cyrilzakka/clinical-trials huggingface dataset:
Bleeding Risk Assessment System for Antithrombotic Therapy of ACS

Antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (ACS), which result in lower risk of mortality and ischemic events. But, accompanied side effect of bleeding always causing worsens outcomes. Tools to evaluate risk/benefit ratio is useful in daily practice. The in-used scores, such as CRUSADE, are derived from retrospective studies, without all types of ACS and without long-term prediction. This project aims to establish a database of anti-thrombosis treatment and bleeding in five large centers in Beijing through the observational registry of ACS. With the database, establish a bleeding risk assessment system that can be used for all ACS patients and can predict the full course of antithrombotic treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age18-85 years old
2. Diagnosed ACS
3. Signed informed consent form

Exclusion Criteria:

1. Any active bleeding
2. Not tolerate to anti-thrombotic drugs
3. A planned elective surgical procedure that would necessitate an interruption in treatment with antiplatelet therapy in the next 6 months after enrollment
4. Patients who died of non-bleeding causes within 24 hours after admission
5. Noncardiac coexisting conditions that could limit life expectancy to less than 1 year
6. Pregnancy or lactation
Dexmedetomidine Infusion in Either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery

Dexmedetomidine Infusion in either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I and II patients undergoing endoscopic sinus surgery in the age group from 18-50 years.

Exclusion Criteria:

* History of allergy to medications used in the study, refusal of patients to participate, hepatic or renal dysfunction, chronic pain condition, psychological and neurological disorders
Sequential Core Stability Corrective Exercise Approach in Lower Crossed Syndrome

The objective of the study will be to determine the effects of Sequential Core Stability Corrective Exercise Approach for Alignment and Muscle Function in Lower Crossed Syndrome.

Lower Crossed Syndrome is one of common postural disorder which occurs due to the muscular imbalance. It refers to specific altered muscle activation and movement patterns along with some postural deviations. Alterations in muscle activation include overactivity of hip flexors and lower back muscles paired underactivity of abdominals and gluteus muscle. This pattern of imbalance creates dysfunction. Postural correction exercise with inner and outer core muscles are necessary. There are different traditional structural approach, functional approach and biomechanics and are presumed to lead to adjustments in the length and strength of local muscles while ignoring other related malalignments and core stability. The objective of the study will be to determine the effects of Sequential Core Stability Corrective Exercise Approach for Alignment and Muscle Function in Lower Crossed Syndrome.

It will be a randomized controlled trial. Sample size will be collected after running the pilot study. The participants will be recruited through convenient sampling technique and then allocated randomly to Groups. Outcome measures will be alignment and muscle function. Pre and post reading and after one month follow-up will be recorded. Data will be analyzed using statistical package for social sciences software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or nonparametric test will be use within a group or between two groups.

Keywords: Alignment, Core Stability, Diaphragm, Muscular Imbalance, Muscle thickness Pelvic floor.

Eligibility Criteria:
Inclusion Criteria:

* • Age group between 18 to 28 years

  * No current incidence of low back pain or past history of low back dysfunction
  * Kendall double leg lowering test: Abdominal muscle weakness to the extent of not being able to maintain posterior pelvic tilt during a double leg lowering test in supine position.
  * Diagnosed with lower cross syndrome through assessment criteria of Janda muscle testing and assessment

Exclusion Criteria:

* • Having any history of low back pain, spinal trauma,

  * Joint dysfunction in past 3 months
  * Congenital deformities at hip or lumbar region,
  * Recent fracture to related joints in past 6 months
  * Any family history of cardiopulmonary disease
  * Any disease or urogenital tract
  * Participants having BMI above 30.
  * Recent history of hepatitis or Fatty liver or
  * Any athlete having high physical activity.
  * History of abdominal, hip or lumbar surgeries in past 3 months
Search for Serum/Plasma Biomarkers in Pompe's Disease

This study aims to analyze serum and plasma samples from patients with late onset Pompe disease treated and not treated with enzyme replacement therapy (ERT) to identify microRNA that could be specific of the disease. The investigators will correlate the concentration of these microRNA with several muscle function tests and quantitative muscle MRI to know whether they are good biomarkers of progression.


Eligibility Criteria:
Inclusion Criteria:

* Genetic confirmation of Pompe disease

Exclusion Criteria:

* Pregnancy
Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

This study will evaluate the usefulness of the Urgent and Emergency Surgery (UES) Delirium Recovery Model. It is hypothesized that the cognitive, physical and psychological recovery of older UES delirium survivors will be improved through the use of the DANE Recovery Model. Participants can expect to be on the study for 18 months.

This is a multi-site, two-arm, single-blinded randomized controlled clinical trial to evaluate the efficacy of the DANE Recovery Model to improve the cognitive, physical and psychological recovery of older UES delirium survivors. At or near the time of discharge, enrolled participants will be randomized to receive the DANE Recovery Model or usual care. The hypothesis is that, after 18 months, older UES delirium survivors who are randomized to the DANE Recovery Model will experience more favorable cognitive, physical and psychological recovery in comparison to those randomized to usual care.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 65 years and older
* Admitted to one of the participating hospitals
* Undergone an abdominal orthopedic, skin, or vascular surgery in an emergency or unplanned fashion
* English-speaking
* Able to provide consent or have a legally authorized representative to provide consent
* Access to a telephone or an internet connected computer or smart device
* Discharged to home or sub-acute rehabilitation
* At least one episode of delirium or subsyndromal delirium, i.e. screen positive on at least one out of the four items on the Confusion Assessment Method-ICU (CAM-ICU) in the period prior to discharge from acute care.

Exclusion Criteria:

* A self-reported diagnosis of cancer with short life expectancy
* A history of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease (AD), Parkinson disease, or vascular dementia, or current prescription of anti-dementia medication, or ruled out by Functional Activities Questionnaire (FAQ) score defining dementia; a history of significant traumatic brain injury
* Acute or subacute neurologic deficit expected to prevent independent living after hospital discharge, e.g., a history of a significant traumatic brain injury
* Have any spinal cord injury with persistent neurologic deficit at the time of study enrollment
* Incarcerated or homeless at the time of study enrollment
* Acquired neurologic injury (stroke, traumatic brain injury, cerebral edema/swelling, anoxic brain injury, or any other acute/subacute severe neurologic deficit) as the admitting diagnosis or a new event during the course of hospitalization (confirmed by EMR)
* A history of bipolar disorder or schizophrenia (confirmed by EMR)
Feasibility of Supportive Care Needs in Patients With Advanced Solid Cancer in a Therapeutic Trial

The purpose of the study is to assess the supportive care needs of patients enrolled in a therapeutic trial for metastatic cancer.

All patients included in a therapeutic trial will be offered an analysis of their supportive care needs from the following options:

* dietetics
* psychological
* pain management
* Palliative medicine consultation or day hospital
* onco-geriatrics
* social assistance
* Physiotherapist care If an intervention(s) is selected, it will be offered in addition to the patient's participation in the therapeutic trial.

Eligibility Criteria:
Inclusion Criteria:

* metastatic cancer
* patient included in a clinical trial

Exclusion Criteria:

- patient deprived of his freedom
Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma

This is a Phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma.

Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoeitic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. Ibrutinib is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with bortezomib and dexamethasone in subjects with relapsed/relapsed and refractory multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with multiple myeloma (MM) who have received 1-3 prior lines of therapy and have demonstrated disease progression since the completion of the most recent treatment regimen. (Subjects may have received prior bortezomib exposure if it does not meet the exclusion criteria for prior proteasome inhibitor use)
* Measurable disease defined by at least one of the following:

  * Serum monoclonal protein (SPEP) ≥1 g/dL (for subjects with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE) or immunoglobulin M (IgM) multiple myeloma SPEP ≥0.5 g/dL)
  * Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine electrophoresis
* Adequate hematologic, hepatic and renal function
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

Exclusion Criteria:

* Subject must not have primary refractory disease
* Refractory or non-responsive to prior proteasome inhibitor (PI) therapy (bortezomib or carfilzomib)
* Peripheral neuropathy Grade ≥2 or Grade 1 with pain at Screening
* Plasma cell leukemia, primary amyloidosis, or POEMS syndrome
* Unable to swallow capsules or disease significantly affecting gastrointestinal function
* Requires treatment with strong CYP3A inhibitors
* Women who are pregnant or breast feeding
Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination

To date, studies on SARS-CoV2and vaccines have been mostly from the general population not exposed to immunosuppressants. The efficacy and safety of COVID-19 vaccines need to be evaluated in these populations.

Longitudinal, comparative, controlled, observational multicenter study based on a cohort of 1500 SARS-CoV-2 seronegative patients with CIRs from the COVID-RIC1 cohort: 750 accepting vaccination and 750 refusing vaccination matched on age (+/-10 years), gender, rheumatism and recruiting center. Schedule: 4 visits over a 12-month period.

An observational routine care study was initiated in 15 French hospitals to assess the SARS-CoV-2 seroprevalence in France in a population with CIRs. The project plans to screen 5000 CIRs patients. The COVID-RIC3 study will thus be proposed to these pre-screened subjects according to their agreement or refusal to be vaccinated against COVID-19 based on a question asked at the time of their inclusion in COVID-RIC1.

The efficacy and safety of the SARS-CoV2 vaccines as well as the vaccine-induced humoral immune responses and their maintenance over time in immunosuppressed patients with CIRs are essential to guide vaccine recommendations in these specific immunocompromised populations in terms of "boost" or booster.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years old,
* Chronic inflammatory arthritis: rheumatoid arthritis, psoriatic arthritis, axial SpA, diagnosed by a rheumatologist
* Having a negative serology for SARS-CoV-2 infection upon inclusion in COVID-RIC1.
* Under csDMARD (conventional synthetic Disease-modifying antirheumatic drug), biotherapy, JAK inhibitor or under symptomatic treatment such as NSAIDs or corticosteroids alone or in combination with a DMARD (Disease-modifying antirheumatic drug)
* Subject having signed a consent
* Affiliated with Social Security
* Having accepted or agreed to be vaccinated against COVID-19 (for vaccine group)
* Having refused to be vaccinated against COVID-19 (for non-vaccine group)

Exclusion Criteria:

* Adult patient under legal protection (guardian, curator)
* Patient vaccinated with an anti-SARS-CoV-2 vaccine before the serological test
* Refusal to be vaccinated (for vaccine group)
* Acceptance to be vaccinated (for non-vaccine group))
* Refusal to participate in the study
* Pregnancy and breast feeding
Identifying Biomarkers for Chronic Pain After Breast Cancer Treatment.

Up to 40% of women experience chronic pain after treatment for breast cancer, and this pain is often very disabling. However, chronic pain after breast cancer remains under-recognised and undertreated. An effective and patient-tailored approach of (chronic) pain after breast cancer indeed requires a thorough knowledge and

evaluation of the pain. In daily clinical practice, however, guidelines for a comprehensive diagnosis of pain in cancer patients and survivors are lacking. Further research in this topic is crucial for an efficient, preventive as well as curative, approach of pain after breast cancer. Besides the high prevalence and the important impact of pain in this population, the breast cancer population is also an ideal population to study chronic pain and its natural time course in different stages, since most patients start pain-free, but almost half of them end up

with chronic pain. Therefore, this study aims to map biomarkers (both predictive, prognostic and diagnostic) for chronic pain after breast cancer treatment. We will study possible biopsychosocial biomarkers in

relation to (chronic) pain and monitor their temporal changes from the moment of diagnosis until 1 year after surgery. The potential biomarkers are situated within the medical imaging of the brain, measurements of pain sensitivity and psychological variables.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral breast cancer
* Pain at enrollment \<3/10 on average during the past week
* First cancer diagnosis

Exclusion Criteria:

* Pre-existing pain conditions
* major pre-existing neurological disorders
* No recurrent cancer or metastasis
* No previous surgery in area
Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia

The purpose of this study is to compare transcutaneous electrical spinal stimulation (TESS) and epidural electrical stimulation (EES); in particular, the motor activity enabled by each method and the potential health benefits of each method.


Eligibility Criteria:
Inclusion Criteria

* Spinal cord injury due to trauma located between the seventh cervical and tenth thoracic vertebrae
* American Spinal Injury Association grading scale of A or B (at least 4 each of A and B) below the level of SCI
* Intact spinal reflexes below the level of SCI
* At least 1-year post-SCI
* At least 22 years of age
* Willing to use medically acceptable methods of contraception, if female and of child-bearing potential

Exclusion Criteria

* Currently a prison inmate, or awaiting trial, related to criminal activity
* Pregnancy at the time of enrollment
* DEXA t score \<-3.5 at spine and femur head
* History of chronic and/or treatment resistant urinary tract infection
* Unhealed decubitus ulcer
* Unhealed skeletal fracture
* Untreated clinical diagnosis of depression
* Presence of joint contractures or an Ashworth spasticity score of 4
* Active anti-spasticity medication regimen within 3 months prior to study enrollment
* Presence of transcranial magnetic stimulation-evoked potentials in leg muscles
* Non MRI-compatible implanted medical devices.
* Undergoing, or planning to undergo, diathermy treatment
* Active participation in another interventional clinical trial
* Presence of conditions or disorders which require MRI monitoring
* For EES cohort subjects, a history of coagulopathy or other significant cardiac or medical risk factors for surgery
* Current use of a ventilator
* Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
* Mass \> 113 kg (250 pounds)
* History of frequent hypotension characterized by light headedness, or loss of consciousness
* History of frequent hypertension characterized by headache, or bradycardia
* History of frequent, severe, autonomic dysreflexia
* Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
Indocyangreen Elimination in Cirrhosis and Acute Liver Failure

Indocyangreen (ICG)is totally biliary eliminated and corresponds to hepatocyte function and liver perfusion.

The ICG-clearance will be evaluated as a prognostic marker in liver disease.

patients with acute liver failure or advanced liver disease will be studied. ICG-clearance will be correlated with established clinical scores and outcome.

Eligibility Criteria:
Inclusion Criteria:

* acute liver failure OR end-stage liver disease
* normal hepatic perfusion by doppler ultrasound

Exclusion Criteria:

* portal vein thrombosis
* allergy to ICG or iodine
* thyroid disease
Use of Low-level Laser Therapy (808nm) to Muscle Fatigue Resistance

The study hypothesis is a improved muscle fatigue resistance induced by low-level laser therapy applied between sets of intense exercises.


Eligibility Criteria:
Inclusion Criteria:

* healthy males
* physically active
* aged between 18-28 years old

Exclusion Criteria:

* smoker
* under medicine
* lower limb lesions limiting the flexion-extension of the knee joint
Angiogenic Switch in Patients With Colorectal Cancer

A group of colorectal cancer (CRC) patients treated with chemotherapy and Bevacizumab (Bev) maintain the same sensitivity after progression to maintenance treatment because they remain dependent on VEGF angiogenic mediator, while other patients in whom there is an angiogenic switch (AS) become dependent on other angiogenic cytokines and become resistant to Bev chemotherapy combinations .


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage IV colorectal adenocarcinoma.
* Age ≥ 18 years .
* Measurable disease by RECIST criteria.
* Life expectancy ≥ 6 months.
* Candidate to receive treatment with first-line chemotherapy.
* Availability of tumor tissue.

Exclusion Criteria:

* Patients who have received prior treatment with first-line chemotherapy for metastatic disease.
* Patients in whom there is contraindication to the administration of either drug used in the study: capecitabine, irinotecan, oxaliplatin or Bev.
* Patients receiving anticoagulant oral treatment.
* Patient with diagnosis of other malignancies within 5 years prior to diagnosis except basal cell carcinoma or cervical carcinoma · in situ. · The inclusion of patients with malignant disease diagnosed more than 5 years ago without recurrence in the previous 3 years will be analyzed individually
* Patients with bone disease as the only manifestation of the disease.
A Comparative Pilot Study Of High-Order Aberrations With Aspheric IOL Models SN60WF and ZCB00

The purpose of this study was to prospectively compare high-order aberrations between eyes implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted with the Tecnis ZCB00 IOL.


Eligibility Criteria:
Inclusion Criteria:

* Requires bilateral extraction of cataracts by phacoemulsification followed by implantation of a posterior chamber intraocular lens;
* Confirmed absence of pre-existing conditions that could skew the results or present contraindications for the IQ intraocular lens (IOL) or the Tecnis ZCB00 IOL;
* \<1 diopter corneal astigmatism preoperatively;
* Able to achieve 6.5 mm dilated pupil;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Chronic disease or illness;
* Irregular optical aberration;
* Amblyopia;
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
* Diabetic retinopathy;
* Macular degeneration;
* History of retinal detachment;
* Other surgeries planned at time of cataract removal;
* Severe dry eye;
* Other protocol-defined exclusion criteria may apply.