cyrilzakka/clinical-trials huggingface dataset:
Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy

The purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy during stepping tasks.

Individuals with bilateral cerebral palsy (BCP) sustain a neonatal brain injury that leads to altered neuromuscular control to the lower limbs. One commonly observed motor impairment from this altered control is loss of selective voluntary motor control (SVMC), defined as the ability to independently move the joints intentionally. Loss of SVMC typically manifests as knee and ankle joint impairment and abnormal coupling between the hip adductors and lower limb extensors. This can make stepping up or down a curb or stair challenging, but quantitative investigation in these closed-chain activities has been limited. This is especially important as performance in stair-climbing is associated with limitations to overall mobility and community participation in cerebral palsy.

The overall aim of this proposal is to investigate the altered neuromuscular control that challenges stair walking in individuals with BCP. Participants who consent to the study will be instructed to perform multiple step-ups and step-downs on a single raised platform. The parameters of the stepping task may change by adding weight to the body or subtracting weight from the body. Using standard gait analysis techniques, biomechanical metrics such as joint kinematics and kinetics will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* aged 5 years to 19 years
* typically developing with no diagnosed medical conditions that affect movement, OR with a diagnosis of bilateral cerebral palsy (including diplegia, tetraplegia, and quadriplegia) where the lower limbs are more affected than the upper limbs
* ability to independently step up, with or without assistive devices.

Exclusion Criteria:

* lower limb surgery in the past year
* botulinum toxin injections to the lower limb muscles in the past 6 months
* cognitive dysfunction that would make following directions difficult
* comorbidities that would make participation unsafe.
Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis

Sleep disturbance is common in people with multiple sclerosis (MS) and contributes to diminished quality of life. Bright light therapy may be an innovative strategy to reduce sleep disturbance in MS, possibly through its effects on a subtype of retinal ganglion cells that help regulate circadian rhythms and sleep. This pilot study will evaluate whether, in people with MS, bright light therapy reduces sleep disturbance and explore whether light therapy improves function of these cells.

Multiple sclerosis (MS), an inflammatory and neurodegenerative disorder of the central nervous system (CNS), is the most common cause of progressive neurologic dysfunction in early to middle adulthood. People with MS are a markedly high risk for sleep disturbance. Estimates of the lifetime prevalence of sleep disturbance in MS reach 50%; sleep disturbance is also associated with excess MS-associated morbidity and diminished quality of life. Despite the high burden of impaired sleep and its contribution to adverse MS outcomes, effective approaches to treat and ameliorate disturbed sleep in people with MS remain poorly understood. There is unmet need to develop safe and effective rehabilitative alternatives to mitigate sleep disturbance in MS. Prior research supports the use of timed bright light therapy (LT) as one such approach for insomnia and sleepiness in those with sleep disorders or other neurologic diseases. Yet, the safety and potential effectiveness of timed LT have yet to be tested in MS. The goal of the proposed study is to conduct a detailed intervention study testing if timed bright LT in people with MS is 1) safe (primary outcome) and 2) potentially effective for reducing sleep disturbance (specifically, reducing insomnia, fatigue and improving sleep efficiency, quantity and quality as secondary outcomes). The study will also explore whether LT stimulates a novel subtype of retinal ganglion cells which are central to the regulation of circadian rhythms and sleep.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS
* Evidence of sleep disturbance
* Stable on immunomodulatory MS therapy or no therapy for at least 6 months prior to study initiation
* Stable on antidepressants for at least 3 months prior to study initiation and no evidence
* Stable on fatigue medication for at least 3 months prior to study initiation
* Willing and able to provide informed consent and follow study procedures.

Exclusion Criteria:

* Evidence of cognitive impairment
* Low risk for sleep disordered breathing
* Other comorbid ophthalmologic disorders (e.g. cataracts, glaucoma, blindness)
* Traveled across two time zones within 90 days of study screening.
* Not participating in shift work
* MS relapse or history of acute optic neuritis within 30 days
* No prior history of bipolar disorder
* No evidence of current depression
* Diagnosis of severe periodic limb movement disorder or severe restless legs syndrome
Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)

The main objective of this study is to demonstrate the superiority or non-inferiority of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with in-stent restenotic native coronary artery lesions.


Eligibility Criteria:
Inclusion Criteria:

* 1. The patient has an in-stent restenosis of \> 50% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement ( 4 weeks). Lesions must meet ISR Classification I-III.

  2. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis. The diagnosis of angina pectoris is defined by Canadian Cardiovascular Society Classification (CCS I, II, III, or IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;

  3. The study target lesion must be located in an in-stent restenotic native coronary artery measuring \> 2.75mm and 3.5mm in diameter and \> 15mm and 40mm in length to allow treatment with a maximum of three 18mm stents. The target lesion must have undergone coronary interventional treatment \> 4 weeks previously. Patients with one or more prior percutaneous coronary interventions at the target lesion are acceptable candidates.

  4. The vessel 1cm distal to the target lesion is \> 2.5mm in diameter;

  5. Ejection Fraction must be \> 40%;

  6. The study target lesion cannot be located in a vessel containing a second lesion requiring treatment at the time of the procedure.

  7. Male or non-pregnant female patients \> 18 years of age inclusive. NOTE: Females of child-bearing potential must have a negative pregnancy test (urine or serum) prior to enrollment and must use birth control for 6 months.

Exclusion Criteria:

1. The study target lesion has definite or possible thrombus present by angiographic criteria.
2. The patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \> 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment.
3. Impaired renal function (Serum creatinine \> 2.0mg/dl);
4. The patient has unstable angina classified as Braunwald III B or C, or is having peri infarction angina.
5. The left ventricular ejection fraction is \< 40%.
6. The target vessel has previously sustained a perforation.
7. Totally occluded vessel (TIMI 0 level);
8. Prior stent within 5mm of target lesion;
9. There is a total occlusion of the restenosed-stent (ISR Classification IV) prior to the interventional procedure.
10. Has an ostial target lesion;
11. Significant (\> 50%) in-stent restenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Clinical Deployment and Validation of Rho

Osteoporosis is a widespread disease characterized by the loss of bone mineral density (BMD). 16 Bit has developed software, called RhoTM, that analyzes various x-rays, performed in patient age 50 and above for any clinical indication, to identify patients with low BMD. RhoTM is intended to function as a pre-screening device for low BMD. This study seeks to assess the clinical performance and impact of implementing RhoTM in real-world settings by analyzing its performance and impact on DXA referrals.

Osteoporosis is a widespread disease characterized by the loss of bone mineral density (BMD). 16 Bit has developed an opportunistic screening tool for low BMD, called RhoTM, that analyzes lumbar spine, thoracic spine, chest, pelvis, knee, and hand radiographs, performed in patient age 50 and above for any clinical indication to estimate lumbar and femoral neck BMD. The estimated BMD T-score is used to classify patients as having normal or low BMD. A finding of low BMD can be included in a radiologist's report, and is intended to support a discussion between healthcare provider and patient regarding the need for osteoporosis diagnosis by dual-energy x-ray absorptiometry (DXA). In this way, RhoTM is intended to function as an opportunistic pre-screening device for low BMD. This study seeks to assess the clinical performance and impact of implementing RhoTM in real-world settings by analyzing the diagnostic performance and impact on DXA referrals.

Eligibility Criteria:
Inclusion Criteria:

* age 50+ years
* outpatient undergoing x-ray examinations of:
* chest
* thoracic spine
* lumbar spine
* pelvis
* knee
* hand/wrist

Exclusion Criteria:

* age \< 50 years
* inpatient
Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery

The purpose of this study is to evaluate the safety and effectiveness of three concentrations of rEV131, a new investigational anti-inflammatory agent, compared to placebo (an inactive substance) and an FDA approved anti-inflammatory agent in patients with ocular inflammation who have undergone cataract extraction with intra-ocular lens implantation.


Eligibility Criteria:
Inclusion Criteria:

* be male or female who has undergone unilateral cataract extraction by phacoemulsification (PHACO) method with implantation of a posterior chamber intraocular lens

Exclusion Criteria:

* have unstable glaucoma
* have an active bacterial and/or viral infection
* use any ocular or systemic anti-inflammatory agents within 1 week prior to enrollment and for the duration of the study.
rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network

Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.

Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. Additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. Targeting several core regions of this network by rTMS might constitute a promising strategy to enhance treatment effects. A new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of subjective chronic tinnitus
* THI \> 38
* Duration of tinnitus more than 6 months

Exclusion Criteria:

* Objective tinnitus
* Treatable cause of the tinnitus
* Involvement in other treatments for tinnitus at the same time
* Clinically relevant psychiatric comorbidity
* Clinically relevant unstable internal or neurological comorbidity
* History of or evidence of significant brain malformation or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorder affecting the brain or prior brain surgery;
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse
* Prior treatment with TMS
A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors

This is a pilot study to assess the changes in white matter, in the brain, in response to radiation therapy and correlate these changes with later declines in cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (age 6-21) who will receive cranial radiotherapy for brian tumors. This could include but is not limited to: low grade glioma, high grade glioma (to include grade III but not grade IV glioma), germ cell tumors, primitive neuroectodermal tumors, craniopharyngioma, or medulloblastoma.
* Patients should, in the estimate of the treating physician, be anticipated to have a median survival of greater than 1 year.

Exclusion Criteria:

* Patients with previous Central Nervous System (CNS) radiation or or CNS tumors that, in the judgement of the investigators, are likely to undergo progression during or shortly after radiotherapy are excluded.
* Patients with glioblastoma, multiforme, gliosarcoma, diffuse pontine glioma, or other tumors presumed to have expected median survival per the investigators of less than 1 year.
* Patients who require sedation for Magnetic Resonance Imagining (MRI)are excluded.
* Patients at risk for nephrogenic systemic sclerosis will be excluded as a safety precaution due to the contrast used in the scans.
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.


Eligibility Criteria:
Key Inclusion Criteria:

* HCV RNA \> 15 IU/mL at screening
* HCV genotype 1 or 4
* Chronic HCV infection (≥ 6 months)
* Prior virologic failure after treatment with SOF in combination with simeprevir (SMV) ± RBV or with RBV ± pegylated interferon (PEG)
* Cirrhotic and non-cirrhotic as determined by standard methods
* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

* Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors
* Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF
* Pregnant or nursing female or male with pregnant female partner
* Coinfection with HIV or hepatitis B virus
* Current or prior history of clinical hepatic decompensation
* Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Linperlisib Combination With Camrelizumab in Patients With Solid Tumor

It is a single-arm, open-label, multicenter, phase I trial,aiming at exploring the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,observing the preliminary efficacy.

The trial can be divided into two parts: dose escalation part and dose expansion part.

Camrelizumab will be administrated intravenously in a predetermined fixed dose(200mgQ3w）in both parts.

In dose escalation part,Linperlisib will be administrated from 40mgQD,60mgQD to 80 mgQD in sequence with the classic "3+3" design.The purposes of this part are figuring out the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,and observing the PK characteristics of Linperlisib when using combination with Camrelizumab.

When finishing the dose escalation part,one combination dose of Linperlisib with Carelizumab will be selected to be studied on a wider scale of patients with advantage solid tumor in dose expansion part.Purposes of this part are further observing the PK characteristics of Linperlisib when using combination with Camrelizumab,while observing the preliminary efficacy of Linperlisib when using combination with Camrelizumab.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old≦age≦75 years old;
* Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors；
* Failure of previous standard treatment (sufficient prior treatment and no better treatment than participating in clinical research);
* Qualified basic organ function and body condition;
* The expected survival is greater than 3 months;
* Adequate washout period.

Exclusion Criteria:

* Prior allergy to study drug components;
* Chronic metabolic diseases that are poorly controlled by medication;
* Brain metastases, infection, hemorrhage, autoimmune disease or cardiovascular disease, whichever is in active state;
* Digestive tract diseases that affect absorption of studied drugs.
The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)

The objective of this study is to determine the difference in the annual incidence rate of uveitis attacks in participants with ankylosing spondylitis (AS) before start initial anti-TNF therapy and after treatment with golimumab (GLM).

This is an open-label, history-controlled, multi-site study of GLM in participants with AS. For evaluation of the primary study outcome measure, participants will serve as their own control. The period before start of treatment with an anti-tumor necrosis factor (TNF) agent will serve as historical control for the incidence of extra-articular manifestations, with a review of the medical records done for the previous 1-year period.

Each participant will participate in the study for approximately 12 months from the time the participant signs the Informed Consent Form through the final contact. After screening, two to four weeks before study start, each participant will be receiving study treatment for approximately 12 months, depending on the response to GLM after 3 months. All participants will be followed for a minimum of 12 months, irrespective of the duration of GLM treatment.

Eligibility Criteria:
Inclusion Criteria:

* May not have been treated with GLM prior to study enrollment
* Must be able to provide retrospective data concerning extra-articular manifestations and episodes with a recall period of at least 12 months prior to anti-TNF use
* Must have definite AS according to the modified New York criteria in the Netherlands
* Must be candidate for treatment with anti-TNF agent according to the Assessment of SpondyloArthritis International Society (ASAS) consensus
* Must be able to adhere to dose and visit schedules

Exclusion Criteria:

* Any exclusion criteria stated in the Summary of Product Characteristics for golimumab
* Use of any investigational biological or chemical agents within 30 days or 2 half-lives (whichever is longest) of screening
Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients

Phase II study to evaluate the clinical potential of 68GaNOTA-anti-MMR-VHH2 for in vivo imaging of Macrophage Mannose Receptor (MMR)-expressing Macrophages by means of Positron Emission Tomography (PET) in patients with non-small cell lung cancer (NSCLC) planned for surgical resection.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given informed consent
* Patients at least 18 years old
* Patient with local, locally advanced or metastatic disease of non-small cell lung cancer, who is planned for resection or surgical biopsy of at least one lesion. In order to minimise partial volume effect, the diameter of the tumour to be resected or biopsied should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions
* Patients who participated already in this study can be included if the subject meets all of the inclusion and none of the exclusion criteria at time of second inclusion.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
* Pregnant patients
* Breast feeding patients
* Patients with any serious active infection
* Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
* Patients who are unlikely to cooperate with the requirements of the study
* Patients who are unwilling and/or unable to give informed consent
* Patients at increased risk of death from a pre-existing concurrent illness