needle knife fistulotomy (NFK) as an initial method for biliary access in patients with stones is associated with high levels of success and low rate of complications. This study evaluated the outcomes of NKF as an initial method for biliary access, in a large number of patients with any type of biliary pathology (tumors and stones), on the basis of success rate, complications and factors associated with success and complications.

Financial resources

All participants included in this study will perform ERCP, laboratory tests and other complementary diagnostic tests after a duly justified medical prescription. Therefore there are no additional costs or consumption of hospital resources.

Ethical considerations

In this study, participants will be included after informed consent. Anonymity and confidentiality will be safeguarded by assigning an individual numeric code. It will also be explained the possibility of withdrawing from the study at any time, with the guarantee of the total elimination of data. All researchers involved in the study will adhere to the Rules of Ethical Conduct and Best Practices in order to comply with the precepts of the Declaration of Helsinki, the Convention on Human Rights and Biomedicine, the guidelines of the Council for International Organizations of Medical Sciences and the Guide to Good Clinical Practice.

Statistical analysis

Qualitative variables will be summarized using absolute and relative frequencies, and quantitative variables will be summarized using the mean and standard deviation or the median and interquartile range, depending on their distribution profiles. The normality of the quantitative variables will be assessed using the histogram distribution.

Relations between categorical variables will be assessed using a chi-square test and Fisher´s exact test. Differences between two or more groups of independent non-normally distributed quantitative variables will be evaluated using a Kruskal-Wallis test.

To explain the risk of pancreatitis, a binomial logistic regression model with multiple predictors will be performed.

The null hypothesis will be rejected when the test statistics p-values are less than \<0.05. Statistical analysis, sample size calculation and graphics will be performed using Stata software (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, StataCorp LP)

Expected results

The results of this study will contribute to a better understanding of what is the best algorithm to follow when performing an ERCP.

Eligibility Criteria:
Inclusion Criteria:

* ERCP with indication for biliary access
* Naïve papilla

Exclusion Criteria:

* Patients unable to sign or understand the informed consent
* Patients with surgically altered anatomy
* Patients with tumors of the papilla
* Previous sphincterotomy
* Spontaneous papillary fistula
* Papilla not visualized
Prepare - How to Reach Women of Reproductive Age With Obesity to Support Weight Loss Before Pregnancy?

Researchers at Harvard Pilgrim Health Care Institute and Massachusetts General Hospital are conducting a study to learn more about how best to reach out to women (age 18-45) who are thinking about a pregnancy in the next couple of years and currently have a BMI greater than 30 kg/m2.

Interested participants will be asked to complete a 15-minute survey. The survey will ask some more questions about their prior reproductive health history, opinions and experiences regarding lifestyle, weight and health. After completing the survey, researchers would like to arrange a time to complete a 20- to 30-minute semi-structured interview about their perceived health in the process of planning pregnancy.

The purpose of this study is to learn the best ways to support healthful behaviors and weight loss prior to pregnancy. Researchers are also interested in what motivates or prevents women of reproductive age from engaging in a structured weight loss program. Participants will be asked for no more than an hour of their time to complete a brief survey and participate in an interview. This study is being conducted by Harvard Pilgrim Health Care Institute. This study is being paid for by the Nutrition Obesity Research Center at Harvard (NORCH).

At the end of the interview, study staff will also talk to participants about the opportunity to be referred to the Mass General Weight Center if they are interested in participating in a program now being offered there.

If participants elect to participate in a program at the weight center, researchers would then like to complete 2 more short interviews with these participants about that process. The first will be about 5 minutes and will take place just after the initial Weight Center Orientation, and the last will be about 10 minutes and take place after 3 months of participation. During this final interview, researchers will ask for participant opinions about the program that they have just participated in.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 years old,
* BMI\>30 mg/m2,
* thinking about planning a pregnancy in the next 2 years

Exclusion Criteria:

* Previous bariatric surgery,
* currently pregnant
A Study of Mirikizumab in Participants With Plaque Psoriasis

This study is known as a "drug interaction study." The purpose is to learn how commonly used drugs or substances (midazolam, warfarin, dextromethorphan, omeprazole, and caffeine) and their breakdown products get into the bloodstream after taking a "cocktail" (combination) of them before and after multiple doses of mirikizumab.

The study will last about 23 weeks for each participant. Screening must be completed within 4 weeks prior to study start.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with chronic plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy
* Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at screening and first admission to the clinical site

Exclusion Criteria:

* Pregnant or nursing (lactating)
* History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection
* Have major surgery within 8 weeks prior to first admission to the clinical site or during the study
* Have a history of lymphoma, leukemia, or any malignancy
* Require treatment with the cocktail drugs within 14 days prior to the first administration of the drug cocktail through the end of Week 12 assessments
* Have participated in any other study with mirikizumab
Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation

The purpose of this study is to see if exercise fitness testing is feasible and safe in persons over 21 years of age who have been diagnosed with a hematological malignancy and are scheduled to undergo a hematopoietic stem cell transplant (HCT). Assessments in this study will look at the capacity of the body before transplantation to see if these measures can help predict how patients do after transplant.


Eligibility Criteria:
Inclusion Criteria:

* Patients with MSK histologically confirmed hematologic malignancy
* Scheduled for autologous or allogenic HCT at MSKCC
* ≥21 years old
* ECOG performance status of 0 or 1
* Completion of baseline CPET
* Willing to comply with protocol related procedures

Exclusion Criteria:

* Any of the following absolute contraindications to cardiopulmonary exercise testing

  * Acute myocardial Infarction (within 3-5 days of any planned study procedures)
  * Unstable angina
  * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
  * Recurrent syncope
  * Active endocarditis
  * Acute myocarditis or pericarditis
  * Symptomatic severe aortic stenosis
  * Uncontrolled heart failure
  * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
  * Thrombosis of lower extremities
  * Suspected dissecting aneurysm
  * Uncontrolled asthma
  * Pulmonary edema
  * Respiratory failure
  * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
  * Presence of any other concurrent, actively treated malignancy;
  * History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer);
  * Room air desaturation at rest ≤85%
  * Mental impairment leading to inability to cooperate
Attention Control Training for the Prevention of PTSD in Firefighters

The study aimed to examine the effect of Attention Control Training (ACT) intervention on reducing PTSD symptoms in firefighters. The study was a randomized controlled trial carried out in Kunming, China, and involved the recruitment of 180 active firefighters as participants. The intervention lasted for an 8-week duration, during which participants participated in ACT exercises delivered through a smartphone application.


Eligibility Criteria:
Inclusion Criteria:

* being an active firefighter and aged between 18 and 50
* with no history of severe PTSD

Exclusion Criteria:

* having suicidal ideation or intent
* having an active psychotic disorder other than PTSD
* prior participation in a cognitive-behavioral intervention
* concurrent participation in another study.
Fu Zheng Jie Du Hua Yu Principle For Treatment Of Severe HBV Related Hepatocellular Carcinoma (FZJDHYPFTOSHBVHCC)

The treatment of HBV related hepatocellular carcinoma has always been a worldwide problem. The aim of this study is to alleviate the progression of hepatitis B related hepatocellular carcinoma by the Chinese medicine "Fu Zheng Jie Du Hua Yu" Principle.


Eligibility Criteria:
Inclusion Criteria:

* Meet the criteria of hepatocellular carcinoma
* Ages Eligible for Study: ≤75 years old;
* Informed consent from the patient.

Exclusion Criteria:

* Serious problem of heart, lung, or kidney with severe dysfunction;
* Pregnant or child breast feeding women;
* Mental or cognitive disorders;
* Participating in other drug trials;
* Who are allergic to the study drug