cyrilzakka/clinical-trials huggingface dataset:
High Intensity Interval Gait Training in Multiple Sclerosis

Over 90% of persons with MS (pwMS) complain of difficulty with walking. High intensity interval gait training (HIIGT), where persons alternate brief periods of walking at high speeds with periods of rest has been found to improve walking in other neurologic diagnoses. However its impact on pwMS is not known. Most gait training in MS is done continuously at a slower pace. The purpose of this study is to compare the effects of HIIGT to traditional Moderate Intensity Continuous Gait Training (MICGT) in pwMS.

Purpose: To determine whether pwMS will have greater improvements in gait with HIIGT as compared to MICGT.

Primary Question: Does HIIGT results in greater improvements in gait parameters in pwMS than MICGT? Secondary question: Will HIIGT result in greater improvements in balance, lower extremity strength, lower extremity range of motion and HR when compared to MICGT in pwMS?

Hypothesis: HIIGT will result in greater improvements in gait parameters in pwMS than MICGT.

Justification: Previous research has shown that MICGT, moderate intensity interval training and high intensity non-gait interval training is effective in pwMS. HIIGT has been shown to be effective in persons with stroke but the effects of HIIGT on pwMS are not known.

Outcomes and dissemination of information: We will present our findings at national conferences and submit manuscripts of our findings to the appropriate peer reviewed journal.

Eligibility Criteria:
Inclusion Criteria:

* Persons diagnosed with Multiple Sclerosis.
* The ability to walk for 6 minutes continuously with or without assistive device.
* The ability to read, understand and sign a consent form so that they are able to understand the study we are doing
* Above the age of 18

Exclusion Criteria:

* Any cardiopulmonary, orthopedic, or non-MS neurologic disease as we are only examining the effects of MS and need to rule out the impact of other conditions
* Report of a recent exacerbation. Rationale: the impact of the rationale can interfere with the impact of the independent variables
Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial studies intensity-modulated external beam radiation therapy in treating patients with prostate cancer.

PRIMARY OBJECTIVES:

I. To demonstrate that patients can safely receive IMRT teletherapy using the proposed IMRT fractionation schedule without experiencing a treatment limiting toxicity.

SECONDARY OBJECTIVES:

I. To assess treatment efficacy through the surrogate measures of PSA nadir and biochemical failure-free survival.

OUTLINE: Patients undergo hypofractionated intensity modulated radiotherapy once daily, 5 days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with intermediate- and high-risk disease may also receive concurrent and adjuvant or long-term androgen deprivation therapy for up to 36 months. After completion of study treatment, patients are followed at 4-6 weeks, every 4 months for 3 years, every 6 months for 2 years, and then annually until year 5.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven adenocarcinoma of the prostate are eligible for protocol enrollment when the following criteria are met; patients must have low, intermediate or high-risk adenocarcinoma of the prostate, as defined by the National Comprehensive Cancer Network (NCCN) criteria
* A diagnostic CT scan of the abdomen and pelvis will be obtained to rule out regional disease (maximum of 60 days prior to registration) for high-risk patients only
* A bone scan showing no evidence of metastatic disease is also required for patients whose prostate-specific antigen (PSA) is greater than 20 ng/ml, Gleason's sum is greater than 7, or T-stage is greater than T2b
* Alkaline phosphatase within 1.5 x upper limit of normal (ULN) is required for all patients beginning hormone therapy
* AST within 1.5 x ULN is required for all patients beginning hormone therapy
* Bilirubin within 1.5 x ULN is required for all patients beginning hormone therapy
* Karnofsky Performance score \>= 80
* Prior to registration, patients having received no more than three months treatment with anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two remain eligible for protocol treatment; the qualifying PSA for these patients will be the value recorded prior to the initiation of the hormone therapy

Exclusion Criteria:

* Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
* Patients with a history of cancer other than skin cancer within five years of the initiation of protocol treatment
* Patients with a history of pelvic irradiation for any reason
Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.

This is a randomized, double-blind, placebo-controlled, parallel group SAD study conducted at one study center. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.

Safety (i.e., adverse events \[AEs\], physical examinations, pulse oximetry, vital signs, orthostatic vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory tests, Columbia suicide severity rating scale \[C-SSRS\], and Mini-Mental State Examination \[MMSE\]) will be assessed throughout the study. Blood samples will be collected through 48 hours post-dose for the PK assessment of XC130-A10H and the metabolites.

Eligibility Criteria:
Major Inclusion Criteria:

* Healthy, adult, male or female of non-childbearing potential only, 18-75 years of age.
* Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
* Medically healthy with no clinically significant findings from medical history, physical examination, laboratory profiles, vital signs or ECGs.
* Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.

Major Exclusion Criteria:

* Mental or legal incapacitation or significant emotional problems either present at the time of the screening visit or expected during the conduct of the study.
* History or presence of clinically significant medical, surgical or psychiatric condition or disease.
* History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
* History of clinically significant hypotension.
* History of orthostatic hypotension in the 12 months prior to screening.
* Clinically significant hypertension at screening.
* History or presence of alcoholism within the 2 years prior to dosing or any history of drug abuse.
Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

In patients undergoing extracorporal circulation during cardiac operation, the hemoglobin is subjected to large changes. The purpose of this study is to see if it is possible with the help of volume kinetic techniques to use these variations to measure blood volume and fluid escape from the intravascular volume.

In many clinical situations, such as extensive surgery, it is of value to determine blood volume and rate of fluid loss from the intravascular space, since hypo- and hypervolemia are combined with increased morbidity and mortality. In this study we which to use the large variations in hemoglobin during extracorporal to calculate both these variables.

Hemoglobin is measured every 5 minutes during one hour beginning shortly before start of the heart-lung machine. When the extracorporal circulation begins the hemoglobin decreases due to the quick mix and dilution of the priming fluid from the heart-lung machine with the patients blood.

From the amount of priming fluid and the fall of the hemoglobin, the blood volume can be calculated. If no further fluid is given the next 20 to 30 minutes, the hemoglobin concentration will in most cases increase as a result of the fluid loss from the vascular space. This increase in combination with the diureses can be used to calculate the intravascular fluid loss to the interstitium during surgery.

Sodium concentration will also be measured in parallel with the hemoglobin concentration.

The Sodium concentrations in combination with given and excreted (urine)Sodium can be used in a mass balance to calculate if intracellular edema is induced.

Eligibility Criteria:
Inclusion Criteria:

* open heart surgery, with extracorporal circulation
* consent to participation
Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers

The most frequent side effects associated with Actimmune (interferon gamma 1b) therapy are the occurrence of 'flu-like symptoms' (FLS),which might include fever, chills, muscle aches, and tiredness. Earlier studies have demonstrated that these symptoms are common in healthy volunteers as well as in patients.

This study is designed to determine whether a titration of dosing reduces the frequency and severity of the FLS. A reported study with another interferon (interferon beta), demonstrated a reduction in the frequency and severity of the FLS when a titration of dosing was used. This study will compare the effects of the standard dose regimen with a titration regimen in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Ability to understand purpose \& risks
* BMI 18-32kg/m2
* Females on contraception

Exclusion Criteria:

* History of HIV,or pos test for HCV Ab,or HBsAg
* History of chronic fatigue syndrome or fibromyalgia
* Flu like illness within 1 month of start
* History of depression or other mood disorder
* History of malignant or pre-malignant disease
* History of severe allergic reactions
* Known allergy to Actimmune or its components
* History of major diseases
* Clinically Significant abnormal labs
* Pregnant or breastfeeding
* Clinically abnormal ECG
* History of alcohol or substance abuse
* Other study participation in last 4 weeks
* Serious infection within 3 months
* Use of Rx products within 4 weeks except contraceptives or dermatology products
* Vaccinations within 2 weeks
* Tobacco products ( with limitations)
* Cant/wont comply with study requirements
* Allergy shots within 1 month
* Blood donation with limitations
* Investigator discretion as to unsuitability
Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old

The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 49 years of age;
* In good health as determined by medical history and physical examination;
* Able and willing to provide written informed consent prior to any study procedure;
* Able to comply with all study procedures and available for all clinic visits scheduled in the study.

Exclusion Criteria:

* Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus
* History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);
* Known or suspected impairment/alteration of immune function
* Receipt of an influenza vaccine within 6 months prior to Visit 1;
* Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
* Laboratory-confirmed influenza disease within 6 months prior to Visit 1
Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations

This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Histological, cytological, or molecular confirmation of recurrent GBM or other glioma, circumscribed astrocytic glioma, or glioneuronalor neuronal tumors that has recurred.
* Radiographically measurable disease.

  . -Karnofsky performance status ≥ 60.
* Life expectancy ≥ 12 weeks.
* Documentation of an actionable FGFR1-3 gene mutation or fusion/rearrangement from tissue : FGFR1-3 fusions or other rearrangements (FGFR1-3 in-frame fusions, any FGFR2 rearrangement, or FGFR1/3 rearrangement with known partner) or a defined FGFR1-3 activating mutation or in-frame deletion. Only participants with FGFR fusions or rearrangements with an intact kinase domain are eligible.
* MRI-documented objective progression after prior therapy and must have no therapy available that is likely to provide clinical benefit.
* Most recent archival tumor specimen must be a tumor block or a minimum of 15 unstained slides from biopsy or resection of primary tumor or metastasis.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Prior receipt of an FGFR inhibitor.
* Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of study drug.
* Participants may have had treatment for an unlimited number of prior relapses but must not have had prior bevacizumab or other VEGF/VEGFR inhibitors (exception: prior bevacizumab is allowed if it was administered for the treatment of radiation necrosis rather than progressive tumor and was stopped at least 12 weeks prior to MRI showing tumor progression).
* Concurrent anticancer therapy
* Candidate for potentially curative surgery.
* Dexamethasone (or equivalent) \> 4 mg daily at the time of study registration
* Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
* Diffuse leptomeningeal disease.
* Radiation therapy administered within 12 weeks before enrollment/first dose of study drug.
* Known additional malignancy that is progressing or requires active systemic treatment.
Multicenter Study on the Role of Neurodegeneration Biomarkers in Obstructive Sleep Apnea Syndrome With Residual Excessive Daytime Sleepiness.

Excessive daytime sleepiness which still remains after an effective treatment with nocturnal ventilotherapy or with other specific treatments (positional therapy, oro-mandibular devices) in patients with obstructive sleep apnea syndrome has a prevalence of 55% of treated cases, representing a notable theme of clinical and research interest.

In recent years there have been several studies on the use of wakefulness-promoting drugs generally prescribed in patients with narcolepsy, in this disorder with promising results. Right in consideration of the forthcoming approval of these drugs, it is important to find biomarkers able to predict which patients will develop daytime sleepiness resistant to ventilatory treatment. Several studies have highlighted the association between obstructive sleep apnea syndrome and the increase of cerebral amyloid beta deposits, concluding that apnoic disorder can be considered a risk factor for the development of cognitive impairment and Alzheimer';s disease.

In this scenario, it would be useful to identify biological markers able to underline which clinical phenotypes of sleep apnea syndrome are more associated with residual excessive daytime sleepiness and/or cognitive impairment. In recent years several kits for the assay of biomarkers of neurodegeneration have been developed not only in CSF, but also in human serum. Among them, the most important are light chain neurofilaments (NFL), amyloid isoforms 40 and 42 (Ab40 and Ab42). Other biomarkers found in neurodegenerative diseases associated with excessive daytime sleepiness are orexin A (OXA) and histamine (HA).

In this view, the aim of this study is to evaluate the role of biomarkers of neurodegeneration in characterizing disease severity and response to treatment of obstructive sleep apnea syndrome with residual excessive daytime sleepiness.


Eligibility Criteria:
Inclusion Criteria:

* Mild or moderate-severe obstructive sleep apnea
* Written informed consent

Exclusion Criteria:

* Other sleep disorders
* Pregnancy or breastfeeding
* Cerebral diseases or neuropsychiatric deficits
* Psychiatric disorders
* Impossibility to provide informed consent
Effect of Vildagliptin in Type 2 Diabetes Treated With Sulphonylurea and Metformin

Dual combination therapy with metformin and sulphonylurea is the most commonly used combination regimen to treat patients with type 2 diabetes. But, treatment with the dual combination therapy is often unsuccessful at achieving glycaemic control in patients with type 2 diabetes. In this setting, use of insulin is often the next therapeutic step.

Recently, dipeptidyl peptidase (DPP)-IV inhibitor is increasingly being used in clinical practice. It is well established that DPP-IV inhibitor improve glycemic control in patients with type 2 diabetes.

But, there have been few studies about the glucose lowering effect of DPP-IV inhibitors (vildagliptin) in Type 2 diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin.The researchers hypothesized that DPP-IV inhibitor as add-on therapy to combination of a sulfonylurea agent and metformin have favorable glucose lowering effect in type 2 diabetic patients. The researchers plan to investigate the change in HbA1C and fasting glucose of 24 weeks treatment with vildagliptin (DPP-IV inhibitor) in combination with a sulfonylurea agent and metformin in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1c ≥ 7%
* Age ≥ 18

Exclusion Criteria:

* Contraindication to Vildagliptin
* Pregnant or breast feeding women
* Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
* Chronic hepatitis B or C (except healthy carrier of HBV)
* Liver disease (AST/ALT \> 3-fold the upper limit of normal)
* Renal failure (Cr \> 2.0)
* Cancer within 5 years
* Not appropriate for oral antidiabetic agent
* Medication which affect glycemic control
* Disease which affect efficacy and safety of drugs
* Other clinical trial within 30 days
The Role of MNS in Improving Motor Performance

Many studies have demonstrated the usefulness of repetitive task practice by using robotic devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR) has proved to be a valuable tool to improve neurorehabilitation training. Our pilot randomized clinical trial aimed at evaluating the correlation between the modifications of brain oscillations during a VR neurorehabilitative training of gait and the motor function recovery in patients with chronic stroke.

Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase were randomized into two groups. One group performed 40 sessions of Lokomat with VR (RAGT+VR) whereas the other group underwent Lokomat without VR (RAGT-VR). Outcomes (clinical, kinematic, and event-related synchronization, ERS, and desynchronization, ERD, at the EEG) were measured before and after the robotic intervention.

The robotic-based rehabilitation combined with VR could be associated with improvements in several measurements of lower limb function, gait, and balance in patient with chronic hemiparesis. Moreover, ERS/ERD analysis can be proposed as a tool to monitor motor performance and to develop non-invasive brain-computer interfaces controlling robotic devices.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥55 years
* A first-ever ischemic supra-tentorial stroke (confirmed by MRI scan) at least 6 months before their enrollment;
* An unilateral hemiparesis, with a Muscle Research Council -MCR- score ≤3
* Ability to follow verbal instructions, with a Mini-Mental State Examination (MMSE) \>24
* A mild to moderate spasticity according to a Modified Ashworth Scale (MAS) ≤2
* No severe bone or joint disease
* No history of concomitant neurodegenerative diseases or brain surgery.

Exclusion Criteria:

* Severe cognitive and behavioral impairments
* Severe osteoporosis and previous bone fractures