cyrilzakka/clinical-trials huggingface dataset:
Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease

The goal of this clinical trial is to analyze the usability and safety of the prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease.

Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.

Neurological and neuromuscular diseases are the main cause of motor disability in children, leading to the inability to stand and walk in many cases. Exoskeletons are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER V2 is a prototype of a robotic gait exoskeleton designed to assist gait in children with motor disability in their homes and the community. The aim of this study is to analyze the safety and usability of the EXPLORER V2 as a proof of concept.

A test phase will be conducted in healthy volunteers (phase 0) as a proof of concept with the aim of evaluating safety and usability in healthy participants prior to the use of the device in children with neurological and neuromuscular disease (phases 1 and 2). After this, participants will use the exoskeleton in 4 different ocassions, 1 in a laboratory of gait analysis and 3 in their homes and the community.

Eligibility Criteria:
Inclusion Criteria:

* Medical authorization for standing, gait training and weight bearing.
* Informed consent signed by legal guardians.
* Maximum user weight of 35 kg.
* Hip width (between greater trochanteres) ≤40 cm.
* Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 21cm to 36cm.
* Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 20cm to 35cm.
* Shoe size ≤38 (EU)

Exclusion Criteria:

* Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
* More than 20º of hip and/or knee flessum at the time of using the exoskeleton.
* Necessity to walk with 15 of hip abduction.
* Skin lesion on parts of the lower extremities that are in contact with the device.
* Scheduled surgery scheduled during the study period.
* History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
* Presence of other conditions causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease).
* Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness or the inability to understand simple comands.
* Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.
Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer

This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer
* Subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, or radiotherapy
* Subjects must meet certain laboratory criteria
* Expected survival \> 3months
* Subjects must have no uncontrolled intercurrent illness

Exclusion Criteria:

* Women who are pregnant or lactating, or who are of childbearing potential , and men who do not use a barrier method
* Subjects with significant cardiac issues
* Subjects using certain medications
* Subjects with certain medical conditions
* Subjects with brain metastasis
* Subjects who have recently been enrolled in other experimental clinical trials of investigational agents
Effect of Switching from Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults with Type 2 Diabetes (Switch CGM T2D)

The goal of this prospective study is to evaluate diabetes outcomes and patient experience following a switch from second generation intermittently scanned continuous glucose monitor (isCGM) to real-time continuous glucose monitor (rtCGM) compared with participants with continued isCGM use among adults with insulin-treated type 2 diabetes (T2D) in a specialist endocrinology clinic setting in Canada. The study aims include:

Primary outcome - Evaluate change in percent time in range (TIR) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with participants with continued second generation isCGM use.

Secondary outcomes - Compare glycemic and metabolic outcomes (ie. additional CGM metrics, HbA1c, and weight), and outcomes related to diabetes management (ie. self-reported hypoglycemia and change in total daily dose \[TDD\] of insulin) at 3-6 months follow-up in the rtCGM switch and isCGM cohorts among adults with insulin-treated T2D.

Exploratory outcomes - Evaluate patient-reported outcomes (PROs) in the rtCGM switch cohort only. PROs will include questions about device satisfaction and psychological distress at baseline and 3-6 months follow-up, and protocol-specific questions about Dexcom Care following use of the rtCGM device at 3-6 months follow-up. Additionally this study will compare percent TIR, percent TBR, percent TAR, and HbA1c between rtCGM switch and isCGM cohorts by insulin therapy subgroup (basal vs MDI therapy).

rtCGM switch participants will be enrolled at an LMC location and asked to complete PROs at baseline and 3-6 month follow-up. Continued isCGM participants will not be asked to complete PROs.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Clinical diagnosis of T2D ≥ one year
* Using insulin for ≥ 6 months
* Continued FreeStyle Libre® 2 isCGM device (isCGM cohort) as of the study start date
* Would like to switch from a FreeStyle Libre® 2 isCGM device to a Dexcom® G7 rtCGM device (rtCGM switch cohort) as of the study start date
* Baseline HbA1c ≥ 7.5%
* Known rtCGM/isCGM start date (month and year)
* Exclusive use of isCGM for ≥ 3 months
* Data on LibreView platforms have percent sensor capture ≥ 70% for 14 days of available data up to 6 months prior to index date
* ≥ 1 value for TIR (%) up to 6 months (± 6 weeks) prior to index date
* ≥ 1 value for HbA1c (%) up to 6 months (± 6 weeks) prior to index date
* Data consent

Exclusion Criteria:

* Have a prior history of rtCGM within 12 months of the index date
* Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date
* Recent or expectant titration of insulin dose ≥ 20% within 30 days of index date
* Are pregnant at the time of study enrollment or intending to become pregnant during the study
* Used the isCGM or rtCGM for \< 3 months
* Using continuous subcutaneous insulin infusion
Three-dimensional Choroidal Vascularity Index in Common Fundus Diseases

Explore the changes of choroidal blood perfusion in common fundus diseases by three-dimensional choroidal vascularity index, an optical coherence tomography (OCT) parameter.

Compared with the choroidal vascularity index on a single OCT image, the three-dimensional choroidal vascularity index can evaluate the choroidal changes of chorioretinal diseases as a whole. In this study, the choroidal changes of patients with common fundus diseases were systematically evaluated by collecting OCT and optical coherence tomography angiography (OCTA) images of patients with common fundus diseases, especially in healthy people, myopic people and patients with central serous chorioretinopathy.

Eligibility Criteria:
1. Healthy participants (1) Inclusion Criteria: 1) without systemic diseases such as diabetes and hypertension 2) best corrected visual acuity BCVA ≥ 1.0 3) aged 18 years or older (2) Exclusion criteria: 1) equivalent spherical refraction between -3 diopters and + 1.0 diopters 2) any visible lesions in the retina, optic nerve, or choroid 3) history of refractive or intraocular surgery
2. Myopia group (1) Inclusion Criteria: 1) equivalent spherical refraction greater than -0.25 diopters 2) without systemic diseases such as diabetes and hypertension 3) Best corrected visual acuity (BCVA) ≥ 1.0 4) aged 10 years or older (2) Exclusion criteria: 1) history of refractive or intraocular surgery 2) history of laser therapy 3) other systemic diseases that may affect the choroid
3. Central serous chorioretinopathy (CSC) group (1) Inclusion Criteria: 1) a diagnosis of CSC (2) Exclusion criteria: 1) high myopia or hyperopia (greater than 26 or +3 diopters of refractive error) 3) other systemic diseases that may affect the choroid 4) any other associated retinal pathology 5) history of refractive or intraocular surgery
Trial Using 125I Embedded Stent in Patients With Advanced Esophageal Cancer

More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, stent placement has been widely accepted to be an option for palliation of the symptoms. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The preliminary clinical trial in a single institute has demonstrated better results than the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.

Esophageal cancer ranks as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. The following preliminary clinical study in a single institute has demonstrated longer survival time, better quality of life and less restenosis of the stent than whose with the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary cancer of esophagus,
* Must be dysphagia caused by esophageal cancer,
* Without esophageal fistulas,
* Must be an inpatient,
* Life expectancy is over 6 months

Exclusion Criteria:

* Esophageal fistulas,
* Tracheal compression with symptoms,
* WBC \<2000/mm3 and Platelet count \<50,000/mm3,
* Concurrent therapies after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease

This is the first study in humans to evaluate the effectiveness of SJP-0132 in the treatment of dry eye disease. This study will evaluate the safety, tolerability, efficacy, and pharmacokinetics of single- and multiple-dose regimens of SJP-0132 in subjects with dry eye disease


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) within 18.5 to 30.0 kg/m2 (inclusive) and body weight between 45 kg and 100 kg
* Generally healthy as determined by medical history, physical examinations, clinical laboratory examination, and ophthalmologic examinations performed at Screening
* Have a subject reported history of Dry Eye Disease in both eyes for at least 6 months prior to Screening
* Non-smoker or ex-smoker for \>12 months

Exclusion Criteria:

* Have clinically significant systemic or ophthalmic disease
* Has a positive serum pregnancy test at Screening or urine pregnancy test
* Have had significant blood loss or have donated or received one or more units (450 mL) of blood or plasma within 30 days before randomization
* Have used or anticipates use of any prescription or over-the-counter medication, including topical medications such as ophthalmic solutions, nasal drops or spray, vitamins, alternative and complementary medicines (including herbal formulations) within 14 days or 5 half-lives (whichever is longer) before randomization or at any time during the study
* Use or anticipates use of prescribed dry eye medications within 28 days prior to randomization or at any time during the study
* Have used or anticipates use CYP3A4 inducers, such as St. John's Wort, within 14 days before randomization or at any time during the study.
* Have consumed red wine, grapefruit or grapefruit juice, Seville oranges, star fruit, or any products containing these items, or any foods that may inhibit CYP3A4, within 48 hours before randomization and throughout the duration of the study
* Have a positive urine alcohol or urine drug test at Screening or Day -1
* Contact lens wearers who cannot discontinue the wear over the trial period
* Have undergone eye surgery (including laser surgery) within the last 12 months or whom the Investigator considers unsuitable
* Have a best corrected visual acuity (BCVA) worse than 20/100 in either eye
* History of permanent punctal occlusion (cautery or laser) or current use of punctal plugs
* Any corneal abnormality or disease which might impact normal tear film spreading
* Active or history of significant corneal disease
* Known allergy or sensitivity to fluorescein, lissamine green or any of the study medications

Other protocol-defined Inclusion/Exclusion Criteria may apply
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children

The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.
* Aged 6 weeks (42 days) to \<6 years at the time of consent.
* Healthy infants and children as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

* Participation in other studies involving investigational drug(s)/vaccine(s) since birth (Cohort 1 only) or in the 6 months prior to study entry (Cohorts 2, 3, and 4) and/or during study participation.
* Other acute or chronic medical or psychiatric condition, including recent laboratory abnormality, that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
* Vaccination with licensed or investigational pneumococcal vaccine.
* Previous vaccination with licensed or investigational Hib vaccine.
A Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes

With the improvement of living level, the incidence rates of diabetes, obesity, and hypertension in China increased quickly, which are 11.6%, 7.1% and 18.8% respectively, according to the newly investigated data. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Sleeve gastrectomy can improve the level of blood glucose and serum lipid of type 2 diabetic rats by ameliorate insulin level and insulin resistance, which may be related with the change of gastrointestinal hormones such as ghrelin and GLP-1. So, intervention of gastrointestinal tract and gastrointestinal hormone secretion may be a new therapy for glycolipids disorder and vascular complications. But, it is lack of evidence-based medicine proof on the relationship between prokinetic drug and glycolipids metabolism. So, the investigators designed a prospective, randomized, double-blinded, placebo control study, and try to evaluate the effects of prokinetic drug (Mosapride) on the blood glucose and serum lipid in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age between 30-65 years old
* Type 2 diabetes
* Duration of diabetes less than 5 years and pancreatic function be in compensated stage.
* 7%≤HbA1C≤9%
* Patients are able to control diet and exercise by themselves in intervention period.

Exclusion Criteria:

* Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
* Type 2 diabetes using insulin, GLP-1 analogues or DPP-IV inhibitors).
* Heart function in NYHA Grade II-IV or history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
* Hypohepatia (AST or ALT is two times higher than the upper limit) or history of cirrhosis, hepatic encephalopathy, esophageal varices or portal shunt.
* Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
* Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia.
* Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
* Fertile woman without contraceptives.
* Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
* Allergic to or have contraindication to the intervention drugs.
A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* females, 18 or older
* recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer
* paraffin-embedded tissue block must be available
* measurable disease
* prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or metastatic setting)
* 0, 1 or 2 chemotherapies in the metastatic setting
* adequate organ function

Exclusion Criteria:

* Metastatic disease confined to bone only
* Symptomatic CNS metastasis
* Concurrent medical condition which may increase the risk of toxicity
* Unable to take oral medication
Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma

This was an open-label, multi-center, single-arm, Phase 1 study. The purpose of this study was for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in Chinese participants with high-risk neuroblastoma


Eligibility Criteria:
1. Signed informed consent form (ICF) and ability to comply with study requirements
2. Age ≥ 12 months at consent
3. Diagnosis of high-risk neuroblastoma according to the International Neuroblastoma Staging System (INSS) criteria.
4. Participants who have previously received induction chemotherapy and achieved a partial or complete response followed by myeloablative therapy and stem cell transplantation. Stem cell transplantation should be completed within 120 days of dinutuximab beta first administration

Exclusion Criteria:

1. Hypersensitivity to ≥ 1 component of dinutuximab beta antibody or against mouse proteins
2. Actively progressive disease (not stabilized) or recurrent disease at the time of inclusion into the study
3. Previous treatment with anti-GD2 antibody before enrolling in this study

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation

This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients scheduled for a first PVI only for paroxysmal atrial fibrillation (AF) (self-terminating or \<7days) or persistent AF (persistent AF is defined as having an AF episode \>7d); (patients with paroxysmal AF or short-standing persistent AF presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial)
* Patients willing to sign informed consent

Exclusion Criteria:

* Patients with long-standing persistent AF (long-standing persistent AF is defined as having an AF episode \>1yr)
* Previous ablation for AF
* Left atrium antero-posterior diameter \>50 mm (parasternal long axis view, PLAX)
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Left atrial appendage (LAA) thrombus. LAA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
* Left ventricular ejection fraction \<35%.
* Cardiac surgery within the previous 90 days.
* Expecting cardiac transplantation or other cardiac surgery within 180 days.
* Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
* Documented history of a thromboembolic event within the previous 90 days.
* Diagnosed atrial myxoma.
* Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
* Women who are pregnant or who plan to become pregnant during the study.
* Acute illness or active infection at time of index procedure
* Advanced renal insufficiency
* Unstable angina.
* History of blood clotting or bleeding abnormalities.
* Contraindication to anticoagulation.
* Life expectancy less than 1 year.
* Presence of a condition that precludes vascular access.
* Unwilling or unable to provide informed consent.