cyrilzakka/clinical-trials huggingface dataset:
The Novel Use of Treadmill Plus Music in MS Patients Gate Rehabilitation

Multiple sclerosis (MS) is characterized by demyelination andaxonal loss of the central nervous system, which progressively results in neurologic dysfunction and is often accompanied by gaite limitations, reduced fitness, and increased risk of falls. Traditional exercises such as treadmill walking orstationary cycling can often be perceived as boring, because theseexercises usually involve repetitive, continuous movements. In recents years the positive effect of the auditory stimulus in the recovery of gait difficulties has been demonstrated in Parkinson's disease, however this methodology on MS patients has been poorly investigated. In addiction the neurophysiological mechanisms by which coupling steps with external auditory cues improves gait remain partially unclear. For this reason, our purpose is to investigate whether patients with MS, compared to the control group, may have improvements in motor and psychological well-being, through training with devices that integrate motor training with musical stimuli (Gait trainer).

Although the number of studies and the extent of available evidence is greater in case of parkinsonism, there is also evidence of the effects of music-based interventions on supporting motor function and emotional well-being in people with multiple sclerosis. Interventions based on music can influence multiple functions. Recently it has been shown that coupling of auditory signals with motor training may be possible to form a rhythmic gait by dragging movement patterns, supporting the generation of better gait patterns; moreover, it can have effects on the rhythmic dragging; the commitment of automatic timing systems; movement planning, execution and learning; and an increase in motivation. Furthermore, this type of coupling has been shown to improve various gait parameters, including cadence, gait speed, stride length, gait time variability and pitch width.

The aim of our study is to evaluate the effectiveness of the treadmill training combined with RAS in terms of mobility, balance and gait parameters, patient's well-being.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of relapsing remitting MS according to Polman criteria;
* presence of gait impairment;
* absence of auditory deficits;
* EDSS \<4.5;
* absence of clinical and/or neuroradiological MS relapse in the 3 months before enrolment;
* stable therapy in the last 3 months.

Exclusion criteria:

* presence of bone or joint disorders;
* history of severe cardiovascular, respiratory, auditory, and muscular-skeletal disease;
* other neurological conditions; and neurologic music therapy in the last 3 month;
* MS relapse in the 6 months before enrolment;
* Expanded Disability Status Scale (EDSS) \> 4.5.
Looking At Triple Negative Breast Cancer Patient Experience Patterns in Medical Trials

Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in Triple Negative Breast Cancer clinical trials, as well as the reasons for withdrawal or discontinuation.

The insights gained from this study will ultimately benefit those with Triple Negative Breast Cancer who may be invited to participate in clinical research in the years to come.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria:

* Pregnant or lactating woman
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
* Inability to perform regular electronic reporting
GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS

The GRACE-2 study is a prospective, multi-center, double-blind, randomized controlled trial of the drug GM-CSF vs placebo in children with sepsis-induced multiple organ dysfunction syndrome (MODS) who have immunoparalysis with mild to moderate inflammation.

The GRACE-2 study is a is a prospective, multi-center, double-blind, randomized controlled trial of the drug GM-CSF vs placebo in children with sepsis-induced multiple organ dysfunction syndrome (MODS) who have immunoparalysis with mild to moderate inflammation. Eligible subjects will undergo centralized immunophenotyping on MODS Day 2. Those who are found to have immunoparalysis (a whole blood LPS-induced TNF-alpha production capacity \< 200 pg/ml) with mild to moderate inflammation (serum ferritin level \< 2000 ng/ml) will be randomized to receive intravenous (IV) GM-CSF at a dose of 125 mcg/m2/day x 7 days or placebo. The primary outcome variable is the cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD)-2 score. Secondary outcomes include measures of health-related quality of life and function status at 3 months from randomization.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 40 weeks corrected gestational age to \< 18 years; AND
* Admission to the PICU or CICU; AND
* Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-sepsis baseline) as measured by the modified Proulx criteria; AND
* Documented or suspected infection as the MODS inciting event.

Exclusion Criteria:

* Weight \<3kg; OR
* Limitation of care order at the time of screening; OR
* Patients at high likelihood of progression to brain death in opinion of the clinical team; OR
* Moribund condition in which the patient is unlikely to survive the next 48 hours in opinion of the clinical team; OR
* History of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia; OR
* Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; OR
* Peripheral white blood cell count \< 1,000 cells/mm3 as the result of myeloablative therapy OR receipt of myeloablative therapy within the previous 14 days; OR
* Known allergy to GM-CSF; OR
* Known pregnancy; OR
* Lactating females; OR
* Receipt of anakinra or GM-CSF within the previous 28 days; OR
* Resolution of MODS by MODS Day 2; OR
* Previous enrollment in the GRACE-2 study.
Detection of Tumor DNA in Blood Samples From Cancer Patients

The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. More generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Have metastatic disease with from a solid tumor (e.g. breast, lung, colon, pancreas, ovary, prostate...) or stage II or III solid tumors undergoing curative surgery or neoadjuvant therapy followed by surgery
* Starting treatment or a new line of treatment
* Able to understand and grant informed consent
* Able to have their blood drawn

Exclusion Criteria:

* Unable to grant informed consent or comply with all study procedures.
* Has a hematological malignancy, i.e. myeloma, lymphoma, MDS, leukemia
Intraoperative Analysis of Cortisol During Adrenal Vein Sampling

Aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and blood pressure. Primary hyperaldosteronism is one of the main endocrine causes of secondary hypertension. The overproduction of aldosteron might in some cases be due to unilateral hyperplasia of the adrenal cortex or a unilateral aldosterone-producing adenoma. In these cases the adrenal can be removed and the patient cured of hypertension. The clinical evaluation of patients with confirmed primary hyperaldosteronism therefore includes selective sampling of blood from the adrenal veins to determine lateralization of overproduction. This is executed as an interventional radiological procedure.

The adrenal vein sampling is challenging, and success is determined by measuring another adrenal hormone named cortisol in the blood samples as a marker of a correctly drawn sample. By routine laboratory assays the procedure is evaluated after the patient has been discharged from the hospital. In the study a rapid assay of cortisol will be evaluated, allowing the radiologist to draw new samples during the same procedure if the first set of samples is unsuccessful. The study hypothesis is that intraoperative measurement of cortisol is a useful tool to evaluate successful sampling, and that fewer patients will need a repeated procedure.


Eligibility Criteria:
Inclusion Criteria:

* Primary hyperaldosteronism
* Motivated for surgery if applicable
* Able to give informed consent

Exclusion Criteria:

* Not able to give informed consent
* Severe kidney failure
Lymphatic Drainage of the Breast, a Retrospective Assessment of Data

retrospective evaluation of patients, in whom blue colour was injected into different sites of the breast before breast reduction, to investigate direction and localisation of lymphatic flow. Investigations were performed at the Wilhelminenspital, Vienna, in the years 1998 to 2009.


Eligibility Criteria:
Inclusion Criteria: Patients, who understood and supported the aim of the study and signed the written consent -

Exclusion Criteria: language barriers, patients, who did not understand and support the aim of the study

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Inertial Sensors Used to Learn Manipulation

* Background Context: no studies have been identified to analyse the effect of real time feedback (using inertial sensors) on physiotherapy students learning the art of posterior-anterior thoracic manipulation (PATM).
* Purpose: to study the effect caused by real-time feedback on the learning process for PATM, comparing two undergraduate physiotherapy student groups. Hypothesis: significant differences will exist in the execution parameters of manipulation among students receiving real-time feedback versus those who do not.
* Study Design/Setting: longitudinal, pre-post intervention.
* Patient Sample: Sixty-one undergraduate physiotherapy students were divided randomly into two groups, G1 (n = 31) (group without feedback in real time) and G2 (n = 30) (group with real-time feedback).
* Outcome Measures: time, displacement and velocity and improvement (only between groups) to reach maximum peak, to reach minimum peak from maximum peak, total manipulation time.
* Methods: two groups of physiotherapy students learned PATM, one using a traditional method and the other using real-time feedback (inertial sensor). Measures were obtained pre- and post-intervention. Intragroup pre- and post-intervention and intergroup post-intervention scores were calculated. An analysis of the measures' stability was developed through an ICC (1,2).
* Results: the values of ICC ranged from 0.881 to 0.997. Statistically significant differences were found in all variables analysed (intra- and inter-group) in favour of G2.
* Conclusions: the learning process for posterior-anterior thoracic manipulation is facilitated when the student receives real-time feedback.


Eligibility Criteria:
Inclusion Criteria:

* Participants did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.

Exclusion Criteria:

* Refusal to participate in the study
A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described

The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.


Eligibility Criteria:
Inclusion Criteria:

* Men over the age of 18 years
* Histologically or cytologically confirmed adenocarcinoma CRPC defined by disease progression despite ADT and may present as a confirmed rise in serum PSA levels (as defined by PCWG3: Rising PSA values at a minimum of 1-week intervals, and a baseline PSA value ≥ 1.0 ng/mL). For patients with a prior ARi treatment (Enzalutamide or Apalutamide), there is no baseline PSA value required
* No evidence of metastasis based on conventional imaging. An imaging assessment needs to be obtained prior to the 1st dose of darolutamide. For patients with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC, M0 status with no evidence of disease progression should be confirmed within 3 months of ARi discontinuation
* Decision to initiate treatment with darolutamide was made as per investigator's routine treatment practice prior to enrollment in the study
* Signed informed consent
* Life expectancy of ≥3 months
* For a patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for less than one year, all toxic effects from prior use of any ARi treatment have to be resolved at the time of enrollment and prior to the 1st dose of darolutamide

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice
* Contraindications according to the local marketing authorization
* Previous treatment with darolutamide (more than 3 days prior to enrollment)
* Patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for more than one year
Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years old
2. Pathologically proven non-small cell lung cancer
3. Karnofsky performance status ≥ 40
4. LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI .
5. No severe abnormal liver and kidney function;
6. Patients have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Evidence of bleeding diathesis or serious infection
2. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
3. Pregnant or lactating women
Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain

Patients with endometriosis-associated pain have conservative surgery performed to remove all visible lesions. Then, patients are randomized into two groups. In the first group patients have depot medroxyprogesterone acetate injections every 3 months for a total of 6 months.In the second group patients have oral contraceptive combined pills everyday for 6 months. Patients are followed up on recurrence of pain for 1 year after medication.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women from 18 to 45 years of age with endometriosis-associated pain for at least 6 months who had conservative surgery performed.

Exclusion Criteria:

* Medical therapies for endometriosis other than NSAID within previous 6 months
* Contraindication to the drugs
* Wish to conceive
* Request for extirpative surgery
* Other pelvic pathology ( adenomyosis, chronic PID, submucous myoma uteri )
Base Curves of Bandage Contact Lenses and Their Effects on Post Trans-PRK Vision and Pain

The objective of this study was to investigate the impact of employing bandage contact lenses with a base curve of 8.4 mm versus 8.8 mm on visual recovery following Trans-PRK in patients characterized by steep corneas and high myopia.

Comparing two kind of bandage lenses in the contralateral eyes of the same individual following Trans-PRK may enable the derivation of reliable conclusions regarding the optimal choice for bandage lenses after Trans-PRK.

Eligibility Criteria:
Inclusion Criteria:

Spherical equivalent refractive error between -6.00 and -8.00 D in either eye.

Astigmatism of no more than 2.0 D in either eye.

Best spectacle-corrected visual acuity (BCVA) according to the logarithm of the Minimum angle of resolution (logMAR) scale of 0 or better in both eyes.

Willing and able to participate in all required activities of the study.

Exclusion Criteria:

Diabetes mellitus.

Systemic connective tissue disease.

Cardiovascular disease, epilepsy.

Eyelid abnormalities.

Corneal disease.

Glaucoma.

A history of ocular disease.

Noncompliance with measurement at enrollment.
A Study with ABL103 in Subjects with Advanced or Metastatic Solid Tumors

This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation study of ABL103 to evaluate the safety, tolerability, MTD (maximum tolerated dose) and/or RP2D (recommended phase 2 dose), pharmacokinetics, immunogenicity, preliminary antitumor activity of ABL103 in subjects with any progressive locally advanced(unresectable) or metastatic solid tumor who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 2 parts: a dose-escalation part and tumor-expansion part


Eligibility Criteria:
Inclusion Criteria:

* Subject must understand and be willing to provide informed consent and be able to comply with the study procedures and restrictions.
* Subject must be ≥18 years of age on the day of signing the informed consent form (ICF)
* Subject must have a histologically confirmed locally advanced unresectable, or metastatic solid tumor.
* Subject must be relapsed or be refractory to available standard therapy or they must be intolerant of available standard therapy.
* Subject must meet Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Subject must have an estimated life expectancy of at least 12 weeks.
* Subjects must be recovered from AEs from prior therapy to Grade 1 or the baseline grade more than 14 days prior to the first administration of the study drug, except alopecia or Grade 2 toxicities that are deemed stable or irreversible (eg, peripheral neuropathy)
* Subjects must have adequate hematologic, renal, hepatic, and thyroid functions confirmed based on the screening laboratory test within 7 days prior to the first administration of ABL103.

Exclusion Criteria:

* Subject has received prior anticancer monoclonal antibody treatment or investigational therapy within 28 days prior to the first administration of study drug.
* Subject has received prior chemotherapy or radiation therapy within 2 weeks or targeted small molecule therapy within 5 half-lives prior to the first administration of study drug.
* Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study drug administration.
* Subject has a history of drug-induced pneumonitis (interstitial lung disease) or currently has pneumonitis.
* Subject has risk factors for bowel obstruction or bowel perforation, including, but not limited to a history of acute diverticulitis, intra-abdominal abscess, and abdominal carcinomatosis.
* Subject discontinued from prior immunomodulatory therapy due to any intolerable immune-related adverse events (irAEs) requiring systemic steroid treatment.
* Subject has received prior treatment with anti-B7-H4 antibody and/or anti-4-1BB antibody.
A Phase II Study of AS1411 in Renal Cell Carcinoma

The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed renal cell carcinoma containing predominant clear cell histology
* Failed or intolerant to 1 or more previous lines of treatments (which must include a Tyrosine Kinase Inhibitor)

Exclusion Criteria:

* Collecting duct histology
* A history of bleeding disorders or currently taking oral vitamin K antagonise medication
* Unstable brain metastases
* History of prior or concomitant malignancy (except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years)
A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)

This study is designed to collect tissue samples from the biopsy specimen that was used to diagnose hepatosplenic T-cell lymphoma (HSTCL), additional patient information, and if possible, to obtain additional samples including a single blood sample, a buccal swab sample and/or a bowel tissue sample. Samples obtained will be stored by the sponsor for future testing. In addition, demographic and clinical patient information will be collected. The study will be conducted in North America. Patients eligible for enrollment include males or females with IBD of any age who have a confirmed diagnosis of HSTCL. Patients will be identified through the sponsor's adverse event reporting systems. Cases reported to the sponsor's Medical Information Center will be queried to ascertain if the reporter is interested in participating in the study. Where appropriate, cases may also be identified through the sponsor's new or on-going clinical trials and registries. Samples may be collected from living patients or from stored tissue of deceased patients. This study will not restrict or introduce any therapeutic interventions, including medications. All patients will continue to be managed by their personal physicians. No healthy subjects will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Inflammatory Bowel Disease with a confirmed diagnosis of Hepatosplenic T-cell Lymphoma
* Provide written informed consent (either by the patient or his/her legal representative). Consent from a legally acceptable representative of a deceased patient will be obtained for enrollment into the study and sample collection
* Be willing to provide a tumor biopsy sample for the study

Exclusion Criteria:

* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
* Is unable to provide critical clinical and/or demographic patient and/or sample information
Vitamin D Status and Bone Metabolism Status in Children With Congenital Epidermolysis Bullosa

This retrospective prospective study is aimed at studying the level of vitamin D supply and identifying markers of bone tissue remodeling in order to develop approaches to the prevention of osteopenia and osteoporosis in children with congenital epidermolysis bullosa.

This retrospective prospective interventional study will examine vitamin D availability and its relationship with clinical disease, patient gender and age, and season. The mechanisms of impairment of phosphorus-calcium metabolism and bone tissue metabolism will be analyzed on the basis of biochemical parameters and instrumental research methods in children with dystrophic epidermolysis bullosa in order to develop personalized approaches for correcting vitamin D status and bone metabolism disorders in children with epidermolysis bullosa, followed by an assessment of their clinical efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Verified diagnosis of epidermolysis bullosa;
* Signing by parents (legal representatives) of informed consent to participate in the study and fulfill the requirements of the study

Exclusion Criteria:

* not planned